K Number
K210052
Device Name
Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))
Manufacturer
Date Cleared
2022-04-01

(448 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Saneso Colonoscope 360-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A, Saneso Processor-A and other ancillary equipment. The Saneso Gastroscope 360-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consistroscope 360-A/Saneso Single Camera Gastroscope-A, Saneso Processor-A and other ancillary equipment. The Saneso Single Camera Colonoscope-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and ileocecal valve). The system also provides access for therventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A/Saneso Single Camera Colonoscope-A, Saneso Processor-A and other ancillary equipment. The Saneso Single Camera Gastroscope-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Gastroscope 360-A/Saneso Single Camera Gastroscope-A. Saneso Processor-A and other ancillary equipment.
Device Description
The Saneso Colonoscope 360-A is an endoscopic platform for diagnostic visualization and therapeutic access to the lower gastrointestinal tract (including the anus, rectum, sigmoid colon, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system enables physicians to view a high resolution wide field of view of up to 360°. The system consists of Saneso camera heads, colonoscope, video system, light source and other ancillary equipment. The Saneso Colonoscope 360-A is a full circular view video colonoscope and features multiple viewing options: 5 camera 360-degree raw images, 5 camera-stitched 360-degree images, and forward only view modes. The selection is made through the video interface. The Saneso Colonoscope 360-A must be used in conjunction with the Saneso Processor-A. The Saneso Processor-A system serves as a control platform for the Saneso Colonoscope 360-A. The processor box consists of the electronics and mechanics required to operate the endoscope. It is responsible for image processing, transferring video signals from the colonoscope, pneumatic control of various external accessories that interface with the system. The accessories include the foot pedal, which is used to control the tissue wash water, the mouse, and the keyboard which are used for interfacing with the software and changing settings as needed. There are two monitors which can be connected, i.e. the master monitor and the slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes. The device is equipped with five cameras in order to provide a maximum 360° field of view (FOV) with high resolution video using external monitors connected through display ports. Each camera has LED light sources enabling the user to visualize in white light and other user selectable spectrum with Select Band Imaging or Dual Band Imaging modes (applicable only with SBI/DBI). The system is configured to transfer data to an external HL7 compliant electronic health record system. The system can be controlled using a mouse and keyboard. The Saneso Gastroscope 360-A is an endoscopic platform for diagnostic visualization and therapeutic access to the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system enables physicians to view a high resolution wide field of view of up to 360°. The system consists of Saneso camera heads, gastroscope, video system, light source and other ancillary equipment. The Saneso Gastroscope 360-A is a full circular view video gastroscope and features multiple viewing options: 5 camera 360-degree raw images, 5 camera-stitched 360-degree images and forward only view modes. The selection is made through the video interface. The Saneso Gastroscope 360-A must be used in conjunction with the Saneso Processor-A. The Saneso Processor-A system serves as a control platform for the Saneso Gastroscope 360-A. The processor box consists of the electronics and mechanics required to operate the endoscope. It is responsible for image processing, transferring video signals from the gastroscope, pneumatic control, and control of various external accessories that interface with the system. The accessories include the foot pedal, which is used to control the tissue wash water, the mouse and the keyboard which are used for interfacing with the software and changing settings as needed. There are two monitors which can be connected, i.e. the master monitor and the slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes. The device is equipped with five cameras in order to provide a maximum 360° field of view (FOV) with high resolution video using external monitors connected through display ports. Each camera has LED light sources enabling the user to visualize in white light and other user selectable spectrum with select either single band imaging or dual band imaging modes (applicable only with SBI/DBI). The system is configured to transfer data to an external HL7 compliant electronic health record system. The data is transferred using Wi-Fi or Ethernet. The system can be controlled using a mouse and keyboard. The Saneso Single Camera Colonoscope-A is an endoscopic platform that provides diagnostic visualization and therapeutic access to the lower gastrointestinal tract including the rectum, colon and ileocecal valve. The system employs Select Band Imaging mode. The Saneso Single Camera Colonoscope-A features a single camera at the distal end that offers a 140° Field of View. The distal end features the front camera. LED light assembly, instrument channel outlet, nozzle, tissue wash outlet. The Saneso Single Camera Colonoscope-A comprises programmable control buttons, insertion tube, suction valve, air/water valve, instrument channel port, umbilical cord, connector, angulation knobs and the bending section. The Saneso Single Camera Colonoscope-A must be used in conjunction with Saneso Processor-A. The Saneso Processor-A is preinstalled with the Saneso Image Processing software and serves as a control platform for the Saneso Single Camera Colonoscope-A. The Saneso Processor processes the image and relays the video signals from the colonoscope to external display monitors. The Saneso Processor also offers pneumatic/water controls and interfaces for insufflation, tissue irrigation and camera lens wash. The Saneso processor also controls various external accessories that interface with the system. The software is operated via a mouse and keyboard. Two monitors are connected to the system i.e a master monitor and slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes. The Saneso Single Camera Gastroscope-A is an endoscopic platform that provides diagnostic visualization and therapeutic access to the upper Gastrointestinal (G.I) tract including the esophagus, stomach and duodenum. The system employs Select Band Imaging mode. The Saneso Single Camera Gastroscope-A consists of the Saneso Single Camera Gastroscope-A which is used in conjunction with the Saneso Processor-A and other ancillary equipment. The gastroscope features a single camera at the distal end that offers a 140° Field of View. The distal end features the front camera, LED light assembly, instrument channel outlet, nozzle, tissue wash outlet. The Saneso Single Camera Gastroscope-A comprises programmable control buttons, insertion tube, suction valve, air/water valve, instrument channel port, umbilical cord, connector, angulation knobs and the bending section. The Saneso Single Camera Gastroscope-A must be used in conjunction with Saneso Processor-A. The Saneso Processor-A is preinstalled with the Saneso Image Processing Software and serves as a control platform for the Saneso Single Camera Gastroscope-A. The Saneso Processor processes the image and relays the video signals from the colonoscope to external display monitors. The Saneso Processor also offers pneumatic/water controls and interfaces for insufflation, tissue irrigation and camera lens wash. The Saneso processor also controls various external accessories that interface with the system. The software is operated via a mouse and keyboard. Two monitors are connected to the system i.e a master monitor and slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.
More Information

No
The summary describes image processing for stitching and displaying video feeds, but there is no mention of AI or ML for analysis, detection, or other functions.

Yes
The device explicitly states it "provides access for therapeutic interventions using standard endoscopy tools." This indicates that beyond diagnostic visualization, it facilitates procedures aimed at treating conditions.

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic visualization." The "Device Description" also repeatedly mentions "diagnostic visualization."

