(85 days)
BIONECT® Hydrogel Gauze Pads provide a moist wound environment that is supportive to wound healing. They 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 this product to determine whether these conditions exist. BIONECT Hydrogel Gauze Pads may also be used under the care of a health cure 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 Gauze Pads are sterile cotton gauze pads impregnated with a hydrogel that is prepared from sodium hyaluronate and purfied water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharidc biopolymer that can increase the viscosity of the gel. BIONECT® Hydrogel Gauze Pads, since they are a hydrogel dressing, provide a soothing, moist environment that is supportive to wound healing.
This document is a 510(k) Premarket Notification for BIONECT® Hydrogel Gauze Pads. It concerns the substantial equivalence of this device to a previously cleared predicate device. The information provided is primarily for regulatory approval and does not contain detailed acceptance criteria and study data in the way one might expect for a diagnostic or AI-driven device.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as would be common for diagnostic devices. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device and showing safety and efficacy for its intended use through biocompatibility and clinical experience.
| Acceptance Criterion Type | Details Provided in Document | Reported Device Performance |
|---|---|---|
| Technological Equivalence | 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. | BIONECT® Hydrogel Gauze Pads are described as providing a "soothing, moist environment that is supportive to wound healing," which is consistent with the predicate. The device functions as a hydrogel to provide a moist wound environment. |
| Biocompatibility | 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 Gauze Pads. The results indicate the materials are non-cytotoxic, non-irritating, and non-sensitizing. This is to ensure "safe use of BIONECT® Hydrogel Gauze Pads as a hydrogel temporary dressing in contact with breached or compromised skin." | The tests found the materials to be non-cytotoxic, non-irritating, and non-sensitizing. This supports the safe use of the device. |
| Clinical Safety & Efficacy | Evidence of safety and effectiveness for intended use. The document states, "Clinical experience with BIONECT® Hydrogel Gauze Pads in approximately 430 patients with various types of ulcers and burns in 16 clinical trials (13 controlled), indicates that BIONECT® Hydrogel Gauze Pads are safe for their intended use." | Clinical experience, based on the mentioned studies, indicates that BIONECT® Hydrogel Gauze Pads are safe for their intended use. The FDA's conditional approval (K984262) further clarifies limitations (e.g., "may not be labeled for use on third degree burns," "may not be labeled as having any accelerating effect on the rate of wound healing or epithelization"). This implies that within the defined scope, the device performed safely. |
| Intended Use Equivalence | The indication statements for BIONECT® Hydrogel Gauze Pads "are not different from the predicate device identified." | The device is indicated for 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. This is consistent with the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: "approximately 430 patients"
- Data Provenance: The document states "Clinical experience... in 16 clinical trials (13 controlled)." It does not specify the country of origin of the data or whether the studies were retrospective or prospective, though "clinical trials" generally implies prospective data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the provided document. The "ground truth" for a wound dressing is typically the observed clinical outcome (e.g., wound healing, absence of adverse events), not a judgment requiring experts to establish a "truth" within a test set as would be for an AI diagnostic. The clinical trials themselves, overseen by healthcare professionals, establish the observed safety and efficacy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in diagnostic studies where multiple readers interpret images or data. For a wound dressing, the clinical outcomes are observed and recorded by the treating clinicians in the clinical trials.
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
This is not applicable to the provided document. The device is a wound dressing, not an AI-driven diagnostic or imaging aid that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to the provided document. The device is a physical wound dressing and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating the performance of BIONECT® Hydrogel Gauze Pads relies on outcomes data from clinical trials, specifically regarding safety and efficacy in wound healing, and biocompatibility testing results. The primary "truth" demonstrated is that the device is "safe for its intended use" and performs similarly to its predicate.
8. The sample size for the training set
This is not applicable to the provided document. As this is not an AI/machine learning device, there is no "training set." The clinical trials served as the basis for demonstrating safety and efficacy for real-world use.
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this type of medical device.
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容202 833 7057
2020
510(k) Premarket Notification
K984262 (Previously K973721)
BIONECT® Hydrogel Gauze Pads
fidia Pharmaceutical Corporation
12:57
02/01/98
February 1, 1999
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- 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
BIONECT® Hydrogel Gauze Pads Trade Name: Common Name: Hyaluronic acid sodium salt hydrogel dressing-impregnated gauze pads Classification Name: Hydrogel Wound and Burn Dressing
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10.1.3 Identification of predicate device to which substantial equivalence is being claimed
BIONECT® Hydrogel Gauze Pads are 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 Gauze Pads, since they contain a hydrogel, provide a moist wound environment that is supportive to wound healing.
Basic scientific concepts that form the basis for the device: BIONECT Hydrogel Gauze Pads, since they are a hydrogel dressing, were 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 Gauze Pads are sterile cotton gauze pads impregnated with a hydrogel that is prepared from sodium hyaluronate and purfied water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharidc biopolymer that can increase the viscosity of the gel. BIONECT® Hydrogel Gauze Pads, since they are a hydrogel dressing, provide 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
8
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fidia Pharmaceutical Corporation
tement of the intended use of the device, including general lescription of the conditions the device will mitigate and the patient population for which the device is intended
BIONECT® Hydrogel Gauze Pads provide a moist wound environment that is supportive to wound healing. They 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 this product to determine whether these conditions exist. BIONECT Hydrogel Gauze Pads may also be used under the care of a health cure 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 and in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization tests) has been performed on the bulk solution that impregnates BIONECT®
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fidia Pharmaceutical Corporation
510(k) Premarket Notification
K984262 (Previously K973721)
BIONECT® Hydrogel Gauze Pads
February 1, 1999
safe use of BIONECT® Hydrogel Gauze Pads as a hydrogel temporary dressing in contact with breached or compromised skin. :::
Clinical experience with BIONECT® Hydrogel Gauze Pads in approximately 430 patients with various types of ulcers and burns in 16 clinical trials (13 controlled), indicates that BIONECT® Hydrogel Gauze Pads are safe for their intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight.
FEB 100 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 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.
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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1028334130
02-02-77 12:584 P.02
Idia Pharmaceutical Corporation
February 1, 1999
INDICATIONS FOR USE 2.
$10(k) Number (if known): K984413 (Previously K963004) 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 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, 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 hurns.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEIJDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CRF 801.109) Or
2
Over-the-Counter Use X
Diolleto
Division Sign-Off
Division of General Restorative Devices
510(k) Number
K984262, K984264, K984
N/A