EverLift™ Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions prior to excision with a snare or other appropriate endoscopic device.

Device Description

The GI Supply EverLift™ Submucosal Lifting Agent (10mL) is a prefilled plastic syringe with attached plunger rod containing 10mL of lifting agent. The syringe has a luer lock connection capable of interfacing with a standard, commercially available endoscopic injection needle.

EverLift™ Submucosal Lifting Agent is an injectable liguid composition for use as a submucosal injection agent during endoscopic mucosal resection (EMR), endoscopic mucosal dissection (ESD), and polypectomy procedures in the gastrointestinal tract. The device is intended for use in endoscopic resection procedures in the upper and the lower gastrointestinal tract, including the esophagus, the stomach, the small intestine, the sigmoid colon, and the rectum, as a submucosal injectable agent during the removal of polyps, adenomas, early-stage cancers, and other pathological lesions by EMR, ESD, or polypectomy.

EverLift™ Submucosal Lifting Agent is injected into the submucosal layer by means of a standard, commercially available endoscopic injection needle, which is inserted into the working channel of the endoscope. The composition, when injected, creates a cushion in situ by lifting the gastrointestinal mucosa from the submucosal layer, allowing the endoscopist to perform an easy and safe resection procedure (EMR, ESD, or polypectomy).

AI/ML Overview

This document focuses on the EverLift™ Submucosal Lifting Agent (10mL) and its substantial equivalence to a predicate device, the EverLift™ Submucosal Lifting Agent (5mL). This is a medical device, not an AI/ML algorithm, therefore most of the requested information regarding AI/ML studies (such as MRMC studies, standalone performance, training set details, or ground truth establishment methods for AI) is not applicable.

The acceptance criteria and device performance are established through a series of non-clinical performance tests designed to show that the 10mL device is as safe and effective as the previously cleared 5mL predicate device.

Here's the relevant information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical performance tests. For each test, the conclusion is that the subject device (10mL) performed equivalently or met the acceptance criteria used for the predicate device (5mL). The specific numerical acceptance criteria for each test are not explicitly detailed in quantifiable values, but rather referred to as "the same method and acceptance criteria as the predicate device" or conforming to specific ISO/USP standards.

Test Description	Conforming Standard(s) / Acceptance Criteria	Reported Device Performance
Syringe Tip Cap Removal Force Testing	Same method and acceptance criteria as the predicate device (not explicitly quantified)	Confirmed that the syringe tip cap removal force is equivalent between the subject and predicate devices.
Product Color Testing	Same method and acceptance criteria as the predicate device (not explicitly quantified)	Confirmed that product color is identical between the two devices.
Injection Flow Rate Testing	Same method and acceptance criteria as the predicate device (not explicitly quantified)	Confirmed that the injection flow rate is equivalent between the subject and predicate devices.
Graduation Marking Tolerance	ISO 7886-1:2017, Sterile hypodermic needles for single use – Part 1: Syringes for manual use (specific criteria from standard not detailed)	Confirmed that the marking tolerance meets the acceptance criteria defined in ISO 7886-1.
Container Closure Integrity Testing	Same method and acceptance criteria as the predicate device (not explicitly quantified)	Confirmed that the container closure integrity is identical between the subject and predicate devices.
Tray Lid Peel Force Testing	Acceptance criteria were met post-distribution simulation (not explicitly quantified)	Confirmed that the differences in secondary packaging do not raise different questions of safety or effectiveness.
Sterility Assurance Level (SAL)	ISO 17665-1, Sterilization of healthcare products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices	Validation results confirmed that the Sterility Assurance Level (SAL) is identical for both devices (10-6).
LAL Testing	USP <85>, Bacterial Endotoxins; USP <161>, Transfusion and Infusion Assemblies and Similar Medical Devices (specific criteria from standards not detailed)	Confirmed that the LAL level is identical between the subject and predicate devices. LAL testing will also be performed on each lot prior to final product release.
Distribution and Post-Distribution Testing	D7386-16, ASTM Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems (acceptance criteria from standard not detailed)	Confirmed that package integrity is identical between the subject and predicate devices.
Accelerated and Post-Accelerated Aging Studies	F1980-16, ASTM Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices (acceptance criteria from standard not detailed)	Results of the testing were identical between the subject and predicate devices.

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

The document does not explicitly state the sample sizes used for each individual non-clinical performance test. It refers to "the subject device" and "the predicate device" implying that samples of each were tested.

