← Product Code KGN · K070269 # MODIFICATION TO COLLAWOUND DRESSING (K070269) _Collamatrix Co., Inc. · KGN · Mar 2, 2007 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K070269 ## Device Facts - **Applicant:** Collamatrix Co., Inc. - **Product Code:** KGN - **Decision Date:** Mar 2, 2007 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use CollaWound™ dressing will be used for the management of partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds, first and second degree burns, surgical wounds and superficial injuries. ## Device Story CollaWound™ dressing is a sterile, single-use, disposable wound dressing composed of porcine-derived collagen. It functions as a thin film layer applied to the wound site to maintain a moist environment, facilitating the management of exudating wounds. The device is intended for clinical use by healthcare providers for various wound types, including ulcers, burns, and surgical wounds. It provides a physical barrier and moisture regulation to support wound healing. ## Clinical Evidence No clinical data; safety and substantial equivalence established via product characterization and biocompatibility testing in accordance with ISO 10993/G95-1. ## Technological Characteristics Material: Porcine-derived collagen. Form factor: Thin film dressing. Sterilization: Sterile, single-use. Biocompatibility: Compliant with ISO 10993/G95-1. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # Attachment 9 # COLLAMATRIX Inc. K070369 1/2 # 510(k) summary ## 1. Date Prepared Jan 18, 2007 ## Submitter name and address 2. MAR 0 2 2007 Collamatrix Inc. 2nd F, 360, RuiGuang Road, Neihu, Taipei, 114, Taiwan #### 3. Contact person | Name: | Dennis J. N. Seah | |-------|-------------------| | Tel: | + 886 2 7720 9988 | | Fax: | + 886 2 7720 9900 | ## 4. Device names | Propriety name: | CollaWound™ dressing | |----------------------|-------------------------| | Common name: | Wound dressing | | Classification name: | Collagen wound dressing | ## ડ. Device classification Regulatory class: Product code: Class II unelassified KGN ## 6. Device description CollaWound™ dressing is a sterile, single use, disposable wound dressing device for the management of exudating wounds. It comprises collagen derived from porcine, which forms a layer of thin film to maintain a moist environment at the wound site. ## 7. Intended use CollaWound™ dressing will be used for the management of partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds, first and second degree burns, surgical wounds and superficial injuries. {1}------------------------------------------------ KC70269 2/2 # COLLAMATRIX Inc. ## 8. Statement of Substantial equivalence CollaWound™ dressing is substantially equivalent in material, function, technological characteristics and intended use to its predicate. ## 9. Safety Biocompatibility tests have confirmed that CollaWound™ dressing meets the reguirements stated in ISO 10993/G95-1. # 10. Conclusion The product characterization studies and biocompatibility studies show that the CollaWound™ dressing is safe and substantially equivalent to its predicate device. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES 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 stripes forming its body and wing. The eagle faces left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Collamatrix Co., Inc. % Mr. Dennis J. Seah Manager 2nd F, 360, RuiGuang Road Neihu, Taipei, 114, Taiwan MAR 0 2 2007 Re: K070269 Trade/Device Name: CollaWound™ dressing Regulatory Class: Unclassified Product Code: KGN Dated: January 19, 2007 Received: January 31, 2007 Dear Mr. Seah: 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 such 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); 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. {3}------------------------------------------------ ## Page 2 - Mr. Dennis J. Seah This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark M. Milkezon Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K07-0369 ## 3 Statement of indications for use 510(k) Number (if known): . Device Name: CollaWound™ dressing Indications for Use: CollaWound™ dressing is intended for the management of partial and full-thickness exudating wounds including: - Pressure ulcers - Venous ulcers - Vascular ulcers - Diabetic ulcers - Trauma wounds (abrasions, lacerations, skin tears) - First and second degree burns - Surgical wounds Mark A. Milkersen Division Sign-Off Division of General, Restorative, and Neurological Devices **510(k) Number** K070269 X Prescription Use_ (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) --- **Source:** [https://fda.innolitics.com/device/K070269](https://fda.innolitics.com/device/K070269) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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