The cannulas, obturators, seals, and related accessories are intended to establish a port of entry for instruments, endoscopes, or accessories. They are intended to be used only in a medical facility by trained medical professionals in accordance with its associated user manual.

Device Description

The subject device 8 mm and 12 mm Assist Cannulas are used as part of a trocar system to establish a port of entry into the surgical site. The 8 mm and 12 mm Assist Cannulas are intended to be used laparoscopically (independently of the da Vinci Systems), but may be used in conjunction with da Vinci systems to assist robotic procedures.
The cannula is a stainless steel hollow tube that serves as a port of entry for endoscopic instruments. A seal is attached to a cannula and an obturator is placed through the seal. The seal attaches to the top of the cannula to create an air-tight system that allows an insufflated body cavity to be maintained. The seal has an insufflation port with a universal luer fitting and stopcock which connects to the da Vinci Insufflator Tube Set with Smoke Evacuation.

AI/ML Overview

This FDA 510(k) clearance letter pertains to medical devices (8 mm and 12 mm Assist Cannulas), not AI/ML software. Therefore, the information typically found for AI/ML device studies (such as acceptance criteria for algorithm performance, sample sizes for test sets, expert consensus, MRMC studies, or training set details) is not present in this document.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing relevant to surgical cannulas, such as dimensional measurements, mechanical and functional verification, biocompatibility, and sterilization.

Here's a breakdown of the available information related to performance and testing, framed to align with your request where applicable, but noting the absence of AI/ML-specific details:

Device: 8 mm Assist Cannula; 12 mm Assist Cannula

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred/Stated)	Reported Device Performance
Mechanical/Functional Performance	Meets design input requirements; performs as intended.	Performance testing (bench and animal) demonstrates that the subject devices design output meets the design input requirements and that the devices perform as intended.
Dimensional Specifications	Specific inner diameters (Funnel Opening, Tube, Tip) and Overall Length as compared to predicate/reference devices.	8 mm Assist Cannula: Funnel Opening: 1.179", Tube: 0.380", Tip: 0.354". Overall Length: 6.336". 12 mm Assist Cannula: Funnel Opening: 1.179", Tube: 0.564", Tip: 0.564". Overall Length: 6.336". (These dimensions are similar/same to predicate/reference devices as detailed in the comparison table).
Material Biocompatibility	Evaluated per ISO 10993-1.	All materials have been evaluated for biocompatibility per ISO 10993-1.
Sterility	Packaged non-sterile; Steam sterilization compatible.	Packaged non-sterile; Steam sterilization.
Use/Disposition	Reusable.	Reusable.
Human Factors/Usability	Address known use-related issues, identify use-related risks, and inform user interface design.	Analysis of post-market data (MAUDE database) for predicate/similar devices. Comparative Task Analysis (CTA) to compare user interaction to predicate. Use-Related Risk Analysis (URRA). Formative usability evaluations.

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

Sample Size: Not explicitly stated numerically. The performance data section vaguely mentions "bench and animal" testing. The human factors evaluation refers to "post-market data and the MAUDE database" and "formative usability evaluations." Specific numbers for test units or subjects are not provided.
Data Provenance:
- Bench and Animal Testing: Implied to be conducted internally or by a testing facility, but no specific country of origin is mentioned. These are typically prospective tests.
- Human Factors Evaluation: "Post-market data and the MAUDE database" is retrospective data from device adverse event reporting. Formative usability evaluations are prospective. No country of origin is specified for these studies.

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

This information is not applicable and not provided in the document as this is a traditional medical device (surgical cannula) clearance, not an AI/ML device that requires expert-established ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. This concept is typically relevant to the establishment of ground truth in AI/ML diagnostic studies through expert review.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating human reader performance with and without AI assistance for diagnostic tasks, which is not relevant for a surgical cannula.

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

No, this is not applicable. The device is a physical surgical tool and does not involve an algorithm.

7. The Type of Ground Truth Used

For the physical device, "ground truth" would correspond to engineering specifications and safe/effective performance. This was established through:

Design Input Requirements: The pre-defined criteria for the device's function and performance.
Bench Testing: Direct physical measurements and functional tests against specifications.
Animal and Cadaver Models: Simulated use to confirm performance in a biological context.
Biocompatibility Standards: Adherence to ISO 10993-1.
Sterilization Standards: Confirmation of steam sterilization methods.
Human Factors Analysis: Identification and mitigation of use-related risks through analysis of historical data and usability assessments.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train AI/ML algorithms. This device does not use an AI/ML algorithm.

