(357 days)
Not Found
Not Found
No
The summary describes a hydrogel foam wound dressing and does not mention any AI or ML capabilities.
Yes
The device is indicated for the dressing and management of various skin conditions like ulcers, wounds, and burns, which are therapeutic applications.
No
Explanation: The device, BIONECT® Hydrogel Foam, is described as a hydrogel dressing for wound management and healing, not for diagnosing conditions. Its intended use is therapeutic, providing a moist environment for healing, and there is no mention of diagnostic capabilities, imaging, AI, or analysis of medical data.
No
The device description clearly states it is a "white foam" prepared from physical materials, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a dressing for managing various types of wounds and skin irritations. This is a topical application for direct contact with the body, not for testing samples taken from the body.
- Device Description: The device is described as a hydrogel foam dressing. This is a physical barrier and wound healing aid, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or the use of reagents for in vitro analysis.
- Performance Studies: The performance studies focus on biocompatibility and clinical experience with wound healing, which are relevant to a topical medical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly interact with and support the healing of wounds on the skin.
N/A
Intended Use / Indications for Use
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.
Product codes
MGQ
Device Description
BIONECT® Hydrogel Foam, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro and in vivo 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. These tests all support the safe use of BIONECT® Hydrogel Foam as a hydrogel temporary dressing in contact with breached or compromised skin.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BIONECT® Hydrogel
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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.
1
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
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.
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.
2
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.
3
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:
-
- These devices may not be labeled for use on third degree burns.
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- These devices may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
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- 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.
4
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
5
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
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.
Prescription
sion Sign Off)
ision of General Restorative Devices
(k) Number K978222
Prescription Use (Per 21 CFR 801.109)