EXCELLAGEN

K110318 · Tissue Repair Company · KGN · Oct 3, 2011 · SU

Device Facts

• Record ID: K110318
• Device Name: EXCELLAGEN
• Applicant: Tissue Repair Company
• Product Code: KGN · SU
• Decision Date: Oct 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for 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.

Device Story

Excellagen is a topical wound dressing composed of 2.6% (26 mg/mL) fibrillar bovine Type I collagen in an isotonic buffer. Supplied in single-use syringes with flexible applicators for direct application to wound surfaces. Purified to remove endotoxins, denatured molecules, and collagen fragments. Stored refrigerated (2-8°C). Used by clinicians for management of various acute and chronic wounds, including pressure, venous, diabetic, and surgical wounds. Acts as a wound dressing to support wound management. Benefits include biocompatible, biodegradable scaffold for wound healing.

Clinical Evidence

Bench testing only. Biocompatibility established via non-clinical in vitro (cytotoxicity) and in vivo (sensitization, intracutaneous reactivity) testing per ISO 10993-1. Sterility validated per USP<71>.

Technological Characteristics

Material: 2.6% (26 mg/mL) fibrillar bovine Type I collagen in isotonic buffer with protein stabilizers. Form: Fibrillar gel. Storage: Refrigerated (2-8°C). Sterilization: USP<71> compliant. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for management of partial/full thickness wounds, pressure/venous/diabetic/chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's/laser, podiatric, dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. Contraindicated for individuals with known sensitivity to bovine-derived products.

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)

Submission Summary (Full Text)

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K 110318

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# 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 [e-mail]

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

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

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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.

#### 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 | | | | | |
|------------------|-----------------------|--------------------------------------------|---------------------------------|------------------------|-----------------------------|--------------------|--------------------|
| | | Integra<br>Flowable | Stimulen | Medifil Gel | HyCure | Collatek | Heliderm |
| 510(k)<br>Number | pending | K072113 | K030774 | K910994 | K955506 | K012990 | K990086 |
| Material | Type I<br>collagen | Type I<br>collagen<br>(x-linked +<br>GAGs) | Soluble<br>modified<br>collagen | Type I<br>collagen | Type I<br>collagen<br>(96%) | Type I<br>collagen | Type I<br>collagen |
| Source | Bovine | Bovine | Bovine | Bovine | Bovine | Bovine | Bovine |
| Form | Fibrillar Gel | Hydrated<br>Granules | Gel | Collagen<br>Suspension | 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 | Refrigerated<br>2-8°C | Room<br>Temp | Room<br>Temp | Refrigerated<br><16°C | Room<br>Temp | Not<br>available | Room<br>Temp |

# 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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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

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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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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:

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.

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