FIBRILLAR COLLAGEN WOUND DRESSING

• K Number: K120250
• Device Name: FIBRILLAR COLLAGEN WOUND DRESSING
• Manufacturer: COLLAFIRM LLC
• Date Cleared: 2013-04-21 ( 450 days)
• Product Code: KGN
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K910944 , K012990
• Predicate For: N/A

Intended Use

CollaFirm Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including; pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular origin, venous ulcers, donor and graft sites, abrasions, traumatic wounds healing by secondary intention, dehisced surgical wounds, first and second degree burns. For Prescription use

Device Description

CollaFirm Collagen Wound Dressing, a highly purified porcine Type I, collagen wound dressing which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound environment in the management of wound healing. The CollaFirm Collagen Wound Dressing is provided in a patient ready, one (1) gram, envelop.

AI/ML Overview

This document describes the 510(k) submission for the CollaFirm Collagen Wound Dressing. As such, it is not a study proving device performance against acceptance criteria in the manner of an AI/ML device. Instead, it demonstrates substantial equivalence to predicate devices through non-clinical testing and shared technological characteristics and intended use.

Here's an breakdown of the information based on the provided text, addressing your questions where applicable to a non-AI/ML device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of medical device (collagen wound dressing), the "acceptance criteria" are typically the standards and tests performed to demonstrate safety, effectiveness, and substantial equivalence to existing predicate devices.

Acceptance Criterion (Standard Test)	Reported Device Performance (CollaFirm Collagen Wound Dressing)
Material/Composition Equivalence	Amino Acid Analysis performed by HPLC compared to Medfil II collagen particles.
	amino acid composition (18 amino acids each) of CollaFirm collagen and predicate device Medfil II is quite similar on comparison.
Biocompatibility - Cytotoxicity	Agar Overlay (direct contact) Cytotoxicity testing.
	Indicated a grade 0. (non-cytotoxic)
Biocompatibility - Irritation	ISO Intracutaneous reactivity (Irritation) testing.
	Indicates a non-irritant.
Biocompatibility - Sensitization	ISO Guinea Pig Maximization Sensitization Test Report.
	Indicates the product is a non-sensitizer.
Stability	Stability has been demonstrated over a three (3) month period at Room Temperature and accelerated conditions.
	Was found to maintain the product's attributes and characteristics.
Sterility	USP Sterility testing.
	Has indicated that the product is sterile.
Pyrogenicity	LAL Chromogenicity testing.
	Indicates the product is non-pyrogenic.
Technological Characteristics	Device is highly purified porcine collagen which absorbs wound fluid, maintains a moist wound environment.
	Equivalent to predicate products currently in commercial distribution. This particular formulation does not affect the intended use or alter the fundamental scientific technology.
Intended Use	CollaFirm Collagen Wound Dressing has the same intended uses as the aforementioned predicate devices.
Safety and Effectiveness	CollaFirm Collagen Wound Dressing is as safe and effective as the predicate devices referenced herein and raises no new issues of safety or effectiveness.

2. Sample Size Used for the Test Set and the Data Provenance

This document does not specify "sample sizes" in the context of a "test set" as would be relevant for an AI/ML device. The "testing" here refers to non-clinical laboratory tests performed on the device material itself. The provenance of this data is from controlled laboratory experiments, not patient data in the sense of a clinical trial or AI model evaluation.

• Sample Size for Test Set: Not applicable in the context of typical AI/ML device evaluation. The "sample" is the manufactured device material used for the specified laboratory tests (e.g., cytotoxicity, irritation, sensitization, sterility, pyrogenicity, stability). The specific number of samples tested for each assay is not detailed in this summary but would be part of the full test reports.
• Data Provenance: The tests were conducted in accordance with ISO standards and USP (United States Pharmacopeia) for sterility. This indicates the testing was performed in a laboratory setting. Country of origin for data is not explicitly stated but would typically be from accredited testing facilities. The data is non-clinical/pre-clinical.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For this type of device submission, there is no "ground truth" in the sense of medical image interpretation or disease diagnosis established by experts. Substantial equivalence relies on comparing the device's characteristics and performance to established standards and predicate devices.

4. Adjudication Method

Not applicable. There is no adjudication method needed for establishing ground truth, as the ground truth concept (expert consensus in diagnostic tasks) does not apply here. The evaluation relies on standardized laboratory tests and comparison to predicate devices, which are objective measurements or assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "CollaFirm Collagen Wound Dressing has not been studied in a clinical setting." This type of study would involve human readers (e.g., clinicians) evaluating cases, which is typically for AI-assisted diagnostic or prognostic tools.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No, a standalone performance study (algorithm only) was not done. This is not an AI/ML device, so concepts like "algorithm only" or "human-in-the-loop" are not relevant. The device is a physical wound dressing.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML. For this submission, "ground truth" is established through:

• Standardized laboratory tests: E.g., ISO standards for biocompatibility (cytotoxicity, irritation, sensitization), USP for sterility, LAL for pyrogenicity. The results of these tests, against predetermined pass/fail criteria, serve as empirical evidence.
• Comparison to predicate devices: The "ground truth" for substantial equivalence often involves demonstrating that the new device's properties and performance are comparable to (or within acceptable limits of) legally marketed predicate devices that have already been deemed safe and effective by the FDA. The amino acid analysis is an example of this.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device, so there is no "training set" or "ground truth for the training set."

