(134 days)
Not Found
No
The device description and performance studies focus on the biological and physical properties of the wound gel, with no mention of AI or ML technology.
Yes
The device is indicated for the topical management of chronic and acute wounds and dermal ulcers, as well as minor abrasions, lacerations, minor cuts, and minor scalds and burns, all of which are conditions that require therapeutic intervention.
No
Explanation: The document describes a wound gel used for managing various types of wounds and ulcers. Its function is to facilitate healing and maintain a moist wound environment, not to diagnose a condition or disease.
No
The device description clearly states it is a "Wound Gel" provided in a "collapsible tube," indicating a physical substance and container, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "topical use in the management of chronic and acute wounds and dermal ulcers." This describes a treatment or management function applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a "Wound Gel" containing collagen and chondroitin sulfate, designed to maintain a moist wound environment and manage wound healing. This aligns with a therapeutic or wound care product, not a diagnostic one.
- Lack of Diagnostic Language: The text does not mention any diagnostic purpose, such as detecting a disease, measuring a substance in a sample, or providing information for diagnosis.
- Performance Studies: The performance studies described are related to biocompatibility and safety (cytotoxicity, irritation, sensitization), which are typical for devices applied to the body, not for evaluating diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This wound gel does not fit that description.
N/A
Intended Use / Indications for Use
Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel is an absorbent wound dressing that provides a moist wound environment. As an Rx, Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel is useful in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites. As an Over the Counter preparation, Hydrolyzed Collagen with 10% Wound Gel is useful in the management of minor abrasions, lacerations, minor cuts and minor scalds and burns. Contraindicated for individuals with a known sensitivity to bovine or collagen.
Rx Indications for Use:
Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound gel is indicated for topical use in the management of chronic and acute wounds and dermal ulcers including the local management of:
- Pressure Ulcers (Stage I-IV) .
- Venous Stasis Ulcers .
- Diabetic Ulcers ●
- First and Second Degrec Burns .
- Surgical wounds .
- . Traumatic wounds
- Superficial wounds .
- Ulcers resulting from arterial insufficiency .
- Grafted wounds and donor sites ●
Contraindications: - Contraindicated for individuals with a known sensitivity to bovine or ● collagen
Over the Counter (OTC) Indications for Use:
- For over the counter use, Hydrolyzed Collagen with 10% Chondroiiin Sulfate . Wound Gel may be used for:
- minor abrasions -
- laccrations -
- minor cuts -
- minor scalds and burns
Contraindications:
- Contraindicated for individuals with a known sensitivity to bovine or . collagen
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound Gel is a line extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) contains Chondroitin Sulfate as Chondroprotec® previously approved for market via 510(k) (K961930). Hydrolyzed Collagcn with 10% Chondroitin Sulfate Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound gel is provided in a patient ready, one (1) ounce, collapsible tube.
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)
Non-Clinical Performance Data: Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel has been evaluated in accordance with Part 10-993 of the International Standard Organization (180). Standard tests which include:
- . Agar Overlay (direct contact) Cytotoxicity testing (Exhibit I) indicated a grade 0 cytotoxic grade.
- ISO Intracutaneous reactivity (Irritation) testing indicates a non-. irritant
- Repeat Patch Dermal Sensitization Test (Buehler Method) . indicates the product is a non-sensitizer.
Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel has not been studied in a clinical setting.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K955506, K990086, K021792, K961930, K072113
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
510(k) Summary
Summary Information:
OCT 3 0 2008
-
Submitters Name and Address: .
Applied Nutritionals 1890 Bucknell Drive Bethlehem, PA 18015 -
Contact Person: Anita Petito . Director of Marketing Phone: 610-865-9876 E-Mail: apetito@hymed.com
-
Establishment Number: 2530949 .
-
User Fee ID Number: MD6036808-956733 .
-
Date of Summary Preparation: June 9, 2008 .
-
Name of Device: .
- Hydrolyzed Collagen with 10% Chondroitin Sulfate Proprietary: O (PSGAG, polysulfated glycosaminoglycan) Wound Gel
- Common: Moist wound gel ்
- Classification Name: Hydrophilic Wound Dressing ্
-
Medical Device Classification: Unclassified .
