Repair of long bone fractures due to trauma or reconstruction o
Reattachment of the greater trochanter in total hip arthroplasty, surface replacement の arthroplasty, or other procedures involving trochanteric osteotomy
Sternotomy closure の
Sublaminar and intrafacet wiring of the spinal column 0

Device Description

The Metagen ActiveLock™ Wire Cerclage System is used in the management of orthopedic trauma and total joint reconstruction to secure and stabilize segments of bone. There are two versions of the device disclosed in this submission. The fundamental components of each device are a straight, annealed CoCr alloy wire and a novel Clamp device to secure the wire is 16.5 gage (.048 inch) fully annealed CoCr alloy. (ASTM F-799). A Clamp is provided to secure the wire after tensioning. The Clamp is offered in a "Single" configuration, which secures opposing ends of a single wire, and a "Double" configuration, which secures the free ends of two adjacent wires.

AI/ML Overview

The provided 510(k) summary for the Metagen ActiveLock™ Wire Cerclage System does not contain information about a study with acceptance criteria and reported device performance in the way typically expected for an AI/ML medical device submission. This document is from 1998 for a mechanical medical device, not an AI/ML device, and therefore the structure and content of the submission are vastly different.

Here's an attempt to extract and reframe the information based on your requested categories, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of this submission.

Acceptance Criteria and Device Performance for Metagen ActiveLock™ Wire Cerclage System

This submission pertains to a mechanical wire cerclage system, not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and "reported device performance" typically associated with diagnostic AI algorithms (e.g., sensitivity, specificity, AUC) is not directly applicable. Instead, the submission focuses on mechanical testing to demonstrate performance against established benchmarks of predicate devices or existing standards. The primary criterion is demonstrating substantial equivalence in mechanical properties, particularly tensile strength, to already accepted devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied/Explicit)	Reported Device Performance (Metagen ActiveLock™ Wire Cerclage System)
Tensile Strength	Equal to or greater than clinically accepted 16 gauge stainless steel wire.	Data demonstrate that the Metagen wire/Clamp design provides tensile strength equal to or greater than that of clinically accepted 16 gage stainless steel wire.
Intended Use	Must align with predicate devices for: - Repair of long bone fractures - Reattachment of greater trochanter - Sternotomy closure - Sublaminar/intrafacet wiring of spinal column	YES - Intended uses are the same as predicate devices.
Design Principles	Fundamentally the same as Metagen ActiveLock™ Cerclage Band system and comparable to pre-amendment stainless steel suture wire and cerclage cable systems.	System features a novel locking Clamp (similar to ActiveLock™ Band). Manual tightening instrument used for reduction/consolidation (similar to ActiveLock™ Band). Clamping methods similar to predicate cable systems (e.g., crimp, swage, sleeve).
Material Composition	Wire: CoCr alloy (ASTM F-799) Clamp: Nitinol (superelastic effect utilized)	Wire: CoCr alloy conforming to ASTM F-799. Clamp: Nitinol, utilizing its superelastic effect for clamping force.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The submission mentions "Mechanical Testing" was performed and "data demonstrate" equivalence, but the number of samples tested is not quantified in this summary.
Data Provenance: Not explicitly stated, but it would be from in-vitro mechanical testing conducted by the manufacturer, Metagen, LLC. It is prospective testing designed to characterize the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a mechanical device, not an AI/ML diagnostic. Ground truth would be based on engineering measurements and material science standards (e.g., ASTM F-799) rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. See point 3. Mechanical tests typically involve direct measurement against defined standards, not human adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. This is not an AI/ML device, so a MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is a mechanical device. The "standalone performance" is its mechanical properties (tensile strength), which were evaluated through direct testing without any human-in-the-loop component in the assessment itself.

7. Type of Ground Truth Used

Engineering Standards and Benchmarks: The "ground truth" for this device's performance is based on established engineering standards for materials (e.g., ASTM F-799 for CoCr alloy) and the performance characteristics (e.g., tensile strength) of predicate devices (like 16 gauge stainless steel wire, DePuy Control Cable System, Howmedica Dall-Miles Stainless Steel Cable) that are already clinically accepted. The "ground truth" is therefore comparative performance against accepted mechanical properties.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device. The device itself is designed and manufactured based on established engineering principles and material science.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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K983976

DEC 3 0 1998

510(k) SUMMARY METAGEN ACTIVELOCK™ WIRE CERCLAGE SYSTEM

Nov 5, 1998

ADMINISTRATIVE INFORMATION

Manufacturer Name	Metagen, LLCOrigen Center428 Technology Drive EastMenomonie, Wisconsin 54751
Official Contact Person	Wesley JohnsonPresidentTelephone (715) 232-4880Fax (715) 235-9570

DEVICE NAME

Classification Name

Trade/Proprietary Name

Common Name

Bone Fixation Wire cerclage Metagen ActiveLock™ Wire Cerclage System

Wire Cerclage System

ESTABLISHMENT REGISTRATION NUMBER

Metagen, LLC is registered with FDA under Establishment Registration Number 55922.

