(29 days)
No
The description focuses on mechanical components (suture anchor, driver, sutures) and a minor modification to the number of preloaded sutures. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for rotator cuff repairs, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is a suture anchor intended for rotator cuff repairs, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components: a titanium suture anchor, a disposable driver with a stainless steel shaft and ABS handle, and braided polyester sutures. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "rotator cuff repairs in the shoulder." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "titanium suture anchor with a self-tapping cutting tip" and a "disposable driver." These are physical implants and tools used in surgery.
- Lack of Diagnostic Purpose: The description does not mention any use for testing samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) during a surgical repair.
N/A
Intended Use / Indications for Use
The ThRevo™ Suture Anchor with Disposable Driver is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The ThRevo™ Suture Anchor with Disposable Driver consists of a titanium suture anchor with a self-tapping cutting tip. The design requires no predrilling and can be inserted by hand into the bone with the accompanying disposable driver. The ThRevo™ Suture Anchor with Disposable Driver is substantially equivalent in design, performance specifications, function and intended use to the Super Revo® Suture Anchor. The design of the implant has not been modified.
The only modification to the currently marketed device is the ThRevo™ Suture Anchor with Disposable Driver is preloaded with three (3) nonabsorbable USP size # 2 braided polyester sutures (green, white and green/white striped) instead of two (2) nonabsorbable, USP size # 2 braided polyester sutures (green and white). The surgical technique has been slightly modified to for account for the addition of the third suture.
The implant design has not been modified in any way. The titanium suture anchor implant of the ThRevo™ Suture Anchor with Disposable Driver is the same as for the Super Revo® Suture Anchor (510(k) # K003984). Both are provided preloaded onto a disposable driver with a stainless steel shaft and ABS handle. Also, both the ThRevoTM Suture Anchor with Disposable Driver and Super Revo® Suture Anchor are 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been conducted to assure that providing the suture anchor with the additional strand of nonabsorbable USP #2 polyester suture does not raise any new issues regarding safety and effectiveness.
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.
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
§ 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.
0
K050227
MAR 2 - 2005
1/3
LINVATEC CORPORATION
February 07, 2005
510(k) SUMMARY
Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the Special 510(k) Summary of Safety and Effectiveness for the ThRevo™ Suture Anchor with Disposable Driver 510(k) Number _
A. Submitter
Linvatec Corporation l 1311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Elizabeth Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX
C. Device Name
| Trade Name: | ThRevo™ Suture Anchor with Disposable
Driver |
|------------------------|---------------------------------------------------------------------------|
| Common Name: | Suture Anchor |
| Classification Names: | Screw, Fastener, Fixation, Nondegradable,
Soft Tissue, 21 CFR 888.3040 |
| Proposed Class/Device: | Class II |
| Product Code: | MBI |
1
KOSO227
LINVATEC CORPORATION
510(k) Summary (Continued)
ThRevo™ Suture Anchor with Disposable Driver 510(k) # February 07, 2005
Predicate/Legally Marketed Devices D.
510(k) # K003984 Super Revo® Suture Anchor Linvatec Corporation
Device Description E.
The ThRevo™ Suture Anchor with Disposable Driver consists of a titanium suture anchor with a self-tapping cutting tip. The design requires no predrilling and can be inserted by hand into the bone with the accompanying disposable driver. The ThRevo™ Suture Anchor with Disposable Driver is substantially equivalent in design, performance specifications, function and intended use to the Super Revo® Suture Anchor. The design of the implant has not been modified.
The only modification to the currently marketed device is the ThRevo™ Suture Anchor with Disposable Driver is preloaded with three (3) nonabsorbable USP size # 2 braided polyester sutures (green, white and green/white striped) instead of two (2) nonabsorbable, USP size # 2 braided polyester sutures (green and white). The surgical technique has been slightly modified to for account for the addition of the third suture.
The implant design has not been modified in any way. The titanium suture anchor implant of the ThRevo™ Suture Anchor with Disposable Driver is the same as for the Super Revo® Suture Anchor (510(k) # K003984). Both are provided preloaded onto a disposable driver with a stainless steel shaft and ABS handle. Also, both the ThRevoTM Suture Anchor with Disposable Driver and Super Revo® Suture Anchor are 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™ Suture Anchor with Disposable Driver is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.
2
K050227
- LINVATEC CORPORATION
510(k) Summary (Continued) ThRevo™ Suture Anchor with Disposable Driver 510(k) # February 07, 2005
Substantial Equivalence G.
The ThRevo™ Suture Anchor with Disposable Driver is substantially equivalent in intended use, scientific technology and design to the Super Revo® Suture Anchor. Testing has been conducted to assure that providing the suture anchor with the additional strand of nonabsorbable USP #2 polyester suture does not raise any new issues regarding safety and effectiveness.
Surgical Specialties, Redding, Pennsylvania, supplies two (2) non-absorbable USP #2 Silicone coated polyester braided sutures (Polyviolene), which are approved under NDA 80-950
TeleFlex Medical, Coventry, Connecticut, supplies the additional third nonabsorbable USP #2 PTFE coated polyester braided suture (Polydek) which is approved for commercial distribution in the U.S. under 510(k) number K021019.
3
Image /page/3/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 words "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
MAR 2 - 2005
Ms. Elizabeth Paul Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773
Re: K050227
Trade/Device Name: ThRevo™ Suture Anchor with Disposable Driver Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: January 24, 2005 Received: February 1, 2005
Dear Ms. Paul:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure) to regary manated to the Medical Device Americans, or to commerce prior to May 20, 1978, the enaordance with the provisions of the Federal Food, Drug. devices mar nave been rochasined in assic approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that do not required to the general controls provisions of the Act. The 1 ou may, dicierore, mance and as requirements for annual registration, listing of general controls provisions 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 If your device is classified (see abor of the tixisting major regulations affecting your device can may be subject to subli additional controller Links - 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 r lease oc advised that i Dr overan that your device complies with other requirements of the Act that IDA has made a dolorimistered by other Federal agencies: You must or any I edetar statutes and seeginements, including, but not limited to: registration and listing (21 Comply with an the Act 8 requirements)01); good manufacturing practice requirements as set CI IC rail 6077, adoling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic rolum in the quality bysellions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Ms. Elizabeth Paul
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of thus, premarket nothication. The PDA midning of backanda vijas
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 If you desire specific advice for your as note the regulation of the regulation entitled, comaci the Office of Compunance at (21 t restarted in (21CFR Part 807.97). You may obtain " Misbranding by responsibilities to premance noutheanswill in the Division of Small other general information on your responsibility to the states and on the manufacturers were workinders by by block Manufacturers, international and Consultip://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
iriam C Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
PROPRIETARY INFORMATION - LINVATEC CORPORATION
January 10, 2005
1
510(k) Number (if known):
Device Name: ThRevo™ Suture Anchor with Disposable Driver
Indications for Use: The ThRevo™ Suture Anchor with Disposable Driver is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.
Over-the-Counter Use Prescription Use_X_ OR (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 1-2-96)
iriam C. Provost
(Division Sign-6 Division of General. Restorative. and Neurological Devi
510(k) Number K650227