(341 days)
Not Found
No
The document describes a standard endoscopic system with image processing functions, but there is no mention of AI, ML, or any related technologies like deep learning or neural networks. The focus is on the hardware components and basic image processing for visualization.
Yes
The device is described as being used for "treatment" in the intended use sections for both the GI endoscope and the colonoscope, as well as the camera system.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "designed for endoscopic observation, diagnosis and treatment."
No
The device description clearly outlines hardware components including disposable endoscopes with LED lamps and a camera system that provides power supply. While it mentions image processing, it is part of a larger hardware system.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described devices (disposable endoscopes and camera system) are used for direct visualization of the internal organs (gastrointestinal tract). They are used in vivo (within the living body) for observation, diagnosis, and treatment.
- No Sample Analysis: The text does not mention the device analyzing any samples taken from the patient. Its primary function is to provide visual information.
Therefore, the Endofresh Digestive Endoscopy System falls under the category of endoscopic devices used for direct visualization and intervention, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The disposable GI endoscope (XZING-W200B) is designed to be used with XZING-S2 Camera System, monitor and other peripheral device for endoscopic observation, diagnosis and treatment of the adult upper gastrointestinal tract. It is a single use disposable device and cannot be reused.
The Disposable Colonoscope (XZING-C200B) is designed to be used with XZING-S2 Camera System, monitor and other peripheral device for electronic colonoscope observation, diagnosis and treatment of the adult lower digestive tract (including the anus, rectum, colon and ileocecal segment). It is a single use disposable device and cannot be reused.
The Camera System is designed to be used with the XZING endoscopes, monitor and other peripheral device for endoscopic observation, diagnosis and treatment.
Product codes (comma separated list FDA assigned to the subject device)
FDF, FDS
Device Description
The proposed system, Endofresh Digestive Endoscopy System, includes a disposable GI endoscope, a disposable colonoscope and a camera system (refer to Table 1) They are used together with the monitor and other peripheral device for electronic endoscopic observation, diagnosis and treatment of adult upper gastrointestinal tract or adult lower digestive tract.
The disposable GI endoscope and disposable colonoscope are the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract. There are two LED lamps to provide illumination for endoscopic diagnosis, treatment and video observation. The disposable GI endoscope and disposable colonoscope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
The camera system is a video processing system which is designed to be used with the proposed endoscopes, monitor and other peripheral device. The camera system only has one imaging mode, white light imaging mode. Apart from the image processing functions, it also provides power supply for the endoscopes.
The display is not included in the Endofresh Digestive Endoscopy System. The display should have following color performance and color space to ensure the color performance of the whole system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
adult upper gastrointestinal tract, adult lower digestive tract (including the anus, rectum, colon and ileocecal segment)
Indicated Patient Age Range
Adult
Intended User / Care Setting
Not Found
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 proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals
- USP41-NF36 Bacterial Endotoxins Test
- ASTM F88/F88M - 15 Standard test method for seal strength of flexible barrier materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ISO 8600-1:2015 Endoscopes - Medical endoscopes and endotherapy devices - part 1: General requirements
- ISO 8600-3:1997/Amd1:2003 Optics and optical instruments -- Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
- ISO 8600-4:2014 Endoscopes -- Medical endoscopes and endotherapy devices -- Part 4: Determination of maximum width of insertion portion
- ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance, including the US National Differences
- IEC 60601-1-2:2014 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier System for Medical Device.
- IEC 62471:2006 Photobiological Safety of Lamps and Lamp Systems.
- ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices
- ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
September 2, 2020
HuiZhou Xzing Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai. 200120 CHINA
Re: K192704
Trade/Device Name: Endofresh Digestive Endoscopy System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF, FDS Dated: September 23, 2019 Received: September 27, 2019
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 (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 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
1
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, PhD 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
2
Indications for Use
510(k) Number (if known) K192704
Device Name Endofresh Digestive Endoscopy System
Indications for Use (Describe)
XZING-W200B Disposable GI Endoscope
The disposable GI endoscope (XZING-W200B) is designed to be used with XZING-S2 Camera System, monitor and other peripheral device for endoscopic observation, diagnosis and treatment of the adult upper gastrointestinal tract. It is a single use disposable device and cannot be reused.
