(76 days)
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No
The device description and intended use are purely mechanical, describing a suture anchor for tissue fixation. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No.
The device, a suture anchor, is used for fixation of soft tissue to bone, which is a structural or mechanical function, not a therapeutic one in the sense of treating a disease or disorder through metabolic, pharmacological, or immunological means.
No
Explanation: The provided text describes the Bio-Fastak Suture Anchor as a device intended for fixation of soft tissue to bone, with specific indications for various anatomical sites. Its function is to reattach soft tissue, an interventional purpose, rather than to diagnose medical conditions or identify diseases.
No
The device description clearly states it is a physical suture anchor made of poly (L, DL-lactide) with a threaded design and suture, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of soft tissue to bone" for various surgical repairs in different anatomical locations. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a physical implantable device made of poly (L, DL-lactide) with a threaded design and suture. This is consistent with a surgical device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool/implant used to physically repair tissue within the body.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device 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.
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, 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)
Not Found
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.
Not Found
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
§ 888.3030 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.
0
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. Brown |
| Manager 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
1
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
2
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.
3
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
4
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