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 laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. 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 "Additional" surgical instruments and adapters are intended as additions to the predicate suite of instruments and adapters previously cleared for use with the TransEnterix Surgical System (Model Senhance™ - K171120 and K180163). All instruments and adapters are multi-use components that are steam sterilized by the end user before the first use and after each use. The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter.

AI/ML Overview

The provided text describes performance testing for new instruments and adapters for the TransEnterix Senhance Surgical System to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain an acceptance criteria table with reported device performance in the format requested, nor does it detail a study that proves the device meets such criteria as an AI-enabled medical device would typically require. The document focuses on demonstrating that new accessories do not raise new safety or effectiveness concerns compared to existing cleared devices.

However, I can extract the relevant information from the document that addresses some of your points. The "acceptance criteria" are implied by the summary statements of each test, confirming the devices "perform as intended", "met requirements", "demonstrated compatibility", or "fulfilled all applicable requirements".

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of acceptance criteria with numerical performance data. Instead, for each test, it provides a summary statement indicating that the device met the requirements or performed as intended.

Test Category	Implied Acceptance Criteria (Summary from document)	Reported Device Performance (Summary from document)
Bench Testing
Senhance System Force Feedback Response	The Senhance system should provide force feedback by measuring forces and conveying information proportionally to the user.	"Demonstrated that the Senhance system provides force feedback by measuring the forces presented to the device and conveying the force information proportionally to the user."
Force Feedback Stability and Sensitivity	The force feedback feature should properly dampen haptic response signals from the instruments to the cockpit handles.	"Demonstrated that the force feedback feature of the Senhance system properly dampens the haptic response signals from the Additional instruments to the cockpit handles."
Manipulator Arm Fulcrum Feature	The fulcrum feature should be properly established for the Additional instruments.	"Demonstrated that the fulcrum feature of the Senhance system can be properly established for the Additional instruments."
ESU Compatibility	All compatible third-party electrosurgical units (ESUs) should be compatible with the Additional instruments and adapters, with rated voltages matching ESU manufacturer settings.	"Demonstrated that all third-party electrosurgical units (ESUs) that are compatible with the Senhance system are also compatible with the Additional instruments and adapters. Testing compared the rated voltage of the instruments with each ESU's manufacturer settings."
Mechanical Verification Testing	Devices should perform as intended when subjected to mechanical integrity tests under simulated use conditions, including Cantilever Bending Reliability, Instrument Jaw Output Force Reliability, and Force to Jaw Failure.	"Demonstrated that the devices perform as intended when subjected to tests of mechanical integrity under conditions of simulated use. Cantilever Bending Reliability Testing, Instrument Jaw Output Force Reliability Testing and Force to Jaw Failure Testing"
Clip Applier Ligation Performance	Burst pressure of clips delivered by the Senhance Weck® Hem-o-lok Clip Applier should not be statistically different from the burst pressure of clips delivered by the legally marketed Teleflex Medical Hem-o-Lok® Clip Applier.	"Demonstrated that the burst pressure of clips delivered by the Senhance Weck® Hem-o-lok Clip Applier when used with the Senhance system was not statistically different than the burst pressure of clips delivered by the legally marketed Teleflex Medical Hem-o-Lok® Clip Applier were not statistically different."
Biocompatibility	Patient-contacting portions should meet applicable safety requirements related to material toxicity and biological responsiveness (Cytotoxicity, Sensitization, Irritation/Inflammatory Response (IR), Acute Systemic Toxicity, and Pyrogenicity) as per ISO 10993-1.	"The results demonstrated that these components met the requirements of ISO 10993-1 with regard to Cytotoxicity, Sensitization, Irritation/Inflammatory Response (IR), Acute Systemic Toxicity, and Pyrogenicity."
Reprocessing, Cleaning, Sterilization
Reprocessing/Cleaning	Cleaning procedures should allow the devices to be effectively cleaned according to processing instructions.	"The test results demonstrated that the cleaning procedures for the Additional instruments and adapters allow them to be effectively cleaned according to the processing instructions provided in the labeling."
Sterilization	A Sterility Assurance Level (SAL) of at least 10^-6 should be demonstrated.	"A validation of the steam sterilization process was conducted to demonstrate a Sterility Assurance Level (SAL) of at least 10^-6."
Electrical Safety and Compatibility
Electrical Safety and Electromagnetic Compatibility	The electrosurgical instruments should be compliant with IEC 60601-2-2:2017 for basic safety and essential performance of high-frequency surgical equipment and accessories.	"The Additional electrosurgical instruments fulfilled all applicable requirements to demonstrate that the instruments are compliant with the current electrical safety standard, IEC 60601-2-2:2017, Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories."
Software
Software	The Senhance system software should continue to reliably operate as designed with the addition of the new instruments and adapters.	"Software testing was conducted to demonstrate that the Senhance system software continues to reliably operate as designed with the addition of the new instruments and adapters."
Design Validation
Design Validation	The Additional instruments and adapters should perform as intended according to defined user needs and intended uses, demonstrating substantial equivalence to predicate devices (K171120).	"Design Validation was conducted to ensure that the subject Additional instruments and adapters perform as intended according to defined user needs and intended uses, and to support substantial equivalence to the predicate devices cleared under K171120. The design validation was conducted in a porcine model, which was used to simulate key human anatomy. This validation used production-equivalent instruments and adapters in a simulated use environment."

