The Stryker Pediatric Mandible Distractor is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandible Distractor is indicated to correct congenital or post traumatic defects in the body and ramus of the mandible of neonates and children up to 4 years old.

Device Description

The Pediatric Mandible Distractor (PMD) System is a distraction system consisting of the following major components: distractor with integrated footplates, a removable activation rod and an activation key. The distractor initially stabilizes and then gradually distracts the bone segments separated by osteotomy. The removable activation rod is connected to the distractor and provides the point of attachment for the external activation key used to initiate the distraction of the bone segments.

The Pediatric Mandible Distractor (Subject Device) includes the distractor body. integrated footblates, a sliding footblate, and the activation ioint (to attach the activation rod). It is available in eight variants with two different distraction lengths (20 and 30 mm), right or left footplate configuration with footplate sizes having either a 2X2 or 3X3 hole pattern.

AI/ML Overview

The Stryker Pediatric Mandible Distractor received 510(k) clearance based on non-clinical performance testing. No clinical testing was performed.

Here's an overview of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Fulfilled criteria in accordance with DIN EN ISO 10993 ff as valid 2013: Part 1 Evaluation and testing within a risk management system.	The Subject Device fulfilled all set acceptance criteria for biocompatibility in accordance with ISO specifications.
Bench Testing	Fulfilled criteria in accordance with ASTM F 382 (Standard Specification and Test Method for Metallic Bone Plates) and ASTM STP 731 (Tables for Estimating Median Fatigue Limits) for static and dynamic four-point bending, compression force, and distraction force tests.	The Subject Device fulfilled all set acceptance criteria for static and dynamic four-point bending test, compression force tests, and distraction force tests in accordance with ASTM specifications.
Cleaning Validation	Internally predetermined acceptance criteria.	The Subject Device fulfilled all set acceptance criteria for cleaning validation.
Sterilization Validation	Fulfilled criteria in accordance with various ISO standards for sterilization (e.g., ISO 11138-1, DIN EN ISO 11737-1/2, DIN EN ISO 14161, DIN EN ISO 14937, EN ISO 15883-1, DIN EN ISO 17664, DIN EN ISO 17665-1, DIN ISO/TS 17665-2).	The Subject Device fulfilled all set acceptance criteria for sterilization validation in accordance with ISO specifications.
Corrosion	Internally predetermined acceptance criteria.	The Subject Device fulfilled all set acceptance criteria for corrosion.
Simulated Aging	Internally predetermined acceptance criteria.	The Subject Device fulfilled all set acceptance criteria for simulated aging.
Residual Moisture after Sterilization	Internally predetermined acceptance criteria.	The Subject Device fulfilled all set acceptance criteria for residual moisture after sterilization.
Handling of System (End Use Test)	Internally predetermined acceptance criteria.	The Subject Device fulfilled all set acceptance criteria for handling of system (end use test).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing was non-clinical.

3. 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, as no clinical testing was performed and therefore no expert-established ground truth on patient data was required. Acceptance criteria were based on recognized engineering and material standards or internally predetermined criteria.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no clinical testing involving human reviewers or adjudication of cases was performed.

5. 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, as this device is a physical medical implant and not an AI-assisted diagnostic or treatment system. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

Not applicable, as this device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical testing was defined by the specific requirements and limits set forth in the referenced ISO or ASTM standards, or by internally predetermined acceptance criteria when no external standards were applicable. This type of ground truth can be characterized as:

Standard-based performance metrics: For categories like biocompatibility, bench testing, and sterility, the device's performance was compared against the objective, quantifiable requirements and limits specified in applicable international (ISO) and American (ASTM) standards.
Engineering specifications/Internal criteria: For other categories (cleaning validation, corrosion, simulated aging, residual moisture, handling), the device was evaluated against internally predetermined specifications and criteria. These likely originated from engineering design requirements, risk assessments, and manufacturing specifications.

8. The sample size for the training set

Not applicable, as this device is a physical medical implant, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set was used for this physical medical device.

Summary

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Stryker Pediatric Mandible Distractor

MAR 2 0 2014

stryker

510(k) Summary

Date prepared:	November 05, 2013
Submitter:	Stryker Leibinger GmbH & Co. KGBötzinger Straße 4179111 FreiburgGermany
Contact:	Jamshed BadarpuraStryker Craniomaxillofacial750 Trade Centre Way, Suite 200Portage, MI 49002, USAPhone: (269) 389-4260Fax: (877) 648-7114jamshed.badarpura@stryker.com
Proprietary Name:	Stryker Pediatric Mandible Distractor
Common Name:	Bone plate system
Proposed Regulatory Class:	Class II
Product Codes:	MQN - Bone Plate
Predicate Devices:	1. OsteoMed Pediatric Intraoral Mandibular Distraction System, Extended - K0628512. KLS Micro Zurich Distractor (aka: Zurich Distraction System) - K0101393. Leibinger Advance Internal Midface Distraction System - K092743

Intended Use:

The Stryker Pediatric Mandible Distractor is intended to be used for bone stabilization and lengthening of the mandibular body and ramus.

