K Number

Device Name

Manufacturer

TISSUE REPAIR COMPANY

Date Cleared

2011-10-03

(243 days)

Product Code

KGN,EXC

Regulation Number

N/A

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K072113,K030774,K910944,K955506,K012990,K990086

Predicate For

N/A

Intended Use

Excellagen is indicated for the management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. This device is packaged for one-time use.

Device Description

Excellagen is a wound care device composed of formulated, 2.6% (26 mg/mL) fibrillar bovine dermal collagen (Type I) that is topically applied directly to the wound surface. Excellagen is packaged as single-use units to ensure safety and provide for easy topical application. The device is tested for sterility in accordance with USP<71>. Excellagen is supplied in one of two kit configurations. One kit configuration consists of four single-use 1.0 cc syringes, each containing 0.5 cc of 2.6% (26 mg/mL) formulated collagen, and four singleuse sterile flexible applicators. This kit can be used for smaller wounds. The second kit configuration consists of one single-use 10.0 cc syringe containing 4.0 cc of 2.6% (26 mg/mL) formulated collagen, and one single-use sterile flexible applicator. This kit can be used for larger or tunneling/undermined wounds. Excellagen is stored at standard refrigeration temperature (2-8°C).

During manufacture, the collagen component of Excellagen is purified using a specialized process that eliminates impurities (including endotoxins), and removes denatured molecules and collagen fragments. Excellagen consists almost exclusively of high molecular weight, intact, fibrillar collagen and is formulated at a concentration of 2.6% (26 mg/mL) in an isotonic buffer with protein stabilizing agents.

AI/ML Overview

The provided 510(k) summary for Excellagen Collagen Wound Dressing describes the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about a clinical study with acceptance criteria, reported device performance, or performance metrics typically associated with AI/software devices.

Instead, this document focuses on demonstrating substantial equivalence based on material composition, intended use, and safety through non-clinical biocompatibility testing.

Here's a breakdown of why many of your requested items cannot be answered from the provided text:

Acceptance Criteria & Reported Device Performance (Table): This document does not present acceptance criteria or reported performance data in the way you've outlined for a clinical study comparing a device's effectiveness against a threshold. The "performance" discussed relates to material properties and safety.
Sample Size (Test Set) & Data Provenance: Not applicable as no clinical test set is described. The "sample" referenced is the device material itself for biocompatibility testing.
Number of Experts & Qualifications (Ground Truth): Not applicable as there's no diagnostic task requiring expert ground truth.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not performed or mentioned.
Standalone Performance: Not performed or mentioned in the context of an algorithm.
Type of Ground Truth: Not applicable for a clinical performance evaluation. The "ground truth" here is the standard for biocompatibility.
Sample Size (Training Set): Not applicable, as this is not a machine learning/AI device that requires a training set.
How Ground Truth for Training Set was Established: Not applicable.

However, I can extract information related to the device's "acceptance" based on the FDA 510(k) process:

The "acceptance" in this context refers to the FDA's determination of Substantial Equivalence (SE) to legally marketed predicate devices. The study proving this "acceptance" is the biocompatibility testing and the comparative analysis of technological characteristics.

Here's the closest I can get to your requested format based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence to Predicate Devices)	Reported Device Performance (Excellagen)
Safety:
* Biocompatibility (in vitro)	In vitro (cytotoxicity) testing in accordance with ISO 10993-1: Found to be biocompatible.
* Biocompatibility (in vivo)	In vivo (sensitization and intracutaneous reactivity) biocompatibility testing in accordance with ISO 10993-1: Found to be biocompatible.
* Sterility	Tested for sterility in accordance with USP<71>: Passed sterility testing.
Functional Equivalence:
* Intended Use Match	Intended use: "management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds... trauma wounds... and draining wounds." This matches the indication of the predicate devices for wound management.
* Material Composition Match	Material: Composed of 2.6% fibrillar bovine dermal collagen (Type I). This is substantially equivalent to predicate devices which also use Type I bovine collagen (e.g., Integra Flowable, Stimulen, Medifil Gel, HyCure, Collatek, HeliDerm - all listed as Type I collagen, bovine source, although Integra includes x-linked + GAGs and Stimulen is soluble modified collagen, the core material is still bovine Type I collagen).
* Application Method Match	Topically applied directly to the wound surface: Consistent with predicate devices.
* Physical Form (Fibrillar Gel)	While predicate devices vary in form (hydrated granules, gel, suspension, powder, microfibrils), Excellagen's fibrillar gel form is considered functionally equivalent for wound dressing.
* Biodegradability	Yes, stated to be biodegradable, matching predicates.

