K Number

Device Name

Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration

Manufacturer

Navbit Pty Ltd

Date Cleared

2020-12-10

(296 days)

Product Code

OLO

Regulation Number

882.4560

Intended Use

For Lateral Patient Registration: The Navbit® Sprint System is a computer-controlled system intended to assist the surgeon in relation to reference axes during orthopedic surgical procedures. The Navbit® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a lateral decubitus position. The Navbit® Sprint System for lateral patient registration is indicated for use: - . in Hip Arthroplasty surgical procedures; - with acetabular cups that are uncemented and allow for post-impaction correction; . - when post-impaction confirmatory measurement checks can be obtained. For Supine Patient Registration: The Navbit® Sprint System is a computer-controlled system intended to assist the surgeon in relation to reference axes during orthopedic surgical procedures. The Navbit® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes. The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine position. The Navbit® Sprint System for supine patient registration is indicated for use: - in Hip Arthroplasty surgical procedures; . - with acetabular cups that are uncemented and allow for post-impaction correction; . - . when post-impaction confirmatory measurement checks can be obtained.

Device Description

The Navbit® Sprint System is a computer assisted surgical navigation system for use in hip arthroplasty procedures. The Navbit® Sprint System utilizes a palm-sized computer module containing sensors including rate gyroscopes and accelerometers to generate real time angular measurements (inclination and anteversion angles) used to guide acetabular cup implantation during orthopedic procedures. During hip arthroplasty procedures, the Navbit® Sprint System assists the surgeon in registering the pelvic coordinate system and determining the inclination angle and the anteversion angle of the introducer/impactor relative to the registered pelvic coordinate system. The device requires registration to be performed in one of two acceptable patient positions - supine and lateral, and alignment guidelines are provided for each. Any surgical approach that allows this registration to be performed is appropriate for use with the Navbit® Sprint. The Navbit® Sprint System is provided terminally sterilized, single-use disposable.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K172462

Reference Devices

ASTM F2554-18, ISO 10993-1:2018

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on sensor-based navigation and computer-assisted guidance, with no mention of AI or ML technologies.

Therapeutic

No.
Explanation: The device is intended to assist surgeons in the accurate positioning of implants during orthopedic surgical procedures, rather than directly treating a disease or condition itself. It is a surgical navigation system, a tool for the surgeon, not a therapeutic agent.

Diagnostic

This device is a computer-assisted surgical navigation system used to guide the accurate positioning of implants during hip arthroplasty procedures, providing real-time angular measurements for surgical assistance rather than diagnosing a condition.

SaMD (Software as a Medical Device)

The device description explicitly states that the system utilizes a "palm-sized computer module containing sensors including rate gyroscopes and accelerometers". It also mentions "System hardware verification/validation testing" in the performance studies section. This indicates the device includes physical hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Navbit® Sprint System is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Navbit® Sprint System Function: The Navbit® Sprint System is a computer-assisted surgical navigation system. It uses sensors to provide real-time angular measurements to assist the surgeon during hip arthroplasty procedures. It interacts directly with the patient's anatomy during surgery, not with specimens taken from the patient.
Intended Use: The intended use clearly states it's for assisting the surgeon during orthopedic surgical procedures to facilitate accurate implant positioning. This is an in-vivo application, not in-vitro.

Therefore, the Navbit® Sprint System falls under the category of a surgical navigation system, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For Lateral Patient Registration:

The Navbit® Sprint System is a computer-controlled system intended to assist the surgeon in relation to reference axes during orthopedic surgical procedures. The Navbit® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes.

The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a lateral decubitus position.

The Navbit® Sprint System for lateral patient registration is indicated for use:

. in Hip Arthroplasty surgical procedures;
with acetabular cups that are uncemented and allow for post-impaction correction; .
when post-impaction confirmatory measurement checks can be obtained.

For Supine Patient Registration:

The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine position.

The Navbit® Sprint System for supine patient registration is indicated for use:

in Hip Arthroplasty surgical procedures; .
with acetabular cups that are uncemented and allow for post-impaction correction; .
. when post-impaction confirmatory measurement checks can be obtained.

Product codes

OLO

Device Description

During hip arthroplasty procedures, the Navbit® Sprint System assists the surgeon in registering the pelvic coordinate system and determining the inclination angle and the anteversion angle of the introducer/impactor relative to the registered pelvic coordinate system.

The device requires registration to be performed in one of two acceptable patient positions - supine and lateral, and alignment guidelines are provided for each. Any surgical approach that allows this registration to be performed is appropriate for use with the Navbit® Sprint.

The Navbit® Sprint System is provided terminally sterilized, single-use disposable.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pelvic

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospital / Operating Theatre

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

System accuracy testing: bench testing with mechanical fixtures to verify angular measurement accuracy using ASTM F2554-18.
Simulated use (cadaver) testing of the Navbit® Sprint System with an advising surgeon to validate that the system meets the requirements for user needs in a simulated use environment provides validation evidence that the product met the predetermined clinical pass/fail criteria.
No clinical trial required. Simulated use testing on cadavers performed.

Key Metrics

Not Found

Predicate Device(s)

OrthAlign Plus® System (K172462)

Reference Device(s)

ASTM F2554-18, ISO 10993-1:2018

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).

Summary

December 10, 2020

Image /page/0/Picture/1 description: The image shows the logo of 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 ADMINISTRATION' in blue text.

