(76 days)
The Bio-Fastak Suture Anchor is intended for fixation of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligamant Reconstruction
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
The Bio-Fastak Suture Anchor is manufactured using poly (L, DL-lactide). It is a threaded design with an evelet of braided polyester suture insert molded down the length of the device. The anchor has a hex head, which is seated in a disposable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a tap. Once in place, additional suture may be passed through the eyelet and used to reattach soft tissue to the bone.
This document describes a 510(k) premarket notification for a medical device called the "Arthrex Bio-Fastak Suture Anchor." A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that does not require premarket approval.
Based on the provided text, there is no information present regarding acceptance criteria or a study proving the device meets acceptance criteria related to software performance, AI/ML algorithms, or diagnostic accuracy. This document is for a physical surgical implant (suture anchor), and the FDA's review focuses on its substantial equivalence to predicate devices, material safety, and intended use.
Therefore, I cannot provide the requested information. The document is concerned with:
- Device Description: What the Bio-Fastak Suture Anchor is made of (poly L, DL-lactide), its design (threaded, eyelet with polyester suture, hex head), and how it's used to reattach soft tissue to bone.
- Intended Use/Indications: The specific surgical procedures and body parts where the anchor is intended to be used (e.g., Rotator Cuff Repair, Bankart Repair, Achilles Tendon Repair, Bladder Neck Suspension).
- Substantial Equivalence: The primary basis for FDA clearance, stating that the device has the same intended use and similar technological characteristics (or proven equivalent safety and effectiveness with different characteristics) as legally marketed predicate devices, and raises no new safety or effectiveness questions.
- Regulatory Classification: The device is classified as Class II, under Product Codes MAI and HWC.
- FDA Clearance Letter: Official communication from the FDA stating that the device has been reviewed and determined to be substantially equivalent, allowing it to be marketed.
The concept of "acceptance criteria" and "device performance" in this context refers to the physical and biological performance of the implant (e.g., strength, biodegradability, biocompatibility), which would have been assessed through bench testing and potentially animal or clinical studies that are NOT detailed in this summary. The document explicitly states that the "material is well characterized, and has been used in a predicate device with a similar indication," implying that the testing on the material properties and the device's mechanical functions were deemed sufficient based on the established equivalence.
No mention is made of:
- Any software, AI, or diagnostic components.
- Test sets for performance evaluation.
- Experts establishing ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Training set information.
Conclusion: The provided text is a 510(k) summary for a physical medical implant, not a software or AI-driven diagnostic device. Therefore, the questions related to acceptance criteria, study design, and performance metrics for AI/ML or diagnostic accuracy are not applicable to the information contained in this document.
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K00-0506
510(k) Summary
02/02/00
| Company: | Arthrex, Inc. |
|---|---|
| Address: | 2885 S. Horseshoe Drive, Naples, FL 34104 |
| Phone: | (941) 643-5553 (ext. 117) |
| Fax: | (941) 643-6218 |
| Contact: | Vernon C. BrownManager of Regulatory Affairs |
| Trade Name: | Arthrex Bio-Fastak Suture Anchor |
| Common Name: | Suture Anchor |
Classification: Description:
The Bio-Fastak Suture Anchor is manufactured using poly (L, DL-lactide). It is a threaded design with an evelet of braided polyester suture insert molded down the length of the device. The anchor has a hex head, which is seated in a disposable driver for insertion purposes. Prior to driving in the anchor, it is necessary to prepare the bone using a tap. Once in place, additional suture may be passed through the eyelet and used to reattach soft tissue to the bone.
Fastener, Fixation, Biodegradable, Soft Tissue
Intended Use:
The Bio-Fastak Suture Anchor is intended for fixation of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligamant Reconstruction
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
000123
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Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device.
The differences between the Bio-Fastak Suture Anchor and the predicate devices cited do not raise any different questions regarding safety and effectiveness. Furthermore, the material is well characterized, and has been used in a predicate device with a similar indication. The device, as designed, is as safe and effective as the predicate devices
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping heads suggesting community or interconnectedness. The symbol is rendered in black, contrasting with the white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2000
Mr. Vernon C. Brown Manager of Regulatory Affairs Arthrex Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K000506 Trade Name: Bio-FASTak Suture Anchor Regulatory Class: II Product Codes: MAI, HWC Dated: February 2, 2000 Received: February 15, 2000
Dear Mr. Brown:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Mr. Vernon C. Brown
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, (2017) 594-1595. Frauncent (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Dune R. buchner.
Celia M. Witten, Ph.D., M.D. 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
The Bio-Fastak is intended for fixation of suture to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligamant Reconstruction
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
Daine R. Luchner.
(Division Sign-Off) Division of General Restorative Devices 510(k) Number KUOOSO G
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.