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 7.7 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 Steroscope 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:
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 Endoscope Sterilization Tray is the same tray previously cleared for sterilizing the endoscopes in STERRAD sterilizers. The tray is now validated for use in the Steris sterilization systems and the Indications for Use are being modified to reflect that capability.

AI/ML Overview

Based on the provided text, the document is a 510(k) premarket notification for an Endoscope Sterilization Tray. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a new, innovative device (like an AI algorithm).

Therefore, much of the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, effect size of human improvement with AI, standalone performance, training set details) is not applicable to this document, as it is related to the validation of a medical device involving software or AI, particularly for diagnostic or interventional tasks.

The document discusses the performance data in terms of sterilization validation and limits of reuse testing for the sterilization tray, demonstrating its functionality and safety. The acceptance criteria here are related to ensuring the tray effectively facilitates sterilization and maintains its integrity over multiple uses, making it equivalent to the predicate device.

Here's an attempt to extract relevant information and explain why other parts of your prompt are not present in this document:

Acceptance Criteria and Device Performance (as inferred from the document)

The core "acceptance criteria" for this device, as per a 510(k) pathway, is to demonstrate substantial equivalence to a predicate device. This is achieved by showing that the subject device is as safe and effective, and performs at least as safely and effectively, as the predicate.

For a physical device like a sterilization tray, this typically involves demonstrating:

Ability to encase and protect the endoscope: This is a fundamental design function.
Compatibility with specified sterilization systems/cycles: The primary focus of this 510(k) is to expand compatibility to additional Steris V-PRO systems.
Maintenance of structural integrity and functionality over multiple uses (limits of reuse): Ensuring the tray remains effective after repeated sterilization cycles.
Cleaning effectiveness: Ensuring the tray can be adequately cleaned.
Biocompatibility: Ensuring the materials are safe for use in a medical context.

Acceptance Criteria (Inferred from 510(k) Process)	Reported Device Performance (Summary from Document)
Material and Design Equivalence: The device should have the same design, materials, and manufacturing processes as the predicate device to support substantial equivalence.	"The subject Intuitive Surgical Endoscope Sterilization Tray is substantially equivalent to the predicate Intuitive Surgical Endoscope Sterilization Tray (K133942) in design, materials, and technological characteristics.""The subject device design, materials and manufacturing processes are identical to the predicate device (Intuitive Surgical Endoscope Sterilization Tray, K142937)." (Note: there seems to be a typo here, K142937 is the subject device, K133942 is the predicate, but the intent is clear).
Functional Equivalence & Compatibility with Sterilization: The device must effectively encase, protect, and be compatible with the specified sterilization systems/cycles.	The primary purpose of this 510(k) is to extend compatibility to new sterilization systems: "The tray is now validated for use in the Steris sterilization systems and the Indications for Use are being modified to reflect that capability."The "Performance Data" states: "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."
Sterilization Validation: The tray must allow for effective sterilization of the enclosed endoscope when used with the specified sterilizers.	"The testing conducted consisted of sterilization validation and limits of reuse testing..." (Specific performance results for sterilization efficacy are not detailed in this summary, but are implied to be satisfactory for substantial equivalence).
Limits of Reuse: The tray must maintain its integrity and performance over its intended lifespan/number of uses.	"...and limits of reuse testing..." (Specific results not detailed, but implied to meet requirements for substantial equivalence).
Cleaning and Biocompatibility: The device should remain cleanable and biocompatible.	"...cleaning, and biocompatibility 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)." (Again, K133942 is the predicate. The performance is inferred from identity to the predicate, which presumable passed these tests).
Dimensional Measurements & Functional Verification: The device must meet its design specifications for size and basic functionality.	"...dimensional measurements, functional verification..." (These were part of the testing carried out previously for the predicate device, not re-done for this submission due to identical design).

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary. For a physical device like this, test samples would be units of the sterilization tray itself subjected to various tests.
- Data Provenance: The tests would have been performed in a laboratory setting by the manufacturer (Intuitive Surgical, Inc.). The document doesn't specify if the testing was retrospective or prospective in the sense of clinical studies, but it would be prospective lab testing for device validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device does not involve expert interpretation or ground truth establishment in the context of diagnostic performance (e.g., radiology images). The "ground truth" for a sterilization tray is its measurable physical performance and its ability to facilitate sterilization, which is determined through engineering and microbiology testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication method is applicable for the validation of this type of device.
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:
- N/A. This device is not an AI software and does not involve human readers for diagnostic interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance would be established by:
  - Standardized sterilization efficacy tests: e.g., using biological indicators or thermocouples to verify sterility within the tray after a cycle.
  - Mechanical and material property tests: e.g., stress testing, dimensional stability measurements, visual inspection for damage after reuse cycles.
  - Biocompatibility standards: Confirmation that materials meet established safety standards.
The sample size for the training set:
- N/A. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- N/A. Since there is no training set, this is not applicable.

Summary

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

February 24, 2015

Intuitive Surgical, Inc. Ms. Nadine Nasr Senior Regulatory Specialist, Regulatory Affairs 1266 Kifer Road Sunnyvale, CA 94086

Re: K142937

Trade/Device Name: Endoscope Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap, Containers, Trays, Cassettes and Other Accessories Regulatory Class: II Product Code: KCT Dated: January 26, 2015 Received: January 28, 2015

Dear Ms. Nasr:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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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Page 2 - Ms. Nasr

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 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/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 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,

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142937

Device Name

Endoscope Sterilization Tray

Indications for Use (Describe)

The Intuitive Surgical Endoscope Sterlization Tray is intended for use to encase and protect da Vinci Xiendoscopes (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 cvcles
· 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 approxinately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of tray and endoscope is 7.7 lbs.

