The Intuitive Surgical 8 mm SureForm 30 staplers and reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

Device Description

The Intuitive Surgical 8 mm SureForm 30 Curved-Tip Stapler and the 8 mm SureForm 30 Stapler are disposable, fully wristed, articulating, surgical staplers and are designed for use exclusively with the Intuitive Surgical da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200 Systems). The staplers are controlled by the surgeon using the Surgeon Console of the IS4000/IS4200 Systems. They are intended for resection, transection and/or creation of anastomoses in surgery. The staplers achieve their intended use by placing multiple staggered rows of implantable staples in the target tissue (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The 8 mm SureForm 30 Reloads consist of a single-use cartridge that contains four staggered rows of implantable titanium alloy (Ti3A12.5V) staples. The reloads are offered in three configurations (gray, white, and blue). Each color represents a different staple leg height and tissue gap for use with various tissue thicknesses.

AI/ML Overview

The provided text describes the regulatory clearance for a medical device, the 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, and SureForm 30 Reloads. The document primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing. However, it does not describe an AI/ML-based medical device where acceptance criteria, test sets, ground truth establishment, or human reader performance are typically discussed in the context of AI model validation.

Therefore, many of the requested elements for describing the acceptance criteria and study that proves an AI/ML device meets those criteria cannot be extracted from this document. The document details design verification (bench tests) and design validation (animal studies) for a surgical stapler, which are standard for hardware medical devices, not AI.

However, I can extract information related to the performance studies conducted for this device and present it in a similar structure, adapting the categories where appropriate to reflect the content available.

Here's an analysis based on the provided text, addressing the points as best as possible given the nature of the device:

Device: 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads

This device is a surgical stapler, not an AI/ML device. Therefore, the questions related to AI/ML specific validation (e.g., human reader improvement with AI assistance, training set details, expert consensus for ground truth on images) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

For this surgical stapler, the "acceptance criteria" are implied by the successful outcomes of the various performance tests, demonstrating that the device meets design input requirements, user needs, and intended use, and is substantially equivalent to the predicate device. The document does not provide specific numerical thresholds for "acceptance criteria" for each test but rather states that the device "met all acceptance criteria" or "demonstrated equivalent performance."

Table: Performance Study Outcomes (Analogous to Acceptance Criteria & Performance)

Study Name	Study Purpose	Implicit Acceptance Criteria / Demonstrated Performance
Design Verification (Bench)	Evaluate physical, mechanical, electrical, UI, equipment interface, reliability, packaging, and labeling.	Device met all of the bench testing acceptance criteria, demonstrating that the design output meets the design input requirements.
Acute Testing: Staple Line Performance	Assess staple line performance and staple formation compared to predicate.	The subject device met all acceptance criteria and exhibited acceptable pass rates in the areas of transection, tissue layer approximation, hemostasis, and staple formation.
Acute Testing: Hemostasis	Assess hemostasis performance compared to predicate.	The subject device demonstrated equivalent hemostasis performance to the predicate device.
Acute Testing: Leak Onset Pressure	Assess leak onset pressure performance on ex vivo tissue compared to predicate.	All staple lines met all acceptance criteria and exhibited acceptable pass rates in leak onset pressure on thick (stomach) tissue and thin (vein) tissue.
Acute Testing: Maximum Torque	Evaluate staple line performance at maximum SmartFire torque limits compared to predicate.	The 8 mm SureForm 30 Stapler and Reloads demonstrated clinically acceptable performance and met all design specifications. The subject device demonstrated equivalent clinical performance when compared to the predicate device in all adjacent fires. No new issues of safety and efficacy were raised.
Acute Testing: Design Validation	Design validation testing in a clinical laboratory setting closely approximating an intraoperative use situation.	The subject device met all acceptance criteria. 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.
Chronic Testing (Lung Lobectomy, Lung Wedge Resection, Small Bowel Anastomosis, Nephrectomy, Gastrectomy)	Assess device performance compared to predicate in various surgical procedures over time.	In all chronic studies, staple lines passed assessments for leaks intra-operatively. All animals survived through the specified survival periods (7, 14, or 28 days+). During 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 the subject and predicate devices.
Human Factors Evaluation	Updated Usability Risk Analysis and conducted human factors evaluation to identify safety-related usability characteristics, hazards, and situations.	The 8 mm SureForm 30 Staplers and Reloads have been found to be safe and effective for the intended users, uses, and use environments based on the results of the studies.

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

The "test set" in this context refers to the animals used in the design validation studies and the bench tests.

Bench Testing (Design Verification): Not specified in terms of sample size, but implies a comprehensive set of tests.
Animal Studies (Design Validation):
- Staple Line Performance: 3 canine models, 1 porcine model
- Hemostasis: 2 porcine models
- Leak Onset Pressure: 1 porcine model
- Maximum Torque: 2 canine models, 1 porcine model
- Design Validation (Acute): 2 canine models, 2 porcine models
- Lung Lobectomy (Chronic): 8 canine models
- Lung Wedge Resection (Chronic): 8 canine models
- Small Bowel Anastomosis (Chronic): 8 porcine models
- Nephrectomy (Chronic): 8 porcine models
- Gastrectomy (Chronic): 8 canine models
Data Provenance: The studies are described as "simulated clinical models (animal)" performed as part of "Design Validation." There is no mention of country of origin for the data or whether it's retrospective or prospective, though animal studies for regulatory submission are typically prospective and conducted under controlled lab environments.

