(451 days)
XenoMem™ Wound Matrix is indicated for the management of wounds including:
- · Partial and full-thickness wounds;
- · Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers;
- · Tunnelled/undermined wounds
- · Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound deliscence),
- · Trauma wounds (abrasions, lacerations, second-degree burns, skin tears);
- Draining wounds.
XenoMem™ Wound Matrix is an acellular, porcine peritoneal matrix, supplied sterile to maintain and support an environment for wound management. It consists of an extracellular tissue matrix, derived from porcine peritoneum. XenoMem™ Wound Matrix porcine peritoneal membrane provides a robust biological matrix that allows for easier handling during preparation and application of the wound dressing. The membrane has undergone a decellularisation, viral inactivation and a freeze-drying process in order to remove donor genetic material, in a non-destructive manner, so as to maintain the structure and function of the tissue. XenoMem is sterilized via gamma irradiation and sold for prescription only.
The provided text describes the 510(k) summary for the XenoMem™ Wound Matrix device, focusing on its substantial equivalence to predicate devices rather than a study proving the device meets specific performance acceptance criteria for a new clinical claim. This document is a regulatory submission for market clearance based on comparing the new device to existing legally marketed devices.
Therefore, the information requested in your prompt regarding acceptance criteria for a new clinical claim, a study that proves it, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies is not available in the provided text.
The closest information available is a "Summary of Testing and Results Supporting Substantial Equivalence," which describes various bench and analytical tests performed to show that the XenoMem™ Wound Matrix is comparable to its predicate device (Oasis® Wound Matrix).
Here's the information that can be extracted from the provided text, reformatted to align with your request, and highlighting the missing elements:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Internal Requirements for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Bench/Analytical Tests: | Met Requirements |
| 1. Tensile strength (with and without fenestration) | Met requirements |
| 2. Thickness | Met requirements |
| 3. Residual DNA analysis | Met requirements |
| 5. Sterility validation to SAL 10-6 | Met requirements |
| 6. Biocompatibility per ISO 10993-1 & FDA guidance | Met requirements |
| 9. Differential scanning calorimetry (DSC) | Met requirements |
| Other Tests: | |
| 4. Packaging validation and post shelf-life product performance | Met requirements |
| 7. Residual chemical risk assessment | Risks deemed acceptable |
| 8. Viral inactivation studies | Reduced to acceptable levels |
Important Note: These are not performance acceptance criteria for a clinical claim in the traditional sense, but rather a list of tests conducted to support the claim of substantial equivalence to a predicate device for regulatory clearance. The "met requirements" indicates the device performed comparably to the predicate or within predefined industry standards for these specific properties.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available. The document does not describe specific "test sets" or clinical studies with human participants that would typically have sample sizes and data provenance details. The tests listed are primarily bench (in vitro) and analytical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not available. No ground truth establishment by external experts is described for these bench and analytical tests. The "ground truth" for these tests would be the established scientific methods and acceptable ranges for each parameter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available. No adjudication method is described as this document pertains to laboratory and analytical testing for substantial equivalence, not a clinical study requiring human interpretation or consensus.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not available. This device is a wound matrix, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available. As above, this is a physical medical device (wound matrix), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the tests listed (tensile strength, thickness, residual DNA, sterility, biocompatibility, DSC, etc.), the "ground truth" would be established scientific and engineering standards, ISO standards, and relevant FDA guidance documents for medical device materials and manufacturing. This is not "expert consensus" or clinical outcomes data in the context of diagnostic performance.
8. The sample size for the training set
- Not applicable/Not available. No "training set" is described as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable/Not available. No training set is described.
In summary, the provided document is an FDA 510(k) clearance letter and summary for a physical medical device (wound matrix). It demonstrates substantial equivalence based on material properties, manufacturing processes, and safety testing, as opposed to a clinical study proving new diagnostic or treatment efficacy claims with specific acceptance criteria that would involve human experts, large test sets, or AI performance metrics.
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Image /page/0/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 human profiles incorporated into its body. The profiles are facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2015
Viscus Biologies LLC Ms. Elaine Duncan Paladian Medical Incorporated P.O. Box 560 Stillwater, Minnesota 55082
Re: K140820
Trade/Device Name: XenoMem™ Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: June 24, 2015 Received: June 25, 2015
Dear Ms. Duncan:
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. 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
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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 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/ResourcesforYou/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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
Indications for Use
510(k) Number (if known) Pending
Device Name
XenoMem(tm) Wound Matrix
Indications for Use (Describe)
XenoMem™ Wound Matrix is indicated for the management of wounds including:
- · Partial and full-thickness wounds;
- · Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers;
- · Tunnelled/undermined wounds
- · Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound deliscence),
- · Trauma wounds (abrasions, lacerations, second-degree burns, skin tears);
- Draining wounds.
Type of Use (Select one or both, as applicable)
_ 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)
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510(K) SUMMARY
TRADITIONAL 510(k)
Submitter- Manufacturer: Viscus Biologics LLC, Peter Gingras, CEO Viscus Biologics LLC, Dayton, OH 45402, USA.