The data provenance is from non-clinical performance testing conducted by the manufacturer, GI Supply. This is typically laboratory or bench testing. There is no mention of human subject data, retrospective, or prospective studies in a clinical setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This question is not applicable as this is a medical device performance study, not a study evaluating an AI/ML algorithm requiring expert ground truth for interpretation of images or other data. The "ground truth" for these tests is defined by the technical specifications of the device and relevant international standards (e.g., ISO, USP, ASTM).

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML study requiring adjudication of expert interpretations. The evaluation is based on objective measurements against predefined technical specifications and standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is not mentioned as this is not an AI/ML device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No. This device is a submucosal lifting agent, a physical medical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" (or basis for acceptance) for these non-clinical performance tests consists of:

Technical specifications of the device (implying equivalence to the predicate device).
International standards such as ISO 7886-1:2017, ISO 17665-1, USP <85>, USP <161>, ASTM D7386-16, and ASTM F1980-16.
The performance of the legally marketed predicate device (K191923) as a benchmark for equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or medical "ground truth" established in this context.

Summary

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September 30, 2020

Gi Supply, Inc. Erika Parry Manager, Quality and Regulatory 5069 Ritter Road Suite 104 Mechanicsburg, Pennsylvania 17055

Re: K202376

Trade/Device Name: EverLift Submucosal Lifting Agent Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: PLL Dated: September 1, 2020 Received: September 2, 2020

Dear Erika Parry:

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

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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 (OS) 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, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202376

Device Name EverLift Submucosal Lifting Agent

Indications for Use (Describe)

EverLift Submucosal Lifting Agent is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers, or other gastrointestinal lesions with a snare or other appropriate endoscopic device.

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)

||X| Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

I. SUBMITTER [Per 807.92(a)(1)]

Sponsor/Manufacturer GI Supply 5069 Ritter Road Suite 104 Mechanicsburg, PA 17055 USA Phone: (800)-451-5797

Contact Person Erika Parry Manager, Quality and Regulatory Phone: (717)-562-7580 Email: e.parry@gi-supply.com

Date Prepared

August 19, 2020 Amended September 29, 2020

II. DEVICE [Per 807.92(a)(2)]

Device Trade/Proprietary Name	EverLift™ Submucosal Lifting Agent
Device Common or Usual Name	Submucosal Injection Agent
Regulation Number	21 CFR 876.1500
Regulation Name	Endoscope and Accessories
Regulatory Class	Class II
Submission Type	Special 510(k)
Product Code	PLL
Classification Panel	Gastroenterology/Urology

III. PREDICATE DEVICE [Per 807.92(a)(3)]

The EverLift™ Submucosal Lifting Agent (10mL) [subject device] is substantially equivalent in terms of its intended use to the claimed predicate device, the 5mL EverLift™ Submucosal Lifting Agent (5mL) (K191923) with respect to device design, fundamental technology, physical characteristics, performance and intended use.

The device design and fundamental technology of the subject device are nearly identical to that of the predicate device. The formulation and composition of the primary packaging materials are identical. There are slight differences in the dimensions of the subject device and predicate device which do not impact safety or effectiveness. Both the subject and predicate devices are delivered sterile and are indicated for single-use only. The Sterilization Method and Shelf Life for the subject device are identical as that for the predicate device.

PredicateDevice	The EverLift™ Submucosal Lifting Agent (10mL) [subject device] is substantially equivalent tothe following predicate device manufactured by GI Supply:• EverLift™ Submucosal Lifting Agent (5mL) (K191923)
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IV. DEVICE DESCRIPTION [Per 807.92(a)(4)]

V. INTENDED USE / INDICATIONS FOR USE [Per 807.92(a)(5)]

Intended Use / Indications for Use

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [Per 807.92(a)(6)]

The EverLift™ Submucosal Lifting Agent (10mL) [subject device] is substantially equivalent to the Gl Supply EverLift™ Submucosal Lifting Agent (5mL) (K191923) [predicate device] based on the same indication for use as the predicate device and the similar or identical functional and performance characteristics of the subject device when compared to the predicate device. The differences between the subject device and predicate device do not raise different issues of safety and effectiveness.

The detailed substantial equivalence comparison of the similarities and differences between the Gl Supply EverLift™ Submucosal Lifting Agent (10ml) [subject device] and the GI Supply EverLift™ Submucosal Lifting Agent (5mL) (K191923) [predicate device] is provided in the table below.