No

The device description explicitly details hardware components such as camera heads, colonoscope/gastroscope, video system, light source, processor box with electronics and mechanics, monitors, foot pedal, mouse, and keyboard. While software is mentioned as being preinstalled on the processor and used for image processing and control, the system is clearly a combination of hardware and software.

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
  • This device is for direct visualization: The Saneso system is an endoscope intended for diagnostic visualization of the gastrointestinal tract by directly viewing the internal anatomy. It uses cameras and light sources to capture images, not to analyze biological samples.
  • The intended use and device description focus on imaging and therapeutic access: The text repeatedly emphasizes "diagnostic visualization," "high resolution wide field of view," "video system," and "therapeutic interventions using standard endoscopy tools." These are all characteristics of an endoscopic device used for direct examination and procedures, not for analyzing samples.

Therefore, the Saneso Colonoscope/Gastroscope system falls under the category of an endoscopic device for direct visualization and intervention, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The Saneso Colonoscope 360-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A, Saneso Processor-A and other ancillary equipment.

The Saneso Gastroscope 360-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consistroscope 360-A/Saneso Single Camera Gastroscope-A, Saneso Processor-A and other ancillary equipment.

The Saneso Single Camera Colonoscope-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and ileocecal valve). The system also provides access for therventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A/Saneso Single Camera Colonoscope-A, Saneso Processor-A and other ancillary equipment.

The Saneso Single Camera Gastroscope-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Gastroscope 360-A/Saneso Single Camera Gastroscope-A. Saneso Processor-A and other ancillary equipment.

Product codes (comma separated list FDA assigned to the subject device)

FDF, FDS, FET, NWB

Device Description

Saneso Colonoscope 360-A (Model: With and Without SBI/DBI)
The Saneso Colonoscope 360-A is an endoscopic platform for diagnostic visualization and therapeutic access to the lower gastrointestinal tract (including the anus, rectum, sigmoid colon, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system enables physicians to view a high resolution wide field of view of up to 360°. The system consists of Saneso camera heads, colonoscope, video system, light source and other ancillary equipment. The Saneso Colonoscope 360-A is a full circular view video colonoscope and features multiple viewing options: 5 camera 360-degree raw images, 5 camera-stitched 360-degree images, and forward only view modes. The selection is made through the video interface.

The Saneso Colonoscope 360-A must be used in conjunction with the Saneso Processor-A. The Saneso Processor-A system serves as a control platform for the Saneso Colonoscope 360-A. The processor box consists of the electronics and mechanics required to operate the endoscope. It is responsible for image processing, transferring video signals from the colonoscope, pneumatic control of various external accessories that interface with the system. The accessories include the foot pedal, which is used to control the tissue wash water, the mouse, and the keyboard which are used for interfacing with the software and changing settings as needed. There are two monitors which can be connected, i.e. the master monitor and the slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.

The device is equipped with five cameras in order to provide a maximum 360° field of view (FOV) with high resolution video using external monitors connected through display ports. Each camera has LED light sources enabling the user to visualize in white light and other user selectable spectrum with Select Band Imaging or Dual Band Imaging modes (applicable only with SBI/DBI). The system is configured to transfer data to an external HL7 compliant electronic health record system. The system can be controlled using a mouse and keyboard.

Saneso Gastroscope 360-A (Model: With and Without SBI/DBI)
The Saneso Gastroscope 360-A is an endoscopic platform for diagnostic visualization and therapeutic access to the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system enables physicians to view a high resolution wide field of view of up to 360°. The system consists of Saneso camera heads, gastroscope, video system, light source and other ancillary equipment. The Saneso Gastroscope 360-A is a full circular view video gastroscope and features multiple viewing options: 5 camera 360-degree raw images, 5 camera-stitched 360-degree images and forward only view modes. The selection is made through the video interface.

The Saneso Gastroscope 360-A must be used in conjunction with the Saneso Processor-A. The Saneso Processor-A system serves as a control platform for the Saneso Gastroscope 360-A. The processor box consists of the electronics and mechanics required to operate the endoscope. It is responsible for image processing, transferring video signals from the gastroscope, pneumatic control, and control of various external accessories that interface with the system. The accessories include the foot pedal, which is used to control the tissue wash water, the mouse and the keyboard which are used for interfacing with the software and changing settings as needed. There are two monitors which can be connected, i.e. the master monitor and the slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.

The device is equipped with five cameras in order to provide a maximum 360° field of view (FOV) with high resolution video using external monitors connected through display ports. Each camera has LED light sources enabling the user to visualize in white light and other user selectable spectrum with select either single band imaging or dual band imaging modes (applicable only with SBI/DBI). The system is configured to transfer data to an external HL7 compliant electronic health record system. The data is transferred using Wi-Fi or Ethernet. The system can be controlled using a mouse and keyboard.

Saneso Single Camera Colonoscope-A (Model: With and Without SBI)
The Saneso Single Camera Colonoscope-A is an endoscopic platform that provides diagnostic visualization and therapeutic access to the lower gastrointestinal tract including the rectum, colon and ileocecal valve. The system employs Select Band Imaging mode. The Saneso Single Camera Colonoscope-A features a single camera at the distal end that offers a 140° Field of View. The distal end features the front camera. LED light assembly, instrument channel outlet, nozzle, tissue wash outlet.

The Saneso Single Camera Colonoscope-A comprises programmable control buttons, insertion tube, suction valve, air/water valve, instrument channel port, umbilical cord, connector, angulation knobs and the bending section.

The Saneso Single Camera Colonoscope-A must be used in conjunction with Saneso Processor-A. The Saneso Processor-A is preinstalled with the Saneso Image Processing software and serves as a control platform for the Saneso Single Camera Colonoscope-A. The Saneso Processor processes the image and relays the video signals from the colonoscope to external display monitors. The Saneso Processor also offers pneumatic/water controls and interfaces for insufflation, tissue irrigation and camera lens wash. The Saneso processor also controls various external accessories that interface with the system. The software is operated via a mouse and keyboard. Two monitors are connected to the system i.e a master monitor and slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.

Saneso Single Camera Gastroscope-A (Model: With and Without SBI)
The Saneso Single Camera Gastroscope-A is an endoscopic platform that provides diagnostic visualization and therapeutic access to the upper Gastrointestinal (G.I) tract including the esophagus, stomach and duodenum. The system employs Select Band Imaging mode. The Saneso Single Camera Gastroscope-A consists of the Saneso Single Camera Gastroscope-A which is used in conjunction with the Saneso Processor-A and other ancillary equipment. The gastroscope features a single camera at the distal end that offers a 140° Field of View. The distal end features the front camera, LED light assembly, instrument channel outlet, nozzle, tissue wash outlet.

