Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the cranial bones that require gradual distraction.

Device Description

Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of cranial bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.

AI/ML Overview

This document is a 510(k) premarket notification for the "Internal Distraction - Sterile" device. The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to a predicate device, the "Zurich Distraction System (K010139)".

Here's a breakdown of the requested information:

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

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Intended Use	The device is intended as a bone stabilizer and lengthening/transport device for correction of congenital deficiencies or post-traumatic cranial bone defects requiring gradual distraction.	The "Internal Distraction - Sterile" device has the same intended use as the predicate device, specifically for cranial bones.
Materials/Biocompatibility	Materials (Titanium Alloy (Ti-6Al-4V) and CP Titanium) should meet biocompatibility requirements as per FDA Blue Book Memo #G95-1 (ISO 10993 Part 1).	The device uses the same materials (Titanium Alloy (Ti-6Al-4V) and CP Titanium) as the previously cleared predicate device, with identical chemical composition, manufacturing processes, and body contact duration. Therefore, no new biocompatibility testing was needed or performed.
Sterilization & Pyrogenicity	Device must be in sterile packaging and meet pyrogenicity limits.	Bacterial Endotoxins testing was conducted (ANSI/AAMI ST72:2011, USP <85>, EP 2.6.14). Results demonstrate conformity to required endotoxin units per device and meet pyrogen limit specifications. The device will be provided sterile via gamma irradiation.
Mechanical Performance	Mechanical properties (axial resistance, torsional loading, material properties, manufacturing tolerances) must be sufficient to withstand anatomical loads and allow for effective and safe bone movement.	Axial load testing, bending torsion testing, axial-torsion testing, and transverse shear testing were performed. All devices passed design requirements for material properties, manufacturing tolerances, axial resistance, and torsional loading, demonstrating sufficient capability to withstand anatomical loads and allow effective/safe boney movement.
Substantial Equivalence	The device must be substantially equivalent to the predicate device in intended use, design, function, manufacturing process, and materials, such that any differences do not raise new questions of safety or effectiveness.	The device is similar to the predicate in intended use, design, function, manufacturing process, and materials. Differences (sterile packaging, cranial-specific indication, ratcheting mechanism, detachable activators) were deemed not to raise new questions of safety or effectiveness.

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

The document primarily relies on non-clinical performance data (bench testing) and comparison to the predicate device.

Biocompatibility: No new testing was performed; it relied on the predicate device's clearance.
Pyrogenicity: The sample size for Bacterial Endotoxins testing is not specified.
Mechanical Performance: The sample size for axial load, bending torsion, axial-torsion, and transverse shear testing is not specified. This was bench testing, not clinical data, so provenance like "country of origin" or "retrospective/prospective" is not applicable in the typical sense for patient data.

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. The study is a 510(k) submission based on non-clinical bench testing and demonstration of substantial equivalence to a predicate device. There was no test set requiring expert ground truth for clinical cases.

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

Not applicable. No clinical test set or adjudication for diagnostic ground truth was performed or required.

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. This device is a medical implant (internal distraction system), not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted.

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

Not applicable. This is a medical device, not an algorithm, so the concept of standalone performance does not apply.

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

Not applicable in the context of clinical ground truth for diagnostic accuracy. The "ground truth" for this submission is based on:

Predicate Device Equivalence: The safety and effectiveness profile of the legally marketed predicate device (Zurich Distraction System, K010139).
Engineering Standards: Compliance with recognized standards for biocompatibility (ISO 10993-1), pyrogenicity (ANSI/AAMI ST72:2011, USP <85>, EP 2.6.14), and mechanical performance through bench testing against design requirements.

8. The sample size for the training set

Not applicable. This is a medical device clearance, not an AI model. There is no concept of a "training set" for the device itself.

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

Not applicable. See point 8.

Summary

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

May 5, 2017

KLS Martin LP Jennifer Damato Director of Quality MGT & Regulatory Affairs 11201 Saint Johns Industrial Parkway South Jacksonville, Florida 32246

Re: K163315

Trade/Device Name: Internal Distraction - Sterile Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PBJ Dated: April 3, 2017 Received: April 4, 2017

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. 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 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 devicerelated adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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,

Michael J. Hoffmann -S

Carlos L. Peña. PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163315

Device Name Internal Distraction - Sterile

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the word "martin" is in gray. The letters "L.P." are in black and are slightly smaller than the other letters in the logo. The logo is simple and modern, and the use of color helps to make it stand out.

