(133 days)
Not Found
No
The 510(k) summary describes a purely mechanical device for suture fixation and does not mention any AI or ML components or functionalities.
No
Explanation: The device is intended for suture fixation of soft tissue to bone to repair rotator cuff tears. It is an implantable device used for mechanical support and reattachment, rather than a device that directly treats a disease or condition through therapeutic action.
No
The device description clearly states its purpose is for "suture fixation of soft tissue to bone" and "repairing rotator cuff tears" by physically securing tissue. It does not mention any function related to identifying, analyzing, or determining the presence or nature of a disease or condition.
No
The device description clearly describes a physical implantable disc made of PLA, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "suture fixation of soft tissue to bone" for repairing rotator cuff tears. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant (a PLA disc) used to secure sutures during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Arthrex Bio-Button does not fit this definition.
N/A
Intended Use / Indications for Use
The Arthrex Bio-Button is intended for the suture fixation of soft tissue to bone, utilizing the Arthrex® Corkscrew™ Suture Anchor, and polyester braided sutures appropriate to the procedure, up to size 5 (single strand). This product is intended for use in repairing rotator cuff tears.
Product codes
MAI, GAS, and KGS
Device Description
The Bio-Button is a PLA disc consisting of four holes for passing suture. Once suture is passed through the soft tissue, the two free ends of the suture are brought through the Bio-Button in any two holes. Soft tissue reattachment is accomplished by tying the suture ends over the Bio-Button securing the suture and disc to the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue to bone (for repairing rotator cuff tears)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
1-983643
510(k) Summary
02/26/99
| Company: | Arthrex, Inc. |
|---|---|
| Address: | 2885 S. Horseshoe Drive, Naples, FL 34104 |
| Phone: | (941) 643-5553 |
| Fax: | (941) 643-6218 |
| Contact: | Vernon C. Brown |
| Manager of Regulatory Affairs and Quality Assurance (ext. 117) |
| Trade Name: | Arthrex Bio-Button |
|---|---|
| Common Name: | Soft Tissue Fastener |
| Classification: | Fastener, Fixation, Biodegradable, Soft Tissue |
Description:
The Bio-Button is a PLA disc consisting of four holes for passing suture. Once suture is passed through the soft tissue, the two free ends of the suture are brought through the Bio-Button in any two holes. Soft tissue reattachment is accomplished by tying the suture ends over the Bio-Button securing the suture and disc to the bone.
Intended Use:
The Arthrex Bio-Button is intended for the suture fixation of soft tissue to bone, utilizing the Arthrex® Corkscrew™ Suture Anchor, and polyester braided sutures appropriate to the procedure, up to size 5 (single strand). This product is intended for use in repairing rotator cuff tears.
Similarities and Differences with Marketed Devices:
The Bio-Button has the same diameter and thickness as the discs used with the Corkscrew Parachute (K974847). Furthermore, it is made out of the same material. There are slight variations in design, including removal of the cross and enlarging the diameter of the four holes to accept #5 suture. None of these changes cause the Bio-Button to be any less safe and effective than the predicate device nor do they raise any different questions regarding safety and effectiveness from the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The bird is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle, with the bird symbol placed in the center.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 1999
Mr. Vernon C. Brown Regulatory Affairs Manager Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
K983843 Re:
Trade Name: Bio-Button Regulatory Class: II Product Codes: MAI, GAS, and KGS Dated: January 22, 1999 Received: January 25, 1999
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 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 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 (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 requirement, 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.
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Page 2 - Mr. Vernon C. Brown
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.
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) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K98 3843
Indications for Use
The Arthrex Bio-Button is intended for the suture fixation of soft tissue to bone, The Arthrex® Corkscrew™ Suture Anchor and polyester braided sutures ultilizing the Antifox® Consocious. So (single strand). This product is intended for use in repairing rotator cuff tears.
Prescription Use
(Per 21 CFR 801.109)
リ :
Signature
(1) ... . h Sign-Off) Dir son of General Restorative De 510(k) Number