The OsteoMed smartflex Cranial Spring Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OsteoMed smartflex Cranial Spring Distraction System is intended for single patient use only.

Device Description

The OsteoMed smartflex Cranial Spring Distraction System is a distraction osteogenesis system consisting of distractors in various sizes. The distractor is anchored to the cranium by the distractor foot plate. The distractor gradually distracts the bone segments by applying a continuous force to the bones of the skull facilitating remodeling to expand the prematurely closed suture. The distractors are removed after consolidation. The instruments used with the system are pliers, benders, plate cutters and other instruments to facilitate the placement and removal of the OsteoMed smartflex cranial spring distractors. The OsteoMed smartflex Cranial Spring Distractors are made from Medical Grade Stainless Steel per ASTM F-138.

AI/ML Overview

This document describes the OsteoMed smartflex Cranial Spring Distraction System and its comparison to predicate devices for 510(k) clearance. The study presented is not a diagnostic device study, but rather a mechanical performance verification and clinical data comparison for a surgical implant. Therefore, several of the requested categories are not directly applicable or are interpreted differently in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on demonstrating "substantial equivalence" to predicate devices in terms of safety and effectiveness. This is achieved through engineering tests and comparison to clinical outcomes of similar devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Stress on Infant Cranial Bone (below yield strength)	Finite Element Analysis showed stress on cranial bone was 80% below the stress of the predicate Cranial Distractor.
Maximum Distraction Distance (safe and effective range)	Maximum possible distraction distance of 55mm was identified as safe. 91 clinical cases with similar devices showed 31 cases reaching 55mm and 60 cases going beyond 55mm with only one skin infection and 3 spring repositioning complications.
Distraction Rate (comparable to clinical practice for similar devices)	Average distraction rate of 1.39mm per day (over a six-week duration) was obtained from clinical data and compared to the predicate's 1mm per day (0.5mm twice a day).
Spring Geometry and Force Targets (as described in literature/design specification)	Spring geometry was verified using an optical comparator. Force was measured during compression between footplates to simulate initial implantation force, verifying targets were met.
Biocompatibility (Medical Grade Stainless Steel per ASTM F-138)	Stated as "Biocompatible" and comparable to the predicate device OsteoMed External Mandibular Distraction System (K063792) which uses similar material.
Sterility (Provided Sterile)	Stated as "Provided Sterile (Gamma)" and comparable to predicate device K922211 for sterility method.
Overall Safety and Effectiveness (comparable to predicate devices)	"In conclusion, the device is safe and effective and performs as well as the OsteoMed Cranial Distraction System and the KLS-Martin predicate devices." Substantiated by similarities in intended use, indications for use, function, performance, operational principle, and materials.

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

Finite Element Analysis: The sample size is not explicitly stated beyond "Cranial Vault Distractor Predicate and the OsteoMed SmartFlex Cranial Spring Distractor were created," implying a comparison of two models. Data provenance is implied to be simulated data based on infant skull properties.
Distraction Distance and Rate Clinical Data:
- Sample Size: 91 clinical cases.
- Data Provenance: Clinical data obtained by surgeons, with cranial spring devices similar to the device, manufactured by a physician. No country of origin is specified, but it's referred to as "clinical data," suggesting retrospective human patient data.

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

Finite Element Analysis: Not applicable in the context of expert ground truth. The "ground truth" here would be established by engineering principles and validated models.
Distraction Distance and Rate Clinical Data: The data was obtained by "surgeons." The number of surgeons is not specified. Their qualifications are implicitly that they are "a physician in cranial distraction," suggesting expert practitioners in the field.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the traditional sense of multiple experts reviewing and reaching consensus on an output, as this is not a diagnostic study. For the clinical data, the "ground truth" appears to be the observed clinical outcomes as recorded by the treating surgeons. There is no mention of independent expert review or adjudication of these historical clinical outcomes for the purpose of this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study compares the performance of the new device to predicate devices and existing clinical data, but not in a multi-reader, human-AI assisted vs. human-only paradigm.

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

The device is a physical surgical implant, not an algorithm or AI system. Therefore, the concept of "standalone" algorithm performance is not applicable. The performance described relates to mechanical characteristics and clinical outcomes of the physical device.