XZING-C200B Disposable Colonoscope
The Disposable Colonoscope (XZING-C200B) is designed to be used with XZING-S2 Camera System, monitor and other peripheral device for electronic colonoscope observation, diagnosis and treatment of the adult lower digestive tract (including the anus, rectum, colon and ileocecal segment). It is a single use disposable device and cannot be reused.
XZING-S2 Camera System
The Camera System is designed to be used with the XZING endoscopes, monitor and other peripheral device for endoscopic observation, diagnosis and treatment.
| 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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3
510(k)Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The as signed 510(k) Number: K192704
-
- Date of Preparation: 8/21/2020
-
- Spons or Identification
HuiZhou Xzing Technology Co., Ltd.
4th floor, Building D, S-16-2 Southernpark, HuiNan Hi-tech Industrial Park, Songbairoad, Huizhou, Guangdong, China
Contact Person: Yonglin Ni Position: Quality manager Tel: +86-752-5754700 Fax: +86-752-5754786 Email: niyonglin@xzing-tech.com
-
- 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: 001-360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Endofresh Digestive Endoscopy System
Common Name: Endoscopic Video Imaging System
Primary Components:
| Endofresh Digestive
| Endoscopy System | Disposable GI endoscope | Model: XZING-W200B |
|---|---|---|
| Disposable colonoscope | Model: XZING-C200B | |
| Camera System | Model: XZING-S2 |
Components 1
Trade Name: Disposable GI Endoscope: Common Name: Endoscopic Video Imaging System Model: XZING-W200B
Components 2
Trade Name: Disposable Colonoscope Common Name: Endoscopic Video Imaging System Model: XZING-C200B
Components 3
Trade Name: Camera System Common Name: Endoscopic Video Imaging System Model: XZING-S2
Regulatory Information
Classification Name: Endoscope and accessories Classification: II Product Code: FDS, FDF Regulation Number: 21 CFR 876.1500 Review Panel: Gas troenterology/Urology
5. Identification of Predicate Device
510(k) Number: K100584 Product Name: EVIS EXERA II 180 System Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP.
Components 1 Trade name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE Component Models: OLYMPUS GIF-Q180
5
Components 2 Trade name: EVIS EXERA II COLONOVIDEOSCOPE Component Models: OLYMPUS CF-Q180AL
Components 1
Trade name: EVIS EXERA II VIDEO SYSTEM CENTER Component Models: OLYMPUS CV-180
Indications for Use: 6.
XZING-W200B Disposable GI Endos cope
The disposable GI endoscope (XZING W200B) is designed to be used with XZING-S2 Camera System, monitor and other peripheral device for endoscopic observation, diagnosis and treatment of the adult upper gastrointestinal tract. It is a single use disposable device and cannot be reused.
XZING-C200B Disposable Colonoscope
The Disposable Colonoscope (XZINGC200B) is designed to be used with XZING-S2 Camera System, monitor and other periphearl device for electronic colonoscope observation, diagnosis and treatment of the adult lower digestive tract (including the anus, rectum, colon and ileocecal segment). It is a single use dis posable device and cannot be reused.
XZING-S2 Camera System
The Camera System is designed to be used with the XZING endoscopes, monitor and other peripheral device for endoscopic observation, diagnosis and treatment.
Device Description
The proposed system, Endofresh Digestive Endoscopy System, includes a disposable GI endoscope, a disposable colonoscope and a camera system (refer to Table 1) They are used together with the monitor and other peripheral device for electronic endoscopic observation, diagnosis and treatment of adult upper gas trointestinal tract or adult lower digestive tract.
