(65 days)
The Piccolo Composite Distal Volar Radius Plate System is indicated for fractures and osteotomies of the distal volar radius.
The Piccolo Composite Distal Volar Radius Plate System comprises implants (plates and screws), and a set of instruments. The "triangular" plates, added in this 510(k) Notification, are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy, like the rest of the Piccolo Composite plates. The "triangular" Piccolo Composite distal volar radius plate is 2.4mm thick. The plate shaft comprises 3 - 5 holes, corresponding to plate lengths in the range of 54 - 72 mm. The screws and pegs are made of titanium alloy. Various screw types are available, such as cortical screws and locking screws, as well as pegs, in various dimensions.
This document is a 510(k) premarket notification for the Piccolo Composite® Distal Volar Radius Plate System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria using human readers or AI.
Instead, the document focuses on mechanical performance testing and substantial equivalence to legally marketed predicate devices, which is a common pathway for medical device clearance in the U.S.
Here's what can be extracted and what is missing based on your request:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bending of construct strength comparable to predicate devices (per ASTM F 382) | "comparable to those of predicate devices" |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. This typically refers to the number of devices tested in the mechanical bending test.
- Data provenance: Not applicable in the context of human reader studies or AI. The data provenance here refers to the mechanical testing performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a bone plate system, not an AI or diagnostic imaging device that requires expert ground truth for its performance evaluation against clinical findings. Its evaluation is based on mechanical properties and substantial equivalence.
4. Adjudication method for the test set:
Not applicable.
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:
No. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an algorithm.
7. The type of ground truth used:
For the mechanical performance testing, the "ground truth" would be the established mechanical properties and performance standards of the predicate devices or relevant ASTM standards (ASTM F 382 in this case). The performance of the new device is compared against these benchmarks.
8. The sample size for the training set:
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is available in the document regarding performance:
The device's performance was evaluated through mechanical testing, specifically bending of construct as per ASTM F 382. The results were found to be comparable to those of predicate devices, which is the basis for demonstrating its safety and effectiveness for its intended use in the context of substantial equivalence. The document does not describe any clinical studies involving human readers, AI, or diagnostic image interpretation.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
CarboFix Orthopedics Ltd. Ms. Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim Street Herzeliya, 4672411 ISRAEL
March 9, 2016
Re: K160002 Trade/Device Name: Piccolo Composite® Distal Volar Radius Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, KTT Dated: February 4, 2016 Received: February 8, 2016
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, 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
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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 Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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 yours,
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
510(k) Number (if known) K160002
Device Name
Piccolo Composite® Distal Volar Radius Plate System
Indications for Use (Describe)
The Piccolo Composite Distal Volar Radius Plate System is indicated for fractures and osteotomies of the distal volar radius.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary
CarboFix Orthopedics Ltd.
Piccolo Composite® Distal Volar Radius Plate System
Applicant Name
CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel
Contact Person
Yael Rubin CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
February 3, 2016
Trade/Proprietary Name
Piccolo Composite® Distal Volar Radius Plate System
Common Name
Bone Plating System
Classification Name
Single/multiple component metallic bone fixation appliances and accessories (21 CFR §888.3030; Product Code HRS, KTT)
Predicate Devices
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- Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate (Synthes; K083694)
Intended Use/Indications for Use
The Piccolo Composite Distal Volar Radius Plate System is indicated for fractures and osteotomies of the distal volar radius.
System Description
The Piccolo Composite Distal Volar Radius Plate System comprises implants (plates and screws), and a set of instruments.
The "triangular" plates, added in this 510(k) Notification, are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy, like the rest of the Piccolo Composite plates.
The "triangular" Piccolo Composite distal volar radius plate is 2.4mm thick. The plate shaft comprises 3 - 5 holes, corresponding to plate lengths in the range of 54 - 72 mm. The screws and pegs are made of titanium alloy. Various screw types are available, such as cortical screws and locking screws, as well as pegs, in various dimensions.
Substantial Equivalence
The Piccolo Composite Distal Volar Radius Plate 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 Distal Volar Radius Plate System components included bending of construct, evaluated per ASTM F 382, and are comparable to those of predicate devices (as applicable) thus demonstrating that the device is safe and effective for its intended use.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.