(85 days)
BIONECT® Hydrogel Spray 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 Spray 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® Hydrogel Spray is a clear, colorless, aqueous solution that is prepared from sodium hyaluronate and purificd 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.
The provided text describes the BIONECT® Hydrogel Spray, a medical device for wound dressing. However, the document is a 510(k) Premarket Notification summary from 1999, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically found in recent AI/ML device submissions.
Based on the provided text, the following information can be extracted or reasonably inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided document. The 510(k) submission for BIONECT® Hydrogel Spray relies on demonstrating substantial equivalence to a predicate device (BIONECT® Hydrogel) and general biocompatibility testing. The acceptance criteria for the "device performance" in modern terms (e.g., accuracy, sensitivity, specificity) for an AI/ML device are not applicable here.
The document states:
- "BIONECT® Hydrogel Spray provides a moist wound environment that is supportive to wound healing." (This is the intended function).
- "These indication statements are not different from the predicate device identified in paragraph (3) of this section."
- "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."
Therefore, the "performance" accepted is that it functions equivalently to the predicate device in providing a moist wound environment and has similar technological characteristics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Clinical experience with BIONECT® Hydrogel Spray in approximately 45 patients with various types of ulcers and surgical wounds..."
- Data Provenance: "...all conducted in Europe..." These were clinical trials, so they were prospective in nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document refers to "clinical experience," which implies medical observation and assessment by healthcare professionals, but does not specify how "ground truth" (e.g., wound healing assessment) was established or adjudicated, nor the number or qualifications of experts involved in that process.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or AI/ML devices where the performance of human readers with and without AI assistance is evaluated. The BIONECT® Hydrogel Spray is a wound dressing, not a diagnostic or AI-powered device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. The device is a physical hydrogel spray, not an algorithm.
7. The Type of Ground Truth Used
The document broadly refers to "clinical experience" and "safe use" based on observations in patients with "various types of ulcers and surgical wounds." This implies that the ground truth was based on clinical assessment and outcomes data (e.g., whether the device was safe and supportive of wound healing in a clinical setting).
8. The Sample Size for the Training Set
This information is not applicable and not provided. The BIONECT® Hydrogel Spray is a physical medical device, not an AI/ML algorithm that requires a training set. The clinical "experience" mentioned (45 patients) would be considered the human-observed performance data, not a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided as there is no AI/ML algorithm requiring a training set in this context.
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13:03
510(k) Premarket Notifica K984266 (Previously K973 BIONECT® Hydrogel Spray
fidia Pharmaceutical 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 Telefax: (202) 371-1666
Date summary was prepared:
February 1, 1999
10.1.2 Name of the Device
Trade Name: Common Name: Classification Name: BIONECT® Hydrogel Spray Hyaluronic acid sodium salt hydrogel dressing Hydrogel Wound and Burn Dressing
7
{1}------------------------------------------------
984266
510(k) Premarket Notification
K984266 (Previously K973724)
BIONECT
Hydrogel Spray
fidia Pharmaceutical Corporation
February 1, 1999
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: Since it is a hydrogel, BIONECT® Hydrogel Spray provides a moist wound environment that is supportive to wound healing.
Basic scientific concepts that form the basis for the device: BIONECT® Hydrogel Spray 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 Spray is a clear, colorless, aqueous solution that is prepared from sodium hyaluronate and purificd 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.
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K984266 (Previously ) BIONECT® Hydrogel Spra
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 Spray 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 Spray 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. bioburden level, moist wound healing, and appearance in the wound when hydrated are not different from the predicate device cited.
9
{3}------------------------------------------------
510(k) Premarket Notification K973724 BIONECT® Hydrogel Spray
fidia Pharmaceutical Corporation
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 BIONECT® Hydrogel Spray bulk solution in accordance with FDA recommendations. These tests all support the safe use of BIONECT® Hydrogel Spray as a hydrogel temporary dressing in contact with breached or compromised skin.
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.
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.
FEB 1 0 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 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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-4A NH4.1 4848334130
u2-02-77 12:582 P.02
IQIa Pharmaceutical Corporation
February 1, 1999
INDICATIONS FOR USF 2.
510(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 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, 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 - CONTINUE ON ANOTHER PAGE IF NEJIDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CRF 801.109) ਮ
2
Over-the-Counter Use X
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K984262, K984264, K98
N/A