← Product Code KGN · K140456 # BIO-CONNEKT WOUND MATRIX (K140456) _MLM Biologics, Inc. · KGN · Jul 22, 2014 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K140456 ## Device Facts - **Applicant:** MLM Biologics, Inc. - **Product Code:** KGN - **Decision Date:** Jul 22, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use The MLM Biologics bio-ConneKt Wound Matrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including: Partial and full thickness wounds Draining wounds Tunneling wounds Pressure sores/ulcers Venous ulcers Chronic vascular ulcers Diabetic ulcers Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears) Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, podiatric wounds, dehisced surgical incisions) ## Device Story bio-ConneKt Wound Matrix is a sterile, porous, conformable wound dressing composed of reconstituted equine tendon-derived Type 1 collagen. The collagen is chemically crosslinked to enhance resistance to enzymatic degradation. The device is applied topically to the wound bed by a clinician to manage exudate and support wound healing. It functions as a physical barrier and scaffold for the local management of various wound types. The device is provided sterile for single-use only. It is intended for prescription use. ## Clinical Evidence No clinical testing was performed. Biocompatibility testing was conducted under GLP in accordance with ISO 10993 for surface devices with >30 days contact duration, including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, and genotoxicity. Results supported biocompatibility. ## Technological Characteristics Type 1 collagen derived from equine tendon; chemically crosslinked. Sterile, porous, conformable dressing. Radiation (E-beam) sterilized to SAL 10^-6. Biocompatibility testing per ISO 10993. ## Predicate Devices - Biopad® ([K040283](/device/K040283.md)) - Collagen Wound Dressing ([K112580](/device/K112580.md)) - Integra Matrix Wound Dressing (AVAGEN) ([K022127](/device/K022127.md)) ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for MLM Biologics Inc. On the left is a circular emblem with the text "More for Less for Many" surrounding a globe with a DNA strand. To the right of the emblem is the text "MLM Biologics" with a small "Inc." in the upper right corner. JUL 2 2 2014 # 510(k) Summary # bio-ConneKt Wound Matrix (K140456) | Date: | June 3, 2014 | |----------------------|------------------------------------------------------------------------------------| | Submitted by: | MLM Biologics
12085 Research Drive
Alachua, FL 32615 | | Representative: | Gregg Ritter, MS, RAC
RA/QA Manager
Phone: 352.494.2122
FAX: 386.462.0875 | | Proprietary Name: | bio-ConneKt Wound Matrix | | Common Name: | Collagen Wound dressing | | Classification: | Unclassified | | Classification Code: | KGN | Predicate Devices: | Trade/Proprietary Name | Manufacturer | 510(k) Number | |-------------------------------------------|----------------------------|---------------| | Biopad® | Euroresearch S.R.L. | K040283 | | Collagen Wound Dressing | Dalim Tissen Co. | K112580 | | Integra Matrix Wound Dressing
(AVAGEN) | Integra LifeSciences Corp. | K022127 | Description: The bio-ConneKt Wound Matrix is a sterile, conformable and porous wound dressing made of reconstituted collagen derived from equine tendon. It is chemically crosslinked to provide resistance to enzymatic degradation. The dressing is provided sterile for single use only. - The MLM Biologics bio-ConneKt Wound Matrix is a collagen-Indications for Use: based wound dressing for the local management of moderately to heavily exuding wounds, including: {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for MLM Biologics Inc. The logo consists of a circular emblem on the left, featuring a globe intertwined with a DNA double helix, surrounded by the text "More for Less for Many". To the right of the emblem is the company name "MLM Biologics" in bold, sans-serif font, with "Inc." in a smaller, superscript font. - . Partial and full thickness wounds Draining wounds ● . Tunneling wounds ● Pressure sores/ulcers . Venous ulcers . Chronic vascular ulcers ● Diabetic ulcers . Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears) . Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, podiatric wounds, dehisced surgical incisions) Technological The bio-ConneKt Wound Matrix is similar in materials and Characteristics: design to the predicate devices. The device consists of Type 1 collagen that has been extracted from animal tissue, crosslinked and sterilized. The only differences in to the predicate devices are given below: Biopad - not crosslinked Dalim Tissen Collagen Wound Dressing - composed of twolayer highly purified porcine skin collagen Integra Matrix Wound Dressing - composed of bovine tendon These differences raise no concerns regarding the potential safety of effectiveness of the applicant device. collagen and glycosaminoglycan, glutaraldehyde crosslinker Biocompatibility testing and in vitro bench testing have been Performance Tests: conducted to evaluate the biological safety and characteristics of the bio-ConneKt Wound Matrix. No clinical testing was performed. Biocompatibility testing was performed under Good Laboratory Practices (GLP) accordance with the relevant parts of ISO 10993 Biological Evaluation of Medical Devices. All GLP testing met the criteria for biocompatibility. The testing criteria followed were based on the following medical device categorization: surface device, breached or compromised surface, >30 days contact duration. Tests were done in the following categories: cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity (acute, sub-acute, sub-chronic) and genotoxicity. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for MLM Biologics Inc. The logo features a globe with a DNA strand wrapped around it on the left side. To the right of the globe is the text "MLM Biologics" in a bold, sans-serif font, with "Inc." in a smaller font as a superscript. Results of an appropriate implantation study support the biocompatibility of bio-ConneKt Wound Matrix as compared to a predicate device control. - bio-ConneKt Wound Matrix is radiation (E-beam) sterilized to Sterilization: provide a sterility assurance level of 10°. - bio-ConneKt Wound Matrix is substantially equivalent to the Conclusion: predicate devices in design, material, and indications for use. From the results of non-clinical testing presented in this application MLM Biologics concludes that the bio-ConneKt Wound Matrix is as safe, as effective and performs as well as or better than the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature. Food and Drug Administration 10903 New Hampshire Avenue Document Contral Center - WO66-G609 Silver Spring, MD 20993-0002 July 22, 2014 MLM Biologics Mr. Gregg Ritter, MS. RAC Regulatory Affairs/Quality Assurance Manager 12085 Research Drive Alachua. Florida 32615 Re: K140456 Trade/Device Name: bio-ConneKt Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: June 3, 2014 Received: June 4, 2014 Dear Mr. Ritter: 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 Mav 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 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. {4}------------------------------------------------ Page 2 - Mr. Gregg Ritter, MS, RAC If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/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 Industry and Consumer Education 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, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Orug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. #### 510(k) Number (if known) K140456 Device Name bio-ConneKt Wound Matrix #### Indications for Use (Describe) The MLM Biologics bio-ConneKt Wound Matrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including: - · Partial and full thickness wounds - · Draining wounds - Tunneling wounds - Pressure sores/ulcers - Venous ulcers - · Chronic vascular ulcers - Diabetic ulcer · Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears) · Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, podiatric wounds, dehisced surgical incisions) Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) # Jiyoung Dang -S This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." --- **Source:** [https://fda.innolitics.com/device/K140456](https://fda.innolitics.com/device/K140456) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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