RegulatoryInformation	[Subject Device]	[Predicate Device]	Similarities /Differences
Manufacturer	GI Supply	GI Supply	Same
Device TradeorProprietaryName	EverLift™ Submucosal Lifting Agent(10mL)	EverLift™ Submucosal Lifting Agent(5mL)	---
RegulatoryInformation	[Subject Device]	[Predicate Device]	Similarities /Differences
510(k)Number	K202376	K191923	---
Device Class	Class II	Class II	Same
DeviceClassificationName	Endoscope and Accessories	Endoscope and Accessories	Same
DeviceCommonName	Submucosal Injection Agent	Submucosal Injection Agent	Same
Product Code	PLL	PLL	Same
RegulationNumber	21 CFR 876.1500	21 CFR 876.1500	Same
Design Features and Capabilities of the Device
Indicationsfor Use	EverLift™ Submucosal Lifting Agentis indicated for use ingastrointestinal endoscopicprocedures for submucosal lift ofpolyps, adenomas, early-stagecancers, or other gastrointestinallesions prior to excision with asnare or other appropriateendoscopic device.	EverLift™ Submucosal Lifting Agentis indicated for use ingastrointestinal endoscopicprocedures for submucosal lift ofpolyps, adenomas, early-stagecancers, or other gastrointestinallesions prior to excision with asnare or other appropriateendoscopic device.	Same
Intended Use	Same as Indications for Use	Same as Indications for Use	Same
Prescriptionor Over-the-Counter(OTC) Use	Prescription Use	Prescription Use	Same
UseEnvironment	Hospital / Clinic	Hospital / Clinic	Same
Sterile	Sterile	Sterile	Same
Single-Use	Single-Use Only	Single-Use Only	Same
Design Features
Packaging	Each individual 10mL COC syringe ispacked inside a thermoformed tray.The tray is sealed with a labeled lidstock with three (3) patient labelsaffixed to the lid stock. Ten (10) ofthe sealed trays are packed into ashelf box with a copy of the IFUplaced between the trays and theshelf box wall. The shelf box isshipped in a regular die cut andscored 200-pound B-flute kraftshipper box sealed with a shipperbox label.	Each individual 5mL COC syringe ispacked along with three (3) patientlabels inside a propionate tube witha friction fit press on closure. Ten(10) tubes are packed into a shelfbox on top of a copy of the IFU. Theshelf box is shipped in a regular diecut and scored 200-pound B-flutekraft shipper box sealed with ashipper box label.	Different. Thedifferences inpackaging donot raisedifferentquestions ofsafety oreffectiveness.A DistributionStudy wasperformed onthe newpackagingconfiguration.
RegulatoryInformation	[Subject Device]	[Predicate Device]	Similarities /Differences
Imagesof Device	Image: Subject Device	Image: Predicate Device	---
SterilizationMethod	Sterilized by moist-heat (steam)sterilization	Sterilized by moist-heat (steam)sterilization	Same
Shelf Life	2-Year Shelf Life	2-Year Shelf Life	Same
Composition	Each steam sterilized syringecontains 10mL of lifting agent withthe following ingredients:• Water• Hydroxyethyl Cellulose• Glycerin• Methylene Blue• Benzyl Alcohol• Sodium Phosphate• Potassium phosphate	Each steam sterilized syringecontains 5mL of lifting agent withthe following ingredients:• Water• Hydroxyethyl Cellulose• Glycerin• Methylene Blue• Benzyl Alcohol• Sodium Phosphate• Potassium phosphate	Sameconcentration;however,volume oflifting agentprovideddiffers.

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VII. SUMMARY OF PERFORMANCE DATA AND PERFORMANCE TEST CONCLUSIONS [Per 807.92(b)(1)(2)(3)]

The determination of substantial equivalence is based on an assessment of non-clinical performance data. To verify that the device design meets its functional and performance requirements, the EverLift™ Submucosal Lifting Agent (10mL) underwent performance testing. Biocompatibility testing was performed only on the 5mL variant as it represented worst-case surface area to volume ratio.

The EverLift™ Submucosal Lifting Agent was developed under GI Supply's risk management process in accordance with ISO 14971:2012 - Medical Devices-Application of Risk Management to Medical Devices. The identified risks were adequately mitigated and verified by means of non-clinical performance testing.

