(85 days)
No
The summary describes a hydrogel wound dressing and its biocompatibility and clinical performance, with no mention of AI or ML technology.
Yes
The device is indicated for the dressing and management of various types of wounds, including burns and ulcers, and is designed to provide a soothing, moist environment supportive to wound healing, which aligns with the definition of a therapeutic device.
No
Explanation: The provided text describes BIONECT Hydrogel as a dressing for wound management and healing, without any mention of its use in diagnosing conditions or diseases. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is a hydrogel dressing prepared from sodium hyaluronate and purified water, indicating it is a physical product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the dressing and management of various types of wounds and skin irritations. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the composition and function of the hydrogel as a wound dressing to provide a moist environment for healing.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition.
- Performance Studies: The performance studies mentioned are biocompatibility tests and clinical experience related to wound healing, not diagnostic accuracy.
IVD devices are used to perform tests in vitro (outside the body) on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is applied in vivo (on the body) for wound management.
N/A
Intended Use / Indications for Use
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.
Product codes
MGQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro und in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization texts) has been performed BIONECT® Hydrogel in accordance with FDA 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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).
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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
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