(42 days)
Not Found
No
The description focuses on mechanical components and performance, with no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is described as a "Locking One-third Tubular Plate System" intended for "fixation of fractures, osteotomies, and non-unions." This indicates a structural and supportive role rather than a direct therapeutic intervention.
No
Explanation: This device is a plate system intended for fracture fixation, not for diagnosing medical conditions.
No
The device description explicitly states it consists of stainless steel components including locking plates and screws, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixation of fractures, osteotomies, and non-unions" of various bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of physical components like plates, screws, and washers, which are implanted into the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
This device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
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.
Product codes
HRS, HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes K011335
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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510(k) Summary
| NAME OF FIRM: | Emerge Medical
790 S. Colorado Blvd.
Suite 550-S
Denver, CO 80246 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | May 20, 2013 |
| 510(K) CONTACT: | Victoria Trafka
Vice President of Engineering & Quality
Tel: (303) 225-7909
Fax: (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 fixation
fastener |
| PRODUCT CODE: | HRS and HWC |
| DEVICE DESCRIPTION: | 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. |
| INDICATIONS FOR USE: | 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. |
| MATERIALS: | Stainless steel (ASTM F138 and F139) |
| PREDICATE DEVICES: | Synthes K011335 |
| TECHNOLOGIC
CHARACTERISTICS: | The fundamental scientific principles and technological
characteristics, including the intended use, material, general
design, and sizes of the device are equivalent to the predicate
device. |
| 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. |
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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
2
Page 2 - Ms. Victoria Trafka
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
3
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