(90 days)
The NCB Periprosthetic Femur Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- · Periprosthetic fractures
- Comminuted fractures
- Supracondylar fractures
- · Fractures in osteopenic bone
- · Nonunions
- · Malunions
The NCB Periprosthetic Femur Plate Provisional Instruments are surgically invasive, non-sterile, reusable devices used to determine the suitable implant length during intra-operative planning as part of the implantation of the NCB Periprosthetic Femur Plates.
The provided document describes the Zimmer NCB® Periprosthetic Femur Polyaxial Locking Plate System, specifically an update with new optional provisional instruments. The performance data focuses on non-clinical testing of these provisional instruments.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bending Test | Not explicitly stated, implied to withstand high handling force. | "A bending test was performed to assess the behavior of the Provisionals under high handling force. The acceptance criteria were successfully met." |
| Radiolucency and Physico-chemical Stability (after cleaning/sterilization) | No discernable or significant differences between pre- and post-processing; no evidence of surface changes, etch degradation, material deformation, significant dimensional changes, and/or cracking. | "Radiolucency and the physico-chemical stability of the polyphenylsulfone with barium sulfate material was compared before and after cleaning and sterilization cycles - results showed no discernable or significant differences between pre- and postprocessing. There was no evidence of surface changes, etch degradation, material deformation, significant dimensional changes and/or cracking of the provisional materials. The acceptance criteria were successfully met." |
| Cytotoxicity | No leachable substances released in cytotoxic concentrations. | "Cytotoxicity of the polyphenylsulfone material with barium sulfate was evaluated post-processing. No leachable substances were released in cytotoxic concentrations from the test item. The acceptance criteria were met." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for any of the tests. The document refers to "the Provisionals" and "the polyphenylsulfone material with barium sulfate," implying a representative number of samples were tested.
- Data Provenance: The studies are non-clinical (laboratory-based) and conducted by Zimmer, GmbH (Switzerland). The document does not specify a country of origin for data in the sense of clinical patient data, as no clinical studies were performed. All tests were retrospective in the sense that they were conducted on already manufactured provisional instruments and material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the studies are entirely non-clinical performance tests of medical device components and materials. There is no "ground truth" established by human experts in the context of diagnostic or treatment efficacy for these types of engineering and biocompatibility tests. The "ground truth" is based on objective measurements against quantifiable standards or observations by trained laboratory personnel.
4. Adjudication Method for the Test Set
- This information is not applicable for non-clinical performance tests. Adjudication methods are typically relevant for clinical studies or studies involving subjective human interpretation (e.g., image reading).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data and conclusions were not needed for this device." The studies were non-clinical performance evaluations of the provisional instruments and their material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable. The device described is a physical medical device (surgical instruments), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
- For the Bending Test: The ground truth would be established by the physical resistance and structural integrity of the provisional instruments under defined high handling forces, measured via engineering standards and metrics.
- For Radiolucency and Physico-chemical Stability: The ground truth is objective measurement of material properties (e.g., optical density for radiolucency, visual inspection for surface changes, dimensional measurements, material characterization techniques to detect degradation) before and after sterilization, compared against a baseline.
- For Cytotoxicity: The ground truth is established by standardized biological assays (e.g., ISO 10993-5) that measure the effect of leachable substances on cell cultures at a cellular level, adhering to pass/fail criteria for cytotoxicity.
8. The Sample Size for the Training Set
- This information is not applicable. There is no machine learning or AI component involved in this device or its testing, therefore no "training set" exists.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as in point 8.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a stylized letter "Z" inside of a circle. Below the circle is the word "zimmer" in a sans-serif font.
OCT 2 6 2011
K112174(1/2)
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
510(k) Summary
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Names and References:
Predicate Device:
Device Description:
Intended Use:
Zimmer, GmbH Sulzer Allee 8 Winterthur, Switzerland CH-8404
Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 371-8760
July 26, 2011
NCB® Periprosthetic Femur Polyaxial Locking Plate System
Locking Plate System
Single/multiple component metallic bone fixation appliances and accessories - 21 CFR § 888.3030
NCB Periprosthetic Femur Polyaxial Locking Plate System
The NCB Periprosthetic Femur Plate Provisional Instruments are surgically invasive, non-sterile, reusable devices used to determine the suitable implant length during intra-operative planning as part of the implantation of the NCB Periprosthetic Femur Plates.
The NCB Periprosthetic Femur Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- . Periprosthetic fractures
- . Comminuted fractures
- Supracondylar fractures
- Fractures in Osteopenic bone .
- . Nonunions
- . Malunions
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KII2174(2/2
Page 2 July 26, 2011
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
The modified NCB Periprosthetic Femur Polyaxial Locking Plate System contains the same implants and instruments as the original NCB Periprosthetic Femur Polyaxial Locking Plate System, except for the addition of new optional provisional instruments.
Non-Clinical Performance and Conclusions:
A bending test was performed to assess the behavior of the Provisionals under high handling force. The acceptance criteria were successfully met.
Radiolucency and the physico-chemical stability of the polyphenylsulfone with barium sulfate material was compared before and after cleaning and sterilization cycles - results showed no discernable or significant differences between pre- and postprocessing. There was no evidence of surface changes, etch degradation, material deformation, significant dimensional changes and/or cracking of the provisional materials. The acceptance criteria were successfully met.
Cytotoxicity of the polyphenylsulfone material with barium sulfate was evaluated post-processing. No leachable substances were released in cytotoxic concentrations from the test item. The acceptance criteria were met. In addition, this material has been used in prior orthopedic instrumentation with the same ISO 10993-1 classification and has a long successful history of clinical use.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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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 consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 6 2011
Zimmer, Inc. % Mr. Stephen McKelvey Senior Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K112174
Trade/Device Name: NCB® Periprosthetic Femur Polyaxial Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: October 3, 2011 Received: October 4, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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
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Page 2 - Mr. Stephen McKelvey
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Erin I Keith
ForMark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative 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® Periprosthetic Femur Polyaxial Locking Plate System
Indications for Use:
The NCB Periprosthetic Femur Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
- · Periprosthetic fractures
- Comminuted fractures
- Supracondylar fractures
- · Fractures in osteopenic bone
- · Nonunions
- · Malunions
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
1, 15, 19
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard Rivers 10/26/11
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112174
20
§ 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.