The intended use for the 12 mm & Stapler Accessories is unchanged from what was cleared in K140553 (EndoWrist Stapler 45, Stapler 45 Reloads). They are being submitted again in this 510(k) to clear them for use with the subject device, da Vinci® Xi (IS4000) 12 mm Endoscope.

The indications for use for the 12 mm Endoscope Sterilization Tray is a modification of the indication statement for the Endoscope Sterilization Tray (K133942). The model numbers for the 12 mm Endoscope have been added. Steris V-Pro was also validated and therefore added to the indication statement. Finally, the maximum weight of the tray and endoscope has been adjusted to reflect the weight of the modified subject devices. The resulting indications for use for the 12 mm Endoscope Sterilization Tray are as follows:

The Intuitive Surgical 12 mm Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 951246 and 951247) for sterilization in any of the following sterilization machines/cycles:

· STERRAD 100NX sterilization system using the Express cycle
· STERRAD 100S sterilization system using the Standard cycle
Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
· Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
· Steris V-PRO 1 using the V-PRO cycle

The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The maximum weight of tray and endoscope is 11.0 lbs. The Intuitive Surgical Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

Device Description

The Intuitive Surgical da Vinci® Xi (IS4000) 12 mm Endoscope and Accessories use the existing endoscopic imaging system submitted in K131861 (cleared March 28, 2014). The 12 mm rigid endoscopes come in both 0° and 30° angles for use through 12 mm ports.

Entry to the body cavity and maintenance of pneumoperitoneum are facilitated through the use of a12 mm & Stapler cannulae (both standard and long lengths), blunt obturators (also in standard and long lengths) and the 12 mm & Stapler Cannula Seal.

The Endoscope Sterilization Tray (an accessory to the 12 mm endoscope) is a thermoformed plastic tray with silicone inserts, a plastic lid, and a stainless steel cover. The tray, lid, and cover contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci 12 mm endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100S. STERRAD 100NX Express and Steris V-Pro sterilization systems.

AI/ML Overview

The provided document is a 510(k) summary for the Intuitive Surgical da Vinci® Xi (IS4000) 12 mm Endoscope and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria for a new type of device. Therefore, the document does not contain a typical "acceptance criteria" table with specific performance thresholds (e.g., sensitivity, specificity, accuracy for a diagnostic device) and reported device performance against those thresholds in the way one might expect for a diagnostic or AI-powered device.

Instead, the acceptance criteria for this device are implicitly tied to meeting the design requirements and demonstrating functionally acceptable performance and equivalence to predicate devices through various tests.

Here's a breakdown of the requested information based on the provided text:

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

As mentioned, there isn't a table of explicit quantitative acceptance criteria with numerical performance metrics for the endoscope's primary function in the way you might see for a diagnostic device. The acceptance criteria are broadly defined by meeting design requirements and ensuring clinically acceptable performance. The reported performance is that all tests "PASSED," indicating the device met the predefined pass/fail criteria (which are not explicitly detailed numerically in this summary).

Test Category	Acceptance Criteria (Implicit from "Purpose")	Reported Device Performance
Design Verification
12 mm Endoscope	Endoscopes meet dimensional, mechanical, functional, and electrical requirements and specifications.	All final tests PASSED
Sterilization Tray	Sterilization Tray meets dimensional, functional, and labeling requirements.	All final tests PASSED
Reliability
Life, 12 mm Endoscope	Endoscopes are robust when exposed to a typical use environment (simulated clinical use, cleaning, sterilization).	All final tests PASSED
STERRAD 100S	Material effects of STERRAD 100NX Express Cycle and 100S Cycle on the 12 mm endoscope are comparable and functional.	All final tests PASSED
Steris V-Pro maX	Material effects of STERRAD 100NX Express Cycle and Steris V-Pro maX on the 12 mm endoscope are comparable and functional.	All final tests PASSED
Animal Testing
Design Validation	The 12 mm Endoscope meets user needs and intended use as documented in the Product Requirements document.	All final tests PASSED
Device Comparison	Basic clinical function of the 12 mm Endoscope is comparable to the predicate 8 mm Endoscope.	All final tests PASSED
Surgeon Evaluation	The 12 mm Endoscope has clinically acceptable performance and allows for safe and effective surgical use.	All final tests PASSED

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

Design Verification (12 mm Endoscope): Sample sizes up to six units were used.
Design Verification (12 mm Endoscope Sterilization Tray): Sample sizes up to four units were used.
Reliability (Life, 12 mm Endoscope): A sample size of nine was used.
Animal Testing (Design Validation): Testing was conducted across three labs using three porcine.
Animal Testing (Device Comparison): Two porcine were used in various setups (pelvic, upper GI, kidney).
Animal Testing (Surgeon Evaluation): Testing was completed across three labs, utilizing canines or porcine.

