The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.

Device Description

The Senhance Articulating platform (internally named Articulating Be4) is intended as an addition to the suite of adapters, couplers and instruments previously cleared for use with the Senhance Surgical System ("Senhance System") most recently cleared under K212054 which is being used as the predicate. This submission requests clearance for one (1) new Articulating Adapter and two (2) Articulating Couplers to be used with the existing articulating instruments.

AI/ML Overview

The provided text describes the acceptance criteria for the Senhance Articulating Platform, an addition to the Senhance Surgical System, and summarizes various studies conducted to demonstrate its substantial equivalence to a predicate device (Senhance Surgical System K212054).

Here's a breakdown of the requested information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal "acceptance criteria" table with specific pass/fail metrics. Instead, it describes performance testing categories and their summaries, demonstrating that the device met expectations or performed as intended. The overarching acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device, meaning it is as safe and effective and performs similarly.

Test Category	Acceptance Criteria (Implied by Summary)	Reported Device Performance (Summary from Text)
Bench Testing	Articulating instruments perform as intended after mechanical integrity tests; Senhance system performs as intended with the articulating platform.	"The following tests confirmed that the articulating instruments perform as intended after tests of mechanical integrity under conditions of simulated use and that the Senhance system performs as intended when used with the subject Senhance Articulating platform: Sterile Drape Reliability, Cantilever Bending Reliability, Jaw Actuation Reliability, Coupler Use Life."
Reprocessing/Cleaning	Cleaning procedures ensure effective cleaning based on protocols for previously cleared couplers.	"The test results demonstrated that the cleaning procedures for the modified articulating couplers allow them to be effectively cleaned according to the processing instructions provided in the labeling."
Sterilization	Steam sterilization process achieves a Sterility Assurance Level (SAL) of at least 10⁻⁶.	"A validation of the steam sterilization process for the modified articulating couplers was conducted to demonstrate a Sterility Assurance Level (SAL) of at least 10⁻⁶."
Electrical Safety & Compatibility	Compliance with relevant IEC standards (60601-1, 60601-1-2, 60601-2-18, 60601-2-2).	"The Senhance Articulating platform used in conjunction with the Senhance system comply with current versions of IEC 60601-1 (Basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-2-18 (Endoscopic equipment interactions), and IEC 60601-2-2 (High frequency surgical equipment)."
Software	Senhance system software continues to reliably operate as designed with the new adapter and couplers.	"Software testing was conducted to demonstrate that the Senhance system software continues to reliably operate as designed with the addition of the new adapter and couplers."
Design Validation	Devices perform as intended according to defined user needs and intended uses in a simulated use environment; applicable user-level requirements are met.	"A single-center, un-blinded, observational, simulated use design validation evaluation... was conducted with users who represented the intended primary user population... All applicable user level requirements were assessed and found to be met."
Usability Testing	Surgical teams can independently perform all critical tasks without use errors leading to harm; overall residual risk of use errors is mitigated to an acceptable level.	"In a simulated use environment, the surgical teams were able to independently perform all critical tasks without use errors that would lead to harm. This study demonstrated that the overall residual risk of use errors with the Senhance Articulating platform have been mitigated to an acceptable level."

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

Sample Size for Test Set: The document does not specify a numerical sample size for any of the individual tests. It uses terms like "comprehensive set of testing," "single-center," and "surgical teams."
Data Provenance: The document generally indicates prospective assessment through various forms of testing (bench, validation, usability). It doesn't specify the country of origin, but given it's an FDA submission for a US company (Asensus Surgical, Inc. in Durham, NC), it's highly likely the data was generated in the United States.

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

The document mentions "users who represented the intended primary user population" for the "Design Validation" and "surgical teams" for "Usability Testing." However, it does not specify the number of experts or their qualifications (e.g., "radiologist with 10 years of experience"). This is a common characteristic of device submissions focusing on mechanical function and usability rather than diagnostic accuracy.