The Saneso Single Camera Gastroscope-A comprises programmable control buttons, insertion tube, suction valve, air/water valve, instrument channel port, umbilical cord, connector, angulation knobs and the bending section.

The Saneso Single Camera Gastroscope-A must be used in conjunction with Saneso Processor-A. The Saneso Processor-A is preinstalled with the Saneso Image Processing Software and serves as a control platform for the Saneso Single Camera Gastroscope-A. The Saneso Processor processes the image and relays the video signals from the colonoscope to external display monitors. The Saneso Processor also offers pneumatic/water controls and interfaces for insufflation, tissue irrigation and camera lens wash. The Saneso processor also controls various external accessories that interface with the system. The software is operated via a mouse and keyboard. Two monitors are connected to the system i.e a master monitor and slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Endoscopy

Anatomical Site

Lower gastrointestinal tract (rectum, colon, cecum, ileocecal valve), Upper gastrointestinal tract (esophagus, stomach, duodenum)

Indicated Patient Age Range

18 - 74 years

Intended User / Care Setting

Physicians / Prescriptive Use

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

Description of the test set: Prospective, multi-center clinical study to assess successful intubation of the third portion of the duodenum in Esophago-gastro-duodenoscopy (EGD) procedures.
Sample size: 22 subjects
Data source: 3 sites
Annotation protocol: Successful completion of EGD procedure defined by successful intubation of the third portion of the duodenum (primary outcome). Qualitative rating by endoscopists of Saneso 360 gastroscope and traditional gastroscope (Olympus GIF-H180 - K100584) (secondary outcome). Potential mucosal injury evaluated using a scoring system of 1-5 immediately after use.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Prospective, multi-center clinical study
Sample Size: 22 subjects
Standalone Performance:

  • Procedural success rate: 100% was achieved with Saneso gastroscope and Olympus gastroscopes.
  • Total procedure time and withdrawal time: Significantly greater for the Saneso gastroscope (p>0.5 and p

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

April 1, 2022

Saneso Inc. % Parul Chansoria Founder and CEO Elexes Medical Consulting, LLC 30 N Gould St Ste R Sheridan, WY 82801

Re: K210052

Trade/Device Name: Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging (DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging (DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF, FDS, FET, NWB Dated: February 25, 2022 Received: March 2, 2022

Dear Parul Chansoria:

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

1

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 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 (QS) 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 medical devices and radiation-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) K210052

Device Name

Saneso -A Series {{Saneso Colonoscope 360-A (Model: with and without SBI/DBI), Saneso Single Camera Colonoscope-A (Model: with and without SBI), Saneso Gastroscope 360-A (Model: with and without SBI/DBI), Saneso Single Camera Gastroscope-A (Model: with and without SBI)}

Indications for Use (Describe)

The Saneso Colonoscope 360-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A, Saneso Processor-A and other ancillary equipment.

The Saneso Gastroscope 360-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consistroscope 360-A/Saneso Single Camera Gastroscope-A, Saneso Processor-A and other ancillary equipment.

The Saneso Single Camera Colonoscope-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and ileocecal valve). The system also provides access for therventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A/Saneso Single Camera Colonoscope-A, Saneso Processor-A and other ancillary equipment.

The Saneso Single Camera Gastroscope-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Gastroscope 360-A/Saneso Single Camera Gastroscope-A. Saneso Processor-A and other ancillary equipment.

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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This 510(k) Summary has been created per the requirements of the Safe Medical Device (SMDA) of 1990, and the content is provided in conformance with 21 CFR Part 807.92.

5.1. Submitter's Information

Saneso, Inc. One Oxford Center, 301 Grant Street Suite 4300 Pittsburgh, PA 15219

Contact Person:

Parul Chansoria, MS, RAC, CQA CEO & Founder, Elexes Medical Consulting Telephone: +408-475-8091 Email: parul@elexes.com Summary prepared:

5.2. Device Information

  • 5.2.1. Common name: Colonoscope, Video Trade name: Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)) Classification name: Endoscope and Accessories Regulatory class: Class II Classification panel: Gastroenterology/Urology Product code: FDF, FET, NWB Regulation number: 876.1500
  • 5.2.2. Common name: Gastroscope, Video Trade name: Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI)) Classification name: Endoscope and Accessories Regulatory class: Class II Classification panel: Gastroenterology/Urology Product code: FDS, FET, NWB Regulation number: 876.1500

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5.3. Predicate Device Information

Saneso Colonoscope 360-A (Model: With and Without SBI/DBI) is substantially equivalent to the following cleared device:

| Company | Predicate
Priority | Product | 510(k)
Number |
|-------------------------------|-----------------------|------------------------------------------------|------------------|
| Shirakawa Olympus Co.,
Ltd | Primary | EVIS EXERA II
Colonovideoscope
CF-H180AL | K100584 |
| Olympus Optical Co. Ltd. | Reference
Device | Evis Exera 140 System
PCF 140L | K954451 |

Saneso Gastroscope 360-A (Model: With and Without SBI/DBI) is substantially equivalent to the following cleared device:

| Company | Predicate
Priority | Product | 510(k)
Number |
|-------------------------------|-----------------------|----------------------------------------------------------|------------------|
| Shirakawa Olympus Co.,
Ltd | Primary | Evis Exera II
Gastrointestinal
Videoscope GIF-H180 | K100584 |
| Olympus Optical Co. Ltd. | Reference
Device | Evis Exera 140 System
GIF 140 | K954451 |

The Saneso Single Camera Colonoscope-A (Model: With and Without SBI) is equivalent to the following FDA-cleared device:

| Company | Predicate
priority | Product | 510(k) Number |
|-------------------------------|-----------------------|------------------------------------------------------|---------------|
| Shirakawa Olympus
Co., Ltd | Primary | EVIS
EXERA II
Colonovideoscope (PCF
Q180AL) | K100584 |

5

The Saneso Single Camera Gastroscope-A (Model: With and Without SBI) is equivalent to the following FDA-cleared device:

| Company | Predicate
priority | Product | 510(k) Number |
|-------------------------------|-----------------------|------------------------|---------------|
| Shirakawa
Olympus Co., Ltd | Primary | Evis Exera II GIF-H180 | K100584 |

5.4. Device Description

Saneso Colonoscope 360-A (Model: With and Without SBI/DBI)

The Saneso Colonoscope 360-A is an endoscopic platform for diagnostic visualization and therapeutic access to the lower gastrointestinal tract (including the anus, rectum, sigmoid colon, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system enables physicians to view a high resolution wide field of view of up to 360°. The system consists of Saneso camera heads, colonoscope, video system, light source and other ancillary equipment. The Saneso Colonoscope 360-A is a full circular view video colonoscope and features multiple viewing options: 5 camera 360-degree raw images, 5 camera-stitched 360-degree images, and forward only view modes. The selection is made through the video interface.

