(119 days)
Indications for the Piccolo Composite Humeral Nail and Proximal Humerus Nail include simple humeral 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 Humeral and Proximal Humerus Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.
The Piccolo Composite Nailing System includes humeral and proximal humerus nails. interlocking screws and a set of instruments.
The Piccolo Composite Nail is a cylindrical solid rod, made of carbon fiber reinforced polymer. The humeral nail diameter ranges from 7 mm to 8.5 mm, with lengths in the range of 180 mm to 280 mm. The dimensions of the proximal humerus nail are 8 mm diameter (11 mm at proximal end), and length of 150 mm. The nails provide for holes at proximal and distal sections, designed for the insertion of self-tapping, titanium-allovmade, interlocking screws. The nails have a closed, pointed distal end, and their proximal end incorporates a thread enabling connection of insertion/extraction instrumentation.
The provided text is a 510(k) summary for the Piccolo Composite Nailing System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical properties and intended use, rather than a clinical study evaluating diagnostic performance, as might be done for AI/ML-driven devices. Therefore, much of the requested information regarding acceptance criteria, study design for diagnostic performance, ground truth establishment, and expert involvement is not present in this document.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The term "acceptance criteria" in this context refers to the criteria for demonstrating substantial equivalence based on mechanical testing and intended use. The document states: "Biomechanical evaluation demonstrates comparable mechanical properties to the predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use substantially equivalent to predicate devices. | Intended use is presented as identical to the predicate device (implied through the substantial equivalence claim and the re-naming of the previous Quantum IM device). |
| Design substantially equivalent to predicate devices. | The system description suggests a similar design to predicate devices for intramedullary nails, with specific dimensions and material (carbon fiber reinforced polymer). |
| Materials substantially equivalent to predicate devices. | The nail is made of carbon fiber reinforced polymer, and interlocking screws are titanium-alloy made. This is implied to be comparable to predicate devices. |
| Technological characteristics substantially equivalent to predicate devices. | The principles of operation are stated to be substantially equivalent. |
| Principles of operation substantially equivalent to predicate devices. | Principles of operation are stated to be substantially equivalent. |
| Biomechanical properties comparable to predicate devices. | Biomechanical evaluation demonstrates comparable mechanical properties to the predicate device. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a mechanical device, and the "test set" would refer to the samples used in biomechanical testing. The document states "Biomechanical evaluation demonstrates comparable mechanical properties," but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this context would typically refer to clinical outcomes or definitive diagnoses for performance studies of AI/ML devices. For a mechanical device, the "ground truth" for biomechanical evaluation would be the physical properties and performance measured against engineering standards or predicate devices. No external experts for "ground truth" establishment are mentioned.
4. Adjudication method for the test set
Not applicable. No clinical test set or adjudication method is described. The evaluation is based on biomechanical testing.
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
Not applicable. This is a medical device, not an AI/ML diagnostic software. No MRMC study was performed or needed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical medical device, not an algorithm.
7. The type of ground truth used
For the biomechanical evaluation, the "ground truth" would be established by standardized mechanical testing protocols and comparison against the known mechanical properties of the predicate devices. The specific type of ground truth (e.g., specific load-bearing capacity, fatigue strength) is not detailed, but it falls under "biomechanical properties."
8. The sample size for the training set
Not applicable. This is a physical device, and the concept of a "training set" is not relevant in the context of this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. As above, a "training set" and its "ground truth" are not relevant to this device's evaluation as described.
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N.M.B. Medical Applications Ltd. Piccolo Composite Nailing System
510(K) Summary
N.M.B. Medical Applications, Ltd. Piccolo Composite Nailing System (previously named the "Quantum IM Composite Nailing System")
Applicant Name
BUN 21 2010
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 February 2010
Trade/Proprietary Name
Piccolo Composite Nailing System (previously named the "Quantum IM Composite Nailing System")
Common Name
Intramedullary Nailing System
Classification Name
Rod, Fixation, Intramedullary and Accessories (21 CFR §888.3020; Product Code HSB)
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Predicate Devices
- 트 Quantum IM Composite Nailing System (N.M.B. Medical Applications, Ltd .; K091425);
- 트 TriGen Straight Humeral Nail System (Smith & Nephew, Inc.; K032722);
- T2 Nailing System / T2 Proximal Humeral Nail (Howmedica Osteonics Corp .; K032523, K042396, K043404);
Intended Use/Indications for Use
Piccolo Composite Humeral and Proximal Humerus Nails
Indications for the Piccolo Composite Humeral Nail and Proximal Humerus Nail include simple humeral 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 Humeral and Proximal Humerus Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.
System Description
The Piccolo Composite Nailing System includes humeral and proximal humerus nails. interlocking screws and a set of instruments.
The Piccolo Composite Nail is a cylindrical solid rod, made of carbon fiber reinforced polymer. The humeral nail diameter ranges from 7 mm to 8.5 mm, with lengths in the range of 180 mm to 280 mm. The dimensions of the proximal humerus nail are 8 mm diameter (11 mm at proximal end), and length of 150 mm. The nails provide for holes at proximal and distal sections, designed for the insertion of self-tapping, titanium-allovmade, interlocking screws. The nails have a closed, pointed distal end, and their proximal end 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.
Biomechanical evaluation demonstrates comparable mechanical properties to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA."
JUN 2 1 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
N.M.B. Medical Applications Ltd. % Hila Wachsler-Avrahami 11 Ha'hoshlim Street Herzeliya 46724 Israel
.
Re: K100497
Trade/Device Name: Piccolo Composite Nailing System (previously named the Quantum IM Composite Nailing System)
Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: June 6, 2010 Received: June 15, 2010
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 – 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 vours.
Barbara Buchner
Mark N. M Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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N.M.B. Medical Applications Ltd. Piccolo Composite Nailing System
Indications for Use
510(K) Number (if known): K100497
Device Name: Piccolo Composite Nailing System
(Previously named the "Quantum IM Composite Nailing System")
Indications for Use:
Piccolo Composite Humeral and Proximal Humerus Nails
Indications for the Piccolo Composite Humeral Nail and Proximal Humerus Nail include simple humeral 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 Humeral and Proximal Humerus Nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the humerus.
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
Smetu for mxm
(Division Sign-Off)
(Division Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100497
Page 1 of 1
§ 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.