(77 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a bioabsorbable suture anchor, with no mention of AI or ML.
No
The device is a suture anchor used for fixation of sutures to bone, which is a structural or supportive function rather than directly treating or preventing disease.
No
Explanation: The provided text describes the Doubleplay™ Suture Anchor as a device intended for fixation of suture to bone in orthopedic procedures. Its purpose is to physically attach suture to bone, which is a therapeutic function, not a diagnostic one. Diagnostic devices are used to identify a disease or condition, which is not the function of this anchor.
No
The device description clearly states it is a bioabsorbable device manufactured from a composite mixture of materials, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of suture to bone in orthopaedic procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "bioabsorbable device manufactured from Bilok®" and is a physical implant.
- 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 physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for conditions. This device is a surgical implant used to repair tissue within the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HWC, JDR
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.
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 and 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
1
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.
2
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.
3
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
4
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