The NaviCam Stomach Capsule 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.

The NaviCam Tether is an accessory of the NaviCam Stomach Capsule. It is intended to aid the Capsule for visualizing the esophagus (not magnetically maneuvered) prior to the Capsule's release into the stomach capsule endoscopy (MCCE) procedure.

Device Description

The NaviCam Xpress Stomach System is a novel 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:

1. Ingestible capsule (CP-US-7005) for obtaining images.
1. Data recorder (MC-US-1006) for logging image data.
1. Locator (SB-US-2006) for turning on the capsule and for determining if the capsule is still in the body.
1. Controller, NaviEC-2000 (MC-US-1002) 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.
Optional Accessory: NaviCam Tether (ES-US-7005) for aiding the capsule in visualizing 6. the esophagus.

AI/ML Overview

This document is a 510(k) summary for a software addition, not a comprehensive clinical study report. Therefore, much of the requested information about clinical performance, ground truth, and expert involvement is not present in this document.

Here's a breakdown of what can be extracted based on the provided text:

Device: NaviCam Xpress Stomach System (addition of GastroScan feature to NaviCtrl software)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for the device's diagnostic capabilities. Instead, it focuses on demonstrating that the software addition does not negatively impact the existing cleared device's performance or introduce new risks. The reported "performance" is that the device "performs as intended based on the non-clinical bench testing."

Acceptance Criteria (Implied by the submission)	Reported Device Performance
Software updates function as intended	Verified through Software Verification Testing
Device remains safe and effective (no new risks introduced by software update)	Demonstrated by Human Factors Engineering/Usability Testing/Evaluation, performance bench testing, software risk analysis, and cybersecurity FMEA risk analysis.
No changes to existing indications for use	The device retains the same Indications for Use as the predicate device.
No degradation in performance compared to the predicate device	Not explicitly quantified, but implied by successful non-clinical testing.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified for any performance testing related to diagnostic accuracy. The non-clinical performance and bench testing would have used specific test cases, but the number of such cases is not provided.
Data Provenance: The new software features were evaluated through non-clinical performance and bench testing. This is typically internal testing. No information about country of origin for this testing or whether it was retrospective or prospective is provided. The document states that "No additional Animal and clinical performance testing were conducted."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this submission, as no new clinical performance testing was conducted. Ground truth for previous clinical evidence (mentioned in point 9) would have been established, but details are not provided here.

4. Adjudication Method for the Test Set

Not applicable for this submission, as no new clinical performance testing was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done for this submission. The document explicitly states "No additional clinical literature has been provided in this submission." It refers to previous clinical evidence from predicate devices but does not provide details of those studies in this document.

6. Standalone Performance Study

A standalone study of the algorithm's core diagnostic performance (e.g., sensitivity/specificity for detecting stomach abnormalities) was not performed as part of this specific submission. The submission focuses on the safety and efficacy of a software addition to an already cleared device. The "performance bench testing" mentioned would assess the functionality of the new software feature (GastroScan) rather than clinical diagnostic accuracy.

7. Type of Ground Truth Used

For this specific submission, the "ground truth" for the non-clinical performance and bench testing would be defined by the expected outcomes of the software functions and hardware interactions as specified in design documents and testing protocols. No clinical ground truth (e.g., pathology, expert consensus on patient cases) was used for this particular submission's evaluation.

8. Sample Size for the Training Set

No training set information is provided, as this submission is for a software feature addition to a previously cleared device. It's unlikely that machine learning model training was a primary component of this specific update.

9. How the Ground Truth for the Training Set Was Established

Not applicable for this submission (see point 8).

Summary of this Submission's Focus:

This 510(k) submission (K230694) is for a software update (GastroScan feature) to an already cleared device (NaviCam Xpress Stomach System, K203192). The primary goal of this submission is to demonstrate that this software addition does not change the indications for use, does not introduce new risks, and does not negatively impact the performance of the existing device. Therefore, the evidence focuses on non-clinical software verification, human factors, and risk analysis, rather than new clinical trials or diagnostic performance metrics. The clinical evidence for the overall system's diagnostic capabilities would have been established in previous submissions (DEN190037 and K203192).

