Ultrasonic Gastrovideoscope

K231813 · Sonoscape Medical Corp. · ODG · Mar 8, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K231813
• Device Name: Ultrasonic Gastrovideoscope
• Applicant: Sonoscape Medical Corp.
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: Mar 8, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The ultrasonic gastrovideoscope (hereinafter called endoscope) is intended to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs. The endoscope should be used in the medical institution. The operator of the endoscope should be a physician or a medical staff supervised by a physician, both of whom have received sufficient training in clinical endoscopy technology.

Device Story

Ultrasonic Gastrovideoscope (EG-UR5) is a reusable flexible endoscope with a radial array ultrasound transducer. Used in medical institutions by trained physicians or supervised staff. Connects to compatible SonoScape endoscopic image processors, light sources, ultrasound systems, and monitors. Captures optical video and ultrasonic images of the upper GI tract, sub-mucosa, and surrounding organs. Provides 360° electronic ring scan ultrasound imaging. Features include detachable balloon, 140° field of view, and enhanced bending angulation compared to predicate. Output displayed on external monitors to assist physicians in visual and ultrasonic diagnosis. Benefits include improved visualization and diagnostic capability for GI sub-mucosa and surrounding structures.

Clinical Evidence

No clinical study included. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, sensitization, irritation), optical performance (color, resolution, distortion), ultrasonic performance (quantization imaging), irrigation/suction performance, backflow prevention, and mechanical fatigue/stability testing. Imaging performance was verified against accelerated aging to ensure no degradation affects clinical use.

Technological Characteristics

Reusable flexible endoscope; radial array ultrasound transducer (4.5-12.5 MHz). Materials comply with ISO 10993. Connectivity: wired to external image processor/ultrasound system. Bending: Up 180°, Down 90°, Left/Right 100°. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, ISO 8600. No sterile claims.

Indications for Use

Indicated for adult patients requiring endoscopic and ultrasound examination and diagnosis of the upper gastrointestinal tract, including sub-mucosa and surrounding organs.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• PENTAX EG-3670URK Ultrasound Video Gastroscope (Radial Array Type) + HI VISION PREIRUS (K130206)

Submission Summary (Full Text)

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March 8, 2024

Sonoscape Medical Corp. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K231813

Trade/Device Name: Ultrasonic Gastrovideoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODG. ITX Dated: February 7, 2024 Received: February 7, 2024

Dear Diana Hong:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Shanil P. Haugen -S

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) K231813

Device Name Ultrasonic gastrovideoscope

#### Indications for Use (Describe)

The ultrasonic gastrovideoscope (hereinafter called endoscope) is intended to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs.

The endoscope should be used in the medical institution. The operator of the endoscope should be a physician or a medical staff supervised by a physician, both of whom have received sufficient training in clinical endoscopy technology.

| 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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## 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number:_ K231813

- 1. Date of Preparation: 03/06/2024
- 2. Sponsor Identification

#### SONOSCAPE MEDICAL CORP.

Room 201 & 202, 12th Building, Shenzhen Software Park Phase II, 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan District, Shenzhen, 518057, Guangdong, China.

Establishment Registration Number: 3004705634

Contact Person: Toki Wu Position: Regulatory Affairs Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

#### Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Subject Device

Device Trade Name: Ultrasonic Gastrovideoscope (EG-UR5) Common Name: Endoscope and accessories

#### Regulatory Information

Classification Name: Endoscopic Ultrasound System, Gastroenterology-Urology Product Class: II Product Code: ODG Regulation Number: 21 CFR 876.1500

#### Indication for Use:

The ultrasonic gastrovideoscope (hereinafter called endoscope) is intended to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs. The endoscope should be used in the medical institution. The endoscope should be a physician or a medical staff supervised by a physician, both of whom have received sufficient training in clinical endoscopy technology.

#### Device Description:

The subject device, Ultrasonic Gastrovideoscope, is consisting of insertion, control section and connector section. The insertion is consisting of a distal end, a bending section and an insertion tube. This Ultrasonic Gastrovideoscope is intended to use in conjunction with Endoscopic Image Processor (HD-550Exp, HD-550, HD-550Pro, HD-550S, HD-510 and HD-500Plus), light source (VLS-55Q, VLS-55T, VLS-51D and VLS-51T), ultrasound system (P60 Exp, P60, P60 Pro, P60 CV, P60S and P60 VO) and monitor to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs.

The Ultrasonic Gastrovideoscope is a reusable device. The Ultrasonic Gastrovideoscope has only one model EG-UR5.

