The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in the STERRAD 100NX sterilization system using the Express cycle and in the STERRAD 100S sterilization system using the standard cycle. The sterilization cycle parameters of the sterilizers are preset by the manufacturer and are not adjustable. The maximum product load per tray is 1 da Vinci Xi Endoscope. The max weight of tray and endoscope is 7.7 lbs.

The Intuitive Surgical Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

Device Description

The Endoscope Sterilization Tray is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid 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 endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100NX and 100S sterilization systems.

AI/ML Overview

This document is a 510(k) Summary for the Intuitive Surgical Endoscope Sterilization Tray (K133942), which is a Class II device. It primarily details a comparison to a predicate device to demonstrate substantial equivalence, rather than providing a detailed study of its own performance against pre-defined acceptance criteria for an AI/CADe device.

Therefore, many of the requested sections for AI/CADe device studies, such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies, are not applicable to this document. This document describes a medical device used for sterilization, not an algorithm or AI system.

However, I can extract the general "performance data" claims from the document as it relates to demonstrating substantial equivalence.

Here's an attempt to answer based solely on the provided text, acknowledging that it does not contain the specific details typically found in AI/CADe performance studies.

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

The document does not explicitly state quantitative acceptance criteria in a table format for performance beyond "dimensional measurements" and "functional verification." It concludes that the device "meets the design input requirements."

Acceptance Criteria (Implied)	Reported Device Performance (Claimed)
Dimensional measurements met	"dimensional measurements... demonstrate that the subject device is substantially equivalent"
Functional verification met	"functional verification... demonstrate that the subject device is substantially equivalent"
Cleaning test requirements met	"cleaning... tests demonstrate that the subject device is substantially equivalent"
Sterilization test requirements met	"sterilization tests demonstrate that the subject device is substantially equivalent"
Substantial Equivalence to Predicate Device (K103213)	"The Intuitive Surgical Endoscope Sterilization Tray is substantially equivalent to the Entellus Medical FinESS Endoscope Sterilization Tray (K103213)."
Compatible with da Vinci Xi 8 mm endoscopes	"Compatible with da Vinci Xi 8 mm endoscopes"
Compatible with STERRAD 100NX and 100S sterilizers	"STERRAD 100NX and 100S"

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

This information is not provided in the document. The document refers to "Performance test data (bench, cleaning, and sterilization tests)" but does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective nature).

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)

This information is not applicable as this is not an AI/CADe device and no "ground truth" in the context of expert review for medical image analysis is described. The device's performance is assessed through physical, chemical, and biological tests related to cleaning and sterilization.

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

This information is not applicable as this is not an AI/CADe device and no adjudication method for expert review of a test set 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

This information is not applicable. An MRMC study is relevant for AI/CADe devices to assess the impact on human reader performance. This document concerns a physical medical device (sterilization tray).

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

This information is not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention, which is not relevant for a sterilization tray.

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

This information is not applicable in the context of AI/CADe devices. For this device, the "truth" or "success" of performance would be determined by objective measurements and standardized test methods for cleaning and sterilization effectiveness (e.g., microbial kill, absence of residues, structural integrity).

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/CADe device.

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

This information is not applicable. There is no "training set" or corresponding "ground truth" for this type of medical device.

Summary

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

August 1, 2014

Intuitive Surgical, Inc. Mr. Brandon Hansen Project Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, CA 94086

Re: K133942

Trade/Device Name: Endoscope Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray Regulatory Class: II Product Code: KCT Dated: July 8, 2014 Received: July 9, 2014

Dear Mr. Hansen:

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

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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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K133942

Device Name Endoscope Sterilization Tray

Indications for Use (Describe)

2 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 ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Sreekanth Gutala -S DN: c=US, o=U.S. Government, ou=HHS ou=FDA, ou=People, 0 9 2342 19200300 100 1 1=2000540490 cn=Sreekanth Gutala -S Date: 2014.08.01 09:55:45 -04'00

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510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Brandon HansenProject Manager, Regulatory AffairsPhone Number: 408-523-7485Fax Number: 408-523-8907Email: Brandon.Hansen@intusurg.com
Date Summary Prepared:	July 9, 2014
Trade Name:	Endoscope Sterilization Tray
Common Name:	Sterilization Tray
Classification:	Class II21 CFR 880.6850, Sterilization Wrap
Product Codes:	KCT
Classification AdvisoryCommittee:	General Hospital
Predicate Device:	Entellus Medical FinESS Endoscope Sterilization Tray(K103213)

Image /page/3/Picture/4 description: The image shows the logo for Intuitive Surgical. The logo consists of the word "INTUITIVE" in gray capital letters, with a small yellow dot above the "I". Below "INTUITIVE" is the word "SURGICAL" in smaller gray capital letters, with a registered trademark symbol to the right.

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Device Description

Intended Use:

To encase and protect da Vinci endoscopes for sterilization.

