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 Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the NaviCam Capsule Endoscope System and the NaviCam Xpress Stomach Capsule Endoscope System to allow for examination of the esophagus prior to releasing the NaviCam Capsule into the stomach. The NaviCam Tether is comprised of a tube which on one end is attached to a capsule cradle and on the other end is attached to a syringe connector. The capsule cradle holds the capsule in place while examining the esophagus. The tube is used to control the downward speed of the capsule in the esophagus. The syringe connector serves for releasing the capsule by attaching to it a standard syringe filled with air. After the examination of the esophagus is accomplished, the syringe piston is pushed to release the capsule for examining the stomach with the NaviCam Capsule Endoscope System or the NaviCam Xpress Stomach Capsule Endoscope System.

AI/ML Overview

The provided text does not describe an AI-powered device or a study proving its performance against specific acceptance criteria. Instead, it is a 510(k) summary for a NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether. This system is a medical device for visualizing the stomach and esophagus, and the submission focuses on demonstrating its substantial equivalence to previously cleared predicate devices.

Therefore, I cannot provide the information requested in the prompt, as it pertains to AI-specific performance criteria and studies, which are not present in the provided document.

Here's an analysis of why the requested information cannot be extracted from the given text:

No mention of AI/ML: The document does not describe the device as having any artificial intelligence or machine learning components. It's a hardware device (capsule endoscope and tether) for aiding visualization.
No acceptance criteria for AI performance: Since there's no AI, there are no acceptance criteria related to its performance (e.g., sensitivity, specificity, AUC).
No study proving AI performance: Consequently, there's no study described that would prove the device meets AI-specific acceptance criteria. The performance data section focuses on non-clinical (biocompatibility, bench testing) and clinical experience (references to scientific literature demonstrating safety and value, and a meta-analysis on battery life), not AI performance.
No data provenance for AI testing: Without AI, there's no test set, training set, or related data provenance for AI models.
No experts for AI ground truth: The concept of experts establishing ground truth for AI model performance isn't applicable here.
No MRMC study: The document does not describe a multi-reader multi-case study, which is typically done to assess the impact of AI assistance on human readers.
No standalone algorithm performance: As it's not an algorithm, there's no standalone performance to report.
No ground truth type for AI: The "ground truth" discussed in the context of AI (e.g., pathology, expert consensus for disease detection) is not relevant for this device's submission.

In summary, the provided FDA 510(k) summary is for a physical medical device (capsule endoscopy system) and does not involve AI. Therefore, the questions related to AI-specific performance criteria and studies cannot be answered from this text.

Summary

{0}------------------------------------------------

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.

November 22, 2022

AnX Robotica Corp Tim Thomas VP, Regulatory/Quality/Clinical 6010 W. Spring Creek Parkway Plano, TX 75024

Re: K221608

Trade/Device Name: NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether Regulation Number: 21 CFR 876.1310 Regulation Name: Magnetically maneuvered capsule endoscopy system Regulatory Class: Class II Product Code: QKZ Dated: October 24, 2022 Received: October 26, 2022

Dear Tim Thomas:

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/cdrl/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.

{1}------------------------------------------------

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-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).

Sincerelv. Glenn B. Bell -S

for 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

{2}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K221608

Device Name

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether,

NaviCan Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether

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)

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 time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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 (6/20)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

{3}------------------------------------------------

K221608 Page 1 of 3

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether Section 5: 510(k) Summary - Revised v3

510(K) SUMMARY NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether 510(k) Number K221608

1. SUBMITTER

Applicant's Name:

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

Primary Contact:

Tim Thomas, RAC VP. Regulatory/Ouality/Clinical Phone: (770) 480-2911 Email: tim.thomas@anxrobotics.com

2. DATE PREPARED 11/17/2022

DEVICE 3.

Trade Name: NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether

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

4. PREDICATE DEVICES

Primary - NaviCam Capsule Endoscope System with NaviCam Stomach Capsule ("NaviCam System") granted the De-Novo submission under DEN190037. NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) cleared under K203192. Reference - Given Imaging PillCam® Express™ Video Capsule Delivery Device ("PillCam Delivery Device") cleared under K101200.

DEVICE DESCRIPTION 5.

{4}------------------------------------------------

INDICATIONS FOR USE 6.

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

Indications

The proposed indications for use of the NaviCam Stomach Capsule and NaviCam Tether, as an optional accessory to the NaviCam Capsule Endoscope System and the NaviCam Xpress Stomach Capsule Endoscope System, are:

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 indications for use of the NaviCam Stomach Capsule and NaviCam Tether complement the indications for use of the NaviCam Capsule Endoscope System and the NaviCam Xpress Stomach Capsule Endoscope System, as appropriate for an optional accessory intended to supplement/augment the performance of the parent device.

Technological Characteristics

The technological characteristics of the NaviCam Stomach Capsule and NaviCam Tether is substantially similar to the PillCam Delivery Device. Both devices are comprised of three elements: a capsule cradle/holder, a tube/catheter, and a syringe/syringe connector. In both

{5}------------------------------------------------

devices the capsule holder/cradle is designed to hold the capsule in place and in both devices an air-filled syringe is used to pneumatically release the capsule from the cradle/holder.

PERFORMANCE DATA 8.

Non-Clinical Performance Testing:

Non-clinical and biological testing was completed to assess the performance and biocompatibility of the NaviCam Stomach Capsule and NaviCam Tether. The data provided in this 510(k) submission shows that the device is biocompatible and performs as intended based on the bench testing. The list of these tests is provided in Table 8-1.

Table 8-1: List of Non-Clinical Tests Completed on NaviCam Tether

Biocompatibility
Cytotoxicity
Sensitization (0.9% NaCl)
Sensitization (Sesame Oil)
Intracutaneous Reactivity
Bench Testing
Third Party Performance Test
Product Verification Test v2
pH Tolerance Test
Bite Force Test
Battery Life Test

Animal and Clinical Performance Testing:

Animal and clinical performance testing was not conducted.

Clinical Experience

The company provided articles on the use of the NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether that were published in the scientific literature. This real-world evidence demonstrates the safety and additional value of using the NaviCam Stomach Capsule and NaviCam Tether as part of the NaviCam stomach procedure (MCCE). Also included in a meta-analysis of esophageal and stomach examination times from clinical studies to show the combined examination time is well within the capsule battery life so both examinations may be completed satisfactorily.

9. CONCLUSION

The NaviCam Stomach Capsule and NaviCam Tether is an optional accessory to the NaviCam Capsule Endoscope System and the NaviCam Xpress Stomach Capsule Endoscope System which aims to supplement and augment the performance of the NaviCam Capsule by allowing the physician to control its downwards speed when moving through the esophagus. The NaviCam Stomach Capsule and NaviCam Tether does not affect the indications and performance of its parent devices, NaviCam Capsule Endoscope System and the NaviCam Xpress Stomach Capsule Endoscope System, and does not pose any new risks to the patient as demonstrated by the use of the device in clinical settings.

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.