(291 days)
Piccolo Composite™ Distal Fibula Plate System: The Piccolo Composite™ Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone.
Piccolo Composite™ One-Third Tubular Plate System: The Piccolo Composite™ One-Third Tubular Plates are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, radius, ulna, pelvis, and fibula including in osteopenic bone.
Piccolo Composite™ Proximal Humerus Plate System: The Piccolo Composite™ Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone.
Piccolo Composite™ Distal Volar Radius Plate System: The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.
The Piccolo Composite™ Distal Fibula and One Third Tubular Plate Systems comprise implants (plates and screws), and sets of instruments. The Plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy. The Screws are made of titanium alloy. Both non-locking screws and locking screws are available, in various dimensions. The general description of the Piccolo Composite™ Proximal Humerus and Distal Volar Radius Plate Systems is not changed as compared to the predicates.
The provided document describes a 510(k) premarket notification for a medical device, the Piccolo Composite™ Plate System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting clinical studies with specific acceptance criteria in the way a pharmaceutical or novel high-risk device might.
Therefore, the information requested regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance as typically applied to AI or diagnostic imaging devices is not applicable to this submission.
Instead, the "study" proving the device meets its acceptance criteria here is a series of biomechanical and material performance tests compared against relevant ASTM standards and predicate devices.
Here's a breakdown of the available information in the requested format, adapted for a device submission of this nature:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Mechanical Performance: Comparable static and dynamic (fatigue) 4-point bending performance to predicate devices and adherence to ASTM F 382 standard. Comparable axial static and dynamic bending performance. Selected screw characteristics evaluation. | Performance characteristics for the Piccolo Composite™ Distal Fibula and One Third Tubular Plate Systems, such as single cycle (static) 4-point bending and dynamic (fatigue) 4-point bending, were evaluated per ASTM F 382 - Standard Specification and Test Method for Metallic Bone Plates and are comparable to those of predicate devices (where applicable). Axial static and dynamic bending tests, selected screws characteristics evaluation, and evaluation in support of the MR Conditional labeling parameters were also provided. All the above demonstrate that the device is safe and effective for its intended use. |
| Material Composition: CFR-PEEK plates with tantalum thread for visualization. Titanium alloy screws. | Plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy. The Screws are made of titanium alloy. Both non-locking screws and locking screws are available, in various dimensions. |
| Intended Use & Design: Similar indications for use and design principles as predicate devices. | The Piccolo Composite™ Plate System intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable. The indications for use match those of the predicate devices (e.g., fractures, osteotomies, non-unions of specific bones). |
| Safety & Effectiveness: Demonstrate overall safety and effectiveness for intended use. | All the above (performance tests, material composition, design and intended use equivalence) demonstrate that the device is safe and effective for its intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of "cases" or "patients." Instead, the "test set" consists of physical samples of the device components (plates and screws) that undergo biomechanical testing. The number of samples for each specific test (e.g., 4-point bending, axial bending) is not detailed in the provided summary.
- Data Provenance: The tests are likely conducted in a controlled laboratory environment. The document does not specify a country of origin for the testing data, but the applicant's address is in Herzeliya, Israel. The data is prospective in the sense that the tests are performed specifically to support this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For this type of device (bone plate system), ground truth is established through adherence to standardized engineering and material science testing protocols (e.g., ASTM F 382) and comparison to the known performance of predicate devices, not through expert consensus on clinical cases. The "ground truth" is the objective outcome of these physical tests.
4. Adjudication method for the test set
- Not applicable. Adjudication typically applies to ambiguous clinical or imaging data reviewed by multiple experts. For biomechanical testing, the results are typically quantitative measurements that are compared directly to predefined standards or predicate device data.
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 device is a bone plate system, not an AI or diagnostic imaging device. MRMC studies are not relevant to its regulatory approval process.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used
- Engineering Standards and Predicate Device Performance: The "ground truth" for this submission is established by the requirements of recognized industry standards like ASTM F 382 for metallic bone plates, and the known, legally marketed performance characteristics (material, mechanical properties) of the identified predicate devices.
8. The sample size for the training set
- Not applicable. This device approval does not involve a "training set" in the context of machine learning or AI. The design and manufacturing process would involve internal development and testing, but not a formally defined "training set" for regulatory purposes here.