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

Sample Size for Test Set: Not explicitly stated with a specific number of cases or samples for each test. The descriptions imply various tests were conducted on the "Additional instruments and adapters" as a group.
Data Provenance: The design validation was conducted in a porcine model, simulating key human anatomy. This indicates animal data. The other bench tests and compatibility tests would likely be conducted in a laboratory setting. There is no mention of human clinical data or geographical origin.

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

This information is not provided in the document. The tests described are primarily engineering, mechanical, electrical, software, and biological safety tests, not diagnostic performance evaluations that would typically involve human expert consensus for "ground truth". The "design validation" involved a porcine model, but the role or number of experts involved in evaluating its success is not detailed.

4. Adjudication Method for the Test Set:

This information is not provided. The nature of the tests (bench, biocompatibility, sterilization, electrical, software) does not typically involve an adjudication method in the way a diagnostic study with human readers would.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Due to the similarity of the subject devices to the predicate devices, new usability and clinical testing were not necessary." The study is focused on demonstrating substantial equivalence of accessories, not evaluating the effectiveness of human readers with vs. without AI assistance.

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

This document describes physical surgical instruments and adapters for a robotic surgical system, not a standalone AI algorithm. Therefore, this question is not applicable. The "software" section refers to the existing system's software continuing to operate reliably with the new instruments, not a new algorithm's standalone performance.

7. The type of ground truth used:

Ground Truth varies by test type:
- Bench Testing: Engineering specifications, physical measurements (e.g., force, voltage), statistical comparisons (for clip applier).
- Biocompatibility: ISO 10993-1 standards (e.g., cytotoxicity, sensitization levels).
- Reprocessing/Cleaning: Effectiveness against established microbial or soil removal standards.
- Sterilization: Sterility Assurance Level (SAL) of 10^-6.
- Electrical Safety: IEC 60601-2-2:2017 standard compliance.
- Software: Expected software behavior and functionality without errors or unexpected changes.
- Design Validation: Performance within a simulated use environment (porcine model) against defined user needs and intended uses.

8. The sample size for the training set:

This document is about physical devices and their compatibility/safety, not an AI model that requires a training set. Therefore, this question is not applicable.

9. How the ground truth for the training set was established:

As this document is not about an AI model with a training set, this question is not applicable.

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 followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.