The disposable GI endoscope and disposable colonoscope are the hand-held, direct-viewing flexible endoscope used for endoscopy and endoscopic surgery within the upper and lower gastrointestinal tract. There are two LED lamps to provide illumination for endoscopic diagnosis, treatment and video observation. The disposable OI endoscope and disposable colonoscope are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
The camera system is a video processing system which is designed to be used with the proposed endoscopes, monitor and other peripheral device. The camera system only has one imaging mode, white light imaging mode. Apat from the image processing functions, it also provides power supply for the endoscopes.
The display is not included in the Endofresh Digestive Endoscopy System. The display should have following color performance and color space to ensure the color performance of the whole system.
6
| Effective display area | 576(H) × 324(V)mm |
|---|---|
| resolution | 1920 (RGB) × 1080 |
| Pixel pitch | 0.300(H) × 0.300(V)mm |
| Displayed color | 1.07billion (true 10 bit) |
| Luminance (type) | 450cd/m² |
| Contrast (Min) | 800:1 |
Table 1 Recommended Color performance and color space of display
-
- Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device
K100584 | Remark |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | FDF and FDS | NWB, FDF and FDS | Analysis 1 |
| Regulation
Number | 21 CFR 876.1500 | 21 CFR 876.1500 | SE |
| Class | II | II | SE |
| Indications
for
Use | Disposable GI Endoscope
The Disposable GI Endoscope
(XZING-W200B) is designed to be
used with XZING-S2 Camera
System, monitor and other peripheral
device for endoscopic observation,
diagnosis and treatment of the adult
upper gastrointestinal tract. It is a
single use disposable device and
cannot be reused. | EVIS EXERA II
GASTROINTESTINAL VIDEOSOOPE
OLYMPUS GIF TYPE Q180,
OLYMPUS GIF TYPE H180
These instruments have been designed
to be used with an Olympus video
system center, light source,
documentation equipment, monitor,
Endo Therapy accessories (such as a
biopsy) and other ancillary equipment
for endoscopy and endoscopic surgery
within the upper digestive tract
(including the esophagus, stomach, and
duodenum). | Analysis 2 |
| | Disposable Colonoscope
The Disposable Colonoscope is
designed to be used with XZING-S2
Camera System, monitor and other
periphearl device for electronic
colonoscope observation, diagnosis
and treatment of the adult lower
digestive tract (including the anus,
rectum, colon and ileocecal segment). | EVIS EXERA II
COLONOVIDEOSCOPE OLYMPUS
CF TYPE Q180AL. OLYMPUS CF
TYPE Q180AI.
These instruments have been designed
to be used with an Olympus video
system center, light source,
documentation equipment, monitor,
EndoTherapy accessories (such as a
biopsy forceps), and other ancillary | |
Table 2. General Comparison
7
| | It is a single use disposable device
and cannot be reused. | equipment for endoscopy and
endoscopic surgery within the lower
digestive tract (including the anus,
rectum, sigmoid colon, colon, and
ileocecal valve). | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | XZING-S2
The Camera System is designed to
be used with the XZING
endoscopes, monitor and other
peripheral device for endoscopic
observation, diagnosis and
treatment. | EVIS EXERA II VIDEO SYSTEM
CENTER OLYMPUS CV-180
This video system center has been
designed to be used with OLYMPUS
camera heads, endoscopes, light sources,
monitors, endo-therapy accessories and
other ancillary equipment for
endoscopic diagnosis, treatment and
video observation. | |
| Single use /
Reuse | Endoscopes: Single use
Image processor/camera system:
Reuse | Endoscopes: Reuse
Image processor/camera system:
Reuse | Analysis 1 |
| Sterile | Yes for disposable endoscope | No | |
| Target population | Adult | No special requirements | |
| | / | Light Source | |
| Configuration
(primary
components) | Image processor | Image processor | |
| | Video Disposable GI Endoscopy | Video Gastroscope | Analysis 3 |
| | Video Disposable Colonoscope | Video Colonoscope | |
| | Accessories and peripheral devices | Accessories and peripheral devices | |
Analysis 1-ProductCode
This product has only white light mode, and the device of the comparative product has narrowband imaging (NBI), so the product code is FDF and FDS, excluding NWB. The code of proposed device is included in the code of the predicate device, the difference of the code will not affect the safety and effectiveness of the device.
