(212 days)
Not Found
No
The summary describes a bioresorbable, 3D braided physical implant for soft tissue reinforcement. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical and biocompatibility testing of the physical material.
Yes.
The device is intended for the reinforcement of soft tissue, including tendons, during surgical procedures, which constitutes a therapeutic use.
No
The device is described as a bioresorbable, three-dimensionally braided construct intended for the reinforcement of soft tissue, not for identifying or assessing a disease or condition.
No
The device description clearly states it is a physical, bioresorbable, three-dimensionally (3-D) braided construct made of PLLA fiber, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reinforcement of soft tissue where weakness exists" and "reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery". This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details a "bioresorbable, three-dimensionally (3-D) braided construct made of poly-L-lactic-acid (PLLA) fiber". This is a physical material designed to be implanted.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. They are used in vitro (outside the body).
The STR GRAFT is a surgical implant, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The STR GRAFT is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
The STR GRAFT is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
The STR GRAFT is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the tendon repair.
Product codes (comma separated list FDA assigned to the subject device)
OWT, OWW
Device Description
The STR GRAFT is a bioresorbable, three-dimensionally (3-D) braided construct made of poly-L-lactic-acid (PLLA) fiber. The STR GRAFT is available in rectangular and square sizes of 23 mm x 12 mm, 23 mm x 23 mm x 40 mm, and 23 mm x 60 mm; all STR GRAFT devices are approximately 1.0 mm thick; with the thickness comprised of three layers of 3-D braided fiber bundles. The STR GRAFT is supplied sterile (EtO) and is single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, rotator cuff, patellar, Achilles, biceps, or quadriceps 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)
Characterization of STR GRAFT devices was performed per the FDA Guidance Document entitled "FDA Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" issued on March 2. 1999 and ISO 10993 standards for biocompatibility. More specifically, mechanical testing of the devices was performed per ASTM Standards F-2150-07, D3787-07, D2261-07a, D882-10, F2392-04, F1877-05, D4032-08, and D6767-11; the test methods were modified as appropriate regarding the length and width of the STR GRAFT. Biocompatibility testing was performed per ISO Standards 10993-3, -5, -7, -10, and -11. In addition, a 12 week ovine model of rotator cuff repair was performed.
The results of physical, mechanical, in-vivo, and biocompatibility testing indicate that the STR GRAFT possesses appropriate physical and mechanical characteristics for reinforcement of soft tissues where weakness exists.
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
§ 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 FOR K121216
NOV 2 1 2012 1
Soft Tissue Regeneration, Inc. - The STR GRAFT
In accordance with 21 CFR 878.3300, the following information is a summary of the 510(k) information regarding Soft Tissue Regeneration Inc.'s STR GRAFT device.
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, LLC. |
|---|---|
| Submitter Address: | 815 Iris Lane, Vero Beach, FL 32963 |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | (514) 901-0796; (973) 738-6097 |
| Fax Number: | (514) 901-0796 |
| Date of Submission: | November 20, 2012 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | Soft Tissue Regeneration, Inc. |
|---|---|
| Manufacturer Address: | 142 Temple Street, Suite 206, New Haven, CT 06510, USA |
| Registration Number: | To be determined |
| Contact Name: | Joseph Reilly |
| Title: | President |
| Device Trade Name: | STR GRAFT |
| Device Common Name: | Surgical mesh |
| Classification Name: | Surgical Mesh; Polymeric |
| Classification Codes: | OWT and OWW - Both are Class II |
| Classification Panel: | General and Plastic Surgery |
| Regulation Number: | 21 CFR § 878.3300 |
C. PREDICATE DEVICES
| K083307 | X-Repair; manufactured by Synthasome, Inc. |
|---|---|
| K071887 | Sport Mesh, Artelon Tissue Reinforcement; manufactured by |
| Artimplant AB | |
| K052830 | Sport Mesh; manufactured by Artimplant AB |
November 20, 2012
1
D. DEVICE DESCRIPTION
The STR GRAFT is a bioresorbable, three-dimensionally (3-D) braided construct made of poly-L-lactic-acid (PLLA) fiber. The STR GRAFT is available in rectangular and square sizes of 23 mm x 12 mm, 23 mm x 23 mm x 40 mm, and 23 mm x 60 mm; all STR GRAFT devices are approximately 1.0 mm thick; with the thickness comprised of three layers of 3-D braided fiber bundles. The STR GRAFT is supplied sterile (EtO) and is single-use only.
