(232 days)
Collagen/Ag Wound Gel is an absorbent wound dressing that provides a moist wound environment and affects the proliferation of bacteria which have been absorbed into the wound gel. Collagen/Ag 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.
Pressure ulcers (Stages I - IV) Venous stasis ulcers Diabetic ulcers Ulcers resulting from arterial insufficiency Surgical wounds Traumatic wounds First and second degree burns Superficial wounds Grafted wounds and donor sites
Hydrolyzed Collagen/Ag Wound Gel is a line extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Collagen/Ag gel is the identical hydrolyzed collagen wound gel formulation with 1.0% silver oxide added to inhibit the growth of microbes that are absorbed into the wound gel. The addition of silver oxide to the HyCure® formulation does not affect the safety or efficacy of Collagen/Ag gel. HyCure® Hydrolyzed Collagen Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Collagen/Ag Wound gel is provided in a patient ready dispensible tube.
The provided text describes the 510(k) premarket notification for "Hydrolyzed Collagen/Ag Wound Gel," a medical device. However, it does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of conducting a new study to prove efficacy and safety according to defined acceptance criteria, the manufacturer argues that their new device is as safe and effective as other similar devices already on the market.
Therefore, many of the requested details about acceptance criteria, study data, sample size, ground truth, and expert involvement are not applicable to this type of regulatory submission as presented. The submission relies on non-clinical data for specific aspects (cytotoxicity and microbial control) rather than broad clinical performance studies.
Here's an attempt to answer the questions based on the provided text, flagging where information is not available or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated for Overall Performance) | Reported Device Performance |
|---|---|
| Overall Clinical Effectiveness | Not applicable. The document states: "Collagen/Ag gel has not been studied in a clinical setting." Substantial equivalence is claimed based on similarity to predicate devices and non-clinical data for specific aspects. |
| Cytotoxicity (ISO 10-993 guideline) | Indicated a grade 1 cytotoxic grade (Exhibit I). |
| Microbial Control within Hydrogel | In vitro evaluation (Exhibit II) supported claims; Collagen/Ag gel was found to control bacterial growth within the hydrogel. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable for overall device performance. For the cytotoxicity and microbial control evaluations, specific sample sizes are not mentioned.
- Data Provenance: The in vitro evaluations (cytotoxicity, microbial control) are non-clinical studies. The country of origin for these specific tests is not stated in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No clinical test set requiring expert ground truth establishment for overall device performance is described. The cytotoxicity and microbial control evaluations would have been conducted in a laboratory setting, not typically requiring "experts" in the sense of clinicians establishing ground truth for patient outcomes.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not done. The document explicitly states: "Collagen/Ag gel has not been studied in a clinical setting."
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
- Yes, in spirit, for specific aspects. While not an "algorithm," the in vitro tests for cytotoxicity and microbial control were standalone evaluations of the device's properties, without human interaction with the wound gel in a clinical setting.
7. The Type of Ground Truth Used
- Not applicable for overall device performance. For the non-clinical tests:
- Cytotoxicity: The ground truth would be based on established laboratory standards and observation of cell viability/response to the material.
- Microbial Control: The ground truth would be based on quantitative microbiological assays measuring bacterial growth inhibition in vitro.
8. The Sample Size for the Training Set
- Not applicable. There is no mention of a training set as this is not an AI/Machine Learning device. The regulatory submission focuses on demonstrating substantial equivalence and presents non-clinical data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, no training set is relevant to this submission.
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The Hymed Group Phone: 610-865-9876
e
Confidential
"510(k)" Premarket Notification Hydrolyzed Collagen/Ag Wound Gel
510(k) Summary
Summary Information: Amended November 14, 2006 as per FDA communications dated June 9, 2006 and November 7, 2006.
- . Submitters Name and Address:
The Hymed Group Corporation 1890 Bucknell Drive Bethlehem, PA 18015
DEC 20 2006
- Contact Person: Dr. George Petito President Phone: 610-865-9876 E-Mail: apetito@hymed.com
- Establishment Number: 2530949 .
- . User Fee ID Number: MD6025566-956733
- Date of Amended Summary Preparation: . November 14 2006
- Name of Device:
- o Proprietary: Hydrolyzed Collagen/Ag Wound Gel
- Common: O Moist wound gel
- ಂ Classification Name: Hydrophilic Wound Dressing
- Medical Device Classification: � Unclassified, PMN Non-exempt
Prolode-FRO
- Identification of predicate devices to which substantial equivalence is being . claimed:
- Description of the Device: Hydrolyzed Collagen/Ag Wound Gel is a line . extension of the previously approved HyCure® Hydrolyzed Collagen (K955506). Collagen/Ag gel is the identical hydrolyzed collagen wound gel formulation with 1.0% silver oxide added to inhibit the growth of
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The Hymed Group Phone: 610-865-9876
Confidential
14061227
page 2072
"510(k)" Premarket Notification Hydrolyzed Collagen/Ag Wound Gel
microbes that are absorbed into the wound gel. The addition of silver oxide to the HyCure® formulation does not affect the safety or efficacy of Collagen/Ag gel. HyCure® Hydrolyzed Collagen Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. Collagen/Ag Wound gel is provided in a patient ready dispensible tube.
- Intended use of the Device: Collagen/Ag Wound Gel is an absorbent wound . dressing that provides a moist wound environment and affects the proliferation of bacteria which have been absorbed into the wound gel. Collagen/Ag 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.
- Technology Characteristics: Collagen/Ag Wound Gel is an aqueous, hydrogel . identical in formulation to HyCure® Hydrolyzed Collagen Wound Gel (K955506). Collagen/Ag Wound Gel contains 1.0% silver oxide for the purpose of controlling bacterial bioburden within the gel as does silver containing hydrogels currently in commercial distribution and the particular change does not affect the intended use or alter the fundamental scientific technology of the device.
- Non-Clinical Performance Data: Hydrolyzed Collagen/Ag Wound Gel has been ● evaluated in accordance with Part 10-993 of the International Standard Organization (ISO). Standard tests which include:
- . cytotoxicity (Exhibit I) indicated a grade 1 cytotoxic grade.
- . Microbial control within the hydrogel claims are supported by invitro evaluation (Exhibit II). Collagen/Ag gel was found to control bacterial growth within the hydrogel.
Collagen/Ag gel has not been studied in a clinical setting.
End of Summary
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Hymed Group Corporation % George Petito, Ph.D. President 1890 Bucknell Drive Bethlehem, Pennsylvania 18015
DEC 2 0 2006
Re: K061227
Trade/Device Name: Hydrolyzed Collagen Gel with Siver Regulation Class: Unclassified Product Code: FRO Dated: November 14, 2006 Received: November 20, 2006
Dear Dr. 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, listing 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, UDA 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.
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Page 2 - George Petito, Ph.D.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
[signature]
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):K061227
Device Name: Hydrolyzed Collagen Gel with Silver Indications For Use:
Pressure ulcers (Stages I - IV) Venous stasis ulcers Diabetic ulcers Ulcers resulting from arterial insufficiency Surgical wounds Traumatic wounds First and second degree burns Superficial wounds Grafted wounds and donor sites
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
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510(k) Number L061227
N/A