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))
Device Facts
| Record ID | 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)) |
| Applicant | Saneso, Inc. |
| Product Code | FDF · Gastroenterology, Urology |
| Decision Date | Apr 1, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Saneso-A series consists of flexible video endoscopes (colonoscopes and gastroscopes) used with the Saneso Processor-A. Devices feature either a single camera (140° FOV) or five cameras (360° FOV) for diagnostic visualization and therapeutic access to the GI tract. Processor-A handles image processing, pneumatic/water control, and interface with external monitors, mouse, keyboard, and foot pedal. Select Band Imaging (SBI) and Dual Band Imaging (DBI) modes provide enhanced visualization. Used in clinical settings by physicians; output displayed on master/slave monitors to guide diagnosis and therapeutic interventions. Data can be transferred to HL7-compliant EHR systems via Wi-Fi or Ethernet. Benefits include wide-field visualization and integration with standard endoscopic tools.
Clinical Evidence
Prospective, multi-center study (n=22, ages 18-74) assessed Saneso 360-A gastroscope performance in EGD procedures. Primary endpoint: successful intubation of the third portion of the duodenum (100% success rate). Secondary endpoints: qualitative endoscopist ratings and mucosal injury scoring (1-5). No complications or mucosal injuries reported. Saneso gastroscope rated superior in FOV compared to Olympus GIF-H180; other mechanical/visualization characteristics rated substantially equivalent.
Technological Characteristics
Flexible video endoscopes with 140° (single camera) or 360° (5-camera) FOV. Materials biocompatible per ISO standards. Energy: LED light source. Connectivity: DVI display output, Wi-Fi/Ethernet for HL7 EHR integration. Processor-A provides pneumatic/water control and image processing. Software: Preinstalled image processing software. Sterilization: High-level disinfection.
Indications for Use
Indicated for diagnostic visualization and therapeutic access to the upper or lower gastrointestinal tract in patients (adults 18-74 years in clinical study). Contraindicated for patients where routine endoscopic procedures are contraindicated due to comorbid conditions; Colonoscope 360-A not indicated for ileoscopy.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- EVIS EXERA II Colonovideoscope CF-H180AL (K100584)
- Evis Exera II Gastrointestinal Videoscope GIF-H180 (K100584)
- EVIS EXERA II Colonovideoscope (PCF Q180AL) (K100584)
Reference Devices
Related Devices
- K241213 — PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) · Pentax of America, Inc. · Dec 6, 2024
- K211882 — HD-550 Video Endoscope System · Sonoscape Medical Corp. · Apr 1, 2022
- K183572 — FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L · Fujifilm Corporation · Jul 16, 2019
- K250432 — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) · Olympus Medical Systems Corporation · May 15, 2025
- K143732 — FUJIFILM Endoscope Models EC-600HL and EC-600LS · Fujifilm Medical Systems U.S.A, Inc. · Jul 6, 2015
Submission Summary (Full Text)
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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
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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)
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-weight: normal;"> <span> <span style="color: rgb(0, 0, 0);"> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span> | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="font-style: normal;"> <span style="font-weight: normal;"> <span> <span style="color: rgb(0, 0, 0);"> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> <span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span> </span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span> |
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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<br>Priority | Product | 510(k)<br>Number |
|-------------------------------|-----------------------|------------------------------------------------|------------------|
| Shirakawa Olympus Co.,<br>Ltd | Primary | EVIS EXERA II<br>Colonovideoscope<br>CF-H180AL | K100584 |
| Olympus Optical Co. Ltd. | Reference<br>Device | Evis Exera 140 System<br>PCF 140L | K954451 |
Saneso Gastroscope 360-A (Model: With and Without SBI/DBI) is substantially equivalent to the following cleared device:
| Company | Predicate<br>Priority | Product | 510(k)<br>Number |
|-------------------------------|-----------------------|----------------------------------------------------------|------------------|
| Shirakawa Olympus Co.,<br>Ltd | Primary | Evis Exera II<br>Gastrointestinal<br>Videoscope GIF-H180 | K100584 |
| Olympus Optical Co. Ltd. | Reference<br>Device | Evis Exera 140 System<br>GIF 140 | K954451 |
The Saneso Single Camera Colonoscope-A (Model: With and Without SBI) is equivalent to the following FDA-cleared device:
| Company | Predicate<br>priority | Product | 510(k) Number |
|-------------------------------|-----------------------|------------------------------------------------------|---------------|
| Shirakawa Olympus<br>Co., Ltd | Primary | EVIS<br>EXERA II<br>Colonovideoscope (PCF<br>Q180AL) | K100584 |
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The Saneso Single Camera Gastroscope-A (Model: With and Without SBI) is equivalent to the following FDA-cleared device:
| Company | Predicate<br>priority | Product | 510(k) Number |
|-------------------------------|-----------------------|------------------------|---------------|
| Shirakawa<br>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
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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
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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
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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.
