(188 days)
No
The summary does not mention AI, ML, or any related concepts like image processing or algorithms that would typically indicate the presence of AI/ML. The focus is on magnetic control and image acquisition.
No
The device is intended for visualization and imaging of the stomach, not for treating a disease or condition.
Yes.
The device is intended for "visualization of the stomach," which is a process of observing the internal structure to identify abnormalities, a key step in diagnosis. The system also includes "ESView software for review of the images obtained by the capsule and generating reports," indicating its role in providing information for diagnostic purposes.
No
The device description explicitly lists multiple hardware components (ingestible capsule, data recorder, locator, controller) in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- NaviCam Xpress Stomach System Function: The NaviCam Xpress Stomach System is an endoscopic capsule imaging system. It is ingested by the patient and takes images inside the body (in vivo) for visualization of the stomach. It does not analyze specimens taken from the body.
Therefore, based on the provided information, the NaviCam Xpress Stomach System falls under the category of an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NaviCam Xpress Stomach System is intended for visualization of the stomach of adults (≥22 years) with BMI
§ 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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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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: (925) 202-2247 Fax: (925) 201-3852
Primary Contact:
Shoshana (Shosh) Friedman Senior Regulatory Affairs Consultant Phone: (704) 430-8695 s.friedman@promedoss.com
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:
-
- Ingestible capsule (AKEM-11SW) for obtaining images.
-
- Data recorder (AKR-1) for logging image data.
-
- Locator (AKS-1) for turning on the capsule and for determining if the capsule is still in the body.
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- Controller (NaviEC-2000) with the NaviCtrl software that allows the navigation of the capsule within the stomach.
-
- 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