(261 days)
Not Found
No
The summary describes a standard ultrasonic gastrovideoscope and its associated image processing and ultrasound systems. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The image processing mentioned refers to standard endoscopic image processing, not AI-driven analysis.
No
The device is described as providing "endoscopic images for the examination and diagnosis" and performing "ultrasound examination and diagnosis," indicating its primary purpose is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device 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 word "diagnosis" clearly indicates its primary function as a diagnostic device.
No
The device description explicitly states that the device is an "Ultrasonic Gastrovideoscope" consisting of physical components like an insertion tube, control section, and connector section. It also mentions being used in conjunction with other hardware like an Endoscopic Image Processor, light source, ultrasound system, and monitor. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ultrasonic Gastrovideoscope is used to directly visualize the upper gastrointestinal tract and perform ultrasound examinations in vivo (within the body). It does not analyze samples taken from the body.
- Intended Use: The intended use is for "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." This is a direct diagnostic procedure performed on the patient, not an analysis of a sample.
Therefore, the Ultrasonic Gastrovideoscope falls under the category of a medical device used for direct imaging and examination within the body, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
ODG, ITX
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic images, ultrasound images
Anatomical Site
upper gastrointestinal tract, upper gastrointestinal sub-mucosa, surrounding organs
Indicated Patient Age Range
The subject device is only intended for use in adults
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
3
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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4
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
-
- Date of Preparation: 03/06/2024
-
- 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: +86-755-26722890 Fax: +86-755-26722850 Email: ra@sonoscape.net
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
5
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
6
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.
7
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.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
-
- Summary of Technological Characteristics
| ITEM | Subject Device | Predicate Device
K130206 | Remark |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Product name | Ultrasonic Gastrovideoscope
EG-UR5 | PENTAX EG-3670URK
Ultrasound Video Gastroscope
(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
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. | for procedure are observed in
adult and pediatric patient
populations. | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Configuration | Ultrasonic gastrovideoscope
including a radial array type
ultrasound transducer | Ultrasonic gastrovideoscope
including a radial array type
ultrasound transducer | Same |
| Use environment | Medical institution | Medical institution | Same |
| Principles of Operation | The endoscope has a long,
thin, flexible tube to enter the
patient's body and capture the
video and ultrasonic image of
inside of the patient's body. | The endoscope has a long, thin,
flexible tube to enter the
patient's body and capture the
video and ultrasonic image of
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 | |||
| EG-UR5 | PENTAX EG-3670URK | |||
| Ultrasound Video Gastroscope / | ||||
| (Radial Array Type) | ||||
| Working length | 1250mm | 1250mm | ||
| Dimensi | ||||
| on | Minimum | |||
| instrument | Ф2.2mm | Ф2.4mm | Similar | |
| orifice | ||||
| inner | ||||
| diameter | ||||
| Maximum | ||||
| insertion section | ||||
| outer diameter | $Φ$ 12.7mm | $Φ$ 13.45mm | ||
| Outer diameter | ||||
| of main hose | $Φ$ 11.5mm | $Φ$ 12.1mm | ||
| Outer diameter | ||||
| of head end | $Φ$ 11.3mm | $Φ$ 12.0mm | ||
| Balloon | Yes, detachable | Yes, detachable | ||
| Ultrasound | ||||
| 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 | ||||
| Imaging | ||||
| 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 | ||||
| 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 | ||||
| classification | Degree of protection against electric shock | BF type application section | BF type application section | Same |
| ITEM | Subject Device | Predicate Device | ||
| 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 | ||||
| requirements | Comply with IEC 60601-2-18 | |||
| Comply with IEC 60601-2-37 | Comply with IEC 60601-2-18 | |||
| 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
10
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.