Navbit Pty Ltd % Elizabeth O'Keeffe, PhD Director of Regulatory Affairs Secure BioMed Evaluations 7828 Hickorv Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K200376

Trade/Device Name: Navbit Sprint Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 11, 2020 Received: November 12, 2020

Dear Elizabeth O'Keeffe:

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 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: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known)

K200376

Device Name Navbit® Sprint

Indications for Use (Describe)

For Lateral Patient Registration:

The Navbit® Sprint System for lateral patient registration is indicated for use:

. in Hip Arthroplasty surgical procedures;
with acetabular cups that are uncemented and allow for post-impaction correction; .
when post-impaction confirmatory measurement checks can be obtained.

For Supine Patient Registration:

The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine position.

The Navbit® Sprint System for supine patient registration is indicated for use:

in Hip Arthroplasty surgical procedures; .
with acetabular cups that are uncemented and allow for post-impaction correction; .
. when post-impaction confirmatory measurement checks can be obtained.

Type of Use (Select one or both, as applicable)

図 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
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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"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."

FORM FDA 3881 (7/17)

5. 510(k) Summary

510(k) Summary - Navbit® Sprint
Required	By section 21 CFR 807.92 (c)
Date Prepared	14th February, 2020
Owners Name	David Thomson QA/RA Manager
Submitter	Navbit Ltd
Suite 1A, Level 1, 136 Willoughby Road
Crows Nest 2065, Australia
Official Contact	Secure BioMed Evaluations
Elizabeth O'Keeffe, Ph.D.
7828 Hickory Flat Highway
Suite 120
Woodstock, GA 30188
770-837-2681 (direct)
855-MED-DEV1 (office)
Regulatory@SecureBME.com
Product Codes	OLO: Orthopedic Stereotaxic Instrument
Class	II
Classification Reference	21 CFR 882.4560
Common/Usual Name	Stereotaxic instrument.
Proprietary Name	Navbit® Sprint
Predicate Device(s)	OrthAlign Plus® System (K172462)
Reason for submission	New Device

5.1. Intended Use and Indications for Use:

For Lateral Patient Registration:

The Navbit® Sprint System is a computer-controlled system intended to assist the surgeon in determining alignment in relation to reference axes during orthopedic surgical procedures. The Navbit® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes.

The Navbit® Sprint System for lateral patient registration is indicated for use:

in Hip Arthroplasty surgical procedures;
. with acetabular cups that are uncemented and allow for post-impaction correction;
. when post-impaction confirmatory measurement checks can be obtained.

For Supine Patient Registration:

The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine position.

The Navbit® Sprint System for supine patient registration is indicated for use:

. in Hip Arthroplasty surgical procedures;
. with acetabular cups that are uncemented and allow for post-impaction correction;
when post-impaction confirmatory measurement checks can be obtained.

5.2. Device Description

The Navbit® Sprint System is provided terminally sterilized, single-use disposable.

5.3. Characteristics between predicate and new device

Trait	Subject Device: Navbit® Sprint	Predicate Device: OrthAlign Plus®	Comparison
510(k) number	K200376	K172462
(prior clearance as K130387)	N/A
FDA Regulation	822.4560	822.4560	Equivalent
Product Code	OLO	OLO	Equivalent
Product
Classification	Class II	Class II	Equivalent
Use	Prescription Use / Rx Only
Part 21 CFR 801 Subpart D	Prescription Use / Rx Only
Part 21 CFR 801 Subpart D	Equivalent
Indications for
Use	The Navbit® Sprint System is a
computer-controlled system intended
to assist the surgeon in determining
alignment in relation to reference axes
during orthopedic surgical procedures.
The Navbit® Sprint System facilitates
the accurate positioning of implants,
relative to these alignment axes.
The clinical setting and target
population for the Navbit® Sprint
System is that of a patient undergoing
a Hip Arthroplasty surgical procedure
by any approach with the patient in a
lateral decubitus /supine position.
The Navbit® Sprint System for
lateral/supine patient registration is
indicated for use:
in Hip Arthroplasty surgical
procedures; with acetabular cups that are
uncemented and allow for
post-impaction correction; when post-impaction
confirmatory measurement
checks can be obtained.	The OrthAlign Plus® System is a
computer-controlled system intended
to assist to the surgeon in determining
reference alignment axes in relation to
anatomical and instrumentation
structures during stereotactic
orthopedic surgical procedures. The
OrthAlign Plus® System facilitates the
accurate positioning of implants,
relative to these alignment axes. The
system aids the surgeon in controlling
leg length and offset discrepancies in
Total Hip Arthroplasty. Ligament
balancing is provided by the OrthAlign
Plus® System in primary revision Total
Knee Arthroplasty.
Example orthopedic surgical
procedures include but are not limited
to:
Total Knee Arthroplasty Total Hip Arthroplasty:
Anterior/Posterior Unicompartmental Knee
Arthroplasty: Tibial transverse
resection Ligament Balancing	Equivalent
Navbit does not
perform functions
associated with
knees, leg length
and offset
Trait	Subject Device: Navbit® Sprint	Predicate Device: OrthAlign Plus®	Comparison
Principle of
Operation	Computer-assisted navigation system	Computer-assisted navigation system	Equivalent
Single Use	Yes	Yes	Equivalent
Location of Use	Hospital / Operating Theatre	Hospital / Operating Theatre	Equivalent
Biocompatibility	Per ISO 10993-1, Externally
Communicating Device,
Tissue/Bone/Dentin Communicating,
with subsystems that have direct and
potential indirect contact for a limited
contact duration (