The CVAC Aspiration System and CVAC Image Processor consists of a sterile single use, steerable ureteral catheter and a reusable software-controlled image processor. It is intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). It employs flexible ureteroscopy within the urinary tract for endoscopic examination of the urinary tract and the interior of the kidney.

The steerable ureteral catheter is used for irrigation of kidney stones and stone dust with dedicated irrigation and vacuum channels under ureteroscopy. The CVAC Aspiration System and CVAC Image Processor can be used with additional accessories to perform various diagnostic and therapeutic procedures.

Device Description

The single use CVAC Aspiration System and the reusable CVAC Image Processor are specialized devices designed to allow physicians to locate kidney stones and to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). The devices are used in a surgical suite and are compatible with standard hospital monitors, vacuum sources, and irrigation sources.

The CVAC Aspiration System is a sterile single-use steerable ureteral catheter employing ureteroscopy with built-in irrigation and vacuum functionality. Accessories provided with the CVAC Aspiration System include an introducer, a laser bridge, a trigger tie, a 3-way stopcock, and a vacuum port cap. The CVAC Aspiration System catheter is compatible with commercially available accessories for stone removal such as appropriately sized single-use laser fibers and stone baskets, which are inserted and used in the vacuum channel. The CVAC Aspiration System connects to the CVAC Image Processor via an attached video cable.

The CVAC Image Processor is a software-controlled, reusable and electrical image processor. The CVAC Image Processor is connected to a standard 110V hospital electrical outlet via a provided power cord. The internal carrier board inside the CVAC Image Processor houses the LED control circuit, the display interface, and supports electrical interconnect between the image signal processing module and the System-on-Module (SOM). This allows the CVAC Image Processor to generate a video signal compatible with standard hospital grade external monitors. Accessories provided with the CVAC Image Processor include a HDMI-to-DVI adapter, a HDMI cable, and a power cable.

AI/ML Overview

The provided text mainly focuses on the FDA's 510(k) clearance for the Calyxo CVAC Aspiration System and CVAC Image Processor, outlining its intended use, comparison to predicate devices, and general performance testing categories. Crucially, the document does NOT contain detailed information about specific acceptance criteria for AI/image processing performance, nor does it describe a study design for proving the device meets those specific criteria.

The "CVAC Image Processor" is mentioned, and "Optical Testing" and "Software" verification are briefly summarized, but these sections do not include:

A table of acceptance criteria for image quality or AI performance.
Reported device performance metrics against such criteria.
Sample sizes for test or training sets for AI/image analysis.
Details on ground truth establishment (number of experts, qualifications, adjudication methods).
Information on Multi-Reader Multi-Case (MRMC) studies or standalone AI performance.

The document indicates that the device's image processing is for "direct vision capability" during endoscopic procedures, implying a live video feed for human users, rather than a diagnostic AI that makes independent interpretations.

Therefore,Based on the provided text, I can only provide general information about the device's testing and highlight what is missing regarding AI/image processing specific acceptance criteria and detailed study data.

Acceptance Criteria and Study for Calyxo CVAC Aspiration System and CVAC Image Processor

The provided document, an FDA 510(k) clearance letter and summary, primarily addresses the substantial equivalence of the CVAC Aspiration System and CVAC Image Processor to existing predicate devices. While the "CVAC Image Processor" is a software-controlled component that generates video, the document focuses on its capability to provide direct vision for the physician during endoscopic procedures, rather than on AI-driven image analysis or diagnostic capabilities with associated performance metrics.

The document does not provide a table of acceptance criteria specifically for the image processor's performance in object detection, segmentation, or other AI-driven tasks, nor does it detail a study proving the device meets such criteria. The "Optical Testing" and "Software" sections are general summaries of regulatory compliance rather than performance studies with quantitative acceptance criteria for image analysis.

Here's an analysis of the information that is present and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The document lists general device characteristics (e.g., working length, shaft OD) in Table 1 but does not present quantitative acceptance criteria or reported performance for image processing or any specific AI/algorithmic function beyond stating that it provides "direct vision capability" and meets optical standards (ISO 8600 series).

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

Not provided in the document for image processing/AI evaluation. The document mentions "extensive bench performance verification and validation testing," a "usability assessment," and various compliance tests (biocompatibility, electrical safety, optical, software, sterilization, packaging). However, it does not specify sample sizes for any test sets related to the image processor's performance (e.g., how many images or videos were used to test its visual capabilities, or if any 'test set' for AI was even relevant). No data provenance (country, retrospective/prospective) is detailed for performance evaluation datasets.

