(78 days)
No
The summary describes a standard endoscope with optical imaging and mechanical controls. There is no mention of AI, ML, image processing for analysis, or any data related to training or testing AI/ML models.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "endoscopic treatment" in addition to observation and diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "observation, diagnosis, and endoscopic treatment." The inclusion of "diagnosis" clearly indicates its role as a diagnostic device.
No
The device description clearly outlines physical hardware components including a control portion, insertion portion with glass fiber bundles, channels, and a CCD image sensor, and an umbilicus with electronic components. While it contains software, it is an integral part of a larger hardware system.
Based on the provided information, the FUJIFILM Endoscope Model EI-740D/S is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "observation, diagnosis, and endoscopic treatment" of the digestive tract. This involves direct visualization and intervention within the body.
- Device Description: The description details a device that is inserted into the body to capture images and facilitate procedures. It describes components like an insertion portion, channels for accessories, and a CCD image sensor for capturing images inside the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This endoscope does not perform such analysis on specimens outside the body.
The device is an endoscope, which is a type of medical device used for internal examination and procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FUJIFILM Endoscope Model EI-740D/S is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Product codes
FDS, FAM
Device Description
FUJIFILM Endoscope Model El-740D/S is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the anqulation of the endoscope. The insertion portion contains glass fiber bundles, several channels and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper digestive tract (esophagus, stomach, and duodenum), Lower digestive tract (rectum and sigmoid colon).
Indicated Patient Age Range
Not Found
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)
Validation of the cleaning, disinfection, and sterilization was performed in accordance with FDA's guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.
Biocompatibility of the subject device was evaluated using the following standards: ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's guidance, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," published June 16, 2016.
Software contained in the subject device was evaluated according to IEC 62304:2015 and the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," published May 11, 2005. Cybersecurity controls were developed according to the FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," published October 2, 2014.
Electrical safety and electromagnetic compatibility of the subject device were evaluated using the following standards: ANSI/AAMI ES 60601-1: 2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
Laser and photobiological safety of the subject device were evaluated using the following standards: IEC 60825-1:2007 and IEC 62471:2006.
Endoscope specific testing was conducted according to ISO 8600-1:2015.
Optical and color performance of the subject device when used with compatible video processors were evaluated according to well-established methods.
Additional performance specifications were evaluated against pre-defined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
FUJIFILM Endoscope Models EG-530D and ES-530WE (K142629)
Reference Device(s)
FUJIFILM Endoscope Model EC-740T/L (K183572)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
April 9. 2021
FUJIFILM Corporation % Jeffrey Wan Senior Regulatory Affairs Specialist FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
Re: K210162 Trade/Device Name: Endoscope Model EI-740D/S Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDS, FAM Dated: February 5, 2021 Received: February 8, 2021
Dear Jeffrey Wan:
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 mav, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (08) 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 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).
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210162
Device Name FUJIFILM Endoscope Model EI-740D/S
Indications for Use (Describe)
FUJIFILM Endoscope Model EI-740D/S is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
| 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
K210162 Page 1 of 7
510(k) SUMMARY FUJIFILM Corporation Endoscope Model El-740D/S
Date: February 5, 2021
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, Japan 258-8538
Contact Person:
Jeffrey Wan Senior Regulatory Affairs Specialist Telephone: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com
ldentification of the Subject Device:
| Device Name: | FUJIFILM Endoscope Model El-740D/S |
|---|---|
| Common Name: | Endoscope |
| Device Class: | Class II |
| Classification Number: | 21 C.F.R. § 876.1500 |
| Classification Name: | Endoscope and accessories |
| Device Panel: | Gastroenterology/Urology |
Product Code Information:
| Product Code Name | CFR Section | Product Code |
|---|---|---|
| Gastroscope and accessories, flexible/rigid | 21 CFR 876.1500 | FDS |
| Sigmoidoscope and accessories, flexible/rigid | 21 CFR 876.1500 | FAM |
Predicate Devices:
FUJIFILM Endoscope Models EG-530D and ES-530WE (K142629)
Reference Device:
FUJIFILM Endoscope Model EC-740T/L (K183572)
4
Intended Use / Indications for Use
FUJIFILM Endoscope Model EI-740D/S is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Device Description
FUJIFILM Endoscope Model El-740D/S is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the anqulation of the endoscope. The insertion portion contains glass fiber bundles, several channels and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.
