(185 days)
The Piccolo Composite Ankle Arthrodesis Nails are indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include: 1. Avascular necrosis of the talus 2. Failed total ankle arthroplasty 3. Trauma (malunited tibial pilon fracture) 4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease 5. Revision ankle arthrodesis 6. Neuroarthropathy 7. Rheumatoid arthritis 8. Osteoarthritis 9. Pseudoarthrosis 10. Post-traumatic arthrosis 11. Previously infected arthrosis 12. Charcot foot 13. Severe endstage degenerative arthritis 14. Severe defects after tumor resection 15. Pantalar arthrodesis
The Piccolo Composite Ankle Arthrodesis Nailing System includes nails, interlocking screws and a set of instruments. The Piccolo Composite Ankle Arthrodesis Nail is a cannulated, cylindrical rod. made of carbon fiber reinforced polymer. Nail diameter ranges from 10mm to 12mm, with lengths in the range of 160mm to 240mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of self-tapping, titanium-alloy-made, interlocking screws.
The CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System - Ankle Arthrodesis (K123810) demonstrates its acceptance criteria and a study proving it meets these criteria through a comparison to predicate devices, as detailed in the provided 510(k) summary.
Here's the breakdown of the information requested based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by the ASTM F 1264 standard. The device performance is deemed met by showing substantial equivalence to predicate devices under this standard.
| Acceptance Criteria (from ASTM F 1264 for Intramedullary Fixation Devices) | Reported Device Performance |
|---|---|
| Evaluation of bending parameters | "Evaluation of expected performance characteristics, such as bending and torsion parameters for the Piccolo Composite ankle arthrodesis nails was based on comparison to predicate devices, per ASTM F 1264." |
| Evaluation of torsion parameters | "Evaluation of expected performance characteristics, such as bending and torsion parameters for the Piccolo Composite ankle arthrodesis nails was based on comparison to predicate devices, per ASTM F 1264." |
| MRI Conditional labeling parameters | "Evaluation in support of MR Conditional labeling parameters was also provided." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical data for an AI/CAD system. Instead, the evaluation focuses on mechanical performance and comparison to predicate devices. Therefore, traditional "sample size" for a clinical test set is not applicable here.
- Data Provenance: The study performed appears to be laboratory-based mechanical testing, not a clinical study involving patient data. The provenance for this type of testing is generally the manufacturer's testing facility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is a mechanical implant, and its evaluation relies on engineering standards (ASTM F 1264) rather than expert interpretation of medical images or conditions for establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable for a mechanical performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems and is not applicable to the mechanical testing of an orthopedic implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is defined by the mechanical performance requirements outlined in the ASTM F 1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices. The device's performance is accepted if it meets or is substantially equivalent to predicate devices based on these standardized mechanical tests.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/CAD system for this device. The evaluation is based on engineering testing and comparison.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth established for it.
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510(K) Summary
JUN 1 4 2013
CarboFix Orthopedics Ltd.
Piccolo Composite® Nailing System - Ankle Arthrodesis
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
May 2013
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
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K123810
CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System - Ankle Arthrodesis
- Phoenix Ankle Arthrodesis Nailing System (Biomet Trauma; K081243, K091976)
- Valor® Ankle Fusion Nail System (Wright Medical Technology, Inc .; K090857)
Intended Use/Indications for Use
Piccolo Composite Ankle Arthrodesis Nails
The Piccolo Composite Ankle Arthrodesis Nails are 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
-
- Osteoarthritis
-
- Pseudoarthrosis
-
- Post-traumatic arthrosis
-
- Previously infected arthrosis
-
- Charcot foot
-
- Severe endstage degenerative arthritis
- l 4. Severe defects after tumor resection
-
- Pantalar arthrodesis
System Description
The Piccolo Composite Ankle Arthrodesis Nailing System includes nails, interlocking screws and a set of instruments.
The Piccolo Composite Ankle Arthrodesis Nail is a cannulated, cylindrical rod. made of carbon fiber reinforced polymer. Nail diameter ranges from 10mm to 12mm, with lengths
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CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System - Ankle Arthrodesis
in the range of 160mm to 240mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of self-tapping, titanium-alloy-made, interlocking screws.
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.
Evaluation of expected performance characteristics, such as bending and torsion parameters for the Piccolo Composite ankle arthrodesis nails was based on comparison to predicate devices, per ASTM F 1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices. Evaluation in support of MR Conditional labeling parameters was also provided. All the above demonstrate that the device is safe and effective for its intended use.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public I lea th Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2013
CarboFix Orthopedics Limited % Ms. Yael Rubin Director of Regulatory Alfairs 11 Ha'hoshlim Street Herzeliya 46724 Israel
Re: K123810
Trade/Device Name: Piccolo Composite™ Nailing System Regulation Nur iber: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 12, 2013 Received: May 14, 2013
Dear Ms. Rubin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above ard 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 Amend:nents, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and-Gosmetic-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. Pleas : note: CDRH docs not evaluate information related to contract liability warranties. We rer ind you; however that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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); lateling (21 CFR Part 801); medical device reporting (reporting of medical
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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 301), 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 CDKH's Office of Surveillance and 3iometrics/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.
For
Sincerely yours.
Erin |. Keith
Mark N. Melkerson Director Division.of Orthopedic_Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(K) Number (if known):
Piccolo Composite® Nailing System Device Name:
Indication for Use:
Piccolo Composite Ankle Arthrodesis Nails
The Piccolo Composite Ankle Arthrodesis Nails are 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 4. accident, paralysis or other neuromuscular disease
-
- Revision ankle arthrodesis
-
- Neuroarthropathy
-
- Rheumatoid arthritis
- Osteoarthritis 8.
-
- Pseudoarthrosis
-
- Post-traumatic arthrosis
-
- Previously infected arthrosis
-
- Charcot foot
-
- Severe endstage degenerative arthritis
-
- Severe defects after tumor resection
- 15 .- Pantalar-arthrodesis
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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
§ 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.