ZETA MULTIZONE LOCKING NAIL SYSTEM by HOWMEDICA CORP.

The Zeta MultiZone Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the femur and tibia. The nails are inserted using an opened or closed technique and can be statically or dynamically locked.

Device Description

The Zeta MultiZone Locking Nail System consists of a family of round nails used for intramedullary nailing of femoral and tibial fractures. The system includes two styles of femoral nails, tibial nails, reconstruction nails, screws and end caps. The nails are available in varying diameters and lengths and have proximal and distal holes for cross-locking. The nails and additional components are fabricated from either titanium alloy or stainless steel.

AI/ML Overview

This 510(k) submission (K982958) concerns the Zeta MultiZone Locking Nail System, an intramedullary fixation rod system for femoral and tibial fractures.

Based on the provided documents, it is important to note that this is a traditional 510(k) submission for a medical device (intramedullary nail system), not an AI/ML-powered diagnostic device. Therefore, many of the requested criteria related to AI/ML performance, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies, and standalone AI performance, are not applicable to this type of submission.

The "acceptance criteria" for this device are established by its substantial equivalence to legally marketed predicate devices, as determined by the FDA. This means the device is deemed safe and effective because its intended use, materials, designs, and operational principles are similar to existing devices.

Here's an analysis based on the provided information, addressing the relevant points and indicating where information is not applicable:

Table of acceptance criteria and the reported device performance

Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance (based on equivalence)
Intended Use Equivalence: The device's intended use must be similar to legally marketed predicate devices.	The Zeta MultiZone Locking Nail System is intended for temporary stabilization of various types of fractures, malunions, and nonunions of the femur and tibia. This is equivalent to the intended uses of the predicate devices.
Materials Equivalence: The materials used must be the same or offer equivalent biocompatibility and mechanical properties as predicate devices.	Fabricated from either titanium alloy or stainless steel, materials commonly used in predicate intramedullary nailing systems.
Design Equivalence: The design and operational principles must be similar to predicate devices. This typically involves demonstrating similar mechanical properties and features (e.g., nail styles, diameters, lengths, locking mechanisms).	The system consists of round nails with proximal and distal holes for cross-locking, available in varying diameters and lengths. This design is considered equivalent to Howmedica's Alta IM Rod System, Grosse & Kempf Locking Nail System, and Gamma Locking Nail System. The ability to be inserted using opened/closed techniques and statically/dynamically locked is also considered equivalent.
Performance Equivalence: Device performance (e.g., mechanical strength, fatigue life) must be demonstrated to be equivalent or superior to predicate devices through engineering analyses and/or testing. (While not explicitly detailed in this summary, such testing would have been part of the full submission).	The submission claims "substantial equivalence... based on an equivalence in intended use, materials, designs and operational principles." This implies that the performance aspects relevant to the device's function (e.g., structural integrity, fixation capabilities) were demonstrated to be comparable to or meet accepted standards for the predicate devices. Specific performance metrics are not provided in this summary.

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 submission relies on substantial equivalence to predicate devices, not a clinical study with a "test set" in the context of diagnostic performance or AI model validation. The "testing" would have been primarily engineering bench testing to demonstrate mechanical properties, which doesn't typically involve a "test set" or data provenance in the same way.
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 by experts is not a component of a 510(k) for this type of implantable device. The evaluation is based on engineering principles and comparison to existing devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for a "test set" is relevant for this type of device submission.
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-powered diagnostic device, so MRMC studies and AI assistance are irrelevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical implantable device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device's acceptance is its demonstrated equivalence in design, materials, and performance (via bench testing and engineering analysis) to existing, legally marketed predicate devices, which have a history of safe and effective use.
The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established
- Not applicable. There is no "training set" or associated ground truth establishment for this type of device.

Summary for K982958: Zeta MultiZone Locking Nail System

The FDA's review and determination of substantial equivalence for the Zeta MultiZone Locking Nail System were based on a comparison of its intended use, materials, designs, and operational principles to several predicate devices already on the market (Howmedica's Alta IM Rod System, Grosse & Kempf Locking Nail System, and Gamma Locking Nail System). This is the standard pathway for typical Class II medical devices in a 510(k) submission. The provided documents do not contain information related to AI/ML performance evaluation, clinical study data beyond what would support substantial equivalence, or the specific details of bench testing that would have been included in the complete submission to justify the equivalence claims.

Summary

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K98 2958

510(k) Summary

Proprietary Name: Common Name: Classification Name & Reference: Proposed Requiatory Class: II Device Product Code:

Zeta MultiZone Locking Nail System IM Rod Intramedullary Fixation Rod 21 CFR 888.3020

87HSB

For information contact:

Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7830 Fax: (201) 507-6870

The substantial equivalence of this device is based on an equivalence in intended use, materials, designs and operational principles to Howmedica's Alta IM Rod System, Grosse & Kempf Locking Nail System and Gamma Locking Nail System.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1998

Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology, Inc. 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey

K982958 Re: Zeta Multizone Locking Nail System Trade Name: Regulatory Class: II Product Code: нав Dated: August 21, 1998 Received: August 24, 1998

Dear Mr. Dichiara:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. John F. Dichiara

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General 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): K 982958

Device Name: Zeta MultiZone SCN Locking Nail

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number_ K982958

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.