(24 days)
No
The device description and intended use are purely mechanical, describing a suture anchor system for attaching soft tissue to bone. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The performance studies are limited to bench testing of mechanical properties.
Yes.
The device is used for the repair of various soft tissue tears and separations, which are medical conditions, and its purpose is to aid in the healing or stabilization of these conditions.
No
The device description clearly states its purpose is to "aid in the attachment of soft tissue to bone," which is a treatment or repair function, not a diagnostic one.
No
The device description clearly states it is a "sterile, single-use, hand-held device" that includes "titanium alloy anchors" and "sutures, needles". This indicates a physical, hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The G-FORCE® Suture Anchor System is a surgical implant used to attach soft tissue to bone during surgical repair procedures. It is a physical device used in vivo (within the body) during surgery, not a test performed on a sample in vitro (outside the body).
The provided information clearly describes a surgical device used for musculoskeletal repair, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The G-FORCE® Suture Anchor System is indicated for use:
- In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap . lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
- In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or . ulnar or radial collateral ligament tear/separation;
- . In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament:
- . In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
- In the repair of foot/ankle instability secondary to tear or separation of the Achilles . tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.
Product codes
MBI, HWC
Device Description
The G-FORCE® Ti Suture Anchor System is a sterile, single-use, hand-held device intended to aid in the attachment of soft tissue to bone. The G-FORCE® Ti Suture Anchor System comes preloaded with non-absorbable polyethylene-based sutures, needles and titanium alloy anchors. The anchors are available in a variety of sizes with correspondingly sized suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, elbow, hand/wrist, knee, foot/ankle
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)
Bench testing was used to demonstrate that the torque and tensile strength characteristics of the G-FORCE® Ti Suture Anchor System are safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ANCHORLOK® Soft Tissue Anchor System (K971282)
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.
0
MAR 2 3 2010
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the G-FORCE® Ti Suture Anchor System.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | February 22, 2010 |
| Contact Person: | Kellen Hills |
| Regulatory Affairs Specialist | |
| Proprietary Name: | G-FORCE® Ti Suture Anchor System |
| Common Name: | Soft Tissue Anchor |
| Classification Name and Reference: | 21 CFR 888.3040 - Smooth or threaded metallic bone |
| fixation fastener - Class II | |
| Device Product Code and Panel Code: | Orthopedics/87/MBI/HWC |
| Predicate Device: | ANCHORLOK® Soft Tissue Anchor System |
| (K971282) |
DEVICE INFORMATION
.
A. DEVICE DESCRIPTION
The G-FORCE® Ti Suture Anchor System is a sterile, single-use, hand-held device intended to aid in the attachment of soft tissue to bone. The G-FORCE® Ti Suture Anchor System comes preloaded with non-absorbable polyethylene-based sutures, needles and titanium alloy anchors. The anchors are available in a variety of sizes with correspondingly sized suture.
B. INTENDED USE
The G-FORCE® Suture Anchor System is indicated for use:
- In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap . lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
- In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or . ulnar or radial collateral ligament tear/separation;
- . In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament:
- . In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
1
- In the repair of foot/ankle instability secondary to tear or separation of the Achilles . tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The indications for use of the G-FORCE® Ti Suture Anchor System are limited in scope when compared to the predicate. The technological characteristics by which the intended use is achieved is the same for both the subject and predicate systems.
The safety and effectiveness of the G-FORCE® Ti Suture Anchor System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k).
D. PERFORMANCE DATA
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bench testing was used to demonstrate that the torque and tensile strength characteristics of the G-FORCE® Ti Suture Anchor System are safe and effective.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Ms. Kellen Hills Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K100579
Trade/Device Name: G-FORCE® Ti Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, HWC Dated: February 23, 2010 Received: March 2, 2010
Dear Ms. Hills:
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.
MAR 2 3 2010
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 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
3
Page 2 - Ms. Kellen Hills
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/ReportalProblem/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, !nternational 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.
Saulane Buehler
Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K100579
Device Name: G-FORCE® Suture Anchor System
Indications For Use:
The G-FORCE® Suture Anchor System is indicated for use:
- In the repair of shoulder instability secondary to Bankart lesion, rotator . cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
- In the repair of elbow instability secondary to biceps tendon detachment. . tennis elbow, or ulnar or radial collateral ligament tear/separation;
- In the repair of hand/wrist instability secondary to tear or separation of the . scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
- In the repair of knee instability secondary to tear or separation of the . medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
- In the repair of foot/ankle instability secondary to tear or separation of the . tendon, lateral stabilization tendons/ligaments, medial Achilles stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.
Prescription Use xxx (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K100579 |
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 of 1