4. Adjudication Method for the Test Set:

The document states the design validation was "un-blinded, observational." It does not mention any explicit adjudication method like "2+1" or "3+1" for conflict resolution, as would be common in studies involving subjective assessment. Given the nature of the tests (mechanical performance, cleaning effectiveness, usability of surgical tools), direct adjudication as seen in image interpretation might not be applicable or described in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating the safety and effectiveness of the new articulating platform itself and its compatibility with the existing Senhance Surgical System, primarily through technical and simulated-use testing. It does not evaluate the improvement of human readers (surgical teams) with or without AI assistance, as this is a surgical system, not a diagnostic AI tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable in the context of the Senhance Articulating Platform. This device is a component of a robotic surgical system that assists human surgeons; it is not a standalone algorithm performing a task without human interaction (like image analysis AI). The "Software" testing confirmed the system's software reliability with the new components, but this is about the system's control functionality, not an AI algorithm performing a task in isolation.

7. Type of Ground Truth Used:

The ground truth or reference standard for this type of device (surgical instrument/platform) is primarily established by:

Performance Specifications/Engineering Standards: For bench testing (e.g., "perform as intended after tests of mechanical integrity," "Sterility Assurance Level (SAL) of at least 10⁻⁶," compliance with IEC standards).
Defined User Needs and Intended Uses: For design validation and usability testing (e.g., "according to defined user needs," "independently perform all critical tasks without use errors that would lead to harm").
Established Reprocessing Protocols: For cleaning effectiveness.

There isn't a "pathology" or "outcomes data" ground truth in the typical diagnostic sense, as this isn't a diagnostic device.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. This is because the submission is for a hardware addition to a robotic surgical system, not a machine learning or AI model that requires a dedicated training set. The "Software" testing is about verifying the existing system's software functions correctly with the new components, not training a new algorithm.

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

Not applicable, as there is no mention of a training set for an AI/ML model in this submission.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

May 27, 2022

Asensus Surgical, Inc. Casey Hinckley Regulatory Affairs Manager 1 TW Alexander Drive, Suite 160 Durham. North Carolina 27703

Re: K220889

Trade/Device Name: Senhance Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: May 2, 2022 Received: May 3, 2022

Dear Casey Hinckley:

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

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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 (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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 Trumbore Assistant 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)

K220889

Device Name Senhance® Surgical System

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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K220889

Special 510(k) SUMMARY

Senhance® Articulating Platform

for use with the Senhance Surgical System

[In accordance with 21CFR 807.92]

510(k) Sponsor:	Asensus Surgical, Inc.
Address:	1 TW Alexander Drive, Suite 160Durham, NC 27703
Contact Person:	Casey HinckleyRegulatory Affairs Manager
Contact Information:	Email: chinckley@asensus.comPhone: 801.310.5491
Date Summary Prepared:	3/22/2022
Proprietary (Trade) Name:	Asensus Surgical® Senhance® Surgical System
Common Name:	Endoscopic Instruments and Accessories
Classification:	Class II
Classification Advisory Committee:	General and Plastic Surgery
Regulation Number:	21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY (System, Surgical, Computer Controlled Instrument)
Predicate Device:	Senhance® Surgical System (K212054)

CONFIDENTIAL

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Device Description:

Image /page/4/Picture/3 description: The image shows a blue articulating instrument. The instrument has a white articulating instrument adapter and an articulating instrument coupler. The instrument is long and cylindrical, with a black cable attached to the back.

Figure 1, Senhance Articulating Platform

Intended Use/ Indications for Use:

Comparison with Predicate Device Intended Use/ Indications for Use:

The Senhance Articulating platforms proposed adapter and couplers have the same intended use/ indications for use as previously cleared Senhance system under K212054. There are no differences in how the Senhance Articulating platform manipulates the instruments that alter the Senhance system's therapeutic effect or raise different questions of safety or effectiveness.

Technological Characteristics:

The substantial equivalence comparison below shows that the subject Senhance Articulating Platform is very similar to the predicate Senhance® Surgical System. Many of the subject devices' technological characteristics and principles of operation are identical or very similar to those of the predicate. Any differences in technological characteristics between the subject and predicate devices have been

Senhance® Articulating Platform Special 510(k) Asensus Surgical, Inc.

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addressed through a comprehensive set of testing using established test methods and do not raise any different questions of safety and effectiveness.