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

Not applicable/Not provided for image processing/AI evaluation. Since no explicit AI/algorithmic diagnostic or analytical function requiring expert-defined ground truth is detailed, information on experts or their qualifications for establishing ground truth is absent. The "direct vision" nature of the image processor means the ground truth is the live anatomical view presented to the clinician.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As there's no described diagnostic AI assessment or need for expert consensus on images, no adjudication method is detailed.

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

Not mentioned/Not conducted or applicable based on the description. The device is described as providing "direct vision" for the physician during a procedure, not as an AI assistance tool that alters or enhances human interpretation in a diagnostic setting that would typically warrant an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable/Not provided. The device's image processor's primary role is to provide a real-time visual feed to a human operator. There's no indication of a standalone diagnostic algorithm being evaluated.

7. Type of Ground Truth Used

Not applicable/Not detailed for image processing. For the image processor (which provides real-time video), the "ground truth" is the actual anatomical view captured by the camera. For other device functions, "ground truth" might refer to engineering specifications or physical measurements (e.g., flow rates, material properties), which are implicitly covered by "bench performance verification and validation."

8. Sample Size for the Training Set

Not provided. No information on a training set size for an AI component is present, as the image processor is described as a direct visualization tool, not an AI for image analysis.

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

Not applicable/Not provided. As there is no described AI model that would require a ground-truth labeled training set for its image analysis capabilities.

In summary, the provided FDA document focuses on the safety and basic functionality of the CVAC Aspiration System and its integral Image Processor, establishing substantial equivalence to predicates for its intended use in urological procedures. It describes the image processor as a tool for "direct vision capability" and its compliance with optical and software standards, but it does not present the specific type of AI performance evaluation details (acceptance criteria, test/training sets, ground truth establishment by experts) that would be expected for a device incorporating advanced diagnostic AI.

Summary

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February 2, 2024

Calyxo, Inc. Diane Mandell Horwitz, Ph.D. Regulatory Consultant 4473 Willow Road. Suite 100 Pleasanton, CA 94588

Re: K233472

Trade/Device Name: CVAC Aspiration System and CVAC Image Processor Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED, FGB Dated: January 4, 2024 Received: January 4, 2024

Dear Diane Mandell Horwitz:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Mark R. Kreitz -S

for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology 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) K233472

Device Name

CVAC Aspiration System and CVAC Image Processor

Indications for Use (Describe)

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 Calyxo. The logo is blue and features the word "Calyxo" in a stylized font. The "C" in Calyxo is large and bean-shaped. The rest of the letters are smaller and connected.

510(k) SUMMARY

GENERAL INFORMATION 1.

Submitter and 510(k) Owner 1.1

Calyxo, Inc. 4473 Willow Road, Suite 100 Pleasanton, CA 94588

1.2 Official Correspondent

Diane Horwitz, Ph.D. Regulatory Consultant 5 Lake Como Ct. Greenville SC 29609 Telephone: 703.307.2921 Email: diane.horwitz(@calyxoinc.com

Date of Preparation 1.3

January 11, 2024

2. NAME OF THE DEVICE

2.1.1 Trade/Proprietary Name

CVAC Aspiration System and CVAC Image Processor

2.1.2 Common/Usual Name

Endoscopic Access Overtube, Gastroenterology-Urology Ureteroscope and Accessories, Flexible/Rigid

2.1.3 Classification Information

Classification Name:	Endoscope and Accessories
Classification Regulation:	21 CFR 876.1500
Class:	II
Product Code:	FED, Endoscopic Access Overtube, Gastroenterology-UrologyFGB, Ureteroscope and Accessories, Flexible/Rigid
Panel:	Urology

PREDICATE DEVICES 3.

The primary predicate device is the CVAC Aspiration System (formerly K-VAC Aspiration Catheter, Calyxo, Inc, K200149). The secondary predicate is Axis Single-Use Digital Flexible Ureteroscope (K180367, Shanghai AnQing Medical Instrument CO., Ltd.).

