The NaviCam Xpress Stomach System is intended for visualization of the stomach of adults (≥22 years) with BMI <38. The system can be used in clinics and hospitals, including ER settings.

Device Description

The NaviCam Xpress Stomach System is a endoscopic capsule imaging system intended to obtain images of the stomach. It differs from passive capsule endoscopy systems in that it uses magnetic fields to allow the position of the capsule within the stomach to be controlled by an operator. The NaviCam Xpress Stomach System includes the following key components: Ingestible capsule (AKEM-11SW) for obtaining images, Data recorder (AKR-1) for logging image data, Locator (AKS-1) for turning on the capsule and for determining if the capsule is still in the body, Controller (NaviEC-2000) with the NaviCtrl software that allows the navigation of the capsule within the stomach, ESView software for review of the images obtained by the capsule and generating reports.

AI/ML Overview

The provided text is a 510(k) summary for the NaviCam Xpress Stomach Capsule Endoscope System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the acceptance criteria or a study proving the device meets those criteria, especially in terms of diagnostic performance or clinical accuracy. The "Performance Data" section solely discusses bench/in-vitro testing related to the controller's functionality and compliance with electrical safety standards, not the diagnostic performance of the capsule endoscope system itself.

Therefore, most of the requested information regarding acceptance criteria, performance, sample sizes, expert involvement, and ground truth for a diagnostic study cannot be extracted from this document.

Here's what can be inferred or explicitly stated based on the provided text, alongside what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Diagnostic Performance: (e.g., Sensitivity, Specificity, Accuracy for detecting gastric abnormalities)	NOT PROVIDED IN THIS DOCUMENT. The document focuses on the controller's performance and system compliance, not the diagnostic capabilities of the capsule endoscope.
NaviCam Xpress Controller meets performance requirements in specifications and implements software functions.	Passed: Verified that the NaviCam Xpress Controller meets its specifications and implements software functions as stated in its User Manual.
Magnetic field intensity range meets specifications with various examination beds.	Passed: Verified that the magnetic field intensity range meets specifications when used with examination beds/tables provided by users.
Mechanical motion range meets specifications.	Passed: Verified that the mechanical motion range meets specifications.
Titanium clips do not affect data communication, and clips do not move during magnetic head rotation.	Passed: Data communication not affected, and clip position does not change.
Compliance with IEC 60601-1, ANSI/AAMI ES60601-1, CAN/CSAC22.2 No. 60601-1:14, EN 60601-1:2006, AAMIIEC 60601-1-2:2014, EN 60601-1-2:2015.	Passed: The system was found to comply with all applicable requirements of these standards.

The following information cannot be extracted from the provided text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Reasoning for Missing Information:

This 510(k) summary focuses on demonstrating substantial equivalence for a modification to an already cleared device (the NaviCam Stomach System). The "Performance Data" section details bench/in-vitro testing and compliance with electrical safety and EMC standards. It explicitly states, "The NaviCam Xpress Stomach System successfully passed the following test," and then lists functional and safety-related tests for the controller. It does not discuss any clinical diagnostic performance studies comparing the NaviCam Xpress Stomach System's ability to detect stomach abnormalities against a ground truth, which would involve patient data, expert review, and metrics like sensitivity or specificity.

Summary

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May 4, 2021

AnX Robotica Corp Shoshana (Shosh) Friedman VP of Quality and Regulatory Affairs 1047 Serpentine Lane Pleasanton, CA 94566

Re: K203192

Trade/Device Name: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) Regulation Number: 21 CFR 876.1310 Regulation Name: Magnetically maneuvered capsule endoscopy system Regulatory Class: II Product Code: QKZ Dated: March 24, 2021 Received: March 26, 2021

Dear Shoshana (Shosh) Friedman:

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

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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 (OS) 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,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203192

Device Name

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System)

Indications for Use (Describe)

The NaviCam Xpress Stomach System is intended for visualization of the stomach of adults (≥22 years) with BMI <38. The system can be used in clinics and hospitals, including ER settings.