The prospective clinical value of the enhanced imaging modes (EWL, SFI, and VIST) has not been demonstrated, and no clinical claims are made.

#### 5. Identification of Predicate Device

#### 510(k) Number: K130206

Device Name: PENTAX EG-3670URK Ultrasound Video Gastroscope (Radial Array Type) + HI VISION PREIRUS

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#### 6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device.

#### Biocompatibility: Cytotoxicity, Skin Sensitization and Oral Mucosal Irritation

#### Performance Testing- Optical performance characteristics

The optical performance test includes color reproduction, depth of field, intensity uniformity, Optical Magnification and Distortion, resolution and Dynamic Range. The test results demonstrate that the subject device and predicate device have the same or similar optical performance.

#### Performance Testing - Ultrasonic Performance Contrast Test

Ultrasonic performance contrast test has been conducted on the subject device and predicate device. The test results demonstrate that the performance indexes of ultrasonic quantization imaging are similar. There was no clinically significant difference in the safety and clinical performance of the subject device and predicate device.

#### Performance Testing - Irrigation Performance Test

Irrigation performance test (including the Air/Water-feeding and Suction Performance) has been conducted on the subject device and predicate device. The test results demonstrate that the subject device and predicate device have the similar irrigation performance.

#### Performance Testing -Backflow Prevention Test

Backflow Prevention Test has been conducted on the subject device, the tested per FDA guidance, Mitigating the risk of Cross-Contamination from valves and Accessories Used for irrigation through Flexible Gastrointestinal Endoscopes, Document issued on November 29, 2016. The test results demonstrate that the air/water valve of EG-UR5 could effectively prevent the contaminated liquid backflow to the proximal irrigation system, so the prevention backflow function of the EG-UR5 Ultrasonic Gastrovideoscope is effective and reliable.

#### Performance Testing - Performance stability

A product performance testing was conducted to evaluate the stability of the subject device when in use. This testing includes two parts, one part is the simulated fatigue testing on the subject device, the other part is used to evaluate the product performance after simulated fatigue testing. Based on the test results, the components mechanically fatigue caused by long-period using will not lead to the decrease of endoscope performance during the clinical use; the endoscope appearance, handle strength, image function, sealing and bending angle still meet the clinical requirements.

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The quality of an imaging device can change over time when it is in clinical use due to changes in the components. Imaging Performance Attenuation Test Report was conducted to ensure that degradations in imaging performance is detected before it results in image quality that lead to misdiagnosis. Image performances include Noisy Point, Color Reducibility, Resolution and Bad Point. The four performance testing was separately conducted on the new devices and the accelerated aging devices in one test report

On the whole, the image performance of system still is in a better condition when the device is over its lifetime of clinical use. The degradations of imaging performance are very little which will not affect the normal use of the endoscope.

- 7. Clinical Test Conclusion
No clinical study is included in this submission.

- 8. Summary of Technological Characteristics

| ITEM | Subject Device | Predicate Device<br>K130206 | Remark |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product name | Ultrasonic Gastrovideoscope<br>EG-UR5 | PENTAX EG-3670URK<br>Ultrasound Video Gastroscope<br>(Radial Array Type) | / |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Product code | ODG | ODG and ITX | Same |
| Class | Class II | Class II | Same |
| Indication for Use | The ultrasonic gastrovideoscope (hereinafter called endoscope) is intended to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs. The endoscope should be used in the medical | The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement | Similar |

Table 1. General Comparison

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| | institution. The operator of<br>the endoscope should be a<br>physician or a medical staff<br>supervised by a physician,<br>both of whom have received<br>sufficient training in clinical<br>endoscopy technology. | for procedure are observed in<br>adult and pediatric patient<br>populations. | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Configuration | Ultrasonic gastrovideoscope<br>including a radial array type<br>ultrasound transducer | Ultrasonic gastrovideoscope<br>including a radial array type<br>ultrasound transducer | Same |
| Use environment | Medical institution | Medical institution | Same |
| Principles of Operation | The endoscope has a long,<br>thin, flexible tube to enter the<br>patient's body and capture the<br>video and ultrasonic image of<br>inside of the patient's body. | The endoscope has a long, thin,<br>flexible tube to enter the<br>patient's body and capture the<br>video and ultrasonic image of<br>inside of the patient's body. | Same |
| Single use/ Reuse | Reuse | Reuse | Same |
| Sterile | No | No | Same |
| Prescription Use/OTC | Prescription Use | Prescription Use | Same |

### Indication for Use Comparison

The subject device and predicate device are all used to provide endoscopic images of the upper gastrointestinal tract of examination and diagnosis, and to perform the ultrasound exam and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs. A difference between the subject device and predicate device is the target population. The subject device is only intended for use in adults; this information has been specified in the user manual.

