(90 days)
No
The summary describes a mechanical implant system for bone fracture fixation and does not mention any software, image processing, or AI/ML capabilities.
Yes
The device is intended to treat fractures of the proximal tibia, which is a therapeutic intervention.
No
Explanation: The device is an implantable plate system designed to treat fractures, not to diagnose them.
No
The device description explicitly states that the system comprises implants (plates and screws) and instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat fractures of the proximal tibia. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a system of implants (plates and screws) used to fix bones. This is a surgical device, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device is used to physically repair a fracture.
N/A
Intended Use / Indications for Use
The Piccolo Composite Proximal Tibia Plate System is intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused.
For Lateral Plates - non-unions, and factures including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
For Medial Plates - intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Piccolo Composite Proximal Tibia Plate System comprises implants (pre-contoured lateral and medial plates (in left and right configurations), and screws) in different dimensions, and instruments.
The Piccolo Composite proximal tibia plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and incorporate tantalum markers. The screws are made of titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal tibia
Indicated Patient Age Range
Adults and adolescents in which the growth plates have fused
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, including plate static and dynamic bending testing (evaluated per ASTM F 382), screw pushout testing from the plate, and screws performance evaluation (including insertion torque, pull out force and dimensional equivalence) are comparable to those of predicate devices (as applicable), thus demonstrating substantially equivalent mechanical performance of the subject device.
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.
K120689, K030597, K032269, K050646
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.
K090877, K102597, K120409, K130061, K182015
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.
0
October 8, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CarboFix Orthopedics, Ltd. Yael Rubin Director of Regulatory Affairs 11 Ha'hoshlim St Herzeliya, 4672411 Israel
Re: K201917
Trade/Device Name: Piccolo Composite Proximal Tibia 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: July 8, 2020 Received: July 10, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for - Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Stereotaxic. Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201917
Device Name
Piccolo Composite® Proximal Tibia Plate System
Indications for Use (Describe)
The Piccolo Composite Proximal Tibia Plate System is intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused.
For Lateral Plates - non-unions, and factures including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
For Medial Plates - intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K201917
510(K) Summary
CarboFix Orthopedics Ltd.
Piccolo Composite® Proximal Tibia 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 September 2020
Trade/Proprietary Name
Piccolo Composite® Proximal Tibia 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).
4
Predicate Devices
Primary
-
. 3.5mm LCP / VA-LCP Proximal Tibia Plate System (DePuy Synthes, Inc .; K120689)
Additional -
. 3.5mm LCP / VA-LCP Proximal Tibia Plate System (DePuy Synthes, Inc .; K030597, K032269, K050646, and more)
-
A.L.P.S Proximal Tibial Plating System (Biomet; K090877) ■
-
Piccolo Composite Plate System (CarboFix Orthopedics Ltd.; K102597, K120409, K130061, K182015, and more)
Indications for Use
The Piccolo Composite Proximal Tibia Plate System is intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused.
- For Lateral Plates non-unions, malunions, and factures including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
- For Medial Plates intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
5
System Description
The Piccolo Composite Proximal Tibia Plate System comprises implants (pre-contoured lateral and medial plates (in left and right configurations), and screws) in different dimensions, and instruments.
The Piccolo Composite proximal tibia plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and incorporate tantalum markers. The screws are made of titanium alloy.
Performance Testing
Performance characteristics, including plate static and dynamic bending testing (evaluated per ASTM F 382), screw pushout testing from the plate, and screws performance evaluation (including insertion torque, pull out force and dimensional equivalence) are comparable to those of predicate devices (as applicable), thus demonstrating substantially equivalent mechanical performance of the subject device.
Substantial Equivalence
The Piccolo Composite Proximal Tibia Plate System intended use, design, materials, technological characteristics, principles of operation, and performance are substantially equivalent to those of the predicate devices, as applicable.