The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other stapler accessories are intended to be used with a compatible da Vinci Surgical System for resection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

Device Description

The Intuitive Surgical SureForm 45 Curved Tip and SureForm 45 Gray Reload are an addition to the existing SureForm 45 Stapling System (SureForm 45 and SureForm 45 Reloads - White, Blue, Green and Black) cleared January 18, 2019, K183224) and are designed for use exclusively with compatible Intuitive da Vinci Surgical Systems (Models IS4000 and IS4200). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The SureForm 45 Curved Tip Stapler Instrument is a disposable, fully wristed articulating device. The SureForm 45 Gray Reload consists of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife.

AI/ML Overview

The provided text describes the regulatory submission for the Intuitive Surgical SureForm 45 Curved Tip and SureForm 45 Gray Reload. However, it does not contain the detailed breakdown of acceptance criteria and device performance in a table, nor does it specify sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance, as these typically apply to AI/software as a medical device (SaMD) clearances.

This document describes a conventional surgical stapling device, which is a hardware device cleared through a 510(k) premarket notification. The studies outlined are primarily bench and animal (in-vivo) testing for device functionality and safety, not AI/ML model validation.

Therefore, many of the requested fields are not applicable to the provided document. I will fill in the available information and explicitly state where information is not present or not applicable.

1. A table of acceptance criteria and the reported device performance

The document describes several animal validation studies (acute and chronic) where "acceptance criteria" were met. However, it does not detail the specific quantitative acceptance criteria or provide a table directly comparing them to reported device performance metrics. Instead, it offers qualitative statements about the outcomes of these studies.

Study Name	Acceptance Criteria (Not explicitly quantified, but implied)	Reported Device Performance (Summary of Study Outcome)
Acute Testing:
Staple Line Performance	Acceptable rates for transection, tissue layer approximation, hemostasis, and staple formation.	The subject device met all acceptance criteria and exhibited acceptable pass rates in the areas of transection, tissue layer approximation, hemostasis, and staple formation.
Buttress Material Compatibility	Clinically acceptable tissue approximation, transection, hemostasis, and well-formed staples (even with buttress material).	Pass rates in the areas of transection, tissue layer approximation, hemostasis, and optimal staple formation were not adversely affected in a statistically significant manner when buttress material was used in accordance with the manufacturer's Instructions for Use.
Maximum Torque	Similar tissue effects (tissue approximation and hemostasis) compared to predicate; no more than three sub-optimal staples within each test fire.	The subject device met all acceptance criteria, exhibiting similar tissue effects (tissue approximation and hemostasis) when compared to the adjacent SureForm 60 staple lines. The subject device also met the staple formation acceptance criteria with no more than three sub-optimal staples within each test fire.
Design Validation	All acceptance criteria met (general statement).	The subject device met all acceptance criteria.
Burst Pressure (Jugular venous)	Non-inferiority to predicate device in burst pressure performance.	The staple lines from the subject device performed substantially equivalent to that of the predicate device. The subject device demonstrated non-inferiority to the predicate EndoWrist 30 Gray Reload.
Chronic Testing:
Lung Lobectomy	No leaks intra-operatively; survival through 28 days; no signs of bleeding or leakage at staple lines during terminal procedures; well-healed staple lines.	All staple lines passed assessment for leaks intra-operatively. All animals survived through the 28 day survival period. During the terminal procedures, there were no signs of bleeding or leakage at the staple lines. Staple lines were well-healed at the end of the survival period for both subject and predicate devices.
Nephrectomy	No leaks intra-operatively; survival through 28 days; no signs of bleeding at staple lines during terminal procedures; well-healed staple lines.	All staple lines passed assessment for leaks intra-operatively. All animals survived through the 28 day survival period. During the terminal procedure, there were no signs of bleeding at the staple lines, and staple lines were well-healed at the end of the survival period for both the subject and predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size:
- Acute Testing:
  - Staple Line Performance: 1 Porcine animal
  - Buttress Material Compatibility: 1 Porcine animal
  - Maximum Torque: 1 Porcine animal
  - Design Validation: 1 Porcine animal
  - Burst Pressure: Porcine (Excised jugular venous tissue) - number of tissue samples not specified
- Chronic Testing:
  - Lung Lobectomy: 8 Canine animals
  - Nephrectomy: 8 Porcine animals
Data Provenance: Animal model (Porcine and Canine), prospective. The country of origin is not specified but generally refers to pre-clinical lab settings associated with the manufacturer (Intuitive Surgical, Inc. in Sunnyvale, California, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a hardware device clearance, and the performance assessment described is based on direct observation of physical outcomes (e.g., staple line integrity, hemostasis, tissue healing) by qualified personnel in a pre-clinical setting, not on interpretation by human experts as with AI/software.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The "ground truth" here is the direct physical outcome of the surgical procedure in animal models. No human expert consensus or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/SaMD product. The studies compare the subject device's performance to predicate devices and established performance criteria for surgical staplers, not human reader performance with or without AI.

