The E240AG LCD Monitor is intended to provide 2D color video displays of images from surgical endoscopic/ laparoscopic camera systems and other compatible medical imaging systems. The E240AG is a widescreen, high definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.

Device Description

The E240AG, C230A, C230M, E240A, JUSHA-E240AG, JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitor is intended primarily for use in a medical environment for displaying images captured during minimally invasive surgical procedures. The monitor features a 23.8-inch widescreen LCD display panel and employs full WUXGA high-definition (HID) performance. In addition to digital signals, the E240AG accepts analog signals and converts them to digital signals. The E240AG LCD Monitor is designed with the flexibility to support a variety of formats with two built-in option slots to select, expand, and change input/output signals.

AI/ML Overview

This document describes the premarket notification (510(k)) for the E240AG LCD Monitor and its variants, which are medical display monitors. The provided text does not describe an AI/ML device or a study proving its performance against acceptance criteria in the context of clinical outcomes. Instead, it details the submission for a medical monitor and its substantial equivalence to a predicate device based on technical specifications and safety standards.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI device is not available in this document.

However, I can extract the relevant information pertaining to the device (medical monitor) performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table for this specific device. Instead, it compares the proposed device's specifications to a predicate device and reports compliance with recognized standards. The "performance data" section details bench testing conducted to ensure the device meets certain display and safety characteristics.

Feature	Predicate Device (Sony LMD-2451MT, K113203)	Proposed Devices (E240AG, C230A, C230M, E240A, JUSHA-E240AG, JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitor)	Reported Performance (via Bench Testing)	Discussion of Differences (if any)
Display Specifications
Screen technology	24" TFT LCD Panel	23.8" TFT LCD Panel	-	Same (TFT LCD Panel)
Viewing angle (H, V)	Horizontal 178°, Vertical 178° (contrast ratio ≥ 10:1)	Horizontal 178°, Vertical 178° (contrast ratio ≥ 10:1)	-	Same
Resolution	1920 x 1200	1920 x 1080	-	Different due to panel size; however, this difference is implicitly deemed not to affect safety or effectiveness given the substantial equivalence conclusion.
Display area	518.4 x 324.0 mm	527.04 x 296.46 mm	-	Different due to panel size; implicitly deemed not to affect safety or effectiveness.
Contrast Ratio (typ)	1000:1	1000:1	-	Same
Recommended brightness	300cd/m²	300cd/m²	-	Same
Pixel Pitch	0.27 x 0.27 mm	0.27 x 0.27 mm	-	Same
Backlighting	LED backlight	LED backlight	-	Same
Grayscale	1024	1024	-	Same
Response time	14ms	14ms	-	Same
Sensor	Backlight sensor	Backlight sensor	-	Same
Input/Output Signals
Input signals	BNC, DVI, SDI, Y/C (S-Video), YPbPr, RGBS, HD15	VGA, DVI-A/D, SDI, Y/C (S-Video), YPbPr, RGBS, CVBS	-	Differences in signal interface types (E240AG has VGA & CVBS). Stated as "nothing to do with the display function."
Input terminational	1 DVI-D Dual Link, 1 HDMI Port	1 DVI-D Dual Link, 1 HDMI Port	-	Same
Output signals	BNC, DVI, SDI, Y/C (S-Video), YPbPr, RGBS, HD15	DVI-D, SDI, Y/C (S-Video), YPbPr, RGBS, CVBS	-	Differences in signal interface types (E240AG has CVBS). Stated as "nothing to do with the display function."
Electrical/Physical
Power Requirement	100 V - 240 Vac ±10%, 50/60 Hz 1.53 A - 0.58 A	100 - 240 Vac ±10%, 47-63 Hz 1.4 - 0.6A	-	Same (in terms of voltage range), minor differences in frequency range and current.
Power Consumptions/Save Mode	125W / less than 0.7W	35W / less than 0.5W	-	Differences due to adapter and components; lower consumption for E240AG. Stated as "nothing to do with the display function."
Dimensions w/o stand (W x H x D)	602.4 x 386.2 x 110 mm	565.3 x 65 x 375.3 mm	-	Different housing design due to different panel size; implicitly deemed not to affect safety or effectiveness.
Applicable Standard Compliance	IEC 60601-1:1988+A1:1991+A2:1995; IEC 60601-1-2 Ed 3:2007	IEC 60601-1:2012; IEC 60601-1-2:2014	Device complies	Same (updated versions of standards applied)
Intended Use	2D and 3D color video displays from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems. For real-time use in ORs, surgical centers, clinics, offices.	2D color video displays from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems. For real-time use in ORs, surgical centers, clinics, offices.	-	The proposed device is only for 2D, while the predicate also offered 3D. This difference is not discussed as affecting substantial equivalence, implying it's either an acceptable difference or within the scope of intended use.

