(131 days)
Not Found
No
The summary describes a mechanical suture anchor for soft tissue fixation to bone and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is a medical implant intended to fix soft tissue to bone for rehabilitation and repair, which falls under the definition of a therapeutic device.
No
The device description and intended use clearly state that it is a bone implant device intended for the fixation of soft tissue to bone, not for diagnosis.
No
The device description explicitly states it is a "bone implant device" and a "fully threaded PEEK-OPTIMA® 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:
- Intended Use and Indications for Use: The intended use and indications clearly describe a device used for the fixation of soft tissue to bone during surgical procedures. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description confirms it's a bone implant device intended for surgical fixation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
- Performance Studies: The performance studies focus on mechanical testing and cadaver lab evaluation, which are relevant to the physical properties and surgical use of an implant, not the analytical performance of an IVD.
Therefore, this device falls under the category of a surgical implant rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: The 2.5mm and 3.5mm Insite™ FT PEEK Suture Anchor is intended for total shoulder arthroplasty of the shoulder.
Indications for Use: The Tornier Insite™ FT PEEK Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite™ FT PEEK Suture Anchors are intended for use in the following applications:
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Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Bicens tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
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Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction.
-
Knee: Medial collateral and Lateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial band tenodesis.
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Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction.
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Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Insite™ FT PEEK Suture Anchor is a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded PEEK-OPTIMA® anchor that is available in two sizes (2.5mm & 3.5mm) for use in a range of fixation applications.
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
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)
Non-clinical performance bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate devices.
- Mechanical Testing (Suture Approximation and Tensile Pull-out): To exceed strength of predicate device - Acceptable
- Mechanical Testing (Cyclic Load Test): To meet the physiological loading requirements - Acceptable
- Mechanical Testing (Anchor Insertion Torque and Driver Torque to Failure Test): To exceed the strength of the expected loading requirements - Acceptable
- Mechanical Testing (Pull to Failure Testing): To determine strength of predicate device - Acceptable
- Cadaver Lab Evaluation: Successful preparation in cadaveric specimens - Acceptable
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.
Not Found
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
Image /page/0/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 a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2015
Tornier, Incorporated Ms. Kaitlyn Rainbow Sr. Regulatory Affairs Specialist 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
Re: K150715
Trade/Device Name: 2.5mm Insite Ft Suture Anchors , 3.5mm Insite Ft Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 19, 2015 Received: June 22, 2015
Dear Ms. Rainbow:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the
1
Page 2 - Ms. Kaitlyn Rainbow
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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K150715
Device Name
2.5mm & 3.5mm Insite™ FT PEEK Suture Anchor
Indications for Use (Describe) ntended Use: The 2.5mm and 3.5mm Insite™ FT PEEK Suture Anchor is intended for total shoulder arthroplasty of the shoulder.
Indications for Use: The Tornier Insite™ FT PEEK Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite™ FT PEEK Suture Anchors are intended for use in the following applications:
-
Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Bicens 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 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Date Prepared: July 24, 2015
I. Administrative Information
| Name: | Tornier, Inc. |
|---|---|
| Address: | 10801 Nesbitt Avenue South |
| Bloomington, MN 55437 | |
| Contact Person: | Kaitlyn Rainbow |
| Senior Regulatory Affairs Specialist | |
| Phone: | 952-426-7637 |
| Fax: | 952-426-7601 |
II. Device Information
Name of Device: Insite™ FT PEEK Suture Anchor Size 2.5mm & 3.5mm
Common Name: Fastener, Fixation, Non-degradable, Soft Tissue Classification Name: 21 CFR 888.3040, Smooth or treaded metallic bone fixation fastener Class II Regulatory Class: Product Code: MBI
III. Predicate Device Information
Tornier Insite™ FT PEEK Knotless Suture Anchor K110773 and Smith and Nephew 2.0PK Suture Anchor K081511.
IV. Device Description
The Insite™ FT PEEK Suture Anchor is a bone implant device intended for the fixation of soft tissue to bone. This device is a fully threaded PEEK-OPTIMA® anchor that is available in two sizes (2.5mm & 3.5mm) for use in a range of fixation applications.
V. Intended Use
The Tornier Insite™ FT PEEK Suture Anchor is intended for the fixation of soft tissue to bone.
VI. Indications for Use
The Tornier Insite FT PEEK Suture Anchors are intended for fixation of soft tissue to bone.
The Tornier Insite FT PEEK Knotless Suture Anchors are intended for use in the following applications:
4
-
- 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.
This device is for single use.
VII. Comparison of Technological Characteristics with the Predicate Device
The Insite™ FT Suture Anchor has the same intended use and fundamental scientific technology as the predicate device. The design differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness.
VIII. Performance Data
Non-clinical performance bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate devices.
Non-clinical Performance Testing Summary for 2.5mm & 3.5mm Insite™ FT PEEK Suture Anchors
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| Validation and/ or Verification
Method | Acceptance Value/Criteria | Verification and
Validation Results |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------|
| Mechanical Testing
(Suture Approximation and
Tensile Pull-out) | To exceed strength of predicate
device | Acceptable |
| Mechanical Testing
(Cyclic Load Test) | To meet the physiological loading
requirements | Acceptable |
| Mechanical Testing
(Anchor Insertion Torque and
Driver Torque to Failure Test) | To exceed the strength of the
expected loading requirements | Acceptable |
| Mechanical Testing
(Pull to Failure Testing) | To determine strength of predicate
device | Acceptable |
| Cadaver Lab Evaluation | Successful preparation in
cadaveric specimens | Acceptable |
IX. Clinical Study
Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device.
X. Conclusions
The Insite™ FT Suture Anchor size 2.5mm and 3.5mm described in this section has the same intended use and the same fundamental scientific technology as the cleared Insite™ FT Suture Anchor and Smith and Nephew 2.0PK Suture Anchor. Based on the testing presented for the design differences between the subject and predicate devices, Tornier concludes that subject device is substantially equivalent to the predicate device.