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4. DESCRIPTION OF THE DEVICE

ട്. INTENDED USE

The intended use / indications for the CVAC Aspiration System and CVAC Image Processor is as follows:

The steerable ureteral catheter is used for irrigation and aspiration of kidney stones and stone dust with dedicated irrigation and vacuum channels under ureteroscopy. The CVAC Aspiration System and CVAC Image Processor can be used with additional accessories to perform various diagnostic and therapeutic procedures.

INTENDED USE COMPARED TO THE PREDICATE 6.

The intended use of the CVAC Aspiration System and CVAC Image Processor includes the combined intended uses of both predicate devices. The mode of operation is the same as the combined modes of action of both predicate devices but is based on the mode of action of the primary predicate. Placement procedures for the subject device and primary predicate are the same. The subject device provides visualization during the procedure, similar to the secondary predicate. The combination of the two capabilities provides a streamlined ability to remove kidney stones and stone dust.

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7. TECHNOLOGY CHARACTERISTICS COMPARED TO THE PREDICATE

There are similarities between the technological characteristics of CVAC Aspiration System and CVAC Image Processor and the primary predicate, and between the subject devices and the secondary predicate. Similarities to the primary predicate include the mode of use of the device, the working length, OD, ID, external catheter profile, the dedicated irrigation channel and aspiration channel and the functionality for irrigation of small kidney stones and stone dust.

Differences compared to the primary predicate include the built-in digital imaging in the subject device, the software controls and electronics, while the primary predicate relies on fluoroscopy for visualization. Additionally, the subject device has a hydrophilic coating to aid in placement.

The CVAC Aspiration System and CVAC Image Processor and the secondary predicate are similar in that both devices are flexible single-use sterile ureteroscopes designed to be used with one companion image processor. Both have visualization via a camera chip at the catheter tip, both are software-controlled and electronic. Table 1 below reviews the technological comparison between the subject device and both predicates.

The different technological characteristics between the subject device and the predicates have been evaluated and it has been determined the subject device does not raise new questions of safety and effectiveness. The sum of the technology of the primary predicate and the secondary predicate supports the substantial equivalence determination.

	Subject DeviceCVAC Aspiration Systemand CVAC Image Processor	Primary PredicateCVAC Aspiration SystemK200419	Secondary PredicateAxis DisposableUreteroscopeK180367
WorkingLength	70 cm	70 cm	65 cm
Total Length	100 cm	90 cm	92 cm
Shaft OD	<12 Fr (4 mm)	<12 Fr (4 mm)	9.3 Fr (3.1 mm)
WorkingChannel ID(also referredto as VacuumChannel)	7 Fr (2.3 mm)	7.5 Fr (2.5 mm)	3.6 Fr (1.2 mm)
ExternalCatheterProfile	Diameter and lengthsufficient to reach kidney,low durometer PEBAX outermaterial at tip, smooth outersurface	Diameter and length sufficientto reach kidney, low durometerPEBAX outer material at tip,smooth outer surface	Diameter and lengthsufficient to reach kidney
Navigation	Ureteroscopic navigation.	Initial placement andnavigation are done underfluoroscopy.	Ureteroscopic navigation.
Coating	Hydrophilic Coating on distal~45 cm of the catheter	No coating	No coating
Distal TipConfiguration(Camera)	Recessed CMOS chip anddual LEDs for direct visioncapability	N/A	Recessed CMOS chip anddual LEDs for direct visioncapability
Single ormultiple use	Single patient use	Single patient use	Single patient use
	Subject DeviceCVAC Aspiration Systemand CVAC Image Processor	Primary PredicateCVAC Aspiration SystemK200419	Secondary PredicateAxis DisposableUreteroscopeK180367
IRRIGATION / ASPIRATION
Irrigation	Via the irrigation port andirrigation channel at cathetertip.	Via the irrigation port andirrigation channel at cathetertip.	Via access port through theworking channel
	Irrigation channel is separateand distinct from workingchannel.	Irrigation channel is separateand distinct from workingchannel.
Aspiration	Use hospital vacuum, settingof 150 to 200 mmHg	Use hospital vacuum, setting of150 to 200 mmHg	No vacuum capabilities
StoneCollector	Integrated into handle	In-line stone collector separatefrom device	No stone collector
	ACCESSORIES AND COMPATIBILITY WITH OTHER DEVICES
Compatiblemedicaldevices	Compatible with standardguidewires and 200-serieslaser fibers.	Compatible with standardguidewires.	"Additional accessories" maybe used per Axis IFU.
	Compatible with standardstone baskets size 1.9Fr		This includes laser fibers thatfit inside the working channel(including 200-series laserfibers). Compatible with stonebaskets.
IntroducerProvided?	Yes (provided in sterile tray)	Yes (provided in sterile tray)	No
CompatibleUreteralAccess Sheathsizes	If clinician desires, can beused with 12/14 Fr ureteralsheath	If clinician desires, can be usedwith 12/14 Fr ureteral sheath	If clinician desires, can beused with 11/13 Fr or 12/14Fr ureteral sheath
IMAGE PROCESSOR
Image System	The CVAC Image Processoris connected to the CVACAspiration System andprovides power to theureteroscope	None	The Video Processor isconnected to the flexibleureteroscope and providespower to the ureteroscope
CompatibleDisplay	Hospital-grade High-Definition Monitor withHDMI or DVI input	N/A	Hospital-grade High-Definition Monitor withHDMI or DVI input
Resolution(pixels)	200 x 200	N/A	400 x 400
Digital VideoTechnology	Color CMOS	N/A	Color CMOS
Illumination	LED	N/A	LED
Field of View(°)	100°	N/A	110°
Direction ofView (°)	0°	N/A	0°
Light (lux)	6000 lux	N/A	>5000 lux

