(28 days)
Not Found
No
The device description focuses on the material and mechanical aspects of the nails and screws, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are based on comparison to predicate devices, not on algorithmic performance metrics.
No.
The device is a medical implant (nails and screws) used for fixation of bones, not a therapeutic device in the sense of delivering treatment like drugs or radiation.
No
This device is a nailing system used for the fixation of fractures and arthrodesis, which are treatments rather than diagnostic procedures.
No
The device description explicitly states that the device includes nails, interlocking screws, and instrumentation sets, which are physical hardware components made of materials like CFR-PEEK and titanium alloy.
Based on the provided information, 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 or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Piccolo Composite Nailing Systems are implants (nails and screws) used for the fixation of bone fractures and for arthrodesis (fusion) of the ankle. These are surgical procedures performed directly on the patient's body, not tests performed on samples outside the body.
Therefore, this device falls under the category of surgical implants or orthopedic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Piccolo Composite Humeral, Proximal Humerus, Tibial and Femoral Nails
Indications include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
Piccolo Composite Ankle Arthrodesis Nails
- Indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include:
Avascular necrosis of the talus; Failed total ankle arthroplasty; Trauma (malunited tibial pilon fracture); Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular discase; Revision ankle arthrodesis; Neuroarthropathy; Rheumatoid arthritis; Osteoarthritis; Pseudoarthrosis; Post-traumatic arthrosis; Previously infected arthrosis; Charcot foot; Severe endstage degencrative arthritis; Severe defects after tumor resection; Pantalar arthrodesis
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Piccolo Composite Nailing Systems include nails, interlocking screws and instrumentation sets.
The nails are made, in general, of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with tantalum markers, to provide for their visualization under fluoroscopy. The nails provide for holes at the proximal and distal sections, designed for the insertion of the titanium-alloy-made screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
humeral, proximal humerus, tibial, femoral, ankle
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)
Evaluation of expected performance characteristics and MR Conditional labeling parameters for the Piccolo Composite Nailing Systems was based on comparison to predicate devices. All the above demonstrate 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.
K091425, K100497, K102369, K111056, K123810, K130061
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.
0
510(K) Summary
CarboFix Orthopedics Ltd.
Piccolo Composite® Nailing Systems
Applicant Name
CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 46724, Israel
Contact Person
Yael Rubin
CarboFix Orthopedics Ltd.
11 Ha'hoshlim St., Herzliya 46724, Israel
Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
September 2013
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 Codc HSB)
ОСТ 0 3 2013
1
Predicate Devices
- Piccolo Composite® Nailing Systems (CarboFix Orthopedics Ltd.; K091425, . K100497, K102369, K111056, K123810)
- Piccolo Composite Plate Systems (CarboFix Orthopedics Ltd.; K130061, and ■ more)
Intended Use/Indications for Use
Piccolo Composite Humeral, Proximal Humerus, Tibial and Femoral Nails
Indications include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
Piccolo Composite Ankle Arthrodesis Nails
- Indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include:
Avascular necrosis of the talus; Failed total ankle arthroplasty; Trauma (malunited tibial pilon fracture); Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular discase; Revision ankle arthrodesis; Neuroarthropathy; Rheumatoid arthritis; Osteoarthritis; Pseudoarthrosis; Post-traumatic arthrosis; Previously infected arthrosis; Charcot foot; Severe endstage degencrative arthritis; Severe defects after tumor resection; Pantalar arthrodesis
System Description
The Piccolo Composite Nailing Systems include nails, interlocking screws and instrumentation sets.
The nails are made, in general, of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with tantalum markers, to provide for their visualization under fluoroscopy. The nails provide for holes at the proximal and distal sections, designed for the insertion of the titanium-alloy-made screws.
2
CarboFix Orthopedics Ltd. Piccolo Composite" Nailing System
There is no change to the general description of the system as compared to the predicate devices.
Substantial Equivalence
The Piccolo Composite Nailing Systems intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.
Evaluation of expected performance characteristics and MR Conditional labeling parameters for the Piccolo Composite Nailing Systems was based on comparison to predicate devices. All the above demonstrate that the device is safe and effective for its intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10403 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
October 3, 2013
CarboFix Orthopedics Limited Ms. Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim Street Herzeliya, 46724 ISRAEL
Re: K132774
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: September 1, 2013 Received: September 5, 2013
Dear Ms. 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. Ilisting 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
4
Page 2 - Ms. Yael Rubin
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Erin | Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(K) Number (if known):
Device Name: Piccolo Composite® Nailing System
Indications for Use:
Piccolo Composite Humeral, Proximal Humerus, Tibial and Femoral Nails
Indications include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following turnor resection and grafting. The nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
Piccolo Composite Ankle Arthrodesis Nails
Indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include:
Avascular necrosis of the talus: Failed total ankle arthroplasty; Trauma (malunited tibial pilon fracture); Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease; Revision ankle arthrodesis; Neuroarthropathy: Rheumatoid arthritis: Osteoarthrosis; Post-traumatic arthrosis; Previously infected arthrosis; Charcot foot; Severe endstage degenerative arthritis; Severe defects after tumor resection; Pantalar arthrodesis
Prescription Use _ _ Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices