The ActivSight Intraoperative Imaging System (ActivSight) is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and near infrared imaging, and at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence, all during minimally invasive surgery.

Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.

Device Description

The ActivSight Intraoperative Imaging System (ActivSight) is an accessory to existing commercial surgical laparoscope systems, including cameras and video processor units. ActivSight provides real-time endoscopic fluorescence and near-infrared imaging. These imaging features allow surgeons to visually assess vessels, blood flow, and tissue perfusion (using fluorescence and near-infrared imaging), and to visually assess at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence. Fluorescence imaging is enabled through use of any commercially available Indocyanine Green (ICG). These visualization features are available for surgeons to use during minimally invasive surgery. ActivSight is intended to be used in a surgical environment.

ActivSight consists of the following reusable components:

ActivSight Imaging Module, consisting of optics and sensing electronics. The imaging module attaches physically between the third-party laparoscope and the third-party imaging system camera. Reprocessing of this component requires cleaning and disinfection between uses.
ActivSight Light Engine, equipment consisting of system electronics that provide laser fluorescence and near-infrared illumination, processing of video input from both the third-party Camera Control Unit (CCI) and the ActivSight lmaging Module, and outputs video to the surgical monitor. This component does not require reprocessing between uses.
ActivSight Light Cable, component consisting of a Y-shaped bifurcated light a cable that connects to the third party white-light source, the ActivSight Light Engine, and the third party laparoscope light post (providing white-light illumination of the surgical site through the laparoscope). Reprocessing of this component requires cleaning and steam sterilization.
ActivSight Sterilization Tray, stainless-steel sterilization tray designed to a properly secure the ActivSight Light Cable for disinfection and sterilization. Reprocessing of this component is accomplished in its use- cleaning and steam sterilization.

ActivSight consists of the following disposable components:

ActivSight Sterile Drape, a sterilized plastic drape that is provided for each use = to provide a sterile barrier between the imaging module and the patient.
-ActivSight Calibration Target, a sterilized paper imaging target containing a checkerboard pattern for calibration of the ActivSight imaging module prior to each use of the device.

AI/ML Overview

The provided text describes the ActivSight Intraoperative Imaging System, its indications for use, and a comparison to predicate devices, but it does not contain explicit acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical trial reports or validation studies.

The document primarily focuses on regulatory approval (510(k) submission) by demonstrating substantial equivalence to a legally marketed predicate device. While "Performance Data" is mentioned, it refers to compliance with general safety and performance standards (e.g., IEC standards for electrical safety, software lifecycle) and an animal study for comparative visualization, not a clinical study to establish quantitative performance against defined acceptance criteria.

Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide the available information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided document. The document focuses on demonstrating compliance with general safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62366-1, ANSI AAMI IEC 62304, IEC 60825-1, IEC 60601-2-18) and a "design validation in an animal study." However, specific quantitative acceptance criteria for parameters like sensitivity, specificity, accuracy, or other clinical efficacy metrics are not provided, nor are the detailed results of such performance against these criteria.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified for any clinical performance or validation study against specific acceptance criteria. The document mentions an "animal study" for design validation, but details like the number of animals or specific data points are omitted.
Data Provenance: The "design validation" was conducted as an "animal study." No information on a human test set or its provenance (e.g., country of origin, retrospective/prospective) is provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No, an MRMC comparative effectiveness study is not mentioned in the provided text. The document refers to an "animal study" for comparative visualization against a predicate's ICG mode, but this is not a human MRMC study to assess reader improvement with AI assistance.
Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was mentioned.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance Study Done: The document describes the device (ActivSight) and its capabilities, including "real-time endoscopic fluorescence and near-infrared imaging" and enabling surgeons to "visually assess vessels, blood flow, and related tissue perfusion." The "animal study" compared ActivSight Perfusion (speckle laser) and ActivSight ICG (fluorescence) modes against the predicate's ICG mode in terms of "comparatively visualizing blood flow and perfusion." This suggests evaluating the device's imaging capabilities (algorithm included), but it is not framed as a formal "standalone performance study" with defined metrics like sensitivity/specificity for disease detection, or an "algorithm only" evaluation completely separated from the hardware and human interpretation, as typically meant by standalone performance in AI/ML medical devices. The primary focus is on the device as a whole system providing real-time visualization.

7. Type of Ground Truth Used

Ground Truth Type: For the "animal study," the ground truth for "comparatively visualizing blood flow and perfusion" is implied to be direct visual assessment by the comparing technologies (ActivSight's modes vs. predicate's ICG mode). The document does not specify an independent, objective ground truth established by pathology, outcomes data, or expert consensus beyond the visual comparison of the imaging techniques themselves.

8. Sample Size for the Training Set

Training Set Sample Size: Not specified. The document does not mention details about algorithm training or associated datasets.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not specified, as training set details are not provided.

Summary

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Activ Surgical, Inc. Matthew King Director of Regulatory Affairs and Quality Assurance 840 Summer Street Boston, Massachusetts 02127

April 8, 2021

Re: K203550

Trade/Device Name: ActivSight Intraoperative Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, OWN, DPT, Dated: March 8, 2021 Received: March 9, 2021

Dear Matthew King:

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 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

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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 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.

Image /page/1/Picture/5 description: The image shows the name "Neil R.P. Ogden" in a large, bold font. To the right of the name, there is the text "Digitally s" followed by "Neil R.P. O" and "Date: 202" and "19:43:42 -". The text on the right appears to be part of a digital signature.

Digitally signed by Neil R.P. Ogden Date: 2021.04.08 19:43:42 -04'00'

Neil R.P. Ogden Assistant Director. THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K203550

Device Name ActivSight

Indications for Use (Describe)

ActivSight is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and nearing, and at least one of the major bile duct, common bile duct or common hepatic duct) using fluorescence, all during minimally invasive surgery.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in large, blue, sans-serif font. Below that, the word "SURGICAL" is in a smaller, light gray, sans-serif font. The logo is simple and modern.

510(k) SUMMARY (21 CFR 807.92)

1. General Information

Submitter Name:	Activ Surgical, Inc.
Submitter Address:	840 Summer Street, Suite 108Boston, MA 02127
Contact Person:	Matthew KingDirector of Regulatory Affairs and QualityAssuranceActiv Surgical, Inc.
Contact Information:	Email: mking@activsurgical.comPhone: 603-459-9755Fax: 617-977-0992
Submission Type	Traditional 510(k)
Date Prepared	December 4, 2020

2. Proposed Device

Proprietary Name	ActivSight Intraoperative Imaging System
Device Common Name	Light Source, Imaging Module, Light Cable
Device Model Number	450-00001
Device Classification Name	Confocal Optical Imaging
Regulation Number	21 CFR 876.1500
Product Code	OWN
Device Classification	II
Review Panel	General and Plastic Surgery
Premarket Review	General and Surgery Devices (DHT4A)

3. Predicate Device and Reference Device

	Predicate Device	Reference Device
Proprietary Name	Stryker Infrared Fluorescence(IRF) Imaging System	Perimed PeriCam PSI
510(k) Number	K142310	K120884
Device ClassificationName	Confocal Optical Imaging	Extravascular blood flow probe
Regulation Number	21 CFR 876.1500	21 CFR 870.2120
Product Code	OWN	DPT
Device Classification	II	II

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Image /page/4/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in blue, with each letter in a bold, sans-serif font. Below "ACTIV" is the word "SURGICAL" in a smaller, light gray, sans-serif font. The logo is simple and modern.

4. Device Description:

ActivSight consists of the following reusable components:

글 ActivSight Imaging Module, consisting of optics and sensing electronics. The imaging module attaches physically between the third-party laparoscope and the third-party imaging system camera. Reprocessing of this component requires cleaning and disinfection between uses.
= ActivSight Light Engine, equipment consisting of system electronics that provide laser fluorescence and near-infrared illumination, processing of video input from both the third-party Camera Control Unit (CCI) and the ActivSight lmaging Module, and outputs video to the surgical monitor. This component does not require reprocessing between uses.
ActivSight Light Cable, component consisting of a Y-shaped bifurcated light a cable that connects to the third party white-light source, the ActivSight Light Engine, and the third party laparoscope light post (providing white-light illumination of the surgical site through the laparoscope). Reprocessing of this component requires cleaning and steam sterilization.
ActivSight Sterilization Tray, stainless-steel sterilization tray designed to a properly secure the ActivSight Light Cable for disinfection and sterilization. Reprocessing of this component is accomplished in its use- cleaning and steam sterilization.