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

This concept is not applicable as this is a hardware device. The "ground truth" is established by direct measurement of physical or physiological parameters (e.g., staple formation, hemostasis, leak onset pressure, absence of bleeding/leakage at staple lines, tissue healing) in the animal models, rather than expert interpretation of medical images. The studies themselves are designed and conducted by qualified scientific and medical personnel as part of the manufacturer's design validation process.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML study involving human interpretation or adjudication of outputs. The results of the tests (e.g., presence/absence of leaks, healing of staple lines) are directly observed and objectively measured.

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/ML device.

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

Not applicable. There is no algorithm, only mechanical and physical performance.

7. The Type of Ground Truth Used

The ground truth for this device's performance validation is based on direct physiological and physical outcomes observed in animal models and measurements from bench testing. Examples include:

Direct observation of staple line formation, transection, tissue approximation, and hemostasis in animal models.
Measurement of leak onset pressure.
Assessment of bleeding and leakage at staple lines during and after surgery.
Histological or gross examination of tissue healing post-procedure.
Measurements of physical specifications and performance under various mechanical and electrical tests.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As there is no AI/ML model, there is no "training set" or ground truth establishment for it.

Summary

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December 10, 2021

Intuitive Surgical, Inc. Amrit Jaggi Senior Regulatory Specialist 1266 Kifer Road Sunnyvale, California 94086

Re: K211997

Trade/Device Name: 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY, GDW Dated: November 5, 2021 Received: November 10, 2021

Dear Amrit Jaggi:

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 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.

Mark Trumbore, Ph.D. Assistant Director THT4A1: Robotically-assissted Surgical Devices Team DHT4A: Division of Sugical 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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Form FDA 3881 – Indications for Use statement 6

There is 1 page in this section following this cover sheet.

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Indications for Use

510(k) Number (if known) New device

Device Name

8 mm SureForm 30 Curved-Tip Stapler 8 mm SureForm 30 Stapler 8 mm SureForm 30 Reloads

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CER 801 Subpart D)	Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) Summary

[As Required by 21 CFR 807.92(c)]

Submitter:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Official Contact:	Amrit JaggiSenior Regulatory SpecialistPhone Number: 949-690-8799Fax Number: 408-523-8907
Date Prepared:	June 25, 2021
Trade Name:	8 mm SureForm™ 30 Curved-Tip Stapler, 8 mm SureForm 30Stapler, 8 mm SureForm 30 Reloads
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 Staplers and Reloads (K190999)

Device Description

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	8 mm SureForm 30 Reloads
Attribute	Gray	White	Blue
No. of staple rowsand staple lineconfiguration	4 rows total;2 on each side of thecut line	4 rows total;2 on each side of thecut line	4 rows total;2 on each side of thecut line
No. of Staples	34 staples	34 staples	34 staples
Unformed stapleleg length	2.0 mm	2.5 mm	3.5 mm
Image	Image: gray stapler	Image: white stapler	Image: blue stapler

Table 1 8 mm SureForm 30 Reloads Specifications

The reloads are single use devices and are shipped sterile to the surgeon with a retainer and bottom cover that protects the staples during shipping and transportation. The 8 mm SureForm 30 Reloads are not compatible with any other Intuitive Surgical stapler instruments and likewise, the existing Intuitive Surgical stapler reloads are not compatible with the 8 mm SureForm 30 Staplers.

Intended Use

The 8 mm SureForm 30 Staplers and Reloads are intended to resect, transect and/or create anastomoses in surgery.

Indications for Use

The Intuitive Surgical 8 mm SureForm 30 Staplers and Reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection and transection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

Comparison of Technological Characteristics

The subject device, 8 mm SureForm 30 Staplers and the predicate device, SureForm 45 Staplers and Reloads (K190999) are regulated under the same regulation number, product code, and classification. They have the same intended use, sterility characteristics (EO sterilization), and principles of operation. The subject device, 8 mm SureForm 30 Staplers and Reloads, and the predicate SureForm 45 Staplers and Reloads

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differ in some design attributes (the subject device has a narrower diameter and shorter staple line length), indications for use (the subject device is indicated for use on vasculature and tissue), and patient-contacting materials (some same, some different).

Performance Data

Performance test data (bench and animal tests) for the 8 mm SureForm 30 Staplers and Reloads demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements, user needs, and intended use. The testing is summarized below.

Design Verification (bench):

The 8 mm SureForm 30 Staplers and Reloads were subject to full design verification testing included:

Physical Specifications ●
Mechanical Requirements ●
Electrical Requirements ●
User Interface Requirements ●
Equipment Interface Requirements ●
Reliability ●
Packaging and labeling

The 8 mm SureForm 30 Staplers and Reloads met all of the bench testing acceptance criteria, demonstrating that that the design output meets the design input requirements.

