This document is a 510(k) premarket notification for a medical device called "EasyClip Xpress," which are superelastic bone staples. It describes the device, its intended use, and its equivalence to legally marketed predicate devices. However, it does not contain the detailed information requested regarding acceptance criteria, study methodologies, or performance metrics in the context of an AI/ML device.

Therefore, I cannot extract the information required by your prompt. This document pertains to a traditional medical device and does not involve AI or algorithms requiring such performance evaluation studies.

Summary

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

Restore Surgical LLC, dba Instratek Mr. Jeff Seavey President 15200 Middlebrook Drive, Suite G Houston, Texas 77058

February 10, 2017

Re: K162321 Trade/Device Name: EasyClip Xpress 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: January 12, 2017 Received: January 13, 2017

Dear Mr. Seavey:

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

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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 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,

Mark N. Melkerson -S

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

Enclosure

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SECTION 006: INDICATIONS FOR USE STATEMENT

510(k) Number: K162321

Device Name: EasyClip Xpress

Indications for Use:

The EasyClip XPress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Restore Surgical LLC, dba Instratek

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SECTION 007: 510(K) SUMMARY

Submission Correspondentand Owner:	Restore Surgical LLC, dba Instratek15200 Middlebrook Dr., Suite GHouston, TX 77058USAPhone: 281-890-8020Fax: 281-890-8068Email: jeff@instratek.comContact: Mr. Jeff SeaveyPresident
Date summary prepared:	August 11, 2016
Device trade name:	EasyClip Xpress
Device classification name:	Staple, Fixation, Bone
Classification:	Class II
Product Code:	JDR
Regulation/Description:	880.3030, Staple, Fixation, Bone
Predicate Devices	Stapix Superelastic Nitinol Fixation System (K133523)Stryker Memory Staple (K122113).
Description of the device:	EasyClip Xpress is comprised of superelastic bone staples, as wellas associated instrumentation required for implantation of thestaples.
Intended use of the device:	The EasyClip Xpress is indicated for hand and foot bonefragments osteotomy fixation and joint arthrodesis.
Technologicalcharacteristics:	The proposed device has the same design, material, and intendeduse as the predicate devices.
Testing:	Dimensional (geometric cross section) and engineering strengthanalyses as well as static and dynamic bending tests wereconducted initially in K122113 and the results support the conclusionthat there are no effects of the modifications subject to thispremarket notification on the safety and effectiveness of theEasyClip staples. Other testing performed: Corrosion Testing as perASTM F2129, Bacterial Endotoxins Test (LAL testing has beenperformed to establish that the subject device meets thespecified 20 EU/device limit).
Conclusions:	The results of the comparison of design, materials, intended use andtechnological characteristics demonstrate that the device is as safeand effective as the legally marketed predicate devices.

Restore Surgical LLC, dba Instratek

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.