(291 days)
Not Found
No
The summary describes a system of bone plates and screws made of specific materials for fracture fixation. There is no mention of AI, ML, image processing for analysis, or any data-driven decision-making components. The performance studies focus on mechanical properties.
Yes.
The device is explicitly indicated for the fixation of fractures, osteotomies, and non-unions, which are conditions requiring treatment or therapy.
No
This device is described as a plate system for treating fractures and osteotomies, meaning it is an orthopedic implant used for surgical fixation, not for diagnosing medical conditions.
No
The device description explicitly states that the system comprises implants (plates and screws) made of physical materials (CFR-PEEK and titanium alloy), which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a system of implants (plates and screws) made of materials like carbon fiber reinforced PEEK and titanium alloy. These are designed to be surgically implanted into the body to fix fractures and other bone issues.
- Intended Use: The intended use clearly states that the plates are indicated for fractures, osteotomies, and non-unions of various bones. This is a therapeutic use, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition based on laboratory testing.
The Piccolo Composite™ Plate System is a surgical implant used for orthopedic fixation.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, KTT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
distal fibula, clavicle, scapula, radius, ulna, pelvis, fibula, proximal humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K102597, K073460, K011335, K081284, K000636, K111041
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
3
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
4
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
5
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'