The Saneso Colonoscope 360-A must be used in conjunction with the Saneso Processor-A. The Saneso Processor-A system serves as a control platform for the Saneso Colonoscope 360-A. The processor box consists of the electronics and mechanics required to operate the endoscope. It is responsible for image processing, transferring video signals from the colonoscope, pneumatic control of various external accessories that interface with the system. The accessories include the foot pedal, which is used to control the tissue wash water, the mouse, and the keyboard which are used for interfacing with the software and changing settings as needed. There are two monitors which can be connected, i.e. the master monitor and the slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.

The device is equipped with five cameras in order to provide a maximum 360° field of view (FOV) with high resolution video using external monitors connected through display ports. Each camera has LED light sources enabling the user to visualize in white light and other user selectable spectrum with Select Band Imaging or Dual Band

6

Image /page/6/Picture/0 description: The image shows the logo for Saneso Endoscopy Reinvented. The logo is red and black. The image also contains the text "K210052 Page 4 of 25".

Imaging modes (applicable only with SBI/DBI). The system is configured to transfer data to an external HL7 compliant electronic health record system. The system can be controlled using a mouse and keyboard.

Saneso Gastroscope 360-A (Model: With and Without SBI/DBI)

The Saneso Gastroscope 360-A is an endoscopic platform for diagnostic visualization and therapeutic access to the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system enables physicians to view a high resolution wide field of view of up to 360°. The system consists of Saneso camera heads, gastroscope, video system, light source and other ancillary equipment. The Saneso Gastroscope 360-A is a full circular view video gastroscope and features multiple viewing options: 5 camera 360-degree raw images, 5 camera-stitched 360-degree images and forward only view modes. The selection is made through the video interface.

The Saneso Gastroscope 360-A must be used in conjunction with the Saneso Processor-A. The Saneso Processor-A system serves as a control platform for the Saneso Gastroscope 360-A. The processor box consists of the electronics and mechanics required to operate the endoscope. It is responsible for image processing, transferring video signals from the gastroscope, pneumatic control, and control of various external accessories that interface with the system. The accessories include the foot pedal, which is used to control the tissue wash water, the mouse and the keyboard which are used for interfacing with the software and changing settings as needed. There are two monitors which can be connected, i.e. the master monitor and the slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.

The device is equipped with five cameras in order to provide a maximum 360° field of view (FOV) with high resolution video using external monitors connected through display ports. Each camera has LED light sources enabling the user to visualize in white light and other user selectable spectrum with select either single band imaging or dual band imaging modes (applicable only with SBI/DBI). The system is configured to transfer data to an external HL7 compliant electronic health record system. The data is transferred using Wi-Fi or Ethernet. The system can be controlled using a mouse and keyboard.

Saneso Single Camera Colonoscope-A (Model: With and Without SBI)

The Saneso Single Camera Colonoscope-A is an endoscopic platform that provides diagnostic visualization and therapeutic access to the lower gastrointestinal tract including the rectum, colon and ileocecal valve. The system employs Select Band Imaging mode. The Saneso Single Camera Colonoscope-A features a single camera at

7

the distal end that offers a 140° Field of View. The distal end features the front camera. LED light assembly, instrument channel outlet, nozzle, tissue wash outlet.

The Saneso Single Camera Colonoscope-A comprises programmable control buttons, insertion tube, suction valve, air/water valve, instrument channel port, umbilical cord, connector, angulation knobs and the bending section.

The Saneso Single Camera Colonoscope-A must be used in conjunction with Saneso Processor-A. The Saneso Processor-A is preinstalled with the Saneso Image Processing software and serves as a control platform for the Saneso Single Camera Colonoscope-A. The Saneso Processor processes the image and relays the video signals from the colonoscope to external display monitors. The Saneso Processor also offers pneumatic/water controls and interfaces for insufflation, tissue irrigation and camera lens wash. The Saneso processor also controls various external accessories that interface with the system. The software is operated via a mouse and keyboard. Two monitors are connected to the system i.e a master monitor and slave monitor. The master monitor can be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.

Saneso Single Camera Gastroscope-A (Model: With and Without SBI)

The Saneso Single Camera Gastroscope-A is an endoscopic platform that provides diagnostic visualization and therapeutic access to the upper Gastrointestinal (G.I) tract including the esophagus, stomach and duodenum. The system employs Select Band Imaging mode. The Saneso Single Camera Gastroscope-A consists of the Saneso Single Camera Gastroscope-A which is used in conjunction with the Saneso Processor-A and other ancillary equipment. The gastroscope features a single camera at the distal end that offers a 140° Field of View. The distal end features the front camera, LED light assembly, instrument channel outlet, nozzle, tissue wash outlet.

The Saneso Single Camera Gastroscope-A comprises programmable control buttons, insertion tube, suction valve, air/water valve, instrument channel port, umbilical cord, connector, angulation knobs and the bending section.

The Saneso Single Camera Gastroscope-A must be used in conjunction with Saneso Processor-A. The Saneso Processor-A is preinstalled with the Saneso Image Processing Software and serves as a control platform for the Saneso Single Camera Gastroscope-A. The Saneso Processor processes the image and relays the video signals from the colonoscope to external display monitors. The Saneso Processor also offers pneumatic/water controls and interfaces for insufflation, tissue irrigation and camera lens wash. The Saneso processor also controls various external accessories that interface with the system. The software is operated via a mouse and keyboard. Two monitors are connected to the system i.e a master monitor and slave monitor. The master monitor can

8

be used for viewing and interfacing with controls on the image processor and the slave monitor is used only for viewing purposes.

ર્ડ. Indications for Use

Saneso Colonoscope 360-A

The Saneso Colonoscope 360-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A, Processor- A and other ancillary equipment.

Saneso Gastroscope 360-A

The Saneso Gastroscope 360-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Gastroscope 360-A, Processor-A and other ancillary equipment.

Saneso Single Camera Colonoscope-A

The Saneso Single Camera Colonoscope is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and ileocecal valve). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Single Camera Colonoscope, Processor-A and other ancillary equipment.

Saneso Gastroscope 360- A

The Saneso Single Camera Gastroscope is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Single Camera Gastroscope, Processor-A and other ancillary equipment.

5.6. Technological Characteristics

Saneso Colonoscope 360-A (Model: With and Without SBI/DBI)

The Indications for Use, key technological characteristics and operating principle of the Subject Device (Saneso Colonoscope 360-A (Model: With and Without SBI/DBI)) is equivalent to the Predicate Device and Reference Device.