ActivSight consists of the following disposable components:

ActivSight Sterile Drape, a sterilized plastic drape that is provided for each use = to provide a sterile barrier between the imaging module and the patient.
-ActivSight Calibration Target, a sterilized paper imaging target containing a checkerboard pattern for calibration of the ActivSight imaging module prior to each use of the device.

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Image /page/5/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in large, blue, sans-serif font. Below that, in a smaller, light gray, sans-serif font, is the word "SURGICAL". The logo is simple and modern.

5. Indications for Use

The ActivSight Intraoperative Imaging System (ActivSight) is intended to provide realtime endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and near infrared imaging, and at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence, all during minimally invasive surgery.

6. Performance Data

Safety and performance of the ActivSight Intraoperative Imaging System has been evaluated and verified in accordance with design specifications and applicable performance standards, including risk management, basic safety and essential performance, electromagnetic disturbances, human factors and usability, software lifecycle processes, safety of laser products. Activ Surgical has performed design validation in an animal study, comparatively visualizing blood flow and perfusion in specific structures with both ActivSight Perfusion (speckle laser) and ActivSight ICG (fluorescence) modes against the predicate's ICG mode. The following performance testing have also been conducted.

Basic safety and essential performance testing completed in accordance with . IEC 60601-1:2005/R(2012) and A1:2012: Medical Electrical Equipment- Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005. MOD). Testing indicates that the proposed device conforms to this standard.
Electrical safety and electromagnetic compatibility testing completed in . accordance with IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral Standard: Electromagnetic disturbances: Requirements and tests. Testing indicates that the proposed device conforms to this standard.
Human factors and usability testing completed in accordance with IEC 62366-1: . 2015 Medical Devices - Application of Usability Engineering to Medical Devices-Evaluation and reporting. Testing indicates that the proposed device presents no unacceptable risk to the user during its intended use, and that the device conforms to this standard.

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Image /page/6/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in a large, sans-serif font and is colored blue. Below "ACTIV" is the word "SURGICAL" in a smaller, sans-serif font and is colored gray. The logo is simple and modern.

Software development and software life cycle processes competed in accordance with ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software-Software Life Cycle Processes, Evaluation, Testing, and Reporting. Testing indicates that the proposed device conforms to this standard.
· Laser safety testing completed in accordance with /EC 60825-1 Ed. 3.0 b:2014 Safety of Laser Products- Part 1: Equipment Classification and Requirements. Testing indicates that the proposed device conforms to this standard.
Safety of endoscopic equipment testing completed in accordance with IEC . 60601-2-18: Edition 3.0 2009-08 Medical Electrical Equipment- Part 2-18: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment. Testing indicates that the proposed device conforms to this standard.

The results of these studies demonstrate that the proposed device is as safe and effective as the predicate.

7. Substantial Equivalence

The ActivSight Intraoperative Imaging System (subject) is substantially equivalent to the Stryker® Infrared Fluorescence (IRF) Imaging System (predicate).

The subject device and predicate device have nearly identical Indications for Use. Both devices provide real-time endoscopic near-infrared fluorescence imaging during minimally invasive surgery. Both are indicated to enable surgeons visually assess blood flow, tissue perfusion, and at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct). Fluorescence imaging of biliary ducts with both devices is intended for use with standard care white light, and when indicated, intraoperative cholangiography.

Both devices achieve their intended use through use of an FDA approved contrast drug agent (indocyanine green (ICG)).

Neither device is intended for stand-alone use for biliary duct visualization.

Differences between the two devices are ActivSight's capability to visualize blood flow and perfusion through speckle laser illumination, and ActivSight does not include laparoscopic equipment or a white light source. Laser speckle illumination is achieved through near-infrared laser diodes, imaging hardware, and imaging software that together display blood flow and perfusion without the aid of an imaging agent, such as ICG. ActivSight is interoperable with the existing laparoscopic equipment of the Stryker Infrared Fluorescence (IRF) Imaging System.

