(97 days)
Not Found
Not Found
No
The 510(k) summary describes bone plates for fracture fixation and does not mention any AI/ML related terms or functionalities.
No
The device, described as plates for fixation of fractures and osteotomies of bones, directly treats a condition (fractures, etc.) and is therefore a therapeutic device.
No
Explanation: The devices described are plates used for the fixation of fractures and other bone issues, which are treatment modalities, not diagnostic tools. They are used for surgical intervention rather than for identifying or determining a medical condition.
No
The intended use describes physical plates for bone fixation, which are hardware devices. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of fractures and ostectomies of bones (distal radius, clavicle, proximal humerus). This is a surgical intervention on the body, not a diagnostic test performed on samples taken from the body.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- No Mention of Diagnostic Testing: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information.
- Anatomical Site: The anatomical sites are bones within the body, not biological samples.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to stabilize bone fractures.
N/A
Intended Use / Indications for Use
a: Distal Radius Plates are indicated for the fixation of Intra- and extra-articular fractures and ostectomies of the distal radius.
b. Clavicle plates are indicated for the fixation of fractures, mal-unions, non-unions and ostectomies of the clavicle.
c. Proximal Humerus plates are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus, particularly in the osteopenic bone.
Product codes
HRS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Distal Radius, Clavicle, Proximal Humerus
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol, with three curved lines representing the bird's body and wings.
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
March 20, 2013
The Orthopaedic Implant Company (OIC) % Mr. Itai Nemovicher President 316 California Ave #701 Reno, Nevada 89509
Re: K123832
Trade/Device Name: OIC Distal Radius Plating System OIC Proximal Humerus Plating System OIC Clavicle 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 Dated: February 21, 2013 Received: February 22, 2013
Dear Mr. Nemovicher:
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
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Page 2 - Mr. Itai Nemovicher
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Erin DKeith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K123832 Page 1 of 1
Indications for Use
510(k) Number {if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
a) OIC Distal Radius Plating System
- OIC Proximal Humerus Plating System b)
- OIC Clavicle Plating System c)
Indications for Use:
a: Distal Radius Plates are indicated for the fixation of Intra- and extra-articular fractures and ostectomies of the distal radius.
b. Clavice plates are indicated for the fixation of fractures, mal-unions, non-unions and ostectomies of the clavicie.
c. Proximal Humerus plates are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus, particularly in the osteopenic bone.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabet标注册:rank -S
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Division of Orthopedic Devices