October 9, 2018

TransEnterix, Inc. Kaitlyn Alexander Regulatory Affairs Specialist 635 Davis Drive, Suite 300 Morrisville, North Carolina 27560

Re: K181517

Trade/Device Name: TransEnterix Senhance Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: September 4, 2018 Received: September 6, 2018

Dear Kaitlyn Alexander:

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/ofdocs/ofpmn.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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181517

Device Name

TransEnterix® 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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510(k) SUMMARY

Additional Senhance Surgical Instruments and Adapters

[In accordance with 21CFR 807.92]

510(k) Sponsor:	TransEnterix, Inc.
Address:	635 Davis Drive, Suite 300Morrisville, NC 27713
Contact Person:	Kaitlyn AlexanderRegulatory Affairs Specialist
Contact Information:	Email: kalexander@transenterix.comPhone: 919.765.8400 ext. 8505Facsimile: 919.765.8459
Date Summary Prepared:	10/5/2018
Proprietary (Trade) Name:	TransEnterix® Senhance™ Surgical System
Common Name:	Endoscopic Instruments and Accessories
Classification:	Class II
Classification AdvisoryCommittee:	General and Plastic Surgery
Regulation Number:	21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY (System, Surgical, Computer Controlled Instrument)
Predicate Devices:	TransEnterix® Senhance™ Surgical System (K171120)TransEnterix® Senhance™ Surgical System Indication Expansion(K180163)

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Device Description:

Passive End Effector	Diameter/Length (mm)	Monopolar End Effector	Diameter/Length (mm)	Bipolar End Effector	Diameter/Length (mm)
Atraumatic Single Action Grasper Cobra Grasper DeBakey Grasper Needle Holder Straight	3/ 280	Monopolar Maryland Dissector Monopolar Metzenbaum Scissors	3/ 280	None	None
Johan Grasper 15 mm Tip Kocher Grasper Allis Grasper Strong Grasper Mixter Dissector Needle Holder Left Needle Holder Right Fundus Grasper	5/ 240	Monopolar Maryland Dissector Monopolar Metzenbaum Scissors 18 mm Tip Monopolar Metzenbaum Scissors 15 mm Tip	5/ 240	Bipolar Large Grasping Forceps Bipolar Maryland Dissector Bipolar Curved Scissors Bipolar Shaft	5/ 250
Babcock Forceps Weck® Hem-o-lok® ML Clip Applier	5/ 2405/ 3105/ 410	None	None	Bipolar Curved Grasping Forceps	5/ 2505/ 310

Additional Senhance Surgical Instruments

Intended Use/ Indications for Use:

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cholecystectomy, and inguinal hernia repair. 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.

Comparison with Predicate Device Intended Use/ Indications for Use:

The Additional surgical instruments and adapters have the same intended use/ indications for use as previously cleared for the Senhance system under K180163, which expanded the original clearance under K171120 to include cholecystectomy and inguinal hernia repair. There are no differences in how the Additional devices are used that alter the Senhance system's therapeutic effect or raise different questions of safety or effectiveness.

Technological Characteristics:

The Additional instruments and adapters are very similar to the predicate devices cleared under K171120, with some differences in length, diameter, end effector types, and voltage ratings.

Performance Data:

Performance testing of the Additional instruments and adapters was conducted to support substantial equivalence to the predicate device and demonstrated that the technological differences between the Additional instruments and adapters and the predicate devices did not raise any different questions of safety or effectiveness.

Testing and evaluation included mechanical verification, biocompatibility evaluation, validation of cleaning, reprocessing, and sterilization, electrical safety and electromagnetic compatibility, electrosurgical unit compatibility, software validation, and design validation.

Due to the similarity of the subject devices to the predicate devices, new usability and clinical testing were not necessary.

The testing conducted for the devices in this submission is summarized below:

Bench Testing:

Test	Summary
Verification of SenhanceSystem Force FeedbackResponse	Demonstrated that the Senhance system provides force feedback bymeasuring the forces presented to the device and conveying the forceinformation proportionally to the user.
Verification of Force FeedbackStability and Sensitivity	Demonstrated that the force feedback feature of the Senhance systemproperly dampens the haptic response signals from the Additional instrumentsto the cockpit handles.
Verification of SenhanceManipulator Arm FulcrumFeature	Demonstrated that the fulcrum feature of the Senhance system can beproperly established for the Additional instruments.

