(24 days)
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation of fractures and osteotomies of long bones.
The NCB Polyaxial Locking Plate System is an extramedullary internal fixation plate system to be used for proximal humeral fractures. It is intended to be implanted either percutaneously or by a traditional open method. The Tivanium 3.5 mm locking screws are used to engage the proximal locking screw holes within the NCB Polyaxial Locking Plate System, Proximal Humeral Plates.
I am sorry, but the provided text is a 510(k) summary for a medical device (NCB Polyaxial Locking Plate System). It describes the device, its intended use, comparison to predicate devices, and regulatory information.
However, it does not contain the specific information required to answer your request about acceptance criteria for a study and its proving evidence.
The "Performance Data (Nonclinical and/or Clinical)" section explicitly states: "Clinical data and conclusions were not needed for this device." This indicates that a clinical study with acceptance criteria for device performance, as you've requested, was not performed or at least not submitted as part of this 510(k). Instead, the performance data cited is: "Class II: Amendment of Design Controls with verification of mechanical integrity and resistance." This likely refers to non-clinical, benchtop testing to ensure the device meets engineering specifications, not a clinical study on patient outcomes or human reader performance.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size for test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This 510(k) summary is for a bone fixation system, not an AI/software device that would typically involve the type of performance evaluation you are asking about (e.g., assessing accuracy, sensitivity, specificity, and human reader improvement with AI).
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Zimmer GmbH Danielle Madureira Senior Specialist, Regulatory Affairs Sulzerallee 8 Winterthur, 8404 CH
Re: K192021
Trade/Device Name: NCB Polyaxial Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: July 25, 2019 Received: July 29, 2019
Dear Danielle Madureira:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali. MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192021
Device Name
NCB® Polyaxial Locking Plate System, Proximal Humerus
Indications for Use (Describe)
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation of fractures and osteotomies of long bones.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
| Sponsor: | Zimmer GmbHSulzerallee 8, P.O. Box8404 Winterthur, Switzerland |
|---|---|
| Contact Person: | Danielle Jannuzzi MadureiraSenior Specialist, Regulatory AffairsTelephone: +41 58 854 82 60Fax: + 41 52 244 86 58 |
| Date: | July 25, 2019 |
| Trade Name: | NCB® Plating System, Proximal Humerus |
| Classification Product Code : | HRS, HWC |
| Device Classification Name: | Plate, Fixation, BoneScrew, Fixation, Bone |
| Regulation Number / Description: | 21 CFR § 888.3030 - Single/multiple component metallic bonefixation appliances and accessories21 CFR § 888.3040 - Smooth or threaded metallic bone fixationfastener. |
| Predicate Device: | NCB® Plating System, manufactured by Zimmer GmbH, K042695,cleared October 29, 2004NCB® Plating System, Proximal Humerus, manufactured byZimmer GmbH, K081759, cleared October 16, 2008 |
| Device Description: | The NCB Polyaxial Locking Plate System is an extramedullaryinternal fixation plate system to be used for proximal humeralfractures. It is intended to be implanted either percutaneously orby a traditional open method.The Tivanium 3.5 mm locking screws are used to engage theproximal locking screw holes within the NCB Polyaxial LockingPlate System, Proximal Humeral Plates. |
| Intended Use: | The NCB Polyaxial Locking Plate System is indicated fortemporary internal fixation and stabilization of fractures andosteotomies of long bones. |
| Comparison to Predicate Device: | The intended use of the modified devices, as described in itslabeling, has not changed as a result of the modificationsproposed in the present submission. The line extension does notalter the fundamental scientific technology shared by both thesubject devices and predicate devices. The proposed packagingconfiguration and the methods to support the package integrityhave been previously cleared for Zimmer GmbH products. ZimmerGmbH is furthermore seeking clearance for certain system-specific Class II instruments - these instruments that havepreviously considered Class I exempt and correction ofclassification to Class II is proposed within present submission. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Class II: Amendment of Design Controls with verification ofmechanical integrity and resistance.Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device. |
| Conclusion: | The subject devices have the same intended use and similarindications for use as the predicate devices. The subject devicesuse the same operating principle, incorporate the same basicdesign and labeling and are manufactured and sterilized using the |
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510(K) SUMMARY
§ 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.