Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The description mentions "automatically segmented" images and "automatic identification of anatomical landmarks" and "automatically computes an initial planning". While these could be achieved through traditional algorithms, the level of automation and the nature of the tasks (segmentation, landmark identification, initial planning) are often indicative of AI/ML use in modern medical imaging software. However, the document does not explicitly mention AI, ML, or related terms, and there is no description of training or test sets typically associated with ML model development. Therefore, it's not possible to definitively confirm or deny the presence of AI/ML based solely on this summary.

Therapeutic

No
This device is a pre-operative planning software, not a device that directly treats or mitigates a disease or condition. It assists in surgical planning for hip replacement.

Diagnostic

No

Explanation: The device is described as software for pre-operative planning and 3D templating of implants for hip surgery. It assists in planning by processing CT images, identifying anatomical landmarks, and computing initial implant planning. While it uses medical images and provides information for a medical procedure, its primary function is not to diagnose a disease or condition, but rather to aid in surgical preparation.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "NAVIPLAN...is a software" and describes its function as processing images and generating a plan, with optional export to a navigation system. There is no mention of any hardware component being part of the Naviplan device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants)." This is a clinical decision support tool used before surgery, not a test performed in vitro on biological samples to diagnose a condition or monitor a treatment.
Device Description: The description focuses on processing medical images (CT scans) and assisting in surgical planning. It does not mention analyzing biological samples or providing diagnostic information based on such analysis.
Input: The input is "CT DICOM images," which are medical images, not biological samples.

IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. Naviplan's function is entirely focused on image-based surgical planning.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Naviplan is indicated for pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants).

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

NAVIPLAN - CT Planning Software for Total Hip Replacement, or "Naviplan", is a software which assists in the pre-operative planning of total hip replacement surgery based on three dimensional CT-images (computed tomography).

The Naviplan allows the user to process CT DICOM images which are automatically segmented. The user gets an automatic identification of anatomical landmarks as an output, which is normally used in hip surgery. The Naviplan automatically computes an initial planning (implant type and size selection as well as positioning) which can be inspected and edited by the user until the optimal configuration is established. The user can export the plan as a pdf report and as a navigation archive to be used with the Naviswiss Hip Navigation System. The export steps are optional, whereas the report serves a documentation purpose.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT-images (computed tomography)
DICOM images

Anatomical Site

Hip

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Suitably licensed and qualified healthcare professional

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This software is considered as a "moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. Dedicated software verification testing has been conducted to compare manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K133022

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K193034

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Naviswiss AG % Stefano Adami Senior Consultant confinis AG Allee 1b Sursee. 6210 SWITZERLAND

October 5, 2021

Re: K211429

Trade/Device Name: NAVIPLAN - CT Planning Software for Total Hip Replacement Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 26, 2021 Received: August 30, 2021

Dear Stefano Adami:

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

1

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

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K211429

Device Name

NAVIPLAN - CT Planning Software for Total Hip Replacement

Indications for Use (Describe)

Naviplan is indicated for pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants)

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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ള NAVISWISS

K211429

5. 510(k) Summary

ln accordance with 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Applicant: Naviswiss AG

Submitter name: Jan Stifter Responsible person: Jan Stifter Phone: +41 78 806 12 60 E-mail: jan.stifter@naviswiss.eu

Official Correspondent:

Contact person:	Stefano Adami
Phone:	+41 79 515 4426
Mailto:	stefano.adami@confinis.com
Date prepared:	26 August 2021

Device Name: NAVIPLAN - CT Planning Software for Total Hip Replacement

Proprietary name:	NAVIPLAN - CT Planning Software for Total Hip Replacement
510(k) number:	To be assigned
Common name:	System, image processing, radiological
Classification
name:	System, image processing, radiological
Product code:	LLZ

Predicate Device:

Substantial equivalence is claimed with the device, K1303022 "ZedView", manufactured by Lexi Co., Ltd. on the basis of equivalent intended use / indications for use, technological characteristics, and principle of operation.

This predicate has not been subject to a design-related recall.

Device Description:

NAVIPLAN - CT Planning Software for Total Hip Replacement, or "Naviplan", is a software which assists in the pre-operative planning of total hip replacement surgery based on three dimensional CT-images (computed tomography).

The Naviplan allows the user to process CT DICOM images which are automatically segmented. The user gets an automatic identification of anatomical landmarks as an output, which is normally used in hip surgery. The Naviplan automatically computes an initial planning (implant type and size selection as well as positioning) which can be inspected and edited by the user until the optimal configuration is established. The user can export

4

the plan as a pdf report and as a navigation archive to be used with the Naviswiss Hip Navigation System. The export steps are optional, whereas the report serves a documentation purpose.

Indications for Use:

Naviplan is indicated for pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants).

Comparison of Technological Characteristics:

Table 05-1 provides a comparison of the predominant technical characteristics of the subject device and the legally marketed predicate device. A more detailed comparison of the devices is presented in Section 12.