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

Not applicable, as there is no AI/ML training set for this device.

Summary

FDA 510(k) Clearance Letter - K251490

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 2, 2025

Intuitive Surgical, Inc.
Melissa Gonzalez
Technical Lead, Regulatory Affairs
1266 Kifer Road
Sunnyvale, California 94086

Re: K251490
Trade/Device Name: 8 mm Assist Cannula; 12 mm Assist Cannula
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: May 9, 2025
Received: May 14, 2025

Dear Melissa Gonzalez:

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"

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K251490 - Melissa Gonzalez Page 2

(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).

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K251490 - Melissa Gonzalez Page 3

Sincerely,

James H. Jang -S
Digitally signed by James H. Jang -S
Date: 2025.07.02 23:37:30 -04'00'

James Jang, Ph.D.
Acting 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

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.	K251490
Please provide the device trade name(s).

8 mm Assist Cannula;
12 mm Assist Cannula

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable).	☒ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

8 mm Assist Cannula Page 9 of 34

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Traditional 510(k) Assist Cannula, 8 mm and 12 mm Page 1 of 8

510(k) Summary (21 CFR § 807.92)

I. Submitter Information

510(k) Owner: Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086

Primary Contact: Melissa S. Gonzalez
Technical Lead, Regulatory Affairs
Phone: 408-523-8684
Email: melissa.gonzalez@intusurg.com

Secondary Contact: Taian Chen
Senior Regulatory Affairs Specialist
Phone: 650-302-8499
Email: taian.chen@intusurg.com

Date Summary Prepared: May 9, 2025

II. Subject Device

Trade Name: 8 mm Assist Cannula and 12 mm Assist Cannula
Common Name: Surgical Cannula
Classification: Class II
Regulation: 21 CFR § 876.1500, Endoscope and Accessories
Product Code: GCJ

III. Predicate Device Information

Predicate Device: 12mm & Stapler Cannula (PN 470375, K142683)

IV. Device Description

K251490

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K251490
Traditional 510(k) Assist Cannula, 8 mm and 12 mm Page 2 of 8

V. Indications for Use

VI. Technological Characteristics

The cannula is a stainless steel hollow tube that serves as a port of entry for endoscopic instruments. A seal is attached to a cannula and an obturator is placed through the seal. The seal attaches to the top of the cannula to create an air-tight system that allows an insufflated body cavity to be maintained. The seal has an insufflation port with a universal luer fitting and stopcock which connects to the da Vinci Insufflator Tube Set with Smoke Evacuation. The following table provides a summary comparison of the technological characteristics between the subject device to the predicate devices and reference device. The differences in technological characteristics do not raise new questions of safety and effectiveness.

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Traditional 510(k) Assist Cannula, 8 mm and 12 mm Page 3 of 8

K251490

Attributes	Subject DevicesAssist Cannulas (8 mm and 12 mm)	Predicate Device12 mm & Stapler Cannula (K142683)	Reference Device8mm Hex Cannula, Standard(K232610)
Manufacturer	Intuitive Surgical, Inc.	SAME as subject deviceIntuitive Surgical, Inc.	SAME as subject deviceIntuitive Surgical, Inc.
Product Code	GCJ	SIMILAR to subject deviceNAY	SIMILAR to subject deviceNAY
Regulation Number and Name	21 CFR 876.1500, Endoscopes and Accessories	SAME as subject device21 CFR 876.1500, Endoscopes and Accessories	SAME as subject device21 CFR 876.1500, Endoscopes and Accessories
Device Classification	Class II	SAME as subject deviceClass II	SAME as subject deviceClass II
Classification Advisory Committee	General and Plastic Surgery	SAME as subject deviceGeneral and Plastic Surgery	SAME as subject deviceGeneral and Plastic Surgery
Intended Use	To establish a port of entry for instruments, endoscopes, or accessories.	SAME as subject deviceTo establish a port of entry for instruments, endoscopes, or accessories.	SAME as subject deviceTo establish a port of entry for instruments, endoscopes, or accessories.
Anatomical Site		SAME as subject device	SAME as subject device