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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510(K) SUMMARY NaviCam Xpress Stomach System 510(k) Number K203192

1. SUBMITTER

Applicant's Name:

AnX Robotica, Corp. 1047 Serpentine Lane (Suite 100) Pleasanton, CA 94566 Nazareth, Israel Phone: (925) 202-2247 Fax: (925) 201-3852

Primary Contact:

Shoshana (Shosh) Friedman Senior Regulatory Affairs Consultant Phone: (704) 430-8695 s.friedman@promedoss.com

2. DATE PREPARED 04/19/2021

3. DEVICE

Trade Name:

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System)

Classification Code: Name: Magnetically maneuvered capsule endoscopy system Product Code: QKZ Regulation No: 21 CFR 876.1310 Class: II Classification Panel: Gastroenterology/Urology

PREDICATE DEVICES 4.

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (NaviCam Stomach System) initially granted the De-Novo submission under DEN190037.

DEVICE DESCRIPTION 5.

The NaviCam Xpress Stomach System includes the following key components:

1. Ingestible capsule (AKEM-11SW) for obtaining images.
1. Data recorder (AKR-1) for logging image data.
1. Locator (AKS-1) for turning on the capsule and for determining if the capsule is still in the body.

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1. Controller (NaviEC-2000) with the NaviCtrl software that allows the navigation of the capsule within the stomach.
1. ESView software for review of the images obtained by the capsule and generating reports.

INDICATIONS FOR USE 6.

The NaviCam Xpress Stomach System is intended for visualization of the stomach of adults (≥22 years) with BMI <38. The system can be used in clinics and hospitals, including ER settings.

7. SUBSTANTIAL EQUIVALENCE

The NaviCam Xpress Stomach System is substantially equivalent to the predicate device based on the following:

Indications for Use

The intended use of the proposed system and the cleared system are identical.

Technology

The purpose of this submission is the modification of the NaviCam Controller for the purpose of making a compact version called Xpress and, consequently, implementation of several changes to the system that were needed to enable this modification.

Main changes that were implemented include:

Integration of the console into the controller and addition of a touch screen. ●
. Separation of the image review function from the main system software to a dedicated review software, named ESView, that can run on PC/laptop.
Removal of the examination bed allowing the use of standard examination beds that . comply with the provided specifications.
Addition of anti-collision sensor to prevent colliding with a person or object and ● replacement of the motor with a safer one.

Operation

The NaviCam procedure with the NaviCam Xpress System was slightly adjusted to accommodate the changes mentioned above.

Discussion

The NaviCam Xpress Stomach System has substantially similar indications and contraindications, technological and performance characteristics, and operational characteristics as these of the NaviCam Stomach System predicate device. Any differences between the two systems have been addressed through testing.

8. PERFORMANCE DATA

Bench/In-Vitro Testing

The NaviCam Xpress Stomach System successfully passed the following test:

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Test	Purpose
NaviCam Xpress Controller System Test	To verify that the NaviCam Xpress Controller meets theperformance requirements stated in its specifications andimplements the software functions stated in its User Manual.
NaviCam Xpress System Magnetic FieldIntensity Range Test	To verify that the magnetic field intensity range of NaviCamXpress meets its specifications when used with examinationbeds/tables provided by the users.
NaviCam Xpress Controller MechanicalMotion Range Test	To verify that the mechanical motion range of the NaviCamXpress Controller meets its specifications.
Influence of Titanium Clips on theController's Ability to Control the Capsuleand the Packet Loss Rate DuringCommunication	To test whether the data communication of the capsule willbe affected when the titanium clip, the capsule and the datarecorder are in the magnetic field of the controller, andwhether the position of the titanium clip will change whenthe magnetic head rotates.

