(167 days)
Piccolo Composite™ Diaphyseal Plate: The Piccolo Composite™ Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients. These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.
Piccolo Composite™ Proximal Humerus Plate: 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: The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.
The Piccolo Composite Plate System comprises implants (plates and screws/pegs), and a set 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 following types of plates are available: Diaphyseal Plates (thickness: 4.5 mm or 5 mm); Proximal Humerus Plate (thickness: 3.7 mm); Distal Volar Radius Plate (thickness: 2.4 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 (to be used only with the Distal Radius Plate), in various dimensions.
The Piccolo Composite™ Plate System is a bone plating system, and its acceptance criteria and supporting study are described below, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Method) | Reported Device Performance (Results) |
|---|---|
| Single cycle (static) 4-point bending per ASTM F 382 | Results were comparable to those of similar predicate devices. |
| Dynamic (fatigue) 4-point bending per ASTM F 382 | Results were comparable to those of similar predicate devices. |
| MRI compatibility (MR Conditional labeling parameters) | Testing in support of MR Conditional labeling parameters was provided. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes for the mechanical testing (static and dynamic bending) or MR Conditional testing. It simply states that "Performance characteristics... were evaluated" and "Testing in support of the MR Conditional labeling parameters was also provided."
The data provenance is intrinsic to the device development and testing, meaning the tests were conducted in a controlled environment to assess the physical properties of the device (likely in a lab setting). This is prospective in the sense that the tests were designed and executed to evaluate the new device. There is no indication of retrospective data or country of origin for the data beyond the manufacturer's location (Israel).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The "test set" in this context refers to the physical devices undergoing mechanical and material property testing, not an AI algorithm evaluated against expert-established ground truth. The "ground truth" for these tests are objective, measurable physical properties, not subjective expert interpretations.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple human reviewers, which is not relevant for the mechanical and material testing performed for this device. The results of the mechanical tests are quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. This device is a physical implant, not an algorithm. Therefore, there is no "standalone" algorithm performance to evaluate. The performance discussed is the physical integrity and characteristics of the plate itself.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Piccolo Composite™ Plate System was based on:
- ASTM F 382 Standard Specification: This provides the defined methodology and criteria for evaluating the mechanical properties (static and dynamic bending) of metallic bone plates. The acceptance is based on the device's performance relative to these established standards and its predicate devices.
- Material Properties and MRI Compatibility Standards: For the CFR-PEEK material, previous clearances (K091425, K100497) established its material properties. For MR Conditional labeling, defined standards and guidelines for MRI safety testing would have been used.
8. Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI algorithm. There is no concept of a "training set" for its development in the context of machine learning. The device's material (CFR-PEEK) was previously cleared, indicating prior testing and validation for its use in medical devices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this device. The "ground truth" for the material and design principles of the device would have been established through extensive material science research, engineering principles, and prior regulatory clearances for similar materials and device types.
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510(K) Summary
FEB 2 4 2011
N.M.B. Medical Applications Ltd. Piccolo Composite™ Plate System
Applicant Name
N.M.B. Medical Applications Ltd. 11 Ha'hoshlim St., Herzeliya 46724, Israel
Contact Person
Hila Wachsler-Avrahami N.M.B. Medical Applications Ltd. 11 Ha'hoshlim St., Herzliya 46724, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
September 2010
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).
Predicate Devices
Intended Use/Design/Technology/Operation
- Synthes 4.5 mm Locking Compression Plate System (Synthes; K082807) ■
- Synthes LCP Proximal Humerus Plate (Synthes; K011815) 트
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- 트 Synthes LCP Proximal Humerus Plate, Long (Synthes; K041860)
- 트 DVR Anatomic Plating System (DePuy Orthopaedics, Inc. (previously Hand Innovations, Inc.); e.g., K002775, K090374)
The above mentioned predicate plates are manufactured from titanium, titanium alloy and/or stainless steel.
Material
- Piccolo Composite™ Nailing System (formerly named Quantum IM Composite . Nailing System) (N.M.B. Medical Applications Ltd .; K091425, K100497)
- . Fixion® DHS System (N.M.B. Medical Applications Ltd .; K031401)
The material of the Piccolo Composite Plate (CFR-PEEK) was previously cleared for use in intramedullary rods (K091425, K100497).
Intended Use/Indications for Use
Piccolo Composite™ Diaphyseal Plate
The Piccolo Composite TM Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients.
These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.
Piccolo Composite™ Proximal Humerus Plate
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
The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.
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System Description
The Piccolo Composite Plate System comprises implants (plates and screws/pegs), and a set 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 following types of plates are available:
- ◆ Diaphyseal Plates (thickness: 4.5 mm or 5 mm);
- · Proximal Humerus Plate (thickness: 3.7 mm);
- · Distal Volar Radius Plate (thickness: 2.4 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 (to be used only with the Distal Radius Plate), in various dimensions.
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.
The Piccolo Composite Plates are manufactured from the identical CFR-PEEK material as the components cleared in K091425 and K100497.
Performance characteristics of the subject plates, 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. Testing in support of the MR Conditional labeling parameters was also provided. Results were comparable to those of similar predicate devices, thus demonstrating that the system is safe and effective for its intended use.
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Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus with three branches. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
N.M.B. Medical Applications Ltd. % Ms. Hila Wachsler-Avrahami Regulatory Affairs 11 Ha'hoshlim Street Herzeliya 46724, Israel
FEB 2 4 2011
Re: K102597
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: II Product Codes: HRS, KTT Dated: January 7, 2011 Received: January 10, 2011
Dear Ms. Wachsler-Avrahami:
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
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Page 2 - Ms. Hila Wachsler-Avrahami
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 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
For
Mark N. Melkerson
Director
Division of Surgical, Orthopedic
and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(K) Number (if known): | K102597 |
|---|---|
| --------------------------- | --------- |
Piccolo Composite™ Plate System Device Name:
Indications for Use:
Piccolo Composite™ Diaphyseal Plate
The Piccolo Composite™ Diaphyseal Plate is indicated for the fixation of various long bones, such as the humerus, femur and tibia, including osteopenic bone, osteotomies, and nonunions or malunions in adult patients.
These plates are also indicated for fracture fixation of diaphyseal areas of long bones in pediatric patients.
Piccolo Composite™ Proximal Humerus Plate
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
The Piccolo Composite™ Distal Volar Radius Plate is indicated for fractures and osteotomies of the distal volar radius.
Prescription Use AND/OR (Part 21 CFR 801, Subpart D)
Over-The-Counter Use (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)
| for M. Melkerson | |
|---|---|
| (Division Sign-Off) |
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K102597 |
|---|---|
| --------------- | --------- |
§ 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.