Comparison of Technological Characteristics
The subject device FUJIFILM Endoscope Model El-740D/S differs from the predicate devices in the following modifications:
- . Dimensional and material changes to the insertion portion
- . Addition of a 2nd forceps/instrument channel
- . Compatibility with different cleaning adapters and forceps valve
5
K210162
Page 3 of 7
| Device name | Predicate Device | Reference Device | Subject Device | |
|---|---|---|---|---|
| Common name | EG-530D | EC-740T/L | EI-740D/S | |
| Manufacturer | Gastroscope | Colonoscope | Endoscope | |
| 510(k) number | FUJIFILM Corporation | FUJIFILM Corporation | FUJIFILM Corporation | |
| Intended Use / | ||||
| Indications for | ||||
| Use | K142629 | K183572 | K210162 | |
| This device is intended for | ||||
| the visualization of the upper | ||||
| digestive tract, specifically for | ||||
| the observation, diagnosis, | ||||
| and | ||||
| endoscopic treatment of the | ||||
| esophagus, stomach, and | ||||
| duodenum. | FUJIFILM Endoscope | |||
| Model EC-740T/L is | ||||
| intended for the | ||||
| visualization of the lower | ||||
| digestive tract, | ||||
| specifically for the | ||||
| observation, diagnosis, | ||||
| and endoscopic | ||||
| treatment of the rectum | ||||
| and large intestine. | FUJIFILM Endoscope Model El- | |||
| 740D/S is intended for the | ||||
| visualization of the upper digestive | ||||
| tract, specifically for the | ||||
| observation, diagnosis, and | ||||
| endoscopic treatment of the | ||||
| esophagus, stomach, and | ||||
| duodenum. | ||||
| This device is also intended for the | ||||
| visualization of the lower digestive | ||||
| tract, specifically for the | ||||
| observation, diagnosis, and | ||||
| endoscopic treatment of the | ||||
| rectum and sigmoid colon. | ||||
| Viewing direction | Forward / 0 degrees | Forward / 0 degrees | Same as Predicate Device | |
| Observation | ||||
| range | 3mm - 100mm | 3mm - 100mm | Same as Predicate Device | |
| Field of view | 140 degrees | 140 degrees | Same as Predicate Device | |
| Distal end | ||||
| diameter | 11.5mm | 9.8mm | 12.8mm | |
| Flexible portion | ||||
| diameter | 11.5mm | 10.7mm | 12.8mm | |
| Up | 210 degrees | 210 degrees | Same as Predicate Device | |
| Bending | ||||
| capability | Down | 90 degrees | 160 degrees | Same as Predicate Device |
| Left | 100 degrees | 160 degrees | Same as Predicate Device | |
| Right | 100 degrees | 160 degrees | Same as Predicate Device | |
| Forceps channel | ||||
| diameter | 2.8mm | 3.2mm | Same as Reference Device | |
| 2nd Forceps | ||||
| channel diameter | 3.8mm | N/A | 3.7mm | |
| Working length | 1090mm | 1690mm | 1030mm | |
| Total length | 1405mm | 1990mm | 1330mm | |
| Video processor / | ||||
| Light source | VP-4440HD / XL-4450 | |||
| VP-7000 / BL-7000 | ||||
| EP-6000 | VP-7000 / BL-7000 | |||
| EP-6000 | Same as Reference Device | |||
| Predicate Device | Reference Device | Subject Device | ||
| Peripherals | Water Tank WT-2, WT-4 | |||
| Endoscopic Accessory (i.e. | ||||
| Forceps) | ||||
| Monitor | ||||
| Printer | ||||
| Electrosurgical Instruments | ||||
| Foot Switch | ||||
| Cart | Water Tank WT-603 | |||
| Endoscopic Accessory | ||||
| (i.e. Forceps) | ||||
| Monitor | ||||
| Printer | ||||
| Electrosurgical | ||||
| Instruments | ||||
| Foot Switch | ||||
| Cart | Same as Reference Device | |||
| Standard | ||||
| accessories | Channel Cleaning Brush | |||
| WB4321FW2 | ||||
| Cylinder/Port Cleaning Brush | ||||
| WB11002FW2 | ||||
| Cleaning Adapter CA- | ||||
| 500D/A | ||||
| Forceps Valve FOV-DV7 | ||||
| Ventilation Adapter AD-7 | ||||
| J Tube JT-500 | ||||
| Air/Water Button AW-500 | ||||
| Suction Button SB-500 | ||||
| Water Jet Inlet Cap | Suction Channel Brush | |||
| WB7025DC | ||||
