(276 days)
Indications for Over-the-Counter Use: Hydrolyzed Collagen/Ag Wound Gel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin.
Indications for Prescription Use: Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Hydrolyzed Collagen/Ag Wound Gel for OTC use is a change in label of the previously approved Hydrolyzed Collagen/Ag Wound Gel with Silver (K061227), for Rx use, to permit its use by the general public without the need for a physician's prescription. The proposed Hydrolyzed Collagen/Ag Wound Gel for OTC use is the identical hydrolyzed collagen wound gel formulation manufactured using the same manufacturing process and conforming to the same specifications as the Collagen Ag Wound Gel (K061227) with elemental silver as a preservative that reduces the growth of bacteria within the dressing.
Hydrolyzed Collagen/Ag Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. The high concentration of hydrolyzed collagen in the gel provides for greater moisture absorption capacity into the gel supporting silver retention within the gel. Hydrolyzed Collagen/Ag Wound gel is provided in a patient ready, one (1) ounce, collapsible tube.
The provided text describes a 510(k) submission for a medical device called Hydrolyzed Collagen/Ag Wound Gel, seeking approval for Over-The-Counter (OTC) use. The submission focuses on demonstrating substantial equivalence to a predicate device and provides non-clinical performance data.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative or numerical format that is commonly seen for diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (SilverMed Antimicrobial Wound Gel, K073019) and meeting established biological safety standards. The "performance" refers to non-clinical test results.
| Acceptance Criterion (Implied) | Reported Device Performance (Hydrolyzed Collagen/Ag Wound Gel) |
|---|---|
| Substantial Equivalence to Predicate Device (SilverMed Antimicrobial Wound Gel) | Met:- Indications for use (OTC and Rx): Matched the predicate device's indications.- Product Code: FRO (matched).- Rx/OTC Status: New submission is for OTC, predicate is already OTC & Rx (the purpose of this submission is to achieve OTC status, which the predicate has).- Physical Form: Hydrogel (matched).- Product Description: Type I Bovine Collagen (matched).- Animal Tissue Source: Dermis (matched).- Preserved: Yes (matched, both use elemental silver).- Dermal Irritant: No (matched - predicate is non-irritant, device passed ISO intracutaneous reactivity).- Cytotoxic: No (matched - predicate is non-cytotoxic, device passed Cytotoxicity test with grade 1).- Dermal Sensitizer: No (matched - predicate is non-sensitizer, device passed ISO Guinea Pig Maximization Sensitization).- Product Classification: Dressing, wound, drug, unclassified (matched).- Elemental Silver as Preservative: Both use elemental silver for controlling bacterial bioburden within the gel dressing. |
| Biological Safety (ISO 10993) | Met:- Cytotoxicity (Exhibit I): Grade 1 cytotoxic grade (considered non-cytotoxic for medical devices).- ISO Guinea Pig Maximization Sensitization (Exhibit II): Negative sensitization incidence for all test animals (non-sensitizer).- ISO Intracutaneous Reactivity (Exhibit III): Considered a non-irritant. |
| Microbial Control (in-vitro) | Met: Found to control bacterial growth within the hydrogel. |
| Manufacturing and Formulation Consistency | The device is the "identical hydrolyzed collagen wound gel formulation manufactured using the same manufacturing process and conforming to the same specifications as the Collagen Ag Wound Gel (K061227)" (which was the Rx version). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a "test set" in the context of clinical trials or AI model evaluation. The non-clinical tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Microbial Control) would have used defined sample sizes for their respective in-vitro or animal models, but these specific numbers are not detailed in the summary. For example, animal studies like Guinea Pig Maximization would involve a specific number of animals, but the exact count isn't provided.
- Data Provenance:
- Country of Origin: Not specified for the non-clinical tests.
- Retrospective or Prospective: These are non-clinical, in-vitro, or animal studies, not retrospective or prospective clinical studies on humans.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable as the submission does not involve clinical data with human expert-derived ground truth for performance evaluation in the typical sense of AI/diagnostic device evaluation. The "ground truth" for the non-clinical tests would be the established scientific methods and readings for cytotoxicity, sensitization, irritation, and microbial growth in a lab setting, interpreted by qualified laboratory personnel following ISO standards.