Additionally, the NaviCam Xpress Stomach System was tested for compliance with the following standards:

IEC 60601-1 Edition 3.1 (2012) ●
ANSI/AAMI ES60601-1 (2005/(R)2012 + A1:2012, C1:2009/(R)2012 + ● A2:2010/(R)2012) - Amendment 1 - Revision Date 2012/08/21
CAN/CSAC22.2 No. 60601-1:14 - Edition 3 - Revision Date 2014/03;
EN 60601-1:2006 + A1:2013 + A12:2014
AAMIIEC 60601-1-2:2014
EN 60601-1-2:2015 ●

The system was found to comply with all applicable requirements of these standards.

CONCLUSION 9.

AnX Robotica, Corp. believes that the NaviCam Xpress Stomach System is substantially equivalent to its predicate device, the NaviCam Stomach System. It has substantially equivalent indications for use, technological, performance characteristics as well as operational characteristics, and therefore does not introduce any new safety or effectiveness concerns.

Regulation Number and Section

§ 876.1310 Magnetically maneuvered capsule endoscopy system.

(a)
Identification. A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing with the device under anticipated conditions of use must evaluate visualization of the intended region and document the adverse event profile.
(2) Non-clinical testing data must demonstrate the optical, mechanical, and functional integrity of the device under physically stressed conditions. The following performance characteristics must be tested, and detailed protocols must be provided for each test:
(i) A bite test must be performed to ensure that the capsule can withstand extreme cases of biting;
(ii) A pH resistance test must be performed to evaluate integrity of the capsule when exposed to a physiological relevant range of pH values;
(iii) A battery life test must be performed to demonstrate that the capsule's operating time is not constrained by the battery capacity;
(iv) A shelf life test must be performed to demonstrate that the device performs as intended at the proposed shelf life date;
(v) Optical testing must be performed to evaluate fundamental image quality characteristics such as resolution, field of view, depth of field, geometric distortion, signal to noise ratio, dynamic range, and image intensity uniformity;
(vi) A color performance test must be performed to compare the color differences between the input scene and output image;
(vii) A photobiological safety analysis must be performed based on maximum (worst-case) light exposure to internal gastrointestinal mucosa, and covering ultraviolet, visible, and near-infrared ranges, as appropriate. A mitigation analysis must be provided;
(viii) Performance testing must demonstrate that the viewing software clearly presents the current frame rate, which is either adjustable manually by the user or automatically by the device. Testing must demonstrate that the viewing software alerts the user when the video quality is reduced from nominal due to imaging data communication or computation problems;
(ix) A data transmission test must be performed to verify the robustness of the data transmission between the capsule and the receiver. This test must include controlled signal attenuation for simulating a non-ideal environment; and
(x) Magnetic field strength testing characterization must be performed to identify the distances from the magnet that are safe for patients and users with ferromagnetic implants, devices, or objects.
(3) Software validation, verification, and hazard analysis must be provided.
(4) Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility testing must be performed.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Performance data must validate the reprocessing instructions for the reusable components of the device.
(7) Performance data must demonstrate the sterility of any device components labeled sterile.
(8) Human factors testing must demonstrate that the intended users can safely and correctly use the device, based solely on reading the instructions for use.
(9) Clinician labeling must include:
(i) Specific instructions and the clinical and technical expertise needed for the safe use of the device;
(ii) A detailed summary of the clinical testing pertinent to use of the device, including information on effectiveness and device- and procedure-related complications;
(iii) The patient preparation procedure;
(iv) A detailed summary of the device technical parameters;
(v) Magnetic field safe zones;
(vi) A screening checklist to ensure that all patients and operating staff are screened from bringing ferromagnetic implants, devices, or objects near the external magnet;
(vii) Reprocessing instructions for reusable components;
(viii) Shelf life for single use components; and
(ix) Use life for reusable components.
(10) Patient labeling must include:
(i) An explanation of the device and the mechanism of operation;
(ii) The patient preparation procedure;
(iii) A brief summary of the clinical study; and
(iv) A summary of the device- and procedure-related complications pertinent to use of the device.