Tel: +1 216 658 4111
Submitted by and Contact Person
| Elaine Duncan | |
|---|---|
| Paladin Medical, Inc. | |
| P.O. Box 560 | |
| Stillwater, MN 55082 | |
| 715-549-6035 | |
| 715-549-5380 | |
| CONTACT PERSON: | Elaine Duncan |
| DATE PREPARED: | June 26, 2015 |
| TRADE NAME: | XenoMem™ Wound Matrix |
| COMMON NAME: | Topical Wound Dressing |
| CLASSIFICATION NAME: | Dressing, Wound, Collagen |
| REGULATION | Unclassified |
| PROCODE and CLASS | General and Plastic Surgery, KGN: Unclassified |
INDICATIONS FOR USE:
XenoMem™ Wound Matrix is indicated for the management of wounds including:
- . Partial and full-thickness wounds;
- Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers;
- Tunnelled/undermined wounds
- Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence),
- Trauma wounds (abrasions, lacerations, second-degree burns, skin tears);
- . Draining wounds.
DESCRIPTION of the DEVICE:
XenoMem™ Wound Matrix is an acellular, porcine peritoneal matrix, supplied sterile to maintain and support an environment for wound management. It consists of an extracellular tissue matrix, derived from porcine peritoneum. XenoMem™ Wound Matrix porcine peritoneal membrane provides a robust biological matrix that allows for easier handling during preparation and application of the wound dressing. The membrane has undergone a decellularisation, viral inactivation and a freeze-drying process in order to remove donor genetic material, in a non-destructive manner, so as
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to maintain the structure and function of the tissue. XenoMem is sterilized via gamma irradiation and sold for prescription only.
SUBSTANTIALLY EQUIVALENT TO:
XenoMem™ Wound Matrix is substantially equivalent to Oasis® Wound Matrix, cleared with Special 510(k) K061711, which is in turn based on SS Matrix cleared via Traditional 510(k) K020732. Oasis Ultra, a line extension, is a triple layer version of Oasis Wound Matrix. Cook Biotech, Inc. manufactures these predicate devices. XenoMem™ Wound Matrix has the same indications, intended use, and the same or similar technological characteristics, principles of operation and performance properties to the Oasispredicates. K112888 (Kensey-Nash Meso Wound Matrix) and K094061 (Kensey-Nash ECM Surgical Patch) are included as Reference Predicates because these devices are also manufactured from porcine peritoneum.
| Oasis® Wound Matrix | XenoMem™ Wound Matrix |
|---|---|
| K061711/K020732 | Pending |
| Cook Biotech, Inc. | Viscus Biologics, LLC |
| Indication: | Indication: |
| The Oasis Wound Matrix is intended for the | XenoMem™ Wound Matrix is indicated for the |
| management of wounds including: | management of wounds including: |
| • Partial and full thickness wounds; | • Partial and full thickness wounds: |
| • Pressure ulcers; | • Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers; |
| • Venous ulcers | • Tunneled/ undermined wounds |
| • Diabetic ulcers | • Surgical wounds (donor sites/grafts, post- |
| • Chronic vascular ulcers; | Mohs' surgery, post-laser surgery, podiatric, wound dehiscence) |
| • Tunneled, undermined wounds; | • Trauma wounds (abrasions, laceration, second-degree burns, and skin tears) |
| • Surgical wounds (donar sites/grafts, post Moh's surgery, post-laser surgery, podiatric, wound dehiscence); | • Draining wounds. |
| • Trauma wounds (abrasions, laceration, second-degree burns, and skin tears) | |
| • Draining wounds. | |
| The device is intended for one-time use. | |
| Material and Origin | Material and Origin |
| Non Cross Linked Extra Cellular MatrixPorcine Small Intestinal Submucosa | Non Cross Linked Extra Cellular MatrixPorcine Peritoneal Membrane |
| Nominal Size | Nominal Size |
| 3 cm X 3.5 cm3 cm X 7 cm | 3 cm X 3.5 cm 3 cm X 7 cm |
| 7 X 10 cm 10 cm X 15 cm | |
| Fenestrated | Sold non-fenestrated; |
| Can be fenestrated for conformability; see IFU | |
| Sterilization method ETO | Sterilization method Gamma |
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510(k) Summary-Continued
SUMMARY OF TESTING and RESULTS SUPPORTING SUBSTANTIAL
EQUIVALENCE:
| Evaluation to Demonstrate SubstantialEquivalence | Conclusion |
|---|---|
| 1) tensile strength (with and withoutfenestration), | Met requirements |
| 2) thickness | Met requirements |
| 3) residual DNA analysis | Met requirements |
| 4) packaging validation and post shelf-lifeproduct performance | Met requirements |
| 5) sterility validation to SAL 10-6 | Met requirements |
| 6) biocompatibility per ISO 10993-1 & FDAguidance | Met requirements |
| 7) residual chemical risk assessment | Risks deemed acceptable |
| 8) viral inactivation studies. | Reduced to acceptable levels |
| 9) differential scanning calorimetry (DSC) | Met requirements |
Therefore, it is concluded that results of testing and comparative analysis have shown that any technological differences between the XenoMem™ and Oasis® wound dressing do not change the intended therapeutic use and do not introduce any new issues of safety and effectiveness.
N/A