CONFIDENTIAL

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Image /page/7/Picture/0 description: The image shows the logo for Activ Surgical. The logo is blue and features the word "ACTIV" in large, bold letters. Below the word "ACTIV" is the word "SURGICAL" in smaller, thinner letters. The logo is simple and modern.

Table 5.1: Comparison to Predicate

	ActivSight IntraoperativeImaging System	Stryker InfraredFluorescence (IRF) ImagingSystem (K142310) - Predicate	Perimed PeriCamPSI (K120884) -Reference Device
Intended Use	Confocal Optical Imaging(OWN)	Confocal Optical Imaging(OWN)	Probe, Blood-Flow,Extravascular (DPT)
Indicationsfor Use	The ActivSightIntraoperative ImagingSystem (ActivSight) isintended to provide real-time endoscopicfluorescence and nearinfrared imaging. ActivSightenables surgeons tovisually assess vessels,blood flow, and relatedtissue perfusion usingfluorescence and nearinfrared imaging, and atleast one of the major bileducts (cystic duct, commonbile duct, or commonhepatic duct) usingfluorescence, all duringminimally invasive surgery.Fluorescence imaging ofbiliary ducts with ActivSightis intended for use withstandard of care white light,and when indicated,intraoperativecholangiography. Thedevice is not intended forstand-alone use for biliaryduct visualization.	The Stryker® IRF Light Sourceand SafeLight Cable areindicated for use to providereal-time endoscopic visibleand near-infrared fluorescenceimaging. The Stryker® IRFLight Source and SafeLightCable enable surgeons toperform minimally invasivesurgery using standardendoscope visible light as wellas visual assessment ofvessels, blood flow and relatedtissue perfusion, and at leastone of the major extra-hepaticbile ducts (cystic duct, commonbile duct and common hepaticduct), using near infraredimaging.Fluorescence imaging of biliaryducts with the Stryker® IRFLight Source and SafeLightCable are intended for use withstandard of care white lightand, when indicated,intraoperativecholangiography. The devicesare not intended for standaloneuse for biliary duct visualization.	The PeriCam PSI isintended for non-invasive two-dimensional imagingof peripheral tissueblood perfusion.
Technological Characteristics
	ActivSight Intraoperative ImagingSystemActivSightPerfusion	Stryker InfraredFluorescence(IRF) ImagingSystem(K142310) -Predicate	PerimedPeriCam PSI(K120884) -ReferenceDevice
Mode of Action	Laser Speckle	Fluorescence	Laser Speckle
Contrast Agent	None	ICG	None
InformationPresentationFormat	Heatmap signaloverlayed onred/green/blue(RGB) or heatmapsignal only	Green Signaloverlayed onred/green/blue(RGB)	Green signaloverlayed ongrayscale	Heatmap signalonly with optionfor adjacentcolor image.
Light Source(s)	Coherent 852 nmlaser	808nm laser	808nm laser	785nm laser
Light SourcePower Rating	Class 3R out ofLight Cable, class 1out of scope	Class 3R out ofLight Cable, class1 out of scope	Class 1M	Class 1
Light Capture	IR sensitive camera	IR sensitivecamera	IR sensitivecamera	IR sensitivecamera
Active Area ofimaging sensor	1/2.9" CMOS,4.98x3.74mm	1/2.9" CMOS,4.98x3.74mm	1/3" CMOS,4.8x3.6mm	Unknown

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Image /page/8/Picture/0 description: The image shows the logo for Activ Surgical. The word "ACTIV" is in large, blue, sans-serif font. Below that, in a smaller, light gray, sans-serif font, is the word "SURGICAL". The logo is simple and modern.

8. Conclusion

Based on the information provided in this premarket notification, and based on a comparison to the indications for use, performance testing, and technological characteristics of the predicate, the ActivSight Intraoperative Imaging System is shown to raise no new questions of safety and efficacy, and is substantially equivalent to the Stryker Infrared Fluorescence (IRF) Imaging System.

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.