(28 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a suture anchor, with no mention of AI or ML technology.
No.
The device is a suture anchor used for the fixation of soft tissue to bone, which is a restorative or reconstructive function rather than a therapeutic one (i.e., treating a disease or condition).
No
The device is a suture anchor intended for 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" consisting of a "fully threaded titanium suture anchor" and associated hardware (suture, needles, inserter). This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "bone implant device" consisting of a suture anchor, inserter, suture, and needles. This is a physical implant used during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device described is a surgical implant used for orthopedic procedures, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Tornier Insite FT Suture Anchor is intended for fixation of soft tissue to bone.
The Tornier Insite FT Suture Anchor is 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 (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Tornier Insite FT Titanium Suture Anchor w/ Needles consists of a bone implant device intended for the fixation of soft tissue to bone. The device is a fully threaded titanium suture anchor preloaded on a disposable inserter assembly, attached USP size#2-0 or USP size #0 UHMWPE suture and comes with needles attached to the ends of the suture.
The Tornier Insite FT Titanium Suture Anchor w/ Needles is used as a means for securing soft tissue to bone. The implant is individually packaged and sterilized though ethylene oxide (EO) using appropriate standard 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
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
Non-clinical laboratory testing was performed to evaluate the device performance per design requirements and risk analysis, including cyclic testing, mechanical insertion and pullout testing, driver torque testing, suture needle pull testing, and cadaveric laboratory simulated use testing. All tests met the pre-established acceptance criteria
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory testing was performed to evaluate the device performance per design requirements and risk analysis, including cyclic testing, mechanical insertion and pullout testing, driver torque testing, suture needle pull testing, and cadaveric laboratory simulated use testing. All tests met the pre-established acceptance criteria
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
K132632
TORNIER
510(k) Summary 4
| 510(K) Owner's Name: | Tornier Inc. |
|---|---|
| Address: | 10801 Nesbitt Avenue South |
| Bloomington, Minnesota 55437 | |
| Phone and Fax Numbers: | Phone: 952.426.7600 |
| Fax: 952.426.7601 | |
| Name of Contact Person: | Janell A. Colley |
| Date Prepared: | August 19, 2013 |
| Trade or Proprietary Name: | Tornier Insite FT Suture Anchor with Needles |
| Common or Usual Name: | Smooth or threaded metallic bone fixation fastener |
| Classification Name: | Product Code: MBI |
| 21 CFR 888.3040 | |
| Legally Marketed Device to | |
| Which Your Firm Is | |
| Claiming Equivalence: | K110773 - Tornier Insite FT Suture Anchor, cleared 2 June 2011 |
| K083268 - Tornier, Inc., Insite Suture Anchor, cleared 12 February 2009 | |
| Description of The Device: | The Tornier Insite FT Titanium Suture Anchor w/ Needles consists of a |
| bone implant device intended for the fixation of soft tissue to bone. The | |
| device is a fully threaded titanium suture anchor preloaded on a disposable | |
| inserter assembly, attached USP size#2-0 or USP size #0 UHMWPE suture | |
| and comes with needles attached to the ends of the suture. | |
| The Tornier Insite FT Titanium Suture Anchor w/ Needles is used as a | |
| means for securing soft tissue to bone. The implant is individually | |
| packaged and sterilized though ethylene oxide (EO) using appropriate | |
| standard and guidelines | |
| Intended Use of the Device: | The Tornier Insite FT Suture Anchor is intended for fixation of soft |
| tissue to bone. | |
| The Tornier Insite FT Suture Anchor is 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. | |
| Technological | |
| Characteristics Compared | |
| To Predicate Device: | The technological characteristics (material, design, sizing, indications, |
| sterilization, failure strength) of the Tornier Insite FT Ti Suture Anchor w/ | |
| Needles are substantially equivalent to the predicate devices. | |
| Summary of the | |
| Nonclinical Tests | |
| Submitted: | Non-clinical laboratory testing was performed to evaluate the device |
| performance per design requirements and risk analysis, including cyclic | |
| testing, mechanical insertion and pullout testing, driver torque testing, | |
| suture needle pull testing, and cadaveric laboratory simulated use testing. | |
| All tests met the pre-established acceptance criteria | |
| Conclusions Drawn From | |
| the Nonclinical and Clinical | |
| Tests: | Based on risk analysis and acceptable results from testing, the Tornier |
| Insite FT Suture Anchor with Needles was found to be substantially | |
| equivalent to the predicate device |
1 9 2013
10801 Nesbitt Avenue South
Bloomington, MN 55437
Phone: (952) 426-7600
. •
Fax: (952) 426-7601
".
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Tornier, Incorporated Ms. Janell Colley Regulatory Affairs Manager 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
September 19, 2013
Re: K132632
Trade/Device Name: Tornier Insite FT Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Il Product Code: MBI Dated: August 19, 2013 Received: August 22, 2013
Dear Ms. Colley:
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
2
Page 2 - Ms. Janell Colley
forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
ff 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.fdagov/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/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, 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Elizabeth L. Frank -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "TORNIER" in a bold, serif font. To the right of the word is a hexagonal shape containing a stylized letter "T" inside. The letter "T" within the hexagon is designed with a tree-like appearance, with the top of the "T" resembling branches.
- Statement of Indications for Use 3
K132632 TBD -510(k) Number:
Device Name: Tornier Insite FT Suture Anchor
Indications for Use
The Tornier Insite FT Suture Anchor is intended for fixation of soft tissue to bone.
The Tornier Insite FT Suture Anchor is intended for use in the following applications:
- Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps ﻨــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.
- Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and ni Metatarsal ligament repair, Hallux Valgus and Midfoot Reconstruction.
-
-
- IKnee: 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 ಳ Ulnar collateral ligament reconstruction.
- Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and 5. Radial collateral ligament reconstruction.
AND/OR Prescription Use X (Part 2) CFR 801 Subpart D)
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRI-I, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Phone: (952) 426-7600 Bloomington, MN 55437
RESERVED FOR FUTURE USE