(85 days)
BIONECT® Clear Hydrogel 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 Clear Hydrogel may also be used under the care of a health care professional for wounds such as partial to full thickness dermal uicers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), and second degree burns.
BIONECT® Clear Hydrogel is a clear, colorless, hydrogel 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® Clear Hydrogel, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.
The provided text describes the 510(k) summary for BIONECT® Clear Hydrogel and related devices. However, it does not contain a study report with specific acceptance criteria and detailed performance results in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and safety data.
Here's a breakdown of the information available and what is not present:
A. Acceptance Criteria and Device Performance Table:
| Criteria/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Safe for use as a hydrogel temporary dressing in contact with breached or compromised skin (implied by "support the safe use") | Passed in vitro and in vivo tests (cytotoxicity, dermal irritation, dermal sensitization) in accordance with FDA recommendations. Clinical experience in 22 trials (17 controlled) in Europe supports safety. |
| Technological Characteristics (vs. Predicate) | Not different from the predicate device | Form, occlusion, conformability, moisture level, moist wound healing enhancement, and appearance when hydrated are not different from the predicate device (BIONECT® Hydrogel). |
| Intended Use | Provides a moist wound environment supportive to wound healing | Serves as a dressing and management for minor burns; superficial cuts, lacerations, and abrasions; minor irritations of the skin. Can also be used under professional care for partial to full thickness dermal ulcers, surgical wounds, and second-degree burns. |
B. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of the requested performance study. The document mentions "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." The specific number of patients across these trials is not provided.
- Data Provenance: Europe (clinical trials). The data is described as "clinical experience," which implies retrospective analysis of previously conducted trials, though it doesn't explicitly state "retrospective" or "prospective." Given the timeframe (1999 submission), it's highly likely this refers to data already collected.
C. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document refers to "clinical experience" and "health care professionals" for indications but does not detail how ground truth was established for the clinical trials.
D. Adjudication method for the test set:
- This information is not provided in the document.
E. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable and not provided. The device is a hydrogel dressing, not an AI-powered diagnostic or assistive tool for human readers.
F. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- This information is not applicable and not provided. The device is a medical product, not an algorithm.
G. The type of ground truth used:
- For the biocompatibility tests: Laboratory test results (cytotoxicity, dermal irritation, dermal sensitization).
- For the clinical experience: Implied clinical outcomes and observations by healthcare professionals in Europe. The document doesn't specify if this involved pathology, objective outcome measures, or expert consensus as a formal "ground truth" definition in the context of a modern AI study.
H. The sample size for the training set:
- This information is not applicable and not provided. The device is not an AI model that requires a "training set."
I. How the ground truth for the training set was established:
- This information is not applicable and not provided.
Summary of Missing Information:
The provided document is a 510(k) summary for a medical device (hydrogel dressing), not the report of a study designed to evaluate an AI algorithm's performance against specific acceptance criteria. Therefore, many of the requested details related to sample sizes for training/test sets, expert adjudication, MRMC studies, and AI-specific ground truth establishment are not present because they are not relevant to this type of medical device submission. The performance assessment primarily relies on biocompatibility testing and existing clinical experience with similar products to demonstrate safety and substantial equivalence.
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公202 833 7057 13:07 02/01/99
2/10/99
fidia Pharmaceutical Corporation
February 1, 1999
...
Clear H
@055
510(k) SUMMARY 10.
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) 371-1325 Telefax: (202) 371-1666
Date summary was prepared:
February 1, 1999
10.1.2 Name of the Device
| Trade Name: | BIONECT® Clear Hydrogel |
|---|---|
| Common Name: | Hyaluronic acid sodium salt hydrogel dressing |
| Classification Name: | Hydrogel Wound and Burn Dressing |
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fidia Pharmaceutical Corporation
10.1.3 Identification of predicate device to which substantial equivalence is being claimed
BIONECT® Clear Hydrogel 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® Clear Hydrogel provides a moist wound environment that is supportive to wound healing.
Basic scientific concepts that form the basis for the device: BIONECT® Clear Hydrogel 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® Clear Hydrogel is a clear, colorless, hydrogel 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® Clear Hydrogel, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.
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510(k) Premarket Notification
K984264 (Previously K973725)
BIONECT® Clear Hydrogel
fidia Pharmaceutical Corporation
February 1, 1999
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® Clear Hydrogel 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 Clear Hydrogel may also be used under the care of a health care professional for wounds such as partial to full thickness dermal uicers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative 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, highurden level. moist wound healing, and appearance in the wound when hydrated are not different from the predicate device cited.
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fidia Pharmaceutical Corporation
February 1, 1999
evinnely KQ
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® Clear Hydrogel in accordance with FDA recommendations. These tests all support the safe use of BIONECT® Clear Hydrogel 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® Clear Hydrogel is safe for its intended use.
1 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, stacked on top of each other.
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.
- 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 3. 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).
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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 your 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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Pharmaceutical Corporation
February 1, 1999
2. INDICATIONS FOR USE
K984413 (Previously K963004) 510(k) Number (if known): K984262 (Previously K973721) K984267 (Previously K973722) K984266 (Previously K973725) K984264 (Previously K973725)
Device 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 munagement 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, Gauzo Pads, Fourn, 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)
ਨ
Prescription Use (Per 21 CRF 801.109)
Over-the-Counter Use X
piollefa
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K984262, K984264, K984266
2
N/A