The Endoscope Sterilization Tray is not intended to mantain sterlity; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatble sterilization wrap in order to maintain sterlity of 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)

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510(k) Summary

510(k) Owner:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Contact:	Nadine NasrSenior Regulatory Specialist, Regulatory AffairsPhone Number: 408-523-7093Fax Number: 408-523-8907Email: Nadine.nasr@intusurg.com
Date Summary Prepared:	February 24, 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 (K133942)

Device Description

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 Endoscope Sterilization Tray is the same tray previously cleared for sterilizing the endoscopes in STERRAD sterilizers. The tray is now validated for use in the Steris sterilization systems and the Indications for Use are being modified to reflect that capability.

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Intended Use:

. 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 7.7 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 substantially equivalent to the predicate Intuitive Surgical Endoscope Sterilization Tray (K133942) in design, materials, and technological characteristics.

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Characteristic	Subject DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray K142937	Predicate DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray K133942
Manufacturer	Intuitive Surgical, Inc.	Intuitive Surgical, Inc.
Trade Name	Endoscope Sterilization Tray	Endoscope Sterilization Tray
510(k) No.	K142937	K133942
510(k) DecisionDate	Not Applicable	August 1, 2014
Common Name	Sterilization Tray	Sterilization Tray
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

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Characteristic	Subject DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray K142937	Predicate DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray K133942
Intended Use	The Intuitive Surgical EndoscopeSterilization Tray is intended toencase and protect da Vinci Xiendoscopes for sterilization in theSTERRAD 100NX sterilizationsystem using the Express cyclesetting, the STERRAD 100Ssterilization system using theStandard cycle setting, and theSteris low temperature hydrogenperoxide gas sterilization systems(V-PRO maX, V-PRO 1 Plus, andV-PRO 1).	Intended to encase and protect daVinci endoscopes for sterilization inthe STERRAD 100NX sterilizationsystem using the Express cyclesetting and the STERRAD 100Ssterilization system using theStandard cycle setting.
Characteristic	Subject DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray K142937	Predicate DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray K133942
Indications forUse	The Intuitive Surgical EndoscopeSterilization Tray is intended foruse to encase and protect da VinciXi endoscopes (Model #'s 470026and 470027) for sterilization inany of the following sterilizationmachines/cycles:STERRAD 100NXsterilization system usingthe Express cycle STERRAD 100Ssterilization system usingthe Standard cycle Steris V-PRO maX usingthe Non Lumen, Flexible,or Lumen cycles Steris V-PRO 1 Plus usingthe Non Lumen or Lumencycles Steris V-PRO 1 using theV-PRO/Lumen Cycle The sterilization cycle parametersof the sterilizers are preset by themanufacturers and are notadjustable. The maximum productload per tray is one da Vinci XiEndoscope. The length of the daVinci Xi Endoscope isapproximately 600 mm and thediameter of the shaft is 8.8 mm.The maximum weight of tray andendoscope is 7.7 lbs.The Endoscope Sterilization Trayis not intended to maintainsterility; it is intended to be usedin conjunction with a legallymarketed, validated, FDA-clearedSTERRAD and Steris compatiblesterilization wrap in order tomaintain sterility of the enclosedmedical instrument.	The Intuitive Surgical EndoscopeSterilization Tray is intended for useto encase and protect da Vinci Xiendoscopes (Model #'s 470026 and470027) for sterilization in theSTERRAD 100NX sterilizationsystem using the Express cycle andthe STERRAD 100S sterilizationsystem using the Standard cycle.The sterilization cycle parameters ofthe sterilizers are preset by themanufacturer and are not adjustable.The maximum product load per trayis 1 da Vinci Xi Endoscope.The maximum weight of tray andendoscope is 7.7 lbs.The Intuitive Surgical EndoscopeSterilization Tray is intended to beused with legally marketed, FDA-cleared STERRAD compatiblesterilization wrap in order tomaintain sterility of the enclosedendoscope.
Characteristic	Subject DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray K142937	Predicate DeviceIntuitive Surgical, Inc. EndoscopeSterilization Tray K133942
Where used(hospital, home,ambulance, etc)	SAME	Hospital
Dimensions(LxW)	SAME	25in. x 15in.
Materials;	SAME	ULTEM™, Elastosil R401/70silicone, stainless steel
Compatibilitywith theenvironment andother devices	SAME	Compatible with da Vinci Xiendoscopes
Sterilizationsystemcompatibility	STERRAD 100NX andSTERRAD 100S and Steris V-PRO maX, V-PRO 1 Plus, and V-PRO 1 low temperature hydrogenperoxide gas sterilization systems	STERRAD 100NX andSTERRAD 100S

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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 limits of reuse testing, including dimensional measurements, functional verification, cleaning, and biocompatibility testing were not repeated as the subject device design, materials and manufacturing processes are identical to the predicate device (Intuitive Surgical Endoscope Sterilization Tray, K133942).

Substantially Equivalent Conclusion:

Based on the intended use, indications for use, technological characteristics, performance data and nonclinical tests performed, the subject Intuitive Surgical Endoscope Sterilization Tray is substantially equivalent and is as safe and as effective, and performs at least as safely and as effectively as the legally marketed predicate device, Intuitive Surgical Endoscope Sterilization Tray (K133942), 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).