(85 days)
BIONECT® Hydrogel Foam provides a moist wound environment that is supportive to wound healing. It indicated for the dressing and management of minor burns; superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. BIONECT® Hydrogel Foam may also be used under the care of a health care professional for wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-opcrative incisions and donor sites), and second degree burns.
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.
The provided document is a 510(k) summary for the BIONECT® Hydrogel Foam and related products. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a novel AI diagnostic device might.
Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test sets, expert qualifications, MRMC studies, ground truth types) are not applicable or not explicitly stated in this type of submission.
However, I can extract information related to performance assessment and "acceptance criteria" as implied by the FDA's review process for substantial equivalence.
Here's a breakdown of the relevant information:
Acceptance Criteria and Reported Device Performance
Note: The "acceptance criteria" here are implied by the FDA's standard for substantial equivalence for this type of medical device (wound dressing), which primarily focuses on safety and efficacy being equivalent to a legally marketed predicate device. Specific quantitative thresholds (e.g., sensitivity, specificity) common in diagnostic device studies are not present.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility: | In vitro and in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization tests) was performed on BIONECT® Hydrogel Foam. |
| - Cytotoxicity | Studies performed. |
| - Dermal Irritation | Studies performed. |
| - Dermal Sensitization | Studies performed. |
| Safety for Intended Use: | Clinical experience with predicate devices (BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads) in 22 European clinical trials (17 controlled) involving various types of ulcers, burns, and surgical wounds indicates that BIONECT® Hydrogel Foam is safe for its intended use. |
| Functional Equivalence: | BIONECT® Hydrogel Foam provides a moist wound environment supportive to wound healing, similar to the predicate device. Technological characteristics such as form, occlusion, conformability, bioburden level, moist wound healing, and appearance when hydrated are not different from the predicate device. |
| Intended Use Equivalence: | The indication statements for BIONECT® Hydrogel Foam are not different from the predicate device: dressing and management of minor burns; superficial cuts, lacerations, and abrasions; minor irritations of the skin; and under professional care for partial to full thickness dermal ulcers, surgical wounds, and second-degree burns. |
Study Details
-
Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for the BIONECT® Hydrogel Foam directly. The document refers to "22 clinical trials (17 controlled) conducted in Europe" with the predicate devices (BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads). The number of patients in these trials is not specified.
- Data provenance: Europe (for the clinical trials on predicate devices). The data for biocompatibility testing is not specified in terms of origin, but it is implied to be laboratory testing. The submission itself is dated February 1, 1999, making it retrospective relative to the submission date.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For this type of device (wound dressing) and submission (510(k) for substantial equivalence), ground truth is not typically established by expert consensus on specific cases in the same way as for an AI diagnostic algorithm. The safety and efficacy data from clinical trials on predicate devices serve as the basis for comparison.
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Adjudication method for the test set: Not applicable. There is no mention of adjudication for a test set in the context of this 510(k) submission.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI assistance on human reader performance, which is not relevant for a wound dressing submission focused on substantial equivalence.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, a standalone algorithm performance study was not done. This device is a physical wound dressing, not an algorithm.
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The type of ground truth used:
- For biocompatibility: Laboratory test results (cytotoxicity, dermal irritation, dermal sensitization).
- For safety/efficacy (by inference from predicate): Clinical outcomes from human patients with various wound types (ulcers, burns, surgical wounds) treated with the predicate devices. This would involve standard clinical assessments, which would serve as the "ground truth" for the predicate's performance.
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The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI algorithm, so there is no training set in the machine learning sense. Clinical experience with predicate devices serves as the basis for demonstrating similarity.
-
How the ground truth for the training set was established: Not applicable, as there is no training set.
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る202 833 7057 13:00
02/01/99
fidia Pharmacoutical Corporation
February 1, 1999
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) 371-1325 (202) 371-1666 Telefax:
Date summary was prepared:
February 1, 1999
10.1.2 Name of the Device
Trade Name: Common Name: Classification Name:
BIONECT® Hydrogel Foam Hyaluronic acid sodium salt hydrogel dressing Hydrogel Wound and Burn Dressing
2031
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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: Since it is a hydrogel, BIONECT" Hydrogel Foam provides a moist wound environment that is supportive to wound healing.
Basic scientific concepts that form the basis for the device: BIONECT Hydrogel Foam was designed to provide 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 provides a moist wound environment that is supportive to wound healing. It indicated for the dressing and management of minor burns; superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care
8
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1012 Pharmaceutical Corporation
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 provides a moist wound environment that is supportive to wound healing. It indicated for the dressing and management of minor burns; superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. BIONECT® Hydrogel Foam may also be used under the care of a health care professional for wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-opcrative incisions and donor sites), and second degree burns,
These indication statements are not different from the predicate device identified in paragraph (3) of this section.
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 form, occlusion, conformability, bioburden level, moist wound healing, and appearance in the wound when hydrated are not different from the predicate device cited.
10.2 Assessment of performance data
In vitro and in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization tests) has been performed on BIONECT® Hydrogel Foam settled foam in
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a Pharmaceutical Corporation
210
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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Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
FEB 10 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Roberto Fiorentini President Fidia Pharmaceutical Corp. 2000 K Street, N.W. - Suite 700 Washington, D.C. 20006
Re: K984262-BIONECT Hydrogel Gauze Pads K984264-BIONECT Clear Hydrogel K984266-BIONECT Hydrogel Spray K984267-BIONECT Hydrogel Foam K984413-BIONECT Hydrogel Regulatory Class: Unclassified Product Code: MGQ Dated: November 17, 1998 Received: November 17, 1998
Dear Mr. Fiorentini:
We have reviewed your Section 510(k) notifications 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 enclosure) 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. 1.
- These devices may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
-
- 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. 4.
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).
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Page 2 - Mr. Roberto Fiorentini
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.
If vour devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it 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 submissions 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 notifications. 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 tollfree 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
Enclosure
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-HX NU. : L7R7CC+1C
112 Pharmaceutical Corporation
February 1, 1999
INDICATIONS FOR USE 2.
510(k) Number (if known): K984413 (Previously K963004) K984262 (Previously K973721) K984267 (Previously K973722) K984266 (Previously K973725) K984264 (Previously K973725)
Devicc Name:
BIONECT® Hydrogel BIONECT® Hydrogel Gauze Pads BIONECT® Hydrogel Foam BIONECT® Hydrogel Spray BIONECT® Clear Hydrogel
Indications for Use:
BIONECT Hydrogel, Gauze Pads, Foam, Spray, and Clear Hydrogel are indicated for the dressing and management of minor burns: superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of these products to determine whether these conditions exist. BIONECT Hydrogel, Gauze Pads, Foam, Spray, and Clear Hydrogel may also be used under the care of a health care professional for wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), and second degree burns.
PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTUNUE. ON ANOTHER PAGE IF NEIJDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Ol
Prescription Use (Per 21 CRF 801.109)
Over-the-Counter Use X
piollefo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K984262, K984264, K984266,
K984267, K984413
2
N/A