The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes 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 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.

Device Description

The Endoscope Sterilization Tray (P/N: 400490) 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 intended for use to encase and protect compatible da Vinci Xi endoscopes (Model #'s 470026, 470027) during the transport and sterilization process.

The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight; it is the same tray as no changes were made to these parameters.

AI/ML Overview

This document is a 510(k) premarket notification for an Endoscope Sterilization Tray (K180964). It asserts substantial equivalence to a previously cleared predicate device (K170640). The core argument is that the subject device is identical to the predicate device in design, materials, and manufacturing processes, with only a minor change to the reprocessing instructions related to where specific endoscope model numbers are referenced.

Therefore, the information you've requested about acceptance criteria and a study proving the device meets those criteria is largely absent because the submission relies on a claim of identity to a previously cleared device, not new performance data.

Here's an attempt to fill in the requested information based on the provided text, with many fields indicating "Not Applicable" or "Not Provided" due to the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Status
Functional Equivalence	Device design, materials, dimensions, and weight must be identical to the predicate device.	The subject Endoscope Sterilization Tray (P/N: 400490) and predicate tray (K170640) are identical in terms of design, materials, dimensions and weight. The document explicitly states "it is the same tray as no changes were made to these parameters."
Indications for Use (IFU)	Intended use must be for encasing and protecting compatible da Vinci Xi endoscopes for sterilization in specified machines/cycles.	The IFU specifies use for compatible da Vinci Xi endoscopes for sterilization in: STERRAD 100NX (Express cycle), STERRAD 100S (Standard cycle), Steris V-PRO maX (Non Lumen, Flexible, or Lumen cycles), Steris V-PRO 1 Plus (Non Lumen or Lumen cycles), and Steris V-PRO 1 (V-PRO/Lumen cycle). The only change made from the predicate's IFU was the removal of specific da Vinci Xi Endoscope model numbers (PNs: 470026 and 470027) from the IFU Statement. These model numbers are now referenced within the reprocessing instructions to clarify usage. The device is still explicitly stated to be used only with these specific da Vinci Xi Endoscope models.
Sterilization Process	Compatibility with specified sterilization machines/cycles and maintained effectiveness of the sterilization process.	"Additionally there are no changes to the sterilization process parameters between the subject device and the predicate device; therefore sterilization validation testing was not repeated." This implies that the previous validation for the predicate device is considered applicable.
Cleaning	Device must be cleanable.	"Cleaning...testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device." Implies compliance based on predicate device data.
Biocompatibility	Materials used in the device must be biocompatible.	"Biocompatibility...testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device." Implies compliance based on predicate device data.
Bench Testing	Device performance and protection capabilities must be demonstrated through bench testing.	"Bench testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device." Implies compliance based on predicate device data.
Physical/Chemical Properties	Physical/chemical properties must be identical to the predicate device.	"The physical/chemical properties of the subject device are identical to the predicate device, since there are no changes to the tray features and materials."

Regarding the study that proves the device meets the acceptance criteria:

The provided document does not describe a new study to demonstrate that the subject device (K180964) meets specific acceptance criteria. Instead, it relies entirely on the assertion of substantial equivalence to a previously cleared predicate device (K170640). The fundamental premise is that because the device itself is identical to the predicate (same design, materials, weight, manufacturing processes), and the only change is in the documentation (where specific model numbers are referenced), no new performance testing (cleaning, biocompatibility, sterilization validation, bench testing) was deemed necessary.

Therefore, the "study" is effectively the original substantial equivalence determination for the predicate device (K170640), which would have included such testing. This current submission leverages that prior clearance.

Additional Requested Information (based on provided text):

2. Sample size used for the test set and the data provenance:

Sample Size: Not Applicable / Not Provided (no new testing performed for this submission)
Data Provenance: Not Applicable / Not Provided (no new testing performed)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not Applicable / Not Provided (no new testing performed and no ground truth establishment relevant to this specific submission)
Qualifications of Experts: Not Applicable / Not Provided

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

Not Applicable / Not Provided (no new testing performed)

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable / Not Provided. This device is a physical sterilization tray, not an AI or diagnostic device.