Summary of Performance Testing

A series of non-clinical performance testing was conducted on the subject device. Please refer to the table below for a summary of all non-clinical performance testing conducted on the subject device in support of substantial equivalence.

Test Description	Conforming Standard(s)	Conclusion in Support of Substantial Equivalence
Syringe Tip CapRemoval ForceTesting	None	Syringe tip cap removal force testing was performed onthe subject device using the same method andacceptance criteria as the predicate device. Results ofthe testing confirmed that the syringe tip cap removalforce is equivalent between the subject and predicatedevices, thereby demonstrating substantial equivalence.
Test Description	Conforming Standard(s)	Conclusion in Support of Substantial Equivalence
Product ColorTesting	None	Product color testing was performed on the subject device using the same method and acceptance criteria as the predicate device. Results of the testing confirmed that product color is identical between the two devices, thereby demonstrating substantial equivalence.
Injection FlowRate Testing	None	Injection flow rate testing was performed on the subject device using the same method and acceptance criteria as the predicate device. Results of the testing confirmed that the injection flow rate is equivalent between the subject and predicate devices, thereby demonstrating substantial equivalence.
GraduationMarkingTolerance	ISO 7886-1:2017, Sterilehypodermic needles for singleuse – Part 1: Syringes for manualuse	Graduation mark tolerance testing was performed on the subject device using the same method as the predicate device, and acceptance criteria as defined in ISO 7886-1. Results of the testing confirmed that the marking tolerance meets the acceptance criteria defined in ISO 7886-1, thereby demonstrating substantial equivalence.
ContainerClosureIntegrity Testing	None	Container closure integrity testing was performed on the subject device using the same method and acceptance criteria as the predicate device. Results of the testing confirmed that the container closure integrity is identical between the subject and predicate devices, thereby demonstrating substantial equivalence.
Tray Lid PeelForce Testing	None	The secondary packaging of the subject device required a minor design change to accommodate the larger 10mL syringe. Tray lid peel force test results post-distribution simulation met acceptance criteria, confirming that the differences in secondary packaging do not raise different questions of safety or effectiveness.
SterilityAssurance Level	ISO 17665-1, Sterilization ofhealthcare products – Moistheat – Part 1: Requirements forthe development, validation androutine control of a sterilizationprocess for medical devices	A sterilization validation was performed on the subject device using the same sterilization process and sterilization parameters as the predicate device. Validation results confirmed that the Sterility Assurance Level (SAL) is identical for both devices (10-6), thereby demonstrating substantial equivalence.
LAL Testing	USP <85>, Bacterial EndotoxinsUSP <161>, Transfusion andInfusion Assemblies and SimilarMedical Devices	LAL testing was performed on the subject device using the same method and acceptance criteria as the predicate device. Results of the testing confirmed that the LAL level is identical between the subject and predicate devices, thereby demonstrating substantial equivalence. Additionally, LAL testing will be performed on each lot prior to final product release.
Distribution andPost-DistributionTesting	D7386-16, ASTM StandardPractice for Performance Testingof Packages for Single ParcelDelivery Systems	Post-distribution testing was performed on the subject device using the same method and acceptance criteria as the predicate device. Results of the testing confirmed that package integrity is identical between the subject and predicate devices, thereby demonstrating substantial equivalence.
Test Description	Conforming Standard(s)	Conclusion in Support of Substantial Equivalence
Accelerated andPost-AcceleratedAging Studies	F1980-16, ASTM Standard Guidefor Accelerated Aging of SterileBarrier Systems for MedicalDevices	Post-accelerated aging testing was performed on thesubject device using the same method and acceptancecriteria as the predicate device. Results of the testingwas identical between the subject and predicate devices,thereby demonstrating substantial equivalence.

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VIII. CONCLUSIONS

Based on the results of the non-clinical performance testing conducted on the subject device, it has been concluded that the proposed EverLift™ Submucosal Lifting Agent is as safe and effective and performs as well as the legally marketed predicate device (K191923). The similar indications for use, intended use, technological characteristics, and performance characteristics for the proposed EverLift™ Submucosal Lifting Agent have been assessed to be substantially equivalent to the predicate device, and any differences do not raise different issues of safety and effectiveness when compared to the predicate device. Therefore, the EverLift™ Submucosal Lifting Agent is substantially equivalent to the predicate device.

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.