(77 days)
The Doubleplay™ Suture Anchor is intended for fixation of suture to bone in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis.
The Doubleplay™ Suture Anchor is a bioabsorbable device manufactured from Bilok®, a composite mixture of poly-L-lactic acid (a synthetic bioabsorbable polymer) and calcium phosphate (bone void filler material). It may be supplied with sutures with or without pre-attached needles.
The provided text describes a 510(k) submission for the Doubleplay™ Suture Anchor, a bioabsorbable device used for fixation of suture to bone in orthopedic procedures. Here's a breakdown of the information requested based on the supplied text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is for a medical device (suture anchor), not an AI device. Therefore, the concept of "acceptance criteria" in the context of sensitivity, specificity, or AUC for an algorithmic diagnostic output does not directly apply. Instead, the "acceptance criteria" implicit in this 510(k) submission are that the device demonstrates substantial equivalence to legally marketed predicate devices in terms of its characteristics, intended use, safety, and effectiveness.
| Acceptance Criteria (Implicit for Substantial Equivalence Determination) | Reported Device Performance (from K061949 Summary) |
|---|---|
| Material Composition | The Doubleplay™ Suture Anchor is manufactured from Bilok®, a composite mixture of poly-L-lactic acid and calcium phosphate. This material has been used in other bone site applications for approximately eight years with no reported incidents of material-related adverse events. |
| Technological Characteristics | "The Doubleplay™ Suture Anchor has the same technological characteristics as the predicate devices and any differences do not raise concerns concerning safety and effectiveness." |
| Intended Use / Indications | "The Doubleplay™ Suture Anchor is intended for fixation of suture to bone in orthopaedic procedures." The indications, contraindications, risks, and potential adverse events are stated to be the same as the identified predicate devices. |
| Non-Clinical Testing | "Test data supplied demonstrates that the Doubleplay™ Suture Anchor is substantially equivalent to the predicate devices and any differences do not raise concerns concerning safety and effectiveness." (Specific test results are not provided in the summary) |
| Resorption Profile (for bioabsorbable material) | Implant studies show the material is not resorbed in less than 12 months, which is greater than the expected bony healing period (typically 12 weeks) and tissue-to-bone healing period (typically 6-8 weeks). |
| Overall Safety and Effectiveness | "No new concerns have been identified regarding safety and effectiveness of the new device." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not mention a "test set" in the context of an algorithm's performance evaluation. The "testing" referred to is primarily non-clinical (e.g., mechanical, material characterization) and potentially clinical experience with the material used.
- No specific sample size for an algorithmic "test set" is provided as this is not an AI device.
- Data provenance for the clinical experience with the material is stated as general "implant studies" and "other bone site applications" over approximately eight years. The country of origin and whether these were retrospective or prospective studies are not specified in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is not an AI device, and the concept of "ground truth" established by experts for an algorithmic test set is not relevant to this submission.
4. Adjudication Method for the Test Set
Not applicable. There is no algorithmic test set or adjudication process described in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI device, and no MRMC study comparing human readers with or without AI assistance is mentioned.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a medical device (suture anchor), not an algorithm.
7. Type of Ground Truth Used
Not applicable in the context of an AI device's performance evaluation. For a physical device like a suture anchor, "ground truth" would be related to clinical outcomes, biomechanical performance, biocompatibility, and material properties, which are assessed through various non-clinical and clinical (in a broader sense, relating to material history) studies rather than expert consensus on diagnostic images.
8. Sample Size for the Training Set
Not applicable. This is not an AI device, and therefore, there is no "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, the establishment of ground truth for it is irrelevant.
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K061949 p4c \$\frac{1}{2}$
SEP 2 5 2006
510(k) SUMMARY
Doubleplay™ Suture Anchor
- Biocomposites Ltd Applicant Keele Science Park Keele Staffordshire England ST5 SNL
- Contact Person Mr Simon Fitzer +44 (0) 1782 338580 Tel: +44 (0) 1782 338599 Fax Email: sf@biocomposites.com
| Classification Name: | Fastener, fixation, biodegradable, soft tissue |
|---|---|
| Common/Usual Name: | Suture anchor, bone anchor |
| Trade/Proprietary Name | Doubleplay™ Suture Anchor |
| Product Code | HWC |
Legally Marketed Predicate Devices
| Trade Name | Manufacturer | 510(k) No |
|---|---|---|
| Arthrex Bio-Corkscrew Suture Anchor | Arthrex Inc | K043337 |
| Model 5000 AxyaLoop Bone Anchor | Axya Medical Inc | K041698 |
Device Description
The Doubleplay™ Suture Anchor is a bioabsorbable device manufactured from Bilok®, a composite mixture of poly-L-lactic acid (a synthetic bioabsorbable polymer) and calcium phosphate (bone void filler material). It may be supplied with sutures with or without pre-attached needles.
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Intended Use / Indications
The Doubleplay™ Suture Anchor is intended for fixation of suture to bone in orthopaedic procedures.
The indications, contraindications, risks and potential adverse events are the same as the identified predicate devices and are thus substantially equivalent.
Summary of Technology
The Doubleplay™ Suture Anchor has the same technological characteristics as the predicate devices and any differences do not raise concerns concerning safety and effectiveness.
Non Clinical Testing
Test data supplied demonstrates that the Doubleplay™ Suture Anchor is substantially equivalent to the predicate devices and any differences do not raise concerns concerning safety and effectiveness.
Clinical Testing
The material used in the manufacture of the Doubleplay™ Suture Anchor has been used in other bone site applications for approximately eight years with no reported incidents of material related adverse events. Implant studies show that the material is not resorbed in less than 12 months. This is greater than the expected bony healing period which is typically 12 weeks. The tissue to bone healing period is typically 6-8weeks.
Substantial Equivalence
Documentation provided demonstrates that the Doubleplay™ Suture Anchor is substantially equivalent to the legally marketed predicate devices in basic features and intended uses. No new concerns have been identified regarding safety and effectiveness of the new device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
SEP 2 5 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biocomposites Ltd % Mr. Simon Fitzer Ouality & Regulatory Affairs Manager Keele Science Park, Keele Staffordshire, England ST5 5NL
Re: K061949
Trade/Device Name: Doubleplay™ Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR Dated: June 30, 2006 Received: July 10, 2006
Dear Mr. Fitzer:
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 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.
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Page 2 - Mr. Simon Fitzer
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" (21 CFR 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/cdrb/industry/support/index.html.
Sincerely yours,
Sarbare Breme
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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INDICATIONS FOR USE
510(k) Number (if known):
R06144
Device Name:
Doubleplay™ Suture Anchor
Indications For Use:
The Doubleplay™ Suture Anchor is intended for fixation of suture to bone in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis.
Prescription Use V (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter use No
(Part 21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Onuchum Onuka
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061491
Page 1 of 1
§ 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.