NaviCam Xpress Stomach System

K203192 · Anx Robotica Corp · QKZ · May 4, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K203192
• Device Name: NaviCam Xpress Stomach System
• Applicant: Anx Robotica Corp
• Product Code: QKZ · Gastroenterology, Urology
• Decision Date: May 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1310
• Device Class: Class 2

Intended Use

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 Story

NaviCam Xpress Stomach System is a magnetically maneuvered capsule endoscopy system for gastric visualization. System components include an ingestible imaging capsule (AKEM-11SW), data recorder (AKR-1), locator (AKS-1), controller (NaviEC-2000) with NaviCtrl software, and ESView review software. Operator uses the controller to generate magnetic fields that manipulate the capsule's position within the stomach. Images are captured by the capsule, logged by the data recorder, and subsequently reviewed by a clinician on a PC/laptop using ESView software to generate reports. Used in clinics, hospitals, and ER settings. The system features an integrated console with a touchscreen, anti-collision sensors, and compatibility with standard examination beds. Benefits include non-invasive gastric visualization through controlled capsule navigation.

Clinical Evidence

Bench testing only. Testing verified controller performance, magnetic field intensity ranges, mechanical motion ranges, and communication stability in the presence of titanium clips. Compliance with IEC 60601-1 and ANSI/AAMI ES60601-1 standards was confirmed.

Technological Characteristics

Magnetically maneuvered capsule endoscopy system. Components: ingestible capsule, data recorder, locator, controller with touchscreen, and PC-based review software. Features anti-collision sensors. Connectivity: wireless capsule-to-recorder communication. Standards: IEC 60601-1 (Ed 3.1), ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, AAMI/IEC 60601-1-2.

Indications for Use

Indicated for visualization of the stomach in adults (≥22 years) with BMI <38.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the magnetically maneuvered capsule endoscopy system is subject to the following special controls:

*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.

Predicate Devices

• NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (DEN190037)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone]

## Primary Contact:

Shoshana (Shosh) Friedman Senior Regulatory Affairs Consultant Phone: [phone] [e-mail]

#### 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 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:

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

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- 4. Controller (NaviEC-2000) with the NaviCtrl software that allows the navigation of the capsule within the stomach.
- 5. 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 the<br>performance requirements stated in its specifications and<br>implements the software functions stated in its User Manual. |
| NaviCam Xpress System Magnetic Field<br>Intensity Range Test | To verify that the magnetic field intensity range of NaviCam<br>Xpress meets its specifications when used with examination<br>beds/tables provided by the users. |
| NaviCam Xpress Controller Mechanical<br>Motion Range Test | To verify that the mechanical motion range of the NaviCam<br>Xpress Controller meets its specifications. |
| Influence of Titanium Clips on the<br>Controller's Ability to Control the Capsule<br>and the Packet Loss Rate During<br>Communication | To test whether the data communication of the capsule will<br>be affected when the titanium clip, the capsule and the data<br>recorder are in the magnetic field of the controller, and<br>whether the position of the titanium clip will change when<br>the 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.