(142 days)
Not Found
No
The document describes a biological surgical mesh and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a surgical mesh indicated for the reinforcement and repair of soft tissues, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device, ProPatch™ Soft Tissue Repair Matrix, is a surgical mesh intended to reinforce soft tissues, not to diagnose medical conditions.
No
The device description clearly states that ProPatch™ Soft Tissue Repair Matrix is an "acellular bovine pericardia based surgical mesh," which is a physical, implantable material, not software.
Based on the provided information, the ProPatch™ Soft Tissue Repair Matrix is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- ProPatch™ Function: The ProPatch™ is a surgical mesh intended to be implanted inside the body to reinforce soft tissues during surgical procedures. It provides structural support and a scaffold for tissue regeneration.
- Intended Use: The intended use clearly describes surgical procedures and reinforcement of tissues within the body, not testing of samples outside the body.
- Device Description: The description details a surgical mesh made from bovine pericardium, designed for implantation.
- Performance Studies: The performance studies focus on the mechanical properties and biocompatibility of the implanted material, not on the accuracy or reliability of diagnostic tests.
Therefore, the ProPatch™ Soft Tissue Repair Matrix is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ProPatch™ Soft Tissue Repair Matrix is indication to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floration of the reinforcement, and reconstructive procedures.
ProPatch™ Soft Tissue Repair Matiz is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendone repair surgery including reinforcement of solt used as them soft includes, biceps, quadriceps, or other tendons.
ProPatch™ Soft Tissue Repair Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendor to the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. ProPatch™ Soft Tissue Repair Matrix reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
FTM, OXB, OXE, OXH, OWY
Device Description
ProPatch™ Soft Tissue Repair Matrix is an acelluar bovine pericardia based surgical mesh. Product configurations consist of a 7 cm round and a 5 x 8 cm oval shapes, and configurations from 1 x 1 cm to 9 x 19 cm. Each surgical mesh is packaged ready to use within a clear peel-away inter pouch, and a foil laminte peelaway outer pouch. The packaged product is supplied sterile and non-pyrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, abdominal and thoracic wall, muscle flap, rectal and vaginal, pelvic, tendon, rotator cuff, patellar, Achilles, biceps, quadriceps
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)
Tissue biomechanics and functional performance testing of ProPatch™ was performed in accordance with the Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (revision: 03/02/1999). Results these tests demonstrate that the product has acceptable tensile strength, stiffines, tear resistance, suture retention strength, and burst and in Diocompatibility testing was performed to meet the Intropies include of the device users at ingl. Drocontinent and support suitable biocompatibility of the product Intramuscular implants of the device were found to be non-irritating relative to the producte control article.
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.
K043388, K031969, K001738, K982330
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
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
NOV 2 2 2006
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92.
| Submitter: | CryoLife, Inc.
1655 Roberts Blvd., NW
Kennesaw, GA 30144
(770) 419-3355 | Contact Person: | John D. Ferros
Director, Regulatory Affairs |
|---------------|----------------------------------------------------------------------------------|-------------------------------------|------------------------------------------------|
| Device Names: | Device Trade Name: | ProPatch™ Soft Tissue Repair Matrix | |
| | Common/Usual Name: | Surgical Mesh | |
| | Proposed Classification Name: | Surgical Mesh (Product Code: FTM) | |
Intended Use:
ProPatch™ Soft Tissue Repair Matrix is indication to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floration of the reinforcement, and reconstructive procedures.
ProPatch™ Soft Tissue Repair Matiz is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendone repair surgery including reinforcement of solt used as them soft includes, biceps, quadriceps, or other tendons.
ProPatch™ Soft Tissue Repair Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendor to the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. ProPatch™ Soft Tissue Repair Matrix reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.
Predicate Devices:
| Device | Company | 510 (k) Number(s),
Clearance Date | Product
Code |
|-----------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------|-----------------|
| OrthADAPTTM
Bioimplant | Pegasus Biologics
6 Jenner, Suite 150
Irvine, CA 92618 | K043388 – 08/05/2005 | FTM |
| Restore® Orthobiologic
Soft Tissue Implant | Depuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46581 | K031969 – 07/28/2003
K001738 – 12/27/2000
K982330 – 09/25/1998 | FTM |
Device Description:
ProPatch™ Soft Tissue Repair Matrix is an acelluar bovine pericardia based surgical mesh. Product configurations consist of a 7 cm round and a 5 x 8 cm oval shapes, and configurations from 1 x 1 cm to 9 x 19 cm. Each surgical mesh is packaged ready to use within a clear peel-away inter pouch, and a foil laminte peelaway outer pouch. The packaged product is supplied sterile and non-pyrogenic.
Testing Supporting Substantial Equivalence:
Tissue biomechanics and functional performance testing of ProPatch™ was performed in accordance with the Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (revision: 03/02/1999). Results these tests demonstrate that the product has acceptable tensile strength, stiffines, tear resistance, suture retention strength, and burst and in Diocompatibility testing was performed to meet the Intropies include of the device users at ingl. Drocontinent and support suitable biocompatibility of the product Intramuscular implants of the device were found to be non-irritating relative to the producte control article.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2014
CryoLife, Inc. % Mr. John D. Ferros Manager, Regulatory Affairs 1655 Roberts Boulevard Northwest Kennesaw, Georgia 30144
Re: K061892
Trade/Device Name: ProPatch™ Soft Tissue Repair Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXB, OXE, OXH, OWY Dated: October 12, 2006 Received: October 13, 2006
Dear Mr. Ferros:
This letter corrects our substantially equivalent letter of November 22, 2006.
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. Iisting 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
2
Page 2 - Mr. John D. Ferros
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.
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
3
Indications for Use
510(k) Number (if known): K061892
Device Name: ProPatch Soft Tissue Repair Matrix
Indications for Use:
ProPatch Soft Tissue Repair Matrix is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures.
ProPatch Soft Tissue Repair Matrix is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
ProPatch Soft Tissue Repair Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. ProPatch Soft Tissue Repair Matrix reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)