(24 days)
The BIOFASTIN RC Threaded Suture Anchor is indicated for shoulder rotator cuff repair.
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.
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a medical device (BIOFASTIN RC Threaded Suture Anchor), and it primarily focuses on establishing substantial equivalence to predicate devices, not on detailing specific performance acceptance criteria or a study demonstrating the device meets those criteria.
The "Safety and Performance" section states: "Results of performance testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This is a high-level statement and does not provide the specific details required to answer your request, such as a table of acceptance criteria, sample sizes, ground truth establishment, or study types.
Therefore, I cannot populate the table or answer the subsequent questions based on the provided text.
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ப்பட 1 2002 510(k) Summary
| Trade Name: | BioFastin RC Threaded Suture Anchor |
|---|---|
| Sponsor: | Mitek Worldwide249 Vanderbilt AvenueNorwood, MA 02062Registration #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, andCosmetic Act, the device classification is Class II. |
| Product Code: | 87 MAI |
| Predicate Device(s): | FASTIN RC Suture AnchorMitek CuffTack Sutureless Fixation DevicePANALOK RC Absorbable Anchor |
| Product Description: | The BIOFASTIN RC Threaded Suture Anchor is anabsorbable, threaded suture anchor. The BIOFASTIN RCanchor has 2 threads of an auger-type design with anoverall nominal diameter of 5.0 mm and nominal length of11.5 mm. The device has two suture holes (90 degreesapart) in the anchor head for fixation of #2 suture to bone(sutures provided pre-attached with affixed taperedneedles). The sutures provided with the BIOFASTIN RCare either the ETHIBOND non-absorbable or PANACRYLabsorbable sutures. |
| Indications for Use: | The BIOFASTIN RC Threaded Suture Anchor is indicatedfor shoulder rotator cuff repair. |
| Safety and Performance: | Results of performance testing have demonstrated that themodified device is substantially equivalent to the predicatedevices. |
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.
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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.
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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
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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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§ 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.