Summary

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April 13, 2023

AnX Robotica Corp. Cathlena Martinez Regulatory and Clinical Affairs Manager 6010 W Spring Creek Pkwy Plano, TX 75024

Re: K230694

Trade/Device Name: NaviCam Xpress Stomach System, NaviCam Xpress System Regulation Number: 21 CFR 876.1310 Regulation Name: Magnetically maneuvered capsule endoscopy system Regulatory Class: Class II Product Code: QKZ Dated: March 13, 2023 Received: March 14, 2023

Dear Cathlena Martinez:

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

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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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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 -S

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230694

Device Name NaviCam Xpress Stomach System

Indications for Use (Describe)

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

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NaviCam Xpress Stomach system GastroScan feature Software Addition Section 7: 510(k) Summary

510(K) SUMMARY NaviCam Xpress Stomach System GastroScan feature Software Addition 510(k) Number

1. SUBMITTER

Applicant's Name:

AnX Robotica, Corp. 6010 W. Spring Creek Parkway Plano, TX 75024 Phone: (469) 606-9495

Primary Contact:

Cathlena Martinez, CQA Manager, Regulatory/Clinical Phone: (859) 801-8517 Email: lena.martinez@anxrobotics.com

2. DATE PREPARED 03/09/2023

DEVICE 3.

Trade Name: NaviCam Xpress Stomach system (NaviCam Xpress system)

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

PREDICATE DEVICES 4.

Primary predicate- NaviCam Xpress Stomach system (NaviCam Xpress system) cleared under the 510(k) submission K203192.

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

DEVICE DESCRIPTION 5.

The NaviCam Xpress Stomach System includes the following key components:

CONFIDENTIAL 007_NaviCam Xpress 510k Summary

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NaviCam Xpress Stomach system GastroScan feature Software Addition Section 7: 510(k) Summary

1. Ingestible capsule (CP-US-7005) for obtaining images.
1. Data recorder (MC-US-1006) for logging image data.
1. Locator (SB-US-2006) for turning on the capsule and for determining if the capsule is still in the body.
1. Controller, NaviEC-2000 (MC-US-1002) 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.
Optional Accessory: NaviCam Tether (ES-US-7005) for aiding the capsule in visualizing 6. the esophagus.

6. INDICATIONS FOR USE

The NaviCam Stomach Capsule 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

Intended Use/ Indications for Use

There are no proposed changes to the indications for use of the NaviCam Xpress system.

Technological Characteristics

The NaviCam Xpress system (subject device) and predicate device (NaviCam Xpress system) system components are identical to the components of the currently marketed predicate device. Both the subject device and the predicate device, use the same mechanisms to fulfill their identical intended use, and share the same technological characteristics, respectively. The subject device operates using the same technology and technological characteristics as the currently marketed predicate device.

Both the subject device, and reference device, are technologically similar which are capsule endoscopy systems comprised of four elements: a capsule, a data recorder, software, controller and a workstation. In both devices the capsule is intended to be used as part of a system to visualize the gastrointestinal (GI) tract.

The only difference between the subject device and the currently marketed predicate device is a change to the NaviCtrl software and labeling for the subject device to add the GastroScan feature to align with the reference device (NaviCam Stomach system) software features which include the GastroScan (previously known as macro command) feature.

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8. PERFORMANCE DATA

Non-Clinical Performance Testing/ Bench Testing:

Non-clinical performance and bench testing was completed to assess the performance of the NaviCam Xpress system with the updates to the NaviCtrl software to include the GastroScan feature. The data provided in this 510(k) submission shows that the device performs as intended based on the non-clinical bench testing. The list of these tests is provided in Table 8-1.

Table 8-1: List of Non-Clinical Tests Completed on NaviCam Xpress Stomach System NaviCtrl Software with GastroScan feature.

Non-clinical/ Bench Testing

Software Verification Testing

Human Factors Engineering/ Usability Testing/ Evaluation

Animal and Clinical Performance Testing:

No additional Animal and clinical performance testing were conducted.

Clinical Experience

No additional clinical literature has been provided in this submission. The previously submitted clinical evidence provided as part of the reference device De Novo, DEN190037, and primary predicate device 510k, K203192, submissions remain applicable and relevant to the subject device.

CONCLUSION 9.

The NaviCam Xpress NaviCtrl software with GastroScan is a low-risk, device software component of the NaviCam Xpress Stomach system. The addition of the GastroScan feature to align with the previously approved marketed device, NaviCam Stomach system (DEN190037) and its component software, does not affect the indications and performance of the predicate device, and does not pose any new risks to the patient as demonstrated by the performance bench testing and software risk analysis, and cybersecurity FMEA risk analysis evaluations.

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.