9

Image /page/9/Picture/0 description: The image shows the word "Saneso" in red font, with the words "Endoscopy Reinvented" in a smaller font below it. To the right of the word "Saneso" is the text "K210052" and "Page 7 of 25". The text is in black font and is aligned to the right.

1

5.6.1. Saneso Colonoscope 360-A (With and Without SBI/DBI) vs. EVIS EXERA II Colonovideoscope CF-H180AL (K100584)

| Table 1: Substantial Equivalence Table for Saneso Colonoscope 360-A (With and Without

SBI/DBI)
ParameterSubject Device:
Saneso Colonoscope
360-A (With and
Without SBI/DBI)Predicate:
EVIS EXERA II
Colonovideoscope
CF-H180AL(K100
  1.                                                                                                                                                                                 | Reference
    

Device Evis
Exera 140
System PCF
140L | Equivalence |
| Manufacturer | Saneso, Inc. | Shirakawa Olympus
Co., Ltd. | Olympus
Optical
Co. Ltd | --- |
| Device Name | Saneso Colonoscope
360-A | EVIS EXERA II
Colonovideoscope
CF-H180AL | Evis Exera
140 System
PCF 140L | --- |
| 510(k)
Number | --- | K100584 | K954451 | --- |
| Classification
Product
Code/
Regulatory
Number | FDF
876.1500 | FDF
876.1500 | FET (now
known as
FDF)
876.1500 | Equivalent |
| Subsequent
Product Code | FET, NWB | FDS | --- | --- |
| Regulatory
Class | II | II | II | Equivalent |
| Indications
for use | The Saneso
Colonoscope 360-A
is intended for
diagnostic
visualization of the
lower gastrointestinal
tract (including the
rectum, colon and
cecum) and Saneso
Colonoscope 360-A
is not indicated for
ileoscopy procedures. | These instruments
have been designed
to be used with an
Olympus video
System center, light
source,
documentation
equipment, video
monitor,
endo-therapy
accessories such as a
biopsy forceps and | The Evis Exera
140 System
PCF 140L is
specifically
designed for
endoscopic
diagnosis
treatment and
photo and
video
documentation
in combination | Equivalent |
| | The system also
provides access for
therapeutic
interventions using
standard endoscopy
tools. The Saneso
system consists of
Saneso Colonoscope
360-A, Saneso
Processor-A and
other ancillary
equipment. | other ancillary
equipment. Use the
EVIS EXERA II
Colonovideoscope
CF-H180AL for
endoscopy and
endoscopic surgery
within the lower
digestive tract
(including the anus,
rectum, sigmoid
colon, colon and
ileocecal valve). | with Olympus
endoscopes
various
accessories
and ancillary
equipment
within the
upper and
lower digestive
tract including
the esophagus,
stomach,
pancreatic
duct, biliary
duct,
duodenum,
small intestine
rectum, and,
colon. | |
| Colonoscope
Type | Flexible | Flexible | - | Equivalent |
| OTC/Rx | Rx | Rx | - | Equivalent |
| | System Operating Ranges | | | |
| Operating
Temperature | 10°C (50F) - 40°C
(104F) | 10°C (50F) - 40°C
(104F) | 10°C (50F) -
40°C (104F) | Equivalent |
| Relative
Humidity | 85% maximum
without condensation | 30% - 85% | 30% - 85% | Equivalent |
| Operating
Range | 120 V and 240V 60
Hz. | 100V- 240V 50/60
Hz | 100V- 240V
50/60 Hz | Different |
| Performance Characteristics | | | | |
| Mode of
Operation | The processor relays
the image from the
endoscope to a video
monitor | The processor relays
the image from the
endoscope to a
video monitor | The processor
relays the
image from
the endoscope
to a video
monitor | Equivalent |
| Maximum
Field of View | 360° | 170° | 140° | Different |
| Depth of
Field [mm]
(Front
camera) | 2-100 | 2-100 | 5-100 | Equivalent |
| Depth of
Field [mm]
(Side camera) | 2-50 | - | - | - |
| Working
Length | 168 cm | 168 cm | 133cm | Equivalent |
| Instrument
Channel
Inner
Diameter | 3.7 mm | 3.7mm | 3.2mm | Equivalent |
| Maximum
Distal End
Outer
Diameter | 15.6 mm | 13.9mm | 11.3mm | Different |
| Insertion
Tube Outer
Diameter | 12.8 mm | 12.8 mm | 11.3mm | Equivalent |
| Bending
Section:
Angulation
Range | Up/Down: 180°
Left/Right: 160° | Up/Down: 180°
Left/Right: 160° | Up/Down:
180°
Left/Right:
160° | Equivalent |
| HD
Technology | Yes | Yes | Yes | Equivalent |
| Processor Box Characteristics | | | | |
| Digital
Output
(Display) | 3 channels DVI | 3 channels DVI | 3 channels
DVI | Equivalent |
| Control
Signals | White balance
A/W pump control
LED control | White balance
A/W pump control
LED control | White balance
A/W pump
control
LED control | Equivalent |
| Electrical
Class | Class I, Type BF | Class I, Type BF | Class I, Type
BF | Equivalent |
| LED
Intensity
Control | Yes | Yes | Yes | Equivalent |
| Enhancement
Mechanism | White light, Select
Band Imaging and
Dual Band Imaging | White light and
Narrow Band
Imaging | Unknown | Different with
respect to
Saneso
Colonoscope
360-A with
SBI/DBI and
equivalent to
Saneso
Colonoscope
360-A without
SBI/DBI |
| Freeze/Releas
e | Yes | Yes | Yes | Equivalent |
| CCD Type | Color | Color | Color | Equivalent |

10

Image /page/10/Picture/0 description: The image shows the word "Saneso" in red font, with the words "Endoscopy Reinvented" in a smaller font below it. To the right of the word "Saneso" is the text "K210052" and "Page 8 of 25". The text is arranged in a way that suggests it is part of a document or report.

11

Image /page/11/Picture/0 description: The image shows the text "K210052 Page 9 of 25" on the right side of the image. To the left of the text is a logo that says "aneso" in red letters. Below the logo, the text "oscopy Reinvented" is written in a smaller font. The image appears to be a page number and document identifier from a larger document.

Saneso, Inc K210052/S003

12

Similarities between Subject Device and Predicate Device 5.6.1.1.

  • The intended use is the same for the Subject and the Predicate Devices and both devices are meant for prescription use.
  • The mode of operation is the same for the Subject and the . Predicate Devices.
  • The operating temperature and relative humidity for both ● devices is the same.
  • The front camera depth of field is the same for the Subject ● and the Predicate Devices.
  • The instrument channel inner diameter, insertion tube outer diameter is the same for the Subject and Predicate Devices.
  • The working length is the same for the Subject and the . Predicate Devices.