Data Provenance: The document does not specify the country of origin of the data. The animal testing and usability studies appear to be prospective in nature, as they involve conducting new tests and evaluations on the device.

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)

For the Animal Testing (Surgeon Evaluation), six independent, external surgeons served as evaluators to complete vision assessments. Their specific qualifications (e.g., years of experience, specialization) are not detailed in this summary, but they are described as "independent, external surgeon evaluators."

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

The document does not explicitly state an adjudication method (like 2+1, 3+1) for establishing ground truth or resolving discrepancies in performance evaluations. The surgeon evaluations mention "All evaluators found each vision criteria clinically acceptable and safe for the subject device," suggesting a consensus or individual assessment against predefined criteria rather than a multi-reader adjudication process for a discrete 'ground truth'.

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

No, an MRMC comparative effectiveness study was not done. This document pertains to a surgical endoscope and its accessories, not an AI-assisted diagnostic or image interpretation device. There is no mention of AI or human readers improving with AI assistance.

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

No, a standalone algorithm-only performance study was not done. This device is an endoscope for human surgeons, not an algorithm.

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

For the performance tests, the "ground truth" seems to be established by predetermined "objective pass/fail criteria" defined in protocols, visual inspections, functional testing, and "clinically acceptable performance" as assessed by external surgeons (a form of expert consensus for clinical utility).
For the animal studies, the "ground truth" for the device's performance against user needs and intended use was based on its ability to complete various surgical and visualization tasks.

8. The sample size for the training set

This document describes performance testing for a physical medical device (an endoscope and its sterilization tray). It does not involve machine learning or AI algorithms with "training sets." Therefore, this question is not applicable.

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

Not applicable, as there is no training set for an AI algorithm mentioned in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked one behind the other, with a wing-like shape extending from the back of the heads.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 10, 2014

Intuitive Surgical Incorporated Ms. Crystal Ong Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086

Re: K142683

Trade/Device Name: 12mm Endoscope and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY, KCT Dated: September 18, 2014 Received: September 19, 2014

Dear Ms. Ong:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

David Krause -S

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

Enclosure

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	DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017
	Indications for Use	See PRA Statement below.
510(k) Number (if known)
K142683
Device Name12 mm Endoscope and Accessories
Indications for Use (Describe)minimally invasive surgery.	The 12 mm Endoscope is intended to provide real-time, 3D, high-definition imaging enabling surgeons to perform






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)
	PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

	FOR FDA USE ONLYConcurrence of Center for Devices and Radiological Health (CDRH) (Signature)

	This section applies only to requirements of the Paperwork Reduction Act of 1995.
	DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
	The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:
	Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff(@fda.hhs.gov
	"An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)	Page 1 of 1	Publishing Services (301) 443-674

Image /page/2/Picture/3 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in gray, all-caps letters, with a yellow dot above the "I". Below "INTUITIVE" is the word "SURGICAL" in smaller, gray, all-caps letters, followed by a registered trademark symbol.

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-012Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)
K142683
Device Name12 mm Endoscope Sterilization Tray
Indications for Use (Describe)The Intuitive Surgical 12 mm Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xiendoscopes (Model #'s 951246 and 951247) for sterilization in any of the following sterilization machines/cycles:
• STERRAD 100NX sterilization system using the Express cycle

· STERRAD 100S sterilization system using the Standard cycle
· Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
· Steris V-PRO 1 Plus using the Non Lumen or Lumen cvcles
· Steris V-PRO 1 using the V-PRO cycle

The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The maximum weight of tray and endoscope is 11.0 lbs. The Intuitive Survical Endoscope Sterilization Tray is intended to be used with legally marketed. FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

Image /page/3/Picture/8 description: This image shows the first page of the FORM FDA 3881 (8/14). It includes information about the type of use, indicating that either prescription use or over-the-counter use can be selected. The form also includes a statement about the Paperwork Reduction Act of 1995 and provides contact information for the Department of Health and Human Services, Food and Drug Administration, and Paperwork Reduction Act (PRA) Staff. The burden time for this collection of information is estimated to average 79 hours per response.