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. Acute clinical validation studies included Staple Line Performance, Hemostasis Testing, Leak Onset Testing, Maximum Torque Evaluation, and Design Validation Testing. Chronic survival studies included Lung Lobectomy Study, Lung Wedge Resection Study, Gastrectomy Study, Small Bowel Anastomosis, and Nephrectomy Study. A side-by-side comparison between the subject and predicate device was performed in the Staple Line Performance, Hemostasis Testing, Leak Onset Testing, Maximum Torque Evaluation, and all Chronic Survival Studies to demonstrate substantial equivalence between the subject and predicate devices. 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.

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Study Name	Study Purpose	AnimalModel	Study Outcome
Acute Testing:
Staple LinePerformance	Assess staple lineperformance and stapleformation of the subjectdevice compared to thepredicate	3 caninemodels1 porcinemodel	The subject device met allacceptance criteria andexhibited acceptable passrates in the areas oftransection, tissue layerapproximation, hemostasis,and staple formation
Hemostasis	Assess hemostasisperformance for the subjectdevice as compared to thepredicate device.	2 porcinemodels	The subject devicedemonstrated equivalenthemostasis performance tothe predicate device.
Leak OnsetPressure	Assess leak onset pressureperformance on ex vivotissue of the subject deviceas compared to the predicatedevice.	1 porcinemodel	All staple lines met allacceptance criteria andexhibited acceptable passrates in leak onset pressureon thick (stomach) tissueand thin (vein) tissue.
MaximumTorque	Evaluate staple lineperformance at maximumSmartFire torque limits ofthe subject device ascompared to the predicatedevice.	2 caninemodels1 porcinemodel	The 8 mm SureForm 30Stapler and Reloadsdemonstrated clinicallyacceptable performance andmet all designspecifications. The subjectdevice demonstratedequivalent clinicalperformance whencompared to the predicatedevice in all adjacent fires.No new of issues of safetyand efficacy were raised.
DesignValidation	Design validation testing ofthe subject device wasperformed in a clinicallaboratory setting closelyapproximating an	2 caninemodels2 porcinemodels	The subject device met allacceptance criteria.
Study Name	Study Purpose	AnimalModel	Study Outcome
	intraoperative use situation.
Chronic Testing:
LungLobectomy	Assess subject deviceperformance as compared tothe predicate device in alung lobectomy procedure.	8 caninemodels	All staple lines passedassessments for leaks intra-operatively. All animalssurvived through the 28 day+ survival period. Duringthe terminal procedures,there were no signs ofbleeding or leakage at thestaple lines. Staple lineswere well-healed at the endof the survival period forboth the subject andpredicate devices.
Lung WedgeResection	Assess subject deviceperformance as compared tothe predicate device in alung wedge resectionprocedure.	8 caninemodels	All staple lines passedassessments for leaks intra-operatively. All animalssurvived through the 7 day +survival period. During theterminal procedures, therewere no signs of bleeding orleakage at the staple lines.Staple lines were well-healed at the end of thesurvival period for both thesubject and predicatedevices.
Small BowelAnastomosis	Assess subject deviceperformance as compared tothe predicate device in asmall bowel anastomosisprocedure.	8 porcinemodels	All staple lines passedassessments for leaks intra-operatively. All animalssurvived through the 14 day+ survival period. Duringthe terminal procedures,there were no signs ofbleeding or leakage at thestaple lines. Staple lineswere well-healed at the endof the survival period forboth the subject and predicate devices.
Study Name	Study Purpose	AnimalModel	Study Outcome
Nephrectomy	Assess subject deviceperformance as compared tothe predicate device in anephrectomy procedure.	8 porcinemodels	All staple lines passedassessments for leaks intra-operatively. All animalssurvived through the 28 day+ survival period. Duringthe terminal procedures,there were no signs ofbleeding or leakage at thestaple lines. Staple lineswere well-healed at the endof the survival period forboth the subject andpredicate devices.
Gastrectomy	Assess subject deviceperformance as compared tothe predicate device in agastrectomy procedure.	8 caninemodels	All staple lines passedassessments for leaks intra-operatively. All animalssurvived through the 14 day+ survival period. During the terminal procedures,there were no signs ofbleeding or leakage at thestaple lines. Staple lines were well-healed at the end of the survival period for both the subject and predicate devices.

Table 2 Summary of Animal Validation Studies

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Human Factors Evaluation:

As part of the Usability Engineering Process for the 8 mm SureForm 30 Staplers and 8 mm SureForm 30 Reloads, the Usability Risk Analysis was updated to identify any new usability characteristics related to safety, as well as foreseeable hazards and hazardous situations. Human factors evaluation was conducted on the 8 mm SureForm 30 Staplers and 8 mm SureForm 30 Reloads. Based on the results of those studies, the 8 mm SureForm 30 Staplers and Reloads has been found to be safe and effective for the intended users, uses, and use environments.

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Based on the indications for use, technological characteristics, and Summary: performance data, the subject device, 8 mm SureForm 30 Staplers and Reloads are substantially equivalent to the predicate devices, the SureForm 45 Staplers and SureForm Reloads.

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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.