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510(k) Summary

DEVICE CLASSIFICATION

Bone fixation wire systems have been classified by FDA as Class II devices, as shown in 21 CFR & 888.3010. The device is reviewed by the Orthopedic and Rehabilitation Devices Panel and the Product Code for the device is JDQ. The wire cerclage applicator instrument is described in this Notification in order to assist in explaining the operation of the Clamping system, but it is not intended to be a subject of the submission. It is an orthopedic manual surgical instrument (Product Code HXN), classified by FDA as a Class I device and exempt from Premarket Notification, according to 21 CFR & 888.4540.

CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards have been established under Section 514. Voluntary standards with which the Metagen ActiveLock™ Wire Cerclage System complies include:

ASTM F-799 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgines for Surgical Implants

ANSI/AAMI ST32-1991 American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) Process Control Guidelines for Gamma Radiation Sterilization

PACKAGING/LABELING/PRODUCT INFORMATION

The Metagen ActiveLock™ Wire Cerclage System components will be packaged in a radiation sterilizable, disposable pouch or tray. The Wire/Clamp assembly will be held in a support trav for easy loading onto the wire cerclage applicator instrument. The sterilizable pouch or tray will be packaged inside a disposable paper box. Product will be provided either non-sterile (appropriately labeled) or sterile. Sterilization will be accomplished by means of Co6 gamma irradiation at a dose of 25 kG (2.5 Mrad) minimum. Sterilization will be validated by the bioburden method, using American National Standards Institute (ANSIMAssociation for the Advancement of Medical Instrumentation (AAMI) Process Control Guidelines for Gamma Radiation Sterilization (ANSI/AAMI ST32-1991). The sterility assurance level (SAL) that Metagen intends to meet for the sterile version of the Metagen ActiveLock™ Wire Cerclage System is 10 . The device is not represented to be "pyrogen free." The wire cerclage applicator instrument will be packaged separately in heat-sealed pouches labeled non-sterile.

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INTENDED USE

The Metagen ActiveLock™ Wire Cerclage System is intended for

Repair of long bone fractures due to trauma or reconstruction o
Reattachment of the greater trochanter in total hip arthroplasty, surface replacement の arthroplasty, or other procedures involving trochanteric osteotomy
Sternotomy closure の
Sublaminar and intrafacet wiring of the spinal column 0

DEVICE DESCRIPTION

Design Characteristics

General Operative Technique

The system is clinically applied to fractured bone segments in the same manner as currently marketed wires or cables. The Clamp is placed in the applicator instrument and the wire is fed through the elongated hole all the way to the stop on the wire. The opposite end of the wire is passed around the bone segments with the aid of a wire passer instrument. The wire is then threaded through the adjacent elongated hole in the Clamp and secured in the tensioning element of the applicator. Tensioning can occur only when the Clamp is in the elongated position. When adequate fracture reduction and alignment are obtained, the Clamp is released, securing the wire in place. Typically, several wire assemblies are used to stabilize a single fracture according to accepted surgical practice.

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510(k) Summary

Material Composition

The wire of the Metagen ActiveLock™ Wire Cerclage System is made of CoCr alloy, which is generally available in a composition conforming to ASTM F-799, shown in Exhibit III. This material is commonly used as external fixation pins, cerclage wire for sternotomy closure and other cerclage applications where very high strength is required. The material is supplied in the fully annealed, malleable condition to optimize handling characteristics.

The Clamp is manufactured from NiTi alloy (Nitinol). Nitinol is an alloy consisting of nearly equal atomic percentages of nickel and titanium. The name is derived from its major elements (Ni, Ti) and the fact that it was originally developed at the US Naval Ordinance Laboratory (NOL). It is one of several types of alloy commonly referred to as a shape memory alloy (SMA). SMAs are unique in that they exhibit dramatically different properties than do conventional alloys or metals.

One unique property is the shape memory effect in which an SMA can be plastically deformed into a desired shape then restored to its original shape with the application of heat. Another unique property is the superelastic effect in which an SMA can be mechanically deformed to a large strain (i.e. 8%), returning to its original shape upon removal of the deforming force. Although the composition of the SMA is similar for both effects previously mentioned, the temperature ranges in which the effects occur vary. The Metagen ActiveLock™ Wire Cerclage System uses the superelastic effect to provide the Clamping force needed to securely lock the wire in place. The temperature sensitive, shape-memory property of the material is not utilized.

