PRECICE Intramedullary Limb Lengthening System by NuVasive Specialized Orthopedics, Inc.

The PRECICE Intramedullary Limb Lengthening (IMLL) System is composed of the PRECICE Nail. locking screws, end cap, surgical instruments, and an External Remote Controller (ERC or ERC 2P). The nail is available in tibial and femoral models; with various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters, lengths, and thread styles. The PRECICE Nail is supplied sterile by gamma radiation; the locking screws and surgical instruments are supplied non sterile, and must be sterilized prior to use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria with specific numerical targets. The "acceptance criteria" here are implied to be that the new device components (new screw thread styles) maintain the same or similar performance characteristics as the predicate device's existing components.

Acceptance Criteria (Implied)	Reported Device Performance
Maintain substantial equivalence to predicate device (K160325) for overall system (nail, end cap, instruments, ERC).	Technological characteristics of subject PRECICE Nails, end cap, instruments, and External Remote Controller (ERC and ERC 2P) are identical to the predicate device. All previous testing on these predicate components is applicable.
New screw thread styles (partially threaded and fully threaded) integrate effectively into the system.	Assessment of substantial equivalence is based on mechanical testing previously performed on the same screws used in the reference device system (K160267).
Mechanical performance of new screws meets recognized standards.	Mechanical testing on locking screws previously performed according to ASTM F1264-14 and ASTM F543-13.
Device is sterile and non-pyrogenic.	Pyrogen testing performed per ANSI/AAMI ST72:2011 to ensure it meets pyrogen limit specifications for sterile implant devices.

Study Information

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" for this submission. The document states that testing was previously performed on the predicate components and on the same screws used in a reference device (K160267). The specific number of screws or nails tested in those prior studies is not mentioned.
- Data Provenance: Not explicitly stated. The document refers to prior testing, but doesn't specify the country of origin or if the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. This submission focuses on engineering and biocompatibility testing (mechanical, pyrogen), not on clinical performance evaluated by experts with patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/None. As this is not a clinical study involving expert interpretation, there is no adjudication method.
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 for bone lengthening, not an AI-assisted diagnostic or therapeutic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical implantable device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth for Mechanical Testing: Adherence to established ASTM standards (material properties, strength, fatigue resistance, etc.) defining acceptable performance for orthopedic implants and screws.
- Ground Truth for Pyrogen Testing: Compliance with ANSI/AAMI ST72:2011 specifications for bacterial endotoxins.
The sample size for the training set:
- Not applicable. This is a physical device, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 7, 2017

Nuvasive Specialized Orthopedics, Inc. Lance Justice Regulatory Affairs Specialist 101 Enterprise. Suite 100 Aliso Viejo, California 92656

Re: K170346

Trade/Device Name: Precice Intramedullary Limb Lengthening System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, HWC Dated: February 1, 2017 Received: February 2, 2017

Dear Lance Justice:

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 device-

Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	K170346 Page 1 of 1Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
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510(k) Number (if known)
K170346

Device Name

Device Name
PRECICE Intramedullary Limb Lengthening System

Indications for Use (Describe)

Indications for Use (Describe)
The PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femur.

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)
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Image /page/3/Picture/1 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and silver graphic to the left of the company name. The company name is written in silver, with the words "Specialized Orthopedics, Inc." written in purple below the name.

PRECICE Intramedullary Limb Lengthening System 510(k) Summary

1. Company: NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
- Contact: Lance Justice Regulatory Affairs Specialist Phone: (949) 544-6540 Fax: (949) 837-3664

Date Prepared: February 27, 2017

Proprietary Trade Name: PRECICE Intramedullary Limb Lengthening System 2.
Classification: 888.3020, 888.3040 3.
1. Product Code: HSB, HWC
Product Description: The PRECICE Intramedullary Limb Lengthening (IMLL) System ട. is composed of the PRECICE Nail. locking screws, end cap, surgical instruments, and an External Remote Controller (ERC or ERC 2P). The nail is available in tibial and femoral models; with various diameters, lengths and screw hole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters, lengths, and thread styles. The PRECICE Nail is supplied sterile by gamma radiation; the locking screws and surgical instruments are supplied non sterile, and must be sterilized prior to use.
Indications for Use: The PRECICE Intramedullary Limb Lengthening System is indicated 6. for limb lengthening of the tibia and femur.
Substantial equivalence: The subject PRECICE IMLL System is substantially equivalent 7. to the most recently cleared PRECICE IMLL System (K160325). Substantial equivalence is based on indications for use, technological characteristics, and principles of operation. In addition, the PRECICE Trauma Nail System (K160267) and Zimmer Natural Nail System (K083497) are designated as a reference devices to further substantiate equivalence of the new screws to be added to the system.

The subject PRECICE IMLL System and the predicate device have the same indications for use. Specifically, both systems are indicated for limb lengthening of the tibia and the femur.

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Image /page/4/Picture/1 description: The image shows the logo for "NUVASIVE SPECIALIZED ORTHOPEDICS, INC.". The logo consists of a stylized leaf-like shape in purple and gray on the left, followed by the company name in silver. Below the company name, "SPECIALIZED ORTHOPEDICS, INC." is written in a smaller, purple font.

The subject PRECICE IMLL System has similar technological characteristics and the same principle of operation as that of the predicate system. The technological characteristics of the subject PRECICE Nails, end cap, instruments, and External Remote Controller (ERC and ERC 2P) are identical to the predicate device. All testing previously performed on these components of the predicate system (i.e. PRECICE Nail, end cap, and External Remote Controller) are applicable to this submission. The difference between the two systems is the addition of two screw thread styles (partially threaded and fully threaded) to the currently available peg style screws of the predicate system.

There are no technological or performance changes to the PRECICE IMLL Nail being made as a result of this submission, therefore all testing previously performed on the predicate PRECICE Nail are applicable.

The assessment of substantial equivalence is based upon mechanical testing previously performed on the same screws used in the reference device system (K160267). Mechanical testing on the locking screws were previously performed according to the methods outlined in ASTM F1264-14 and ASTM F543-13.

Pyrogen testing was performed per ANSI/AAMI ST72:2011 – Bacterial Endotoxins – Test Methods, Routine Monitoring, and Alternatives to Batch Testing on the subject device to ensure it meets the pyrogen limit specifications for sterile implant devices.

Conclusions can be drawn from these tests that the subject PRECICE IMLL System is substantially equivalent to the predicate device.

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.