Performance Data and Study:

The study conducted was a bench test to demonstrate compliance with recognized standards.

Measurement of the luminance non-uniformity characteristics of the display screen.
Measurement of the chromaticity non-uniformity characteristics of the display screen.
Measurement of contrast ratio.
Performance data on luminance stability.
Electrical safety and electromagnetic compatibility (EMC) testing.

2. Sample size used for the test set and the data provenance: Not applicable. This is a technical performance test of hardware, not a clinical study involving a dataset of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance like luminance, contrast, and electrical safety is established through engineering specifications and objective measurements, not expert radiologists reviewing images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a display monitor, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used: For display characteristics (luminance, contrast, chromaticity, luminance stability), the "ground truth" would be established by the industry standards and specifications the device aims to meet. For electrical safety and EMC, the ground truth is defined by compliance with IEC 60601-1 and IEC 60601-1-2 standards. It's objective, quantitative measurement against engineering standards, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Conclusion from document: The manufacturer concluded that the E240AG LCD Monitor is substantially equivalent to the predicate device (Sony LMD-2451MT) based on similarities in overall purpose, function, technical characteristics, performance, application, and intended use. The bench testing demonstrated compliance with applicable safety and performance standards (IEC 60601-1 and IEC 60601-1-2). The document explicitly states that animal or clinical studies were not required to support substantial equivalence.

Summary

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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 Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 31, 2019

Nanjing Jusha Display Technology Co., Ltd Zilong Liang Certification Manager Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing International Service Outsourcing Mansion Nanjing, China 210036

Re: K190831

Trade/Device Name: E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 1, 2019 Received: April 1, 2019

Dear Zilong Liang:

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Jennifer R. Stevenson Acting Division Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190831

Device Name

E240AG, C230A, C230M, E240A, JUSHA-E240AG, JUSHA-C230M, JUJSHA-E240A LCD Monitor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	December 2,2018
Submitter:	Nanjing Jusha Display Technology Co., LtdAdd: 301, Hanzhongmen Street, 8F Block A, No.1,Nanjing International Service Outsourcing Mansion,Nanjing, 210036 China
Primary Contact Person:	Zilong LiangCertification ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783271
Secondary Contact Person:	Dongdong LiQuality ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783271
Device Trade Name:	E240AG, C230A, C230M, E240A, JUSHA-E240AG,JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitor
Common/Usual Name:	LCD Monitor
Classification Name:	Endoscope and Accessories
Product Code:	GCJ
Predicate Device(s):	Sony LMD-2451MT LCD Monitor, K 113203
Device Description:	The E240AG, C230A, C230M, E240A, JUSHA-E240AG,JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCDMonitor is intended primarily for use in a medical

