(30 days)
Not Found
No
The summary describes a mechanical implant system for treating femur fractures and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is indicated for the treatment of various proximal femur fractures, indicating a therapeutic purpose.
No
The device is a system of nails and screws used for the treatment of femur fractures, not for diagnosing them.
No
The device description explicitly states that the system includes nails, screws, and instruments, which are physical hardware components.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (nails and screws) used to treat bone fractures in the proximal femur. This is a device that is physically implanted into the body for structural support and healing, not a device used to analyze samples outside the body.
The description focuses on the physical characteristics of the implant, its materials, and its application in treating fractures. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
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, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.
Product codes
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, optionally, the lag screws) are made of carbon fiber reinforced polymer and incorporate small amount of titanium/titanium alloy. Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging. The distal screws, and, optionally, the lag screws, are made of titanium alloy.
Mentions image processing
Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging.
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 implants construct, and are comparable to those of predicate devices (as applicable), thus demonstrating that the device is safe and effective for its intended use.
In addition, bacterial endotoxin testing was conducted.
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
§ 888.3020 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/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
December 28, 2017
CarboFix Orthopedics Ltd. Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim Street Herzeliya, Israel 4672411
Re: K173652
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: November 26, 2017 Received: November 28, 2017
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 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 (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
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: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173652
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.
X 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(K) Summary
CarboFix Orthopedics Ltd.
Piccolo Composite® Proximal Femur Nailing System
Applicant Name
CarboFix Orthopedics Ltd.
11 Ha'hoshlim St., Herzeliya 4672411, Israel
Contact Person
Yael Rubin CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
December 2017
Trade/Proprietary Name
Piccolo Composite® Nailing System
Common Name
Intramedullary Nailing System
Classification Name
Rod, Fixation, Intramedullary and Accessories (21 CFR §888.3020; Product Code HSB).
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Predicate Devices
Primary Predicate:
-
Piccolo Composite® Proximal Femur Nailing System (CarboFix Orthopedics Ltd.; K153536, K151010)
Additional Predicate: -
Gamma3® Nail System (Stryker (Howmedica Osteonics Corp.); K043431 and ■ more)
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, 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, optionally, the lag screws) are made of carbon fiber reinforced polymer and incorporate small amount of titanium/titanium alloy. Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging. The distal screws, and, optionally, the lag screws, are made of titanium alloy.
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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.
Performance characteristics for the Piccolo Composite Proximal Femur Nailing System components included static and dynamic bending of implants construct, and are comparable to those of predicate devices (as applicable), thus demonstrating that the device is safe and effective for its intended use.
In addition, bacterial endotoxin testing was conducted.