(357 days)
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.
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.
This document, K973724, is a 510(k) Premarket Notification for BIONECT® Hydrogel Spray. It describes the device, its intended use, and claims substantial equivalence to a predicate device, BIONECT® Hydrogel.
Here's an analysis of the provided information concerning acceptance criteria, clinical studies, and data provenance:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the typical sense of a medical device's performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance for BIONECT® Hydrogel Spray appears to be based on:
- Substantial Equivalence: To the predicate device, BIONECT® Hydrogel. This implies that if the predicate device is considered safe and effective, and the new device is substantially equivalent in function, intended use, and technological characteristics, it will also be considered safe and effective.
- Biocompatibility: Showing that the device is not harmful when in contact with the body.
- Safety in Clinical Use: Demonstrating safety in human subjects for its intended use.
| Acceptance Criteria Category | Stated Performance / Evidence |
|---|---|
| Substantial Equivalence (to BIONECT® Hydrogel) | Claimed for function, intended use, and technological characteristics (occlusion, bioburden level, moist wound healing). |
| Biocompatibility | Performed in vitro and in vivo studies (cytotoxicity, dermal irritation, dermal sensitization) on the bulk solution, in accordance with FDA recommendations (ISO-10993). All tests "support the safe use." |
| Clinical Safety | Clinical experience in approximately 45 patients with various ulcers and surgical wounds in 2 clinical trials (1 controlled), conducted in Europe, "indicates that BIONECT® Hydrogel Spray is safe for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "approximately 45 patients" were included in the clinical trials.
- Data Provenance:
- Country of Origin: "all conducted in Europe."
- Retrospective or Prospective: Not explicitly stated as retrospective or prospective, but clinical trials are generally prospective studies. Given the context of seeking premarket notification, these would typically be designed as prospective studies to gather safety and efficacy data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally relevant for AI/CAD device submissions where expert consensus or adjudication is needed to define "ground truth" for image interpretation or diagnosis.
For a hydrogel wound dressing like BIONECT® Hydrogel Spray, the "ground truth" for safety and effectiveness is established through standard medical assessments of wound healing progress, adverse events, etc., conducted by treating physicians and medical staff. The document does not specify a number of experts or their qualifications for establishing ground truth in the clinical trials, as this is typically inherent in the conduct of clinical investigations by medical professionals.
4. Adjudication Method for the Test Set
Again, adjudication methods like 2+1 or 3+1 are primarily used in AI/CAD studies where there's a need to resolve discrepancies in expert interpretation of data (e.g., medical images).
For a wound dressing study, clinical outcomes are assessed by the treating physicians and investigators. There is no mention of an explicit adjudication method for the clinical trial results in this document. Any disputes or differing opinions on patient outcomes would typically be resolved through standard clinical practice and protocol adherence, rather than a formal expert adjudication panel as seen in AI studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating human reader performance, especially with or without an AI assist, in interpreting medical images or data. BIONECT® Hydrogel Spray is a wound dressing, not an imaging or diagnostic device. Therefore, no MRMC comparative effectiveness study was done or would be applicable for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This concept is applicable to AI/CAD algorithms that provide automated analysis. BIONECT® Hydrogel Spray is a physical medical device (a hydrogel dressing), not an algorithm. Therefore, no standalone performance assessment (in the context of an algorithm) was done.
7. The Type of Ground Truth Used
For the clinical trials, the "ground truth" for the device's safety and effectiveness would be based on:
- Clinical Outcomes Data: This includes observations of wound healing progression (e.g., reduction in wound size, epithelization), resolution of skin irritations, absence of infection, and reporting of adverse events. These are assessed by clinicians following established clinical protocols.
- Patient Feedback: (Implicitly) regarding comfort, pain, and other subjective experiences.
8. The Sample Size for the Training Set
There is no mention of a "training set" as this term is specific to machine learning and AI model development. This device is a hydrogel dressing, not an AI product.
9. How the Ground Truth for the Training Set Was Established
Since there is no AI component or "training set," this question is not applicable. The ground truth for the clinical studies (for safety and function) was established through direct clinical observation and assessment by medical professionals in the context of the clinical trials.
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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:
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- 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.
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- 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)
8
N/A