7. The Type of Ground Truth Used

Finite Element Analysis: Engineering models and "infant skull properties" as established physical parameters.
Distraction Distance and Rate: Clinical outcomes data (observed distraction distances and rates, and complications) from actual patient cases.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning. The clinical data on 91 cases mentioned for distraction distance and rate appears to be the primary observational data used for performance comparison and justification, not a "training set" for an algorithm.

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

Not applicable, as there is no explicitly defined "training set" for an algorithm in this submission. The 91 clinical cases' outcomes were established by the treating surgeons and their medical records.

Summary

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

Image /page/0/Picture/0 description: The image shows the word "OSTEOMED" in a bold, sans-serif font. The word is enclosed in a black oval shape. The oval shape has a white outline, which makes the word stand out. The logo appears to be for a company called Osteomed.

K123885

510(k) Summary

JUN 0 3 2013

Submitter Information:

OsteoMed 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601

Contact Person:

Mrs. Piedad Peña

Date Prepared:

May 15, 2013

Device Information:

Common Name: Classification Name:

Proprietary/Trade Name: OsteoMed smartflex Cranial Spring Distraction System Cranial Spring Distractor

o Requlation Number: 21 CFR 882,5330

o Regulation Name: Preformed nonalterable cranioplasty plate
o Product Code: PBJ

Device Class: II

Predicate Devices:

OsteoMed Cranial Distraction System, K121304

o Classification Name: Regulation Number: 21 CFR 882.5330
· Regulation Name: Preformed nonalterable cranioplasty plate
o Product Code: PBJ

Device Class: II

KLS - Martin, Molina Orbital Malar Distractor, K003883

o Classification Name: Regulation Number: 21 CFR 872.4760
o Regulation Name: Bone Plate
o Product Code: JEY
Device Class: II

OsteoMed External Mandibular Distraction System, K063792

o Classification Name: Regulation Number: 872.4760
o Regulation Name: Bone Plate
o Product Code: MQN

Device Class: 11

OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779

Image /page/0/Picture/34 description: The image shows the logo for Colson Associate. The logo consists of a circular emblem with the word "Colson" written inside it in a stylized font. To the right of the emblem, the words "A COLSON ASSOCIATE" are written in a smaller, sans-serif font. The overall design is simple and professional.

{1}------------------------------------------------

Device Description:

The instruments used with the system are pliers, benders, plate cutters and other instruments to facilitate the placement and removal of the OsteoMed smartflex cranial spring distractors.

The OsteoMed smartflex Cranial Spring Distractors are made from Medical Grade Stainless Steel per ASTM F-138.

Indications For Use/Intended Use:

Intended use is equivalent to the OsteoMed Cranial Distraction System and the KLS-Martin predicate devices.

Target Population:

Pediatrics; Sub-population - Infant greater than 1 month to 2 years of age

Technological Characteristics:

The OsteoMed and KLS predicate devices are internal distractors for bone elongation, which distracts manually via a threaded rod and are anchored using bone screws. The KLS distractor predicate has hook feet which anchor to the cranial bone edge and uses bone screws to anchor to the cranial bone. The OsteoMed smartflex Cranial Spring Distractor is also an internal distractor for bone elongation as the predicate devices, but it distracts via continuous spring force and is anchored by hook feet to the cranial bone edge.

Material used for the OsteoMed smartflex Cranial Spring Distractor is medical grade stainless steel. The material used for the OsteoMed External Mandibular Distraction System (K063792) implantable K-wires, which are implanted during distraction, are medical grade stainless steel. The stainless steel material used in the OsteoMed smartflex Cranial Spring Distractor and the OsteoMed Implantable K-wire is biocompatible.

OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "OSTEOMED" in bold, sans-serif font. The word is enclosed in a black, oval shape that curves above and below the text. The logo appears to be a company logo or brand name.

Performance / Clinical Data:

The OsteoMed smartflex Cranial Spring Distraction System was compared to the distraction rates and verified forces of the OsteoMed Cranial Distraction System. Verification testing consisted of the following tests;

