(101 days)
Not Found
No
The device description and intended use focus on mechanical components for external fixation of fractures, with no mention of AI/ML capabilities or related data processing.
Yes
The device is described as an external fixation system used for the stabilization of bone fractures, which directly contributes to the healing and recovery of the patient.
No
The device is an external fixation system used for stabilizing bone fractures, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components made of carbon fiber, titanium, aluminum, and stainless steel, which are used for the external stabilization of bone fractures.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the OIC External Fixation system is used for the external stabilization of bone fractures. It involves implanting pins into bone and connecting them with external components to hold bone fragments in place.
- Intended Use: The intended use is for provisional and temporary fixation of fractures in the extremities and pelvis. This is a mechanical function, not a diagnostic test performed on a sample.
The device is a surgical implant/external fixation system, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The OIC External Fixation system is intended to be used in adult and pediatric patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.
Product codes
KTT
Device Description
The device is used for the external stabilization of bone fractures. It consists of: Carbon fiber composite bars, 11mm diameter, 100mm to 650mm lengths Titanium and aluminum combination clamp, 5 & 8 hole pin clamp Aluminum straight and angled posts Stainless steel 4mm and 5mm pins, blunt tip and threaded 150mm lengths, 15mm through 120mm thread lengths. Stainless steel 5mm transfixing pin, 300mm length Stainless steel instruments for implantation The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower and upper extremities and pelvis
Indicated Patient Age Range
adult and pediatric patients
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)
Magnetic resonance imaging (MRI) compatibility testing was performed on the OIC External Fixation System. Testing shows that the system has acceptable MRI characteristics for the intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known) K183682
Device Name
OIC External Fixation System
Indications for Use (Describe)
The OIC External Fixation system is intended to be used in adult and pediatic patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of periarticular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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April 8, 2019
Orthopaedic Implant Company Douglas Fulton Quality Assurance Manager 770 Smithridge Dr. #400 Reno, Nevada 89502
Re: K183682
Trade/Device Name: OIC External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: March 11, 2019 Received: March 12, 2019
Dear Douglas Fulton:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
2
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Summary
Prepared 4/4/2019
Name and Address of Manufacturer: The Orthopaedic Implant Company (OIC) 770 Smithridge Drive. Suite 400 Reno, NV 89502
Contact: Douglas Fulton Quality Assurance Manager Telephone: 775-636-8281 Fax: 775-636-8284 Email: doug@orthoimplantcompany.com
Device Identification: Trade Name: OIC External Fixation System Common Name: External fixation components Classification Name: Single/multiple component metallic bone fixation appliances and accessories Classification: Class II, 21 CFR 888.3030 Panel: Orthopedic Product Code: KTT
Indications for Use:
The OIC External Fixation system is intended to be used in adult and pediatric patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.
Device Description:
The device is used for the external stabilization of bone fractures. It consists of:
Carbon fiber composite bars, 11mm diameter, 100mm to 650mm lengths
Titanium and aluminum combination clamp, 5 & 8 hole pin clamp
Aluminum straight and angled posts
Stainless steel 4mm and 5mm pins, blunt tip and threaded 150mm lengths, 15mm through 120mm thread lengths.
Stainless steel 5mm transfixing pin, 300mm length
Stainless steel instruments for implantation
The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.
Comparison of Technological Characteristics (Substantial Equivalence):
Predicate devices: K171211 OIC External Fixation System, K082650 Synthes Large External Fixation MR Conditional The OIC External Fixation System has the following similarities to those which previously received 510(k) concurrence:
· has the same indicated use,
- · uses the same operating principle,
- · incorporates the same design, and
- · incorporates the same or similar materials
Performance Testing:
Magnetic resonance imaging (MRI) compatibility testing was performed on the OIC External Fixation System. Testing shows that the system has acceptable MRI characteristics for the intended uses.
Conclusion:
The OIC External Fixation System described in this submission is, in our opinion, substantially equivalent to the predicate devices.