Indication for Use:

Traditional 510(k)

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Stryker Pediatric Mandible Distractor : 上一篇: 上一篇:

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

Image /page/1/Picture/17 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the "s", which is uppercase. There is a small superscript symbol to the right of the "r".

Device Description:

Technological and Operational Characteristics:

The Stryker Pediatric Mandible Distractor is similar to its predicate devices having the following technological and operational characteristics:

Both the subject device and the predicate devices Material: are made of biocompatible titanium:
- . The subject device is made of commercially pure titanium (CP Ti) and stainless steel.
- The Predicate Device Nº 1 is made of titanium . and nickel titanium.
- The Predicate Device Nº 2 is made of titanium . allov.
- . The Predicate Device Nº 3 is made of titanium, titanium alloy, and stainless steel.
Design:

The design of the subject device is similar to the predicate devices. They all have the same components: body, footplates, activation joint (for activation rod connection), In addition, the subject device uses the same components and interfaces (e.q. activation rod) for distraction activation as the predicate devices. The subject device and its predicate devices offer various options of

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distraction lengths and footplate sizes. The footplates of the subject device are fully integrated (i.e. non-welded) compared to the predicate device Nº1 (assembled), Nº 2 (welded footplates), and the predicate device Nº 3 (screwed footplates).

The basic operational principle of the subject Principal of device as well as the predicate devices is for bone Operation: stabilization and lengthening. The method of site preparation and fixation is the same for both subject and predicate devices. The subject device and predicate devices are temporary implants.

The subject device and all predicate devices are Packaging: . dispensed non-sterile.

Clinical Testing:

No clinical testing was performed to support this submission.

Non-Clinical Testing:

Verification and Validation (V&V) evaluation has been performed on the Subject Device in the following categories: biocompatibility, corrosion, cleaning validation, sterilization validation, simulated aging, residual moisture after sterilization, bench testing (static and dynamic four-point bending test, compression force, distraction force tests), and handling of system (end use test). The Subject Device fulfilled all set acceptance criteria for each category in accordance with either ISO or ASTM specifications, or internally predetermined acceptance criteria if no standards were applicable. All applied ISO standards are listed below:

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stryker®

Reference	Title
Biocompatibility
DIN EN ISO 10993 ff asvalid 2013	Biological evaluation of medical devices. Part 1:Evaluation and testing within a risk managementsystem
Bench Testing
ASTM F 382	Standard Specification and Test Method for MetallicBone Plates
ASTM STP 731	Tables for Estimating Median Fatigue Limits
Sterility/Reprocessing
ISO 11138-1:2006	Sterilization of health care products - Biologicalindicators - Part 1: General requirements
DIN EN ISO 11737-1:2009	Sterilization of medical devices - Microbiologicalmethods - Part 1: Determination of a population ofmicroorganisms on products
DIN EN ISO 11737-2:2009	Sterilization of medical devices - Microbiologicalmethods - Part 2: Tests of sterility performed in thevalidation of a sterilization process
DIN EN ISO 14161:2011	Sterilization of health care products - Biologicalindicators - Guidance for the selection, use andinterpretation of results
DIN EN ISO 14937:2009	Sterilization of health care products - general criteriafor characterization of a sterilizing agent anddevelopment, validation and routine control of asterilization process
EN ISO 15883-1:2009	Washer-disinfectors: General requirements, termsand definitions and tests
DIN EN ISO 17664:2004	Sterilization of medical devices - Information to be
Reference	Title
	provided by the manufacturer for the processing ofresterilizable medical devices
DIN EN ISO 17665-1:2006	Sterilization of health care products – Moist heat –Part 1: Requirements for the development, validationand routine control of a sterilization process formedical devices
DIN ISO/TS 17665-2:2009	Sterilization of health care products – Moist heat -Part 2: Guidance on the application of ISO 17665-1

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stryker

Substantial Equivalence Conclusion:

The Stryker Pediatric Mandible Distractor is substantially equivalent to its predicate devices with respect to its intended use, design, materials and operational principle. Further, the performance testing confirms that the Stryker Pediatric Mandible Distractor is safe and effective for its intended use, and performs as well as the predicate devices.

Traditional 510(k)

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Image /page/5/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right. The image is black and white.

Public Health Service

Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2014

Stryker Leibinger GmbH & Co. KG C/O Mr. Jamshed Badarpura Senior Regulatory Compliance Analyst Stryker Craniomaxillofacial 750 Trade Center Way, Suite 200 Portage. MI 49002

Re: K133398

Trade/Device Name: Stryker Pediatric Mandible Distractor Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate System Regulatory Class: II Product Code: MQN Dated: February 10, 2014 Received: February 14, 2014

Dear Mr. Badarpura:

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. Ilisting 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 cither 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.

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Page 2 - Mr. Badarpura

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID

FOR

Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	K133398
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Device Name: Stryker Pediatric Mandible Distractor

Indications For Use: The Stryker Pediatric Mandible Distractor is intended to be used for bone stabilization and lengthening of the mandibular body and ramus. The Stryker Pediatric Mandible Distractor is indicated to correct congenital or post traumatic defects in the body and ramus of the mandible of neonates and children up to 4 years old.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K133398

Mary S. Runner -S
Susan Runner DDS, MS 2014.03.19
09:42:59 -04'00'

Page 1 of

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.