(148 days)
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)
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 provided document describes the 510(k) summary for the bio-ConneKt Wound Matrix, which is a medical device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or reader improvement in an AI context.
Therefore, many of the requested items related to an AI device's performance study (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment) are not applicable to this document. This document details a collagen-based wound dressing, not an AI or diagnostic device.
Here's an analysis based on the information available in the provided text, addressing the applicable points:
Acceptance Criteria and Study for bio-ConneKt Wound Matrix (K140456)
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to existing predicate devices, particularly regarding safety and effectiveness, rather than meeting specific quantifiable performance metrics in a clinical trial. The performance reported focuses on non-clinical testing.
| Acceptance Criterion (Demonstrating Substantial Equivalence) | Reported Device Performance (Non-Clinical Testing) |
|---|---|
| Biocompatibility | - Performed under GLP in accordance with relevant parts of ISO 10993 (Biological Evaluation of Medical Devices).- Categorization: surface device, breached/compromised surface, >30 days contact duration.- Tests included: cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity (acute, sub-acute, sub-chronic), genotoxicity.- All GLP testing met criteria for biocompatibility.- Results of an appropriate implantation study support biocompatibility as compared to a predicate device control. |
| Sterility | - Radiation (E-beam) sterilized.- Provides a sterility assurance level (SAL) of 10⁻⁶. |
| Technological Characteristics (Material & Design Similarity) | - Made of Type I collagen from equine tendon, chemically crosslinked, sterile.- Similar in materials and design to predicate devices.- Differences from predicates (e.g., crosslinking presence, animal origin, specific components) were reviewed and determined to raise no concerns regarding potential safety or effectiveness. |
| Indications for Use Similarity | - Indications for use are consistent with those of the predicate devices for local management of moderately to heavily exuding wounds (e.g., partial/full thickness wounds, ulcers, trauma wounds, surgical wounds).- Found to be substantially equivalent in indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical "test set" in the context of an AI device's performance evaluation was used. The evaluation relied on non-clinical (laboratory/bench) testing.
- Data Provenance: Not applicable for clinical data. Non-clinical biocompatibility and sterility testing data were generated internally by MLM Biologics Inc. or contracted labs.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. No human expert review was involved in establishing a "ground truth" for a diagnostic or AI performance evaluation. The evaluation focused on physical and biological properties.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method for a test set was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging or AI interpretation devices, which the bio-ConneKt Wound Matrix is not.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a wound dressing, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable for clinical ground truth. The "ground truth" for this device's evaluation came from established scientific methods for material characterization, biocompatibility testing (in vitro and in vivo animal studies for implantation), and sterility testing (e.g., SAL determination). These are objective measurements rather than expert consensus on clinical cases or pathology.
8. The Sample Size for the Training Set
- Not applicable. There was no "training set" as this is not an AI device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This question pertains to AI development, which does not apply to the bio-ConneKt Wound Matrix.
Summary of Device Evaluation Approach:
The submission for the bio-ConneKt Wound Matrix (K140456) is a 510(k) premarket notification, which aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. For this type of device (a wound dressing), the primary evidence provided is non-clinical testing:
- Biocompatibility testing: Conducted under GLP according to ISO 10993 standards, including various toxicity and reactivity tests. An implantation study was also performed.
- Sterilization validation: Demonstrated a Sterility Assurance Level (SAL) of 10⁻⁶.
- Technological characteristics comparison: Analysis of material composition (Type I collagen, equine tendon, crosslinking) and design compared to predicate devices.
The conclusion drawn by MLM Biologics, and concurred by the FDA (as indicated by the 510(k) clearance letter), is that the bio-ConneKt Wound Matrix is "as safe, as effective and performs as well as or better than the predicate devices" based on these non-clinical tests. No clinical testing was performed or required for this submission.
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JUL 2 2 2014
510(k) Summary
bio-ConneKt Wound Matrix (K140456)
| Date: | June 3, 2014 |
|---|---|
| Submitted by: | MLM Biologics12085 Research DriveAlachua, FL 32615 |
| Representative: | Gregg Ritter, MS, RACRA/QA ManagerPhone: 352.494.2122FAX: 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:
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- . 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.
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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.
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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.
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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
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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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