(15 days)
Indications for the Piccolo Composite Tibial and Femoral Nails 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 Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
The Piccolo Composite Nailing System includes nails, screws and a set of instruments.
The Piccolo Composite Nail, indicated for treatment of the tibia and femur, is a cannulated, cylindrical rod, made of carbon fiber reinforced polymer. The tibial nail diameter ranges from 9 to 11 mm, with lengths in the range of 260 to 400 mm; the femoral nail diameter ranges from 10 to 12 mm, with lengths in the range of 160 to 420 mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of titanium-alloy-made screws. The nail has a pointed distal end, and its proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.
The provided text is a 510(k) summary for the CarboFix Orthopedics Ltd. Piccolo Composite™ Nailing System. This document describes a medical device (intramedullary nailing system) and its substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, and expert involvement for AI/ML performance is not present in this document.
The document indicates that the company performed static 4-point bending evaluation, static torsion evaluation, dynamic evaluation, and evaluation supporting MR Conditional labeling, demonstrating that the device is safe and effective for its intended use. However, explicit acceptance criteria values and the detailed results of these evaluations are not provided in this summary.
Therefore, I cannot fulfill your request for the specific table and details related to AI/ML device performance and testing.
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KIII026(113)
510(K) Summary
CarboFix Orthopedics Ltd.
Piccolo Composite™ Nailing System -- Tibia & Femur
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
April 2011
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)
Predicate Devices
- 트 Piccolo Composite™ Nailing System (CarboFix Orthopedics Ltd.); K091425, K100497, K102369)
- T2 Tibial Nail (Stryker (Howmedica Osteonics Corp.); K003018 and more) 으
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- T2 Femoral Nail (Stryker (Howmedica Osteonics Corp.); K010801 and more) ●
- UTN Solid Tibial Nail/CTN Cannulated Tibial Nail (Synthes; K914453, K962047) I
- Expert R/AFN Retrograde/Antegrade Femoral Nail (Synthes; K033618) I
- Fixion Interlocking Intramedullary Nailing System (CarboFix Orthopedics Ltd.); ■ K002783, K013449, K032588)
- . M/DN® Intramedullary Fixation System (Zimmer; K965098)
Intended Use/Indications for Use
Piccolo Composite Tibial and Femoral Nails
Indications for the Piccolo Composite Tibial and Femoral Nails 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 Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
System Description
The Piccolo Composite Nailing System includes nails, screws and a set of instruments.
The Piccolo Composite Nail, indicated for treatment of the tibia and femur, is a cannulated, cylindrical rod, made of carbon fiber reinforced polymer. The tibial nail diameter ranges from 9 to 11 mm, with lengths in the range of 260 to 400 mm; the femoral nail diameter ranges from 10 to 12 mm, with lengths in the range of 160 to 420 mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of titanium-alloy-made screws. The nail has a pointed distal end, and its proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.
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( KIII056
CarboFix Orthopedics Ltd. Piccolo Composite™ Nailing System - Tibia & Femur
Substantial Equivalence
The Piccolo Composite Nailing System intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.
The Company performed static 4-point bending evaluation, static torsion evaluation, dynamic evaluation, and evaluation supporting MR Conditional labeling, demonstrating that the device is safe and effective for its intended use.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
CarboFix Orthopedics Ltd. % Ms. Yael Rubin Director of Regulatory Affairs Ha'hoshlim Street 11 46724 Herzeliya Israel
MAY - 3 2011
Re: 'K111056
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: April 14, 2011 Received: April 18, 2011
Déar 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
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Page 2 - Ms. Yael Rubin
Enclosure
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Aij Vs. R.h.
for
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(K) Number (if known):
Device Name: Piccolo Composite™ Nailing System
Indications for Use:
Piccolo Composite Tibial and Femoral Nails
Indications for the Piccolo Composite Tibial and Femoral Nails 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 Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
Prescription Use AND/OR Over-The-Counter Use -(Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ar K. Mekerson
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
§ 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.