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.
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.
Here's a breakdown of the acceptance criteria and study details for the Saneso-A Series devices, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance
The FDA clearance letter refers to "acceptance criteria" through various performance tests, but it doesn't explicitly list numerical thresholds that were accepted. Instead, it states that the devices "met all acceptance criteria" for the respective tests. The reported device performance is generally described in terms of equivalence to predicate devices and successful completion of procedures.
| Acceptance Criteria Category | Specific Test / Characteristic | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | General Performance | "Performs as intended" and "safe and effective as the predicate device" |
| Electrical Safety & EMC | IEC 60601-1-2, ANSI AAMI ES60601-1 | Met all acceptance criteria in accordance with these standards. |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation | Biocompatible. Testing performed on Saneso Endoscope 360-A (same components/manufacturing as Saneso Single Camera Endoscope-A). Reprocessing steps met worst-case scenario for assessment. |
| Reprocessing Effectiveness | Cleaning Validation | Met all acceptance criteria; demonstrated cleaning process does not impact functionality. |
| High Level Disinfection Report | Met all acceptance criteria; demonstrated high-level disinfection does not impact functionality. | |
| Performance (Bench) | Design Verification & Validation, Performance Test Requirements | Met all design verification & validation, performance test requirements. |
| Software Performance | Software Verification and Validation Testing | Conducted and documented as recommended by FDA guidance; software considered 'moderate' level of concern. |
| Clinical Performance (Gastroscope) | Primary Outcome: Successful intubation of the third portion of the duodenum | 100% successful procedure rate (achieved with both Saneso and Olympus gastroscopes). |
| Secondary Outcome: Qualitative rating by endoscopists | Saneso gastroscope rated superior to Olympus gastroscope in terms of field of view. Rated substantially equivalent in other visualization and mechanical characteristics. | |
| Secondary Outcome: Mucosal injury | No complications or evidence of mucosal injury reported/observed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 22 subjects
- Data Provenance: Prospective, multi-center clinical study. The document does not specify the country of origin for the sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The text mentions "endoscopists who performed the procedure" but does not specify the exact number of experts or their specific qualifications (e.g., years of experience). They were responsible for qualitative ratings and assessing mucosal injury.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "qualitative rating by the endoscopists" suggests individual assessments, and it doesn't mention a process for resolving discrepancies if multiple endoscopists were evaluating the same case.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
While a comparative study was done using the Saneso gastroscope and a traditional gastroscope (Olympus GIF-H180), it was not a traditional MRMC study with AI assistance. It was a comparison of two different endoscopy devices.
- Comparison: Saneso gastroscope vs. traditional gastroscope (Olympus GIF-H180).
- Effect Size (Human Readers with/without AI assistance): Not applicable, as this study compared devices, not the effect of AI assistance on human readers. The Saneso device itself does not appear to incorporate AI for assisted reading, but rather offers a wider field of view.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable. The described device is an endoscopic visualization system, not an AI algorithm for standalone image interpretation. The "software" mentioned is for control and image processing, not for AI analysis.
7. The Type of Ground Truth Used
- Clinical Ground Truth: For the clinical study, the primary outcome of "successful intubation of the third portion of the duodenum" served as a procedural success ground truth. This would have been determined by the performing endoscopist.
- Expert Opinion: Qualitative ratings by endoscopists on aspects like field of view and mucosal injury assessment were also part of the evaluation, relying on expert observation and judgment.
8. The Sample Size for the Training Set
The document does not mention any training set size. This is consistent with the device being a visualization tool rather than an AI-driven diagnostic algorithm that typically requires a large training dataset.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As no AI training set is mentioned for this device, a method for establishing its ground truth is also not described.
