(90 days)
The Synthes 2.4 mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
The Synthes 2.4 mm Cannulated Screw is a machined metallic screw with a cannulation that is self-tapping and self-drilling and that can be guided into position via a guidewire.
The provided text is a 510(k) summary for a medical device (Synthes 2.4 mm Cannulated Screw) seeking substantial equivalence to existing devices. It focuses on device description, indications for use, and a declaration of substantial equivalence.
It does not contain information on acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot populate the requested tables and information based solely on the provided text. The document is a regulatory approval summary, not a technical performance study report.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria or performance metrics are provided in the document. | No specific quantitative performance data is provided in the document. |
Other Requested Information (Not Present in Document):
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this is not an AI/imaging device).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study is detailed.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
This document primarily serves to state that the device is "substantially equivalent" to other legally marketed devices, indicating it meets the same safety and effectiveness profile based on comparison rather than extensive de novo performance studies.
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DEC 0 3 2001
K012945
page 1 of 1
Summary of Safety and Effectiveness Information
| Sponsor | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| Company Contact | Matthew M. Hull(610) 647-9700 ext. 7191 |
| Name of the Device | Synthes 2.4 mm Cannulated Screw |
| Device Classification(s) | Class II, §888.3040 - Screw, Fixation, Bone |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes 2.4 mmCannulated Screw to be substantially equivalent to other legallymarketed devices. |
| Device Description | The Synthes 2.4 mm Cannulated Screw is a machined metallic screwwith a cannulation that is self-tapping and self-drilling and that can beguided into position via a guidewire. |
| Indications | The Synthes 2.4 mm Cannulated Screw is intended for fixation offractures and non-unions of small bones and small bone arthrodeses.Examples include, but are not limited to scaphoid and other carpalfractures, metacarpal and phalangeal fusions, osteotomies, andbunionectomies. |
| Materials | Stainless Steel or Titanium Alloy |
CONFIDENTIAL
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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2001
Mr. Matthew M. Hull Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K012945
Trade/Device Name: Synthes (USA) 2.4 mm Cannulated Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: HWC Dated: August 31, 2001 Received: September 4, 2001
Dear Mr. Hull:
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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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 you 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.
L. Martin A. Milkman
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
Indications for Use Statement
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes 2.4 mm Cannulated Screw
The Synthes 2.4 mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
તા ਮ Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use_No
Mark A Milliman
vision Sign-Off) Division of General, Restorative and Neurological Devices
KO 12945
CONFIDENTA(K) Number
Synthes(USA) Synthes 2.4 mm Cannulated Screw 510(k)
000004
§ 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.