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Test	Summary
Verification of ESUCompatibility	Demonstrated that all third-party electrosurgical units (ESUs) that arecompatible with the Senhance system are also compatible with the Additionalinstruments and adapters. Testing compared the rated voltage of theinstruments with each ESU's manufacturer settings.
Mechanical VerificationTesting for AdditionalInstruments and InstrumentAdapters	Demonstrated that the devices perform as intended when subjected to tests ofmechanical integrity under conditions of simulated use.Cantilever Bending Reliability Testing Instrument Jaw Output Force Reliability Testing and Force to JawFailure Testing
Clip Applier LigationPerformance	Demonstrated that the burst pressure of clips delivered by the SenhanceWeck® Hem-o-lok Clip Applier when used with the Senhance system was notstatistically different than the burst pressure of clips delivered by the legallymarketed Teleflex Medical Hem-o-Lok® Clip Applier were not statisticallydifferent.

Biocompatibility:

Test	Summary
Biocompatibility	Biocompatibility evaluation and testing were performed to demonstrate thatthe patient-contacting portions of the subject Additional instruments:meet all applicable safety requirements related to material toxicity andbiological responsiveness of limited contacting devices. do not result in an unacceptable adverse biological response resultingfrom contact of the devices' materials with the body. The results demonstrated that these components met the requirements of ISO10993-1 with regard to Cytotoxicity, Sensitization, Irritation/InflammatoryResponse (IR), Acute Systemic Toxicity, and Pyrogenicity.

Test

Summary

Biocompatibility

Biocompatibility evaluation and testing were performed to demonstrate thatthe patient-contacting portions of the subject Additional instruments:meet all applicable safety requirements related to material toxicity andbiological responsiveness of limited contacting devices. do not result in an unacceptable adverse biological response resultingfrom contact of the devices' materials with the body. The results demonstrated that these components met the requirements of ISO10993-1 with regard to Cytotoxicity, Sensitization, Irritation/InflammatoryResponse (IR), Acute Systemic Toxicity, and Pyrogenicity.

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 instruments andadapters used with the Senhance system to confirm the overall effectiveness ofthe prescribed cleaning procedures. The test results demonstrated that thecleaning procedures for the Additional instruments and adapters allow them tobe effectively cleaned according to the processing instructions provided in thelabeling.
Sterilization	A validation of the steam sterilization process was conducted to demonstrate aSterility Assurance Level (SAL) of at least 10-6.

Test

Summary

Reprocessing/ Cleaning

A cleaning effectiveness validation study was conducted consistent with theprocedures and protocols utilized for the previously cleared instruments andadapters used with the Senhance system to confirm the overall effectiveness ofthe prescribed cleaning procedures. The test results demonstrated that thecleaning procedures for the Additional instruments and adapters allow them tobe effectively cleaned according to the processing instructions provided in thelabeling.

Sterilization

A validation of the steam sterilization process was conducted to demonstrate aSterility Assurance Level (SAL) of at least 10-6.

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Electrical Safety and Compatibility:

Test	Summary
Electrical Safety andElectromagneticCompatibility Testing	The Additional electrosurgical instruments fulfilled all applicable requirementsto demonstrate that the instruments are compliant with the current electricalsafety standard, IEC 60601-2-2:2017, Medical electrical equipment Part 2-2:Particular requirements for the basic safety and essential performance of highfrequency surgical equipment and high frequency surgical accessories.

Software:

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

Design Validation:

Test	Summary
Design Validation	Design Validation was conducted to ensure that the subject Additionalinstruments and adapters perform as intended according to defined user needsand intended uses, and to support substantial equivalence to the predicatedevices cleared under K171120. The design validation was conducted in aporcine model, which was used to simulate key human anatomy. This validationused production-equivalent instruments and adapters in a simulated useenvironment,

Test

Summary

Design Validation

Design Validation was conducted to ensure that the subject Additionalinstruments and adapters perform as intended according to defined user needsand intended uses, and to support substantial equivalence to the predicatedevices cleared under K171120. The design validation was conducted in aporcine model, which was used to simulate key human anatomy. This validationused production-equivalent instruments and adapters in a simulated useenvironment,

Conclusions/ Substantial Equivalence:

The data acquired from the performance testing and software testing of the TransEnterix® Additional Senhance™ Surgical Instruments and Adapters, as summarized herein, demonstrate that the devices are as safe and effective and perform similarly to the predicate devices cleared under K171120. The intended use/ indications for use for the subject devices are identical to those cleared under K180163. The Additional instruments and adapters 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.