E. INTENDED USE
The STR GRAFT is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
The STR GRAFT is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
The STR GRAFT is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patelles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the tendon repair.
F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The technological characteristics of Soft Tissue Regeneration's STR GRAFT devices are the same or similar to the cited predicated devices. The subject STR GRAFT device is fabricated from PLLA fiber; the predicate device X-Repair is also fabricated with PLLA fiber. The sizes and thickness of the STR GRAFT and X-Repair are similar. The principle difference with X-Repair is that the STR GRAFT is fabricated via a proprietary 3-D braiding technology: X-Repair is a simple two-dimensional woven construct. The STR GRAFT possesses similar sizes and thickness as Artimplant's SportMesh device; SportMesh is also fabricated from a bioresorbable fiber material (Artelon). The STR GRAFT is surgically attached to soft tissue and/or anchored to underlying bony structures with sutures, which is the same means of implantation as the cited predicate devices. The indications for use for the subject STR GRAFT is identical to that for the predicate X-Repair device and similar in intended use as Artimplant's SportMesh. Biocompatibility, physical, and mechanical testing per the FDA Guidance Document for Soft Tissue Mesh implants and ISO standards for biocompatibility show the minor technological differences between the subject STR GRAFT and predicate X-Repair and SportMesh devices do not raise new types of safety and efficacy issues; the STR GRAFT is therefore substantially equivalent to the cited predicate devices.
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G. PERFORMANCE DATA
Characterization of STR GRAFT devices was performed per the FDA Guidance Document entitled "FDA Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" issued on March 2. 1999 and ISO 10993 standards for biocompatibility. More specifically, mechanical testing of the devices was performed per ASTM Standards F-2150-07, D3787-07, D2261-07a, D882-10, F2392-04, F1877-05, D4032-08, and D6767-11; the test methods were modified as appropriate regarding the length and width of the STR GRAFT. Biocompatibility testing was performed per ISO Standards 10993-3, -5, -7, -10, and -11. In addition, a 12 week ovine model of rotator cuff repair was performed. The results of physical, mechanical, in-vivo, and biocompatibility testing indicate that the STR GRAFT possesses appropriate physical and mechanical characteristics for reinforcement of soft tissues where weakness exists.
G. CONCLUSION
The materials used in manufacture, the results of physical and mechanical testing per the FDA Guidance document for surgical mesh and ASTM standards, the results of biocompatibility testing per ISO 10993 standards, design features, in vivo animal testing and a comparable intended use support a determination that the STR GRAFT is substantially equivalent to the identified predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 21, 2012
Soft Tissue Regeneration, Incorporated % Biovera, LLC Mr. Robert A. Poggie, Ph.D. President 815 Iris Lane Vero Beach, Florida 32963
Re: K121216
Trade/Device Name: STR GRAFT Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OWT, OWT, OWW Dated: October 26, 2012 Received: November 07, 2012
Dear Dr. Poggie:
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
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Page 2 - Mr. Robert A. Poggie, Ph.D.
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/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 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
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Soft Tissue Regeneration, Inc.
510(k) Number (if known): K121216
Device Name:
STR GRAFT
Indications For Use:
The STR GRAFT is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.
The STR GRAFT is also intended for reinforcement of soft Essues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.
The STR GRAFT is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the tendon repair.
Prescription X Use (Part 21 CFR 801 Subpart D)
ಿ ಸ
AND/OR . . .
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
David Krause 2012.11.20 14:27:59 -05'00'
(Division Sign-Off) Division of Surgical Devices 510 (k) Number: K121216