Characteristic	Subject Device	Predicate Device
Name	Modified Senhance ArticulatingPlatform for use with the SenhanceSurgical System	Senhance Articulating Platform foruse with the Senhance SurgicalSystemK212054
Classification/Product Code	Class II, NAY (System, Surgical,Computer Controlled Instrument)	Class II, NAY (System, Surgical,Computer Controlled Instrument)
Intended Use/Indications forUse	The Senhance® Surgical System isintended to assist in the accuratecontrol of laparoscopic instrumentsfor visualization and endoscopicmanipulation of tissue includinggrasping, cutting, blunt and sharpdissection, approximation, ligation,electrocautery, suturing,mobilization and retraction. TheSenhance Surgical System isintended for use in generallaparoscopic surgical proceduresand laparoscopic gynecologicalsurgery. The system is indicated foradult use. It is intended for use bytrained physicians in an operatingroom environment in accordancewith the Instructions for Use.	The Senhance® Surgical System isintended to assist in the accuratecontrol of laparoscopic instrumentsfor visualization and endoscopicmanipulation of tissue includinggrasping, cutting, blunt and sharpdissection, approximation, ligation,electrocautery, suturing,mobilization and retraction. TheSenhance Surgical System isintended for use in generallaparoscopic surgical proceduresand laparoscopic gynecologicalsurgery. The system is indicated foradult use. It is intended for use bytrained physicians in an operatingroom environment in accordancewith the Instructions for Use.
TargetPopulation	Adult Patients	Adult Patients
AnatomicalAreasof Use	Abdomen and pelvis	Abdomen and pelvis
SoftwareVersion	Senhance Software Version 2.7.1.52	Senhance Software Version2.6.0.282

	Table 1, Substantial Equivalence Comparison

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Characteristic	Subject Device	Predicate Device
ArticulatingInstrumentAdapter	Motorized articulating adapter thatattaches to the manipulator armand drives articulation (or "tilt") androtation of the instrument tip("roll"), while jaw actuationcontinues to be driven by actuationof the trolley pin in the adapter likethe predicate. The articulatingadapter is covered by a sterile,disposable drape before each uselike the Senhance capitalequipment. The adapter has apocket compartment and latch forattaching the articulatinginstrument couplers.	Motorized articulating adapter thatattaches to the manipulator arm anddrives articulation (or "tilt") androtation of the instrument tip("roll"), while jaw actuationcontinues to be driven by actuationof the trolley pin in the adapter likethe predicate. The articulatingadapter is covered by a sterile,disposable drape before each uselike the Senhance capitalequipment.
ArticulatingInstrumentCouplers	Reusable instrument specificarticulating couplers that connectthe articulating instruments to thearticulating adapter.	Reusable articulating coupler thatconnects the articulatinginstruments to the articulatingadapter.
EquipmentDrapes	Single use, sterile, articulatingadapter drape pack is provided tocover the articulating adapterduring use. The pack includes aninstrument interface drape with aright-angle USB Type-C cableconnector, an articulating adapterdrape with an integrated USB Type-C cable and a tear-away portion tofurther ensure the preservation ofthe sterile barrier.The drapes are manufactured byDAS Medical and are classified asClass 2, 510(k)-exempt devicesunder product code PUI.	Single use, sterile, articulatingadapter drape pack is provided tocover the instrument interface andarticulating adapter during use. Thepack includes an instrumentinterface drape with a right-angleUSB Type-C cable connector and anarticulating adapter drape with anintegrated USB Type-C cable. Thedrapes are manufactured by DASMedical and are classified as Class 2,510(k)-exempt devices underproduct code PUI.
Characteristic	Subject Device	Predicate Device
ArticulatingInstruments	Single use, sterile, laparoscopic articulating instruments with an articulating design at the distal tip that simulates the human wrist. The 5mm x 310mm articulating instruments include a bipolar grasper and needle driver.	Single use, sterile, laparoscopic articulating instruments with an articulating design at the distal tip that simulates the human wrist. The 5mm x 310mm articulating instruments include a bipolar grasper and needle driver.
Biocompatibility	The instruments are made from biocompatible metals and plastics with a long history of safe use and demonstrated to be non-toxic, non-irritating, non-sensitizing, and non-pyrogenic.	The instruments are made from biocompatible metals and plastics with a long history of safe use and demonstrated to be non-toxic, non-irritating, non-sensitizing, and non-pyrogenic.

