(92 days)
No
The summary describes a magnetically maneuvered capsule endoscope system for visualization. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the mechanical control and visualization capabilities.
No.
The device is intended for "visualization of the stomach" and "visualizing the esophagus", which are diagnostic purposes, not therapeutic ones.
Yes
The device aids in the visualization of anatomical sites (stomach and esophagus) to inform diagnosis, which aligns with the definition of a diagnostic device.
No
The device description clearly details a physical capsule endoscope and a tether, which are hardware components. The summary also mentions clinical and bench testing related to the performance of this physical system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The NaviCam Xpress Stomach Capsule System is a medical device used for visualization of the stomach and esophagus. It involves a capsule that is swallowed and transmits images from inside the body. This is an in vivo procedure (performed within a living organism), not an in vitro procedure.
- Intended Use: The intended use clearly states "visualization of the stomach" and "visualizing the esophagus." This aligns with diagnostic imaging, not in vitro testing.
- Device Description: The description focuses on the mechanical and imaging capabilities of the capsule and the system for controlling its movement and capturing images.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or performing any laboratory-based tests.
Therefore, the NaviCam Xpress Stomach Capsule System is a medical device used for endoscopic imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NaviCam Xpress Stomach Capsule is intended for visualization of the stomach of patients => 6 years old with BMI == 6 years old
Intended User / Care Setting
clinics and hospitals, including ER settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Experience: The company is providing articles on the use of the NaviCam Stomach Capsule System that were published in the scientific literature along with unpublished clinical reports. The clinical data demonstrate using the system on lower age patients and higher BMI doesn't affect performance of the device. This real-world evidence demonstrates the safety and adds value by reaching additional patients that would benefit from the NaviCam Xpress Stomach Capsule System procedure. The NaviCam Xpress Stomach Capsule System procedure does not require sedation which is particularly important for children and obese patients from a procedure risk perspective.
Bench Testing: The company provided technical data demonstrating capsule and system performance would not be affected by increasing the BMI of the patient up to the limitations stated in the report.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows 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.
October 3, 2023
AnX Robotica Corporation Tim Thomas VP, Regulatory/Quality/Clinical 6010 W Spring Creek Parkway Plano, Texas 75024
Re: K231960
Trade/Device Name: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam 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: June 30, 2023 Received: July 5, 2023
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.
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).
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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 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-reportingcombination-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-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.
Sivakami Venkatachalam -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 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
510(k) Number (if known) K231960
Device Name
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether
Indications for Use (Describe)
The NaviCam Xpress Stomach Capsule is intended for visualization of the stomach of patients => 6 years old with BMI = 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."
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510(K) SUMMARY
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Express Stomach System) with NaviCam Stomach Capsule and NaviCam Tether
510(k) Number K231960
1. SUBMITTER
Applicant's Name:
AnX Robotica, Corp. 6010 W. Spring Creek Parkway Plano, TX 75024 Phone: (469) 606-9495
Primary Contact:
Tim Thomas, RAC VP, Regulatory/Quality/Clinical Phone: (770) 480-2911 Email: tim.thomas@anxrobotics.com
2. DATE PREPARED 06/30/2023
3. DEVICE
| Trade Name: | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Express 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
PREDICATE DEVICES 4.
Primary - NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Express Stomach System) with NaviCam Stomach Capsule and NaviCam Tether (K221608). References - Given PillCam Platform with PillCam SB Capsules with PillCam SensorBelt (K103088) and Given PillCam Platform with PillCam SB Capsules, Given AGILE Patency System (K090557).
5. DEVICE DESCRIPTION
NaviCam® Xpress Stomach Capsule Endoscope System enables the operator to control the capsule endoscope inside the stomach. The capsule endoscope can be moved in any
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direction during examination. The direction and angulation of the capsule camera head can be adjusted in 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.
6. INDICATIONS FOR USE
The NaviCam Xpress Stomach Capsule is intended for visualization of the stomach of patients ≥ 6 years old with BMI ≤ 65 and a waist circumference ≤ 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 and NaviCam Tether, are:
The NaviCam Xpress Stomach Capsule is intended for visualization of the stomach of patients ≥ 6 years old with BMI ≤ 65 and a waist circumference ≤ 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 of the NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Express Stomach System) with NaviCam Stomach Capsule and NaviCam Tether are the same to the indications for use of the previous FDA clearance except for the expanded age limitation and BMI limitation based on clinical data and bench testing. The changes are similar to Given PillCam indications that expanded the age limit and expanded the BMI limit based on available clinical data.
Technological Characteristics
The technological characteristics of the NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Express Stomach System) with NaviCam Stomach Capsule and NaviCam Tether are equivalent (the same system) to the NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Express Stomach System) with NaviCam Stomach Capsule and NaviCam Tether. No changes to the equipment nor the software have been made, just the indication for use statement has been expanded.
8. PERFORMANCE DATA
Clinical Experience
5
The company is providing articles on the use of the NaviCam Stomach Capsule System that were published in the scientific literature along with unpublished clinical reports. The clinical data demonstrate using the system on lower age patients and higher BMI doesn't affect performance of the device. This real-world evidence demonstrates the safety and adds value by reaching additional patients that would benefit from the NaviCam Xpress Stomach Capsule System procedure. The NaviCam Xpress Stomach Capsule System procedure does not require sedation which is particularly important for children and obese patients from a procedure risk perspective.
Bench Testing
The company provided technical data demonstrating capsule and system performance would not be affected by increasing the BMI of the patient up to the limitations stated in the report.
9. CONCLUSION
The expansion of the indications for use does not affect the performance of its parent device, the NaviCam Xpress Stomach Capsule Endoscope Systems, and does not pose any new risks to the patient as demonstrated using the device in clinical settings.