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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
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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)
| 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 | PredicatePriority | Product | 510(k)Number |
|---|---|---|---|
| Shirakawa Olympus Co.,Ltd | Primary | EVIS EXERA IIColonovideoscopeCF-H180AL | K100584 |
| Olympus Optical Co. Ltd. | ReferenceDevice | Evis Exera 140 SystemPCF 140L | K954451 |
Saneso Gastroscope 360-A (Model: With and Without SBI/DBI) is substantially equivalent to the following cleared device:
| Company | PredicatePriority | Product | 510(k)Number |
|---|---|---|---|
| Shirakawa Olympus Co.,Ltd | Primary | Evis Exera IIGastrointestinalVideoscope GIF-H180 | K100584 |
| Olympus Optical Co. Ltd. | ReferenceDevice | Evis Exera 140 SystemGIF 140 | K954451 |
The Saneso Single Camera Colonoscope-A (Model: With and Without SBI) is equivalent to the following FDA-cleared device:
| Company | Predicatepriority | Product | 510(k) Number |
|---|---|---|---|
| Shirakawa OlympusCo., Ltd | Primary | EVISEXERA IIColonovideoscope (PCFQ180AL) | 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 | Predicatepriority | Product | 510(k) Number |
|---|---|---|---|
| ShirakawaOlympus 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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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 WithoutSBI/DBI) | ||||
|---|---|---|---|---|
| Parameter | Subject Device:Saneso Colonoscope360-A (With andWithout SBI/DBI) | Predicate:EVIS EXERA IIColonovideoscopeCF-H180AL(K100584) | ReferenceDevice EvisExera 140System PCF140L | Equivalence |
| Manufacturer | Saneso, Inc. | Shirakawa OlympusCo., Ltd. | OlympusOpticalCo. Ltd | --- |
| Device Name | Saneso Colonoscope360-A | EVIS EXERA IIColonovideoscopeCF-H180AL | Evis Exera140 SystemPCF 140L | --- |
| 510(k)Number | --- | K100584 | K954451 | --- |
| ClassificationProductCode/RegulatoryNumber | FDF876.1500 | FDF876.1500 | FET (nowknown asFDF)876.1500 | Equivalent |
| SubsequentProduct Code | FET, NWB | FDS | --- | --- |
| RegulatoryClass | II | II | II | Equivalent |
| Indicationsfor use | The SanesoColonoscope 360-Ais intended fordiagnosticvisualization of thelower gastrointestinaltract (including therectum, colon andcecum) and SanesoColonoscope 360-Ais not indicated forileoscopy procedures. | These instrumentshave been designedto be used with anOlympus videoSystem center, lightsource,documentationequipment, videomonitor,endo-therapyaccessories such as abiopsy forceps and | The Evis Exera140 SystemPCF 140L isspecificallydesigned forendoscopicdiagnosistreatment andphoto andvideodocumentationin combination | Equivalent |
| The system alsoprovides access fortherapeuticinterventions usingstandard endoscopytools. The Sanesosystem consists ofSaneso Colonoscope360-A, SanesoProcessor-A andother ancillaryequipment. | other ancillaryequipment. Use theEVIS EXERA IIColonovideoscopeCF-H180AL forendoscopy andendoscopic surgerywithin the lowerdigestive tract(including the anus,rectum, sigmoidcolon, colon andileocecal valve). | with Olympusendoscopesvariousaccessoriesand ancillaryequipmentwithin theupper andlower digestivetract includingthe esophagus,stomach,pancreaticduct, biliaryduct,duodenum,small intestinerectum, and,colon. | ||
| ColonoscopeType | Flexible | Flexible | - | Equivalent |
| OTC/Rx | Rx | Rx | - | Equivalent |
| System Operating Ranges | ||||
| OperatingTemperature | 10°C (50F) - 40°C(104F) | 10°C (50F) - 40°C(104F) | 10°C (50F) -40°C (104F) | Equivalent |
| RelativeHumidity | 85% maximumwithout condensation | 30% - 85% | 30% - 85% | Equivalent |
| OperatingRange | 120 V and 240V 60Hz. | 100V- 240V 50/60Hz | 100V- 240V50/60 Hz | Different |
| Performance Characteristics | ||||
| Mode ofOperation | The processor relaysthe image from theendoscope to a videomonitor | The processor relaysthe image from theendoscope to avideo monitor | The processorrelays theimage fromthe endoscopeto a videomonitor | Equivalent |