Image /page/3/Picture/9 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in a sans-serif font, with a small yellow dot above the "I". Below the word "INTUITIVE" is the word "SURGICAL" in a smaller, sans-serif font. The overall design is simple and modern.

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510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Crystal OngRegulatory AffairsPhone Number: 408-523-8636Fax Number: 408-523-8907Email: crystal.ong@intusurg.com
Date Summary Prepared:	September 18, 2014
Trade Name:	da Vinci® Xi (IS4000) 12 mm Endoscope and Accessories
Common Name:	Endoscope and accessories
Classification:	Class II21 CFR 876.1500, Endoscope and Accessories
Product Codes:	NAY (System, Surgical, Computer Controlled Instrument)KCT (Sterilization Wrap)
Classification Advisory Committee:	General and Plastic Surgery
Predicate Device:	da Vinci® Xi Surgical System device, K131861EndoWrist® Stapler 45, Stapler 45 Reloads,K140553Intuitive Surgical Endoscope Sterilization Tray, K133942

Device Description

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Intended Use/Indications for Use:

The 12 mm Endoscope is intended to provide real-time, 3D, high-definition imaging enabling surgeons to perform minimally invasive surgery.

· STERRAD 100NX sterilization system using the Express cycle
· STERRAD 100S sterilization system using the Standard cycle
Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
· Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
· Steris V-PRO 1 using the V-PRO cycle

Technological Characteristics:

In terms of intended use, indications for use, and technological characteristics, the da Vinci Xi (IS4000) 12 mm Endoscope and Accessories are substantially equivalent to the currently marketed da Vinci Xi Surgical System device, cleared under K131861, EndoWrist" Stapler 45, Stapler 45 Reloads cleared under K140553, and the Intuitive Surgical Endoscope Sterilization Tray, cleared under K133942.

Performance Data:

Performance test data (bench and animal tests) demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input

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requirements for the da Vinci® Xi (IS4000) 12 mm Endoscopes. The testing conducted consisted of design verification, reliability and animal testing.

Design Verification:

The testing provided in this submission consisted of dimensional measurements, mechanical, and functional verification.

Test	Summary
Design Verification, 12 mm Endoscope – Allfinal tests PASSED	The purpose of this test was to verify that theendoscopes met the dimensional, mechanical,functional, and electrical requirements andspecifications. Test methods were based onpre-defined test procedures, and objectivepass/fail criteria were defined in the protocoland used. Sample sizes up to six units wereused. The following design verification testswere performed:- Illumination- Mechanical- Electrical- Equipment Interface- Cleaning and Sterilization- Labeling
Design Verification, 12 mm EndoscopeSterilization Tray – All final tests PASSED	The purpose of this test was to verify that the12 mm Endoscope Sterilization Tray met thedimensional, functional, and labelingrequirements. Test methods were based onpre-defined test procedures, and objectivepass/fail criteria were defined in the protocoland used. Sample sizes up to four units wereused.

Test

Summary

Design Verification, 12 mm Endoscope – Allfinal tests PASSED

The purpose of this test was to verify that theendoscopes met the dimensional, mechanical,functional, and electrical requirements andspecifications. Test methods were based onpre-defined test procedures, and objectivepass/fail criteria were defined in the protocoland used. Sample sizes up to six units wereused. The following design verification testswere performed:- Illumination- Mechanical- Electrical- Equipment Interface- Cleaning and Sterilization- Labeling

Design Verification, 12 mm EndoscopeSterilization Tray – All final tests PASSED

The purpose of this test was to verify that the12 mm Endoscope Sterilization Tray met thedimensional, functional, and labelingrequirements. Test methods were based onpre-defined test procedures, and objectivepass/fail criteria were defined in the protocoland used. Sample sizes up to four units wereused.

Reliability:

The testing provided in this submission consisted of simulated use cycling test articles through their typical use environment, including sterilization. The evaluation method included visual inspections as well as functional testing.

