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, laparoscopic gynecological surgery, and laparoscopic urological surgery. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

Use of the device is limited to patients two (2) years of age and older and a weight equal to or above 10kg, who are suitable to be subjected to a conventional endoscopic technique.

Device Description

The Senhance Surgical System is a multi-arm, console-based robotic system that allows a surgical team to perform laparoscopic surgery in the abdomen and pelvis in a manner similar to a manual laparoscopic approach. Each robotic arm can hold either a laparoscopic surgical instrument or an endoscope to facilitate a surgeon remotely operating the instrument from the cockpit.

More specifically, the Senhance Surgical System consists of: a surgeon console (cockpit), which provides remote manipulators or handles to allow the surgeon to maneuver the surgical instruments and a video monitor to display the endoscopic signal; manipulator arms, which hold and maneuver the instruments and endoscope based on inputs from the surgeon; Intelligent Surgical Unit (ISU), which is the system communication hub, connecting the cockpit and manipulator arms; and instruments, which manipulate the tissue of interest.

In addition, force feedback provides an optional tactile sensory input to the surgeon control handles to give a sense of tissue elasticity. An eye tracking feature provides the surgeon an optional method to control the endoscope from the cockpit, rather than using the surgeon control handles. The ISU allows for three additional methods of camera control, in addition to the optional eye tracking method.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details based on the provided text for the Senhance Surgical System:

Acceptance Criteria and Device Performance

The provided document does not explicitly state numerical acceptance criteria for the expanded indication. Instead, it demonstrates that the Senhance Surgical System's performance for urological procedures is comparable or superior to existing alternative surgical techniques (robotic, laparoscopic, and open surgery) based on several clinical outcome metrics derived from a Systematic Literature Review (SLR) and real-world evidence from the TRUST registry.

The core acceptance is that the device, with its expanded indications for use, "does not raise different questions of safety or effectiveness or alter the fundamental therapeutic use of the system" compared to the predicate devices. The performance data presented in Table 18 supports this claim by showing favorable or similar outcomes.

Table 1: Acceptance Criteria (Implied Comparability) and Reported Device Performance

Metric	Implied Acceptance Criterion (Compared to Predicate/Alternative Methods)	Reported Senhance System Performance (TRUST Registry)	Reported SLR Data Averages (Robotic)	Reported SLR Data Averages (Laparoscopy)	Reported SLR Data Averages (Open)
Length of Stay (Days)	Comparable or better than alternative methods	5.0	2.6	3.1	6.1
Surgical Complication	Comparable or better than alternative methods	0.48%	2.43%	2.64%	1.93%
Conversion Rate	Comparable or better than alternative methods	To Traditional Laparoscopy: 7.1%, To Open: 0.5%	3.06%	3.60%	n/a
Estimated Blood Loss (mL)	Comparable or better than alternative methods	261	307.23	416	697
Readmission Rates (30 days)	Comparable or better than alternative methods	0.48%	7.10%	10.66%	17.99%
Reoperation Rates (30 days)	Comparable or better than alternative methods	0%	18.09%	15.18%	0%
Mortality	Comparable or better than alternative methods	0%	0.36%	0.42%	0.69%
Postoperative Complication	Comparable or better than alternative methods	2.4%	54.19%	23.49%	24.87%
Operative Time (mins)	Comparable to alternative methods	197.1	178.58	124.92	176.29

