(19 days)
Not Found
No
The summary describes a biological matrix for wound management and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is intended for the management of moderately to severely exudating wounds, indicating its use in treating a medical condition.
No
The device is described as an extracellular matrix (xenograft) intended for wound management, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is an "animal-derived extracellular matrix (xenograft)" and a "decellularized equine pericardial extracellular matrix," which are physical, biological materials, not software.
Based on the provided information, the Synovis Orthopedic and Woundcare Unite® Biomatrix is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the management of wounds, which is a therapeutic application on the body, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a biomatrix for wound healing, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the Unite® Biomatrix is a medical device intended for direct application to wounds, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Synovis Orthopedic and Woundcare Unite® Biomatrix is an animal-derived extracellular matrix (xenograft) intended for the management of moderately to severely exudating wounds, including:
- Partial and full thickness wounds
- Draining wounds
- Pressure sores/ulcers
- Venous ulcers
- Chronic vascular ulcers
- Diabetic ulcers
- Trauma wounds (e.g., abrasions, lacerations, partial thickness [second-degree] 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 Unite® Biomatrix is a decellularized equine pericardial extracellular matrix (xenograft) which has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use. The device is for single use, single patient application 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)
Not Found
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
KII2399
1
2
SEP - 7 2011
Synovis Orthopedic and Woundcare, Inc.
Special 510(k) Unite® Biomatrix
510(K) SUMMARY
| Company Name: | Synovis Orthopedic and Woundcare, Inc. | |
|---|---|---|
| B. | Company Address: | 6 Jenner, Suite 150 |
| Irvine, CA 92618 | ||
| C. | Company Phone: | (949) 502-3240 |
| D. | Company Facsimile: | (949) 502-3241 |
| E. | Contact Person: | Amy Boucly |
| Manager, Regulatory Affairs | ||
| amy.boucly@synovisorthowound.com | ||
| F. | Date: | August 18, 2011 |
| A. | Device Trade Name: | Unite® Biomatrix |
| B. | Common Name: | Animal-derived extracellular matrix |
| (xenograft) wound care product | ||
| C. | Classification Name(s): | Unclassified |
| D. | Classification Regulation: | Unclassified |
| E. | Device Class: | Unclassified |
| F. | Product Code(s): | KGN |
| G. | Advisory Panel: | General and Plastic Surgery |
3 Identification of Predicate Devices
The Unite™ Biomatrix is substantially equivalent to the following devices, which are cleared for commercial distribution in the United States:
- · Unite® Biomatrix, Pegasus Biologics (K071425)
- · Oasis® Wound Matrix, Cook Biotech Incorporated (K061711)
4 Device Description
The Unite® Biomatrix is a decellularized equine pericardial extracellular matrix (xenograft) which has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for
Page 1/2
1
LAL endotoxin limit for a medical device. The product must be rinsed prior to use. The device is for single use, single patient application only.
5 Indications for Use
The Synovis Orthopedic and Woundcare Unite® Biomatrix is an animal-derived extracellular matrix (xenograft) intended for the management of moderately to severely exudating wounds, including:
- · Partial and full thickness wounds
- · Draining wounds
- Pressure sores/ulcers .
- · Venous ulcers
- · Chronic vascular ulcers
- · Diabetic ulcers
- · Trauma wounds (e.g., abrasions, lacerations, partial thickness [seconddegree] burns, skin tears)
- . Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced surgical incisions)
Substantial Equivalence 6
The Unite® Biomatrix is identical to the predicate device (Unite® Biomatrix, Pegasus Biologics) in terms of intended use, technology, design, materials and performance and is equivalent to the Oasis Wound Matrix in terms of intended use, technology, and design.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MID 20993-0002
Synovis Orthopedic and Woundcare, Inc. % Ms. Amy Boucly Manager. Regulatory Affairs 6 Jenner Street. Suite 150 Irvine, California 92618
Re: K112399
Trade/Device Name: Unite® Biomatrix Regulatory Class: Unclassified Product Code: KGN Dated: August 18, 2011 Received: August 19, 2011
2011
Dear Ms. Boucly:
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
3
Page 2 - Ms. Amy Boucly
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/McdicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K112399 .
Device Name: Unite® Biomatrix
Indications For Use:
The Synovis Orthopedic and Woundcare Unite® Biomatrix is an animal-derived extracellular matrix (xenograft) intended for the management of moderately to severely exudating wounds, including:
- · Partial and full thickness wounds
- · Draining wounds
- Pressure sores/ulcers
- Venous ulcers
- Chronic vascular ulcers
- Diabetic ulcers
- · Trauma wounds (e.g., abrasions, lacerations, partial thickness [second-degree] burns, skin tears)
- · Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced surgical incisions)
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Knorofu MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Device
510(k) Number K112399