(24 days)
Not Found
Not Found
No
The device description and summary of performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
No
The device, a suture anchor, is used for mechanical fixation during shoulder rotator cuff repair. It does not provide any therapeutic function (e.g., drug delivery, energy delivery, or biological stimulation) to treat a disease or condition.
No
The device description indicates it is a physical suture anchor used for repair, not for diagnosing medical conditions.
No
The device description clearly states it is an absorbable, threaded suture anchor with physical dimensions and suture holes, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "shoulder rotator cuff repair." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "threaded suture anchor" used to fix suture to bone. This is a physical implant used during surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided clearly describes a surgical implant, not a diagnostic test performed on in vitro samples.
N/A
Intended Use / Indications for Use
The BIOFASTIN RC Threaded Suture Anchor is indicated for shoulder rotator cuff repair.
Product codes (comma separated list FDA assigned to the subject device)
87 MAI, HWC, MAI, GAM, GAS
Device Description
The BIOFASTIN RC Threaded Suture Anchor is an absorbable, threaded suture anchor. The BIOFASTIN RC anchor has 2 threads of an auger-type design with an overall nominal diameter of 5.0 mm and nominal length of 11.5 mm. The device has two suture holes (90 degrees apart) in the anchor head for fixation of #2 suture to bone (sutures provided pre-attached with affixed tapered needles). The sutures provided with the BIOFASTIN RC are either the ETHIBOND non-absorbable or PANACRYL absorbable sutures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder
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)
Results of performance testing have demonstrated that the modified device is substantially equivalent to the predicate devices.
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
§ 888.3040 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
ப்பட 1 2002 510(k) Summary
| Trade Name: | BioFastin RC Threaded Suture Anchor |
|---|---|
| Sponsor: | Mitek Worldwide |
| 249 Vanderbilt Avenue | |
| Norwood, MA 02062 | |
| Registration #1221934 | |
| Contact: | Ruth Forstadt, Senior Regulatory Affairs Associate |
| Device Generic Name: | Fastener, Fixation, Biodegradable Soft Tissue |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. | |
| Product Code: | 87 MAI |
| Predicate Device(s): | FASTIN RC Suture Anchor |
| Mitek CuffTack Sutureless Fixation Device | |
| PANALOK RC Absorbable Anchor | |
| Product Description: | The BIOFASTIN RC Threaded Suture Anchor is an |
| absorbable, threaded suture anchor. The BIOFASTIN RC | |
| anchor has 2 threads of an auger-type design with an | |
| overall nominal diameter of 5.0 mm and nominal length of | |
| 11.5 mm. The device has two suture holes (90 degrees | |
| apart) in the anchor head for fixation of #2 suture to bone | |
| (sutures provided pre-attached with affixed tapered | |
| needles). The sutures provided with the BIOFASTIN RC | |
| are either the ETHIBOND non-absorbable or PANACRYL | |
| absorbable sutures. | |
| Indications for Use: | The BIOFASTIN RC Threaded Suture Anchor is indicated |
| for shoulder rotator cuff repair. | |
| Safety and Performance: | Results of performance testing have demonstrated that the |
| modified device is substantially equivalent to the predicate | |
| devices. |
くい
Conclusion:
Based on 1) safety and performance data, and 2) similarities in design, operating principles, biocompatibility and sterilization method, the BIOFASTN RC Threaded Suture Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles an abstract human form or a bird-like shape, composed of three curved lines or strokes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2002 . IUL
Ms. Ruth C. Forstadt Senior Regulatory Affairs Associate Mitek Worldwide 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K021883
Trade/Device Name: BIOFASTIN RC Threaded Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Codes: HWC, MAI, GAM, GAS Dated: June 6, 2002 Received: June 7, 2002
Dear Ms. Forstadt:
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.
2
Page 2 – Ms. Ruth C. Forstadt
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Neil RP Ozden
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
3
Page 1 of 1
510(k) Number (if known): K021803
Device Name: BIOFASTIN RC Threaded Suture Anchor
Indications for Use:
The BIOFASTIN RC Threaded Suture Anchor is indicated for shoulder rotator cuff repair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
NRa for cmw
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
2021883 510(k) Number -
Prescription Use న (Per 21 CFR 801.109)
OR
Over-the -Counter Use
Confidential
2002-06-06 0007
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