(29 days)
The NCB Plating System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.
The NCB Plating System is an extramedullary internal fixation plate system to be used for either distal femoral or proximal humeral fractures. It is intended to be implanted either percutaneously or by a traditional open method.
This document is a 510(k) premarket notification from Zimmer, Inc. to the FDA for the NCB® Plating System. The notification focuses on establishing substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria based on performance data.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The "Performance Data" section explicitly states: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." This indicates that the evaluation was based on laboratory testing, not a clinical study involving human patients or complex AI models that would require the detailed information you've requested.
Here's why the requested information cannot be extracted:
- No Acceptance Criteria or Reported Device Performance Table: The document does not define specific performance metrics or acceptance criteria that a device must meet (e.g., accuracy percentages, sensitivity, specificity for an AI model). It also doesn't report performance against such criteria.
- No Information on Test Set or Data Provenance: This being a medical device (plate and screws), there is no "test set" in the context of an AI study. The "Performance Data" refers to non-clinical (laboratory) testing, not data provenance or sample sizes for testing an algorithm.
- No Experts for Ground Truth, Adjudication, or MRMC Study: These concepts are relevant to studies involving human reading or AI interpretation of medical images/data. The NCB® Plating System is a physical implant, so these considerations do not apply.
- No Standalone Algorithm or Ground Truth Type: Again, this is a physical medical device, not an algorithm.
- No Training Set or Ground Truth for Training Set: These are concepts related to machine learning and AI development, which are not applicable to the Zimmer NCB® Plating System as described.
In summary, the provided document is a regulatory submission for a physical medical device (bone plating system) seeking substantial equivalence, not a performance study of a device that relies on complex data analysis or AI.
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OCT 2 9 2004
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Stephen H. McKelveyManager, Corporate Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 372-4605 |
| Date: | September 29, 2004 |
| Trade Name: | NCB® Plating System |
| Common Name: | Plate, Fixation, BoneScrew, Fixation, Bone |
| Classification Reference: | 21 CFR § 888.3030, 3040 |
| Predicate Devices: | Synthes Anatomical Locking Plate System (akaLISS), K961413, cleared 8-7-96DePuy Orthopedics Pe.R.I. II Knee FractureSystem, K003235, cleared 11-06-00Synthes LCP Proximal Humerus Plate, K011815,cleared 9-6-01. |
| Device Description: | The NCB Plating System is an extramedullaryinternal fixation plate system to be used for eitherdistal femoral or proximal humeral fractures. It isintended to be implanted either percutaneously orby a traditional open method. |
| Intended Use: | The NCB Plating System is indicated for temporaryinternal fixation and stabilization of fractures andosteotomies of long bones. |
| Comparison to Predicate Device: | The NCB Plating System has the same intendeduse, similar performance characteristics, ismanufactured from similar materials and is similarin design to the predicate devices. |
| Performance Data: | The results of non-clinical (laboratory) performancetesting demonstrate that the device is safe andeffective. |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a head, body, and legs.
OCT 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen H. McKelvey Manager, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581
Re: K042695
Trade/Device Name: NCB® Plating System Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS, HWC Dated: September 29, 2004 Received: September 30, 2004
Dear Mr. McKelvey:
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 - Mr. Stephen H. McKelvey
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 (240) 276-0120. 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 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,
Mark H. Millenson
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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Indications for Use
510(k) Number (if known):
Device Name:
NCB® Plating System
Indications for Use:
The NCB Plating System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Milkusen
for Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number.
Page 1 of 1
§ 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.