Additional Breakdown based on provided document:

Sample size used for the test set and the data provenance:
- Test Set: For biocompatibility testing, the "sample size" refers to the tested material of Excellagen. Specific quantitative sample sizes (e.g., number of test specimens or animals) are not provided in this summary, but the testing was conducted in vitro (e.g., cytotoxicity assays) and in vivo (e.g., animal models for sensitization and intracutaneous reactivity).
- Data Provenance: The standard cited for biocompatibility testing is ISO 10993-1. The origin of specific test data (e.g., country) is not mentioned, but it would have been generated in a lab setting adhering to these international standards. This testing is prospective for the device's regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for biocompatibility is established by the test standards themselves (ISO 10993-1) and the objective results (e.g., cell viability, observed reactions). There are no experts establishing a "ground truth" in a diagnostic sense.
Adjudication method for the test set: Not applicable. Biocompatibility testing results are typically objectively measured and interpreted against pre-defined criteria in the standard, not through an adjudication process.
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: Not applicable. This device is not an AI/software device, nor does it involve human readers interpreting data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
The type of ground truth used:
- For biocompatibility: Adherence to ISO 10993-1 standards and objective laboratory measurements (e.g., cytotoxicity levels, immune responses).
- For substantial equivalence comparison: Categorical attributes of the device (material, intended use, form, biodegradability, sterility etc.) compared directly to the published characteristics of the predicate devices.
The sample size for the training set: Not applicable. This is not a machine learning/AI device.
How the ground truth for the training set was established: Not applicable.

Summary

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K 110318

P 1/3

510(k) SUMMARY

OCT - 3 2011

Submitter's Information Name :

Address:

Tissue Repair Company 12255 El Camino Real, Suite 250 San Diego, CA 92130 858-793-6641 858-793-7243

Telephone: Fax:

Contact Person

Name: Telephone: Email:

Lois Chandler, Ph.D. 858-436-1012 Ichandler@cardiumthx.com

Date Summary was Prepared: October 4, 2011

Device Information

Proprietary Name: Common Name: Classification Name: Product Code:

Excellagen Collagen Wound Dressing Dressing, Wound, Collagen KGN

Predicate Devices

Integra Flowable Wound Matrix, K072113 Stimulen Collagen, K030774 Medifil gel, K910944 HyCure Hydrolyzed Collagen, K955506 Collatek Powder, K012990 HeliDerm Collagen Wound Dressing, K990086

Device Description

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< 110318 P 2/3

second kit configuration consists of one single-use 10.0 cc syringe containing 4.0 cc of 2.6% (26 mg/mL) formulated collagen, and one single-use sterile flexible applicator. This kit can be used for larger or tunneling/undermined wounds. Excellagen is stored at standard refrigeration temperature (2-8°C).

Intended Use

Excellagen is a wound care device intended for the management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. This device is packaged for onetime use.

Excellagen is contraindicated for individuals with a known sensitivity to products of bovine origin.

	Excellagen	Predicates
		IntegraFlowable	Stimulen	Medifil Gel	HyCure	Collatek	Heliderm
510(k)Number	pending	K072113	K030774	K910994	K955506	K012990	K990086
Material	Type Icollagen	Type Icollagen(x-linked +GAGs)	Solublemodifiedcollagen	Type Icollagen	Type Icollagen(96%)	Type Icollagen	Type Icollagen
Source	Bovine	Bovine	Bovine	Bovine	Bovine	Bovine	Bovine
Form	Fibrillar Gel	HydratedGranules	Gel	CollagenSuspension	Powder	Powder	Microfibrils
Biodegradable	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Biocompatible	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Sterile	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Storage	Refrigerated2-8°C	RoomTemp	RoomTemp	Refrigerated<16°C	RoomTemp	Notavailable	RoomTemp

Technological Characteristics Compared to Predicates

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Safety

The safety of Excellagen has been established based on standard non-clinical in vitro (cytotoxicity) and in vivo (sensitization and intracutaneous reactivity) biocompatibility testing in accordance with ISO 10993-1. Excellagen was found to be biocompatible in all tests.

Substantial Equivalence

Excellagen is substantially equivalent in function (wound management), materials (bovine Type I collagen), intended use (direct topical application to dermal wounds) and safety profile (biodecradable and biocompatible, passed sterility testing in accordance with USP<71>) to the following products which have been cleared to market under Section 510(k) premarket notifications: Integra Flowable Wound Matrix (K072113), Stimulen Collagen (K030774) Medifil gel (K910944), HyCure Hydrolyzed Collagen (K955506), Collatek Powder (K012990), HeliDerm Collagen Wound Dressing (K990086).

Conclusion

Excellagen is safe under the proposed conditions of use and substantially equivalent to its predicate devices.

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Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text is small and difficult to read, but it appears to be the name of an organization or agency. The symbol in the center consists of three curved lines that resemble a bird in flight or a stylized representation of water waves. The logo has a simple, clean design and is likely used to represent the organization or agency it belongs to.

Food and Drug Achumstration 10903 New Hamoshire Avenue Document Control Room --WO66-G609 Silver Spring, MD 20993-0002

Tissue Repair Company % Lois Chandler, Ph.D. 12255 El Camino Real. Suite 250 San Diego. California 92130

Re: K110318

Trade/Device Name: Excellagen Regulatory Class: Unclassified Product Code: KGN Dated: September 26. 2011 Received: September 27. 2011

OCT - 3 2011

Dear Dr. Chandler:

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

{4}------------------------------------------------

Page 2 - Lois Chandler, Ph.1).

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.

ff 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/CDRHQffices/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/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometries/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Kim

Coalition

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

Enclosure

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Indications for Use

KII 0318 510(k) Number (if known): __

Device Name: Excellagen

Indications for Use:

Prescription Use(Part 21 CFR 801 Subpart D)	X
AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)(Division Sign-Off)Division of Surgical, Orthopedic,and Restorative Devices
CONFIDENTIAL Number	1k 110318

Regulation Number and Section

N/A