-
Identification of predicate devices to which substantial equivalence is being . claimed:
| o HyCure® Hydrolyzed Collagen | K955506 |
|---|---|
| o HeliDerm™ Collagen Wound Dressing | K990086 |
| o Integra ® Bilayer Matrix Wound Dressing | K021792 |
| o Chondroprotec® (10% Polysulfated GlycosaminoGlycan) | K961930 |
| o Integra® Flowable Wound Matrix | K072113 |
Description of the Device: Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) Wound Gel is a line extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan) contains Chondroitin Sulfate as Chondroprotec® previously approved for market via 510(k) (K961930). Hydrolyzed Collagcn with 10% Chondroitin Sulfate Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Hydrolyzed Collagen with 10% Chondroitin Sulfate (PSGAG, Polysulfated glycosaminoglycan)
1
Wound gel is provided in a patient ready, one (1) ounce, collapsible tube.
- Intended use of the Device: Hydrolyzed Collagen with 10% Chondroitin Sulfate . Wound Gel is an absorbent wound dressing that provides a moist wound environment. As an Rx, Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel is useful in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites. As an Over the Counter preparation, Hydrolyzed Collagen with 10% Wound Gel is useful in the management of minor abrasions, lacerations, minor cuts and minor scalds and burns. Contraindicated for individuals with a known sensitivity to bovine or collagen.
- Technology Characteristics: Hydrolyzed Collagen with 10% Chondroitin Sulfate ● Wound Gel is an aqueous hydrogel identical in formulation to HyCure® Hydrolyzed Collagen Wound Gel (K955506) combined with Chondroprotec® (K961930). Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel contains 10.0% Polysulfated glycosaminoglycan for the purpose of improving wound fluid retention within the gel and facilitating fibroblast mobility within the wound as in predicate products currently in commercial distribution. Chondroprotec® (10% Chondroitin Sulfate) is currently approved for market (K961930) for use in the identical indications as referenced herein. This particular formulation does not affect the intended use or alter the fundamental scientific technology of the device.
- Non-Clinical Performance Data: Hydrolyzed Collagen with 10% Chondroitin . Sulfate Wound Gel has been evaluated in accordance with Part 10-993 of the International Standard Organization (180). Standard tests which include:
- . Agar Overlay (direct contact) Cytotoxicity testing (Exhibit I) indicated a grade 0 cytotoxic grade.
- ISO Intracutaneous reactivity (Irritation) testing indicates a non-. irritant
- Repeat Patch Dermal Sensitization Test (Buehler Method) . indicates the product is a non-sensitizer.
Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel has not been studied in a clinical setting.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2008
Applied Nutritionals % Ms. Anita Petito President 1890 Bucknell Drive Bethlehem, Pennsylvania 18015
Re: K081724
Trade/Device Name: Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel Regulatory Class: Unclassified Product Code: KGN Dated: October 10, 2008 Received: October 17, 2008
Dear Ms. Petito:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Anita Petito
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Rx Indications for Use
8/1724
510(k) Number: K081724
Device Name: Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel
Indications for Use:
Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound gel is indicated for topical use in the management of chronic and acute wounds and dermal ulcers including the local management of:
- Pressure Ulcers (Stage I-IV) .
- Venous Stasis Ulcers .
- Diabetic Ulcers ●
- First and Second Degrec Burns .
- Surgical wounds .
- . Traumatic wounds
- Superficial wounds .
- Ulcers resulting from arterial insufficiency .
- Grafted wounds and donor sites ●
Contraindications:
- Contraindicated for individuals with a known sensitivity to bovine or ● collagen
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart AND/OR D) | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Ail RPOhl for mxa
(Division Sign-Off)
Division of General. Restorative, and Neurological Devices
510(k) Number K081724
5
Over the Counter (OTC) Indications for Use
510(k) Number: K081724
Device Name: Hydrolyzed Collagen with 10% Chondroitin Sulfate Wound Gel
Indications for Use:
- For over the counter use, Hydrolyzed Collagen with 10% Chondroiiin Sulfate . Wound Gel may be used for:
- minor abrasions -
- laccrations -
- minor cuts -
- minor scalds and burns
Contraindications:
- Contraindicated for individuals with a known sensitivity to bovine or . collagen
Over-The-Counter Use X Prescription Use AND / OR (21 CFR 801 Subpart (Part 21 CFR 801 Subpart C) D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Nèdre Ople formen
(Division Sign-Off (Division Sign-On)
Division of General, Restorative, Division of Occal Devices
Nursing
510(k) Number K081724