13

Image /page/13/Picture/0 description: The image shows the logo for Saneso, a company that reinvents endoscopy. The logo is in red and features the company name in a bold, sans-serif font. The text "Endoscopy Reinvented" is written in a smaller font below the company name. The image also contains the text "K210052 Page 11 of 25".

  • The Angulation range is the same for the Subject and the ● Predicate Devices.
  • The Electrical Class of both devices is the same.
  • o Both devices incorporate HD technology and use white light and Narrow Band Imaging as the Enhancement Mechanism.
  • . The processor box characteristics of both devices are the same in terms of display method, electrical class and features such as LED intensity control, zooming and freeze/release.

Differences 5.6.1.2.

The differences between the Subject Device and the Predicate Devices do not raise new questions of safety and efficacy. Testing conducted by Saneso, Inc demonstrates that the Subject Device performs as intended.

Saneso Gastroscope 360-A

The Indications for Use, key technological characteristics and operating principle of the Subject Device (Saneso Gastroscope 360-A) is equivalent to the Predicate Device and Reference Device.

5.6.2. Saneso Gastroscope 360-A (Model: With and Without SBI/DBI) vs. Evis Exera II Gastrointestinal Videoscope GIF-H180 (K100584)

| Table 2: Substantial Equivalence Table for Saneso Gastroscope 360-A (Model: With and

Without SBI/DBI)
TitleSubject Saneso
Gastroscope
360-A (Model:
With and
Without
SBI/DBI)Predicate: Evis
Exera II
Gastrointestinal
Videoscope
GIF-H180
(K100584)Reference Device
Evis Exera 140
System GIF 140Equivalence
ManufacturerSaneso, Inc.Shirakawa Olympus
Co., Ltd.Olympus Optical
Co. Ltd---
Device NameSaneso
Gastroscope
360-AEvis Exera II
Gastrointestinal
Videoscope
GIF-H180Evis Exera 140
System GIF 140---

14

Image /page/14/Picture/5 description: The image contains the logo for Saneso, a company that specializes in endoscopy. The logo is red and features the company name in a bold, sans-serif font. Below the name is the tagline "Endoscopy Reinvented" in a smaller font. The logo is simple and modern, and it effectively communicates the company's focus on endoscopy.

| 510(k)

Number--K100584K954451--
Classification
Product
Code/
Regulatory
NumberFDS
876.1500FDS
876.1500FET (now known
as FDS) 876.1500Equivalent
Subsequent
Product CodeFET, NWBFDS----
Regulatory
ClassIIIIIIEquivalent
Indications for
useThe Saneso
Gastroscope
360-A is intended
for diagnostic
visualization of
the upper
gastrointestinal
tract (including
the esophagus,
stomach and
duodenum). The
system also
provides access
for therapeutic
interventions
using standard
endoscopy tools.
The Saneso
system consists of
Saneso
Gastroscope
360-A Saneso
Processor-A and
other ancillary
equipment.These instruments
have been designed to
be used with an
Olympus video system
center, light source,
documentation
equipment, monitor,
endo-therapy
accessories (such as a
biopsy and other
ancillary equipment).
Use the EVIS EXERA
II Gastrointestinal
Videoscope GIF-
H180, for endoscopy
and endoscopic
surgery within the
upper digestive tract
(including the
esophagus, stomach,
and duodenum).The Evis Exera
140 System GIF
140 is specifically
designed for
Endoscopic
Diagnosis,
treatment and
photo and video
documentation in
combination with
Olympus
endoscopes
various
accessories and
Ancillary
equipment within
the upper and
lower digestive
tract including the
Esophagus,
Stomach,
pancreatic duct,
biliary duct,
duodenum, small
intestine rectum
and, colon.Equivalent
Gastroscope
TypeFlexibleFlexibleFlexibleEquivalent
OTC/RxRxRxRxEquivalent

Saneso, Inc
K210052/S003

15

System Design and Operating Ranges
Operating
Temperature10°C (50F) -
40°C (104F)10°C (50°F) - 40°C
(104°F)10°C (50°F) -
40°C (104°F)Equivalent
Relative
Humidity85% maximum
without
condensation30% - 85%30% - 85%Equivalent
Performance Characteristics
Operating
Range120 V and 240V
60 Hz.100V- 240V 50/60 Hz100V- 240V 50/60
HzDifferent
Mode of
OperationThe processor
relays the image
from the
endoscope to a
video monitorThe processor relays
the image from the
endoscope to a video
monitorThe processor
relays the image
from the
endoscope to a
video monitorEquivalent
Maximum
Field of View360°140°120°Different
Depth of Field
(mm) (Front
camera)2-1002-1003-100Equivalent
Depth of Field
(mm) (Side
camera)2-50---
Working
Length (cm)104103103Different
Instrument
Channel Inner
Diameter
(mm)3.72.82.8Different
Maximum
Distal End
Outer
Diameter
(mm)15.69.89.8Different
Insertion Tube
Outer
Diameter(mm
)12.89.89.8Different
Bending
Section:
Angulation
RangeUp/Down: 180°
Left/Right: 160°Up/Down: 210°/90°
Left/Right: 100°/100°Up/Down:
210°/90°
Left/Right:
100°/100°Different
HD
TechnologyYesYesYesEquivalent
Processor Box Characteristics
Digital Output
(Display)3 channels DVI3 channels DVI3 channels DVIEquivalent
Control
SignalsWhite balance
A/W pump
control
LED controlWhite balance
A/W pump control
LED controlWhite balance
A/W pump
control
LED controlEquivalent
Electrical
ClassClass I, Type BFClass I, Type BFClass I, Type BFEquivalent
LED Intensity
ControlYesYesYesEquivalent
Enhancement
MechanismWhite light,
Select Band
Imaging and Dual
Band ImagingWhite light and
Narrow Band ImagingNoneDifferent
with respect
to Saneso
Gastroscope
360-A with
SBI/DBI and
equivalent to
Saneso
Gastroscope
360-A
without
SBI/DBI
Freeze/
ReleaseYesYesYesEquivalent
CCD TypeColorColorColorEquivalent

Saneso, Inc
K210052/S003

16

5.6.2.1. Similarities between Subject Device and Predicate Device

· The intended use is the same for the Subject and the

17

Predicate Devices and both devices are meant prescription use.

  • 0 The mode of operation is the same for the Subject and the Predicate Device.
  • o The operating temperature and relative humidity for both devices is the same.
  • The front camera depth of field is the same for the Subject 0 and the Predicate Device.
  • The Electrical Class of both devices is the same. O
  • o Both devices incorporate HD technology and use white light and Narrow Band Imaging as the Enhancement Mechanism.
  • 0 The processor box characteristics of both devices are the same in terms of display method, electrical class and features such as LED intensity control, zooming and freeze/release.