| MaximumField of View | 360° | 170° | 140° | Different |
| Depth ofField [mm](Frontcamera) | 2-100 | 2-100 | 5-100 | Equivalent |
| Depth ofField [mm](Side camera) | 2-50 | - | - | - |
| WorkingLength | 168 cm | 168 cm | 133cm | Equivalent |
| InstrumentChannelInnerDiameter | 3.7 mm | 3.7mm | 3.2mm | Equivalent |
| MaximumDistal EndOuterDiameter | 15.6 mm | 13.9mm | 11.3mm | Different |
| InsertionTube OuterDiameter | 12.8 mm | 12.8 mm | 11.3mm | Equivalent |
| BendingSection:AngulationRange | Up/Down: 180°Left/Right: 160° | Up/Down: 180°Left/Right: 160° | Up/Down:180°Left/Right:160° | Equivalent |
| HDTechnology | Yes | Yes | Yes | Equivalent |
| Processor Box Characteristics | ||||
| DigitalOutput(Display) | 3 channels DVI | 3 channels DVI | 3 channelsDVI | Equivalent |
| ControlSignals | White balanceA/W pump controlLED control | White balanceA/W pump controlLED control | White balanceA/W pumpcontrolLED control | Equivalent |
| ElectricalClass | Class I, Type BF | Class I, Type BF | Class I, TypeBF | Equivalent |
| LEDIntensityControl | Yes | Yes | Yes | Equivalent |
| EnhancementMechanism | White light, SelectBand Imaging andDual Band Imaging | White light andNarrow BandImaging | Unknown | Different withrespect toSanesoColonoscope360-A withSBI/DBI andequivalent toSanesoColonoscope360-A withoutSBI/DBI |
| Freeze/Release | 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 andWithout SBI/DBI) | ||||
|---|---|---|---|---|
| Title | Subject SanesoGastroscope360-A (Model:With andWithoutSBI/DBI) | Predicate: EvisExera IIGastrointestinalVideoscopeGIF-H180(K100584) | Reference DeviceEvis Exera 140System GIF 140 | Equivalence |
| Manufacturer | Saneso, Inc. | Shirakawa OlympusCo., Ltd. | Olympus OpticalCo. Ltd | --- |
| Device Name | SanesoGastroscope360-A | Evis Exera IIGastrointestinalVideoscopeGIF-H180 | Evis Exera 140System 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)Number | -- | K100584 | K954451 | -- |
|---|---|---|---|---|
| ClassificationProductCode/RegulatoryNumber | FDS876.1500 | FDS876.1500 | FET (now knownas FDS) 876.1500 | Equivalent |
| SubsequentProduct Code | FET, NWB | FDS | -- | -- |
| RegulatoryClass | II | II | II | Equivalent |
| Indications foruse | The SanesoGastroscope360-A is intendedfor diagnosticvisualization ofthe uppergastrointestinaltract (includingthe esophagus,stomach andduodenum). Thesystem alsoprovides accessfor therapeuticinterventionsusing standardendoscopy tools.The Sanesosystem consists ofSanesoGastroscope360-A SanesoProcessor-A andother ancillaryequipment. | These instrumentshave been designed tobe used with anOlympus video systemcenter, light source,documentationequipment, monitor,endo-therapyaccessories (such as abiopsy and otherancillary equipment).Use the EVIS EXERAII GastrointestinalVideoscope GIF-H180, for endoscopyand endoscopicsurgery within theupper digestive tract(including theesophagus, stomach,and duodenum). | The Evis Exera140 System GIF140 is specificallydesigned forEndoscopicDiagnosis,treatment andphoto and videodocumentation incombination withOlympusendoscopesvariousaccessories andAncillaryequipment withinthe upper andlower digestivetract including theEsophagus,Stomach,pancreatic duct,biliary duct,duodenum, smallintestine rectumand, colon. | Equivalent |
| GastroscopeType | Flexible | Flexible | Flexible | Equivalent |
| OTC/Rx | Rx | Rx | Rx | Equivalent |
Saneso, Inc
K210052/S003
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| System Design and Operating Ranges | ||||
|---|---|---|---|---|
| OperatingTemperature | 10°C (50F) -40°C (104F) | 10°C (50°F) - 40°C(104°F) | 10°C (50°F) -40°C (104°F) | Equivalent |
| RelativeHumidity | 85% maximumwithoutcondensation | 30% - 85% | 30% - 85% | Equivalent |
| Performance Characteristics | ||||
| OperatingRange | 120 V and 240V60 Hz. | 100V- 240V 50/60 Hz | 100V- 240V 50/60Hz | Different |
| Mode ofOperation | The processorrelays the imagefrom theendoscope to avideo monitor | The processor relaysthe image from theendoscope to a videomonitor | The processorrelays the imagefrom theendoscope to avideo monitor | Equivalent |