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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.
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### 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<br>SBI/DBI) | | | | |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | Subject Device:<br>Saneso Colonoscope<br>360-A (With and<br>Without SBI/DBI) | Predicate:<br>EVIS EXERA II<br>Colonovideoscope<br>CF-H180AL(K100<br>584) | Reference<br>Device Evis<br>Exera 140<br>System PCF<br>140L | Equivalence |
| Manufacturer | Saneso, Inc. | Shirakawa Olympus<br>Co., Ltd. | Olympus<br>Optical<br>Co. Ltd | --- |
| Device Name | Saneso Colonoscope<br>360-A | EVIS EXERA II<br>Colonovideoscope<br>CF-H180AL | Evis Exera<br>140 System<br>PCF 140L | --- |
| 510(k)<br>Number | --- | K100584 | K954451 | --- |
| Classification<br>Product<br>Code/<br>Regulatory<br>Number | FDF<br>876.1500 | FDF<br>876.1500 | FET (now<br>known as<br>FDF)<br>876.1500 | Equivalent |
| Subsequent<br>Product Code | FET, NWB | FDS | --- | --- |
| Regulatory<br>Class | II | II | II | Equivalent |
| Indications<br>for use | The Saneso<br>Colonoscope 360-A<br>is intended for<br>diagnostic<br>visualization of the<br>lower gastrointestinal<br>tract (including the<br>rectum, colon and<br>cecum) and Saneso<br>Colonoscope 360-A<br>is not indicated for<br>ileoscopy procedures. | These instruments<br>have been designed<br>to be used with an<br>Olympus video<br>System center, light<br>source,<br>documentation<br>equipment, video<br>monitor,<br>endo-therapy<br>accessories such as a<br>biopsy forceps and | The Evis Exera<br>140 System<br>PCF 140L is<br>specifically<br>designed for<br>endoscopic<br>diagnosis<br>treatment and<br>photo and<br>video<br>documentation<br>in combination | Equivalent |
| | The system also<br>provides access for<br>therapeutic<br>interventions using<br>standard endoscopy<br>tools. The Saneso<br>system consists of<br>Saneso Colonoscope<br>360-A, Saneso<br>Processor-A and<br>other ancillary<br>equipment. | other ancillary<br>equipment. Use the<br>EVIS EXERA II<br>Colonovideoscope<br>CF-H180AL for<br>endoscopy and<br>endoscopic surgery<br>within the lower<br>digestive tract<br>(including the anus,<br>rectum, sigmoid<br>colon, colon and<br>ileocecal valve). | with Olympus<br>endoscopes<br>various<br>accessories<br>and ancillary<br>equipment<br>within the<br>upper and<br>lower digestive<br>tract including<br>the esophagus,<br>stomach,<br>pancreatic<br>duct, biliary<br>duct,<br>duodenum,<br>small intestine<br>rectum, and,<br>colon. | |
| Colonoscope<br>Type | Flexible | Flexible | - | Equivalent |
| OTC/Rx | Rx | Rx | - | Equivalent |
| | System Operating Ranges | | | |
| Operating<br>Temperature | 10°C (50F) - 40°C<br>(104F) | 10°C (50F) - 40°C<br>(104F) | 10°C (50F) -<br>40°C (104F) | Equivalent |
| Relative<br>Humidity | 85% maximum<br>without condensation | 30% - 85% | 30% - 85% | Equivalent |
| Operating<br>Range | 120 V and 240V 60<br>Hz. | 100V- 240V 50/60<br>Hz | 100V- 240V<br>50/60 Hz | Different |
| Performance Characteristics | | | | |