Image /page/6/Picture/8 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, also in light gray.

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Test	Summary
Design Verification, Life, 12 mm Endoscope -	The purpose of this test was to verify that the
All final tests PASSED	endoscopes were robust when exposed to a
	typical use environment. A sample size of nine
	was used. Test articles were cycled through
	Simulated clinical use including the following:
	Visual Inspection-
	Mechanical Stressing-
	RFID Functional Test-
	Stereo Vision Test-
	Simulated Use-
	Clean-
	Sterilize-
Design Verification, 12 mm Endoscope	The purpose of this test was to compare the
STERRAD 100S Compatibility-All final	material effects of STERRAD 100NX Express
tests PASSED	Cycle to the material effects of the STERRAD
	100S Cycle on the 12 mm endoscope. A visual
	inspection of certain sites on the endoscope
	(different materials) was performed before and
	after sterilization cycling. Functional testing
	was also performed to confirm that the test
	article successfully survived sterilization
	cycling.
Design Verification, 12 mm Endoscope Steris	The purpose of this test was to compare the
V-Pro maX Compatibility-All final tests	material effects of STERRAD 100NX Express
PASSED	Cycle to the material effects of the Steris V-Pro
	maX on the 12 mm endoscope. A visual
	inspection of certain sites on the endoscope(different materials) was performed before and

	after sterilization cycling. Functional testingwas also performed to confirm that the test
	article successfully survived sterilization
	cycling.

Animal Testing:

The testing provided in this submission was performed using simulated clinical models (animal) to evaluate the performance of the da Vinci Xi (IS4000) 12 mm Endoscope. This included design validation to confirm that the device meets the user needs and intended use, comparison testing against the predicate device (IS4000 8 mm Endoscope), and surgeon evaluations.

Image /page/7/Picture/5 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in gray, all-caps letters. Below that, the word "SURGICAL" is in smaller, gray, all-caps letters, with a registered trademark symbol to the right of the word.

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Test	Summary
Design Validation – All final tests PASSED	The purpose of this testing was to confirm thatthe da Vinci Xi (IS4000) 12 mm Endoscopemeets the user needs and intended use asdocumented in the Product Requirementsdocument. Testing was completed across threelabs conducted with three porcine. A varietyof surgical tasks were completed to evaluatethe 12 mm Endoscope's vision characteristics.Test methods were based on pre-defined testprocedures and objective pass/fail criteria weredefined in the protocol and used.
Device Comparison – All final tests PASSED	This testing compared the basic clinicalfunction of the da Vinci Xi (IS4000) 12 mmEndoscope with respect to the predicate device(IS4000 8 mm Endoscope). The study was aside-by-side comparison of the da Vinci Xi(IS4000) 12 mm Endoscope to the predicatedevice (IS4000 8 mm Endoscope). Twoporcine were used in a pelvic, an upper GI, anda kidney setup to complete variousvisualization tasks for each device.
Surgeon Evaluation – All final tests PASSED	The purpose of this testing was to confirm thatthe da Vinci Xi (IS4000) 12 mm Endoscopehas clinically acceptable performance andallows for safe and effective surgical use asassessed by independent, external surgeonevaluators. Testing was completed acrossthree labs, utilizing canines or porcine. Sixindependent, external surgeons served asevaluators to complete the vision assessments.All evaluators found each vision criteriaclinically acceptable and safe for the subjectdevice.

Human Factors and Usability Testing:

Summative usability validation studies were conducted with users (surgeons and operating room staff) for the da Vinci® Xi Surgical System (K131861). These studies were conducted with the predicate endoscopes in a simulated operating room and involved typical workflow scenarios as well as certain troubleshooting scenarios related to safety-critical tasks. With the exception of a separable light guide, the work-flow with the subject device is unchanged from the previously evaluated predicate device.

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Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the da Vinci® Xi (IS4000) 12 mm Endoscope and Accessories are substantially equivalent to the currently marketed da Vinci Xi Surgical System device, cleared under K131861, EndoWrist® Stapler 45, Stapler 45 Reloads cleared under K140553, and the Intuitive Surgical Endoscope Sterilization Tray, cleared under K133942.

Image /page/9/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 the registered trademark symbol next to it. There is also 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.