Analysis 2- Indications for use, single use/reuse, sterile and target population
The Endofresh Digestive Endoscopy System and predicate device are difference on the indications for use, sterile and target population.
The endoscope of the predicate device is non-sterile and reusable. The endoscope must be cleaned and disinfected after and before every usage. The proposed endoscope is single use and provided sterile. It doesn't need reprocessing and reduces the risk of cross contamination.
The target population of the proposed device is adult, and the target population of the predicate device is
8
not specified. To specify the target population can help the clinician select the proper endoscope. Based on above analysis, we think the differences on the indications for use, sterile and target population will not raise new questions on the safety and effectiveness of the proposed device.
Analysis 3-Configuration
The configuration of the proposed device is different from the predicate device. The proposed device has two LEDs on the distal end of the endoscope and the predicate device has an external LED source. The LEDs on the distal end of the endoscope have the same role as that of the external light source, and the internal LED light source of the proposed device makes operating the device less cumbersome. Therefore, this difference on light source does not affect the safety and effectiveness of the proposed device.
| ITEM | Proposed device | Predicate device
K100584 | Remark |
|-------------------------------|--------------------------------------------------|-------------------------------------------------|------------|
| Model | XZING-W200B | GIF-Q180 | / |
| Field of view | 100°±10% | 140° | Analysis 4 |
| Depth of focus | 3-100mm | 3-100mm | SE |
| Front view | 0° | 0° | SE |
| Sensortype | CMOS | color CCD | Analysis 5 |
| Distal end outer diameter | 11mm | 8.8mm | Analysis 6 |
| Insert section outer diameter | 11mm | 8.8mm | Analysis 6 |
| Bend angle | UP:180°
DOWN:160°
RIGHT:160°
LEFT:160°" | UP:210°
DOWN:90°
RIGHT:100°
LEFT:100°" | Analysis 7 |
| Worklength | 1300mm | 1030mm | Analysis 8 |
| Biopsy channel inner diameter | 3.2mm | 2.8mm | Analysis 6 |
Specifications Comparis on of Disposable GI Endos cope Table 3
Analysis 4-Field of view
The field of view of Disposable GI Endoscope is different from that of the predicate device. The field of view of the proposed device meets the requirements of ISO 8600-1 standard. Therefore, this difference on field of view does not affect the safety and effectiveness of the proposed device.
Analysis 5-Sensortype
The sensor type of Disposable GI Endoscope is different from that of the predicate device. Although the CMOS sensor and CCD sensor have different photosensitive logic, but both they can provide high quality image. And the CMOS sensor has been commonly used in the endoscope systems. Therefore, this difference on sensor type does not affect the safety and effectiveness of the proposed device.
9
Analysis 6-Diameters
The Distal end outer diameter, Insert section outer diameter and Biopsy channel inner diameter of Disposable GI Endoscope is similar as those of the predicate devices. Those diameters meet the industrial standard. Therefore, this itemis considered substantially equivalent.
Analysis 7-Bend Angle
The bend angles of Disposable GI Endoscope are similar as those of the predicate devices. The subject endoscopes are the electronic flexible endoscopes; it bends up, down, left, and right through the bending section (Bending angles of up to 160° in all directions can be assisted to it gives all-round observation angle >360°) by bending up/down/left/tight of endoscope's bending section. The subject endoscopes meet the angle requirement during endoscopic observation and disgnosis of upper/lower gastrointestinal tract: We think this slight difference on bend angle between the proposed device and predicate devices does not affect the safety and effectiveness of the proposed device.
