(82 days)
The Synthes Stainless Steel Modular Hand System consists of plates and screws intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.
The Synthes Stainless Steel Modular Hand System is a series of plates and screws of varying lengths and thickness, and configurations including straight, T-, Y-, and extended H- plates. These plates are attached to bone via 1.8 mm buttress pins and 1.0, 1.3, 1.5, 2.0, and 2.4 mm self-tapping cortex screws.
This document is a 510(k) premarket notification for a medical device called the "Synthes Stainless Steel Modular Hand System." It establishes the device's substantial equivalence to other legally marketed devices, rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in the provided text.
Here is the information that can be extracted or deduced from the provided documents:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as this document is a 510(k) submission for substantial equivalence. The primary "acceptance criteria" for a 510(k) are demonstrating substantial equivalence to a legally marketed predicate device.
- Reported Device Performance: Not reported in terms of specific metrics, as this is not a study report. The document indicates that "Documentation is provided which demonstrated the Synthes Stainless Steel Modular Hand System to be substantially equivalent to other legally marketed devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a 510(k) submission for substantial equivalence, not a clinical or performance study that utilizes a test set in the described manner.
3. 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 applicable. Ground truth establishment is not relevant in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are not relevant in this 510(k) submission.
5. 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
- No MRMC comparative effectiveness study was done, as this is a submission for a mechanical implant system, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth is not relevant in this 510(k) submission. The basis for approval is substantial equivalence to predicate devices, implying similar design, materials, and intended use, rather than performance against a "ground truth" as in diagnostic accuracy studies.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
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APR 2 2 2003
K 0303/0
page 191
3. Summary of Safety and Effectiveness Information [510(k) Summary]
| Sponsor | Synthes (USA)1690 Russell RoadPaoli, PA 19301 |
|---|---|
| Company Contact | Lisa M. Boyle(610) 647-9700 |
| Name of the Device | Synthes Stainless Steel Modular Hand System |
| Device Classification(s) | Class II, §888.3030 - Plate, fixation, bone non-spinalClass II, §888.3040 - Screw, fixation, bone non-spinal |
| Substantial Equivalence | Documentation is provided which demonstrated the Synthes StainlessSteel Modular Hand System to be substantially equivalent to otherlegally marketed devices. |
| Device Description | The Synthes Stainless Steel Modular Hand System is a series of platesand screws of varying lengths and thickness, and configurationsincluding straight, T-, Y-, and extended H- plates. These plates areattached to bone via 1.8 mm buttress pins and 1.0, 1.3, 1.5, 2.0, and2.4 mm self-tapping cortex screws. |
| Indications | The Synthes Stainless Steel Modular Hand System is intended for usein selective trauma, reconstructive procedures, and general surgery ofthe hand, wrist, and other small bones. |
| Material | Stainless steel |
CONFIDENTIAL
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Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized lines representing the bird's head and neck. The eagle faces right, and the seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
APR 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Boyle Regulatory Associate Synthes USA 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
Re: K030310
Trade/Device Name: Synthes Stainless Steel Modular Hand System Regulation Number: 21 CFR §888. 3030 and §888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, and Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS and HWC Dated: January 29, 2003 Received: January 30, 2003
Dear Ms. Boyle:
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
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Page 2 - Ms. Lisa M. Boyle
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. 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), 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) you may obtain. 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 vours.
Sincerely yours,
Mark A. Milliken
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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2. Indications for Use Statement
510(k) Number (if known):
Device Name:
Indications for Use:
Koso310
Synthes Stainless Steel Modular Hand System
The Synthes Stainless Steel Modular Hand System consists of plates and screws intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use 16 (Per 21 CFR 801.109 A Restorative opical Dottes 030310 510(k) Number
Synthes(USA) Synthes Stainless Steel Modular Hand System 510(k) CONFIDENTIAL
§ 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.