4. Adjudication Method for the Test Set:
This is not applicable as there is no independent "test set" requiring expert adjudication in the context of this 510(k) submission. The non-clinical tests are standard laboratory procedures with objective endpoints.
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:
No. A MRMC comparative effectiveness study was not done. The device is a wound gel, not an AI-assisted diagnostic or imaging tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. The device is a wound gel, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical data, the "ground truth" is based on:
- Established ISO Standard Methods: The biological safety tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity) are conducted and interpreted according to the defined protocols of ISO 10993 standards.
- In-vitro Microbial Growth Assays: Laboratory measurements of bacterial growth inhibition.
8. The sample size for the training set:
Not applicable. This device is a wound gel, not an AI algorithm requiring a training set. The term "training set" is relevant to machine learning/AI models.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no AI algorithm or training set for this device.
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The Hymed Group Confidential hymed@hymed.com Phone: 610-865-9876 Collagen Ag Rx to Rx & OTC K132891 This eCopy is an exact duplicate of the paper copy
510(k) Summary
JUN 1 9 2014
| Submitters Name and Address: | The Hymed Group Corporation |
|---|---|
| 1890 Bucknell Drive | |
| Bethlehem, PA 18015 |
George Petito Contact Person: President. The Hymed Group Phone: 610-865-9876 E-Mail: gpetito@hymed.com
Establishment Number: 2530949
User Fee ID Number: MD6070502-956733
May 28, 2014 Date of Summary Preparation:
Name of Device:
Hydrolyzed Collagen/Ag Wound Gel with Silver Proprietary: Common: Moist wound gel Classification Name: Dressing, Wound, Drug
Medical Device Classification: Unclassified
Product Code: FRO (Dressing, Wound, Drug)
Purpose of this submission: This submission seeks approval for Collagen/Ag to be available also as an Over-The-Counter (OTC) wound care product substantially equivalent to SilverMed Antimicrobial Wound Gel which was approved for OTC and Rx use via K073019.
Identification of predicate devices to which substantial equivalence is being claimed and for which approval was granted for both Rx and OTC: SilverMed™ Antimicrobial Hydrogel (Rx & OTC), K073019
Description of the Device: Hydrolyzed Collagen/Ag Wound Gel for OTC use is a change in label of the previously approved Hydrolyzed Collagen/Ag Wound Gel with Silver (K061227), for Rx use, to permit its use by the general public without the need for a physician's prescription. The proposed Hydrolyzed Collagen/Ag Wound Gel for OTC use is the identical hydrolyzed collagen wound gel formulation manufactured using the same manufacturing process and conforming to the same specifications as the Collagen Ag Wound Gel (K061227) with elemental silver as a preservative that reduces the growth of bacteria within the dressing.
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The Hymed Group Confidential hymed@hymed.com Phone: 610-865-9876 Collagen Ag Rx to Rx & OTC K132891 This eCopy is an exact duplicate of the paper copy
The addition of the silver preservative to hydrolyzed collagen formulation does not affect the safety or efficacy of Collagen/Ag gel for use by the general public. Hydrolyzed Collagen/Ag Wound Gel contains a high concentration of water bound to the hydrolyzed collagen which maintains a moist wound environment as it manages wound healing. The high concentration of hydrolyzed collagen in the gel provides for greater moisture absorption capacity into the gel supporting silver retention within the gel. Hydrolyzed Collagen/Ag Wound gel is provided in a patient ready, one (1) ounce, collapsible tube.
Intended use of the Device: Hydrolyzed Collagen/Ag Wound Gel (Rx) is currently approved for use in partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Hydrolyzed Collagen/Ag Wound Gel for OTC use is an absorbent hydrogel wound dressing that is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin.