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

Not Applicable / Not Provided. This device is a physical sterilization tray, not an algorithm.

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

Not Applicable / Not Provided. For the predicate device, the ground truth would have been established through validated sterilization efficacy, cleaning efficacy, and biocompatibility testing according to relevant standards.

8. The sample size for the training set:

Not Applicable / Not Provided. This is not an AI/machine learning device.

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

Not Applicable / Not Provided. This is not an AI/machine learning device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 28, 2018

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

Re: K180964

Trade/Device Name: Endoscope Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: August 29, 2018 Received: August 30, 2018

Dear Kunal 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 of medical device-related adverse events) (21 CFR 803); good

{1}------------------------------------------------

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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name

Endoscope Sterilization Tray

Indications for Use (Describe)

· 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 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X 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 the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Image /page/2/Picture/28 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, the word "SURGICAL" is in a smaller, sans-serif font, with the registered trademark symbol next to it. The logo is simple and modern.

{3}------------------------------------------------

510(k) Summary (K180964)

510(k) Owner:	Intuitive Surgical, Inc.
	1266 Kifer Road
	Sunnyvale, CA 94086
Contact:	Kunal Gunjal
	Regulatory Affairs Specialist
	Phone Number: 408-523-8017Fax Number: 408-523-8907
	Email: Kunal.Gunjal@intusurg.com
Date Summary Prepared:	September 27, 2018
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 (K170640)

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

{4}------------------------------------------------

Device Description

The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight; it is the same tray as no changes were made to these parameters.

Indications for 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

Image /page/4/Picture/13 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font in gray, with a yellow dot above the "I". Below that, in a smaller font, is the word "SURGICAL" with a registered trademark symbol.

{5}------------------------------------------------

Characteristic	Subject DeviceEndoscope Sterilization TrayK180964	Predicate DeviceEndoscope Sterilization TrayK170640
Manufacturer	Intuitive Surgical, Inc.	Intuitive Surgical, Inc.
Trade Name	Endoscope Sterilization Tray	SAME as subject device
Common Name	Sterilization Tray	SAME as subject device
Regulation No.	21 CFR 880.6850	SAME as subject device
Product Code	KCT	SAME as subject device
Device Class/Regulation Name	Class II	SAME as subject device
ClassificationAdvisory Committee	General Hospital	SAME as subject device
Characteristic	Subject DeviceEndoscope Sterilization TrayK180964	Predicate DeviceEndoscope Sterilization TrayK170640
Indications for Use	The Intuitive Surgical EndoscopeSterilization Tray is intended for use toencase and protect compatible da Vinci Xiendoscopes for sterilization in any of thefollowing sterilization machines/cycles:STERRAD 100NX sterilizationsystem using the Express cycle STERRAD 100S sterilization	The Intuitive Surgical EndoscopeSterilization Tray is intended for use toencase and protect da Vinci Xi endoscopes(Model #'s 470026 and 470027) forsterilization in any of the followingsterilization machines/cycles:STERRAD 100NX sterilizationsystem using the Express cycle STERRAD 100S sterilizationsystem using the Standard cycle Steris V-PRO maX using the NonLumen, Flexible, or Lumencycles Steris V-PRO 1 Plus using theNon Lumen or Lumen cycles Steris V-PRO 1 using the V-PRO/Lumen cycle The 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 the tray andendoscope is 8.9 lbs. The EndoscopeSterilization Tray is not intended tomaintain sterility; it is intended to be usedin conjunction with a legally marketed,validated, FDA-cleared STERRAD andSteris compatible sterilization wrap inorder to maintain sterility of the enclosedmedical instrument.
Where used (hospital,home, ambulance, etc)	Hospital	SAME as subject device
Characteristic	Subject DeviceEndoscope Sterilization TrayK180964	Predicate DeviceEndoscope Sterilization TrayK170640
Sterilizationmachines/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	SAME as subject device
ReprocessingInstructions	The following changes have been made to the Reprocessing instructions for the EndoscopeSterilization Tray, since the most recently cleared legally marketed device (K170640):- The da Vinci Xi Endoscope model numbers (PNs: 470026 and 470027) were removedfrom the Indications for Use Statement.- The da Vinci Xi Endoscope model numbers (PNs: 470026 and 470027) are referencedwithin the Reprocessing Instructions to clarify the use of the Endoscope Sterilization Trayto encase and protect these specific da Vinci Xi Endoscopes during the sterilizationprocess.
Sterility / Disposableor Multiple use	Multiple use	SAME as subject device
EndoscopeSterilization TrayModel Number	400490	SAME as subject device
Endoscopes ModelNumberscompatible with theEndoscopeSterilization Tray(PN 400490)	470026 and 470027	SAME as subject device
Principle ofOperation	The subject Endoscope Sterilization Tray isdesigned to encase and protect da Vinci Xiendoscopes during transport andsterilization. The tray and lid containperforations to allow sterilization gases topenetrate the tray and sterilize theendoscope	SAME as subject device
Characteristic	Subject DeviceEndoscope Sterilization TrayK180964	Predicate DeviceEndoscope Sterilization TrayK170640
Features	The subject Endoscope Sterilization Tray(Model# 400490) is a thermoformed plastictray with silicone inserts and a clear lid.The tray and lid contain perforations toallow sterilization gases to penetrate thetray and sterilize the endoscope. The trayhas a cavity running diagonally that cradlesthe da Vinci Endoscope. The tray lid hasstainless steel latches on either end to securethe lid to the base.	SAME as subject device
Materials	• Lid and Base - High Temperature,Transparent, Polyetherimide Blend• Base Inserts - Silicone• Latches and Handles - StainlessSteel	SAME as subject device
Packaging	Non-sterile packaging, reusable	SAME as subject device

