(27 days)
Not Found
No
The description focuses on the mechanical components and materials of a suture anchor and driver, with no mention of AI or ML capabilities.
Yes
This device is a medical implant intended for surgical repair of rotator cuffs, which falls under the definition of a therapeutic device.
No
The device is a titanium suture anchor implant used for rotator cuff repairs, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines physical components including a titanium suture anchor implant, non-absorbable sutures, a disposable driver with a stainless steel shaft and ABS handle. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Description and Intended Use: The description clearly states the device is a "titanium suture anchor implant" used for "rotator cuff repairs in the shoulder." This is a surgical implant used directly within the body for structural repair.
- Lack of IVD Characteristics: There is no mention of testing bodily samples, analyzing biological markers, or providing diagnostic information based on laboratory analysis.
The device is a surgical implant used for musculoskeletal repair, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.
Product codes
MBI
Device Description
The ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures is a titanium suture anchor implant pre-threaded with three (3) distinct non-absorbable #2 ultra high molecular weight polyethylene sutures (white, blue and white striped, black and white striped). The design requires no pre-drilling and can be inserted by hand into the bone with the accompanying disposable driver. The device is substantially equivalent in design, performance specifications, function and intended use to the Super Revo Hi-Fi Suture Anchor. The design of the implant has not been modified.
The only difference between the ThRevo Anchor, Disposable Driver, Hi-Fi Sutures and the Super Revo with Hi-Fi is the addition of the third Hi-Fi suture. This modification introduces the use of black nylon 6.6 as a marker for the black cobraid, similar to the blue polypropylene for the blue cobraided suture.
The ThRevo Anchor, Disposable Driver, Hi-Fi Sutures is provided preloaded onto a disposable driver with a stainless steel shaft and ABS handle. It is supplied sterile and single use.
This modification does not affect the device's intended use, fundamental scientific technology or performance specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder
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
Testing conducted prior to product release assures that the new device does not raise any new issues of safety and efficacy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 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.
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510(k) SUMMARY
ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number_KO 3481 .
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
Company Contact B.
JAN - 7 2008
Joy Lovett Requlatory Affairs Specialist (727) 399-5137 Telephone (727) 399-5264 FAX
். Device Name
Trade Name: ThRevo® Anchor, Disposable Driver, Hi-Fi Sutures
Common Name: Suture Anchor
Classification Name: Screw, Fastener, Fixation, Nondegradable, Soft Tissue
Proposed Class/Device: Class II
Product Code: MBI
D. Predicate/Legally Marketed Devices
| 510(k) Name | Classification Panel | Classification Name | 510(k) # | Owner |
|---|---|---|---|---|
| Super Revo | ||||
| Herculine | ||||
| Suture Anchor | Orthopedic | Screw, Fastener, | ||
| Fixation, | ||||
| Nondegradable, | ||||
| Soft Tissue 21 | ||||
| CFR 888.3040 | K041713 | Linvatec | ||
| Corporation |
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K073481
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E. Device Description
The ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures is a titanium suture anchor implant pre-threaded with three (3) distinct non-absorbable #2 ultra high molecular weight polyethylene sutures (white, blue and white striped, black and white striped). The design requires no pre-drilling and can be inserted by hand into the bone with the accompanying disposable driver. The device is substantially equivalent in design, performance specifications, function and intended use to the Super Revo Hi-Fi Suture Anchor. The design of the implant has not been modified.
The only difference between the ThRevo Anchor, Disposable Driver, Hi-Fi Sutures and the Super Revo with Hi-Fi is the addition of the third Hi-Fi suture. This modification introduces the use of black nylon 6.6 as a marker for the black cobraid, similar to the blue polypropylene for the blue cobraided suture.
The ThRevo Anchor, Disposable Driver, Hi-Fi Sutures is provided preloaded onto a disposable driver with a stainless steel shaft and ABS handle. It is supplied sterile and single use.
This modification does not affect the device's intended use, fundamental scientific technology or performance specifications.
F. Intended Use
The ThRevo Anchor, Disposable Driver, Hi-Fi Sutures is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.
G. Technological Characteristics
The ThRevo Anchor, Disposable Driver, Hi-Fi Sutures is identical to the predicate device cleared in the original submissions except for the addition of a third polyethylene suture - Super Revo with Hi-Fi. This modification does not affect the device's intended use or performance specifications in a manner that raises any new issues regarding safety and effectiveness.
H. Substantial Equivalence
The ThRevo Anchor, Disposable Driver, Hi-Fi Sutures is substantially equivalent in intended use, design and technological characteristics to the below listed system.
| 510(k) Name | 510(k) # | Owner |
|---|---|---|
| Super Revo Herculine Suture Anchor | K041713 | Linvatec |
| Corporation |
Testing conducted prior to product release assures that the new device does not raise any new issues of safety and efficacy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 7 2008
ConMed Linvatec % Ms. Joy Lovett Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773
Re: K073481
Trade/Device Name: ThRevo® Anchor, Disposable Drive, Hi-Fi"" Sutures Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: December 3, 2007 Received: December 11, 2007
Dear Ms. Lovett:
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.
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 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); 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.
3
Page 2 - Ms. Joy Lovett
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) 276-0115. 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. Mullens
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K073481
Device Name: ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures
Indications for Use:
The ThRevo® Anchor, Disposable Driver, Hi-Fi™ Sutures is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.
Prescription Use_ X (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 If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K073481