(29 days)
Not Found
No
The device description focuses on the material composition and mechanical properties of a bioimplant, with no mention of AI or ML technologies. The performance studies described are standard biocompatibility and biomechanical testing, not related to algorithmic performance.
Yes
The device is used to reinforce soft tissue and support tendon repair, which aligns with the definition of a therapeutic device as something that treats or ameliorates a condition.
No
The device is described as an implant used to reinforce soft tissue, not to diagnose conditions. Its function is to support and strengthen existing tissues after repair or during reconstructive procedures.
No
The device description clearly states it is comprised of a collagen matrix and woven polymer, which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for implantation to reinforce soft tissue in various parts of the body. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a collagen matrix reinforced by a polymer, derived from equine tissue, and sterilized. This is consistent with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) outside the body to diagnose a condition, monitor treatment, or screen for diseases. The device's function is structural reinforcement within the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
PROseries™ Bioimplants are intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures.
The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
PROseries Bioimplants are 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.
Product codes
FTM, FTL
Device Description
PROseries Bioimplants are comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, derived from equine pericardial tissue, has been decellularized and crosslinked and the entire device has been exposed to a liquid chemical sterilant. The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use following the procedures described in the Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal and thoracic wall, muscle, tendons (rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons)
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)
Biocompatibility testing, biomechanical bench testing, and in vivo performance testing have been conducted to evaluate the biological safety and biomechanical performance characteristics of PROseries Bioimplants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) SUMMARY
K112786
OCT 25 2011
Submitter Information 1
2
| A. | 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 | ||
| F. | Date: | October 17, 2011 |
| Device Identification | ||
| A. | Device Trade Name: | PROseriesTM Bioimplants-PROcuffTM/PROankleTM |
| B. | Models: | PROcuffTM, PROankleTM, PROxxx (TBD) |
| C. | Common Name: | Surgical Mesh |
| D. | Classification Name(s): | Mesh, Surgical |
| E. | Classification Regulation: | 878.3300 |
| F. | Device Class: | Class II |
| G. | Device Code(s): | FTM, FTL |
| H. | Advisory Panel: | General and Plastic Surgery |
3 Identification of Predicate Device
The PROseries™ Bioimplants – PROcuff™/PROankle™ are substantially equivalent to the OrthADAPT® PR Bioimplant, Pegasus Biologics, Inc., K090288.
4 Device Description
PROseries Bioimplants are comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, derived from equine pericardial tissue, has been decellularized and crosslinked and the entire device has been exposed to a liquid chemical sterilant. The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use following the procedures described in the Instructions for Use.
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5 Statement of Intended Use
PROseries™ Bioimplants are intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures.
The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
PROseries Bioimplants are 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.
Biocompatibility and Performance Data 6
Biocompatibility testing, biomechanical bench testing, and in vivo performance testing have been conducted to evaluate the biological safety and biomechanical performance characteristics of PROseries Bioimplants.
7 Comparison with Predicate Devices
The PROseries Bioimplants are identical to the predicate device in terms of design, technology, intended use, materials, performance and processing methods.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synovis Orthopedic and Woundcare, Inc. % Ms. Amy Boucly Manager, Regulatory Affairs 6 Jenner Street, Suite 150 Irvine, California 92618
OCT 2 5 2011
Re: K112786
Trade/Device Name: PROseries Bioimplants – PROcuff"/PROankle"* Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM, FTL Dated: September 23, 2011 Received: September 27, 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
3
Page 2 - Ms. Amy Boucly
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 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/MedicalDevices/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,
For No. 10.11.20
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): K112786
Device Name:
PROseries Bioimplants - PROcuff /PROankle
Indications For Use:
PROseries™ Bioimplants are intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, abuominal and other reconstructive procedures.
The device is also intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
PROseries Bioimplants are 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.
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)
Dail Kucie for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112786
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