(42 days)
The Emerge Medical Locking One-third Tubular Plate 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.
The System consists of stainless steel components including locking plates and standard cortex screws, locking cortex screws and standard cancellous screws and washers. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The screws and plates are provided non-sterile.
The provided text describes a medical device, the "Emerge Medical Locking One-third Tubular Plate System," and its 510(k) summary, which outlines its substantial equivalence to a predicate device. However, it does not contain information related to an AI/ML powered device, acceptance criteria related to such a device, nor any study proving an AI/ML device meets certain acceptance criteria.
Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them, as the provided input pertains to a traditional medical device (bone plates and screws) and its mechanical performance, not an AI/ML-powered device.
The document explicitly states under "PERFORMANCE DATA": "Mechanical testing performed according to ASTM F543 and 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 was based on mechanical testing, a common approach for such devices, rather than a study involving human readers, AI assistance, or complex ground truth establishment as would be relevant for an AI/ML product.
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510(k) Summary
| NAME OF FIRM: | Emerge Medical790 S. Colorado Blvd.Suite 550-SDenver, CO 80246 |
|---|---|
| DATE PREPARED: | May 20, 2013 |
| 510(K) CONTACT: | Victoria TrafkaVice President of Engineering & QualityTel: (303) 225-7909Fax: (800) 698-1440 |
| PROPOSED TRADE NAME: | Emerge Medical Locking One-third Tubular Plate System |
| DEVICE CLASSIFICATION: | Class II; 21 CFR 888.3030 and 888.3040 |
| CLASSIFICATION NAME: | Plate, Fixation, Bone; Smooth or threaded metallic bone fixationfastener |
| PRODUCT CODE: | HRS and HWC |
| DEVICE DESCRIPTION: | The System consists of stainless steel components includinglocking plates and standard cortex screws, locking cortex screwsand standard cancellous screws and washers. The plates areavailable in a variety of lengths with the number of holes varyingdepending on plate length. The screws and plates are providednon-sterile. |
| INDICATIONS FOR USE: | The Emerge Medical Locking One-third Tubular Plate 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. |
| MATERIALS: | Stainless steel (ASTM F138 and F139) |
| PREDICATE DEVICES: | Synthes K011335 |
| TECHNOLOGICCHARACTERISTICS: | The fundamental scientific principles and technologicalcharacteristics, including the intended use, material, generaldesign, and sizes of the device are equivalent to the predicatedevice. |
| PERFORMANCE DATA: | Mechanical testing performed according to ASTM F543 and ASTMF382 demonstrated that the device performs as well as or betterthan the 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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized lines forming the body and wings, and two curved lines representing the legs or tail.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2013
Emerge Medical % Ms. Victoria Trafka Vice President of Engineering and Quality 790 South Colorado Road, Suite 550-S Denver, Colorado 80246
Re: K131480
Trade/Device Name: Emerge Medical Locking One-Third Tubular Plate 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: May 31, 2013 Received: June 13, 2013
Dear Ms. Trafka:
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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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.
Erin Keith
· 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
510(k) Number (if known): K131480
Device Name: Emerge Medical Locking One-Third Tubular Plate System
Indications for Use:
The Emerge Locking One-third Tubular Plate 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × or Over-The-Counter Use _
(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)
Elizabeth L. Frank -S
Division of Orthopedic Devices
§ 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.