(28 days)
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
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.
The provided text is a 510(k) summary for the CarboFix Orthopedics Ltd. Piccolo Composite® Nailing Systems. This type of submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a novel device that requires extensive clinical studies to establish safety and effectiveness from scratch. As such, the information you're requesting regarding acceptance criteria and performance studies (often seen in PMA submissions or for novel high-risk devices) is not typically found in a 510(k) summary.
A 510(k) typically relies on:
- Comparison to predicate devices: Showing that the new device has the same intended use, similar technological characteristics, and comparable performance to a legally marketed device.
- Bench testing: Mechanical and material testing to confirm that the device meets established engineering standards and performs as intended under simulated conditions.
- Material characterization: Ensuring the materials used are biocompatible and meet specifications.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the way one might see in a clinical trial report. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance is assessed by comparison to these predicates and through general evaluation, not quantified against specific clinical performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The submission refers to "evaluation of expected performance characteristics" based on comparison to predicate devices, which implies bench testing and material comparisons rather than clinical trials with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. Ground truth establishment for a test set (as in a diagnostic AI study) is not part of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication for a test set is not part of this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not a diagnostic AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. This 510(k) does not present a study requiring clinical ground truth for validation. The "ground truth" for demonstrating substantial equivalence is adherence to engineering standards and functional similarity to predicates.
8. The sample size for the training set
Not applicable. This refers to an AI training set, which is not relevant for this device.
9. How the ground truth for the training set was established
Not applicable. This refers to an AI training set, which is not relevant for this device.
Summary Table (based on available information):
| Information Category | Details from K132774 |
|---|---|
| Acceptance Criteria | Based on "substantial equivalence" to predicate devices. This implies meeting the same safety and performance profiles through: - Intended Use: Same as predicates. - Design: Compared to predicates. - Materials: Compared to predicates (Carbon Fiber Reinforced PEEK with tantalum markers). - Technological Characteristics: Compared to predicates. - Principles of Operation: Same as predicates. |
| Reported Device Performance | "Evaluation of expected performance characteristics and MR Conditional labeling parameters for the Piccolo Composite Nailing Systems was based on comparison to predicate devices." Conclusion: "All the above demonstrate that the device is safe and effective for its intended use." (This points to bench testing and comparison, not clinical performance metrics). |
| Sample Size (Test Set) | Not applicable for clinical testing, likely refers to samples for bench/material testing (details not provided in summary). |
| Data Provenance (Test Set) | Not applicable for clinical testing. |
| Number of Experts (Ground Truth) | Not applicable. |
| Qualifications of Experts | Not applicable. |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study | No. Not an AI-assisted diagnostic device. |
| Standalone Performance Study (Algorithm Only) | No. Not an AI algorithm. |
| Type of Ground Truth Used | Not applicable. Evaluation primarily based on engineering and material standards, and comparison to predicates. |
| Sample Size (Training Set) | Not applicable. |
| Ground Truth Establishment (Training Set) | Not applicable. |
In essence, a 510(k) submission like this focuses on demonstrating substantial equivalence to existing devices, relying on a dossier of engineering, materials, and functional comparisons, rather than de novo clinical studies with specific performance metrics and acceptance criteria as outlined in your request.
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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
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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.
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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.
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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
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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 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
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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
§ 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.