ENDOFORM DERMAL TEMPLATE

K092096 · Mesynthes, Ltd. · KGN · Jan 21, 2010 · SU

Device Facts

Record IDK092096
Device NameENDOFORM DERMAL TEMPLATE
ApplicantMesynthes, Ltd.
Product CodeKGN · SU
Decision DateJan 21, 2010
DecisionSESE
Submission TypeTraditional
Device ClassClass U
AttributesTherapeutic

Intended Use

Endoform™ is supplied sterile and is intended for single use in the treatment of the following wounds: - 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) - draining wounds

Device Story

Endoform™ Dermal Template is a sterile, ovine collagen-based wound dressing; supplied as intact, perforated, or meshed sheets (9cm2 to 400cm2). Applied by clinicians to manage various wound types including ulcers, surgical sites, and trauma wounds. Acts as a scaffold to support wound healing. No electronic or software components.

Clinical Evidence

Bench testing only. Extensive non-clinical testing performed to assess biocompatibility and performance.

Technological Characteristics

Ovine collagen-based wound dressing; supplied as sterile, intact, perforated, or meshed sheets. Dimensions range from 9cm2 to 400cm2. No energy source or software.

Indications for Use

Indicated for patients with partial/full-thickness wounds, pressure/venous/diabetic/chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites, grafts, post-Moh's/laser/podiatric surgery, dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ JAN 8 1 2010 # 510(k) Summary for the Mesynthes Limited, Endoform™ Dermal Template #### 1. SUBMITTER/510(K) HOLDER Mesynthes Ltd 69 Gracefield Road Lower Hutt Wellington New Zealand 5010 Contact Person Brian Ward Telephone: (+64 4) 931-3275 Date Prepared: July 10, 2009 #### 2. DEVICE NAME Proprietary Name: Endoform™ Dermal Template Common/Usual Name: Endoform™ Classification Name: Collagen Wound Dressing # 3. PREDICATE DEVICES - 피 OaSIS® Wound Matrix (Cook Biotech) (K061711, K973170, K993948) - 트 UBM Lyophilized Wound Dressing (MatriStem™) (ACell) (K021637) - . Unite Biomatrix™ (Pegasus Biologics) (K071425) - . Promogran® Matrix Wound Dressing (Johnson and Johnson) (K014129) - 트 IntegraTM Wound Matrix (Integra Life Sciences) (K021792) #### 4. DEVICE DESCRIPTION Endoform™ Dermal Template is a wound dressing primarily composed of ovine collagen and is supplied as a sterile intact, perforated or meshed sheet ranging in size from 9cm2 to 400cm2. {1}------------------------------------------------ K092096 page 2/2 ## 5. INTENDED USE Endoform™ is supplied sterile and is intended for single use in the treatment of the following wounds: - · 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) - · draining wounds # 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE The Endoform™ Dermal Template is substantially equivalent to the predicate devices with respect to material composition, device characteristics and intended use, #### 7. PERFORMANCE TESTING The Endoform™ Dermal Template has been subjected to extensive non-clinical testing to assess the biocompatibility and the performance of the device. Endoform™ Dermal Template was shown to be safe and effective as a wound dressing. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. JAN 2 1 2010 Food and Drug Administration 10903 New Hampshire Avenue Dacument Control Room W-066-0609 Silver Spring, MD 20993-0002 Mesynthes Limited % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane, RAC Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760 Re: K092096 Trade/Device Name: Endoform™ Dermal Template Regulatory Class: Unclassified Product Code: KGN Dated: December 21, 2009 Received: December 22, 2009 Dear Ms. McNamara-Cullinane: 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 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 {3}------------------------------------------------ Page 2 - Ms. Mary McNamara-Cullinane, RAC 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/cdrh/mdr/ 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Sincerely yours, Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Endoform™ Dermal Template Indications for Use: The Endoform™ Dermal Template is supplied sterile and is intended for single use in the treatment of the following wounds: - � 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) - draining wounds � Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David Krause kamxm (Division Sign Off) Division of Surgical, Orthopedic. and Restorative Devices 510(k) Number K092096
Innolitics
510(k) Summary
Decision Summary
Classification Order
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