(152 days)
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
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.
This is a 510(k) premarket notification for a medical device (3.4mm QuickDraw™ Convertible Fixation Implant), which primarily focuses on demonstrating substantial equivalence to predicate devices through device description, intended use, and a general statement of testing. It does not contain the detailed information necessary to answer all your questions regarding acceptance criteria and study particulars for an AI/ML powered device.
Here's what can be extracted based on the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
The document broadly states: "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."
This is a very high-level summary and does not provide a specific table of acceptance criteria or the reported device performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given 510(k) summary. The summary refers to "Data have been provided in the submission," but the specifics of that data (sample size, provenance) are not included in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a physical implant, not an AI/ML powered diagnostic device. Therefore, the concept of "ground truth" established by experts in the context of image interpretation or similar tasks is not applicable. The "data" mentioned likely refers to mechanical testing results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical implant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable for a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable for a physical implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this device, the "ground truth" would likely refer to established engineering and biomechanical principles, and the measurement of physical properties like "anchor pullout forces" using standardized testing methods. It would not be expert consensus, pathology, or outcomes data in the way it applies to AI/ML diagnostics.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm that undergoes a "training phase" in the traditional sense.
9. How the ground truth for the training set was established
Not applicable for a physical implant.
In summary:
The provided K103262 document is a 510(k) summary for a physical medical device (a surgical implant). It focuses on demonstrating substantial equivalence to predicate devices based on materials, intended use, and general performance (e.g., pullout forces). It does not contain the detailed study information, acceptance criteria tables, or specifics about expert involvement that would be present for an AI/ML powered device. Many of your questions are specifically tailored to AI/ML device evaluations and are therefore not addressed by this type of submission.
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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 888.3040Smooth 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 DeviceSuture 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.
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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
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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
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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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§ 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.