Endoscope Sterilization Tray

K142937 · Intuitive Surgical, Inc. · KCT · Feb 24, 2015 · General Hospital

Device Facts

• Record ID: K142937
• Device Name: Endoscope Sterilization Tray
• Applicant: Intuitive Surgical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Feb 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

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 Story

Thermoformed plastic tray with silicone inserts and clear lid; designed to encase and protect da Vinci Xi endoscopes during transport and low-temperature hydrogen peroxide gas sterilization. Tray features perforations for gas penetration. Used in hospital settings; operated by clinical staff. Device does not maintain sterility independently; must be used with FDA-cleared sterilization wrap. Subject device expands compatibility of previously cleared tray (K133942) to include Steris V-PRO sterilization systems. Benefits include standardized protection and validated sterilization compatibility for da Vinci Xi endoscopes.

Clinical Evidence

Bench testing only. Sterilization validation testing was performed to confirm compatibility with Steris V-PRO maX, V-PRO 1 Plus, and V-PRO 1 systems. Functional verification and dimensional measurements were conducted. Biocompatibility, cleaning, and previous functional data from the predicate device (K133942) were leveraged as the design and materials are identical.

Technological Characteristics

Thermoformed plastic tray (ULTEM), Elastosil R401/70 silicone inserts, stainless steel components. Dimensions: 25in x 15in. Perforated design for H2O2 gas penetration. Compatible with STERRAD 100NX/100S and Steris V-PRO maX/1 Plus/1 systems. Multiple use. Non-powered.

Indications for Use

Indicated for encasing and protecting da Vinci Xi endoscopes (Model #'s 470026 and 470027) during sterilization in specified STERRAD and Steris low-temperature hydrogen peroxide gas sterilization systems. Not intended to maintain sterility post-process; requires use with compatible sterilization wrap.

Regulatory Classification

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.

Predicate Devices

• Intuitive Surgical Endoscope Sterilization Tray (K133942)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.<br>1266 Kifer Road<br>Sunnyvale, CA 94086 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nadine Nasr<br>Senior Regulatory Specialist, Regulatory Affairs<br>Phone Number: 408-523-7093<br>Fax Number: 408-523-8907<br>Email: [e-mail] |
| Date Summary Prepared: | February 24, 2015 |
| Trade Name: | Endoscope Sterilization Tray |
| Common Name: | Sterilization Tray |
| Classification: | Class II<br>21 CFR 880.6850, Sterilization Wrap |
| Product Codes: | KCT |
| Classification Advisory<br>Committee: | General Hospital |
| Predicate Device: | Intuitive Surgical Endoscope Sterilization Tray (K133942) |

### 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:

- 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:

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.

# 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 Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray K142937 | Predicate Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray K133942 |
|----------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Manufacturer | Intuitive Surgical, Inc. | Intuitive Surgical, Inc. |
| Trade Name | Endoscope Sterilization Tray | Endoscope Sterilization Tray |
| 510(k) No. | K142937 | K133942 |
| 510(k) Decision<br>Date | 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/<br>Regulation Name | Class II/ Sterilization Wrap | Class II/ Sterilization Wrap |
| Classification<br>Advisory<br>Committee | General Hospital | General Hospital |
| Sterilization<br>Method | SAME | H2O2 chemical sterilization |
| Sterility /<br>Disposable or<br>Multiple use | SAME | Multiple use |

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| Characteristic | Subject Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray K142937 | Predicate Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray K133942 |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Intuitive Surgical Endoscope<br>Sterilization Tray is intended to<br>encase and protect da Vinci Xi<br>endoscopes for sterilization in the<br>STERRAD 100NX sterilization<br>system using the Express cycle<br>setting, the STERRAD 100S<br>sterilization system using the<br>Standard cycle setting, and the<br>Steris low temperature hydrogen<br>peroxide gas sterilization systems<br>(V-PRO maX, V-PRO 1 Plus, and<br>V-PRO 1). | Intended to encase and protect da<br>Vinci endoscopes for sterilization in<br>the STERRAD 100NX sterilization<br>system using the Express cycle<br>setting and the STERRAD 100S<br>sterilization system using the<br>Standard cycle setting. |
| Characteristic | Subject Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray K142937 | Predicate Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray K133942 |
| Indications for<br>Use | The Intuitive Surgical Endoscope<br>Sterilization Tray is intended for<br>use to encase and protect <i>da Vinci<br/>Xi</i> endoscopes (Model #'s 470026<br>and 470027) for sterilization in<br>any of the following sterilization<br>machines/cycles:<br>STERRAD 100NX<br>sterilization system using<br>the Express cycle STERRAD 100S<br>sterilization system using<br>the Standard cycle Steris V-PRO maX using<br>the Non Lumen, Flexible,<br>or Lumen cycles Steris V-PRO 1 Plus using<br>the Non Lumen or Lumen<br>cycles Steris V-PRO 1 using the<br>V-PRO/Lumen Cycle The sterilization cycle parameters<br>of the sterilizers are preset by the<br>manufacturers and are not<br>adjustable. The maximum product<br>load per tray is one <i>da Vinci Xi</i><br>Endoscope. The length of the <i>da<br/>Vinci Xi</i> Endoscope is<br>approximately 600 mm and the<br>diameter of the shaft is 8.8 mm.<br>The maximum weight of tray and<br>endoscope is 7.7 lbs.<br><br>The Endoscope Sterilization Tray<br>is not intended to maintain<br>sterility; it is intended to be used<br>in conjunction with a legally<br>marketed, validated, FDA-cleared<br>STERRAD and Steris compatible<br>sterilization wrap in order to<br>maintain sterility of the enclosed<br>medical instrument. | The Intuitive Surgical Endoscope<br>Sterilization Tray is intended for use<br>to encase and protect <i>da Vinci Xi</i><br>endoscopes (Model #'s 470026 and<br>470027) for sterilization in the<br>STERRAD 100NX sterilization<br>system using the Express cycle and<br>the STERRAD 100S sterilization<br>system using the Standard cycle.<br><br>The sterilization cycle parameters of<br>the sterilizers are preset by the<br>manufacturer and are not adjustable.<br>The maximum product load per tray<br>is 1 <i>da Vinci Xi</i> Endoscope.<br><br>The maximum weight of tray and<br>endoscope is 7.7 lbs.<br><br>The Intuitive Surgical Endoscope<br>Sterilization Tray is intended to be<br>used with legally marketed, FDA-<br>cleared STERRAD compatible<br>sterilization wrap in order to<br>maintain sterility of the enclosed<br>endoscope. |
| Characteristic | Subject Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray K142937 | Predicate Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray K133942 |
| Where used<br>(hospital, home,<br>ambulance, etc) | SAME | Hospital |
| Dimensions<br>(LxW) | SAME | 25in. x 15in. |
| Materials; | SAME | ULTEM™, Elastosil R401/70<br>silicone, stainless steel |
| Compatibility<br>with the<br>environment and<br>other devices | SAME | Compatible with da Vinci Xi<br>endoscopes |
| Sterilization<br>system<br>compatibility | STERRAD 100NX and<br>STERRAD 100S and Steris V-<br>PRO maX, V-PRO 1 Plus, and V-<br>PRO 1 low temperature hydrogen<br>peroxide gas sterilization systems | STERRAD 100NX and<br>STERRAD 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.