5.6.2.2. Differences

The differences between the Subject Device and the Predicate Devices do not raise new questions of safety and efficacy. Testing conducted by Saneso, Inc, demonstrates that the Subject Device performs as intended.

5.6.3. Saneso Single Camera Colonoscope-A (Model: With and Without SBI) Vs EVIS EXERA II Colonovideoscope PCF-Q180AL

| Table 3: Substantial Equivalence table for Saneso Single Camera Colonoscope-A (Model: With

and Without SBI)
ParameterSubject Device: Saneso
Single Camera
Colonoscope (Model: With
and Without SBI)Predicate Device: EVIS
EXERA II Colonovideoscope
PCF-Q180ALEquivalence
ManufacturerSaneso, Inc.Shirakawa Olympus Co., Ltd-
Device NameSaneso Single Camera
Colonoscope-AEVIS EXERA II
Colonovideoscope-

18

K210052 Page 16 of 25

PCF-Q180ALEndoscopy Reinvented™
510(k) NumberK100584
Classification
Product
Code/Regulator
NumberFDF
876.1500FDF
876.1500
Subsequent
Product CodeFET, NWBFDS
Regulatory
ClassIIIIEquivalent
Indications for
UseThe Saneso Single Camera
Colonoscope-A is intended
for diagnostic visualization
of the lower gastrointestinal
tract including the rectum,
colon and ileocecal valve.
The system also provides
access for therapeutic
interventions using standard
endoscopy tools. The Saneso
system consists of Saneso
Single Camera
Colonoscope-A, Saneso
Processor- A and other
ancillary equipment.These instruments have been
designed to be used with an
Olympus video system center,
light source, documentation
equipment, video monitor,
endo-therapy accessories suchas a biopsy forceps and other
ancillary Equipment. Use the
EVIS EXERA II
Colonovideoscope
PCF-Q180AL for endoscopy
and endoscopic surgery within
the lower digestive tract
(including the anus, rectum,
sigmoid colon, colon and
ileocecal valve).Equivalent
Colonoscope
typeFlexibleFlexibleEquivalent
OTC/RxRxRxEquivalent
System Operating Ranges
Operating
Temperature10°C - 40°C10°C - 40°CEquivalent
Relative
Humidity85% maximum without
condensation30% - 85%Equivalent
Operating
Range120V and 240V 60Hz100V - 240 V(50/60 Hz)Different
Performance Characteristics
Mode of
OperationThe Processor relays video
signals from the endoscope
to a video monitor.The Processor relays video
signals from the endoscope to a
video monitor.Equivalent
Maximum Field
of View140°140°Equivalent
Depth of Field
[mm]2 - 100 mm3 - 100 mmDifferent
Working
Length168 cm168 cmEquivalent
Instrument
Channel Inner
Diameter3.7 mm3.2 mmDifferent
Maximum
Distal End
Outer Diameter11.6 mm11.3 mmDifferent
Insertion Tube
Outer Diameter11.8 mm11.5 mmDifferent
Bending
Section:
Angulation
RangeUp/Down: 180°
Left/Right: 160°Up/Down: 180°
Left/Right: 160°Equivalent
HD TechnologyYesYesEquivalent
Processor Box Characteristics
Digital Output
(Display)3 channels DVI3 channels DVIEquivalent
Control SignalsWhite balance A/W pump
control Light controlWhite balance A/W pump
control Light controlEquivalent
Electrical ClassClass I, Type BFClass I, Type BFEquivalent
Light Intensity
ControlYesYesEquivalent
Enhancement
MechanismYes (White Light with Select
Band Imaging)Yes (White Light and Narrow
Band Imaging)Equivalent
with respect
to Saneso
Single
Camera
Colonoscope-
A
with/without
SBI
Freeze/ReleaseYesYesEquivalent
CCD TypeColourColourEquivalent

19

20

5.6.3.1. Similarities

  • The intended use is the same for the Subject Device and Predicate Device.
  • The System Operating Ranges such as the Operating ● Temperature, and Relative Humidity are the same for both the Subject Device and Predicate Device.
  • The Mode of Operation and technological characteristics like ● the Maximum Field of View, Working length and Bending Section Angulation range is identical for both the Subject Device and Predicate Device.
  • The Process Box Characteristics such as the Digital Output, ● Control Signals, Electrical Class and features such as the light Intensity Control and freeze/release are identical for both the Subject Device and Predicate Device.

Differences 5.6.3.2.

  • Characteristics such as the Voltage Operating Range, Depth of . Field. Instrument channel Inner Diameter, Maximum Distal End Outer Diameter and Insertion Tube Outer Diameter are different for both the Subject Device and Predicate Device.
    The differences between the Subject Device and the Predicate Device do not raise new questions of safety and efficacy. Testing conducted by Saneso demonstrates that the Subject Device performs as intended.

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T

5.6.4. Saneso Single Camera Gastroscope-A, (Model: With and Without SBI) VS EVIS EXERA II GIF-H180

| Table 4: Substantial Equivalence table for Saneso Single Camera Gastroscope-A (Model: With

and Without SBI)
ParameterSubject Device: Saneso
Single Camera
Gastroscope-A (Model:
With and Without SBI)Predicate Device: Evis
Exera II GIF-H180Equivalence
ManufacturerSaneso, Inc.Shirakawa Olympus Co., Ltd-
Device NameSaneso Single Camera
Gastroscope-AEvis Exera II GIF-H180-
510(k) NumberK100584-
Classification
Product
Code/Regulator
NumberFDF
876.1500FDF
876.1500-
Subsequent Product
CodeFET, NWBFDS-
Regulatory ClassIIIIEquivalent
Indications for UseThe Saneso Single
Camera Gastroscope-A
is intended for diagnostic
visualization of the
upper gastrointestinal
tract (including the
esophagus, stomach and
duodenum). The system
also provides access for
therapeutic interventions
using standard
endoscopy tools. The
Saneso system consists
of Saneso Single Camera
Gastroscope-A, Saneso
Processor-A and other
ancillary equipment.The EVIS EXERA II
GIF-H180 has been designed
to be used with an Olympus
video system center,
light source, documentation
equipment, monitor,
EndoTherapy accessories
(such as a biopsy and other
ancillary equipment for
endoscopy and endoscopic
surgery within the upper
digestive tract (including the
esophagus, stomach, and
duodenum).Equivalent