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Traditional 510(k) Assist Cannula, 8 mm and 12 mm Page 4 of 8

K251490

Attributes	Subject DevicesAssist Cannulas (8 mm and 12 mm)	Predicate Device12 mm & Stapler Cannula (K142683)	Reference Device8mm Hex Cannula, Standard(K232610)
Anatomical Site	Abdomen and Thoracic	Abdomen and ThoracicSAME as subject device	Abdomen and ThoracicSAME as subject device
Where Used (hospital, home, ambulance, etc)	Hospital, Surgical Operating Rooms	Hospital, Surgical Operating RoomsSAME as subject device	Hospital, Surgical Operating RoomsSAME as subject device
Compatible Trocar Accessories	8 mm Assist Cannula- Universal Seal- da Vinci Insufflator Tube Set with Smoke Evacuation- 8 mm Cannula Gage Pin- 8 mm Blunt Obturator (Reusable)- 8 mm Bladeless Optical Obturator (Disposable)connected through the use of the Universal Seal	12 mm & Stapler Cannula- Universal Seal- da Vinci Insufflator Tube Set with Smoke Evacuation**connected through the use of the Universal SealSIMILAR to subject device	8 mm Hex Cannula- Universal Seal- da Vinci Insufflator Tube Set with Smoke Evacuation- 8 mm Cannula Gage Pin- 8 mm Blunt Obturator (Reusable)- 8 mm Bladeless Optical Obturator (Disposable)connected through the use of the Universal SealSAME as subject device

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Traditional 510(k) Assist Cannula, 8 mm and 12 mm Page 5 of 8

K251490

Attributes	Subject DevicesAssist Cannulas (8 mm and 12 mm)	Predicate Device12 mm & Stapler Cannula (K142683)	Reference Device8mm Hex Cannula, Standard(K232610)
Compatible Trocar Accessories (continued)	12 mm Assist Cannula- Universal Seal- da Vinci Insufflator Tube Set with Smoke Evacuation- 12 mm & Stapler Blunt Obturator (Reusable)- 12 mm & Stapler Bladeless Obturator (Reusable)connected through the use of the Universal Seal	12 mm & Stapler Cannula- Universal Seal- da Vinci Insufflator Tube Set with Smoke Evacuation- 12 mm & Stapler Blunt Obturator (Reusable)- 12 mm & Stapler Bladeless Obturator (Reusable)connected through the use of the Universal SealSAME as subject device	NA
Compatible Devices	8 mm Assist Cannula: Compatible with instruments, imaging devices, and surgical accessories ranging in size from 5 mm to 8 mm.12 mm Assist Cannula: Compatible with instruments, imaging devices, and surgical accessories ranging in size from 5 mm to 12 mm.	SIMILAR to subject device: Compatible with robotic instruments, imaging devices, and surgical accessories ranging in size from 5 mm to 8 mm.SIMILAR to subject device: Compatible with robotic instruments, imaging devices, and surgical accessories ranging in size from 5 mm to 12 mm.	NANA

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Traditional 510(k) Assist Cannula, 8 mm and 12 mm Page 6 of 8

K251490

Attributes	Subject DevicesAssist Cannulas (8 mm and 12 mm)	Predicate Device12 mm & Stapler Cannula (K142683)	Reference Device8mm Hex Cannula, Standard(K232610)
Compatible Devices (continued)	12 mm Assist Cannula- Universal Seal- da Vinci Insufflator Tube Set with Smoke Evacuation- 12 mm & Stapler Blunt Obturator (Reusable)- 12 mm & Stapler Bladeless Obturator (Reusable)connected through the use of the Universal Seal8 mm Assist Cannula: Compatible with instruments, imaging devices, and surgical accessories ranging in size from 5 mm to 8 mm.12 mm Assist Cannula: Compatible with instruments, imaging devices, and surgical accessories ranging in size from 5 mm to 12 mm.	12 mm & Stapler Cannula- Universal Seal- da Vinci Insufflator Tube Set with Smoke Evacuation- 12 mm & Stapler Blunt Obturator (Reusable)- 12 mm & Stapler Bladeless Obturator (Reusable)connected through the use of the Universal SealSIMILAR to subject deviceSIMILAR to subject device: Compatible with robotic instruments, imaging devices, and surgical accessories ranging in size from 5 mm to 8 mm.SIMILAR to subject device: Compatible with robotic instruments, imaging devices, and surgical accessories ranging in size from 5 mm to 12 mm.	NANANA

