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Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

Page Type
Product Code
Definition
This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.
Physical State
This device is supplied as a hydrogel filled capsule that is ingested orally.
Technical Method
This device occupies space in the stomach to promotes fullness to help patients manage and/or lose weight. The device passes from the body via the natural gastrointestinal tract.
Target Area
The device is ingested orally, transiently occupies space in the stomach, and passes from the body via the natural gastrointestinal tract.
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5982
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss

§ 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss.

(a) Identification. This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows:

(i) Performance bench testing in a simulated use model must evaluate device disintegration and device hydration state throughout the gastrointestinal tract;

(ii) Bioburden and moisture content assessments must evaluate device infection risk throughout the labeled shelf life; and

(iii) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life.

(3) Clinical performance testing must demonstrate the device performs as intended and evaluate the following:

(i) Weight change;

(ii) All adverse events, including obstruction, dilation, diarrhea, constipation, and dehydration; and

(iii) Interaction with representative medications.

(4) Physician and patient device labeling must state:

(i) The clinical benefit of the device as assessed by using percent total body weight loss;

(ii) Treatment must be offered in combination with diet and exercise;

(iii) Instructions on how to use the device as intended including how to avoid interaction with medication; and

(iv) The shelf life of the device.

[86 FR 70372, Dec. 10, 2021]

Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

Page Type
Product Code
Definition
This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.
Physical State
This device is supplied as a hydrogel filled capsule that is ingested orally.
Technical Method
This device occupies space in the stomach to promotes fullness to help patients manage and/or lose weight. The device passes from the body via the natural gastrointestinal tract.
Target Area
The device is ingested orally, transiently occupies space in the stomach, and passes from the body via the natural gastrointestinal tract.
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5982
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss

§ 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss.

(a) Identification. This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows:

(i) Performance bench testing in a simulated use model must evaluate device disintegration and device hydration state throughout the gastrointestinal tract;

(ii) Bioburden and moisture content assessments must evaluate device infection risk throughout the labeled shelf life; and

(iii) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life.

(3) Clinical performance testing must demonstrate the device performs as intended and evaluate the following:

(i) Weight change;

(ii) All adverse events, including obstruction, dilation, diarrhea, constipation, and dehydration; and

(iii) Interaction with representative medications.

(4) Physician and patient device labeling must state:

(i) The clinical benefit of the device as assessed by using percent total body weight loss;

(ii) Treatment must be offered in combination with diet and exercise;

(iii) Instructions on how to use the device as intended including how to avoid interaction with medication; and

(iv) The shelf life of the device.

[86 FR 70372, Dec. 10, 2021]