. Finite Element Analysis of Forces Applied to Adjacent bone simulating infant skull properties for the Cranial Vault Distractor Predicate and the OsteoMed SmartFlex Cranial Spring Distractor were created. The results show that both devices exerted a stress on the cranial bone below the vield strength of infant cranial bone. The stress on the cranial bone for the Cranial Spring Distractor was 80% below the stress on the cranial bone of the Cranial Distractor (predicate).
Distraction distance was evaluated graphically using clinical data obtained by . surgeons with cranial spring devices similar to our device. The data included 91 clinical cases performed on infants ranging in age from 3 - 8.5 months with cranial springs manufactured by a physician in cranial distraction, 31 cases reached 55mm of distraction and 60 cases went safely beyond 55mm with only one clinical complication, a skin infection and 3 spring related complications (repositioning of the springs). The maximum possible distraction distance of the OsteoMed Cranial Spring Distractor is 55mm because that is the maximum length at free state that does not compromise patient safety.
Distraction rate was obtained from the clinical data and distraction rates . compared to the predicate. The distraction rate on average with a six week duration was 1.39mm per day.
The OsteoMed smartflex Cranial Spring Device design was verified to prove the . spring geometry and force targets were met as described in the literature. Spring geometry was verified using an optical comparator and the implants were compressed between the footplates to simulate initial force at implantation, where the force was measured.

The indications for use of the OsteoMed smartflex Cranial Spring Distraction System are the same as the OsteoMed Cranial Distraction System (K121304) and KLS-Martin Molina Distraction System (K003883) predicate devices.

Clinical Testing is not required to support substantial equivalence.

In conclusion, the device is safe and effective and performs as well as the OsteoMed Cranial Distraction System and the KLS-Martin predicate devices.

Substantial Equivalence:

Substantial equivalence for this device is based on similarities in intended use, indications for use, function, performance, and operational principle to the predicate devices, OsteoMed Cranial Distraction System (K121304) and KLS-Martin Molina Distraction System (K003883), based on their promotional materials, labeling and clearance letters. The basis for substantial equivalence for this device is also on similarities in materials with the OsteoMed External Mandibular Distraction System (K063792) implantable Stainless Steel K-wires base on their promotional materials, labeling and clearance letters. The system is provided sterile based on the predicate device (K922211) Sterilization Testing.

OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "OSTEOMED" in bold, sans-serif font. The word is enclosed in a black oval shape. The oval shape is thicker on the bottom than on the top. The image is in black and white.

