(189 days)
The Tarsus Medical Meta-Lock Suture Anchor System is intended for fixation of suture to bone for the indications listed below:
SHOULDER: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, Deltoid repair
ANKLE: Lateral instability, medial instability, achilles tendon repair/reconstruction, Midfoot reconstructions
FOOT: Hallux valgus reconstruction
WRIST: Scapholunate ligament
HAND: Ulnar or lateral collateral ligament reconstruction
ELBOW: Biceps tendon reattachment
KNEE: Extra capsular repairs; reattachment of : medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tendonesis; patellar ligament and tendon avulsions.
The Meta-Lock™ Suture Anchor System is a suture anchor used for the reattachment of soft tissue to bone.
The provided document is a 510(k) summary for a medical device (Meta-Lock™ Suture Anchor System) and does not contain the information requested about acceptance criteria and a study proving device performance in the context of an AI/algorithm-based medical device.
The document discusses:
- Device Type: A traditional medical device (suture anchor system).
- Approval Type: 510(k) premarket notification.
- Performance Evaluation: Non-clinical tests (tensile testing, cyclic testing, MR testing, galvanic corrosion testing, simulated movement, and simulated use testing) to demonstrate substantial equivalence to a predicate device, not to establish novel performance against specific acceptance criteria in the way an AI/algorithm would be tested.
- Human Involvement: Not relevant as it's a physical implant, not an AI assisting human readers.
- Ground Truth: Not applicable in the context of this physical device's non-clinical testing.
- Training Set: Not applicable.
Therefore, I cannot extract the requested information (points 1-9) from the provided text.
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SEP 2 7 2011
5. 510(k) Summary
| General Information | |
|---|---|
| Date Compiled | September 21, 2011 |
| Classification | Class II, 21 CFR § 888.3040, Smooth or threaded metallic bone fixation fastener.Product code MBI |
| Trade Name | Meta-Lock™ Suture Anchor System |
| Submitter | Tarsus Medical, Inc.465 Fairchild DriveSuite 230Mountain View, CA 94043 |
| Contact | Nicholas MourlasPresident and CEOTel: (650) 237-0070Fax: (650) 237-0071 |
| Intended Use |
The Tarsus Medical Meta-Lock Suture Anchor System is intended for fixation of suture to bone for the indications listed below:
| SHOULDER: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, |
|---|
| capsule shift/capsulo-labral reconstruction, biceps tenodesis, Deltoid repair |
- Lateral instability, medial instability, achilles tendon repair/reconstruction, Midfoot ANKLE: reconstructions
- FOOT: Hallux valgus reconstruction
- WRIST: Scapholunate ligament
- HAND: Ulnar or lateral collateral ligament reconstruction
- ELBOW: Biceps tendon reattachment
- . KNEE: Extra capsular repairs; reattachment of : medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tendonesis; patellar ligament and tendon avulsions.
Predicate Device GII QuickAnchor Plus Manufactured by Depuy Mitek
Device Description
The Meta-Lock™ Suture Anchor System is a suture anchor used for the reattachment of soft tissue to bone.
Materials
The Meta-Lock is comprised of Commercially Pure Titanium (Grade 2) conforming to ASTM F67-06, Stainless Steel (Biodur 108 Alloy) conforming to ASTM F2229, and polyester suture.
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110800 2/2
Testing
The non-clinical tests performed by the company include anchor tensile testing, system tensile testing, cyclic testing, magnetic resonance (MR) testing, galvanic corrosion testing, simulated movement testing, and simulated use testing. The test results demonstrate that the Meta-Lock is substantially equivalent to the legally marketed predicate device.
Summary of Substantial Equivalence
Tarsus Medical, Inc. believes the Meta-Lock Suture Anchor System is substantially equivalent to the predicate product. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to the existing legally marketed predicate product.
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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 caduceus symbol, which features three diagonal lines that curve and merge into a single line at the bottom. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Tarsus Medical, Inc. % Nicholas Mourlas 465 Fairchild Drive, Suite 230 Mountain View, CA 94043
SEP 2 7 2011
Re: K110800
Trade/Device Name: Meta-Lock™ Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: August 16", 2011 Received: August 17", 2011
Dear Dr. Mourlas:
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 cither 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, Paris 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Nicholas Mourlas
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 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 vours.
Eimel Keith
for 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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4. Indications for Use Statement
| 510(k) Number(if known): | This application | K110800 |
|---|---|---|
| ------------------------------ | ------------------ | --------- |
Device Name:
Meta-Lock™ Suture Anchor System
| Indications for Use: | The Tarsus Medical Meta-Lock Suture Anchor System is intended for fixation of suture to bone for the indications listed below: |
|---|---|
| SHOULDER: | Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis; deltoid repair |
| ANKLE: | Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstructions |
| FOOT: | Hallux valgus reconstruction |
| WRIST: | Scapholunate ligament |
| HAND: | Ulnar or lateral collateral ligament reconstruction |
| ELBOW: | Biceps tendon reattachment |
| KNEE: | Extra capsular repairs; reattachment of : medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tendonesis; patellar ligament and tendon avulsions. |
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 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)
Michael Olsen for MXM
(Division Sign-Off)
Division of Surgical. Orthopedic, and Restorative Dev ترك
510(k) Number K110806
011
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.