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environment for displaying images captured duringminimally invasive surgical procedures. The monitor featuresa 23.8-inch widescreen LCD display panel and employs fullWUXGA high-definition (HID) performance. In additionto digital signals, the E240AG accepts analog signals andconverts them to digital signals.The E240AG LCD Monitor is designed with the flexibility tosupport a variety of formats with two built-in option slots toselect, expand, and change input/output signals.
Intended Use:	The E240AG, C230A, C230M, E240A, JUSHA-E240AG,JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitoris intended to provide 2D color video displays of images fromsurgical endoscopic/laparoscopic camera systems and othercompatible medical imaging systems. The E240AG is awidescreen, high-definition, medical grade monitor for real-timeuse during minimally invasive surgical procedures and is suitablefor use in hospital operating rooms, surgical centers, clinics,doctors' offices and similar medical environments.
Technologicalcharacteristicand Substantialequivalence:	The E240AG, C230A, C230M, E240A, JUSHA-E240AG,JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitorhas the same overall purpose and function as the predicate devicecited above. Both of the devices are intended to provide colorvideo displays of images from surgical camera systems, primarilyin endoscopic/laparoscopic applications.
PerformanceTesting:	Testing of the E240AG, C230A, C230M, E240A,JUSHA-E240AG, JUSHA-C230A, JUSHA-C230M,JUJSHA-E240A LCD Monitor demonstrated that the deviceis in compliance with applicable requirements of recognizedstandards for electromagnetic compatibility and electricalsafety.
Conclusion:	Based on the similarities in overall purpose and function, the
	E240AG LCD Monitor has demonstrated substantial equivalence
	to the cited predicate device and any differences do not affect the
	safety or effectiveness of the device.

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12.1 Product Comparison

This comparison identifies the similarities and differences of the proposed E240AG LCD Monitor device to the legally marketed predicate Sony LMD-2451MT LCD Monitor device to which substantial equivalency is claimed.

Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	Sony LMD-2451MT	E240AG, C230A, C230M,E240A, JUSHA-E240AG,JUSHA-C230A,JUSHA-C230M,JUJSHA-E240A LCDMonitor
510(k) Number	K113203	/
Display Performance/Specifications
Screen technology	24" TFT LCD Panel	23.8" TFT LCD Panel	Same
Viewing angle(H,V)	Horizontal178°, Vertical 178° (thecontrast ratio ≥ 10 : 1 )	Horizontal 178°, Vertical178° (the contrast ratio ≥ 10 :1)	Same
Resolution	$1920 \times 1200$	$1920 \times 1080$	Different Resolutiondesign due to thedifferent panel size.
Display area	$518.4 \times 324.0$ mm	$527.04 \times 296.46$ mm	Different Displayarea design due to thedifferent panel size.
ContrastRatio(typ)	1000:1	1000:1	Same
Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	Sony LMD-2451MT	E240AG, C230A, C230M,E240A, JUSHA-E240AG,JUSHA-C230A,JUSHA-C230M,JUJSHA-E240A LCDMonitor
510(k) Number	K113203	/
Recommendedbrightness	300cd/m²	300cd/m²	Same
Pixel Pitch	0.27×0.27 mm	0.27×0.27 mm	Same
Backlighting	LED backlight	LED backlight	Same
grayscale	1024	1024	Same
Response time	14ms	14ms	Same
Sensor	Backlight sensor	Backlight sensor	Same
Input signals	BNC、DVI、SDI、Y/C(S-Video)、YPbPr、RGBS、HD15	VGA、DVI-A/D、SDI、Y/C(S-Video)、YPbPr、RGBS、CVBS	The differencescaused by differentsignals interface typeused in the medicaldisplay, the E240AGhasVGA&CVBS ,Thisonly shows thesignals interface typeisdifferent, nothingto do with the displayfunction
Inputterminational	1 DVI-D Dual Link1 HDMI Port	1 DVI-D Dual Link1 HDMI Port	Same
Display controller	Off the shelf	Off the shelf	Same
Video Signal Output
Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	Sony LMD-2451MT	E240AG, C230A, C230M,E240A, JUSHA-E240AG,JUSHA-C230A,JUSHA-C230M,JUJSHA-E240A LCDMonitor
510(k) Number	K113203	/
Output signals	BNC\u3001DVI\u3001SDI\u3001Y/C(S-Video)\u3001YPbPr\u3001RGBS\u3001HD15	DVI-D\u3001SDI\u3001Y/C(S-Video)\u3001YPbPr\u3001RGBS\u3001CVBS	The differencescaused by differentsignals interface typeused in the medicaldisplay, the E240AGhasVGA&CVBS ,Thisonly shows thesignals interface typeis different, nothingto do with the displayfunction
PowerRequirement	100 V - 240 Vac \u00b110%,50/60 Hz 1.53 A - 0.58 A	100 - 240 Vac \u00b110%, 47-63Hz 1.4 - 0.6A	Same
PowerConsumptions/Save Mode	125W/less than 0.7W	35W/less than 0.5W	The differencescaused by differentadapter andcomponents used inthe medicaldisplay,the E240AGhas lower powerconsumptions,Thisonly shows the powerconsumption isdifferent, nothing todo with the displayfunction
Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	Sony LMD-2451MT	E240AG, C230A, C230M,E240A, JUSHA-E240AG,JUSHA-C230A,JUSHA-C230M,JUJSHA-E240A LCDMonitor
510(k) Number	K113203	/
Dimensions w/ostand(W x H x D)	With stand:$602.4\u00d7454\u00d7302$ mmWithout stand:$602.4\u00d7386.2\u00d7110$ mm	With stand:565.3x238x460.3mmWithout stand:565.3x65x375.3mm	Different housingdesign due to thedifferent panel size.
Indication for use	The Sony LMD-2451MTLCD Monitor is intendedto provide 3D and 2Dcolorvideodisplays of images fromsurgicalendoscopic/laparoscopiccamera systems and othercompatible medicalimaging systems. TheLMD-2451MT is awidescreen,high-definition, medicalgrade monitor forreal-time use duringminimally invasivesurgical procedures and issuitable for use in hospitaloperating rooms, surgicalcenters, clinics, doctors'offices and similar medicalenvironments.	The E240AG, C230A,C230M, E240A,JUSHA-E240AG,JUSHA-C230A,JUSHA-C230M,JUJSHA-E240A LCDMonitor is intended toprovide 2D color videodisplays of images fromsurgicalendoscopic/laparoscopiccamera systems and othercompatible medicalimaging systems. TheE240AG is a widescreen,high-definition, medicalgrade monitor for real-timeuse during minimallyinvasive surgicalprocedures and is suitablefor use in hospitaloperating rooms, surgicalcenters, clinics, doctors'offices and similar medicalenvironments.	Same
Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	Sony LMD-2451MT	E240AG, C230A, C230M,E240A, JUSHA-E240AG,JUSHA-C230A,JUSHA-C230M,JUJSHA-E240A LCDMonitor
510(k) Number	K113203	/
Applicablestandard	1 IEC 60601-1Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance1988+A1 : 1991 + A2:19952 IEC 60601-1-2 Edition3:2007, Medical electricalequipment - Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic compatibilityRequirements and tests	1 IEC 60601-1:2012 Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance.2 IEC 60601-1-2:2014,Medical electricalequipment-Part 1-2:Generalrequirements for basic safetyand essentialperformance-CollateralStandard:Electromagneticdisturbances-Requirements andtests	Same

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PERFORMANCE DATA:

The following performance data were provided in support of the substantial equivalence determination.

Bench testing:

Bench testing was conducted to demonstrate the E240AG meets all performance standards as follows:

Measurement of the luminance non-uniformity characteristics of the display screen

Measurement of the chromaticity non-uniformity characteristics of the display screen

Measurement of contrast ratio.

Performance data on luminance stability

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the E240AG The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.

Animal and clinical study

The subject of this premarket submission, E240AG, does not require animal or clinical studies to support substantial equivalence.

CONCLUSIONS

E240AG, C230A, C230M, E240A, JUSHA-E240AG, JUSHA-C230A, JUSHA-C230M,

JUJSHA-E240A LCD Monitor is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The non-clinical data support the safety of the device. The device should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the E240AG Medical Display does not raise any new issues of safety or effectiveness.

Regulation Number and Section

§ 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.