NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)

K241934 · Anx Robotica Corp · QKZ · Jul 31, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K241934
• Device Name: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
• Applicant: Anx Robotica Corp
• Product Code: QKZ · Gastroenterology, Urology
• Decision Date: Jul 31, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1310
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The NaviCam Stomach Capsule is intended for visualization of the stomach of patients greater than or equal to 6 years old with BMI less than or equal to 65 and a waist circumference less than or equal to 77 inches. 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 for a stomach capsule endoscopy (MCCE) procedure.

Device Story

NaviCam Xpress Stomach System is a magnetically maneuvered capsule endoscopy system. Operator controls capsule movement inside the stomach in X, Y, and Z axes, including rotation, via magnetic manipulation. System captures real-time video images of the stomach; tether accessory allows esophageal visualization prior to capsule release. Used in clinics and hospitals, including ER settings, by trained clinicians. Output consists of visual imagery for clinical assessment of gastric mucosa. Benefits include non-invasive visualization of the stomach. Device incorporates a 915 MHz radio transmission frequency for data communication.

Clinical Evidence

Bench testing only. Software verification and validation were performed to confirm the integration of the 915 MHz radio transmission frequency.

Technological Characteristics

Magnetically maneuvered capsule endoscope system. Radio transmission frequency: 915 MHz (reduced from 2.4 GHz to lower SAR). Single-use capsule and tether accessory. System enables 6-degree-of-freedom movement (X, Y, Z, and rotation).

Indications for Use

Indicated for visualization of the stomach in patients ≥ 6 years old, BMI ≤ 65, and waist circumference ≤ 77 inches. Tether accessory indicated for esophageal visualization prior to stomach release.

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 Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (K231960)

Reference Devices

• NaviCam Small Bowel Capsule Endoscope System with NaviCam SB Capsule/Tether (K233229)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 31, 2024

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

Re: K241934
Trade/Device Name: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
Regulation Number: 21 CFR 876.1310
Regulation Name: Magnetically Maneuvered Capsule Endoscopy System
Regulatory Class: Class II
Product Code: QKZ
Dated: June 28, 2024
Received: July 2, 2024

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K241934 - Tim Thomas
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/medical-device-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-devices/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-advice-comprehensive-regulatory-assistance/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).

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K241934 - Tim Thomas
Page 3

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 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
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)

K241934

Device Name

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/ Tether)

Indications for Use (Describe)

The NaviCam Stomach Capsule is intended for visualization of the stomach of patients greater than or equal to 6 years old with BMI less than or equal to 65 and a waist circumference less than or equal to 77 inches. 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 for a stomach capsule endoscopy (MCCE) procedure.

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.

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K241934
Page 1 of 3
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System)
with NaviCam Stomach Capsule/Tether
510(k) Summary

# 510(K) SUMMARY

NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether

510(k) Number K241934

# 1. SUBMITTER

Applicant's Name:
AnX Robotica, Corp.
6010 W. Spring Creek Parkway
Plano, TX 75024
Phone: [phone]

Primary Contact:
Tim Thomas, RAC
VP, Regulatory/Quality/Clinical
Phone: [phone]
Email: [e-mail]

# 2. DATE PREPARED

JUNE 28, 2024

# 3. DEVICE

Trade Name: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/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 Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (K231960).
Reference – NaviCam Small Bowel Capsule Endoscope System with NaviCam SB Capsule/Tether (K233229).

# 5. DEVICE DESCRIPTION

NaviCam® Stomach Capsule Endoscope Systems enable the operator to control the capsule endoscope inside the stomach. The capsule endoscope can be moved in any direction during examination. The direction and angulation of the capsule camera head can be adjusted in

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K241934
Page 2 of 3
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System)
with NaviCam Stomach Capsule/Tether
510(k) Summary

real-time, hence realizing complete control of capsule endoscope movement and attitude during examination in the X left and right, Y forward and backward, Z up and down directions as well as rotation clockwise and counterclockwise.

The NaviCam Capsule/Tether is a single use accessory device for the NaviCam Xpress Stomach System to allow for visualization of the esophagus (not magnetically maneuvered) prior to releasing the Capsule into the stomach.

## 6. INDICATIONS FOR USE

The NaviCam Stomach Capsule is intended for visualization of the stomach of patients greater than or equal to 6 years old with BMI less than or equal to 65 and a waist circumference less than or equal to 77 inches. 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 for a stomach capsule endoscopy (MCCE) procedure.

## 7. SUBSTANTIAL EQUIVALENCE

### Indications

The proposed indications for use of the NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Express Stomach System) with NaviCam Stomach Capsule/Tether are: The NaviCam Stomach Capsule is intended for visualization of the stomach of patients greater than or equal to 6 years old with BMI less than or equal to 65 and a waist circumference less than or equal to 77 inches. 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 for a stomach capsule endoscopy (MCCE) procedure.

The current indications for use of the NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Express Stomach System) with NaviCam Stomach Capsule/Tether (K23190) are as follows:

The NaviCam Stomach Capsule is intended for visualization of the stomach of patients greater than or equal to 6 years old with BMI less than or equal to 65 and a waist circumference less than or equal to 77 inches. 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 for a stomach capsule endoscopy (MCCE) procedure.

The indications for use are the same, no change.

### Technological Characteristics

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NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether 510(k) Summary

K241934 Page 3 of 3

The technological characteristics of the NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether are like the existing cleared NaviCam Xpress Stomach System. The only difference is that the capsule radio transmission frequency has been changed from 2.4 GHz to 915 MHz which has a lower SAR (specific absorption rate, i.e., energy absorption rate through human body) than 2.4 GHz. The 915 MHz frequency has been cleared by FDA for the reference device, the NaviCam Small Bowel Capsule Endoscope System with NaviCam SB Capsule/Tether (K233229).

## 8. PERFORMANCE DATA

Software verification and validation was conducted to ensure that the NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether successfully incorporated the prior radio transmission frequency.

## 9. CONCLUSION

The indications for use have not changed for the NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/ Tether. The technological characteristics of the two capsules are substantially equivalent. Therefore, the NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether is substantially equivalent to the NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.