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Traditional 510(k) Assist Cannula, 8 mm and 12 mm Page 7 of 8

K251490

Attributes	Subject DevicesAssist Cannulas (8 mm and 12 mm)	Predicate Device12 mm & Stapler Cannula (K142683)	Reference Device8mm Hex Cannula, Standard(K232610)
Inner Diameter	8 mm Assist Cannula:Funnel Opening: 1.179"Tube: 0.380"Tip: 0.354"12 mm Assist Cannula:Funnel Opening: 1.179"Tube: 0.564"Tip: 0.564"	SIMILAR to subject deviceFunnel Opening: 1.179"Tube: 0.564"Tip: 0.564"SAME as subject deviceFunnel Opening: 1.179"Tube: 0.564"Tip: 0.564"	SAME as subject deviceFunnel Opening: 1.179"Tube: 0.380"Tip: 0.354"NA
Overall Length	6.336"	SAME as subject device6.336"	NA
Overall Design	8 mm Assist Cannula:Funnel: Bowl shapeTube: Ribbed12 mm Assist Cannula:Funnel: Bowl shapeTube: Ribbed	SIMILAR to subject deviceFunnel: Bowl shape with magnetic finTube: SmoothSIMILAR to subject deviceFunnel: Bowl shape with magnetic finTube: Smooth	NANA
Tip Design	8 mm Assist Cannula:Hexagonal with chisel tip12 mm Assist Cannula:Round with chisel tip	SIMILAR to subject deviceRound with flat tipSIMILAR to subject deviceRound with flat tip	SAME as subject deviceHexagonal with chisel tipNA
Patient Contact Materials	Funnel: 17-4 stainless steel	SAME as subject deviceFunnel: 17-4 stainless steel	NA

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Traditional 510(k) Assist Cannula, 8 mm and 12 mm Page 8 of 8

K251490

Attributes	Subject DevicesAssist Cannulas (8 mm and 12 mm)	Predicate Device12 mm & Stapler Cannula (K142683)	Reference Device8mm Hex Cannula, Standard(K232610)
Patient Contact Materials (continued)	Tube: 304 Full Hard stainless steel (patient contacting material)	SIMILAR to subject device465 Carpenter Steel (patient contacting material)	NA
Biocompatibility	All materials have been evaluated for biocompatibility per ISO 10993-1	SAME as subject deviceAll materials have been evaluated for biocompatibility per ISO 10993-1	NA
Sterility	Packaged non-sterile; Steam sterilization	SAME as subject devicePackaged non-sterile; Steam sterilization	NA
Use/Disposition	Reusable	SAME as subject deviceReusable	NA
Packaging	Corrugate insert with retention features, inside a corrugate box	SAME as subject deviceCorrugate insert with retention features, inside a corrugate box	NA

VII. Performance Data

The following testing was conducted to demonstrate substantial equivalence to the predicate devices.

Performance testing (bench and animal) demonstrates that the subject devices design output meets the design input requirements and that the devices perform as intended. The testing conducted consisted of dimensional measurements, mechanical and functional verification, and simulated use in animal and cadaver models.

Human Factors evaluation for the subject devices included the following activities:

Known use-related issues for predicate devices and devices similar to the subject devices were analyzed using post-market data and the MAUDE database. All identified use related issues that are relevant to the use of the subject devices were documented in the risk analysis.
A Comparative Task Analysis (CTA) was conducted to describe all aspects of the user device interaction, through the breakdown of steps into user tasks, and to provide an analysis of comparison to the predicate for each task.
A Use-Related Risk Analysis (URRA) was conducted to identify all use-related risks for each user task identified as New or Modified from the predicate in the CTA.
Formative usability evaluations were conducted during the development process to inform the device user interface design and confirm assessment of use-related risks.

VIII. Conclusion

Based on the intended use, indications for use, technological characteristics, and performance data the subject devices, 8 mm Assist Cannula and 12 mm Assist Cannula are substantially equivalent to the predicate device 12 mm & Stapler Cannula.

K251490

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.