| MaximumField of View | 360° | 140° | 120° | Different |
| Depth of Field(mm) (Frontcamera) | 2-100 | 2-100 | 3-100 | Equivalent |
| Depth of Field(mm) (Sidecamera) | 2-50 | - | - | - |
| WorkingLength (cm) | 104 | 103 | 103 | Different |
| InstrumentChannel InnerDiameter(mm) | 3.7 | 2.8 | 2.8 | Different |
| MaximumDistal EndOuterDiameter(mm) | 15.6 | 9.8 | 9.8 | Different |
| Insertion TubeOuterDiameter(mm) | 12.8 | 9.8 | 9.8 | Different |
| BendingSection:AngulationRange | Up/Down: 180°Left/Right: 160° | Up/Down: 210°/90°Left/Right: 100°/100° | Up/Down:210°/90°Left/Right:100°/100° | Different |
| HDTechnology | Yes | Yes | Yes | Equivalent |
| Processor Box Characteristics | ||||
| Digital Output(Display) | 3 channels DVI | 3 channels DVI | 3 channels DVI | Equivalent |
| ControlSignals | White balanceA/W pumpcontrolLED control | White balanceA/W pump controlLED control | White balanceA/W pumpcontrolLED control | Equivalent |
| ElectricalClass | Class I, Type BF | Class I, Type BF | Class I, Type BF | Equivalent |
| LED IntensityControl | Yes | Yes | Yes | Equivalent |
| EnhancementMechanism | White light,Select BandImaging and DualBand Imaging | White light andNarrow Band Imaging | None | Differentwith respectto SanesoGastroscope360-A withSBI/DBI andequivalent toSanesoGastroscope360-AwithoutSBI/DBI |
| Freeze/Release | Yes | Yes | Yes | Equivalent |
| CCD Type | Color | Color | Color | Equivalent |
Saneso, Inc
K210052/S003
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5.6.2.1. Similarities between Subject Device and Predicate Device
· The intended use is the same for the Subject and the
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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: Withand Without SBI) | |||
|---|---|---|---|
| Parameter | Subject Device: SanesoSingle CameraColonoscope (Model: Withand Without SBI) | Predicate Device: EVISEXERA II ColonovideoscopePCF-Q180AL | Equivalence |
| Manufacturer | Saneso, Inc. | Shirakawa Olympus Co., Ltd | - |
| Device Name | Saneso Single CameraColonoscope-A | EVIS EXERA IIColonovideoscope | - |
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K210052 Page 16 of 25
| PCF-Q180AL | Endoscopy Reinvented™ | ||
|---|---|---|---|
| 510(k) Number | K100584 | ||
| ClassificationProductCode/RegulatorNumber | FDF876.1500 | FDF876.1500 | |
| SubsequentProduct Code | FET, NWB | FDS | |
| RegulatoryClass | II | II | Equivalent |
| Indications forUse | The Saneso Single CameraColonoscope-A is intendedfor diagnostic visualizationof the lower gastrointestinaltract including the rectum,colon and ileocecal valve.The system also providesaccess for therapeuticinterventions using standardendoscopy tools. The Sanesosystem consists of SanesoSingle CameraColonoscope-A, SanesoProcessor- A and otherancillary equipment. | These instruments have beendesigned to be used with anOlympus video system center,light source, documentationequipment, video monitor,endo-therapy accessories suchas a biopsy forceps and otherancillary Equipment. Use theEVIS EXERA IIColonovideoscopePCF-Q180AL for endoscopyand endoscopic surgery withinthe lower digestive tract(including the anus, rectum,sigmoid colon, colon andileocecal valve). | Equivalent |
| Colonoscopetype | Flexible | Flexible | Equivalent |
| OTC/Rx | Rx | Rx | Equivalent |
| System Operating Ranges | |||
| OperatingTemperature | 10°C - 40°C | 10°C - 40°C | Equivalent |
| RelativeHumidity | 85% maximum withoutcondensation | 30% - 85% | Equivalent |
| OperatingRange | 120V and 240V 60Hz | 100V - 240 V(50/60 Hz) | Different |
| Performance Characteristics | |||
| Mode ofOperation | The Processor relays videosignals from the endoscopeto a video monitor. | The Processor relays videosignals from the endoscope to avideo monitor. | Equivalent |
| Maximum Fieldof View | 140° | 140° | Equivalent |
| Depth of Field[mm] | 2 - 100 mm | 3 - 100 mm | Different |
| WorkingLength | 168 cm | 168 cm | Equivalent |
