(85 days)
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 delermine whether these conditions exist. BIONECT Hydrogel, Gauze 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.
BIONECT Hydrogel is propared 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 was designed to provide a soothing, moist environment that is supportive to wound healing.
The provided text describes the BIONECT® Hydrogel, and its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics. The information focuses on regulatory approval (510(k) summary) and intended use. Therefore, a direct answer to the request for acceptance criteria and a study proving device performance as typically expected from a clinical trial with statistical outcomes is not fully available in the provided text.
Based on the provided text, here's an attempt to answer the questions, highlighting what information is present and what is missing:
1. Table of acceptance criteria and the reported device performance
The provided document is a 510(k) summary and not a clinical study report. It focuses on demonstrating "substantial equivalence" of BIONECT® Hydrogel to already marketed predicate devices based on technological characteristics and intended use. Therefore, explicit, quantitatively defined "acceptance criteria" and direct, statistically reported "device performance" in the sense of a new clinical trial proving efficacy against a predefined benchmark are not presented. The "performance" is primarily described in terms of biocompatibility and safety, and by claiming equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility (cytotoxicity, dermal irritation, dermal sensitization) | Met: In vitro and in vivo biocompatibility testing performed in accordance with FDA recommendations (ISO-10993). These tests "all support the safe use of BIONECT® Hydrogel as a hydrogel temporary dressing in contact with breached or compromised skin." Met: Clinical experience in approximately 600 patients in 21 clinical trials (18 controlled) conducted in Europe indicates BIONECT® Cream (a related product) is safe for its intended use. (Note: This refers to BIONECT Cream, not directly Hydrogel, but is cited as supporting safety. Specific performance metrics like adverse event rates are not provided.) |
| Technological Equivalence: Form, occlusion, conformability, bioburden level, moist wound healing, appearance in the wound when hydrated vs. predicate devices. | Met: "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 devices cited." |
| Intended Use Equivalence: Indications for use being the same as predicate devices. | Met: "These indication statements are not different from the predicate device identified in paragraph (3) of this section." (Paragraph (3) refers to predicate devices like Argidene™ Gel, Carrasyn™ Hydrogel Wound Dressing, and DuoDERM Hydroactive™ Gel). |
2. Sample size used for the test set and the data provenance
- Test Set (for biocompatibility): Not explicitly stated. The document mentions "in vitro and in vivo biocompatibility testing" but doesn't provide specific sample sizes for these tests.
- Test Set (for clinical experience): "approximately 600 patients with various types of ulcers, burns, and surgical wounds" across "21 clinical trials (18 controlled)".
- Data Provenance: Europe (for the clinical experience cited). The text does not specify retrospective or prospective. Given they are "clinical trials," they are typically prospective, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide this information. The clinical experience cited (from Europe) is referred to generally in support of safety, not as a ground-truthed test set for a specific AI or diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide this information.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study is mentioned or implied. This device (BIONECT® Hydrogel) is a wound dressing, not an AI-assisted diagnostic or imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. BIONECT® Hydrogel is a physical wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests, the ground truth would be established by the biological responses observed in the in vitro and in vivo models according to established standards. For the clinical experience (cited for safety), "outcomes data" related to safety (e.g., adverse events) would be the ground truth, though details aren't provided.
8. The sample size for the training set
Not applicable. This is a medical device (wound dressing), not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable.
Summary of Limitations from the Text:
The provided text is a 510(k) Premarket Notification summary for a wound dressing. Its purpose is to demonstrate substantial equivalence to existing devices for regulatory approval, primarily based on safety and similar technological characteristics, not to present a detailed clinical study with performance criteria for a novel device or AI. Therefore, most of the specific questions related to acceptance criteria, sample sizes for test/training sets, expert involvement, and advanced study designs (like MRMC) as commonly discussed for AI/diagnostic devices are not addressed in this type of document.
{0}------------------------------------------------
る202 833 7057 02/01/99 12:54
2/10/99
fidia Pharmaceutical Corporation
February 1, 1999
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) 371-1325 Telefax: (202) 371-1666
Date summary was prepared:
February 1, 1999
10.1.2 Name of the Device
Trade Name: BIONECT® Hydrogel Common Name: Hyaluronic acid sodium salt hydrogel dressing Classification Name: Hydrogel Wound and Burn Dressing
{1}------------------------------------------------
010
510(k) Premarket Notification
K984413 (Previously K963004)
BIONECT® Hydrogel
fidia Pharmaceutical Corporation
February 1, 1999
10.1.3 Identification of predicate device to which substantial equivalence is being claimed
BIONECT® Hydrogel is substantially equivalent in function and intended use to the following commercially available non-interactive wound and burn dressings:
- Argidene™ Gel (K945835) (Telios Pharmaceuticals, Inc.) .
- Carrasyn™ Hydrogel Wound Dressing (K902345) (Carrington Laboratories, Inc.)
- DuoDERM Hydroactive™ Gel (K830708) (ConvaTec.) ◆
10.1.4 Device description
Explanation of how the device functions: Since it is a hydrogel, BIONECT® Hydrogel provides a moist wound environment that is supportive to wound healing.
Basic scientific concepts that form the basis for the device: BIONECT 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 Hydrogel is propared 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 was designed to provide a soothing, moist environment that is supportive to wound healing.
{2}------------------------------------------------
2028334157 FAX NO.:
K984413
510(k) Premarket Notification
K984413 (Previously K963004)
BIONECT® 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® Hydrogel provides a moist wound environment that is supportive to wound healing. It is indicated for the dressing and management of minor burns; superficial cuss, 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 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.
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 devices cited.
10.2 Assessment of performance data
In vitro und in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization texts) has been performed BIONECT® Hydrogel in accordance with FDA
{3}------------------------------------------------
K984413 (Previously KS ONECT® Hydr
fidia Pharmaceutical Corporation
February 1, 1999
recommendations. These tests all support the safe use of BIONECT Hydrogel as a hydrogel temporary dressing in contact with breached or compromised skin.
Clinical experience in approximately 600 patients with various types of ulcers, burns, and surgical wounds in 21 clinical trials (18 controlled) conducted in Europe indicates that BIONECT® Cream 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.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 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 a stylized image of three birds in flight, arranged in a row.
FEB 1 0 1099
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 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 aboye would be considered a major modification in the intended use of the devices and would require a premarket notification submission (21 CFR 807.81).
{5}------------------------------------------------
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
{6}------------------------------------------------
fidia 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 BIQNECT® 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 delermine whether these conditions exist. BIONECT Hydrogel, Gauze 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)
Prescription Use (Per 21 CRF 801.109)
or
Over-the-Counter Use X
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K962426 K984264, K98
2
N/A