9. How the ground truth for the training set was established
- Not applicable. As a physical implant and not an AI system, there is no "training set" or corresponding "ground truth" to be established in this context. The engineering design and manufacturing processes follow established medical device quality systems.
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Piccolo Composite™ Plate System - Distal Fibula & One-Third Tubular
510(K) Summary
CarboFix Orthopedics Ltd. Piccolo
Composite™ Plate System
Applicant Name
CarboFix Orthopedics, Ltd.
11 Ha'hoshlim St., Herzeliya 46724, Israel
Contact Person
Yael Rubin
CarboFix Orthopedics, Ltd.
11 Ha'hoshlim St:, Herzeliya 46724, Israel
Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
April 2012
Trade/Proprietary Name
Piccolo Composite™ Plate System
Common Name
Bone Plating System
Classification Name
Single/multiple component metallic bone fixation appliances and accessories; (21 CFR §888.3030; Class II; Product Code HRS, KTT).
NOV 2 6 2012
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Piccolo Composite™ Plate System - Distal Fibula & One-Third Tubular
Predicate Devices
1
- Piccolo Composite™ Plate System (CarboFix Orthopedics Ltd.; K102597) 트
- 포 Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates (Synthes; K073460)
- I Synthes One Third Tubular LCP Plate (Synthes; K011335)
- D VariAx™ Distal Fibula Plate and Fibula Straight Plates (Stryker (Howmedica Osteonics Corp.); K081284)
- . SPS Small Fragment Set (Stryker (Howmedica Osteonics Corp.); K000636)
- I Mini Variable System (OrthoHelix Surgical Designs, Inc .; K111041)
Indications for Use
Piccolo Composite™ Distal Fibula Plate System
The Piccolo Composite™ Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone.
Piccolo Composite™ One-Third Tubular Plate System
The Piccolo Composite™ One-Third Tubular Plates are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, radius, ulna, pelvis, and fibula including in osteopenic bone.
Piccolo Composite™ Proximal Humerus Plate System
The Piccolo Composite™ Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone.
Piccolo Composite™ Distal Volar Radius Plate System
The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.
System Description
The Piccolo Composite™ Distal Fibula and One Third Tubular Plate Systems comprise implants (plates and screws), and sets of instruments.
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Piccolo Composite™ Plate System - Distal Fibula & One-Third Tubular
The Plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are.marked with a tantalum thread, to provide for their visualization under fluoroscopy.
The Screws are made of titanium alloy. Both non-locking screws and locking screws are available, in various dimensions.
The general description of the Piccolo Composite™ Proximal Humerus and Distal Volar Radius Plate Systems is not changed as compared to the predicates.
Substantial Equivalence
The Piccolo Composite™ 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 Fibula and One Third Tubular Plate Systems, such as single cycle (static) 4-point bending and dynamic (fatigue) 4-point bending, were evaluated per ASTM F 382 - Standard Specification and Test Method for Metallic Bone Plates and are comparable to those of predicate devices (where applicable). Axial static and dynamic bending tests, selected screws characteristics evaluation, and evaluation in support of the MR Conditional labeling parameters were 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 26, 2012
CarboFix Orthopedics, Limited % Mr. Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim Street Herzeliya, Israel 46724
Re: K120409
Trade/Device Name: Piccolo Composite™ 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: November 20, 2012 Received: November 23, 2012
Dear Mr. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2- Mr. Yael Rubin
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHVCDRHOffices/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/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 yours,
Erin I. Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and . Radiological Health
Enclosure
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510(K) Number (if known): __
Piccolo Composite™ Plate System - Distal Fibula & One-Third Tubular
Indications for Use 170406
Piccolo Composite™ Plate System Device Name:
Indications for Use:
Piccolo Composite™ Distal Fibula Piate System
The Piccolo Composite™ Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone.
Piccolo Composite™ One-Third Tubular Plate System
The Piccolo Composite™ One-Third Tubular Plates are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, radius, ulna, pelvis, and fibula including in osteopenic bone.
Piccolo Composite™ Proximal Humerus Plate System
The Piccolo Composite™ Proximal Humerus Plate is indicated for fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including in osteopenic bone.
Piccolo Composite™ Distal Volar Radius Plate System
The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.
Prescription Use _____________ V (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR . (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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
2012.11.26 12:46:22 -05'00'
§ 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.