P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 ● Fax 904-641-7378 www.klsmartinnorthamerica.com

5. 510(K) SUMMARY

Submitter:	KLS Martin LP11201 Saint Johns Industrial Pkwy SJacksonville, FL 32246
Contact Person:	Jennifer DamatoDirector of Quality MGT and Regulatory AffairsPhone: 1-800-625-1557Fax: 904-641-7378
Date Prepared:	May 4, 2017
Trade Name:	Internal Distraction - Sterile
Common Name:	Preformed nonalterable cranioplasty plate
Classification Name:	Cranial Distraction SystemClass II, 21 CFR 882.5330, Product Code PBJ
Predicate Devices:	Zurich Distraction System (K010139) (Primary)

Device Description

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Image /page/4/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the words "martin L.P." are in gray. The logo is simple and modern, and it is likely used to represent the company in its marketing and branding materials. The logo is horizontally oriented.

The purpose of this submission is to offer the previously cleared KLS Martin LP nonsterile predicate cranial distractors sterile via gamma irradiation and encompasses the following device:

Zurich Distraction System - K010139: The Zurich Distraction System includes devices intended as a bone stabilizer and lengthening (and or transport) device when correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, symphysis), mid-face, and cranial bones require gradual distraction.

Indications for Use

Technological Characteristics/Substantial Equivalence Discussion

Similarities to Predicate Devices

Internal Distraction - Sterile is similar to the Zurich Distraction System (K010139) predicate device with respect to intended use, but identical in materials, manufacturing process, principles of operation, and placement/fixation methods. The design mechanisms are similar with regard to the drive screws, distractor body, footplate shapes and sizes, distractor drive lengths, activators, and screws used to attach the footplates to the bone. The subject device performance characteristics are the same and testing performed demonstrates the devices are safe and effective for the intended use.

Differences to Predicate Devices

Internal Distraction - Sterile differs from the Zurich Distraction System (K010139) predicate device in that it will be provided in sterile packaging and will have different stock numbers from the originally cleared stock numbers to identify the product as sterile. In addition, the intended use differs only from the predicate device in that Internal Distraction - Sterile will be intended for correction of bones in the cranium, and will not include mid-face or mandible bones. The design mechanisms differ slightly in the subject devices compared to the predicate devices in that the distractors are manufactured with a ratcheting mechanism and specific activation arms are designed to be detachable based on patient need and distraction location.

Non-Clinical Performance Data

Biocompatibility Testing

Biocompatibility requirements were assessed in accordance with FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The patient-contacting materials Titanium Alloy (Ti-6Al-4V) and CP Titanium used for the Internal Distraction - Sterile devices and their components were

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Image /page/5/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while the word "martin" is in gray. The letters "L.P." are in black. The logo is simple and modern.

.O. Box 16369 · Jacksonville, FL 32245-6369 04-641-7746 or 800-625-1557 ● Fax 904-641-7378 www.klsmartinnorthamerica.com

tested for biocompatibility and are previously cleared in the predicate device. The Internal Distraction - Sterile devices and their components are comprised of the same materials, have the same chemical composition, undergo the same manufacturing processes, and have the same body contact duration as these devices; therefore, biocompatibility testing for Internal Distraction - Sterile is not needed.

Pyrogenicity Testing

Bacterial Endotoxins testing was conducted in accordance to ANSI/AAMI ST72:2011, USP <85>, and EP 2.6.14 for detection and quantitation of bacterial endotoxins. The results of the testing demonstrate that the subject devices conform to the required endotoxin units per device for medical devices and meet pyrogen limit specifications.

Performance Testing - Bench

Axial load testing, bending torsion testing, axial-torsion testing, and transverse shear testing were performed to evaluate the mechanical properties of the subject devices. All devices passed design requirements for material properties, manufacturing tolerances, axial resistance, and torsional loading. The results of the testing demonstrate the devices are sufficiently capable of withstanding the anatomical loads placed upon them and allow for effective and safe boney movement during their intended use.

Clinical Performance Data

Clinical testing was not necessary for the determination of substantial equivalence.

Conclusion

Internal Distraction - Sterile is similar in its intended use, design, function, manufacturing process, and is composed of the same materials as the predicate device. The similarities and differences in technological characteristics do not raise new questions of safety or effectiveness. Internal Distraction - Sterile will encompass the previously cleared predicate device intended for correction of cranial bones and provide them sterile. Therefore, the information presented supports substantial equivalence of Internal Distraction - Sterile to the predicate device.

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).