(112 days)
The device is intended to be used for internal fracture fixation of small and large bones. It is to be used in combination with 3.5mm diameter and 4.5 mm diameter stainless steel cortical bone screws.
It is not intended for use in the attachment of screws or other devices to the posterior elements of the cervical, thoracic or lumbar spine.
Not Found
I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for "The Answer Screw Supplementation System." It primarily addresses the regulatory approval of the device based on substantial equivalence to a predicate device.
The document does not contain the following information:
- A table of acceptance criteria and reported device performance.
- Details about a study proving the device meets acceptance criteria.
- Sample size used for a test set, data provenance, number of experts, adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Information about standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set or how its ground truth was established.
The letter focuses on:
- Correcting information about the sponsor.
- Stating that the device is substantially equivalent to legally marketed predicate devices.
- Indicating the regulatory class (Class II) and product code (HWC).
- Outlining general controls and other applicable regulations.
- Defining the intended use: "internal fracture fixation of small and large bones. It is to be used in combination with 3.5mm diameter and 4.5 mm diameter stainless steel cortical bone screws. It is not intended for use in the attachment of screws or other devices to the posterior elements of the cervical, thoracic or lumbar spine."
To provide the information you requested, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed engineering specification document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jun 2 1 2004
Barry T. Bickley, M.D. President Simplicity Orthopedic Solutions, LLC. 15 Woodbury Lane North Andover, MA 01845
Re: K032966
Trade/Device Name: The Answer Screw Supplementation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 16, 2003 Received: December 17, 2003
Dear Dr. Bickley:
This letter corrects our substantially equivalent letter of January 13, 2004, regarding The Answer Screw Supplementation System, which incorrectly listed the sponsor of your 510(k) premarket notification as Amco Precision Tool, Inc.
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 (PMA). You, DIUg, 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 additional controls. Existing major regulations of ecting 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
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Page 2 - Dr. Barry T. Bickley
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 100-1150.
This letter will allow you to continue 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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 devise, please contact the Office of Compliance at (301) 594-4639. Other general information on your device responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmandsmam.html.
Sincerely yours,
L. Mark A. Milhurn
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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510(k) Number: K032966
Device Name: The Answer Screw Supplementation System
Indications For Use:
The device is intended to be used for internal fracture fixation of small and large bones. It is to be used in combination with 3.5mm diameter and 4.5 mm diameter stainless steel cortical bone screws.
It is not intended for use in the attachment of screws or other devices to the posterior elements of the cervical, thoracic or lumbar spine.
for Mark N. Milkem
Division Sig
Division of G : Restorative
and Neurolog Devices
-) Numt:
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR § 801.109)
OR
Over-the-Counter Use (Optional Format 1-2-96)
3
N/A