(148 days)
Not Found
No
The 510(k) summary describes a collagen-based wound dressing and its biocompatibility testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is a wound dressing intended for the local management of various exuding wounds, which is a therapeutic purpose.
No
This device is a wound dressing intended for the management of moderately to heavily exuding wounds. It is a treatment device, not a diagnostic one, as it does not diagnose or identify medical conditions.
No
The device description clearly states it is a "sterile, conformable and porous wound dressing made of reconstituted collagen derived from equine tendon," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "collagen-based wound dressing for the local management of moderately to heavy exuding wounds." This describes a device used directly on a patient's body for therapeutic purposes (wound healing).
- Device Description: The description details the physical characteristics and composition of the wound dressing.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health status, disease, or condition. IVDs are used for diagnostic purposes, not for direct treatment of a wound.
The information provided aligns with a medical device intended for wound care, which is a therapeutic application, not an in vitro diagnostic application.
N/A
Intended Use / Indications for 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 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)
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing and in vitro bench testing have been 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.
Results of an appropriate implantation study support the biocompatibility of bio-ConneKt Wound Matrix as compared to a predicate device control.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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
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