InstaFix™ Shape Memory Fixation System is intended for use in:
Fixation of Osteotomies of the Hand, Foot and Tibia
Arthrodesis of the Joints of the Hand and Foot
Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament
InstaFix™ Shape Memory Fixation System is also indicated for adjunctive fixation of Small Bone Fragments of:
The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula
The Lower Extremity, such as the Tibia, Fibula and the Femur
The Upper Torso, such as the Sternum and the Ribs

Device Description

InstaFix™ Shape Memory Fixation System is a set of dynamic compression implants made from shape memory metal nickel-titanium alloy called NiTinol. The staples are available in sizes 8mm to 30mm. The NiTinol construction causes the legs of the implant to deflect, thereby creating a compressive force across the site of fixation. InstaFix™ Shape Memory Fixation implants are advantageous to screws and plates in that they require less disruption of the surrounding bone for implantation and provide 'low-profile' fixation. The most important factor related to the use of NiTinol is its ability to maintain a compressive force across the site of fixation during the healing process. Each staple is packaged sterile along with the corresponding drill guide and implant holder. The one time use Accessory Kit and the Sizer Kit are packaged sterile to assist in the procedure. The Accessory Kit contains one drill and two locating pins. The Sizer Kit contains samples of the available staple sizes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the InstaFix™ Shape Memory Fixation System, based on the provided document:

This document is a 510(k) summary for a medical device. For such submissions, the primary "study" proving acceptance criteria is a demonstration of substantial equivalence to a previously cleared predicate device. This typically involves non-clinical testing to show that the new device performs at least as well as the predicate device in relevant performance areas. There isn't usually a clinical study with human patients and outcomes data for this type of submission.

Therefore, many of the requested categories related to clinical studies, human readers, and training data will not be applicable or will have limited information.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implicitly that the device performs functionally equivalent or better than the predicate device in key mechanical and material characteristics. The reported device performance is presented as successful completion of these non-clinical tests, demonstrating equivalence. Specific quantitative acceptance targets are not explicitly stated in a table within this summary, but rather are inherent in demonstrating performance comparable to the predicate.

Acceptance Criteria (Implicit)	Reported Device Performance
Staple Fatigue Life: Demonstrate sufficient durability under cyclic loading.	Testing performed; conclusions state the proposed device "performs as well as the predicate device."
Pull-out Fixation Strength: Demonstrate adequate fixation strength in bone.	Testing performed; conclusions state the proposed device "performs as well as the predicate device."
Elastic Static Bending: Demonstrate appropriate mechanical properties under bending.	Testing performed; conclusions state the proposed device "performs as well as the predicate device."
Sterilization Validation: Ensure device can be reliably sterilized.	Testing performed; the method (gamma radiation) is the same as the predicate and successfully validated.
Packaging Validation: Ensure package integrity and sterility maintenance.	Testing performed; successfully validated.
Sealing and Aging Study: Verify long-term package integrity and device stability.	Testing performed; successfully validated.
Biocompatibility: Demonstrate materials are safe for human contact.	"All patient contact components are made from biocompatible materials. This indicates that the components are safe for their intended use." (This implies testing was done to confirm biocompatibility, although details are not provided in this summary.)

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

Sample Size: Not explicitly stated for each non-clinical test (e.g., how many staples were tested for fatigue life). However, this refers to numbers of physical devices tested, not human subjects or patient data.
Data Provenance: Not applicable in the context of clinical data. The tests are benchtop, non-clinical studies performed on the physical device itself. The data is generated from laboratory testing of the InstaFix™ devices.

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

Not applicable. This is a non-clinical device performance study. "Ground truth" in this context refers to established engineering standards or the performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical device performance study.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic devices or devices where human interpretation plays a significant role. The InstaFix™ system is a surgical fixation device.

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

Not applicable. This device does not involve algorithms or human-in-the-loop performance in the sense of AI. Its "performance" is based on its mechanical and material properties.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through bench-top engineering tests designed to evaluate the mechanical and material performance of the device against a known predicate device's performance standards/characteristics and relevant industry standards for orthopedic implants.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in this non-clinical submission, as it does not involve machine learning or AI.

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

Not applicable. There is no training set.

