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 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/Lumen 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 length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of tray and endoscope is 8.9 lbs.
The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

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 Xi endoscopes (Model #'s 470026 and 470027) during transport and sterilization. The tray is compatible with the STERRAD 100NX (Express cycle), STERRAD 100S (Standard cycle) and the following Steris low temperature hydrogen peroxide gas sterilization systems:

o Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
o Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
Steris V-PRO 1 using the V-PRO/Lumen Cycle o
The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight. The purpose of this 510(k) is to update the Indications for Use to reflect that the tray can accommodate a heavier endoscope. The previous Indications for Use reflected that the tray could accommodate a maximum of 7.7 lbs for the combined weight of the endoscope and tray, while the Indications for Use in this 510(k) reflect that the tray can accommodate a maximum of 8.9 lbs for the combined weight of the endoscope and tray.

AI/ML Overview

This document describes a 510(k) premarket notification for an "Endoscope Sterilization Tray" (K151450) from Intuitive Surgical, Inc. The purpose of this submission is to update the Indications for Use for an existing, legally marketed predicate device (K142937) to accommodate a heavier endoscope.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative manner as one might expect for a diagnostic or AI-driven device. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, particularly regarding its ability to accommodate a heavier endoscope and maintain sterilization efficacy.

The key performance aspect being validated is the ability of the tray to facilitate sterilization with the specified sterilizers, even with an increased maximum weight. The "acceptance criteria" can be inferred from the "Performance Data" section.

Acceptance Criteria (Implied)	Reported Device Performance
Device must accommodate a maximum combined weight of 8.9 lbs (tray + endoscope).	The new Indications for Use state: "The maximum weight of tray and endoscope is 8.9 lbs." This directly addresses the weight increase.
Device must allow for effective sterilization of the endoscope within the specified sterilization machines/cycles with the new weight.	"Performance test data demonstrates that the subject device is substantially equivalent to the predicate device... The testing conducted consisted of sterilization validation and bench testing, included verification testing for weight and functional specifications." This indicates that sterilization efficacy was validated for the new weight.

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

Sample Size for Test Set: The document does not specify a numerical sample size for the "sterilization validation and bench testing." It generally refers to "testing conducted."
Data Provenance: Not explicitly stated, but given it's a 510(k) submission from a US-based company (Intuitive Surgical, Inc., Sunnyvale, CA 94086), the testing would typically be conducted according to US regulatory standards and likely in a controlled laboratory environment. It is a retrospective evaluation against a predicate device.

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

This information is not provided in the document. The nature of the device (sterilization tray) doesn't typically involve expert interpretation of medical images or conditions for establishing "ground truth" in the way a diagnostic AI device would. The "ground truth" here is the physical ability to hold the endoscope and allow for effective sterilization, which is assessed through laboratory testing and engineering specifications.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple experts. For this device, the "acceptance" is based on meeting technical specifications and demonstrating equivalency through validation tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done. This device is an endoscope sterilization tray, which is a physical medical device, not a diagnostic or AI-assisted system that involves human readers or interpretation of cases. Therefore, the concept of "human readers improving with AI" is not relevant here.

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

Not applicable/Not done. This device is a physical product, not an algorithm. The concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering and performance specifications related to the physical dimensions of the tray, its material properties, and its ability to withstand and facilitate sterilization processes.
- Weight Capacity: The actual measured weight of the endoscope and tray against the specified maximum.
- Sterilization Efficacy: Demonstrated through validation tests that confirm the sterilizer cycles achieve the required sterility assurance level (SAL) when the endoscope is contained within the tray. This would involve standard microbiology tests, not expert consensus on medical images or pathology.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable/Not provided. As there is no training set for an AI/ML algorithm, there is no ground truth established for a training set. The relevant "ground truth" for this medical device's function (sterilization and protection) is established through established scientific and engineering principles and validated testing protocols.

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing right, with flowing lines representing hair or clothing.

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

January 12, 2016

Intuitive Surgical, Inc. Kunal Gunjal Regulatory Affairs Specialist 1266 Kifer Road Sunnyvale, California 94086

Re: K151450

Trade/Device Name: Endoscope Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: December 15, 2015 Received: December 16, 2015

Dear Mr. Gunjal:

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 devicerelated 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.

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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/ResourcesforYou/Industry/default.htm. 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

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.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below
510(k) Number (if known)K151450
Device NameEndoscope Sterilization Tray
Indications for Use (Describe)
	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 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/Lumen Cycle
	The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximumproduct load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mmand the diameter of the shaft is 8.8 mm. The maximum weight of tray and endoscope is 8.9 lbs.
	The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with alegally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterilityof the enclosed medical instrument.
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.
	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 (8/14)	Page 1 of 1

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510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Kunal GunjalRegulatory Affairs Specialist, Regulatory AffairsPhone Number: 408-523-8017Fax Number: 408-523-8907Email: Kunal.Gunjal@intusurg.com
Date Summary Prepared:	December 15, 2015
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:	Intuitive Surgical Endoscope Sterilization Tray (K142937)

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Device Description

o Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
o Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
Steris V-PRO 1 using the V-PRO/Lumen Cycle o

The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight. The purpose of this 510(k) is to update the Indications for Use to reflect that the tray can accommodate a heavier endoscope. The previous Indications for Use reflected that the tray could accommodate a maximum of 7.7 lbs for the combined weight of the endoscope and tray, while the Indications for Use in this 510(k) reflect that the tray can accommodate a maximum of 8.9 lbs for the combined weight of the endoscope and tray.

