(51 days)
Not Found
No
The device description and intended use focus on mechanical components for external fixation and do not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is used to provide treatment for fractures and other musculoskeletal conditions, directly impacting the patient's physical well-being and recovery.
No
Explanation: The device is an external fixation system used for the treatment and stabilization of fractures, not for diagnosing medical conditions.
No
The device description explicitly lists physical components made of medical-grade stainless steel, titanium alloy, and carbon fiber reinforced epoxy, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Cardinal Health External Fixation System is a physical device used to stabilize bone fractures and soft tissues. It is implanted externally to the body and does not involve testing samples taken from the body.
The information provided clearly describes a surgical implant and its associated tools for treating bone fractures, which falls under the category of a surgical or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Cardinal Health External Fixation System is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
The system can be used for:
- Stabilization of soft tissues and fractures
- Polytrauma/multiple orthopedic trauma
- Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
- Arthrodeses and osteotomies with soft tissue problems; failures of total joints
- Neutralization of fractures stabilized with limited internal fixation
- Non-unions/septics non-unions
- Intra-operative reductions/stabilization tool to assist with indirect reduction
- Unilateral rectilinear bone segment transport or leg lengthening
Product codes
KTT
Device Description
The Cardinal Health External Fixation System consists of rod-to pin clamps, rod-to-rod clamps, rods, pins. Schanz screws and associated instruments for site preparation and implant insertion. All components intended to be attached to bone are fabricated from medical grade stainless steel (316L Stainless Steel per ASTM F138). External clamps are fabricated from Titanium Alloy (Ti-6Al-4V-ELI per ASTM F136), and radiolucent external fixation rods are fabricated from carbon fiber reinforced epoxy. The Cardinal Health External Fixation System is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone and pelvic
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)
Testing was performed on the Cardinal Health External Fixation System in accordance with ASTM F2182-11a, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging, ASTM F2052-06, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment, and ASTM F2213-11, Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment. Results demonstrate that the Cardinal Health External Fixation System is safe and compatible in the MR environment as an "MR Conditional" device. The predicate 510(k), K140675, included performance testing conducted per ASTM F1541-02 (2001). In all instances, the External Fixation System met acceptance criteria, functioned as intended and performed as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles embedded within its wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2015
Cardinal Health Ms. Tatyana Bogdan Director, Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085
Re: K150579
Trade/Device Name: Cardinal Health 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 5, 2015 Received: March 9, 2015
Dear Ms. Bogdan:
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
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Page 2 - Ms. Tatyana Bogdan
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150579
Device Name
Cardinal Health External Fixation System
Indications for Use (Describe)
The Cardinal Health External Fixation System is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
The system can be used for:
- Stabilization of soft tissues and fractures
- · Polytrauma/multiple orthopedic trauma
- · Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
- · Arthrodeses and osteotomies with soft tissue problems; failures of total joints
- · Neutralization of fractures stabilized with limited internal fixation
- · Non-unions/septic non-unions
- Intra-operative reductions/stabilization tool to assist with indirect reduction
- · Unilateral rectilinear bone segment transport or leg lengthening
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Research Use Only (21 CFR 201.3 Subject to Section 510(k)) |
|---|
| ☐ Over-The-Counter Use Only (21 CFR 201.3 Subject to Section 510(k)) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) SUMMARY
510(k) Number: K150579
Submitter's Name, Address, Telephone Number:
Cardinal Health 1500 Waukegan Road Waukegan IL 60085
Contact Person:
Tatyana Bogdan Director, Regulatory Affairs Phone: 847.887.2325 Facsimile: 847.785.2461 Email: tatyana.bogdan-curvin@cardinalhealth.com
Prepared by:
Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street, NW, 12th Floor Washington, DC 20005 202.552.5800
Date Prepared: March 5, 2015
Device Name: Cardinal Health External Fixation System
Device Classification: Class II; 21 CFR 888.3030
Classification Name:
Single/multiple component metallic bone fixation appliances and accessories
Product Code: KTT
Device Description:
The Cardinal Health External Fixation System consists of rod-to pin clamps, rod-to-rod clamps, rods, pins. Schanz screws and associated instruments for site preparation and implant insertion. All components intended to be attached to bone are fabricated from medical grade stainless steel (316L Stainless Steel per ASTM F138). External clamps are fabricated from Titanium Alloy (Ti-6Al-4V-ELI per ASTM F136), and radiolucent external fixation rods are fabricated from carbon fiber reinforced epoxy. The Cardinal Health External Fixation System is provided non-sterile.
Indications for Use:
The Cardinal Health External Fixation is intended for use to provide treatment for long bone
4
and pelvic fractures that require external fixation.
The system can be used for:
- . Stabilization of soft tissues and fractures
- Polytrauma/multiple orthopedic trauma ●
- Vertically stable pelvic fractures. or as a treatment adjunct for vertically unstable pelvic ● fractures
- Arthrodeses and osteotomies with soft tissue problems; failures of total joints ●
- Neutralization of fractures stabilized with limited internal fixation Non-unions/septic non-unions
- Intra-operative reductions/stabilization tool to assist with indirect reduction
- Unilateral rectilinear bone segment transport or leg lengthening
Predicate Device:
Emerge External Fixation System (K140675)
Performance Data:
Testing was performed on the Cardinal Health External Fixation System in accordance with ASTM F2182-11a, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging, ASTM F2052-06, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment, and ASTM F2213-11, Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment. Results demonstrate that the Cardinal Health External Fixation System is safe and compatible in the MR environment as an "MR Conditional" device. The predicate 510(k), K140675, included performance testing conducted per ASTM F1541-02 (2001). In all instances, the External Fixation System met acceptance criteria, functioned as intended and performed as well as the predicate device.
Substantial Equivalence:
The Cardinal Health External Fixation System is substantially equivalent to the legally marketed predicate based on intended use, basic design, materials, sizing and performance.