Description	Subject Device	Predicate Device
Device Name	Naviplan	ZedView (ZedHip)
510(k) Number	To be assigned	K133022
Manufacturer	Naviswiss AG	Lexi Co., Ltd.
Prescription device	Yes	Yes
Intended Use	Naviplan is intended to be used
by a suitably licensed and quali-
fied healthcare professional to ac-
cess medical images with the in-
tention of using such images, in
conjunction with templates for
prosthetic devices, for the pur-
poses to assist qualified
healthcare professional in choos-
ing the nature and characteristics
of the prosthetic device to be
used when planning a potential
surgical hip procedure.
The software is basically intended
to be standalone, however the
planning data can be imported
into the "Naviswiss System" (navi-
gation system) for intra-operative
use.	ZedView is intended to be used to
assist qualified medical profession-
als to perform fast and effective pre-
operative planning for various surgi-
cal procedures related to hip and
knee by using 2D image data. The
software is basically intended to be
standalone, however some part of
the software provides features for
communicating with PACS servers
to acquire the CT data of various pa-
tients or to upload planned projects,
images or
reports to the servers.
ZedHip is the specific 3-Dimensional
Pre-Op. Planning software for Total
Hip Arthroplasty with CT images.
Indications for use	Naviplan is indicated for pre-oper-
ative planning for surgical proce-
dures related to hip, such as artifi-
cial joint replacement (3D tem-
plating of implants).	Zed View is indicated for pre-opera-
tive planning for various surgical pro-
cedures related to hip and knee,
such as artificial joint replacement
(3D templating of implants) and os-
teotomy.
Principles of Oper-
ations	The user can manage a database
of patients data and perform a
pre-operative planning per pa-
tient. For each patient a hip DI-
COM series of a CT scan can be	The software primarily provides im-
port and storage of CT images of
various patients in DICOM or other
formats which are automatically seg-
mented by the software. ZedView
Description	Subject Device	Predicate Device
	loaded and automatically seg-
mented. When the segmentation,
which is done on the local com-
puter, is completed, the user can
edit the initialized case.
While planning the user can try
different configurations of im-
plant types, sizes, positions, orien-
tations and more. The planning
view shows the user useful met-
rics such as resulting leg length,
lateral offset, acetabular orienta-
tion, CCD-angle, femoral offset
and femur antetorsion. The pre-
operative planning can be ex-
ported in PDF format for printing
or in the Naviswiss Hip Naviga-
tion System as a binary format for
intra-operative use.	provides a means of 3D templating
of implants and positioning of fixa-
tion devices by calculating surgical
parameters in simulated environ-
ments and performing 3D measure-
ments on each pre-operative patient
data using 2D image viewing and
manipulations, 3D visualizations and
various MPR (Multi-Planar Recon-
struction) functions.

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Image /page/6/Picture/0 description: The image shows the logo for NAVISWISS. The logo consists of a square with a design inside of it, followed by the word "NAVISWISS". The "NAVI" portion of the word is in black, while the "SWISS" portion is in red.

The technological principle for both the subject and predicate devices is to use DICOM image standards that are automatically segmented, and the software provides anatomical landmarks and an initial proposed planning that can be edited by the surgeon to find the best implant configuration and positioning. Both software can be configured to be launched from within a workstation environment or as a standalone PC application for planning orthopedic procedures related to the hip joint.

Both software can manaqe a database of patient's data and perform a pre-operative planning per patient based on DICOM series of a CT scan and allow different configurations of implant types, sizes, positions, orientations and more and show the user useful metrics such as resulting leg length, lateral offset, acetabular orientation, CCD-angle, femoral offset and femur antetorsion.

Naviplan has an additional feature that allows export of planning data to be used in the Naviswiss Hip Navigation system (K193034). This difference does not represent a substantial difference since it is just an export feature to allow visualization of the planned positioning of the orthopedic implant to the intraoperative navigation.

Summary of Testing:

The relevant requirements set forth in standards listed in Section 9 by the manufacturer are sufficient to assure a safe and effective functioning of the NAVIPLAN - CT Planning Software for Total Hip Replacement. The device has fulfilled the requirements detailed above. The results of the bench and performance testing are summarized in the verification and validation plan and report enclosed.

The following performance data were provided in support of the substantial equivalence determination.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This

7

ള NAVISWISS

software is considered as a "moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider. Dedicated software verification testing has been conducted to compare manual segmentation and landmark positioning to the NAVIPLAN - CT Planning Software for Total Hip Replacement automated segmentation and planning.

Conclusion:

Based on equivalence of intended use / indications for use, technological characteristics and operational principle the applicant concludes, that substantial equivalence between the new and the predicate device has been demonstrated and that the new device, NAV-IPLAN - CT Planning Software for Total Hip Replacement, is at least as safe and as effective as the legally marketed predicate device, Zedview (K133022).