For the convenience of the surgeons, all of the optical properties of the proposed device have been included in the user manual, including bend angle. The surgeon will select the proper endoscope cope based on her/his experiences and clinical conditions.
Analysis 8- Working length
The working length of Disposable GI Endoscope is similar as that of the predicate devices. And the working length of proposed device meets the requirements of ISO 8600-1 standard. There are many legally marketed endoscope with different working lengths. Therefore, this difference on working length does not affect the safety and effectiveness of the proposed device.
For the convenience of the surgeons, all of the optical properties of the proposed device have been included in the user manual, including working length. The surgeon will select the proper endoscope cope based on her/his experiences and clinical conditions.
| ITEM | Proposed device | Predicate device
K100584 | Remark |
|------------------------------|----------------------|-----------------------------|-------------|
| Model | XZING-C200B | CF-Q180AL | / |
| Field of view | $110^\circ \pm 10%$ | $170^\circ$ | Analysis 9 |
| Depth of focus | 3-100mm | 3-100mm | SE |
| Front view | $0^\circ$ | $0^\circ$ | SE |
| Sensor type | CMOS | color CCD | Analysis 10 |
| Distal end outer
diameter | 14mm | 13.2mm | Analysis 11 |
Table 4. Specifications Comparison of Disposable Colonoscope
10
| Insert section outer
| diameter | 14mm | 12.8mm | Analysis 11 |
|---|---|---|---|
| Bend angle | UP:180° | ||
| DOWN:180° | |||
| RIGHT:160° | |||
| LEFT:160° | UP:180° | ||
| DOWN:180° | |||
| RIGHT:160° | |||
| LEFT:160° | SE | ||
| Work length | 1300mm | 1680mm | Analysis 12 |
| Biopsy channelinner | |||
| diameter | 3.2mm | 3.7mm | Analysis 11 |
Analysis 9-Field of view
The field of view of Disposable Colonoscope is different from that of the predicate device. The field of view of the proposed device meets the requirements of ISO 8600-1 standard. Therefore, this difference on field of view does not affect the safety and effectiveness of the proposed device.
Analysis 10-Sensortype
The sensor type of Disposable Colonoscope is different from that of the predicate device. Although the CMOS sensor and CCD sensor have different photosens tive logic, but both they can provide high quality image. And the CMOS sensor has been commonly used in the endoscope systems. Therefore, this difference on sensor type does not affect the safety and effectiveness of the proposed device.
Analysis 11-Diameters
The Distal end outer diameter, Insert section outer diameter and Biopsy channel inner diameter of Disposable Colonoscope is similar as those of the predicate devices. Those diameters meet the industrial s tandard. Therefore, this item is considered substantially equivalent.
Analysis 12-Working length
The working length of Disposable Colonoscope is similar as that of the predicate devices. And the working length of proposed device meets the requirements of ISO 8600-1 standard. There are many legally marketed colonoscope with different working lengths. Therefore, this difference on working length does not affect the safety and effectiveness of the proposed device.
For the convenience of the surgeons, all of the optical properties of the proposed device have been included in the user manual, including working length. The surgeon will select the proper colonoscope cope based on her/his experiences and clinical conditions.
11
| ITEM | Proposed Device | Predicate Device
K100584 | Remark |
|---------------------------------|------------------------|---------------------------------------------------------|-------------|
| Model | XZING-S2 | OLYMPUS CV-180 | SE |
| Power supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz | SE |
| Over-current protection | Fuse type | Fuse type | SE |
| Input current | 65VA | 150VA | Analysis 13 |
| Video signal output | DVI:2 | RGB:3
Y/C:4
VBS:4
HDTV:1 | Analysis 14 |
| Auto white balance | Automatically adjusted | Automatically adjusted | SE |
| Automatic gain control | Provided | Provided | SE |
| Image modes | White-light imaging | White-light imaging Narrow
Band Imaging (NBI) modes. | Analysis 15 |
| Communication with
endoscope | Provided | Provided | SE |
| Foot switch connector | Provided | Provided | SE |
| Pixel | 2 million pixels | Unknown | Analysis 16 |
| Resolution | 16001200 | 40962160
38402160
19201080 | Analysis 17 |
Specifications Comparison of Camera System Table 5.
