(99 days)
Not Found
No
The device description and intended use are for physical suture anchors, and there is no mention of AI or ML in the provided text.
Yes
The device is described as "suture anchors" intended for "reattachment of soft tissue to bone" for a variety of injuries and conditions, which directly implies a therapeutic function to treat medical issues.
No
Explanation: The device is described as "suture anchors" intended for "reattachment of soft tissue to bone." There is no mention of it being used to identify or analyze a medical condition.
No
The device description explicitly states the devices are fabricated from titanium, PLLA absorbable polymer, and acetal polymer, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the reattachment of soft tissue to bone in various anatomical locations. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is described as suture anchors fabricated from materials like titanium and polymers, designed to facilitate the attachment of soft tissue to bone. This aligns with a surgical implant or device used during a procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the living body) to analyze samples and provide diagnostic information. This device is used in vivo during surgery.
N/A
Intended Use / Indications for Use
Tornier® Insite™ Bioabsorbable Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulabral 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
Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
Product codes
MBI, MAI
Device Description
The devices described in this 510(k) Notice are exactly the same device as the predicate Axya Medical Suture anchors described in the 510(k) Notices listed above. The various anchors are fabricated from titanium, PLLA absorbable polymer and acetal polymer. They are provided in diameters of 3mm, 5mm and 6.5mm to facilitate the attachment of soft tissue to bone.
No changes have been made to the devices.
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, Pelvis
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003971, K011912, K052491, K051983, K041698, K151250, K060970
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
长083268
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
- Name: Tornier, Inc. Contact: Howard Schrayer Regulatory Affairs Consultant
FEB 1 2 2009
Address: 100 Cummings Center Suite 444C Beverly, MA 01915
Telephone: (978) 232 - 9997 (978) 232 — 9998 Fax:
- Date Prepared November 4, 2008
General Device Information
Product Name: Insite™ Suture anchors
"Non-degradable soft tissue fixation fastener" Classification: Product code: MBI - Class II
Predicate Devices
| Original
510(k) Notice | Anchor Material | Nominal Anchor
Size (Diameter) | Date Cleared |
|---------------------------|-----------------|-----------------------------------|-----------------|
| K003971 | Titanium | 3mm | March 21, 2001 |
| K011912 | Titanium | 5mm | August 31, 2001 |
| K052491 | Titanium | 6.5mm | October 7, 2005 |
| K051983 | PLLA Polymer | 3mm | August 5, 2005 |
| K041698 | PLLA Polymer | 5mm | October 5, 2004 |
| K151250 | PLLA Polymer | 6.5mm | June 9, 2005 |
| K060970 | Acetal Polymer | 3, 5 and 6.5mm | July 5, 2006 |
1
pg. 2 of 2)
Description
The devices described in this 510(k) Notice are exactly the same device as the predicate Axya Medical Suture anchors described in the 510(k) Notices listed above. The various anchors are fabricated from titanium, PLLA absorbable polymer and acetal polymer. They are provided in diameters of 3mm, 5mm and 6.5mm to facilitate the attachment of soft tissue to bone.
No changes have been made to the devices.
Intended Use (Indications)
Tornier® Insite™ Bioabsorbable Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulabral 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
Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
Substantial Equivalence
This submission supports the position that the Tornier Insite™ Suture anchors are substantially equivalent to the previously cleared Axya Medical devices listed above.
Conclusions
Tornier. Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same range of clinical applications as the Tornier Insite™ Suture anchors. The materials from which the Tornier devices are fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tornier, Inc. C/o Mr. Howard Schrayer Regulatory Affairs Consultant 100 Cummings Center Beverly, MA 01915
FEB 1 2 2009
Re: K083268
Trade/Device Name: Insite™ 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, MBI Dated: November 4, 2008 Received: November 18, 2008
Dear Mr. Schrayer:
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. Isting of devices, good manufacturing 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 may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Mr. Howard Schrayer
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474: For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): 1083268
Device Name: Insite™ Suture Anchors
Indications For Use:
Tornier® Insite™ Suture Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulabral 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, Iliotibial 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
Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
4
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milken
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
510(k) Number