(152 days)
Not Found
No
The device description and intended use focus solely on a mechanical implant and surgical procedure, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an implant used for fixation of soft tissue to bone during surgical procedures and does not perform a therapeutic function on its own.
No
The device is described as an implant for fixation of soft tissue to bone during surgical procedures, not for diagnosing conditions. Its intended use is for repair and reconstruction, not for identifying diseases or conditions.
No
The device description clearly states it is a physical implant system made of PEEK and suture, pre-mounted on a disposable inserter, and used with a reusable drill guide. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "arthroscopic or mini-open surgical procedures" for "fixation of soft tissue to bone." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a "bone anchor," "suture," and "inserter," all components of a surgical implant system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device's function is mechanical fixation within the body during surgery.
N/A
Intended Use / Indications for Use
The Tornier, 3.4mm QuickDraw™ Convertible Fixation Implant is intended for use in arthroscopic or mini-open surgical procedures either as a standard bone anchor or as a knotless system for fixation of soft tissue to bone.
The QuickDraw™ Implant is intended for use in the following applications:
Shoulder: Rotator Cuff Repair, Bankart Repair, Anterior Shoulder Stabilization, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction
Foot/Ankle: Lateral or Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair. Bunionectomy
Elbow, Wrist and Hand: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondvlitis Repair
Knee: Extra-capsular Repairs, Patellar Realignment and Tendon Repairs, Iliotibial Band Tenodesis
Product codes
MBI
Device Description
The Implant system includes a 3.4mm diameter PEEK (polyether-etherketone) bone anchor, pre-mounted on a disposable inserter. The anchor is preloaded with USP size 2 Ultra High Molecular Weight Polyethylene suture, and a threading device. The device is designed to be inserted into a pre-drilled hole using a reusable drill guide. The anchor may be used as a tied implant, or it can be converted to a knotless fixation device by following the instructions for use. Thus, the QuickDraw™ Convertible Fixation Implant allows the user to select between tied or knotless fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Elbow, Wrist, Hand, Knee
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)
Data have been provided in the submission that demonstrates that in both the traditional knotted suture and knotless configurations the anchor pullout forces are equivalent or superior to referenced predicate devices.
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
§ 888.3040 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
510(k) SUMMARY (Per 21 CFR 807.92)
General Company Information
Name: Tornier, Inc. Contact: Lael J. Pickett Director Regulatory and Clinical Affairs Tornier, Inc.
Office: 952-426-7641 Cell: 612-219-7350 Fax: 952-426-7601 Email: Ipickett@tornier.com
Date Prepared March 14, 2011
General Device Information
| Product Name: | 3.4mm QuickDraw™ Convertible Fixation Implant |
|---|---|
| Classification: | "Non-degradable soft tissue fixation fastener" |
| Product code: MBI - Class II | |
| Regulation: | 21 CFR 888.3040 |
| Smooth or threaded metallic bone fixation fastener |
Predicate Device
| Smith & Nephew, Inc. | Bioraptor™ 2.3 PK Suture Anchor.
[510(k) Number K071586] |
|----------------------|-----------------------------------------------------------------------------|
| ArthroCare, Inc. | LabraLock P™ Knotless Fixation Device
Suture Anchors
[510(k) K061349] |
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K103262
Description
The Implant system includes a 3.4mm diameter PEEK (polyether-etherketone) bone anchor, pre-mounted on a disposable inserter. The anchor is preloaded with USP size 2 Ultra High Molecular Weight Polyethylene suture, and a threading device. The device is designed to be inserted into a pre-drilled hole using a reusable drill guide. The anchor may be used as a tied implant, or it can be converted to a knotless fixation device by following the instructions for use. Thus, the QuickDraw™ Convertible Fixation Implant allows the user to select between tied or knotless fixation.
Intended Use (Indications)
The Tornier, 3.4mm QuickDraw™ Fixation Implant is intended for use in arthroscopic or mini-open surgical procedures either as a standard bone anchor or as a knotless system for fixation of soft tissue to bone.
The QuickDraw™ Implant is intended for use in the following applications:
Shoulder: Rotator Cuff Repair, Bankart Repair, Anterior Shoulder Stabilization, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction
Foot/Ankle: Lateral or Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair. Bunionectomy
Elbow, Wrist and Hand: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondvlitis Repair
Knee: Extra-capsular Repairs, Patellar Realignment and Tendon Repairs, Iliotibial Band Tenodesis
Substantial Equivalence
This submission supports the position that the Tornier QuickDraw™ 3.4mm Fixation Implant System is substantially equivalent to previously cleared devices, including those listed above. Data have been provided in the submission that demonstrates that in both the traditional knotted suture and knotless configurations the anchor pullout forces are equivalent or superior to referenced predicate devices. The referenced predicate devices list the same range of clinical uses.
Conclusions
Tornier, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Tornier QuickDraw™ Fixation Implant System. The materials from which the Tornier device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA quidelines.
Page 2 of 2
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Tornier, Inc. % Ms. Lael J. Pickett Director Regulatory and Clinical Affairs 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915
APR - 5 2011
Re: K103262
Trade/Device Name: 3.4mm QuickDraw™ Convertible Fixation Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 14, 2011 Received: March 16, 2011
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
3
Page 2 – Ms. Lael J. Pickett
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 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/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 vours,
A. B. A. fa.
Mark N. Melkerson 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): K 10326Z
Device Name: 3.4mm QuickDraw™ Convertible Fixation Implant
Indications For Use:
The Tornier, 3.4mm QuickDraw™ Convertible Fixation Implant is intended for use in arthroscopic or mini-open surgical procedures either as a standard bone anchor or as a knotless system for fixation of soft tissue to bone.
The QuickDraw™ Implant is intended for use in the following applications:
Shoulder: Rotator Cuff Repair, Bankart Repair, Anterior Shoulder Stabilization, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction
Foot/Ankle: Lateral or Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy
Elbow, Wrist and Hand: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondvlitis Repair
Knee: Extra-capsular Repairs, Patellar Realignment and Tendon Repairs, Iliotibial Band Tenodesis
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Mulkerson
(Division Sign-Qfr) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
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