INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS

K072211 · Intuitive Surgical, Inc. · KCT · Feb 28, 2008 · General Hospital

Device Facts

• Record ID: K072211
• Device Name: INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS
• Applicant: Intuitive Surgical, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Feb 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Intuitive Surgical Instrument and Accessory Sterilization Trays are intended for the protection, organization and delivery to the surgical field of Intuitive Surgical EndoWrist instruments and Intuitive Surgical Re-usable Accessories ONLY, as listed in Table 1 below. The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.

Device Story

Sterilization trays designed to hold and organize Intuitive Surgical EndoWrist instruments and re-usable accessories during pre-vacuum steam sterilization, storage, and transport. Trays feature rectangular bases with latchable lids and perforations to facilitate sterilant penetration; internal grooves custom-fit specific instruments. Used in clinical settings; operated by sterile processing staff. Trays require an FDA-cleared sterilization wrap to maintain sterility post-process. Benefits include organized instrument delivery and protection of delicate surgical components during the sterilization cycle.

Clinical Evidence

Bench testing only. Validation testing demonstrated successful sterilization of Intuitive Surgical EndoWrist instruments and re-usable accessories when enclosed in the trays using a pre-vacuum steam cycle (132°C, 4-minute exposure, 30-minute dry time).

Technological Characteristics

Rectangular sterilization trays with latchable lids; perforated for steam penetration; internal grooves for instrument organization. Materials: standard medical-grade materials. Sterilization method: pre-vacuum steam autoclave (132°C). Dimensions range from 21.1" to 24.1" length; 3.5" to 5.5" height.

Indications for Use

Indicated for the protection, organization, and delivery of Intuitive Surgical EndoWrist instruments (8mm and 5mm) and re-usable accessories (cannulae, obturators, cannula mounts, sterile adapters) for da Vinci and da Vinci S surgical systems to the surgical field.

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

• PolyVac Surgical Instrument Delivery System (K012105)
• Paragon Medical Surgical Instrument Delivery System (K032119)
• Olympus Sterilization Trays (K033222)

Submission Summary (Full Text)

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### Section II

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# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K072211

| Date | Feb 11, 2008 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Intuitive Surgical®, Inc.<br>950 Kifer Road<br>Sunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | Michael Yramategui<br>Sr. Director, Regulatory & Quality Affairs<br>Telephone: (408) 523 - 2145 ; Fax: (408) 523 - 1390<br>E-mail: [e-mail] |
| Subject<br>Device | Trade Name(s):<br>Intuitive Surgical® Instrument and Accessory Sterilization<br>Trays<br><br>Classification Name:<br>Sterilization wrap containers, trays, cassettes & other<br>Accessory (21CFR §880.6850)<br><br>Common Name:<br>Sterilization Cassettes, Instrument Tray, Sterilization Tray,<br>Instrument Delivery System<br><br>Device Class:<br>Class II (KCT) |
| Predicate<br>Devices | PolyVac Surgical Instrument Delivery System (K012105)<br>Poly Vac Inc.<br><br>Paragon Medical Surgical Instrument Delivery System<br>(K032119)<br>Paragon Medical, Inc. |
| Predicate<br>Devices (Cont.) | Olympus Sterilization Trays (K033222)<br>Olympus Winter & Ibe |
| Device<br>Description | Intuitive Surgical® Instrument and Accessory Sterilization<br>Trays are intended only for use with Intuitive Surgical®<br>EndoWrist Instruments and Intuitive Surgical Re-usable<br>Accessories. These trays are used to enclose and hold the<br>Instruments and Accessories in an organized manner during<br>the sterilization process and subsequent storage and<br>transportation. The trays are to be used with an approved<br>sterilization wrap in order to maintain the sterility of the<br>enclosed devices.<br><br>The trays are different sizes of the same basic configuration: a<br>rectangular base with latchable lids. The trays have<br>perforations on the lid, bottom and sides to allow sterilant<br>penetration. The bottom surface of the trays contains grooves<br>custom made to fit and accommodate Intuitive Surgical®<br>EndoWrist Instruments and Accessories. The grooves<br>facilitate the Instruments and Accessory to be arranged in an<br>organized manner when placed in the tray.<br><br>The sterilization trays have been tested for use ONLY with the<br>Intuitive Surgical® EndoWrist Instruments and Accessories<br>for a sterilization cycle of Pre-Vac steam sterilization 132°C,<br>4min cycle with a 30 min dry time. This cycle parameter is<br>similar to the current recommended sterilization cycle for the<br>Intuitive Surgical® EndoWrist Instruments and Accessories. |
| Intended<br>Use | Intuitive Surgical Instrument and Accessory Sterilization<br>Trays are intended for the protection, organization and<br>delivery to the surgical field of Intuitive Surgical EndoWrist<br>Instruments and Intuitive Surgical Re-usable Accessories<br>ONLY, as listed in Table 1 below. |

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#### TABLE 1: List of Compatible Devices

| INTENDED CONTENT | DESCRIPTION |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intuitive Surgical<br>EndoWrist Instruments | da Vinci & da Vinci S families of<br>8mm & 5mm EndoWrist Instruments |
| Intuitive Surgical Re-usable<br>Accessories | da Vinci and da Vinci S families of<br>8mm & 5mm accessories including<br>cannulae, obturators, cannula mount,<br>sterile adapters etc |

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Intended Use The trays are not intended to maintain sterility by themselves. (Cont.) They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.