| InstrumentChannel InnerDiameter | 3.7 mm | 3.2 mm | Different |
| MaximumDistal EndOuter Diameter | 11.6 mm | 11.3 mm | Different |
| Insertion TubeOuter Diameter | 11.8 mm | 11.5 mm | Different |
| BendingSection:AngulationRange | Up/Down: 180°Left/Right: 160° | Up/Down: 180°Left/Right: 160° | Equivalent |
| HD Technology | Yes | Yes | Equivalent |
| Processor Box Characteristics | |||
| Digital Output(Display) | 3 channels DVI | 3 channels DVI | Equivalent |
| Control Signals | White balance A/W pumpcontrol Light control | White balance A/W pumpcontrol Light control | Equivalent |
| Electrical Class | Class I, Type BF | Class I, Type BF | Equivalent |
| Light IntensityControl | Yes | Yes | Equivalent |
| EnhancementMechanism | Yes (White Light with SelectBand Imaging) | Yes (White Light and NarrowBand Imaging) | Equivalentwith respect |
| to SanesoSingleCameraColonoscope-Awith/withoutSBI | |||
| Freeze/Release | Yes | Yes | Equivalent |
| CCD Type | Colour | Colour | Equivalent |
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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: Withand Without SBI) | |||
|---|---|---|---|
| Parameter | Subject Device: SanesoSingle CameraGastroscope-A (Model:With and Without SBI) | Predicate Device: EvisExera II GIF-H180 | Equivalence |
| Manufacturer | Saneso, Inc. | Shirakawa Olympus Co., Ltd | - |
| Device Name | Saneso Single CameraGastroscope-A | Evis Exera II GIF-H180 | - |
| 510(k) Number | K100584 | - | |
| ClassificationProductCode/RegulatorNumber | FDF876.1500 | FDF876.1500 | - |
| Subsequent ProductCode | FET, NWB | FDS | - |
| Regulatory Class | II | II | Equivalent |
| Indications for Use | The Saneso SingleCamera Gastroscope-Ais intended for diagnosticvisualization of theupper gastrointestinaltract (including theesophagus, stomach andduodenum). The systemalso provides access fortherapeutic interventionsusing standardendoscopy tools. TheSaneso system consistsof Saneso Single CameraGastroscope-A, SanesoProcessor-A and otherancillary equipment. | The EVIS EXERA IIGIF-H180 has been designedto be used with an Olympusvideo system center,light source, documentationequipment, monitor,EndoTherapy accessories(such as a biopsy and otherancillary equipment forendoscopy and endoscopicsurgery within the upperdigestive tract (including theesophagus, stomach, andduodenum). | Equivalent |
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| OTC/Rx | Rx | Rx | Equivalent |
|---|---|---|---|
| System Operating Ranges | |||
| OperatingTemperature | 10℃ - 40℃ | 10℃ - 40℃ | Equivalent |
| Relative Humidity | 85% maximum withoutcondensation | 30% - 85% | Equivalent |
| Operating Range | 120V and 240V 60Hz | 100V - 240 V(50/60 Hz) | Equivalent |
| Performance Characteristics | |||
| Mode of Operation | The Processor relaysvideo signals from theendoscope to a videomonitor. | The Processor relays videosignals from the endoscopeto a video monitor. | Equivalent |
| Maximum Field ofView | 140° | 140° | Equivalent |
| Depth of Field [mm] | 2 - 100 mm | 2 - 100 mm | Equivalent |
| Working Length | 104 cm | 103 cm | Different |
| Instrument channelInner Diameter | 3.7 mm | 2.8 mm | Different |
| Maximum Distal EndOuter Diameter | 11.6 mm | 9.8 mm | Different |
| Insertion Tube OuterDiameter | 11.5 mm | 9.8 mm | Different |
| Bending Section:Angulation Range | Up/Down: 180°Left/Right: 160° | Up: 210°Down: 90°Left/Right: 100° | Different |
| HD Technology | Yes | Yes | Equivalent |
| Processor Box Characteristics | |||
| Digital Output(Display) | 3 channels DVI | 3 channels DVI | Equivalent |
| Control Signals | White balance A/W | White balance A/W pump | Equivalent |
| pump control Lightcontrol | control Light control | ||
| Electrical Class | Class I, Type BF | Class I, Type BF | Equivalent |
| Light IntensityControl | Yes | Yes | Equivalent |
| EnhancementMechanism | Yes (White Light withSelect Band Imaging) | Yes (White Light andNarrow Band Imaging) | Equivalentwith respectto SanesoSingleGastroscopewith/withoutSBI |
