BIONECT® Hydrogel Foam is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns.

Device Description

BIONECT® Hydrogel Foam is a white foam that is prepared from sodium hyaluronate and purified water to form a hydrogel dressing. BIONECT® Hydrogel Foam, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for BIONECT® Hydrogel Foam and does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (BIONECT® Hydrogel) by comparing technological characteristics, intended use, and providing a summary of prior biocompatibility testing and clinical experience.

Here's a breakdown of what is and is not in the document, based on your request:

What IS in the document:

BIONECT® Hydrogel Foam Device Description: It's a white foam prepared from sodium hyaluronate and purified water, designed to provide a soothing, moist environment for wound healing.
Intended Use: Dressing and management of partial to full thickness dermal ulcers, various wounds (cuts, abrasions, donor sites, post-operative incisions), skin irritations, and first and second-degree burns.
Predicate Device: BIONECT® Hydrogel.
Biocompatibility Testing: In vitro and in vivo testing (cytotoxicity, dermal irritation, dermal sensitization) was performed on the bulk solution in accordance with FDA recommendations (ISO-10993). These tests supported safe use. This is a type of performance data, but not framed as meeting specific numerical acceptance criteria.
Clinical Experience (for predicate device/similar products): "Clinical experience with BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads in 22 clinical trials (17 controlled) conducted in Europe in patients with various types of ulcers, burns, and surgical wounds indicates that BIONECT® Hydrogel Foam is safe for its intended use." This is a statement of safety based on past clinical use, but lacks specific statistical performance metrics for the proposed device.
FDA Clearance: The FDA found the device substantially equivalent to a legally marketed predicate device, with specific limitations on labeling (e.g., not for third-degree burns, no claims of accelerating wound healing).

What IS NOT (or not sufficiently) in the document to fulfill your request:

A table of acceptance criteria and the reported device performance: No specific, quantifiable acceptance criteria (e.g., "must demonstrate a 90% wound closure rate by X weeks") are listed, nor are numerical performance results against such criteria. The document relies on substantial equivalence and a general statement of safety from prior clinical experience.
Sample size used for the test set and the data provenance: The document mentions "22 clinical trials (17 controlled) conducted in Europe" for related products (BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads). This is a general reference to support safety for the intended use of the new foam, not a specific "test set" for the foam itself with detailed provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there isn't a described "test set" with ground truth established by experts in the context of device performance metrics.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not applicable, as this device is not an imaging or diagnostic AI device. The document describes a medical dressing.
If a standalone performance study was done: The biocompatibility tests are standalone performance tests for material safety, but not for its clinical efficacy in wound healing against specific benchmarks. The clinical experience refers to related products.
The type of ground truth used: Not applicable in the context of quantitative performance ground truth, but implicitly, "safety for its intended use" from clinical trials would have relied on physician assessments of patient outcomes.
The sample size for the training set: Not applicable, as this is a medical device (hydrogel foam), not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided submission (K973722) for BIONECT® Hydrogel Foam focuses on demonstrating substantial equivalence to a predicate device and relies on prior biocompatibility testing and general clinical experience with similar hydrogel products to assert its safety and intended use, rather than presenting a study with specific, quantifiable acceptance criteria and performance data for the device itself.

Summary

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K973722

Image /page/0/Picture/1 description: The image shows a date, "SEP 2 2 1998". The month is September, and the day is the 2nd. The year is 1998. The text is in a bold, sans-serif font.

510(k) Premarket Notification K973722 BIONECT® Hydrogel Foam Amendment No. 3 11

July 9, 1998

fidia Pharmaceutical Corporation

10. 510(k) SUMMARY

Summary Information 10.1

10.1.1 Submitter's name and address

FIDIA Pharmaceutical Corporation 2000 K Street, NW, Suite 700 Washington, DC 20006

Contact person and telephone number:

Roberto Fiorentini, M.D., President Telephone: (202) 371-9898 (202) 371-1666 Telefax:

Date summary was prepared:

July 9, 1998

10.1.2 Name of the Device

Trade Name:	BIONECT® Hydrogel Foam
Common Name:	Hyaluronic acid sodium salt hydrogel dressing
Classification Name:	Hydrogel Wound and Burn Dressing

10.1.3 Identification of predicate device to which substantial equivalence is being claimed

BIONECT® Hydrogel Foam is substantially equivalent in function and intended use to the following cleared non-interactive wound and burn dressing: BIONECT® Hydrogel.

10.1.4 Device description

Explanation of how the device functions: BIONECT® Hydrogel Foam, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

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fidia Pharmaceutical Corporation

July 9, 1998

Basic scientific concepts that form the basis for the device: BIONECT® Hydrogel Foam, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: BIONECT® Hydrogel Foam is a white foam that is prepared from sodium hyaluronate and purified water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharide biopolymer that can increase the viscosity of the gel. BIONECT® Hydrogel Foam, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

10.1.5 Statement of the intended use of the device, including general description of the conditions the device will mitigate and the patient population for which the device is intended

These indication statements are not substantially different from the predicate device identified in Section 10.1.3.

10.1.6 Statement of how the technological characteristics of the device compare to those of the predicate device

The technological characteristics of the device such as occlusion, bioburden level, and moist wound healing are not different from the predicate device cited.

10.2 Assessment of performance data

In vitro and in viyo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization tests) has been performed on the bulk solution that impregnates BIONECT® Hydrogel Foam in accordance with FDA recommendations.5 These tests all support the safe use of BIONECT® Hydrogel Foam as a hydrogel temporary dressing in contact with breached or compromised skin.

5 Office of Device Evaluation General Program Memorandum #695-1, International Standard ISO-10993, "Biological Evaluation of Medical Devices part 1: Evaluation and Testing," dated 1 May 1995.

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510(k) Premarket Notification K973722 BIONECT® Hydrogel Foam Amendment No. 3

fidia Pharmaceutical Corporation

...

July 9, 1998

Clinical experience with BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads in 22 clinical trials (17 controlled) conducted in Europe in patients with various types of ulcers, burns, and surgical wounds indicates that BIONECT® Hydrogel Foam is safe for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1998

Roberto Fiorentini, M.D. President Fidia Pharmaceutical Corporation 2000 K Street, N.W., Suite 700 Washington, D.C. 20006

K973721. K973722. K973724 and K973725 Re: Trade Name: Bionect Hydrogel Gauze Pads, Bionect Hydrogel Foam Bionect Hyrdogel Spray and Bionect Clear Hydrogel Regulatory Class: Unclassified Product Code: MGQ Dated: July 1 and July 8, 1998 Received: July 1 and July 9, 1998

Dear Dr. Fiorentini:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market your devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

1. These devices may not be labeled for use on third degree burns.
1. These devices may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
1. These devices may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
These devices may not be labeled as a treatment or a cure for any type of 4. wound.

The labeling claims listed above would be considered a major modification in the intended use of the devices and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Roberto Fiorentini. M.D.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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510(k) Premarket Notification K973722 BIONECT® Hydrogel Foam Amendment No. 3

fidia Pharmaceutical Corporation

July 9, 1998

2. INDICATIONS FOR USE

510(k) Number (if known): K973722

Device Name: Indications for Use: BIONECT® Hydrogel Foam

Prescription

sion Sign Off)
ision of General Restorative Devices
(k) Number K978222

Prescription Use (Per 21 CFR 801.109)

Regulation Number and Section

N/A