(27 days)
Not Found
No
The description focuses on the mechanical properties and materials of the device, with no mention of AI or ML capabilities.
Yes.
The device is used for the treatment of various fractures, which is a therapeutic purpose.
No
The device is a system of nails, screws, and instruments used for the treatment of bone fractures, not for diagnosing them.
No
The device description clearly states that the device includes physical components such as nails, screws, and instruments made of materials like carbon fiber reinforced polymer and titanium alloy. This indicates it is a hardware medical device, not software-only.
Based on the provided information, 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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Piccolo Composite Proximal Femur Nails are implants used for the surgical treatment of bone fractures in the proximal femur. They are physical devices inserted into the body to stabilize and aid in the healing of broken bones.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information based on such analysis. Its function is purely mechanical and structural within the body.
Therefore, the Piccolo Composite Proximal Femur Nailing System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, malunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Piccolo Composite Nailing System includes nails, screws and a set of instruments. The Piccolo Composite nail indicated for treatment of the proximal femur is a cylindrical rod. Nail mid-shaft diameter is 11mm, with the proximal end diameter of up to 17mm. Nail lengths are 180mm, 200mm, and in the range of 300 – 460mm. The nail provides for holes at the proximal and distal sections, designed for the insertion of a lag screw and interlocking screws. The lag screw is of 10.4mm diameter, with its length being in the range of 80mm to 110mm. The nails and lag screws are made of carbon fiber reinforced polymer and incorporate small amount of titanium alloy. Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging. The distal screws are made of titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal 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)
Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components included static and dynamic bending of construct, and lag screw torque to failure, and are comparable to those of predicate devices (as applicable), thus demonstrating that the device is safe and effective for its intended use.
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.
K151010, K102369, K111056, K043431
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
§ 888.3020 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are facing to the right. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2016
CarboFix Orthopedics, Limited Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim St. Herzeliya, 4627411 ISRAEL
Re: K153536
Trade/Device Name: Piccolo Composite® Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: December 8, 2015 Received: December 10, 2015
Dear Yael Rubin:
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 Parts 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/Resourcesfor You/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,
Lori A. Wiggins -S
for 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)
Device Name Piccolo Composite® Nailing System
Indications for Use (Describe)
Piccolo Composite Proximal Femur Nails
The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.
| 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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510(K) Summary
CarboFix Orthopedics Ltd.
Piccolo Composite® Nailing System – Proximal Femur
Applicant Name
CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel
Contact Person
Yael Rubin CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
December 2015
Trade/Proprietary Name
Piccolo Composite® Nailing System
Common Name
Intramedullary Nailing System
Classification Name
Rod, Fixation, Intramedullary and Accessories (Class II, per 21 CFR §888.3020; Product Code HSB)
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Predicate Devices
- 트 Piccolo Composite® Nailing System (CarboFix Orthopedics Ltd .; K151010, K102369, K111056)
- Gamma3 Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and more)
Intended Use/Indications for Use
Piccolo Composite Proximal Femur Nails
The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, malunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.
System Description
The Piccolo Composite Nailing System includes nails, screws and a set of instruments. The Piccolo Composite nail indicated for treatment of the proximal femur is a cylindrical rod. Nail mid-shaft diameter is 11mm, with the proximal end diameter of up to 17mm. Nail lengths are 180mm, 200mm, and in the range of 300 – 460mm. The nail provides for holes at the proximal and distal sections, designed for the insertion of a lag screw and interlocking screws. The lag screw is of 10.4mm diameter, with its length being in the range of 80mm to 110mm. The nails and lag screws are made of carbon fiber reinforced polymer and incorporate small amount of titanium alloy. Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging. The distal screws are made of titanium alloy.
Substantial Equivalence
The Piccolo Composite Proximal Femur Nailing System intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.
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Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components included static and dynamic bending of construct, and lag screw torque to failure, and are comparable to those of predicate devices (as applicable), thus demonstrating that the device is safe and effective for its intended use.