The Emerge Medical Small Fragment Locked Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

Device Description

The System consists of stainless steel plates (including straight, reconstruction, periarticular t-plates, humerus, one-third tubular), standard cortex screws, locking cortex screws, standard cancellous screws, and washers. The plates are available in a variety of styles and lengths with the number of holes varying depending on plate length, and include threaded locking holes and non-threaded dynamic compression slots. The screws and plates are provided non-sterile. The Emerge Medical Small Fragment Locked Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "Emerge Medical Small Fragment Locked Plating System," which is a metallic bone fixation device. This type of device is an orthopedic implant, not an AI/ML medical device, and therefore the concepts of acceptance criteria related to algorithmic performance, study designs like MRMC studies, ground truth establishment, and training/test sets are not applicable in this context.

The "Performance Data" section explicitly states: "Mechanical testing performed according to ASTM F382 demonstrated that the device performs as well as or better than the predicate device. Clinical data were not needed to demonstrate substantial equivalence."

This indicates that the regulatory clearance for this device was based on mechanical equivalency to existing predicate devices, not on the performance of a diagnostic or assistive algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, as it is not applicable to this submission.

Summary

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NAME OF FIRM:	Emerge Medical720 S. Colorado Blvd.Suite 550-SDenver, CO 80246	JAN - 8 2014
DATE PREPARED:	Nov. 8, 2013
510(K) CONTACT:	Michelle PotvinVice President of Quality AssuranceTel: (720) 459-6392Emerge Medical Small Fragment Locked Plating SystemClass II; 21 CFR 888.3030 and 888.3040
PROPOSED TRADE NAME:DEVICE CLASSIFICATION:
CLASSIFICATION NAME:	Plate, Fixation, Bone; Smooth or threaded metallic bone fixationfastener
PRODUCT CODE:HRS and HWC
DEVICE DESCRIPTION:	The System consists of stainless steel plates (including straight,reconstruction, periarticular t-plates, humerus, one-third tubular),standard cortex screws, locking cortex screws, standard cancellousscrews, and washers. The plates are available in a variety of stylesand lengths with the number of holes varying depending on platelength, and include threaded locking holes and non-threadeddynamic compression slots. The screws and plates are providednon-sterile.The Emerge Medical Small Fragment Locked Plating System isintended for fixation of fractures, osteotomies, and non-unions ofthe clavicle, scapula, olecranon, humerus, radius, ulna, pelvis,distal tibia, and fibula, including osteopenic bone.
INDICATIONS FOR USE:
MATERIALS:Stainless steel (ASTM F138 and F139)
PREDICATE DEVICES:	Synthes K000684 and K041860
TECHNOLOGICCHARACTERISTICS:	fundamental scientific principles and technologicalThecharacteristics, including the intended use, material, generaldesign, and sizes of the devices are equivalent to the predicatedevices.
PERFORMANCE DATA:	Mechanical testing performed according to ASTM F382demonstrated that the device performs as well as or better thanthe predicate device. Clinical data were not needed todemonstrate substantial equivalence.

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 903 New Hampshire Avenue ocument Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2014

Emerge Medical Incorporated Ms. Michelle Potvin Vice President of Quality Assurance 720 South Colorado Boulevard, Suite 550-S Denver, Colorado 80246

Re: K133452

Trade/Device Name: Emerge Medical Small Fragment Locked Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: November 8, 2013 Received: November 14, 2013

Dear Ms. Potvin:

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. Drue, 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. Iisting 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 - Ms. Michelle Potvin

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" (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 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,

Lori A. Wiggins

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

Enclosure

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Indications for Use Statement

K133452 510(k) Number (if known):

Device Name: Emerge Medical Small Fragment Locked Plating System

Indications for Use:

X Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use or

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabet标办公Frank -S

Division of Orthopedic Devices

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.