Indications for Use:

o STERRAD 100NX sterilization system using the Express cycle
STERRAD 100S sterilization system using the Standard cycle ●
o 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/Lumen 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 length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 8.9 lbs.

The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

Technological Characteristics:

The subject Intuitive Surgical Endoscope Sterilization Tray is identical to the predicate Intuitive Surgical Endoscope Sterilization Tray (K142937) in design, materials and technological characteristics; it is the same tray.

Characteristic	Subject DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray	Predicate DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray K142937
Manufacturer	Intuitive Surgical, Inc.	Intuitive Surgical, Inc.
Trade Name	Endoscope Sterilization Tray	Endoscope Sterilization Tray
510(k) No.	K151450	K142937
510(k) DecisionDate	Not Applicable	February 24, 2015
Common Name	Sterilization Tray	Sterilization Tray

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Characteristic	Subject DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray	Predicate DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray K142937
Regulation No.	21 CFR 880.6850	21 CFR 880.6850
Product Code	KCT	KCT
Device Class/Regulation Name	Class II/ Sterilization Wrap	Class II/ Sterilization Wrap
ClassificationAdvisoryCommittee	General Hospital	General Hospital
SterilizationMethod	SAME	H2O2 chemical sterilization
Sterility /Disposable orMultiple use	SAME	Multiple use
Intended Use	SAME	The Intuitive Surgical EndoscopeSterilization Tray is intended to encaseand protect da Vinci Xi endoscopes forsterilization in the STERRAD 100NXsterilization system using the Expresscycle setting, the STERRAD 100Ssterilization system using the Standardcycle setting, and the Steris lowtemperature hydrogen peroxide gassterilization systems (V-PRO maX, V-PRO 1 Plus, and V-PRO 1).
Characteristic	Subject DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray	Predicate DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray K142937
Indications for Use	The Intuitive Surgical EndoscopeSterilization Tray is intended for use toencase and protect da Vinci Xiendoscopes (Model #'s 470026 and470027) for sterilization in any of thefollowing sterilization machines/cycles:• STERRAD 100NX sterilizationsystem using the Express cycle• STERRAD 100S sterilizationsystem using the Standard cycle• Steris V-PRO maX using theNon Lumen, Flexible, or Lumencycles• Steris V-PRO 1 Plus using theNon Lumen or Lumen cycles• Steris V-PRO 1 using the V-PRO/Lumen CycleThe sterilization cycle parameters of thesterilizers are preset by the manufacturersand are not adjustable. The maximumproduct load per tray is one da Vinci XiEndoscope. The length of the da Vinci XiEndoscope is approximately 600 mm andthe diameter of the shaft is 8.8 mm. Themaximum weight of tray and endoscopeis 8.9 lbs.The Endoscope Sterilization Tray is notintended to maintain sterility; it isintended to be used in conjunction with alegally marketed, validated, FDA-clearedSTERRAD and Steris compatiblesterilization wrap in order to maintainsterility of the enclosed medicalinstrument.	The Intuitive Surgical EndoscopeSterilization Tray is intended for use toencase and protect da Vinci Xiendoscopes (Model #'s 470026 and470027) for sterilization in any of thefollowing sterilization machines/cycles:• STERRAD 100NX sterilizationsystem using the Express cycle• STERRAD 100S sterilizationsystem using the Standard cycle• Steris V-PRO maX using theNon Lumen, Flexible, or Lumencycles• Steris V-PRO 1 Plus using theNon Lumen or Lumen cycles• Steris V-PRO 1 using the V-PRO/Lumen CycleThe sterilization cycle parameters of thesterilizers are preset by the manufacturersand are not adjustable. The maximumproduct load per tray is one da Vinci XiEndoscope. The length of the da Vinci XiEndoscope is approximately 600 mm andthe diameter of the shaft is 8.8 mm. Themaximum weight of tray and endoscopeis 7.7 lbs.The Endoscope Sterilization Tray is notintended to maintain sterility; it isintended to be used in conjunction with alegally marketed, validated, FDA-clearedSTERRAD and Steris compatiblesterilization wrap in order to maintainsterility of the enclosed medicalinstrument.
Where used(hospital, home,ambulance, etc)	SAME	Hospital
Dimensions(LxW)	SAME	25in. x 15in.
Characteristic	Subject DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray	Predicate DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray K142937
Materials;	SAME	ULTEM™, Elastosil R401/70 silicone,stainless steel
Compatibilitywith theenvironment andother devices	SAME	Compatible with da Vinci Xi endoscopes
Sterilizationsystemcompatibility	SAME	STERRAD 100NX and STERRAD 100Sand Steris V-PRO maX, V-PRO 1 Plus,and V-PRO 1 low temperature hydrogenperoxide gas sterilization systems

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Performance Data:

Performance test data demonstrates 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 sterilization validation and bench testing, included verification testing for weight and functional specifications. Cleaning, biocompatibility, and limits of reuse testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device (Intuitive Surgical Endoscope Sterilization Tray, K142937).

Substantially Equivalent Conclusion:

Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject device, Intuitive Surgical Endoscope Sterilization Tray (K151450) is substantially equivalent and is as safe, as effective, and performs as well as the legally marketed predicate device, Intuitive Surgical Endoscope Sterilization Tray (K142937), Class II (21 CFR 880.6850), Product code KCT.

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).