Indications for Use:

The Intuitive Surgical Endoscope Sterilization Trav is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in the STERRAD 100NX sterilization system using the Express cycle and in the STERRAD 100S sterilization system using the standard cycle. The sterilization cycle parameters of the sterilizers are preset by the manufacturer and are not adjustable. The maximum product load per tray is 1 da Vinci Xi Endoscope. The max weight of tray and endoscope is 7.7 lbs.

Technological Characteristics:

The Intuitive Surgical Endoscope Sterilization Tray is substantially equivalent to the Entellus Medical FinESS Endoscope Sterilization Tray (K103213) in design, materials, technological characteristics, and intended use.

Characteristic	Subject DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray (K133942)	Predicate DeviceEntellus MedicalFinESS™ Endoscope SterilizationTray (K103213)
Manufacturer	Intuitive Surgical, Inc.	Entellus Medical, Inc.
Trade Name	Endoscope Sterilization Tray	FinESS™ Endoscope SterilizationTray
510(k) No.	K133942	K103213
510(k) DecisionDate	Not Applicable	2 February 2011

Image /page/4/Picture/12 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font and is in all caps. Below that, the word "SURGICAL" is in a smaller sans-serif font and is also in all caps. There is a yellow dot above the word "INTUITIVE".

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Characteristic	Subject DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray (K133942)	Predicate DeviceEntellus MedicalFinESS™ Endoscope SterilizationTray (K103213)
Common Name	Sterilization Tray	Identical
Regulation No.	21 CFR 880.6850	Identical
Product Code	KCT	Identical
Device Class/Regulation Name	Class II/ Sterilization Wrap	Identical
ClassificationAdvisoryCommittee	General Hospital	Identical
SterilizationMethod	H2O2 chemical sterilization	Identical
Sterility /Disposable orMultiple use	Multiple use	Identical
Intended Use	Intended to encase and protect daVinci endoscopes for sterilizationin the STERRAD 100NXsterilization system using theexpress cycle setting and the 100Ssterilization system using thestandard cycle setting	Intended to encase and protect theFinESS™ Endoscope forsterilization in STERRAD 100NXusing the standard cycle setting andNX sterilization system using theadvanced cycle setting
Characteristic	Subject DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray (K133942)	Predicate DeviceEntellus MedicalFinESS™ Endoscope SterilizationTray (K103213)
Indications forUse	The Intuitive SurgicalEndoscope Sterilization Tray isintended for use to encase andprotect da Vinci Xi endoscopes(Model #'s 470026 and 470027)for sterilization in theSTERRAD 100NX sterilizationsystem using the Express cycleand in the STERRAD 100Ssterilization system using thestandard cycle. The sterilizationcycle parameters of thesterilizers are preset by themanufacturer and are notadjustable. The maximumproduct load per tray is 1 daVinci Xi Endoscope. The maxweight of tray and endoscope is7.7 lbs.The Intuitive SurgicalEndoscope Sterilization Tray isintended to be used with legallymarketed, FDA-clearedSTERRAD compatiblesterilization wrap in order tomaintain sterility of theenclosed endoscope.	The FinESS™ EndoscopeSterilization Tray is intended for useto encase and protect the FinESS™Endoscope for sterilization inSTERRAD 100NX using thestandard cycle setting and NXSterilization Systems using theadvanced cycle setting.The sterilization cycleparameters of theSTERRAD sterilizers arepreset by the manufacturerand are not adjustable. The maximum product loadper FinESS™ EndoscopeSterilization Tray includes 1FinESS™ Endoscope and 2light post adapters. The FinESS™ EndoscopeSterilization Tray is intended to beused with legally marketed, FDA-cleared STERRAD compatiblesterilization wrap in order tomaintain sterility of the enclosedendoscope.
Where used(hospital, home,ambulance, etc)	Hospital	Identical
Dimensions(LxW)	25in. x 15in.	7.6 in. x 4.1 in.
Materials;	ULTEM™, Elastosil R401/70Silicone, stainless steel	Identical

Image /page/5/Picture/3 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.

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Image /page/6/Picture/3 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. There is a yellow dot above the word "INTUITIVE".

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Characteristic	Subject DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray (K133942)	Predicate DeviceEntellus MedicalFinESS™ Endoscope SterilizationTray (K103213)
Compatibilitywith theenvironment andother devices	Compatible with da Vinci Xi 8mm endoscopes	Compatible with the FinESSendoscope
Sterilizationsystemcompatibility	STERRAD 100NX and 100S	STERRAD 100NX and NX

Performance Data:

Performance test data (bench, cleaning, and sterilization tests) demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of dimensional measurements, functional verification, and cleaning and sterilization testing.

Summary:

Based on the intended use, indications for use, technological characteristics, and performance data, the Intuitive Surgical Endoscope Sterilization Tray is substantially equivalent to the Entellus Medical FinESS Endoscope Sterilization Tray (K103213).

Image /page/7/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 also in all caps and in a smaller font size, also in light gray, with a registered trademark symbol next to it. There is a yellow dot above the word "INTUITIVE".

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).