Summary

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JUL 1 1 2014

510(K) SUMMARY

Owner's Name	William Rhoda
Submitter's	OT Medical
Address	1000 Continental Drive, Suite 240King of Prussia, PA 19034
Phone Number	(484) 588-2063
Fax Number	(484) 588-2064
510(k) Owner	OT Medical
Contact Person	William Rhoda, President & CEO
Date Prepared	June, 10 2014
Trade Name	InstaFix™ Shape Memory Fixation System
Common Name	Staple, Fixation, Bone
Classification	Sec. 888.3030 Single/multiple component metallic bone fixationappliances and accessories
Section	Orthopedic
Product Code	JDR
Predicate Device	reVERTO™ Shape Memory Staples (K071477)
DeviceDescription	InstaFix™ Shape Memory Fixation System is a set of dynamiccompression implants made from shape memory metal nickel-titanium alloy called NiTinol. The staples are available in sizes 8mmto 30mm. The NiTinol construction causes the legs of the implant todeflect, thereby creating a compressive force across the site offixation. InstaFix™ Shape Memory Fixation implants areadvantageous to screws and plates in that they require lessdisruption of the surrounding bone for implantation and provide'low-profile' fixation. The most important factor related to the useof NiTinol is its ability to maintain a compressive force across thesite of fixation during the healing process. Each staple is packagedsterile along with the corresponding drill guide and implant holder.The one time use Accessory Kit and the Sizer Kit are packagedsterile to assist in the procedure. The Accessory Kit contains onedrill and two locating pins. The Sizer Kit contains samples of theavailable staple sizes.
Reason for510(k)	Modified device
Indications forUse	InstaFix™ Shape Memory Fixation System is intended for use in:Fixation of Osteotomies of the Hand, Foot and TibiaArthrodesis of the Joints of the Hand and FootFixation of Soft Tissue to Bone, as in the case of theAnterior Cruciate LigamentInstaFix™ Shape Memory Fixation System is also indicated foradjunctive fixation of Small Bone Fragments of:The Upper Extremity, such as the Radius, Ulna, Humerus,Clavicle and ScapulaThe Lower Extremity, such as the Tibia, Fibula and theFemurThe Upper Torso, such as the Sternum and the Ribs
TechnologicalCharacteristics	The InstaFix™ Shape Memory Fixation System implant is made ofthe same Nitinol material as the predicate. The implant is single useand sterilized by gamma radiation, which is the same as thepredicate. The accessories are single use versus reusable. The staplesizes available are the same as the predicate.All patient contact components are made from biocompatiblematerials. This indicates that the components are safe for theirintended use.
SubstantialEquivalence	The InstaFix™ Shape Memory Fixation System is substantiallyequivalent in design, materials, intended use, indications for use,principles of operations and technological characteristics as thepredicate reVERTO™ Shape Memory Staples K071477. There aredifferences in the packaging and the accessories are single useinstead of reusable. The shelf life and sterilization method is thesame. The risk analysis performed, raised no new issues of safety orefficacy.
Nonclinical TestPerformed	The verification and validation testing of the InstaFix™ ShapeMemory Fixation implant included staple fatigue life, pull-outfixation strength and elastic static bending. Design verification andvalidation testing included sterilization validation, packagingvalidation, sealing and aging study.
ConclusionsDrawn	The substantial equivalence of the InstaFix™ Shape MemoryFixation System is based on the equivalence in intended use,materials, operational principals, technological characteristics andindications for use to reVERTO™ Shape Memory Staples K071477.Non-clinical testing demonstrates that the proposed device is safe,effective, and performs as well as the predicate device, thereforedemonstrating substantial equivalence

. . . . . .

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END OF 510(K) SUMMARY

and the comments of the comments of

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Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white.

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

July 11, 2014

OT Medical Mr. William Rhoda President & CEO 1000 Continental Drive, Suite 240 King of Prussia, Pennsylvania 19406

Re: K141550 Trade/Device Name: InstaFix™ Shape Memory Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: June 11, 2014 Received: June 12, 2014

Dear Mr. Rhoda:

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

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Page 2 - Mr. William Rhoda

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 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" (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 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 yours, Lori A. Wigqins

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510 (K) NUMBER IF KNOWN: _K141550 DEVICE NAME: InstaFix™ Shape Memory Fixation System

Indications for Use:

InstaFix™ Shape Memory Fixation System is intended for use in:

Fixation of Osteotomies of the Hand, Foot and Tibia

Arthrodesis of the Joints of the Hand and Foot

Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament InstaFix™ Shape Memory Fixation System is also indicated for adjunctive fixation of Small Bone Fragments of:

The Upper Extremity, such as the Radius, Ulna. Humerus. Clavicle and Scapula The Lower Extremity, such as the Tibia, Fibula and the Femur

The Upper Torso, such as the Sternum and the Ribs

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

Over-the-Counter Use O (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)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Page 1/1

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.