To offer KLS Martin Quick Disc, KLS Martin Sternal Talon and KLS Martin Sternal Plating System in sterile packaging with the following indications for use:

K062857 KLS Martin Quick Disc is intended for reattachment of cranial bone flaps after a craniotomy, covering burr holes, and fixation of cranial fractures.

K051165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are intended for stabilization and fixation of antenor chest wall fractures including sternal fixation subsequent to stemotomy and sternal reconstructive procedures.

Device Description

The KLS Martin Quick Disc is a two-sided cranial closure device. The lower disc is attached to a threaded post. The upper disc is threaded down and locked on the post securely holding the bone flap in place. The KLS Martin Quick Disc diameters range from 12mm to 22mm in size

The KLS-Martin Sternal Talon is a two-piece clamping device with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open

A second emergency re-entry is position. provided by cut points adjacent to the screw.

KLS - Martin Sternal Plating System consists of plates having a thickness from 1.0mm to 3.0mm and screws having a diameter of 2.3mm to 3.2mm.

AI/ML Overview

This 510(k) premarket notification describes the KLS Martin Quick Disc, Sternal Talon, and KLS Martin Sternal Plating System in sterile packaging. The submission asserts substantial equivalence to previously cleared devices based on identical manufacturing and materials, with the primary difference being the sterile packaging and associated new stock numbers.

Here’s a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the way that would typically be seen for a novel device or a device with new technological characteristics requiring performance testing.

Instead, the submission leverages "substantial equivalence" to predicate devices. This means the performance is assumed to be equivalent to the predicate devices because the new device (KLS Martin Quick Disc, Sternal Talon, and Sternal Plating System in sterile packaging) is identical in manufacturing and materials to the non-sterile versions and substantially equivalent in sterilization and packaging to an already cleared sterile fixation system.

Therefore, the "acceptance criteria" here are met by demonstrating the following:

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (Claimed Equivalence)
Manufacturing and Materials: Identical to previously cleared, non-sterile versions (K062857, K051165, K032413).	Performance of the sterile Quick Disc, Sternal Talon, and Sternal Plating System is identical to their non-sterile predicate devices. This implies mechanical and functional equivalence.
Sterilization and Packaging: Identical to a previously cleared sterile fixation system (KLS Martin Rigid Fixation - Sterile K060177).	Performance related to sterility and packaging integrity is equivalent to the KLS Martin Rigid Fixation - Sterile (K060177). This implies maintained sterility and packaging effectiveness.
Intended Use/Indications: Same as the predicate devices.	The devices are intended for reattachment of cranial bone flaps, covering burr holes, fixation of cranial fractures (Quick Disc), and stabilization/fixation of anterior chest wall fractures including sternal fixation after sternotomy and sternal reconstructive procedures (Sternal Talon and Sternal Plating System).

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

Not applicable. This submission relies on substantial equivalence to predicate devices, not on a new performance study with a test set of data.

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

Not applicable. No new clinical or performance data requiring expert ground truth establishment for a test set was generated or submitted for this 510(k). The equivalence is based on engineering and material comparisons.

4. Adjudication Method for the Test Set

Not applicable. No new performance study or test set requiring adjudication was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant to a submission based on substantial equivalence for a change in packaging and sterilization for an already cleared mechanical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a mechanical surgical implant device, not an AI/algorithm-based diagnostic or therapeutic tool.

7. The Type of Ground Truth Used

Not applicable / Implied by Predicate Device Clearance. The "ground truth" for the safety and effectiveness of these devices is implicitly established by the prior clearance of the predicate devices, which would have undergone their own regulatory review processes, potentially including clinical data, bench testing, and material biocompatibility assessments, all of which would have been reviewed by the FDA. For this 510(k), the "ground truth" is that the sterile versions are physically and functionally identical to the already cleared non-sterile versions, and their sterilization is equivalent to another cleared sterile device.

8. The Sample Size for the Training Set

Not applicable. No training set for an algorithm was used or described.

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

Not applicable. No training set for an algorithm was used or described.

Summary

{0}------------------------------------------------

kus martin L.P.