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OTC/RxRxRxEquivalent
System Operating Ranges
Operating
Temperature10℃ - 40℃10℃ - 40℃Equivalent
Relative Humidity85% maximum without
condensation30% - 85%Equivalent
Operating Range120V and 240V 60Hz100V - 240 V(50/60 Hz)Equivalent
Performance Characteristics
Mode of OperationThe Processor relays
video signals from the
endoscope to a video
monitor.The Processor relays video
signals from the endoscope
to a video monitor.Equivalent
Maximum Field of
View140°140°Equivalent
Depth of Field [mm]2 - 100 mm2 - 100 mmEquivalent
Working Length104 cm103 cmDifferent
Instrument channel
Inner Diameter3.7 mm2.8 mmDifferent
Maximum Distal End
Outer Diameter11.6 mm9.8 mmDifferent
Insertion Tube Outer
Diameter11.5 mm9.8 mmDifferent
Bending Section:
Angulation RangeUp/Down: 180°
Left/Right: 160°Up: 210°
Down: 90°
Left/Right: 100°Different
HD TechnologyYesYesEquivalent
Processor Box Characteristics
Digital Output
(Display)3 channels DVI3 channels DVIEquivalent
Control SignalsWhite balance A/WWhite balance A/W pumpEquivalent
pump control Light
controlcontrol Light control
Electrical ClassClass I, Type BFClass I, Type BFEquivalent
Light Intensity
ControlYesYesEquivalent
Enhancement
MechanismYes (White Light with
Select Band Imaging)Yes (White Light and
Narrow Band Imaging)Equivalent
with respect
to Saneso
Single
Gastroscope
with/without
SBI
Freeze/ReleaseYesYesEquivalent
CCD TypeColourColourEquivalent

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5.6.4.1. Similarities

  • The intended use is the same for the Subject Device and O Predicate Device. Both devices belong to the same Regulatory class and both are prescription devices.
  • The System Operating Ranges such as the Operating O Temperature, and Relative Humidity are the same for both the Subject Device and Predicate Device.
  • The Mode of Operation and technological characteristics O such as the Maximum Field of View, is identical for both the Subject Device and Predicate Device.
  • The Process Box Characteristics such as the Digital Output, O Control Signals, Electrical Class and features such as the light Intensity Control and freeze/release are identical for both the Subject Device and Predicate Device.

Differences 5.6.4.2.

  • Characteristics such as the Voltage Operating Range, O Working length, Instrument channel Inner Diameter, Maximum Distal End Outer Diameter, Insertion Tube and Bending Section Angulation Range are different for both the Subject Device and Predicate Device.

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The differences between the Subject Device and the Predicate Device do not raise new questions of safety and efficacy. Testing conducted by Saneso demonstrates that the Subject Device performs as intended.

5.7. Non-Clinical Study

Saneso-A Series (Saneso Colonoscope 360-A (With and Without SBI/DBI), Saneso Gastroscope 360-A (With and Without SBI/DBI), Saneso Single Camera Colonoscope-A (With and Without SBI), Saneso Single Camera Gastroscope-A (With and Without SBI))

The performance testing has been carried out in accordance with the FDA guidelines. The performance of the device was tested against the established System and Software Requirements to ensure that the device performs as intended. The Device Hazard analysis was completed and the risk controls were implemented to mitigate all the identified hazards. The testing results reflect that all the hardware specifications and software specifications have met the specified acceptance criteria. The performance testing demonstrates that Saneso-A series is safe and effective as the predicate device. The Saneso-A system complies with applicable standards for Electromagnetic Compatibility, Electrical Safety and Biocompatibility according to national and international standards. The following testing has been performed to demonstrate that the design outputs of the device meet the design input requirements. The tests were conducted either within Saneso, Inc.'s laboratory or by accredited third parties.

Table 5: List of Tests Performed - Saneso-A Series
Testing TypeTest DescriptionTest Result
Electrical Safety
and
Electromagnetic
Compatibility
Testing- IEC 60601-1-2
  • ANSI AAMI
    ES60601-1 | The Saneso-A series met all
    acceptance criteria in
    accordance with IEC
    60601-1-2, ANSI AAMI
    ES60601-1 |
    | Biocompatibility | - Cytotoxicity
  • Sensitization
  • Irritation | The Saneso-A series is
    biocompatible. Saneso, Inc., has
    performed biocompatibility
    testing for Saneso Endoscope
    360-A, which has the same
    components and manufacturing
    processes as the Saneso Single
    Camera Endoscope-A. Also,
    Saneso, Inc., has provided a |

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| | | comparison table outlining the
reprocessing steps performed
prior to conducting the
cytotoxicity study and the
reprocessing steps outlined in
the Reprocessing Manual which
meets the worse case scenario
for assessing biocompatibility. |
|------------------------------|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cleanability | Cleaning Validation | The Saneso-A series met all the
acceptance criteria and
demonstrated that the cleaning
process does not impact the
functionality of the device. |
| High Level
Disinfection | High Level
Disinfection Report | The Saneso-A series met all the
acceptance criteria and
demonstrated that high level
disinfection does not impact the
functionality of the device. |
| Performance
Bench Testing | Verification Reports | The Saneso-A series met all the
design verification & validation,
performance test requirements. |

Software Verification and Validation Testing

Saneso-A Series (Saneso Colonoscope 360-A (With and Without SBI/DBI), Saneso Gastroscope 360-A (With and Without SBI/DBI), Saneso Single Camera Colonoscope-A (With and Without SBI), Saneso Single Camera Gastroscope-A (With and Without SBI))

Software Verification and Validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered as a 'moderate' level of concern, since the software device is an accessory to a medical device that has a Moderate Level of Concern.

5.8. Clinical study

Saneso, Inc. has performed a prospective, multi-center clinical study to assess the successful intubation of the third portion of the duodenum, as per the protocol defined. The objective of the study can be described as the confirmation of procedural

Saneso, Inc K210052/S003

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performance of the Saneso 360-A gastroscope in Esophago-gastro-duodenoscopy (EGD) procedures. The study was performed on 22 subjects across 3 sites and consisted of subjects of both genders within the age range of 18 - 74 years, who were indicated for a routine EGD procedure. Pregnant women and subjects for whom routine endoscopic procedures are contraindicated due to comorbid medical conditions were excluded. The primary outcome of the study was successful completion of the EGD procedure. Procedure success is defined as by successful intubation of the third portion of the duodenum. Secondary outcomes of the study included qualitative rating by the endoscopists of the Saneso 360 gastroscope and the traditional gastroscope (Olympus GIF-H180 - K100584). Any potential mucosal injury resulting from use of the study device was evaluated using a scoring system of 1 - 5 immediately after the use of the device.

The Subject Device was comparable to the Predicate Device in terms of performance and safety. Procedural success rate of 100% was achieved with both Saneso and Olympus gastroscopes. The total procedure time and withdrawal time was significantly greater for the Saneso gastroscope (p>0.5 and p