| Cylinder/Inlet Brush | ||||
| WB11003DV | ||||
| Distal End Brush | ||||
| WB1318DE | ||||
| Cleaning Adapter CA- | ||||
| 610 | ||||
| Air/Water Channel | ||||
| Cleaning Adapter CA- | ||||
| 611 | ||||
| Forceps Valve FOV-DV7 | ||||
| Ventilation Adapter AD-7 | ||||
| J Tube JT-500 | ||||
| Air/Water Valve AW-603 | ||||
| Suction Valve SB-605 | ||||
| Water Jet Inlet Cap | Same as Reference Device: | |||
| Suction Channel Brush | ||||
| WB7025DC | ||||
| Cylinder/Inlet Brush | ||||
| WB11003DV | ||||
| Distal End Brush WB1318DE | ||||
| Air/Water Channel Cleaning | ||||
| Adapter CA-611 | ||||
| Ventilation Adapter AD-7 | ||||
| J Tube JT-500 | ||||
| Air/Water Valve AW-603 | ||||
| Suction Valve SB-605 | ||||
| Water Jet Inlet Cap | ||||
| Introduced in this submission: | ||||
| Cleaning Adapter CA-617 | ||||
| Forceps Valve FV-001 | ||||
| Optional | ||||
| accessories | Air leak tester LT-7F | Air leak tester LT-7F | Same as Predicate Device: | |
| Air leak tester LT-7F | ||||
| Forceps Valve FOV-DV7* | ||||
| *This accessory was changed | ||||
| from standard to optional. | ||||
| Introduced in this submission: | ||||
| Cleaning Adapter CA-614 | ||||
| Predicate Device | Reference Device | Subject Device | ||
| Device name | ES-530WE | EC-740T/L | EI-740D/S | |
| Common name | Sigmoidoscope | Colonoscope | Endoscope | |
| Manufacturer | FUJIFILM Corporation | FUJIFILM Corporation | FUJIFILM Corporation | |
| 510(k) number | K142629 | K183572 | K210162 | |
| Intended Use / | ||||
| Indications for Use | This device is intended for the | |||
| visualization of the lower | ||||
| digestive tract, specifically for | ||||
| the observation, diagnosis, | ||||
| and endoscopic treatment of | ||||
| the rectum and sigmoid | ||||
| colon. | FUJIFILM Endoscope | |||
| Model EC-740T/L is | ||||
| intended for the | ||||
| visualization of the lower | ||||
| digestive tract, | ||||
| specifically for the | ||||
| observation, diagnosis, | ||||
| and endoscopic | ||||
| treatment of the rectum | ||||
| and large intestine. | FUJIFILM Endoscope Model El- | |||
| 740D/S is intended for the | ||||
| visualization of the upper digestive | ||||
| tract, specifically for the | ||||
| observation, diagnosis, and | ||||
| endoscopic treatment of the | ||||
| esophagus, stomach, and | ||||
| duodenum. | ||||
| This device is also intended for the | ||||
| visualization of the lower digestive | ||||
| tract, specifically for the | ||||
| observation, diagnosis, and | ||||
| endoscopic treatment of the | ||||
| rectum and sigmoid colon. | ||||
| Viewing direction | Forward / 0 degrees | Forward / 0 degrees | Same as Predicate Device | |
| Observation | ||||
| range | 3mm – 100mm | 3mm – 100mm | Same as Predicate Device | |
| Field of view | 140 degrees | 140 degrees | Same as Predicate Device | |
| Distal end | ||||
| diameter | 12.8mm | 9.8mm | Same as Predicate Device | |
| Flexible portion | ||||
| diameter | 12.8mm | 10.7mm | Same as Predicate Device | |
| Bending | ||||
| capability | Up | 180 degrees | 210 degrees | Same as Reference Device |
| Down | 180 degrees | 160 degrees | 90 degrees | |
| Left | 160 degrees | 160 degrees | 100 degrees | |
| Right | 160 degrees | 160 degrees | 100 degrees | |
| Forceps channel | ||||
| diameter | 3.8mm | 3.2mm | Same as Reference Device | |
| 2nd Forceps | ||||
| channel diameter | N/A | N/A | 3.7mm | |
| Working length | 790mm | 1690mm | 1030mm | |
| Total length | 1090mm | 1990mm | 1330mm | |
| Video processor / | ||||
| Light source | VP-4440HD / XL-4450 | |||
| VP-7000 / BL-7000 | ||||
| EP-6000 | VP-7000 / BL-7000 | |||
| EP-6000 | Same as Reference Device | |||
| Predicate Device | Reference Device | Subject Device | ||
| Peripherals | Water Tank WT-2, WT-4 | |||
| Endoscopic Accessory (i.e. | ||||