Technical Characteristic Table

Image /page/5/Picture/4 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in a sans-serif font, with a yellow dot above the "I". Below that, the word "SURGICAL" is in a smaller, similar font, with a registered trademark symbol next to it. The text is light gray.

{6}------------------------------------------------

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. Above the "I" is a yellow dot. Below "INTUITIVE" is the word "SURGICAL" in a smaller font size and also in a light gray color with a registered trademark symbol.

{7}------------------------------------------------

{8}------------------------------------------------

Technological Characteristics and Principle of Operation:

The technological characteristics/principle of operation of the subject device is identical to the predicate device.

Physical/Chemical Properties:

The physical/chemical properties of the subject device are identical to the predicate device, since there are no changes to the tray features and materials.

Performance Data:

The purpose of this 510(k) is to remove the da Vinci Xi Endoscope model numbers (PNs: 470026 and 470027) from the Indications for Use Statement. These da Vinci Xi Endoscope model numbers (PNs: 470026 and 470027) are referenced within the Reprocessing Instructions to clarify the use of the Endoscope Sterilization Tray to encase and protect these specific da Vinci Xi Endoscopes during the sterilization process. The subject device Endoscope Sterilization Tray (PN 400490) is only being used with FDA Cleared da Vinci Xi Endoscope Model numbers (PNs: 470026 and 470027) and is not used with any other endoscope models/ medical instruments.

{9}------------------------------------------------

Cleaning, biocompatibility and bench testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device.

Additionally there are no changes to the sterilization process parameters between the subject device and the predicate device; therefore sterilization validation testing was not repeated.

Conclusion:

Based on the conclusions drawn from the intended use, technological characteristics and nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, Endoscope sterilization tray cleared under K170640 under regulation 21 CFR 880.6850, product code KCT.

Image /page/9/Picture/6 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 in a smaller font and also in a light gray color, with the registered trademark symbol next to it. There is a yellow dot above the "I" in "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).