System/ MFGDevice	OsteoMedSmartflexCranial SpringDistractor	OsteoMedCranialDistractionSystem	KLS-Martin MolinaOrbital MalarDistractor	OsteoMed ExternalMandibular DistractionSystem	OsteoMedReFlexion ToeImplant System
510 (k)	(New)	K121304	K003883	K063792	K922211
Purpose		(Predicate)	(Predicate)	(Predicate - Materialimplant)	(Predicate - GammaSterilization)
Product Code/Classification	PBJ21CFR882.5330	PBJ21CFR882.5330	JEY, 21CFR872.4760	JEY 21CFR872.4760	LZJ, Unclassifed
Intended use:	Cranialconditions	Cranial conditions	Cranial and MidfaceConditions	External distraction ofMandible Conditions	reconstruction of the1st MTP, resultingfrom osteoarthritis,rheumatoid arthritis,traumatic arthritis orrevision of previousarthroplasty
Indications foruse:	Intended foruse in thetreatment ofcranialconditions suchas syndromiccraniosynostosis andcongenitaldeficiencies inwhichosteotomiesand gradualbone distractionare indicated.This device isintended toprovidetemporarystabilizationand graduallengthening ofthe cranialbones. Thisdevice isintended to beremoved afterconsolidation.	Intended for usein the treatment ofcranial conditionssuch assyndromiccraniosynostosisand congenitaldeficiencies inwhichosteotomies andgradual bonedistraction areindicated. Thisdevice is intendedto providetemporarystabilization andgraduallengthening of thecranial bones.This device isintended to beremoved afterconsolidation.	KLS-Martin MolinaOrbital Malar Distractoris intended for use inthe treatment of cranialand midface conditionssuch as syndromiccraniosynostosis andcongenital midfacedeficiencies in whichosteotomies andgradual bonedistraction areindicated. This deviceis intended to providetemporary stabilizationand graduallengthening of thecranial and midfacebones.	The OsteoMed ExternalMandibular DistractionSystem, which is a familyof external distractionosteogenesis devices forbone elongation for thecorrection of congenitaldeficiencies, mandibularhypoplasia or posttraumatic defects of themandible that requiregradual distraction. TheOsteoMed ExternalMandibular DistractionSystem is intended foruse in either adults orpediatric patients.The OsteoMed ExternalMandibular DistractionSystem is intended forsingle patient use only.	three-piece implantsystem designed forthe reconstruction ofthe 1st MTP,resulting fromosteoarthritis,rheumatoid arthritis,traumatic arthritis orrevision of previousarthroplasty
Targetpopulation:	Pediatrics	Pediatrics	Pediatrics	Pediatrics and Adults	Adults
Anatomicalsites:	Cranium	Cranium	Cranium and Midface	Mandible	1st MPJ (toe)
Function:	Distraction ofcranial bones	Distraction ofcranial bones	Distraction of cranialand midface bones.	Distraction of mandibularbones	Reconstruction ofthe 1st MPJ
Design:	Distraction viaspring forcesandAnchored byhooks on feet(feet plates)	Distraction forceapplied bysurgeon/parent byactivating thedistraction rod.	Distraction forceapplied bysurgeon/parent byactivating thedistraction rod.	Distraction force appliedby surgeon/parent/patientby activating thedistraction rod onto the K-wires.Anchored by K-Wiresthrough the mandibularbone.	N/A
Maximum	55mm*	25mm	35mm	70mm	N/A
System/ MFGDevice	OsteoMedSmartflexCranial SpringDistractor	OsteoMedCranialDistractionSystem	KLS-Martin MolinaOrbital MalarDistractor	OsteoMed ExternalMandibular DistractionSystem	OsteoMedReFlexion ToeImplant System
510 (k)	(New)	K121304	K003883	K063792	K922211
Distractionrate:	0.4mm per day	1mm per day(0.5mm twice aday)	1mm per day(0.5mm twice a day)	1mm per day(0.5mm twice a day)	N/A
Materials forImplants:	Distractor:Stainless Steel(316 SS LVM)ASTM F-138			Implantable K-Wires:Stainless Steel (316 SSLVM) ASTM F-138	Titanium Alloy,CoCrMo Alloy,UHMWPE
Bio-compatibility:	Biocompatible	Biocompatible	Biocompatible	Biocompatible	Biocompatible
Sterility:	Provided Sterile(Gamma)	Provided non-sterile (SteamSterilization byend user)	Provided non-sterile(Steam Sterilization byend user)	Provided non-sterile(Steam Sterilization byend user)	Provided Sterile(Gamma)
Techno-logicalChar-acteristics:	Springdistractor	Distraction rodand tool fordistraction	Distraction rod and toolfor distraction	Distraction rod and toolfor distraction	N/A
OperationalPrinciple:	Distractionosteogenesis	Distractionosteogenesis	Distractionosteogenesis	Distraction osteogenesis	N/A

OsteoMed OsteoMed OsteoMed OsteoMed
(388 Addison, Tepahone Addison, Tepahone (1800)
(872) 677-4600 Addison, Texas (2001)
(872) 677-4600 Addison, 1989 (2007) 1589 (200

colson a culson associate

. ·

{4}------------------------------------------------

Due to the similarity of intended use, indications for use, function, materials, performance, and operational principle to the predicate devices, OsteoMed believes that the OsteoMed smartflex Cranial Spring Distraction System does not raise any new safety or effectiveness issues.

OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779

Image /page/4/Picture/4 description: The image shows the logo for A Colson Associate. The logo consists of the word "Colson" in a stylized font inside of a black circle. To the right of the circle, the words "A Colson Associate" are written in a smaller, sans-serif font.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is aligned to the left. There is a logo to the left of the text. The logo is a stylized image of three lines.

June 3rd, 2013

Public Health Service

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

OsteoMed % Ms. Piedad Peña Manager, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001

Re: K123885

Trade/Device Name: OsteoMed smartflex Cranial Spring Distraction System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PBJ Dated: April 23, 2013 Received: April 24, 2013

Dear Ms. Peña:

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 -Gosmetic-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 [II (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

{6}------------------------------------------------

Page 2 - Ms. Piedad Peña

device-related 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.

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,

Joyce M. Whang -S

for Victor Krauthamer. Ph.D. Acting Director Director of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number (if known): K123885

Device Name: OsteoMed smartflex Cranial Spring Distraction System

Indications For Use:

The OsteoMed smartflex Cranial Spring Distraction System is intended for single patient use only.

Target Population: Pediatrics; Sub-population - Infant greater than 1 month to 2 years of age

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_CONT.INUE_ON.ANOTHER.PAGE.IF NEEDED)-

Concurrence of CDRH. Office of Device Evaluation (ODE)

Joyce M. Whang -

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K123885

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).