Note on Acceptance Criteria: The document focuses on demonstrating substantial equivalence by showing that the Senhance System's performance for urological procedures is safe and effective and comparable to established methods, rather than setting specific numerical thresholds as "acceptance criteria." The favorable comparison against SLR data serves as the "proof" of meeting this implied standard.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: 416 urology cases performed using the Senhance system.
- Data Provenance: Retrospective clinical data review from the TRUST registry. "TRUST" is a prospective, multi-center patient registry primarily for European clinical centers. For this study, sites additionally retrospectively enrolled previously treated patients (after obtaining informed consent) and entered retrospective data. The data collection for the TRUST registry is stated to be still ongoing. The study collected data from December 2017 to August 2023.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not explicitly state the number of experts or their qualifications for establishing the ground truth of the TRUST registry data. The data originates from clinical centers participating in the TRUST registry, implying that surgical outcomes and patient data were recorded by the healthcare professionals (surgeons, nurses, etc.) at those centers as part of their routine clinical practice and study participation.
Adjudication Method for the Test Set:
- The document does not specify an adjudication method (e.g., 2+1, 3+1) for the clinical data collected in the TRUST registry. The data appears to be collected directly from clinical records and reported outcomes within the registry structure.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not performed as described. The study compared the device's performance (Senhance System) to the performance of other surgical techniques (Robotic, Laparoscopy, Open) based on aggregated data from a registry and a systematic literature review. It did not involve multiple human readers assessing cases with and without AI assistance to measure reader improvement.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, in essence. The entire evaluation focuses on the performance of the "Senhance Surgical System" itself, which is a robotic-assisted surgical system. While a human surgeon is "in the loop" operating the system, the performance metrics (e.g., surgical complications, blood loss, operative time) are attributed to the system's use rather than analyzing the human-machine interaction for "improvement." The clinical data demonstrates the system's performance in isolation from a specific human reader improvement claim. The device is assisting the surgeon, so the performance reported is inherently "with assistance," but there isn't a comparison of human performance without the Senhance system to human performance with the Senhance system in a controlled observation experiment of the surgeon's performance. Instead, it compares the overall patient outcomes when using the system versus other surgical approaches.
Type of Ground Truth Used:
- Clinical Outcomes Data: The ground truth for the test set (TRUST registry) is based on real-world clinical outcomes data and patient records from surgical procedures. This includes metrics like Length of Stay, Surgical Complications, Estimated Blood Loss, Readmission Rates, Reoperation Rates, Mortality, and Postoperative Complications.
- Expert Consensus (Implicit in SLR): For the comparative data from the Systematic Literature Review, the "ground truth" for the aggregated averages comes from peer-reviewed research publications, where clinical outcomes are established and reported by the medical community.
Sample Size for the Training Set:
- The document does not describe a "training set" in the context of an AI-driven imaging or diagnostic algorithm. The Senhance Surgical System is a robotic-assisted surgical system, and its development and validation would involve engineering verification and validation, bench testing, and clinical studies rather than an AI training/test split of data in the typical sense. The "Performance Data" section mentions "Extensive bench testing was conducted on the previously cleared Senhance system," but does not specify a separate training set.
How the Ground Truth for the Training Set Was Established:
- As there is no "training set" described in the context of AI specific to this submission, this question is not directly applicable. The underlying engineering, functional, and safety validations for the robotic surgical system would have established its operational capabilities and safety through various testing methodologies, often guided by industry standards and expert engineering principles.

Summary

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July 19, 2024

Asensus Surgical, Inc. Madhuvanthi Soundirarajan Senior Regulatory Affairs Specialist 1 TW Alexander Dr Suite 160 Durham, North Carolina 27703

Re: K233866

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: June 20, 2024 Received: June 20, 2024

Dear Madhuvanthi Soundirarajan:

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,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.07.19 14:26:20 -04'00'

Mark Trumbore, Ph.D. 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

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Indications for Use

Submission Number (if known)

K233866

Device Name

Senhance Surgical System

Indications for Use (Describe)

Use of the device is limited to patients two (2) years of age and older and a weight equal to or above 10kg, who are suitable to be subjected to a conventional endoscopic technique.

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 Senhance Surgical System [In accordance with 21 CFR § 807.92]

Submitter Information

Submitter:	Asensus Surgical, Inc.1 TW Alexander Drive, Suite 160Durham, NC 27703
Contact:	Madhuvanthi SoundirarajanSr. Regulatory Affairs SpecialistEmail: msoundirarajan@asensus.comPhone: 352-44-9130

Date Summary Prepared: 12/11/2023

Subject Device Information

Proprietary (Trade) Name:	Senhance® Surgical System
Common Name:	System, Surgical, Computer Controlled Instrument
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 Information

Primary Predicate Device:	Senhance® Surgical System (K223095)
Reference Device:	Intuitive Surgical da Vinci Si Surgical System (K171699)

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Device Description

The purpose of this traditional 510(k) submission is to seek clearance for modifications to the indications for use to be expanded to include laparoscopic urological surgery.

