(85 days)
The FASTIN RC Anchor is intended for: Shoulder: Rotator Cuff Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair and SLAP Repair; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Tennis Elbow, Ulnar or Radial Collateral Ligament Reconstruction.
The FASTIN RC Anchor is a threaded titanium alloy implantable suture anchor preloaded on a disposable inserter assembly intended for fixation of two strands of suture. The anchors are made from Titanium 6A1-4V ELI per ASTM F- 136. The attached suture is then used to reattach soft tissue back to bone where it reconnects through the healing process. Once the tissue has healed (about six weeks) the anchor function is complete and the implant becomes dormant in the The FASTIN RC Anchor is available in 5.0mm and 6.5mm sizes and is offered with three suture options, non-absorbable Ethibond, absorbable Panacryl, and composite Orthocord.
The provided text describes the 510(k) summary for the FASTIN RC Anchor. This document focuses on demonstrating substantial equivalence to pre-existing devices rather than presenting the results of a primary study proving performance against acceptance criteria. Therefore, most of the requested information (acceptance criteria table, study sample sizes, expert ground truth details, adjudication methods, MRMC studies, standalone performance, training set details) is not available in this document.
Here's what can be extracted based on the provided text:
Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the FASTIN RC Anchor. Instead, the "Safety and Performance" section indicates that substantial equivalence was determined through non-clinical laboratory testing. This testing demonstrated that the device is safe and can be considered substantially equivalent to the predicate FASTIN Anchor for the proposed new intended uses. The specifics of what constitutes "safe" or "substantially equivalent" in terms of measurable performance are not detailed.
Study Type and Design:
The study performed was non-clinical laboratory testing to support the claim of substantial equivalence to predicate devices (FASTIN Anchor - K945203, and Arthrex Titanium Corkscrew Anchor - K003816).
Here's a breakdown of the requested information based on the provided text:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as numerical performance targets. The "acceptance" was demonstrating safety and substantial equivalence to predicate devices through non-clinical laboratory testing.
- Reported Device Performance: The device was found to be safe and substantially equivalent to the predicate device for its proposed new intended uses based on non-clinical laboratory testing. No specific performance metrics (e.g., pull-out strength, fatigue life) are detailed in this summary.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified, but generally, non-clinical lab testing data would originate from the manufacturer's testing facilities. It's prospective in the sense that the tests were specifically conducted for this submission.
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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):
- Not applicable as this was non-clinical laboratory testing, not a clinical study involving expert interpretation of medical data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this was non-clinical laboratory testing.
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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. This is not an AI/imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/imaging device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For non-clinical laboratory testing, the "ground truth" would be established by the physical and mechanical properties measured during the tests (e.g., material properties, strength, durability) compared against established standards or the properties of the predicate device.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable.
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K60664 page 1 of 2
JUN -6 2006
SECTION 6 -- 510(k) SUMMARY
Page 1 of 2
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company325 Paramount Drive,Raynham, MA 02767 USA |
|---|---|
| Contact Person | Ruth Forstadt, RACProject Management Lead, Regulatory AffairsDePuy Miteka Johnson & Johnson company325 Paramount Drive,Raynham, MA 02767 USATelephone: (508) 977-3988Facsimile: (508) 828-3750e-mail: rforstad@dpyus.jnj.com |
| Name of Medical Device | Device Regulation:Fastener, Fixation, Non-Degradable, Soft Tissue(21 CFR 888.3040)Product code: 87 MBICommon/Usual Name:Proprietary Name:FASTIN RC Anchor |
| Device Classification | In accordance with per 21 CFR 888.3040, suture anchors are classifiedby the FDA as Class II Medical Devices. |
| Indications for Use | The FASTIN RC Anchor is intended for: Shoulder: Rotator CuffRepair, Biceps Tenodesis, Acromio-Clavicular Separation Repair andSLAP Repair; Foot/Ankle: Lateral Stabilization, Medial Stabilization,Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair,Lateral Collateral Ligament Repair, Patellar Tendon Repair, PosteriorOblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: BicepsTendon Reattachment, Tennis Elbow, Ulnar or Radial CollateralLigament Reconstruction. |
| Device Description | The FASTIN RC Anchor is a threaded titanium alloyimplantable suture anchor preloaded on a disposable inserter assemblyintended for fixation of two strands of suture. The anchors are madefrom Titanium 6A1-4V ELI per ASTM F- 136. The attached suture isthen used to reattach soft tissue back to bone where it reconnectsthrough the healing process. Once the tissue has healed (about six.weeks) the anchor function is complete and the implant becomesdormant in theThe FASTIN RC Anchor is available in 5.0mm and6.5mm sizes and is offered with three suture options, non-absorbableEthibond, absorbable Panacryl, and composite Orthocord. |
| Substantial Equivalence | The FASTIN RC Anchor is a commercially marketed device that wasoriginally subject of K983818 (cleared November 23, 1998). Whenused for the proposed indications the device is substantially equivalentto the FASTIN Anchor (K945203) and the Arthrex Titanium CorkscrewAnchor (K003816). |
| Safety and Performance | The determination of substantial equivalence for this device was basedon a detailed device description. Non-clinical laboratory testing wasperformed demonstrating that the device is safe and can be consideredsubstantially equivalent to the predicate FASTIN Anchor for theproposed new intended uses. |
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510(k) SUMMARY
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized representation of three human figures connected at the shoulders.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2006
DePuy Mitek a Johnson & Johnson Company c/o Ms. Ruth Forstadt, RAC Project Management Lead, Regulatory Affairs 325 Paramount Drive, Raynham, Massachusetts 02767
Re: K060664
Trade/Device Name: Fastin RC Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: May 3, 2006 Received: May 5, 2006
Dear Ms. Forstadt:
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.
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
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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.
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 Office of Compliance at (240) 276- 0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Hubert Lenfercus
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ Ko6o664
Device Name: FASTIN RC Anchor
The FASTIN RC Anchors are indicated for the following:
- Shoulder: Rotator Cuff Repair, SLAP Repair, Biceps Tenodesis, Acromio-. Clavicular Separation Repair and SLAP Repair
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair .
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, . Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Elbow: Biceps Tendon Reattachment, Tennis Elbow, Ulnar or Radial Collateral . Ligament Reconstruction.
Prescription Use
OR
Over-the -Counter Use K (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulut Turner
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K060664
§ 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.