EQUIVALENCE TO MARKETED PRODUCT

The Metagen ActiveLock™ Wire Cerclage System is substantially equivalent in indications and design principles to the following predicate or pre-amendment devices:

Metagen ActiveLock™ Cerclage System (K972327) featuring a bone Band device
. Monofilament wire from manufacturers such as Ethicon and Zimmer
DePuy Control Cable System .
Howmedica Dall-Miles Stainless Steel/CoCr Cable .

Intended Use

The indications for use for the Metagen ActiveLock™ Wire Cerclage System and the predicate devices are the same. All of the cable systems are intended for repair of long bone fractures due to trauma or reconstruction, reattachment of the greater trochanter in total hip arthroplasty, or other procedures involving trochanteric osteotomy. The monofiliament wire and most cable systems are indicated for sternotomy closure and segmental sublaminar or intrafacet wiring of the spinal column.

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510(k) Summary

Design and Materials

The design and functional characteristics of the Metagen ActiveLock™ Wire Cerclage System are fundamentally the same as the Metagen ActiveLock™ Cerclage Band system. Each system features a novel locking Clamp to secure the cerclage device. Each uses a manual tightening instrument to achieve reduction of a fracture and consolidation of bony fragments. The band of the Metagen ActiveLock™ Cerclage System is made of titanium alloy or Nitinol, while the wire of the Metagen ActiveLock™ Wire Cerclage System is made from CoCr alloy.

The Metagen ActiveLock™ Wire Cerclage System is also comparable to pre-amendment stainless steel suture wire (16 gage). Each device can be used to reduce and a fracture by applying tension, then is fixed in place. In general, monofilament wire is secured by twisting the wire on itself, whereas the subject device is secured by a novel Clamping method.

The subject device is also equivalent to cerclage cable systems, including the DePuy Control Cable System (K934557) and Howmedica Dall-Miles Stainless Steel Cable (K844068, K900926, K961569). Clamping methods for the predicate and subject devices are similar. The predicate devices use a crimp. swage or sleeve in order to maintain tension on the cable after placement and tensioning. Once the cable has been secured by a crimp it can only be removed by cutting. The subject device can be easily removed , re-tensioned and secured without compromising its strength.

Mechanical Testing

Mechanical properties of the subject device were evaluated and compared to 16 gage monofilament wire. The test methods used were identical to those used in K972327 (ActiveLock™ Cerclage Band). The data demonstrate that the Metagen wire/Clamp design provides tensile strength equal to or greater than that of clinically accepted 16 gage stainless steel wire.

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SUMMARY: TABLE OF SUBSTANTIAL EQUIVALENCE

The Metagen ActiveLock™ Wire Cerclage System is substantially equivalent to the Encore Orthopedics CCG Wire Cerclage System, monofilament suture wire, DePuy Control Cable System, and Howmedica Dall-Miles Stainless Steel Cable in the following respects:

	SubjectDevice	PredicateDevices
	MetagenActiveLock™WireCerclageSystem	EncoreOrthopedicsCCG WireCerclageSystem(K932024)	Mono-filamentsuturewire(EthiconZimmer,others)	DePuy Control™Cable System(K934557)	Howmedica Dall-Miles Stainless SteelCable(K844068,K900926, K961569)
INTENDED USE
Repair of long bonefractures,reattachment of thegreater trochanter,and other orthopedicrepairs wherecerclage wiring isindicated	YES	YES	YES	YES	YES
DESIGN
Wire cerclage type	Wire	Wire	Wire	Multi-filamentcable	Multi-filament cable
Clamping method	Release ofsuperelasticClamp	Slidefastener	Wiretwist	Crimp sleeve	Crimp sleeve
MATERIALS
Cerclage	CoCr alloy	CP Ti	Stainlesssteel	Co-Cr-W-Nialloy	Stainless steel
Clamp	Nitinol	CP Ti	None	Co-Cr-W-Nialloy	Stainless steel

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 30 1998

Mr. Wesley Johnson President Metagen L.L.C. Origen™ Center 428 Technology Drive East Menomonie, Wisconsin 54751

K983976 Re: Metagen ActiveLock™ Wire Cerclage System Trade Name: Regulatory Class: II Product Code: JDQ Dated: November 5, 1998 Received: November 9, 1998

Dear Mr. Johnson:

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 requlations 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 Requlation (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 In addition, FDA may publish further announcements action. 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 requlations.

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Page 2 - Mr. Wesley Johnson

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 regulation (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,

1~Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K983976

Indications for Use Statement

Device Name: Metagen ActiveLock™ Wire Cerclage System

Indications for Use:

Repair of long bone fractures due to trauma or reconstruction

Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy

Sternotomy closure

Sublaminar and intrafacet wiring of the spinal column

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use >

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

B&&=========================================================================================================================================================================

Klen Lazam L.C.M.

General Rest

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.