(257 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a suture anchor, with no mention of AI or ML.
Yes.
The device is described as a "bone implant device intended for the fixation of soft tissue to bone" for various repairs in different anatomical sites, which directly addresses medical conditions or injuries for therapeutic purposes.
No.
The device is a suture anchor used for the fixation of soft tissue to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "bone implant device" and a "fully threaded biocomposite anchor," indicating it is a physical hardware device, not software.
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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Tornier Insite™ FT Biocomposite Suture Anchors are implantable devices intended for the fixation of soft tissue to bone within the body. This is a surgical procedure performed directly on the patient, not an analysis of a specimen outside the body.
- Performance Studies: The performance studies mentioned are mechanical testing (pullout strength, degradation) and biocompatibility, which are relevant for implantable devices, not IVDs.
Therefore, the Tornier Insite™ FT Biocomposite Suture Anchor is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tornier Insite™ FT Biocomposite Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite™ FT Biocomposite Suture Anchors are intended for use in the following applications:
-
- Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
-
- Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
-
- Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
-
- Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
-
- Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
Product codes
MAI, HWC
Device Description
The Tornier Insite™ FT Biocomposite Suture Anchor consists of a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded biocomposite (85/15 PLLA/βTCP) anchor that is available in three sizes (4.5mm, 5.5mm, and 6.5mm) for use in a range of fixation applications. The device is assembled pre-loaded onto the insertion device with attached USP size #2 UHMWPE braided sutures.
The Tornier Insite™ FT Biocomposite Suture Anchor is individually packaged and sterilized through ethylene oxide (EO) using appropriate standards and guidelines.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow (specific to soft tissue to bone fixation)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-clinical laboratory testing and assessments were performed; these are: The fixation strength of the Tornier Insite™ FT Biocomposite Suture Anchors in mechanical insertion and pullout testing as compared to the predicate devices for the specific indications for use. The failure strength of the Tornier Insite™ FT Biocomposite Suture Anchor in invitro degradation. The material biocompatibility assessment of the finished sterile device. The results of these tests and assessments indicate that the Tornier Insite™ FT Biocomposite Suture Anchors is substantially equivalent in performance and efficacy to the above cited predicate devices within their intended use.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
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K122635 Insite™ FT Biocomposite Suture Anchor
510(k) Summary of Safety and Effectiveness Information Requiatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
1. Device name
| Device name: | Tornier Insite™ FT Biocomposite Suture Anchors |
|---|---|
| Device: | Fastener, fixation, biodegradable, soft tissue |
| Screw, fixation, bone | |
| Classification name: | Single/multiple component metallic bone fixation appliances |
| and accessories. | |
| Classification number: | 888.3030; 888.3040 |
| Product code: | MAI; Fastener, fixation, biodegradable |
| HWC; screw, fixation, bone |
2. Submitter
Tornier Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437 Registration Number: 9100540
3. Company contact
Lael J. Pickett Tornier Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437 Phone: 612-219-7350 Fax: 952-426-7601 Email: Ipickett@tornier.com
4. Classification
Device class: Class II Classification panel: Orthopedic Product code: MAI/HWC
5. Legally Marketed Device to which Equivalence is Claimed:
The Tornier Insite™ FT Biocomposite Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:
- · TORNIER, INC., INSITE BIO-ABSORBABLE SUTURE ANCHOR K083268
- · ARTHREX, INC., BIO-CORKSCREW FT SUTURE ANCHOR K061863
- ARTHREX, INC., BIO-COMPÒSITE CORKSCREW FT SUTURE ANCHOR K071177
1
1
6. Device Description
The Tornier Insite™ FT Biocomposite Suture Anchor consists of a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded biocomposite (85/15 PLLA/βTCP) anchor that is available in three sizes (4.5mm, 5.5mm, and 6.5mm) for use in a range of fixation applications. The device is assembled pre-loaded onto the insertion device with attached USP size #2 UHMWPE braided sutures.
The Tornier Insite™ FT Biocomposite Suture Anchor is individually packaged and sterilized through ethylene oxide (EO) using appropriate standards and guidelines.
7. Materials
The Tornier Insite™ FT Biocomposite Suture Anchor is available in a bioabsorbable (85/15 PLLA/ BTCP) material with attached USP size #2 UHMWPE braided sutures.
8. Indications for Use
The Tornier Insite™ FT Biocomposite Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite™ FT Biocomposite Suture Anchors are intended for use in the following applications:
-
- Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
-
- Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
-
- Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
-
- Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
-
- Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
9. Summary of Technologies
The technological characteristics (material, design, sizing, indications, sterilization, fixation strength) of the Tornier Insite™ FT Biocomposite Suture Anchors are similar or identical to the cited predicate devices.
10. Nonclinical Testing
Non-clinical laboratory testing and assessments were performed; these are: The fixation strength of the Tornier Insite™ FT Biocomposite Suture Anchors in mechanical insertion and pullout testing as compared to the predicate devices for the specific indications for use. The failure strength of the Tornier Insite™ FT Biocomposite Suture Anchor in invitro degradation. The material biocompatibility assessment of the finished sterile device. The results of these tests and assessments indicate that the Tornier Insite™ FT
2
. . . .
.
.
:
Biocomposite Suture Anchors is substantially equivalent in performance and efficacy to the above cited predicate devices within their intended use.
.
. . .
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the caduceus in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
· Letter dated: May 13, 2013
Tornier, Incorporated % Ms. Lael J. Pickett Regulatory Affairs 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
Re: K122635
Trade/Device Name: Tornier Insite™ FT Biocomposite Suture Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: March 6, 2013 Received: March 12, 2013
Dear Ms. Pickett:
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 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
4
Page 2 - Ms. Lael J. Pickett
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 yours,
Mark NijMelkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K122635
Tornier Insite™ FT Biocomposite Suture Anchors Device Name:
Indications for Use
The Tornier Insite™ FT Biocomposite Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite™ FT Biocomposite Suture Anchors are intended for use in the following applications:
-
- Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
-
- Foot/Ankle: Lateral and Medial stabilization. Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot Reconstruction.
-
- Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
-
- Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
-
- Elbow: Biceps tendon reattachment, Tennis clhow repair, Ulnar and Radial collateral ligament reconstruction.
| · Prescription Use ___________________________________________________________________________________________________________________________________________________________ | AND/OR | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabethiji Erank -S
Division of Orthopedic Devices
510(k) Submission: Tornier Insite™ FT Biocomposite Suture Anchors Tornier Inc.
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