Indication For Use

Use of the device is limited to patients two (2) years of age and older and a weight equal to or above 10kg, who are suitable to be subjected to a conventional endoscopic technique.

Summary of Technological Characteristics

The subject device has the same technological characteristics as the primary predicate device, the Senhance Surgical System (K223095), and similar characteristics to the reference device. Both the subject and predicate devices involve robotically assisted tele-operation as the primary technological principle. It is based on the accurate translation of user inputs to robotically assisted outputs. It involves the use of endoscopic instrumentation for manipulation of tissue and vessels in the insufflated body cavity.

The Senhance Surgical System consists of: a surgeon console (cockpit), which provides remote manipulators or handles to allow the surgeon to maneuver the surgical instruments and a video monitor display the endoscopic signal; manipulator arms, which hold and maneuver the instruments and endoscopic based on inputs from the surgeon; Intelligent Surgical Unit (ISU), which is the system

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communication hub, connecting the cockpit and manipulator arms; and instruments, which manipulate the tissue of interest.

In addition, force feedback provides optional tactile sensory input to the surgeon control handles to give a sense of tissue elasticity. An eye tracking feature provides the surgeon an optional method to control the endoscope from the cockpit, rather than using the surgeon control handles. The ISU allows for three additional methods of camera control, in addition to the optional eye tracking method.

The Senhance instruments are similar in design and materials to traditional laparoscopic instrumentation.

Since there are no technological differences between the subject Senhance system and the primary predicate, no different questions of safety or effectiveness have been raised.

Substantial Equivalence:

The subject Senhance Surgical System with the expanded indications for use is substantially equivalent to the legally marketed primary predicate, Senhance Surgical System most recently cleared through K223095, and to the reference device, the Intuitive Surgical System, IS3000 (K171699).

The subject Senhance Surgical System has the same intended use, technological characteristics, and principles of operation as the primary predicate. The expanded indications for use for the subject device are supported by real-world clinical evidence and do not raise different questions of safety or effectiveness or alter the fundamental therapeutic use of the system; they also align with the intended user population cleared for the secondary predicate/reference device.

Performance Data:

There have been no changes to the device since the previous clearance (K223095), other than the modifications to expand the indications for use to include laparoscopic urological surgery indications. Extensive bench testing was conducted on the previously cleared Senhance system, and these data remain applicable to the subject device. The previously collected compatibility, mechanical integrity, functionality, reliability, and safe use, addressing verification of key device functions including video signal, endoscope compatibility, surgical instruments, and adapters, as well as validation of the system's camera control and force feedback features.

The recognized consensus standards for the predicate Senhance system (K223095) are still applicable as there have been no changes to the technological characteristics of the device.

Cybersecurity Data:

Cybersecurity information demonstrating compliance with section 524B of the FD&C Act consistent with current "FDA Guidance: Cybersecurity in Medical Devices - Quality System Considerations and Content of Premarket Submissions" was provided in this submission.

Clinical Data

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To demonstrate that the subject device is safe and effective for the expanded indications for use, the company has collected real-world evidence on the Senhance Surgical System. A retrospective clinical data review was performed using data from the TRUST registry.

Asensus Surgical is sponsoring a clinical registry "TRUST" and encourages clinical centers in Europe to participate and enter information about the actual use of the Senhance Surgical System and its accessories into the database. This study is a prospective, multi-center patient registry. Sites additionally retrospectively enrolled previously treated patients (after obtaining informed consent) and entered retrospective data into case report forms online.

The TRUST registry aims to enable the collection of real-world evidence on the effectiveness and safety of the Senhance Surgical System and its accessories as it is routinely used within three surgical disciplines: abdominal surgery, gynecological surgery, and urological surgery.

