ENDOSCOPE STERILIZATION TRAY

K133942 · Intuitive Surgical · KCT · Aug 1, 2014 · General Hospital

Device Facts

• Record ID: K133942
• Device Name: ENDOSCOPE STERILIZATION TRAY
• Applicant: Intuitive Surgical
• Product Code: KCT · General Hospital
• Decision Date: Aug 1, 2014
• Decision: SESE
• Submission Type: Abbreviated
• 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 the STERRAD 100NX sterilization system using the Express cycle and in the STERRAD 100S sterilization system using the standard cycle. The sterilization cycle parameters of the sterilizers are preset by the manufacturer and are not adjustable. The maximum product load per tray is 1 da Vinci Xi Endoscope. The max weight of tray and endoscope is 7.7 lbs. The Intuitive Surgical Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

Device Story

Thermoformed plastic tray with silicone inserts and clear lid; designed to encase and protect da Vinci Xi endoscopes during transport and H2O2 chemical sterilization. Perforated design allows sterilization gas penetration. Used in hospital settings; compatible with STERRAD 100NX and 100S systems. Protects endoscope from damage; maintains sterility when used with compatible sterilization wrap.

Clinical Evidence

Bench testing only. Testing included dimensional measurements, functional verification, and cleaning and sterilization validation to demonstrate substantial equivalence.

Technological Characteristics

Thermoformed plastic tray with silicone inserts and clear lid. Materials: ULTEM, Elastosil R401/70 Silicone, stainless steel. Perforated design for H2O2 gas penetration. Dimensions: 25in x 15in. Multiple use. Compatible with STERRAD 100NX and 100S systems.

Indications for Use

Indicated for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) during sterilization in STERRAD 100NX (Express cycle) and STERRAD 100S (standard cycle) systems. Maximum load: 1 endoscope; max weight 7.7 lbs. Requires use of FDA-cleared STERRAD 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

• Entellus Medical FinESS Endoscope Sterilization Tray (K103213)

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

August 1, 2014

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

Re: K133942

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

Dear Mr. Hansen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mary S. Runner -S

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

Enclosure

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# Indications for Use

510(k) Number (if known) K133942

Device Name Endoscope Sterilization Tray

Indications for Use (Describe)

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

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

2 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: | Brandon Hansen<br>Project Manager, Regulatory Affairs<br>Phone Number: 408-523-7485<br>Fax Number: 408-523-8907<br>Email: [e-mail] |
| Date Summary Prepared: | July 9, 2014 |
| 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: | Entellus Medical FinESS Endoscope Sterilization Tray<br>(K103213) |

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

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## Device Description

The Endoscope Sterilization Tray is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100NX and 100S sterilization systems.

#### Intended Use:

To encase and protect da Vinci endoscopes for sterilization.

#### Indications for Use:

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

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

## Technological Characteristics:

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

| Characteristic | Subject Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray (K133942) | Predicate Device<br>Entellus Medical<br>FinESS™ Endoscope Sterilization<br>Tray (K103213) |
|-------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Manufacturer | Intuitive Surgical, Inc. | Entellus Medical, Inc. |
| Trade Name | Endoscope Sterilization Tray | FinESS™ Endoscope Sterilization<br>Tray |
| 510(k) No. | K133942 | K103213 |
| 510(k) Decision<br>Date | Not Applicable | 2 February 2011 |

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

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| Characteristic | Subject Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray (K133942) | Predicate Device<br>Entellus Medical<br>FinESS™ Endoscope Sterilization<br>Tray (K103213) |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Sterilization Tray | Identical |
| Regulation No. | 21 CFR 880.6850 | Identical |
| Product Code | KCT | Identical |
| Device Class/<br>Regulation Name | Class II/ Sterilization Wrap | Identical |
| Classification<br>Advisory<br>Committee | General Hospital | Identical |
| Sterilization<br>Method | H2O2 chemical sterilization | Identical |
| Sterility /<br>Disposable or<br>Multiple use | Multiple use | Identical |
| Intended Use | Intended to encase and protect da<br>Vinci endoscopes for sterilization<br>in the STERRAD 100NX<br>sterilization system using the<br>express cycle setting and the 100S<br>sterilization system using the<br>standard cycle setting | Intended to encase and protect the<br>FinESS™ Endoscope for<br>sterilization in STERRAD 100NX<br>using the standard cycle setting and<br>NX sterilization system using the<br>advanced cycle setting |
| Characteristic | Subject Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray (K133942) | Predicate Device<br>Entellus Medical<br>FinESS™ Endoscope Sterilization<br>Tray (K103213) |
| Indications for<br>Use | The Intuitive Surgical<br>Endoscope Sterilization Tray is<br>intended for use to encase and<br>protect da Vinci Xi endoscopes<br>(Model #'s 470026 and 470027)<br>for sterilization in the<br>STERRAD 100NX sterilization<br>system using the Express cycle<br>and in the STERRAD 100S<br>sterilization system using the<br>standard cycle. The sterilization<br>cycle parameters of the<br>sterilizers are preset by the<br>manufacturer and are not<br>adjustable. The maximum<br>product load per tray is 1 da<br>Vinci Xi Endoscope. The max<br>weight of tray and endoscope is<br>7.7 lbs.<br>The Intuitive Surgical<br>Endoscope Sterilization Tray is<br>intended to be used with legally<br>marketed, FDA-cleared<br>STERRAD compatible<br>sterilization wrap in order to<br>maintain sterility of the<br>enclosed endoscope. | The FinESS™ Endoscope<br>Sterilization Tray is intended for use<br>to encase and protect the FinESS™<br>Endoscope for sterilization in<br>STERRAD 100NX using the<br>standard cycle setting and NX<br>Sterilization Systems using the<br>advanced cycle setting.<br>The sterilization cycle<br>parameters of the<br>STERRAD sterilizers are<br>preset by the manufacturer<br>and are not adjustable. The maximum product load<br>per FinESS™ Endoscope<br>Sterilization Tray includes 1<br>FinESS™ Endoscope and 2<br>light post adapters. The FinESS™ 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. |
| Where used<br>(hospital, home,<br>ambulance, etc) | Hospital | Identical |
| Dimensions<br>(LxW) | 25in. x 15in. | 7.6 in. x 4.1 in. |
| Materials; | ULTEM™, Elastosil R401/70<br>Silicone, stainless steel | Identical |

Image /page/5/Picture/3 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, with the registered trademark symbol next to it.

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Image /page/6/Picture/3 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, also in light gray. There is a yellow dot above the word "INTUITIVE".

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| Characteristic | Subject Device<br>Intuitive Surgical, Inc. Endoscope<br>Sterilization Tray (K133942) | Predicate Device<br>Entellus Medical<br>FinESS™ Endoscope Sterilization<br>Tray (K103213) |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Compatibility<br>with the<br>environment and<br>other devices | Compatible with da Vinci Xi 8<br>mm endoscopes | Compatible with the FinESS<br>endoscope |
| Sterilization<br>system<br>compatibility | STERRAD 100NX and 100S | STERRAD 100NX and NX |

#### Performance Data:

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

#### Summary:

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

Image /page/7/Picture/7 description: The image shows the logo for Intuitive Surgical. The word "INTUITIVE" is in all caps and in a light gray color. Below that, the word "SURGICAL" is also in all caps and in a smaller font size, also in light gray, with a registered trademark symbol next to it. There is a yellow dot above the word "INTUITIVE".