Technology Characteristics: Hydrolyzed Collagen/Ag Wound Gel for OTC use is an aqueous, hydrogel identical in formulation to Hydrolyzed Collagen/Ag Wound Gel with silver (K061227) and substantially equivalent to SilverMed Antimicrobial Hydrogel (073019) which is approved for Rx & OTC market and whose market approval references the sponsors Collagen/Ag Wound Gel (K061227) as substantially equivalent to SilverMed. Hydrolyzed Collagen/Ag Wound Gel contains, as a preservative, elemental silver for the purpose of controlling bacterial bioburden within the gel dressing as does SilverMed Antimicrobial Hydrogel (K073019) currently in commercial distribution. The label use change to OTC availability does not 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, .
- · ISO Guinea Pig Maximization Sensitization (Exhibit II) wherein a negative sensitization incidence was interpreted for all test animals and
- ISO intracutaneous reactivity (Exhibit III) which indicated that the product would . be considered a non-irritant.
- Microbial control within the hydrogel claims are supported by in-vitro evaluation. . Collagen/Ag gel was found to control bacterial growth within the hydrogel.
- Collagen/Ag gel has not been studied in a clinical setting. Hydrolyzed . Collagen/Ag Wound Gel with Silver (K061227) has been marketed as a Prescription wound dressing since 2007.
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| Hydrolyzed Collagen/Ag Wound Gel - SilverMed Antimicrobial Wound Gel | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | ---------------------------------------------------------------------- | -- |
| Device Comparison Table | ||
|---|---|---|
| Parameters | Hydrolyzed Collagen/AgWound Gel(K132891) | SilverMed AntimicrobialWound Gel(K073019) |
| Indications for use | Indications for OTC Use:Collagen/Ag Wound Gel isindicated for themanagement of minorburns, superficial cuts,lacerations, abrasions andminor irritation of the skin.Rx: Under the supervisionof a healthcare professional,it is indicated for partial andfull thickness woundsincluding pressure ulcers,venous stasis ulcers,diabetic ulcers, first andsecond degree burns,abrasions, lacerations, skintears, grafted wounds,donor sites and surgicalwounds. | Indications for OTC Use:SilverMed Gel is indicatedfor the management ofminor burns, superficialcuts, lacerations, abrasionsand minor irritation of theskin.Rx: Under the supervisionof a healthcare professional,it is indicated for partial andfull thickness woundsincluding pressure ulcers,venous stasis ulcers,diabetic ulcers, first andsecond degree burns,abrasions, lacerations, skintears, grafted wounds,donor sites and surgicalwounds. |
| Product Code | FRO | FRO |
| Rx | Yes | Yes |
| OTC* | No (hence the purpose ofthis submission*) | Yes |
| Physical | Hydrogel | Hydrogel |
| Product Description | Type I Bovine Collagen | Type I Bovine Collagen |
| Animal Tissue | Dermis | Dermis |
| Preserved | Yes | Yes |
| Dermal Irritant | No | No |
| Cytotoxic | No | No |
| Dermal Sensitizer | No | No |
| Product Classification | Dressing, wound, drug,unclassified | Dressing, wound, drug,unclassified |
Conclusion: These data support the safe use of the Hydrolyzed Collagen/Ag Wound Gel in contact with breached or compromised skin.
End of Summary
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Image /page/3/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human form or a caduceus, rendered in a bold, black color.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2014
The Hymed Group Corporation Mr. George Petito President 1890 Bucknell Drive Bethlehem, Pennsylvania 18015
Re: K132891
Trade/Device Name: Hydrolyzed Collagen Ag Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: May 12, 2014 Received: May 13, 2014
Dear Mr. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Mr. George Petito
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm:
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K132891
Device Name Hydrolyzed Collagen Ag Wound Gel
Indications for Use (Describe)
Indications for Over-the-Counter Use: Hydrolyzed Collagen/Ag Wound Gel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin.
Indications for Prescription Use: Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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PIST PRODUCT OF OF FOR FDA USE ONLY OF CONSTITUTION OF CONSTITUTION OF
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Jiyoung Dang -S
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