(357 days)
Not Found
Not Found
No
The summary describes a hydrogel dressing and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the dressing and management of various types of wounds, including ulcers and burns, which are therapeutic applications aimed at promoting healing and providing a moist environment for recovery.
No
The device, BIONECT® Hydrogel Spray, is described as a hydrogel dressing that provides a soothing, moist environment supportive to wound healing. Its intended use is for dressing and managing ulcers, wounds, irritations, and burns. This indicates a therapeutic or supportive role in wound care, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions.
No
The device description clearly states it is a hydrogel spray, which is a physical substance applied to wounds, indicating it is a hardware/physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that BIONECT® Hydrogel Spray is for the "dressing and management of partial to full thickness dermal ulcers, wounds, irritations of the skin, and first and second degree burns." This describes a topical application for wound care and skin treatment.
- Device Description: The description details a "hydrogel dressing" made from sodium hyaluronate and purified water. This is a physical dressing applied to the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition. IVDs are designed for diagnostic purposes, not for direct treatment or wound management.
The information provided aligns with a medical device used for wound care and skin treatment, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
BIONECT® Hydrogel Spray is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis 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
MGO
Device Description
BIONECT® Hydrogel Spray, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing. BIONECT® Hydrogel is a clear, colorless, aqueous solution 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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
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 Spray in accordance with FDA recommendations. These tests all support the safe use of BIONECT® Hydrogel Spray as a hydrogel temporary dressing in contact with breached or compromised skin.
Clinical experience with BIONECT® Hydrogel Spray in approximately 45 patients with various types of ulcers and surgical wounds in 2 clinical trials (1 controlled), all conducted in Europe, indicates that BIONECT® Hydrogel Spray is safe for its intended use.
Key Metrics
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
SEP 2 2 1998
510(k) Premarket Notification K973724 BIONECT® Hydrogel Spray Amendment No. 3
fidia Pharmaceutical Corporation
July 1, 1998
10. 510(k) SUMMARY
10.1 Summary Information
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 Telefax: (202) 371-1666
Date summary was prepared:
July 1, 1998
10.1.2 Name of the Device
| Trade Name: | BIONECT® Hydrogel Spray |
|---|---|
| Common Name: | Hyaluronic acid sodium salt hydrogel dressing spray |
| Classification Name: | Hydrogel Wound and Burn Dressing |
10.1.3 Identification of predicate device to which substantial equivalence is being claimed
BIONECT® Hydrogel Spray 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 Spray, 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 1, 1998
Basic scientific concepts that form the basis for the device: BIONECT® Hydrogel Spray, 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 is a clear, colorless, aqueous solution 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 Spray, 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 Spray is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis 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.
Assessment of performance data 10.2
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 Spray in accordance with FDA recommendations.6 These tests all support the safe use of BIONECT® Hydrogel Spray as a hydrogel temporary dressing in contact with breached or compromised skin.
6 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 K973724 BIONECT® Hydrogel Spray Amendment No. 3
fidia Pharmaceutical Corporation
July 1, 1998
Clinical experience with BIONECT® Hydrogel Spray in approximately 45 patients with various types of ulcers and surgical wounds in 2 clinical trials (1 controlled), all conducted in Europe, indicates that BIONECT® Hydrogel Spray 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 features a stylized eagle with three stripes forming its body and wings. The eagle is facing right and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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
Re: K973721, K973722, K973724 and K973725 Trade Name: Bionect Hydrogel Gauze Pads, Bionect Hydrogel Foam Bionect Hyrdogel Spray and Bionect Clear Hydrogel Regulatory Class: Unclassified Product Code: MGO 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.
-
- 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 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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures _________________
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fidia Pharmaceutical Corporation
July 1, 1998
2. INDICATIONS FOR USE
510(k) Number (if known): K973724
Device Name: Indications for Use: BIONECT® Hydrogel Spray ~
BIONECT® Hydrogel Spray 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.
Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K973724
R 801.109)
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