Summary

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APR 2 1 2013

K120250

510(k) SUMMARY

1. Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

CollaFirm LLC 7 Deer Park Drive, Suite M-7 Monmouth Junction, New Jersey 08852

Telephone No.: 732-823-1051 Facsimile No .:

Contact Person: Surendra Batra Ph.D. E-Mail: [e-mail]

Date Prepared: April 17, 2013

2. Name of Device and Name/Address of Sponsor

CollaFirma Collagen Wound Dressing

CollaFirm LLC 7 Deer Park Drive, Suite M-7 Monmouth Junction, New Jersey 08852

• 3. Common or Usual Name: Collagen Wound Dressing
• 4. Classification: Dressing, Wound, Collagen Regulatory Class: Unclassified Product Code: KGN
• 5. Description: CollaFirm Collagen Wound Dressing, a highly purified porcine Type I, collagen wound dressing which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound environment in the management of wound healing. The CollaFirm Collagen Wound Dressing is provided in a patient ready, one (1) gram, envelop.

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K120250

6. Predicate Devices

• Medifil Particles K910944 , BioCore Medical Technologies,Inc. O
• CollaTek Power K012990 BioCore Medical Technologies,Inc. O
• 7. Intended Use/Indication for Use: CollaFirm Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including; pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular origin, venous ulcers, donor and graft sites, abrasions, traumatic wounds healing by secondary intention, dehisced surgical wounds, first and second degree burns. For Prescription use
• 8. Amino Acid Analysis: Amino Acid Analysis for CollaFirm collagen was performed by HPLC and was compared with Medfil II collagen particles. The amino acid composition (18 amino acids each) of CollaFirm collagen and predicate device Medfil II is quite similar on comparison.
• 9. Technological Characteristics: CollaFirm Collagen Wound Dressing is highly purified porcine collagen which absorbs wound fluid, maintains a moist wound environment and is equivalent to predicate products currently in commercial distribution.

This particular formulation does not affect the intended use or alter the fundamental scientific technology of the device.

• 10. Substantial Equivalence: The CollaFirm Collagen Wound Dressing is as safe and effective as the predicate devices referenced herein. CollaFirm Collagen Wound Dressing has the same intended uses, technological characteristics, and basic principles of operation as the aforementioned predicate devices and raises no new issues of safety or effectiveness. CollaFirm Collagen Wound Dressing is substantially equivalent to the predicate devices referenced.

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K120250

• 11. Non-Clinical Performance Data: The CollaFirm Collagen Wound Dressing has been evaluated in accordance with Part 10-993 of the International Standard Organization (ISO). Standard tests which include:
  • Agar Overlay (direct contact) Cytotoxicity testing indicated a grade 0 . cytotoxic grade.
  • ISO Intracutaneous reactivity (Irritation) testing indicates a nono irritant.
  • ISO Guinea Pig Maximization Sensitization Test Report indicates the . product is a non-sensitizer.
  • Stability has been demonstrated over a three (3) month period and . Room Temperature and accelerated conditions and was found to maintain the products attributes and characteristics.
  • . USP Sterility testing has indicated that the product is sterile.
  • LAL Chromogenicity testing indicates the product is non-pyrogenic. .
  • CollaFirm Collagen Wound Dressing has not been studied in a clinical . setting.

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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 features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird figure in a circular fashion.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

CollaFirm, LLC % Surendra Batra, Ph.D. 7 Deer Park Drive, Suite M-7 Monmouth, New Jersey 08852

April 21, 2013

Re: K120250

Trade/Device Name: CollaFirma Collagen Wound Dressing · Regulatory Class: Unclassified Product Code: KGN Dated: April 08, 2013 Received: April 10, 2013

Dear Dr. Batra:

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 comply 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

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Page 2 - Surendra Batra, Ph.D.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Safetv/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CollaFim LLC Phone: [phone] [e-mail]

CollaFirm Collagen Wound Dressing This eCopy is an exact duplicate of the paper copy

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K120250/S002

Indications for Use

510(k) Number: K120250

Device Name: CollaFirm Collagen Wound Dressing

Indications for Prescription (Rx) Use:

CollaFirm Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including; pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular origin, venous ulcers, donor and graft sites, abrasions, traumatic wounds healing by secondary intention, dehisced surgical wounds, first and second degree burns.

Prescription Use 1 (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JiyoungDang -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K120250

Regulation Number and Section

N/A