From December 2017 to August 2023, 416 urology cases were performed using the Senhance system at four centers. All patients treated with the Senhance system within this retrospective dataset were eligible for laparoscopic procedures with general anesthesia. The data collection at the sites are still ongoing.

Systematic Literature Review (SLR)

Clinical data collected from the TRUST registry was compared with the results from 62 peer-reviewed research publications describing the clinical outcomes for laparoscopic urological procedures using three alternative surgical techniques: laparoscopic, open, and robotically assisted surgery. The table below (Table 18) summarizes the clinical data on Senhance Surgical System compared to data from the systematic literature review. Figure 13 show the Literature Search Strategy and Inclusion and Exclusion Criteria for the SLR

	Senhance System(TRUST Registry)	SLR Data Averages
		Robotic	Laparoscopy	Open
Length of Stay(Days)	5.0	2.6	3.1	6.1
SurgicalComplication	0.48%	2.43%	2.64%	1.93%
Conversion rate	Traditionallaparoscopy: 7.1%Open: 0.5%	3.06%	3.60%	n/a

Table 18, SLR Data Average and TRUST Registry Data for Urological Procedures

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	Senhance System(TRUST Registry)	SLR Data Averages
	Robotic	Laparoscopy	Open
Estimated BloodLoss (mL)	261	307.23	416	697
Readmission rates(30 days)*	0.48%†	7.10%	10.66%	17.99%
Reoperation rates(30 days)*	0%	18.09%	15.18%	0%
Mortality	0%	0.36%	0.42%	0.69%
PostoperativeComplication	2.4%	54.19%	23.49%	24.87%
Operative Time(mins)	197.1	178.58	124.92	176.29

Both the readmission and reoperation rates were calculated based on information available from adverse event listing notes. Both readmissions occurred during the 12-month follow-up phase after the patient's discharge from the hospital. Therefore, both readmission and reoperation occurred any time between the day of discharge and 12 months after discharge.

†Follow-up was performed on only 122 patients in Minsk. Hence the missing values were not included in the n% calculation.

Conclusion

The clinical analysis of the subject Senhance Surgical System demonstrated that the device is safe and effective for use in urological surgical procedures, which is comparable to that indicated for the secondary predicate (Intuitive da Vinci Si Surgical System, K171699).

The subject Senhance Surgical System has the same intended use as the predicates and its expanded indications for use do not affect the safety or effectiveness of the device. In addition, the subject device has the same technological characteristics and principles of operation as the primary predicate device. Analysis and clinical performance of the device with urological procedures indicate that no new issues of safety or effectiveness are raised for the expanded claim. Thus, the subject Senhance Surgical System is substantially equivalent to the predicate device.

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Figure 12 Flowchart for literature search

Image /page/8/Figure/2 description: The image shows two flow charts that describe the process of identifying studies for a qualitative synthesis. The flow chart on the left starts with 913 records identified through database searching, which is reduced to 886 after duplicates are removed. After screening, 85 records are assessed for eligibility, and 37 studies are included in the qualitative synthesis. The flow chart on the right starts with 433 records, which is reduced to 393 after duplicates are removed, 82 records are assessed for eligibility, and 25 studies are included in the qualitative synthesis.

PubMed

Embase

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Figure 13 Inclusion and exclusion criteria for literature search

Inclusion Criteria

US or EU Study, to reduce variation in surgical method
. Adult and pediatric patients only
. Studies on robotic-assisted laparoscopy
. LOE <3*
Studies on urological procedures
Data collected 2018 - August 17, 2023
Study is a prospective randomized controlled trials on robotic assisted laparoscopy, comparative study reporting on robotic assisted urological cases versus minimally invasive, laparoscopic urological surgery, or open surgery, and/or cohort or case series publications.

Exclusion Criteria

Non-US or EU study
. Meta-Analysis/SLRs (summary data from meta-analysis/SLRs were excluded, however, the references from the meta-analysis/SLRs were analyzed for inclusion as selected articles)
Publications not on robotic assisted laparoscopic procedure
Publication is an HTA that was not published in a peer reviewed journal ●
Follow up study, missing original surgery data
. Animal studies

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.