(164 days)
Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
The Piccolo Composite Nailing System includes nails, interlocking screws and a set of instruments.
The Piccolo Composite Nail indicated for treatment of the tibia and femur is a cannulated, cylindrical rod, made of carbon fiber reinforced polymer. The tibial nail diameter ranges from 9 to 11 mm, with lengths in the range of 260 to 380 mm; the femoral nail diameter ranges from 10 to 12 mm, with lengths in the range of 300 to 420 mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of titanium-alloy-made screws. The nail has a pointed distal end and incorporates a thread enabling connection of insertion/extraction instrumentation.
This is a submission for a medical device called the "Piccolo Composite Nailing System," which is an intramedullary nailing system for treating bone fractures. This type of submission (510(k)) focuses on demonstrating substantial equivalence to previously cleared devices, rather than comprehensive clinical performance studies like those typically seen for new drug approvals or high-risk devices. Therefore, the information provided focuses on engineering and material performance criteria rather than acceptance criteria related to diagnostic accuracy or clinical outcomes with a human-in-the-loop.
Here's an analysis of the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material/Design Equivalence | The Piccolo Composite Nailing System's intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to predicate devices. |
| Static 4-point Bending Test | Performed (results not detailed specifically against criteria, but implied to meet standards for substantial equivalence). |
| Static Torsion Test | Performed (results not detailed specifically against criteria, but implied to meet standards for substantial equivalence). |
| Dynamic Tests | Performed (results not detailed specifically against criteria, but implied to meet standards for substantial equivalence). |
| MR Conditional Labeling Support | Testing performed to support MR Conditional labeling. |
| Performance per ASTM F 1264 | Performance characteristics evaluated per ASTM F 1264 are comparable to those of predicate devices. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or human evaluation. The tests mentioned (static bending, torsion, dynamic, MRI compatibility) are bench tests on the device itself. Therefore, sample sizes would refer to the number of nails or components tested, and the provenance would be laboratory testing rather than patient data. No patient or human subject data is mentioned for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for this device's acceptance is based on engineering standards and performance characteristics, not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set
This information is not applicable. There is no human adjudication process involved as the tests are for device performance against engineering standards.
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
There was no MRMC comparative effectiveness study done. This device is a surgical implant, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This information is not applicable. This device is a surgical implant, not a standalone algorithm.
7. The type of ground truth used
The ground truth used for demonstrating the device's safety and effectiveness is based on engineering standards and performance characteristic comparisons to predicate devices. Specifically, compliance with or comparability to ASTM F 1264 and the results of static and dynamic mechanical tests and MR compatibility testing.
8. The sample size for the training set
This information is not applicable. There is no training set in the context of machine learning or AI as this is a medical implant, not a diagnostic algorithm.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as above.
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Ki02369(1/3)
N.M.B. Medical Applications, Ltd. Piccolo Composite™ Nailing System - Tibia & Femur
510(K) Summary
JAN 3 1 2011
N.M.B. Medical Applications, Ltd.
Piccolo Composite™ Nailing System - Tibia & Femur
Applicant Name
N.M.B. Medical Applications, Ltd. 11 Ha'hoshlim St., Herzeliya 46724, Israel
Contact Person
Yael Rubin N.M.B. Medical Applications, Ltd. 11 Ha'hoshlim St., Herzliya 46724, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
January 2011
Trade/Proprietary Name
Piccolo Composite Nailing System
Common Name
Intramedullary Nailing System
Classification Name
Rod, Fixation, Intramedullary and Accessories (21 CFR 8888.3020; Product Code HSB)
Predicate Devices
- Piccolo Composite Nailing System (N.M.B. Medical Applications, Ltd .; K091425, . K100497):
- Intramedullary Nail (Smith & Nephew, Inc .; K983942, K061019); 다
- 트 T2 Tibial Nail (Stryker (Howmedica Osteonics Corp.); K003018 and more);
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- T2 Femoral Nail (Stryker (Howmedica Osteonics Corp.); K010801 and more).
- 이 UTN Solid Tibial Nail/CTN Cannulated Tibial Nail (Synthes: K914453, K962047).
- . UFN Unreamed Femoral Nail/CFN Cannulated Femoral Nail (Synthes: K923580, K954856)
- D Fixion Interlocking Intramedullary Nailing System (N.M.B. Medical Applications, Ltd .; K002783, K013449, K032588)
Intended Use/Indications for Use
Piccolo Composite Tibial and Femoral Nails
Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonumions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
System Description
The Piccolo Composite Nailing System includes nails, interlocking screws and a set of instruments.
The Piccolo Composite Nail indicated for treatment of the tibia and femur is a cannulated, cylindrical rod, made of carbon fiber reinforced polymer. The tibial nail diameter ranges from 9 to 11 mm, with lengths in the range of 260 to 380 mm; the femoral nail diameter ranges from 10 to 12 mm, with lengths in the range of 300 to 420 mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of titanium-alloy-made screws. The nail has a pointed distal end and incorporates a thread enabling connection of insertion/extraction instrumentation.
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Substantial Equivalence
The Piccolo Composite Nailing System intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.
N.M.B. Medical Applications Ltd. performed static 4-point bending test, static torsion test, dynamic tests, and testing supporting MR Conditional labeling.
Performance characteristics evaluated per ASTM F 1264 are also comparable to those of predicate devices, thus demonstrating that the device is safe and effective for its intended use.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
N.M.B Medical Applications Inc. % Ms. Yael Rubin Director of Regulatory Affairs Ha'hoshlim Street 11 46724 Herzeliva Israel
JAN 3 1 2011
Re: K102369
Trade/Device Name: Piccolo Composite™ Nailing System. Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 25, 2011 Received: January 27, 2011
Dear Ms. 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.
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 - Ms. 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/CDRH0ffices/ucm115809.html 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
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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Indication for Use
510(K) Number (if known): _ K102369 __________________________________________________________________________________________________________________________________________
Piccolo Composite™ Nailing System Device Name:
Indication for Use:
Piccolo Composite Tibial and Femoral Nails
Indications for the Piccolo Composite Tibial and Femoral Nails include simple fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathological fractures; reconstruction, following tumor resection and grafting. The Piccolo Composite Tibial and Femoral Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
Prescription Use______________________________________________________________________________________________________________________________________________________________ (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)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. Melkerm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102369
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.