(265 days)
No
The 510(k) summary describes a mechanical implant (intramedullary nail system) and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical testing, not related to data analysis or image processing.
No
The device provides temporary fixation for fractures, which is a structural or mechanical support function, not a therapeutic action like treating a disease or restoring a physiological function.
No
This device is an intramedullary nail system intended for temporary fixation of femur fractures, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the system consists of titanium alloy intramedullary (IM) nails, locking screws, and end caps, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "temporary fixation of the femur for various types of open or closed fractures." This describes a surgical implant used to stabilize bone fractures, which is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details "titanium alloy intramedullary (IM) nails, locking screws and end caps." These are physical implants designed to be inserted into the bone, not reagents, instruments, or software used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a medical device, specifically a surgical implant for orthopedic use.
N/A
Intended Use / Indications for Use
The Cardinal Health Trochanteric IM Nail System is intended to provide temporary fixation of the femur for various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), pathologic fractures, and impending pathologic fractures. Fracture types include pertrochanteric fractures, intertrochanteric fractures, basal neck fractures. Long Length Nails: Fracture types include pertrochanteric fractures, subtrochanteric fractures, intertrochanteric fractures, femoral shaft fractures, and basilar neck fractures.
Product codes
HSB
Device Description
The System consists of titanium alloy intramedullary (IM) nails, locking screws and end caps. The rigid, cannulated IM nails are inserted into the medullary canal and available in a variety of styles and lengths with proximal and distal holes for locking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur
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
Testing was performed according to ASTM F1264-03 (Reapproved 2012) Standard Specification and Test Methods for Intramedullary Fixation Devices and ASTM F543-13e1 Standard Specification and Test Method for Medical Bone Screws
CONCLUSIONS The mechanical testing demonstrates that the Cardinal Health Trochanteric IM Nail System should perform as well as the predicate device in the specified use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2015
Cardinal Health Ms. Kvungvoon Kang Regulatory Affairs Manager 720 South Colorado Boulevard, Suite 550S Denver, Colorado 80246
Re: K150769
Trade/Device Name: Cardinal Health Trochanteric IM Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: November 7, 2015 Received: November 12, 2015
Dear Ms. Kang:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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" (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 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 Statement
510(k) Number (if known): K150769
Device Name: Cardinal Health Trochanteric IM Nail System
Indications for Use: The Cardinal Health Trochanteric IM Nail System is intended to provide temporary fixation of the femur for various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), pathologic fractures, and impending pathologic fractures. Fracture types include pertrochanteric fractures, intertrochanteric fractures, basal neck fractures. Long Length Nails: Fracture types include pertrochanteric fractures, subtrochanteric fractures, intertrochanteric fractures, femoral shaft fractures, and basilar neck fractures.
Prescription 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)
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510(k) Summary
| NAME OF FIRM: | Cardinal Health
1500 Waukegan Road
Waukegan IL 60085 |
| --------------- | ------------------------------------------------------------ |
|---|
- DATE PREPARED: March 17, 2015
- Tatyana Bogdan 510(K) CONTACT: Director, Regulatory Affairs Cardinal Health 1500 Waukegan Road Waukegan IL 60085 Phone: 847.887.2325 Facsimile: 847.785.2461 Email: tatyana.boqdan-curvin@cardinalhealth.com
PROPOSED TRADE NAME:
Cardinal Health Trochanteric IM Nail System
DEVICE
| CLASSIFICATION: | Class II; 21 CFR 888.3020 |
|---|---|
| ----------------- | --------------------------- |
CLASSIFICATION NAME:
Intramedullary fixation rod
PRODUCT CODE: HSB
DEVICE The System consists of titanium alloy intramedullary DESCRIPTION: (IM) nails, locking screws and end caps. The rigid, cannulated IM nails are inserted into the medullary canal and available in a variety of styles and lengths with proximal and distal holes for locking screws.
INDICATIONS FOR The Cardinal Health Trochanteric IM Nail System is USE: intended to provide temporary fixation of the femur for various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), pathologic fractures, and impending pathologic fractures. Fracture types include pertrochanteric fractures, intertrochanteric fractures, basal neck fractures. Long Length Nails: Fracture types include pertrochanteric fractures, subtrochanteric fractures, intertrochanteric fractures, femoral shaft fractures, and basilar neck fractures.
4
MATERIALS: Titanium alloy (ASTM F136)
- PREDICATE Stryker Gamma 3 Nail System (K034002); Previously DEVICES: Cleared Emerge Medical IM Nail System & Screws (K141347) is used as a reference device in this submission.
TECHNOLOGIC The Cardinal Health Trochanteric IM Nail System CHARACTERISTICS: incorporates the same design elements as the predicate devices. The material composition is the same and the sizing comparable. The Cardinal Health (subject) and predicate both incorporate rigid, cannulated, reamed, IM nails with static and dynamic locking options. All incorporate proximal and distal screws for static and dynamic properties, as well as end caps and trochanteric set screws for fixation. For the Cardinal Health Trochanteric IM Nail System, as well as the predicate, targeting devices are used routinely for placement of the lag screw and freehand placement with image verification is used for distal screw placement. Differences between the Cardinal and predicate devices include different sizes and fewer options. These differences do not impact safety effectiveness. as demonstrated by and the performance testing.
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Mechanical Testing
Testing was performed according to ASTM F1264-03 (Reapproved 2012) Standard Specification and Test Methods for Intramedullary Fixation Devices and ASTM F543-13e1 Standard Specification and Test Method for Medical Bone Screws
- CONCLUSIONS mechanical testing demonstrates that The the Cardinal Health Trochanteric IM Nail System should perform as well as the predicate device in the specified use conditions.