(451 days)
No
The device description and performance studies focus on the biological and structural properties of the wound matrix, with no mention of AI or ML.
Yes
The device is indicated for the management of various types of wounds, including partial and full-thickness wounds, ulcers, and surgical wounds, which are conditions that require therapeutic intervention.
No
The device description and intended use indicate that XenoMem™ Wound Matrix is a wound management product designed to support the healing environment, not to diagnose medical conditions.
No
The device description clearly states it is an acellular, porcine peritoneal matrix, which is a physical biological 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 for the management of various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a biological matrix used as a wound dressing. It does not describe any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of Diagnostic Information: There is no mention of the device being used to detect, measure, or analyze any substances or characteristics in a biological sample to provide diagnostic information.
- Performance Studies: The performance studies focus on the physical properties, safety, and biological compatibility of the wound matrix, not on its ability to perform a diagnostic test.
Therefore, XenoMem™ Wound Matrix is a medical device intended for wound management, not an in vitro diagnostic device.
N/A
Intended Use / 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 deliscence),
- · Trauma wounds (abrasions, lacerations, second-degree burns, skin tears);
- Draining wounds.
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
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.
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)
Evaluation to Demonstrate Substantial Equivalence:
- tensile strength (with and without fenestration), Met requirements
- thickness, Met requirements
- residual DNA analysis, Met requirements
- packaging validation and post shelf-life product performance, Met requirements
- sterility validation to SAL 10-6, Met requirements
- biocompatibility per ISO 10993-1 & FDA guidance, Met requirements
- residual chemical risk assessment, Risks deemed acceptable
- viral inactivation studies., Reduced to acceptable levels
- differential scanning calorimetry (DSC), Met requirements
Conclusion:
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.
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.
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 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
1
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
2
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
4
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 Matrix | |
| Porcine Small Intestinal Submucosa | Non Cross Linked Extra Cellular Matrix |
| Porcine Peritoneal Membrane | |
| Nominal Size | Nominal Size |
| 3 cm X 3.5 cm | |
| 3 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 |
5
510(k) Summary-Continued
SUMMARY OF TESTING and RESULTS SUPPORTING SUBSTANTIAL
EQUIVALENCE:
| Evaluation to Demonstrate Substantial
| Equivalence | Conclusion |
|---|---|
| 1) tensile strength (with and without | |
| fenestration), | Met requirements |
| 2) thickness | Met requirements |
| 3) residual DNA analysis | Met requirements |
| 4) packaging validation and post shelf-life | |
| product performance | Met requirements |
| 5) sterility validation to SAL 10-6 | Met requirements |
| 6) biocompatibility per ISO 10993-1 & FDA | |
| guidance | 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.