| Forceps) | ||||
| Monitor | ||||
| Printer | ||||
| Electrosurgical Instruments | ||||
| Foot Switch | ||||
| Cart | Water Tank WT-603 | |||
| Endoscopic Accessory | ||||
| (i.e. Forceps) | ||||
| Monitor | ||||
| Printer | ||||
| Electrosurgical | ||||
| Instruments | ||||
| Foot Switch | ||||
| Cart | Same as Reference Device | |||
| Standard | ||||
| accessories | Channel Cleaning Brush | |||
| WB4321FW2 | ||||
| Cylinder/Port Cleaning Brush | ||||
| WB11002FW2 | ||||
| Cleaning Adapter CA-500D/A | ||||
| Forceps Valve FOV-DV7 | ||||
| Ventilation Adapter AD-7 | ||||
| J Tube JT-500 | ||||
| Air/Water Button AW-500 | ||||
| Suction Button SB-500 | ||||
| Water Jet Inlet Cap | Suction Channel Brush | |||
| WB7025DC | ||||
| Cylinder/Inlet Brush | ||||
| WB11003DV | ||||
| Distal End Brush | ||||
| WB1318DE | ||||
| Cleaning Adapter CA- | ||||
| 610 | ||||
| Air/Water Channel | ||||
| Cleaning Adapter CA- | ||||
| 611 | ||||
| Forceps Valve FOV-DV7 | ||||
| Ventilation Adapter AD-7 | ||||
| J Tube JT-500 | ||||
| Air/Water Valve AW-603 | ||||
| Suction Valve SB-605 | ||||
| Water Jet Inlet Cap | Same as Reference Device: | |||
| Suction Channel Brush | ||||
| WB7025DC | ||||
| Cylinder/Inlet Brush | ||||
| WB11003DV | ||||
| Distal End Brush WB1318DE | ||||
| Air/Water Channel Cleaning | ||||
| Adapter CA-611 | ||||
| Ventilation Adapter AD-7 | ||||
| J Tube JT-500 | ||||
| Air/Water Valve AW-603 | ||||
| Suction Valve SB-605 | ||||
| Water Jet Inlet Cap | ||||
| Introduced in this submission: | ||||
| Cleaning Adapter CA-617 | ||||
| Forceps Valve FV-001 | ||||
| Optional | ||||
| accessories | Air leak tester LT-7F | Air leak tester LT-7F | Same as Predicate Device: | |
| Air leak tester LT-7F | ||||
| Forceps Valve FOV-DV7* | ||||
| *This accessory was changed from | ||||
| standard to optional. | ||||
| Introduced in this submission: | ||||
| Cleaning Adapter CA-614 |
Table 1 – Comparison of El-740D/S to EG-530D for upper Gl endoscopy
6
K210162
Page 4 of 7
7
Table 2 – Comparison of El-740D/S to ES-530WE for sigmoidoscopy
8
Performance Data
Validation of the cleaning, disinfection, and sterilization was performed in accordance with FDA's guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.
Biocompatibility of the subject device was evaluated using the following standards: ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's guidance, "Use of International Standard ISO 10993-1,
9
'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," published June 16, 2016.
Software contained in the subject device was evaluated according to IEC 62304:2015 and the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," published May 11, 2005. Cybersecurity controls were developed according to the FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," published October 2, 2014.
Electrical safety and electromagnetic compatibility of the subject device were evaluated using the following standards: ANSI/AAMI ES 60601-1: 2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
Laser and photobiological safety of the subject device were evaluated using the following standards: IEC 60825-1:2007 and IEC 62471:2006.
Endoscope specific testing was conducted according to ISO 8600-1:2015.
Optical and color performance of the subject device when used with compatible video processors were evaluated according to well-established methods.
Additional performance specifications were evaluated against pre-defined acceptance criteria.
Conclusions
The subject device El-740D/S shares the same intended use and substantially similar indications to the predicate devices. Bench testing demonstrates that the subject device is as safe and effective as the predicate devices. Thus, El-740D/S is substantially equivalent to the listed predicate devices.