Classification

Number

Classification Name

Class

Identification

D.1100

Arterial blood

sampling kit

2

An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.

J.5780

Medical support

stocking

2

A medical support stocking is made from elastic materials. It is designed to apply appropriate pressure to the legs with gradually decreasing pressure from the ankle upwards. Its medical purpose is to prevent the accumulation of blood or interstitial fluid in the leg.

M.5844

Corrective spectacle lens

1, 2

A corrective spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections. The device may be modified to protect the eyes from bright sunlight (i.e., corrective sunglasses). Corrective sunglass lenses may be reflective, tinted, polarizing, or photosensitized. Products made with this corrective spectacle lens include corrective and protective sports goggles, such as swimmers’ goggles, ski goggles, racquetball eye guards, and diving goggles.

Among all, products that can modulate eye growth to slow down the progression of myopia or to reduce the degree of nearsightedness in children are regulated as class 2 devices. Other products are class 1 devices.

Classification

Number

Classification Name

Class

Identification

A.1355

Integrated continuous glucose monitoring system

2, 3

Integrated continuous glucose monitoring system (iCGM) is designed to continuously or frequently automatically measure glucose concentrations in body fluids over a specified period of time.

Devices that are only used for self-management by diabetes patients are regulated as class 2 devices.

Devices that connect measured data to automated insulin delivery systems for feedback and insulin dose adjustment are regulated as class 3 devices.

C.3045

In vitro diagnostic device for Bacillus spp. detection

2

An in vitro diagnostic device for Bacillus species (spp.) detection is a device used to detect and differentiate among Bacillus spp. and presumptively identify B. anthracis and other Bacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp.

This device may consist of Bacillus spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to presumptively identify bacillus-like organisms in clinical specimens; bacteriophage used for differentiating B. anthracis from other Bacillus spp. based on susceptibility to lysis by the phage; or antigens used to identify antibodies to B. anthracis (anti-toxin and anti-capsular) in serum. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, and gastrointestinal disease and non-gastrointestinal infections caused by B. cereus.

C.3955

Human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing technology

2

The HIV drug resistance assay using next generation sequencing (NGS) technology is an in vitro diagnostic medical device intended for use in detecting HIV genomic mutations that confer resistance to specific antiretroviral drugs. The device is intended to be used as an aid in monitoring and treating HIV infections.

D.1505

Ventilatory electrical impedance tomography

2

The Ventilatory electrical impedance tomography system for ventilation is a non-invasive, non-radioactive device used to assess local impedance changes in the cross-sectional area of a patient's chest.

H.1520

Gastrointestinal Lesion Software Detection System

2

The gastrointestinal lesion software detection system is a computer-assisted detection equipment used in conjunction with endoscopy to assist in the detection of gastrointestinal lesions.

This equipment includes software for image assistance and may also involve hardware for connecting to an endoscope.

I.4454

Non-absorbable, hemostatic gauze for temporary internal use

2

Non-absorbable, hemostatic gauze for temporary internal use are devices temporarily placed inside the body to control severe bleeding wounds, such as surgical incisions and traumatic injuries. This device may be coated or impregnated with hemostatic agents to enhance the hemostatic effect through physical means. Once the patient’s condition is stable, this device will be removed.

M.1100

Retinopathy detection software device

2

Retinopathy detection software device assesses ophthalmic images through algorithms to assist in the diagnosis or screening of retinal diseases or conditions.

O.0007

Wheelchair

positioning device

1

The wheelchair positioning device is a product designed for medical purposes that must be used in conjunction with a wheelchair. It is used to assist in stabilizing, posture correcting, or supporting individuals with neurological or musculoskeletal disorders to maintain their posture in a wheelchair.

These kinds of devices may include:

1. Wheelchair backrest with a contoured rigid base and soft padding.
2. Wheelchair positioning frame that is locked onto the wheelchair or backrest and has adjustable mechanical structures.
3. Wheelchair headrest system with adjustable support height, front-to-back position, and angle.
4. Devices fixed to the wheelchair, designed to provide pelvic, hip joint, and thigh support by conforming to the seat shape to prevent pelvic or thigh deformity due to abnormal muscle tension.

P.2060

Radiological Computer-assisted diagnostic software for lesions suspicious of cancer

2

Radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images (such as magnetic resonance imaging, mammography, radiography, or computed tomography).

This device characterizes lesions based on features or information extracted from the images and provides information about the lesions to the user and assist clinical professionals in making diagnoses and disease management decisions.

P.2070

Radiological Medical image analyzer

2

Radiological medical image analyzers include computer-assisted/aided detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, and radiograph lung nodules.

The device is intended to identify, mark, highlight, or in any other manner direct the clinical physicians’ attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinical physicians. Such device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. The device is not intended to replace the judgment of qualified physicians and is not intended to be used for triage or to recommend diagnosis.

P.2080

Radiological computer aided triage and notification software

2

The radiological computer-aided triage and notification software is an image processing software intended to aid in prioritization and triage of radiological medical images. This software analyzes the images to facilitate triage and notifications, expediting clinical physician interpretation of time sensitive radiological medical images.

The software does not mark, highlight, or direct the users’ attention to a specific location in the original images. The software does not remove cases from a reading queue. This software operates by default in conjunction with standard clinical procedures in all situations.