. 1999

: 上一篇:

K070169

510(K) SUMMARY

MAR 2 6 2007

Submitter:	KLS-Martin, L.P.11239-1 St. Johns Industrial Parkway SouthJacksonville, FL 32246Phone: 904-641-7746Fax: 904-641-7378
Contact Person:	Jennifer DamatoDirector RA/QA
Date of Summary:	5 March 2007
Device Name:	KLS Martin Quick Disc, Sternal Talon andSternal Plating - Sterile
Trade Name:	KLS Martin Quick Disc, KLS Martin SternalTalon and KLS Martin Sternal Plating
Common Name:	KLS Martin Quick Disc - Plate, cranioplasty,preformed, non-alterable
	KLS Martin Sternal Talon - Single/multiplecomponent metallic bone fixation appliancesand accessories
	KLS Martin Sternal Plating System -Single/multiple component metallic bonefixation appliances and accessories
ClassificationName and Number:	KLS Martin Quick Disc - 882.5330 Preformednonalterable cranioplasty plate (CFR882.5330)
	KLS Martin Sternal Talon - Single/multiplecomponent metallic bone fixation appliancesand accessories (CFR 888.3030)
	KLS Martin Sternal Plating System -Single/multiple component metallic bonefixation appliances and accessories (CFR888.3030)

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Regulatory Class:

Predicate Devices:

Intended Use:

Device Description: ll

KLS Martin Quick Disc (K062857)

KLS Martin Sternal Talon (K051165)

KLS Martin Sternal Plating System (K032413)

KLS Martin Rigid Fixation - Sterile (K060177)

To offer KLS Martin Quick Disc, KLS Martin Sternal Talon and KLS Martin Sternal Plating System in sterile packaging with the following indications for use:

K062857 KLS Martin Quick Disc is intended for reattachment of cranial bone flaps after a craniotomy, covering burr holes, and fixation of cranial fractures.

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A second emergency re-entry is position. provided by cut points adjacent to the screw.

KLS - Martin Sternal Plating System consists of plates having a thickness from 1.0mm to 3.0mm and screws having a diameter of 2.3mm to 3.2mm.

Technological Characteristics:

Similarities to Predicate

The KLS Martin Quick Disc, Sternal Talon and Sternal Plating System - Sterile are identical in manufacturing and materials as the KLS Martin Quick Disc (K062857), KLS Martin Sternal Talon (K051165) and KLS Martin Sternal Plating System (K032413).

The KLS Martin Quick Disc, Sternal Talon and Sternal Plating System - Sterile will be sterilized by gamma radiation and packaged in exactly the same manner as the KLS Martin Rigid Fixation - Sterile (K060177)

Difference to Predicate

The KLS Martin Quick Disc, Sternal Talon and Sternal Plating System - Sterile will be packaged sterile and will have different stock numbers from originally cleared stock numbers to identify the product as sterile.

Substantial Equivalence:

The KLS Martin Quick Disc, Sternal Talon and Plating System are substantially Sternal equivalent in manufacturing and materials to the KLS Martin Quick Disc (K062857), KLS Martin Sternal Talon (K051165), and KLS Martin Sternal Plating System (K032413) and in sterilization and packaging to the KLS Martin Rigid Fixation - Sterile (K060177)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KLS-Martin L.P. % Ms. Jennifer Damato Director, Regulatory Affairs and Quality Assurance 11239-1 St. Johns Industrial Parkway South Jacksonville, Florida 32246

MAR 2 6 2007

Re: K070169

Trade/Device Name: KLS Martin Sternal Talon and KLS Martin Plating 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

Trade/Device Name: KLS Martin Ouick Disc Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: March 5, 2007 Received: March 7, 2007

Dear Ms. Damato:

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.

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Page 2 - Ms. Jennifer Damato

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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson 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): K070169

KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile Device Name:

Indications For Use: To offer KLS Martin Quick Disc, KLS Martin Sternal Talon and KLS Martin Sternal Plating in sterile packaging with the following indications for use:

K062857 KLS Martin Quick Disc is intended for use in the reattachment of cranial bone flaps after a craniotomy, covering burr holes, and fixation of cranial fractures.

K051165 KLS Martin Sternal Talon and K032413 KLS Martin Sternal Plating System are intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

Prescription Use V (Part 21 CFR 801 Subparl 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)

Chlara Pnebun

and Ne

Page 1 of

510(k) Number K070164

Regulation Number and Section

§ 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.