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Performance Data:

The following performance testing of the Senhance Articulating platform was conducted to demonstrate substantial equivalence of the device to the predicate.

Bench Testing:

Test	Summary
Bench Testing	Bench testing evaluated the performance of the Senhance Articulating instruments as well as compatibility of the Senahance Articulating platform when used with Senhance Surgical System. The following tests confirmed that the articulating instruments perform as intended after tests of mechanical integrity under conditions of simulated use and that the Senhance system performs as intended when used with the subject Senhance Articulating platform. Sterile Drape Reliability Cantilever Bending Reliability Jaw Actuation Reliability Coupler Use Life

Test

Summary

Bench Testing

Bench testing evaluated the performance of the Senhance Articulating instruments as well as compatibility of the Senahance Articulating platform when used with Senhance Surgical System. The following tests confirmed that the articulating instruments perform as intended after tests of mechanical integrity under conditions of simulated use and that the Senhance system performs as intended when used with the subject Senhance Articulating platform. Sterile Drape Reliability Cantilever Bending Reliability Jaw Actuation Reliability Coupler Use Life

Reprocessing, Cleaning, and Sterilization:

Test	Summary
Reprocessing/ Cleaning	A cleaning effectiveness validation study was conducted consistent with theprocedures and protocols utilized for the previously cleared coupler usedwith the Senhance Surgical System to confirm the overall effectiveness of theprescribed cleaning procedures. The test results demonstrated that thecleaning procedures for the modified articulating couplers allow them to be

Asensus Surgical, Inc. Senhance® Articulating Platform Special 510(k)

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	effectively cleaned according to the processing instructions provided in thelabeling.
Sterilization	A validation of the steam sterilization process for the modified articulatingcouplers was conducted to demonstrate a Sterility Assurance Level (SAL) ofat least $10^{-6}$ .

Electrical Safety and Compatibility:

Test	Summary
Electrical Safety Testing	The Senhance Articulating platform used in conjunction with the Senhancesystem comply with current versions of IEC 60601-1 (Basic safety andessential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC60601-2-18 (Endoscopic equipment interactions), and IEC 60601-2-2 (Highfrequency surgical equipment).

Software:

Test	Summary
Software	Software testing was conducted to demonstrate that the Senhance systemsoftware continues to reliably operate as designed with the addition of thenew adapter and couplers.

Design Validation:

Test	Summary
Design Validation	Design validation of the Senhance Articulating platform was conducted toensure that the devices perform as intended according to defined user needsand intended uses when used with the Senhance system in a simulated useenvironment. A single-center, un-blinded, observational, simulated usedesign validation evaluation of the Senhance system used in conjunction withSenhance Articulating platform was conducted with users who representedthe intended primary user population. The design validation was conductedin a simulated patient model. All applicable user level requirements wereassessed and found to be met.

Test

Summary

Design Validation

Design validation of the Senhance Articulating platform was conducted toensure that the devices perform as intended according to defined user needsand intended uses when used with the Senhance system in a simulated useenvironment. A single-center, un-blinded, observational, simulated usedesign validation evaluation of the Senhance system used in conjunction withSenhance Articulating platform was conducted with users who representedthe intended primary user population. The design validation was conductedin a simulated patient model. All applicable user level requirements wereassessed and found to be met.

Usability:

Test	Summary
Usability Testing	A summative usability validation study was performed with final instructionsfor use and training materials. In a simulated use environment, the surgicalteams were able to independently perform all critical tasks without use errorsthat would lead to harm. This study demonstrated that the overall residual

Asensus Surgical, Inc. Senhance® Articulating Platform Special 510(k)

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risk of use errors with the Senhance Articulating platform have been mitigated to an acceptable level.
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Conclusions/ Substantial Equivalence:

The data acquired from the performance testing and software testing of the Senhance Articulating platforms adapter and couplers, as summarized herein, demonstrate that the devices are as safe and effective and perform similarly to the predicate devices cleared under K212054. The intended use/ indications for use for the subject devices are identical to those cleared under K212054. The Senhance Articulating platforms adapter and couplers do not raise any new issues of safety or effectiveness when compared to the predicate devices, thus, they are 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.