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.

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, screws and end caps are supplied sterile by gamma radiation while the 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 noninvasively 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.

AI/ML Overview

This document is a 510(k) summary for the Precice® Bone Transport System. It refers to a medical device that recently underwent design modifications and is seeking clearance from the FDA. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove a device meets acceptance criteria.

Therefore, the information required to directly answer your request (acceptance criteria, device performance, sample sizes for test/training, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth specifics) is not available in this document.

Here's why and what information is present:

Acceptance Criteria and Reported Device Performance: This document does not list specific acceptance criteria (e.g., target sensitivity, specificity, or accuracy) for a new algorithm or a device relying on complex performance metrics. Instead, it demonstrates the Precice® Bone Transport System's performance in terms of mechanical testing against relevant ASTM standards.
- Mechanical Performance Data (from the table provided):
  - Static Compression Bending Strength: Tested against ASTM F1264.
  - Dynamic Compression Bending Strength: Tested against ASTM F1264.
  - Torsion: Tested against ASTM F1264.
  - Torque Resistance: Tested against ASTM F543.
  - Axial Pullout: Tested against ASTM F543.
  - Retention Force Testing: N/A (Standard not specified)
  - Distraction Force: N/A (Standard not specified)
- Reported Performance: The document states, "The results demonstrate that the subject Precice® Bone Transport System is substantially equivalent to the predicate." However, it does not provide numerical performance data for these tests. It simply confirms the equivalence.
Sample sizes used for the test set and the data provenance: Not applicable. This document describes mechanical testing, not a clinical study involving a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic devices (e.g., by experts interpreting images) is not relevant to this mechanical device submission.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. The device is a physical intramedullary fixation rod, not an AI or diagnostic tool that would involve human readers.
Standalone (algorithm only) performance: Not applicable. This is a physical medical device, not an algorithm.
Type of ground truth used: Not applicable in the context of expert consensus or pathology. The "ground truth" for the mechanical testing would be defined by the specifications and tolerances within the cited ASTM standards.
Sample size for the training set: Not applicable. This refers to machine learning, which is not described here.
How the ground truth for the training set was established: Not applicable.

In summary, this FDA submission focuses on showing that a modified physical device is as safe and effective as its predecessor through mechanical testing, rather than presenting a performance study for an AI or diagnostic software product.

Summary

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NuVasive Specialized Orthopedics, Inc. Madison Heffron Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656

Re: K201567

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: June 9, 2020 Received: June 11, 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 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 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

August 10, 2020

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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 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 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

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Indications for Use

510(k) Number K201567

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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Precice® Bone Transport System 510(k) Summary

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: June 8, 2020

B. Device Name

Trade or Proprietary Name:	Precice® Bone Transport System
Common or Usual Name:	Intramedullary Fixation Rod
Classification Name:	Intramedullary Fixation Rod

Device Class:	Class II
Classification:	21 CFR § 888.3020
Product Code (primary):	HSB
Product Code (additional):	HWC

C. Predicate Devices

The subject Precice® Bone Transport System is substantially equivalent to the primary predicate device, Precice® Bone Transport System (K193016).

D. Device Description

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The purpose of this submission is to introduce design modifications to the distal portion of the Precice ® Bone Transport device.

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 (K193016) previously cleared by the FDA for commercial distribution in the United States. 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	ASTM F1264 - Standard Specification andTest Methods for Intramedullary FixationDevices
Dynamic CompressionBending strength
Torsion
Torque Resistance	ASTM F543 - Standard Specification and TestMethods for Metallic Medical Bone Screws
Axial Pullout
Retention Force Testing	N/A
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.

Regulation Number and Section

§ 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.