| Mode of<br>Operation | The processor relays<br>the image from the<br>endoscope to a video<br>monitor | The processor relays<br>the image from the<br>endoscope to a<br>video monitor | The processor<br>relays the<br>image from<br>the endoscope<br>to a video<br>monitor | Equivalent |
| Maximum<br>Field of View | 360° | 170° | 140° | Different |
| Depth of<br>Field [mm]<br>(Front<br>camera) | 2-100 | 2-100 | 5-100 | Equivalent |
| Depth of<br>Field [mm]<br>(Side camera) | 2-50 | - | - | - |
| Working<br>Length | 168 cm | 168 cm | 133cm | Equivalent |
| Instrument<br>Channel<br>Inner<br>Diameter | 3.7 mm | 3.7mm | 3.2mm | Equivalent |
| Maximum<br>Distal End<br>Outer<br>Diameter | 15.6 mm | 13.9mm | 11.3mm | Different |
| Insertion<br>Tube Outer<br>Diameter | 12.8 mm | 12.8 mm | 11.3mm | Equivalent |
| Bending<br>Section:<br>Angulation<br>Range | Up/Down: 180°<br>Left/Right: 160° | Up/Down: 180°<br>Left/Right: 160° | Up/Down:<br>180°<br>Left/Right:<br>160° | Equivalent |
| HD<br>Technology | Yes | Yes | Yes | Equivalent |
| Processor Box Characteristics | | | | |
| Digital<br>Output<br>(Display) | 3 channels DVI | 3 channels DVI | 3 channels<br>DVI | Equivalent |
| Control<br>Signals | White balance<br>A/W pump control<br>LED control | White balance<br>A/W pump control<br>LED control | White balance<br>A/W pump<br>control<br>LED control | Equivalent |
| Electrical<br>Class | Class I, Type BF | Class I, Type BF | Class I, Type<br>BF | Equivalent |
| LED<br>Intensity<br>Control | Yes | Yes | Yes | Equivalent |
| Enhancement<br>Mechanism | White light, Select<br>Band Imaging and<br>Dual Band Imaging | White light and<br>Narrow Band<br>Imaging | Unknown | Different with<br>respect to<br>Saneso<br>Colonoscope<br>360-A with<br>SBI/DBI and<br>equivalent to<br>Saneso<br>Colonoscope<br>360-A without<br>SBI/DBI |
| Freeze/Releas<br>e | Yes | Yes | Yes | Equivalent |
| CCD Type | Color | Color | Color | Equivalent |
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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.
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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
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#### 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.
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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<br>Without SBI/DBI) | | | | |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------|-------------|
| Title | Subject Saneso<br>Gastroscope<br>360-A (Model:<br>With and<br>Without<br>SBI/DBI) | Predicate: Evis<br>Exera II<br>Gastrointestinal<br>Videoscope<br>GIF-H180<br>(K100584) | Reference Device<br>Evis Exera 140<br>System GIF 140 | Equivalence |
| Manufacturer | Saneso, Inc. | Shirakawa Olympus<br>Co., Ltd. | Olympus Optical<br>Co. Ltd | --- |
| Device Name | Saneso<br>Gastroscope<br>360-A | Evis Exera II<br>Gastrointestinal<br>Videoscope<br>GIF-H180 | Evis Exera 140<br>System GIF 140 | --- |
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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)<br>Number | -- | K100584 | K954451 | -- |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification<br>Product<br>Code/<br>Regulatory<br>Number | FDS<br>876.1500…