| Freeze/Release | Yes | Yes | Equivalent |
| CCD Type | Colour | Colour | Equivalent |
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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 Type | Test Description | Test Result |
| Electrical SafetyandElectromagneticCompatibilityTesting | - IEC 60601-1-2- ANSI AAMIES60601-1 | The Saneso-A series met allacceptance criteria inaccordance with IEC60601-1-2, ANSI AAMIES60601-1 |
| Biocompatibility | - Cytotoxicity- Sensitization- Irritation | The Saneso-A series isbiocompatible. Saneso, Inc., hasperformed biocompatibilitytesting for Saneso Endoscope360-A, which has the samecomponents and manufacturingprocesses as the Saneso SingleCamera Endoscope-A. Also,Saneso, Inc., has provided a |
{25}------------------------------------------------
| comparison table outlining thereprocessing steps performedprior to conducting thecytotoxicity study and thereprocessing steps outlined inthe Reprocessing Manual whichmeets the worse case scenariofor assessing biocompatibility. | ||
|---|---|---|
| Cleanability | Cleaning Validation | The Saneso-A series met all theacceptance criteria anddemonstrated that the cleaningprocess does not impact thefunctionality of the device. |
| High LevelDisinfection | High LevelDisinfection Report | The Saneso-A series met all theacceptance criteria anddemonstrated that high leveldisinfection does not impact thefunctionality of the device. |
| PerformanceBench Testing | Verification Reports | The Saneso-A series met all thedesign 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
{26}------------------------------------------------
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<0.5 respectively). No complications or evidence of mucosal injury were reported/observed with the use of Saneso gastroscopes.
Further, the Saneso gastroscope was rated superior to Olympus gastroscope in terms of the field of view by the endoscopists who performed the procedure. The Saneso gastroscope was rated substantially equivalent to Olympus GIF-H180 gastroscope in other visualization and mechanical characteristics.
The results of the study are documented in the clinical study report.
5.9. Conclusion
Saneso Colonoscope 360-A (Model: With and Without SBI/DBI)
Saneso Colonoscope 360-A is substantially equivalent to the Predicate Device, EVIS EXERA II Colonovideoscope CF-H180AL and Reference Device, Evis Exera 140 System PCF 140L in terms of technological characteristics, performance characteristics, system operating ranges and intended use. Performance testing demonstrates that Saneso Colonoscope 360-A is as safe and effective as the Predicate Device.
Saneso Gastroscope 360-A (Model: With and Without SBI/DBI)
Saneso Gastroscope 360-A is deemed substantially equivalent to the Predicate Device, Evis Exera II Gastrointestinal Videoscope GIF-H180 and Reference Device, Evis Exera 140 System GIF 140 in terms of technological characteristics, performance characteristics, system operating ranges and intended use. Performance testing demonstrates that Saneso Gastroscope 360-A is safe and effective as the Predicate
{27}------------------------------------------------
Device.
Saneso Single Camera Colonoscope-A (Model: With and Without SBI)
The Saneso Single Camera Colonoscope-A is deemed substantially equivalent to the Predicate Device Olympus PCF Q180AL in terms of technological characteristics, performance characteristics, system operating ranges and intended use. Performance testing demonstrates that Saneso Single Camera Gastroscope-A is safe and effective as the Predicate Device.
Saneso Single Camera Gastroscope-A (Model: With and Without SBI)
The Saneso Single Camera Gastroscope-A is deemed substantially equivalent to the Predicate Device, Evis Exera II GIF-H180 in terms of technological characteristics, performance characteristics, system operating ranges and intended use. Performance testing demonstrates that Saneso Single Camera Gastroscope-A is safe and effective as the Predicate Device.
§ 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.