Autoclave Sterilization Parameter:

- Cycle: Pre-vacuum Temperature: 270-272°F (132-134°C) Minimum Exposure Time: 4 mins Minimum Dry Time: 30 mins
Table 2 provides description of 4 configurations of Intuitive Surgical Instrument and Accessory Sterilization Trays

| TRAY<br>NAME | INTENDED<br>CONTENT<br>(Intuitive Surgical<br>EndoWrist<br>Instruments and<br>Intuitive Surgical<br>Re-usable<br>Accessories ONLY) | DIMENSION<br>(Inches)<br>L x W x H | WEIGHT<br>(Pounds)<br>UL:<br>Unloaded<br>FL: Fully<br>Loaded |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|--------------------------------------------------------------|
| Single<br>Instrument<br>Tray (P/N<br>400220) | One EndoWrist<br>Instrument | 24.1" x 9.7" x<br>3.5" | UL: 1 lb<br>FL: 2 lb |
| Instrument<br>Tray (P/N<br>400221) | Eight EndoWrist<br>Instruments | 24.1" x 9.7" x<br>3.5" | UL: 1 lb<br>FL: 2 lb |
| Accessory<br>Tray (P/N<br>400222) | Accessories | 21.1" x 9.7" x<br>3.5" | UL: 5 lb<br>FL: 13 lb |
| Procedure<br>Tray (P/N<br>400223) | Eight EndoWrist<br>Instruments &<br>Accessories | 24.1" x 9.7" x<br>5.5" | UL: 7 lb<br>FL: 21 lb |

TABLE 2: Intuitive Surgical Instrument and Accessory Sterilization Trays

Comparison to Predicate Device

Based on the comparison of design, technology, materials, manufacturing, performance, specifications, and method of use, the Intuitive Surgical® Instrument and Accessory Sterilization Trays are substantially equivalent to the identified 510(k) cleared predicate devices.

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| Technological<br>Characteristics | The technological characteristics of the subject devices are<br>equivalent to the predicate devices. The trays are made of<br>standard medical grade materials are don't incorporate any<br>new technological characteristics. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Data | Design analysis and testing has been conducted to confirm<br>that basic functional characteristics of the subject devices are<br>substantially equivalent to the predicate devices cited, and<br>that design output meets the design input requirements.<br><br>Sterilization validation testing was performed to demonstrate<br>successful sterilization of the Intuitive Surgical® EndoWrist<br>Instruments and Intuitive Surgical Re-usable Accessories<br>when enclosed in the sterilization trays and sterilized using a<br>pre-vacuum cycle of 132°C, 4 mins with a 30 min dry time. |
| Conclusion | Based upon available technical information, intended use and<br>performance information provided in this pre-market<br>notification, the Intuitive Surgical® Instrument and Accessory<br>Sterilization Trays described herein are substantially<br>equivalent to current legally marketed predicate devices. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 28 2008

Intuitive Surgical, Incorporated C/O Mr. Morten S. Christensen Responsible Third Party Official Underwriters Laboratories, Incorporated 455 East Trimble Road San Jose, California 95131-1230

Re: K072211

Trade/Device Name: Intuitive Surgical® Instrument and Accessory Sterilization Trays Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: February 14, 2008 Received: February 15, 2008

Dear Mr. Christensen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Morten

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Clive
Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): K072211

# Device Name: Intuitive Surgical® Instrument and Accessory Sterilization Trays

Indications for Use:

Intuitive Surgical Instrument and Accessory Sterilization Trays are intended for the protection, organization and delivery to the surgical field of Intuitive Surgical EndoWrist instruments and Intuitive Surgical Re-usable Accessories ONLY, as listed in Table 1 below.

| INTENDED CONTENT | DESCRIPTION |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Intuitive Surgical<br>Endo Wrist Instruments | da Vinci & da Vinci S families<br>of 8mm & 5mm EndoWrist<br>Instruments |
| Intuitive Surgical Re-usable<br>Accessories | da Vinci and da Vinci S families<br>of 8mm & 5mm accessories<br>including cannulae, obturators,<br>cannula mount, sterile adapters<br>etc |

TABLE 1: List of Compatible Devices

The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.

ponents. Shila M Murphy

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Page 1 of 2

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Autoclave Sterilization Parameter:

Cycle: Pre-vacuum Temperature: 270-272°F (132-134°C) Minimum Exposure Time: 4 mins Minimum Dry Time: 30 mins

Table 2 provides the description of the 4 configurations of the Intuitive Surgical Instrument and Accessory Sterilization Trays

| TRAY NAME | INTENDED CONTENT (Intuitive<br>Surgical EndoWrist<br>Instruments and<br>Intuitive Surgical Re-<br>usable Accessories<br>ONLY) | DIMENSION<br>(Inches)<br>L x W x H | WEIGHT<br>(Pounds)<br>UL: Unloaded<br>FL: Fully<br>Loaded |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------|
| Single<br>Instrument Tray<br>(P/N 400220) | One EndoWrist<br>Instrument | 24.1" x 9.7" x<br>3.5" | UL: 1 lb<br>FL: 2 lb |
| Instrument Tray<br>(P/N 400221) | Eight EndoWrist<br>Instruments | 24.1" x 9.7" x<br>3.5" | UL: 1lb<br>FL: 2 Ib |
| Accessory Tray<br>(P/N 400222) | Accessories | 21.1" x 9.7" x<br>3.5" | UL: 5 Ib<br>FL: 13 Ib |
| Procedure Tray<br>(P/N 400223) | Eight EndoWrist<br>Instruments &<br>Accessories | 24.1" x 9.7" x<br>5.5" | UL: 7 Ib<br>FL: 21 lb |

TABLE 2: Intuitive Surgical Instrument and Accessory Sterilization Trays

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use__X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of device Evaluation (ODE)