Table 1. Technology Comparison of CVAC Aspiration System and CVAC Image Processor and Predicate Devices

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Table 1. Technology Comparison of CVAC Aspiration System and CVAC Image Processor

and Predicate Devices

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8. PERFORMANCE TESTING

The 510(k) submission provided performance data to establish the substantial equivalence of the CVAC Aspiration System and CVAC Image Processor (the subject device) to the predicate devices. A summary of these performance tests is provided below.

Performance Test, Bench: Results of extensive bench performance verification and validation testing confirm that the aspiration and irrigation and other device characteristics meet product specifications, and the device meets design input requirements.

Usability Assessment: A usability assessment was conducted to evaluate the User's understanding of the User Manuals and Quick Reference Guide when performing and asked about critical tasks during use of the CVAC Aspiration System and CVAC Image Processor. Results confirm that the acceptance criteria for usability have been met by intended users in the intended use environments. All participants were observed to safely perform all primary operating functions and critical tasks. The risk profile was acceptable, user training and User Manuals and Quick Reference Guide were interpreted correctly.

Biocompatibility Data: Biocompatibility testing was conducted for the CVAC Aspiration System and accessories as an external communicating device, tissue/bone/dentin contacting, limited duration exposure. Cytotoxicity (MEM Elution Method), Sensitization (Guinea Pig Maximization Test, Magnusson-Kligman Method), Irritation (Intracutaneous test), Acute Systemic Toxicity, Material Mediated Pyrogen Test (LAL Test) testing all resulted in passing test results. This conclusion is that the CVAC Aspiration is biocompatible and meets the requirements of ISO 10993-1.

Electrical Safety and Electromagnetic Compatibility: Electrical safety and electromagnetic compatibility (EMC) was successfully performed to applicable requirements of IEC 60601-1, IEC 60601-1-2, and IEC 60601-4-2.

Optical Testing: Optical testing was successfully performed to appliable requirements of ISO 8600-1, ISO 8600-3, ISO 8600-4 and ISO 8600-6.

Software: Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance documents, "Content of Premarket Submissions for Device Software Functions," issued on June 14, 2023, and "Off-The-Shelf Software Use in Medical Devices," issued on August 11, 2023. Cybersecurity risk assessment was conducted in accordance with FDA guidance document, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," issued on September 27, 2023. The software complies with IEC 62304.

Sterilization: Sterilization validation studies using ethylene oxide (EtO) confirmed sterilization to a sterility assurance level (SAL) of 10°. The sterilization process was validated in accordance with ANSI AAMI ISO 11135: 2014, Over-Kill Approach.

Packaging and Shelf Life: Packaging validation testing, including transportation and distribution testing, demonstrated the product packaging protects and maintains device integrity and functionality for the CVAC Aspiration System and CVAC Image Processor. It also confirmed that the product packaging maintained product sterility and supports a 12-month shelf life for the CVAC Aspiration System.

CONCLUSIONS 9.

This 510(k) submission demonstrates that the CVAC Aspiration System and CVAC Image Processor is substantially equivalent to the predicate devices.

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.