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K Number
K112399
Device Name
UNITE BIOMATRIX
Manufacturer
SYNOVIS ORTHOPEDIC & WOUNDCARE
Date Cleared
2011-09-07

(19 days)

Product Code
KGN
Regulation Number
N/A
Type
Special
Panel
General & Plastic Surgery
Reference & Predicate Devices
K071425,K061711
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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)
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.

AI/ML Overview

This is a 510(k) premarket notification for the Unite® Biomatrix from Synovis Orthopedic and Woundcare, Inc. The document states that the device is substantially equivalent to a previously cleared device. Therefore, a de-novo study is not required.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and reported device performance:

The document does not specify explicit "acceptance criteria" in terms of statistical thresholds (e.g., sensitivity, specificity, accuracy percentages) for clinical performance. Instead, the substantial equivalence decision is based on:

Acceptance Criterion (Implicit)Reported Device Performance (as stated for "substantial equivalence")
Intended UseIdentical to predicate device (Unite® Biomatrix, K071425), Equivalent to predicate device (Oasis® Wound Matrix, K061711)
TechnologyIdentical to predicate device (Unite® Biomatrix, K071425), Equivalent to predicate device (Oasis® Wound Matrix, K061711)
DesignIdentical to predicate device (Unite® Biomatrix, K071425), Equivalent to predicate device (Oasis® Wound Matrix, K061711)
MaterialsIdentical to predicate device (Unite® Biomatrix, K071425)
PerformanceIdentical to predicate device (Unite® Biomatrix, K071425)
Safety (Sterility & Endotoxin)Passed USP sterility test; Satisfies FDA requirements for LAL endotoxin limit for a medical device.

2. Sample size used for the test set and data provenance:

  • Sample size: Not applicable. This document is a 510(k) submission based on substantial equivalence to existing devices, not a new clinical study with a "test set" and outcome data for the device itself.
  • Data provenance: Not applicable for a new clinical study. The "provenance" here relates to the predicate devices which are already cleared for commercial distribution in the United States.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

  • Not applicable. No new test set for clinical performance was generated for this 510(k) submission.

4. Adjudication method for the test set:

  • Not applicable. No new test set for clinical performance was generated.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers with vs. without AI assistance:

  • Not applicable. This device is a biomatrix, not an AI or imaging diagnostic tool. No MRMC study was performed.

6. If a standalone (algorithm only without human-in-the-loop performance) was done:

  • Not applicable. This device is a biomatrix, not an algorithm.

7. The type of ground truth used:

  • The "ground truth" for this 510(k) submission is the established safety and efficacy of the predicate devices (Unite® Biomatrix, K071425, and Oasis® Wound Matrix, K061711) which have already been cleared by the FDA. The new device is deemed substantially equivalent based on its identical characteristics to the primary predicate.

8. The sample size for the training set:

  • Not applicable. This is not a study involving a training set for machine learning.

9. How the ground truth for the training set was established:

  • Not applicable. This is not a study involving a training set for machine learning.

In summary:

The provided document is a 510(k) premarket notification for a medical device (Unite® Biomatrix) seeking clearance based on substantial equivalence to already legally marketed predicate devices. It does not describe a new clinical study or a study to demonstrate performance against specific numerical acceptance criteria. The "study" mentioned is the comparison to predicate devices, focusing on fundamental characteristics like intended use, technology, design, materials, and performance, along with basic safety tests (sterility and endotoxin). The acceptance criteria are therefore implicitly based on demonstrating that the new device shares these essential characteristics with the cleared predicates, and meets basic safety standards.

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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 150Irvine, CA 92618
C.Company Phone:(949) 502-3240
D.Company Facsimile:(949) 502-3241
E.Contact Person:Amy BouclyManager, Regulatory Affairsamy.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

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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.

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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

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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

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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

N/A