(192 days)
The PRECICE® Bone Transport System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
The PRECICE® Bone Transport System includes the PRECICE® Bone Transport Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE® Bone Transport nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression of the intercalary bone segment and providing internal fixation for fractures of long bones. The PRECICE® Bone Transport intramedullary nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE® Bone Transport nail contains an enclosed rare earth magnet, distraction rod, and planetary gearing which allows the extension of the distraction rod to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE® Bone Transport nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models. The purpose of this submission is to introduce additional compatible locking screws to the system.
This FDA 510(k) premarket notification (K193016) is for the PRECICE® Bone Transport System. This device is an intramedullary fixation rod used for limb lengthening, fracture fixation, and bone transport.
The document describes performance data for the device, but it does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner of a clinical or AI-driven diagnostic study. Instead, it focuses on nonclinical performance verification testing to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested elements for a study proving acceptance criteria (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context as this is an evaluation of a physical medical device, not a diagnostic algorithm or AI.
However, I can extract the relevant information regarding the performance data that was provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, the "acceptance criteria" presented here is based on demonstration of substantial equivalence to the predicate device through performance testing. The reported device performance is that the "results demonstrate that the subject PRECICE® Bone Transport System is substantially equivalent to the predicate."
| Testing Description | Applicable Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Static Compression Bending Strength | ASTM F1264 | Performance comparable to predicate device | Substantially equivalent to predicate |
| Dynamic Compression Bending Strength | ASTM F1264 | Performance comparable to predicate device | Substantially equivalent to predicate |
| Torsion | ASTM F1264 | Performance comparable to predicate device | Substantially equivalent to predicate |
| Torque Resistance | ASTM F543 (for locking screws) | Performance comparable to predicate device/standard requirements | Substantially equivalent to predicate |
| Axial Pullout | ASTM F543 (for locking screws) | Performance comparable to predicate device/standard requirements | Substantially equivalent to predicate |
| Distraction Force | N/A (likely internal test method with reference to predicate) | Performance comparable to predicate device | Substantially equivalent to predicate |
2. Sample size used for the test set and the data provenance
This section is not applicable as the evaluation is based on nonclinical engineering performance testing (e.g., mechanical tests on physical parts), not a dataset of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. Ground truth, in the context of this device, would be established by validated engineering methodologies and potentially comparison to the predicate device's established performance.
4. Adjudication method for the test set
This section is not applicable. Mechanical testing results are objective measurements, not subject to expert adjudication.
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
This section is not applicable as this is not an AI-driven diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as this is not an AI-driven diagnostic device.
7. The type of ground truth used
The "ground truth" for this device's performance testing is established through industry standards (ASTM F1264, ASTM F543) and inherent performance characteristics of the predicate device. The testing aims to show that the new device's mechanical properties meet relevant standards and are comparable to those of the already cleared predicate device.
8. The sample size for the training set
This section is not applicable as this is not an AI-driven device requiring a training set.
9. How the ground truth for the training set was established
This section is not applicable as this is not an AI-driven device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a bold, sans-serif font, with the word "ADMINISTRATION" underneath.
NuVasive Specialized Orthopedics, Inc. Madison Heffron Regulatory Affairs Specialist 101 Enterprise Suite 100 ALISO VIEJO, CA 92656
May 8, 2020
Re: K193016
Trade/Device Name: PRECICE® Bone Transport System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: April 7, 2020 Received: April 9, 2020
Dear Madison Heffron:
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 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
{1}------------------------------------------------
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) 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 (QS) 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 medical devices and radiation-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,
Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty 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)
Device Name
PRECICE® Bone Transport System
Indications for Use (Describe)
The PRECICE® Bone Transport System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ❌ 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}------------------------------------------------
Image /page/3/Picture/1 description: The image contains the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and gray leaf-like shape on the left. To the right of the shape is the word "NUVASIVE" in gray, block letters. Below the company name is the text "SPECIALIZED ORTHOPEDICS, INC." in a smaller font size.
PRECICE® Bone Transport System 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR $807.92, the following summary of information is provided:
A. Submitted by:
Madison Heffron Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo. CA 92656 Telephone: (949) 532-7868
Date Prepared: May 7, 2020
B. Device Name
| Trade or Proprietary Name: | PRECICE® Bone Transport System |
|---|---|
| Common or Usual Name: | Intramedullary Fixation Rod |
| Classification Name: | Rod, Fixation, Intramedullary and AccessoriesScrew, Fixation, Bone |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3020 |
| Product Code (primary): | HSB |
| Product Code (subsequent): | HWC (screw, fixation, bone) |
C. Predicate Devices
The subject PRECICE® Bone Transport System is substantially equivalent to the primary predicate device, PRECICE® Bone Transport System (K182170).
D. Device Description
The PRECICE® Bone Transport System includes the PRECICE® Bone Transport Nail, locking screws, end caps, surgical instruments, and external remote controller (ERC). The PRECICE® Bone Transport nails and end caps are supplied sterile by gamma radiation while the locking screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression of the intercalary bone segment and providing internal fixation for fractures of long bones. The PRECICE® Bone Transport intramedullary nail is implanted using locking screws, end caps, and reusable surgical instruments. The PRECICE® Bone Transport nail contains an enclosed rare earth magnet, distraction rod, and planetary gearing which allows the extension of the distraction rod to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE® Bone Transport nail is available in various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The locking screws are
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized leaf-like shape in purple and gray on the left. To the right of the shape is the word "NUVASIVE" in gray, with the words "SPECIALIZED ORTHOPEDICS, INC." in smaller, red font below.
also available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.
The purpose of this submission is to introduce additional compatible locking screws to the system.
E. Indications for Use
The PRECICE® Bone Transport System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
F. Comparison of Technological Characteristics with the Predicate Device
As was established in this submission, the subject PRECICE® Bone Transport System is substantially equivalent to the predicate PRECICE® Bone Transport System (K182170) previously cleared by the FDA for commercial distribution in the United States. There have been no design changes to the implants previously cleared in the predicate 510(k)s. The subject device has been shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.
G. Performance Data
Nonclinical performance verification testing was performed to demonstrate that the subject PRECICE® Bone Transport System is substantially equivalent to the predicate device. The following testing was performed:
| Testing Description | Applicable Standard |
|---|---|
| Static CompressionBending Strength | |
| Dynamic CompressionBending Strength | ASTM F1264 - Standard Specification and TestMethods for Intramedullary Fixation Devices |
| Torsion | |
| Torque Resistance | ASTM F543 - Standard Specification and TestMethods for Metallic Medical Bone Screws |
| Axial Pullout | |
| Distraction Force | N/A |
The results demonstrate that the subject PRECICE® Bone Transport System is substantially equivalent to the predicate.
H. Conclusions
The subject PRECICE® Bone Transport System has been shown to be substantially equivalent to the legally marketed predicate device for its intended use.
§ 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.