(95 days)
Not Found
No
The device description and intended use clearly define a mechanical implantable suture retention device. There is no mention of software, algorithms, or any technology that would suggest AI/ML is involved.
No
The device is described as an implantable suture retention device used to repair meniscal tears, which is a structural repair and not inherently a therapeutic treatment.
No
The device is described as an "implantable suture retention device" used for "soft tissue repairs, including the repair of meniscal tears." It facilitates a repair, rather than diagnosing a condition.
No
The device description clearly states it is an implantable suture retention device consisting of physical components (FiberWire suture and PEEK tubes), indicating it is a hardware medical device, not software-only.
Based on the provided information, the Arthrex Meniscal Cinch is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for facilitating percutaneous or endoscopic soft tissue repairs, specifically meniscal tears. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implantable suture retention device made of suture and PEEK tubes. This is a physical implant used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. The Arthrex Meniscal Cinch does not perform any such diagnostic testing on specimens.
Therefore, the Arthrex Meniscal Cinch is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex Meniscal Cinch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
Product codes
GAT, MBI
Device Description
The Arthrex Meniscal Cinch is an implantable suture retention device consisting of FiberWire suture and small PEEK tubes. The FiberWire suture is offered in a #2-0 size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Testing of the Arthrex Meniscal Cinch compared to that of the predicate K072322 FAST-Fix support the common functionality and intended use as well as substantial equivalence of the device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
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K073149 pg 1 ct 1
defective
Table 1 510(k) Summary of Safety and Effectiveness
| Manufacturer/Sponsor | Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 |
|---|---|
| 510(k) Contact | Ann Waterhouse, RAC |
| Regulatory Affairs Project Manager | |
| Telephone: 239/643.5553, ext. 1179 | |
| Fax: 239/598.5508 | |
| Email: awaterhouse@arthrex.com | |
| Trade Name | Meniscal Cinch |
| Common Name | Suture, non-degradable, |
| Fastener, Fixation, non-degradable soft tissue | |
| Product Code | GAT |
| MBI | |
| Predicate Devices | K072322, Smith & Nephew ULTRA FAST-FIX & ULTRA FAST-FIX |
| AB Meniscal Repair Systems | |
| Device Description and | |
| Intended Use | The Arthrex Meniscal Cinch is an implantable suture retention |
| device consisting of FiberWire suture and small PEEK tubes. The | |
| FiberWire suture is offered in a #2-0 size. | |
| The Arthrex Meniscal Cinch is an implantable suture retention | |
| device which facilitates percutaneous or endoscopic soft tissue | |
| repairs, including the repair of meniscal tears. | |
| Substantial Equivalence | |
| Summary | Testing of the Arthrex Meniscal Cinch compared to that of the |
| predicate K072322 FAST-Fix support the common functionality and | |
| intended use as well as substantial equivalence of the device. | |
| The Arthrex Meniscal Cinch is substantially equivalent to predicate | |
| devices where the basic features and intended uses are the same. | |
| Minor differences between the Arthrex Meniscal Cinch and the | |
| predicate device do not raise any questions concerning safety and | |
| effectiveness and has no apparent effect on the performance, | |
| function, or intended use of this device. |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
FEB 11 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arthrex, Inc. % Ms. Ann Waterhouse 1370 Creekside Blvd. Naples, FL 34108
K073149 Re: Trade/Device Name: Arthrex Meniscal Cinch Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, MBI Dated: February 4, 2008 Received: February 5, 2008
Dear Ms. Waterhouse:
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, Jrug, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 aft 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the ecoloric product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Ann Waterhouse
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K073149 Device Name: Arthrex Meniscal Cinch
The Arthrex Meniscal Cinch is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.
Prescription Use (Per 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) PAGE 1 of 1
ula Bonem
(Division Sign-Off)
Division of General, Restorative. and Neurological Devices
510(k) Number K873149