The difference on the indication for use statement does not raise new problem on the safety and effectiveness of the subject device.

| ITEM | | Subject Device | Predicate Device K130206 | Remark |
|---------------------------------|----------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------|-----------|
| Product name | | Ultrasonic Gastrovideoscope<br>EG-UR5 | PENTAX EG-3670URK<br>Ultrasound Video Gastroscope /<br>(Radial Array Type) | |
| | Working length | 1250mm | 1250mm | |
| Dimensi<br>on | Minimum<br>instrument | Ф2.2mm | Ф2.4mm | Similar |
| | orifice<br>inner<br>diameter | | | |
| | Maximum<br>insertion section<br>outer diameter | $Φ$ 12.7mm | $Φ$ 13.45mm | |
| | Outer diameter<br>of main hose | $Φ$ 11.5mm | $Φ$ 12.1mm | |
| | Outer diameter<br>of head end | $Φ$ 11.3mm | $Φ$ 12.0mm | |
| | Balloon | Yes, detachable | Yes, detachable | |
| Ultrasound<br>Imaging | Scanning method | Electronic ring scan | Electronic ring scan | Same |
| | Scanning direction | Perpendicular to insertion direction | Perpendicular to insertion direction | Same |
| | Scanning angle | 360° | 360° | Same |
| | Acoustic Frequency | 4.5~12.5 MHz | 5-10MHz | similar |
| Endoscope<br>Imaging<br>Systems | Balloon | Removable | Removable | Same |
| | Field of view | 140° (Direct view mirror) | 140° (Direct view mirror) | Same |
| | Depth of field | 3~100mm | 4~100mm | Similar |
| Bend<br>Angulation | Up and down bending angle range | Up: 180°, Down: 90° | Up: 130°, Down: 60° | Different |
| | Left and right bend angle range | Left: 100°, Right: 100° | Left: 60°, Right: 60° | |
| | | | | |
| Safety<br>classification | Degree of protection against electric shock | BF type application section | BF type application section | Same |
| | | | | |
| | | | | |
| ITEM | Subject Device | Predicate Device<br>K130206 | Remark | |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same | |
| Particular<br>requirements | Comply with IEC 60601-2-18<br>Comply with IEC 60601-2-37 | Comply with IEC 60601-2-18<br>Comply with IEC 60601-2-37 | Same | |
| Biocompatibility | No Cytotoxicity | Comply with the ISO 10993 | Same | |
| | No Sensitization | series standards | | |
| | No Irritation | | | |

Table 2. Comparison table of specifications

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#### Similar - Dimension

The dimension of the subject device is similar as those the predicate device. The ISO 8600 performance testing has conducted on the subject device and the test result show the performance of the subject device meets the requirements of ISO 8600. Therefore, the difference on dimension will not affect the safety and effectiveness of the subject device.

#### Similar -Acoustic Frequency

The acoustic frequency range of subject device is similar as that of the predicate device. Based on the acoustic performance comparison testing, the subject device and predicate device are basically the same

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based on the comparison of the phantom test on 14 quantitative indexes of ultrasonic imaging performance. Some frequency segments are slightly better or slightly worse, all within the range of measurement error. Therefore, the difference on acoustic frequency will not affect the safety and effectiveness of the subject device.

#### Similar- Depth of field

The depth of field of the subject device is similar as the predicate device. However, the depth of field comparison testing has conducted on the subject device and the test result show the there is no statistical difference on the performance of the subject device and the predicate device. Therefore, the difference on depth of field will not affect the safety and effectiveness of the subject device.

#### Different –Bend Angulation

The bend angulation of the subject device is different from the predicate device. The ISO 8600 performance testing has conducted on the subject device and the test result show the performance of the subject device meets the requirements of ISO 8600. Meanwhile, the angulation of the subject device is greater than the predicate device, which provides more operating space for the physician in clinical operation for different situations.

Therefore, the difference on bend angulation will not affect the safety and effectiveness of the subject device.

Table 3. Safety Comparison

#### 9. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device, Ultrasonic Gastrovideoscope EG-UR5, is substantially equivalent to the predicate.