(92 days)
The Piccolo Composite foot and ankle plates are indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bone fragments in adult and adolescent (12 - 21 years) patients, including the foot and ankle, and including in osteopenic bone.
The MTP plates are indicated for treatment of deformations, fractures, nonunions and replantations of the 1st metarsophalangeal joint and 1st metatarsal bone.
The Piccolo Composite MTP Plate System comprises implants (plates and screws), 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 screws are made of titanium alloy. Both non-locking and locking 2.7mm screws are available, in various lengths. Cannulated Lag Screws are also provided.
The provided text describes a 510(k) premarket notification for a medical device called the "Piccolo Composite® Plate System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria in a clinical study sense with AI algorithms.
Therefore, the information requested in your prompt (Acceptance Criteria, Study details, Sample sizes, Expert qualifications, Adjudication method, MRMC studies, Standalone performance, Ground truth, Training set information) is not applicable to this document. The document outlines:
- Device Name: Piccolo Composite® Plate System
- Manufacturer: CarboFix Orthopedics, Ltd.
- Regulation Number: 21 CFR 888.3030 (Single/Multiple Component Metallic Bone Fixation Appliances And Accessories)
- Regulatory Class: Class II
- Product Code: HRS
- Indications for Use: Fixation of osteotomies, fusions, fractures, nonunions, malunions, and replantations of small bone fragments in adult and adolescent (12-21 years) patients, including the foot and ankle, and in osteopenic bone. Specifically, MTP plates are indicated for the 1st metatarso-phalangeal joint and 1st metatarsal bone.
- Predicate Devices: Primarily previous versions of the Piccolo Composite® Plate System (K102597, K120409, K130061, 143496, 160002), and additional predicates from Synthes and Tornier (OrthoHelix Surgical Designs Inc.).
- Substantial Equivalence Claim: Based on intended use, design, materials, technological characteristics, and principles of operation, and performance characteristics including static and dynamic bending (evaluated per ASTM F 382).
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance testing, specifically mechanical testing per ASTM standards, rather than clinical trials or AI algorithm validation studies.
Here's a breakdown of why your specific questions cannot be answered by this document:
- Acceptance Criteria/Reported Performance: The document only states that performance characteristics were "comparable to those of predicate devices (as applicable)" and "demonstrating that the device is safe and effective for its intended use" based on tests like ASTM F 382. It does not provide a table of numerical acceptance criteria or reported device performance metrics from a clinical study, as these are not required for this type of submission for a bone fixation device.
- Sample Size/Data Provenance/Experts/Adjudication/MRMC/Standalone Performance/Ground Truth/Training Set: These concepts are relevant to the validation of AI/ML-based medical devices or complex diagnostic devices, often involving human readers interpreting data. This document describes a mechanical implant, not an AI algorithm. Therefore, there are no "test sets," "training sets," "experts establishing ground truth," "adjudication methods," or "MRMC studies" in the context of human interpretation of medical images or data. The "ground truth" for this device's performance would be engineering specifications and mechanical test results (e.g., force at failure, fatigue life).
In summary: The provided text is a regulatory clearance letter for a mechanical medical device (bone plate system), not an AI-powered diagnostic or therapeutic device. Thus, the questions related to AI/ML validation methodologies are not applicable. The "proof" of meeting acceptance criteria for this device came from engineering and mechanical testing, not clinical studies involving expert readers or AI algorithms.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2017
CarboFix Orthopedics, Ltd. Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim St. Herzeliya, 4672411 ISRAEL
Re: K170401
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 Dated: April 19, 2017 Received: April 21, 2017
Dear Yael 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
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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 devicerelated 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 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,
Vincent J. Devlin -S
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) K170401
Device Name Piccolo Composite® Plate System
Indications for Use (Describe)
The Piccolo Composite foot and ankle plates are indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bone fragments in adult and adolescent (12 - 21 years) patients, including the foot and ankle, and including in osteopenic bone.
The MTP plates are indicated for treatment of deformations, fractures, nonunions and replantations of the 1st metarsophalangeal joint and 1st metatarsal bone.
X 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® MTP 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., Herzeliya 4672411, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
May 2017
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).
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Predicate Devices
Primary Predicate:
-
Piccolo Composite® Plate System (CarboFix Orthopedics Ltd.; K102597, K120409. K130061, 143496, 160002)
Additional Predicates: -
트 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System – First MTP Fusion (Synthes; K100776)
-
MaxLock Extreme MTP Plate Systems (Tornier (OrthoHelix Surgical Designs Inc.); K101962, K100618, and more)
Indications for Use
The Piccolo Composite foot and ankle plates are indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bones and small bone fragments in adult and adolescent (12 - 21 years) patients, including the foot and ankle, and including in osteopenic bone.
The MTP plates are indicated for treatment of deformations, fractures, nonunions and replantations of the 1st metatarso-phalangeal joint and 1st metatarsal bone.
System Description
The Piccolo Composite MTP Plate System comprises implants (plates and screws), 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 screws are made of titanium alloy. Both non-locking and locking 2.7mm screws are available, in various lengths. Cannulated Lag Screws are also provided.
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Substantial Equivalence
The Piccolo Composite MTP 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 included, among others, static and dynamic bending (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. In addition, bacterial endotoxin testing was conducted.
§ 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.