Analysis 13-Input Current
The input current of Camera System is similar as that of the predicate device. In addition, the imput current proposed device complies with IEC 60601-1 standard. Therefore, this difference on input current is considered not affect the safety and effectiveness of the proposed device.
Analysis 14-Video Signal Output
The types of video signal output are different between camera system and predicate device. However, both the proposed system and predicate system are the high-definition endoscope system. Highdefinition interface: DVI interfaces are substantially equivalent to the HDTV interface. Therefore, the difference on video signal output will not affect the safety and effectiveness of the proposed device.
Analysis 15-Imaging mode
The proposed device only has white-light imaging mode. This white-light imaging mode of proposed
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device is substantially equivalent to the white-light imaging mode of predicate device.
Analysis 16-Pixel
The pixel of predicate device is unknown, the proposed device pixel is 2 million pixels. High resolution means that the pixels of the sensor are greater than or equal to 1.3 million, and the pixels of the proposed device are already higher than 1.3 million, so the proposed device can clearly see the scene inside the patient. In addition, electrical safety and EMC test has been conducted on the proposed device and the test result can comply with related standards requirement. Therefore, this difference will not affect substantial equivalence between proposed device and equivalent device.
Analysis 17-Resolution
The proposed device resolution is 1600×1200×1, the predicate device has 4069×2160 px1, 3840×2160, 1920×1080 resolution can be select. The resolution for device is mainly related to the horizontal and vettical propotion of the display, and electrical safety and EMC test has been conducted on the proposed device and the test result can comply with related standards requirement. Therefore, this difference will not affect substantial equivalence between proposed device and equivalent device.
| ITEM | Proposed device | Predicate device
K100584 | Remark |
|-------------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------|-------------|
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Particular requirements | Comply with IEC 60601-2-18 | Comply with IEC 60601-2-18 | SE |
| Product Performance | Comply with ISO 8600-1 and ISO
8600-7 | Comply with ISO 8600-1 and ISO
8600-7 | SE |
| Patient-contact
component and material | Refer to Tab 12 Biocompatibility | Unknown | Analysis 1 |
| Biocompatibility | Cytotoxicity: ISO 10993-5
Sensitization: ISO 10993-10
Irritation: ISO 10993-10 | Unknown | Analysis 18 |
Table 6. Safety Comparison
Analysis 18-Patient-contact component and material/Biocompatibility
Although the patient-contacting materials of the predicated device are unknown, the Disposable GI Endoscope is biocompatible and conforms to ISO 10993 series standards. Therefore, the proposed device is claimed to be substantially equivalent to the predicate devices.
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8. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals
-
USP41-NF36 Bacterial Endotoxins Test
- A A STM F88/F88M - 15 Standard test method for seal strength of flexible barrier materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by > Dye Penetration
-
ISO 8600-1:2015 Endoscopes - Medical endoscopes and endotherapy devices - part 1: General requirements
-
ISO 8600-3:1997/Amd1:2003 Optics and optical instruments -- Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
-
ISO 8600-4:2014 Endoscopes -- Medical endoscopes and endotherapy devices -- Part 4: Determination of maximum width of insertion portion
- ♪ ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- A ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-
IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance, including the US National Differences
-
IEC 60601-1-2:2014 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
-
IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety andessential performance of endoscopic equipment
-
A STM D4169-16 Standard Practice for Performance Testing of Shipping Containers andSystems
-
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier System for Medical Device.
- A IEC 62471:2006 Photobiological Safety of Lamps and Lamp Systems.
-
ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices
-
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection.
- Clinical TestConclusion 9.
No clinical study is included in this submission.
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10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.