DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253

K073112 · Intuitive Surgical, Inc. · NVE · Aug 1, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K073112
• Device Name: DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253
• Applicant: Intuitive Surgical, Inc.
• Product Code: NVE · Gastroenterology, Urology
• Decision Date: Aug 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The da Vinci® SonicPro™ Cleaning System is intended for the automated cleaning of reusable EndoWrist Instruments and Accessories used with the da Vinci and da Vinci S surgical systems. The Cleaning System when used in accordance with its labeling provides an automated cleaning method as part of the re-processing sequence for the EndoWrist Instruments and Accessories.

Device Story

The da Vinci SonicPro Cleaning System is a floor-standing automated washer for reusable EndoWrist surgical instruments. It utilizes an ultrasonic tank, fluid pumps, flushing tubing, sensors, and controllers to perform cleaning. The system uses pressurized water, an enzymatic cleaning agent, and ultrasonic agitation to clean instruments based on pre-programmed cycle configurations. It is intended for use in a clinical reprocessing environment. After the automated cycle, instruments are removed, dried, and prepared for sterilization. The system does not perform disinfection. It is designed exclusively for Intuitive Surgical EndoWrist instruments.

Clinical Evidence

Bench testing only. Simulated-use testing was conducted to evaluate the cleaning efficacy of the SonicPro Cleaning System in effectively cleaning the intended EndoWrist instruments. No clinical data provided.

Technological Characteristics

Floor-standing automated washer. Components: ultrasonic tank, fluid pumps, flushing tubing, sensors, controllers, and instrument basket. Principle: ultrasonic agitation combined with pressurized water and enzymatic cleaning agent. Operation: pre-programmed cycle configurations. Connectivity: not specified. Sterilization: not applicable (cleaning system only).

Indications for Use

Indicated for automated cleaning of reusable EndoWrist Instruments and Accessories used with da Vinci and da Vinci S surgical systems as part of the reprocessing sequence. No specific patient population or contraindications described.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Manzi Cleaner System (K043314)

Reference Devices

• Intuitive Surgical EndoWrist Endoscopic Instruments and Accessories (K063220)
• Intuitive Surgical EndoWrist Endoscopic Instruments and Accessories (K021036)

Submission Summary (Full Text)

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K073112

Page 10 of 355

## Section II

# AUG - 1 2008

## 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.

| Date | Nov 02, 2007 |
|-------------------|----------------------------------------------------------------------------|
| Submitter | Intuitive Surgical®, Inc. |
| | 950 Kifer Road |
| | Sunnyvale, CA 94086 |
| ER Number | 2955842 |
| Contact | Michael Yramategui |
| | Sr. Director, Regulatory Affairs |
| | Telephone: (408) 523 - 2145 |
| | Fax: (408) 523 - 1390 |
| | E-mail: [e-mail] |
| Subject<br>Device | Trade Name(s): |
| | da Vinci SonicPro Cleaning System |
| | Classification Name: |
| | Medical Washer |
| | Common Name: |
| | Medical<br>Washer, Automated Washer, Automated<br>Cleaner, Cleaning System |
| | Device Class: |
| | Class II (NVE) |

## 510(k) Number:

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CONFIDENTIAL

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| Predicate<br>Devices | K043314<br>Manzi Cleaner System<br>Langford IC Systems, Inc. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K063220, K021036<br>Intuitive Surgical EndoWrist Endoscopic Instruments and<br>Accessories cleared for use with da Vinci and da Vinci S<br>Surgical Systems<br>Intuitive Surgical, Inc. |
| Device<br>Description | The da Vinci SonicPro Cleaning System is intended for the<br>automated cleaning of the reusable EndoWrist Instruments and<br>Accessories only. The cleaning system is intended to provide<br>an automated method for the cleaning step as part of the<br>reprocessing procedure for the Intuitive Surgical EndoWrist<br>Instruments and Accessories. This system is not intended to<br>perform disinfection. |
| | The SonicPro Cleaning System is a floor standing model<br>comprised of an ultrasonic tank, fluid pumps, flushing tubing,<br>various sensors and controllers, and a basket to hold the<br>devices intended to be cleaned using this system. Using<br>pressurized water, an enzymatic cleaning agent and ultrasonic<br>agitation, the SonicPro provides an automated cleaning<br>process. Effective cleaning of the EndoWrist Instruments and<br>Accessories is achieved through qualified and controlled<br>process parameters, and pre-programmed cycle<br>configurations. |
| | After completion of the cleaning cycle, the devices are to be<br>removed from the cleaning system, dried and further prepared<br>for sterilization. The SonicPro cleaning system has been<br>tested for use ONLY with the Intuitive Surgical® devices as<br>detailed in the instructions for use document provided with the<br>cleaning system. |
| Intended<br>Use | The da Vinci® SonicPro™ Cleaning System is intended for the<br>automated cleaning of reusable EndoWrist Instruments and<br>Accessories used with the da Vinci and da Vinci S surgical<br>systems. The Cleaning System when used in accordance with<br>its labeling provides an automated cleaning method as part of<br>the re-processing sequence for the EndoWrist Instruments and<br>Accessories. |
| Comparison to Predicate Device | Based on the comparison of design, technology, principle, mechanism and method of use, the da Vinci SonicPro Cleaning System is substantially equivalent to similar automated washers as previously cleared by FDA (K043314). |
| Based on cleaning efficacy, steps and process parameters of the cleaning cycle, the SonicPro Cleaning System is equivalent to the currently used manual cleaning method for reprocessing of EndoWrist Instruments and Accessories cleared under K063220 and K021036. | |
| Technological Characteristics | The technological characteristics and mechanisms of the subject da Vinci SonicPro Cleaning System is equivalent to the predicate device. |
| The SonicPro automated cleaning system uses similar principles and parameters as the predicate manual cleaning method. | |
| This system does not incorporate any new technological characteristics. | |
| Performance Data | Design analysis and testing is conducted to confirm that basic functional characteristics of the subject devices are substantially equivalent to the predicate device cited, and that design output meets the design input requirements. |
| Simulated-Use test is conducted to evaluate the cleaning efficacy of the SonicPro Cleaning System in effectively cleaning the devices intended to be used with the system. | |
| Conclusion | Based upon available technical information, intended use and performance information provided in this pre-market notification, the da Vinci SonicPro Cleaning System described herein is substantially equivalent to current legally marketed predicate devices. |

2/3 Traditional 510(K)

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle with three stripes extending from its wing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2008

Intuitive Surgical, Inc. % Mr. Michael H. Yramategui Principal Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086

Re: K073112

Trade/Device Name: da Vinci SonicPro Cleaning System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NVE Dated: July 30, 2008 Received: August 1, 2008

Dear Mr. Yramategui:

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.

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 (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.

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### Page 2 - Mr. Michael H. Yramategui

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 vours.

Mark N Millman

- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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### Section III

### Indications for Use

Ko73112

510(k) Number (if known):

Device Name: da Vinci SonicPro Cleaning System

Indications for Use:

The da Vinci® SonicPro™ Cleaning System is intended for the automated cleaning of reusable EndoWrist Instruments and Accessories used with the da Vinci and da Vinci S surgical systems. The Cleaning System when used in accordance with its labeling provides an automated cleaning method as part of the re-processing sequence for the EndoWrist Instruments and Accessories.

Prescription Use. (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use XX ** (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)

Mark A. Milken

Page 1 of 1

(Division Sign-Off) (Division Sign-on of General, Restorative, Divisionrological Devices

510(k) Number