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

Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the performance studies is primarily based on:

Direct observation of physical outcomes: E.g., visual assessment of staple line integrity, tissue approximation, hemostasis, gross pathology during survival periods and terminal procedures.
Physiological measurements: E.g., burst pressure testing.
Animal survival rates and health over a chronic period.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no "training set" in the context of an AI/ML model. The design and engineering process would involve iterative testing and refinement, but this is not analogous to an AI training set.

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

Not applicable, as there is no training set mentioned or implied for an AI/ML model.

Summary

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Build Correspondence

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July 12, 2019

Intuitive Surgical, Inc. Nadine Nasr Regulatory Technical Lead 1266 Kifer Road Sunnyvale, California 94086

Re: K190999

Trade/Device Name: SureForm 45 Curved Tip, SureForm 45 Gray Reload Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GDW Dated: April 15, 2019 Received: April 16, 2019

Dear Nadine Nasr:

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.

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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 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 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,

Long Chen, 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

Enclosure

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Indications for Use

510(k) Number (if known) K190999

Device Name

SureForm 45 Curved Tip and SureForm 45 Gray Reload

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

[As Required by 21 CFR 807.92(c)]

K190999

July 12, 2019

Submitter:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Official Contact:	Nadine NasrRegulatory Technical LeadPhone Number: 408-523-7093Fax Number: 408-523-8907
Trade Name:	SureForm 45 Curved Tip and SureForm 45 Gray Reload
Common Name:	System, surgical, computer controlled instrument
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories21 CFR 878.4750, Implantable Staple
Product Codes:	NAY (Endoscope and accessories)GDW (Implantable Staple)

Predicate Device: SureForm 45 (K183224) - primary

EndoWrist 30 Gray Reload (K170508) - secondary

Device Description: The Intuitive Surgical SureForm 45 Curved Tip and SureForm 45 Gray Reload are an addition to the existing SureForm 45 Stapling System (SureForm 45 and SureForm 45 Reloads - White, Blue, Green and Black) cleared January 18, 2019, K183224) and are designed for use exclusively with compatible Intuitive da Vinci Surgical Systems (Models IS4000 and IS4200). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple (transection). line The

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SureForm 45 Curved Tip Stapler Instrument is a disposable, fully wristed articulating device. The SureForm 45 Gray Reload consists of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless steel knife. The specifications for the SureForm 45 Gray Reload are provided in Table 1.

Attribute	Gray Reload
No. of staple rows and staple lineconfiguration	6 rows total;3 on each side of transection;66 staples total
Unformed staple leg length	2.0 mm
Pictures	Image: Gray Reload

Table 1: SureForm 45 Gray Reload Specifications

The Gray Reload is a single use device and is shipped sterile to the surgeon with a retainer that protects the staples during shipping and transportation. The SureForm 45 Gray reloads, as well as the SureForm 45 White, Blue, Green and Black reloads, are compatible with the SureForm 45 and SureForm 45 Curved Tip instruments. The SureForm 45 Gray, White. Blue, Green and Black reloads are not compatible with any other Intuitive Surgical stapler instruments (the SureForm 60, IS4000 Stapler 30 and 45 instruments and the IS3000 Stapler 45 instrument), and likewise, the SureForm 60, IS4000 Stapler 30 and 45 reloads and IS3000 Stapler 45 reloads are not compatible with the SureForm 45 and SureForm 45 Curved Tip instruments.

Image /page/4/Picture/7 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is in a smaller font and also in a light gray color, with the registered trademark symbol to the right of it. There is a yellow dot above the word "INTUITIVE".

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Indications for Use: The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other stapler accessories are intended to be used with a compatible da Vinci Surgical System for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

Technological Characteristics: The SureForm 45 Curved Tip and SureForm 45 Gray Reload are an addition to the predicate SureForm 45 Stapler System (SureForm 45 and SureForm 45 White, Blue, Green and Black Reloads, K183224, cleared January 18, 2019). The SureForm 45 Curved Tip is equivalent to the predicate device (SureForm 45) in terms of the indications for use, design, materials, technology, and performance specifications. Modifications from the predicate are based on a change in the distal tip. The subject SureForm 45 Curved Tip is the same as the predicate SureForm 45 from a design perspective with the exception of the of the curved anvil tip feature. The curved anvil tip feature allows the surgeon to better visualize the tip of the instrument and facilitates access around and behind tissues.

The SureForm 45 Gray Reload is a new disposable reload for use with the SureForm 45 Instruments (Straight and Curved Tip anvil configurations). It is an addition to the existing family of SureForm 45 Reloads (White, Blue, Green and Black). It is equivalent to the Endo Wrist 30 Gray Reload (K170508, cleared March 10, 2017) in terms of the indications for use, design, technology and performance specifications.

The changes to the distal tip and introduction of a new reload do not substantially change the function of the subject device relative to the function of the predicate devices.

Performance Data: The SureForm 45 Curved Tip and Gray Reload were evaluated using bench testing, acute and chronic in-vivo testing (animal model) to demonstrate that the design output meets the input requirements and the device performed as intended.

Design Verification (bench): The subject device, SureForm 45 Curved Tip and Gray Reload, was subjected to series of bench tests equivalent to those for the predicate device to evaluate performance and to demonstrate that the design outputs meet the design input requirements. Testing was performed with a compatible da Vinci surgical system. The design verification testing included confirmation that the device meets the:

Physical Specifications .
Mechanical Requirements ●
. Electrical Requirements
User Interface Requirements
Equipment Interface Requirements .

INTUITIVE SURGICAL®

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Design Validation (animal):

A series of acute and chronic clinical validation studies were performed using simulated clinical models (animal) to evaluate the performance of the subject device, SureForm 45 Curved Tip and SureForm 45 Gray Reload. This included Staple Line Performance, Buttress Material Compatibility Testing, Maximum Torque Evaluation, Design Validation Testing and Burst Pressure Testing. A side-by-side comparison between the subject and predicate devices (SureForm 45 and EndoWrist 30 Gray Reload) was performed in the Staple Line Performance, Maximum Torque and Burst Pressure Testing to demonstrate substantial equivalence between the subject and predicate devices. Buttress Material Compatibility Testing and Design Validation Testing demonstrated that the design outputs of the subject device fulfill the design input requirements and that user needs and intended uses are met. A summary of the animal validation studies is provided in Table 2 below.

Image /page/6/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, with a registered trademark symbol next to it.

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K190999

SureForm 45 Curved Tip and Gray Reload

Study Name	Study Purpose	Type/Number of animals	Study Outcome
Acute Testing:
Staple LinePerformance	Assess staple line performanceand staple formation of thesubject device compared to thepredicate EndoWrist 30 GrayReload.	Porcine (1 animal)	The subject device met all acceptance criteria and exhibited acceptablepass rates in the areas of transection, tissue layer approximation,hemostasis, and staple formation.
ButtressMaterialCompatibility(Gore, Baxterand Cook)	Confirm the ability of thesubject device to produce well-formed staples in-vivo as wellas a staple line which exhibitsclinically acceptable tissueapproximation, transection, andhemostasis and not be affectedwhen Gore SeamguardBioabsorbable Staple LineReinforcement (510(k) clearedunder K053202), BaxterPeriStrip Dry with VeritasCollagen Matrix Staple LineReinforcement (510(k) clearedunder K041669) and CookBiodesign Staple LineReinforcement (510(k) clearedunder K170945) were used inaccordance with themanufacturer's Instructions forUse.	Porcine (1 animal)	Pass rates in the areas of transection, tissue layer approximation,hemostasis, and optimal staple formation were not adversely affected ina statistically significant manner when buttress material was used inaccordance with the manufacturer's Instructions for Use.
MaximumTorque	Evaluate staple lineperformance at maximumSmartFire torque limits of thesubject device as compared tothe SureForm 60 and SureForm60 White Reloads	Porcine (1 animal)	The subject device met all acceptance criteria, exhibiting similar tissueeffects (tissue approximation and hemostasis) when compared to theadjacent SureForm 60 staple lines. The subject device also met the stapleformation acceptance criteria with no more than three sub-optimalstaples within each test fire.

			Table 2: Summary of Animal Validation Studies
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Image /page/7/Picture/5 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with a registered trademark symbol.

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SureForm 45 Curved Tip and Gray Reload

Study Name	Study Purpose	Type/Number of animals	Study Outcome
DesignValidation	Design validation testing of thesubject device was performedin a clinical laboratory settingclosely approximating anintraoperative use situation.	Porcine (1 animal)	The subject device met all acceptance criteria.
Burst Pressure(Juglar venous)	Assess burst pressure of thesubject device as compared tothe predicate EndoWrist 30Gray Reload.	Porcine(Excised jugularvenous tissue)	The staple lines from the subject device performed substantiallyequivalent to that of the predicate device. The subject devicedemonstrated non-inferiority to the predicate EndoWrist 30 GrayReload.
Chronic Testing:
LungLobectomy	Assess subject deviceperformance as compared to theEndoWrist 30 Gray Reload in alung lobectomy procedure.	Canine (8 animals)	All staple lines passed assessment for leaks intra-operatively.All animals survived through the 28 day survival period. During theterminal procedures, there were no signs of bleeding or leakage at thestaple lines. Staple lines were well-healed at the end of the survivalperiod for both subject and predicate devices.
Nephrectomy	Assess subject deviceperformance as compared to theEndoWrist 30 Gray Reload in anephrectomy procedure.	Porcine (8 animals)	All staple lines passed assessment for leaks intra-operatively.All animals survived through the 28 day survival period. During theterminal procedure, there were no signs of bleeding at the staple lines,and staple lines were well-healed at the end of the survival period forboth the subject and predicate devices.

Image /page/8/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with the registered trademark symbol.

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SureForm 45 Curved Tip and Gray Reload

Summary: Based on the indications for use, technological characteristics, and performance data, the subject device, SureForm 45 Curved Tip and SureForm 45 Gray Reload are substantially equivalent to the predicate devices, the SureForm 45 and SureForm 45 Reloads and the EndoWrist 30 Gray Reload.

Image /page/9/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a larger, sans-serif font above the word "SURGICAL" which is in a smaller font. There is a yellow dot above the word "INTUITIVE".

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.