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 Description

The da Vinci SonicPro Cleaning System is intended for the automated cleaning of the reusable EndoWrist Instruments and Accessories only. The cleaning system is intended to provide an automated method for the cleaning step as part of the reprocessing procedure for the Intuitive Surgical EndoWrist Instruments and Accessories. This system is not intended to perform disinfection.

The SonicPro Cleaning System is a floor standing model comprised of an ultrasonic tank, fluid pumps, flushing tubing, various sensors and controllers, and a basket to hold the devices intended to be cleaned using this system. Using pressurized water, an enzymatic cleaning agent and ultrasonic agitation, the SonicPro provides an automated cleaning process. Effective cleaning of the EndoWrist Instruments and Accessories is achieved through qualified and controlled process parameters, and pre-programmed cycle configurations.

After completion of the cleaning cycle, the devices are to be removed from the cleaning system, dried and further prepared for sterilization. The SonicPro cleaning system has been tested for use ONLY with the Intuitive Surgical® devices as detailed in the instructions for use document provided with the cleaning system.

AI/ML Overview

The provided text describes a medical device, the "da Vinci SonicPro Cleaning System," and its 510(k) summary for FDA clearance. However, the document does not contain specific acceptance criteria, performance metrics, or details of a study that directly proves the device meets those criteria.

Instead, it states that:

"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."
"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."

Given the limitations of the provided text, I cannot extract the detailed information requested in the prompt. The text focuses on establishing substantial equivalence to predicate devices and manual cleaning methods, rather than presenting a performance study against predefined quantitative acceptance criteria.

Therefore, I cannot populate the table or provide specific answers for most of the requested points. Below is what can be inferred or explicitly stated based on the text provided:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified in text	"Effective cleaning of the EndoWrist Instruments and Accessories"
Not specified in text	"Equivalent to the currently used manual cleaning method for reprocessing of EndoWrist Instruments and Accessories" (in terms of cleaning efficacy, steps, and process parameters)

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

Sample size for test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The study type is referred to as "Simulated-Use test."

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

Not specified. The document does not mention experts or ground truth establishment in the context of the "Simulated-Use test."

4. Adjudication method for the test set:

Not specified.

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. This device is an automated cleaning system, not an AI-assisted diagnostic or interpretive device involving human "readers."

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

The "Simulated-Use test" likely reflects a standalone performance of the cleaning system as an automated process, but specific metrics are not provided. The system is designed for automated cleaning without human intervention during the cleaning cycle itself.

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

Not explicitly stated. For a cleaning efficacy study, ground truth would typically involve objective measurements of cleanliness (e.g., residual soil, protein, hemoglobin) rather than expert consensus on images or pathology. The document only mentions "cleaning efficacy."

8. The sample size for the training set:

Not applicable. The description does not suggest a machine learning model that would require a "training set."

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

Not applicable.

Summary

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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: mike.yramategui@intusurg.com
SubjectDevice	Trade Name(s):
	da Vinci SonicPro Cleaning System
	Classification Name:
	Medical Washer
	Common Name:
	MedicalWasher, Automated Washer, AutomatedCleaner, Cleaning System
	Device Class:
	Class II (NVE)

510(k) Number:

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CONFIDENTIAL

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

PredicateDevices	K043314Manzi Cleaner SystemLangford IC Systems, Inc.
	K063220, K021036Intuitive Surgical EndoWrist Endoscopic Instruments andAccessories cleared for use with da Vinci and da Vinci SSurgical SystemsIntuitive Surgical, Inc.
DeviceDescription	The da Vinci SonicPro Cleaning System is intended for theautomated cleaning of the reusable EndoWrist Instruments andAccessories only. The cleaning system is intended to providean automated method for the cleaning step as part of thereprocessing procedure for the Intuitive Surgical EndoWristInstruments and Accessories. This system is not intended toperform disinfection.
	The SonicPro Cleaning System is a floor standing modelcomprised of an ultrasonic tank, fluid pumps, flushing tubing,various sensors and controllers, and a basket to hold thedevices intended to be cleaned using this system. Usingpressurized water, an enzymatic cleaning agent and ultrasonicagitation, the SonicPro provides an automated cleaningprocess. Effective cleaning of the EndoWrist Instruments andAccessories is achieved through qualified and controlledprocess parameters, and pre-programmed cycleconfigurations.
	After completion of the cleaning cycle, the devices are to beremoved from the cleaning system, dried and further preparedfor sterilization. The SonicPro cleaning system has beentested for use ONLY with the Intuitive Surgical® devices asdetailed in the instructions for use document provided with thecleaning system.
IntendedUse	The da Vinci® SonicPro™ Cleaning System is intended for theautomated cleaning of reusable EndoWrist Instruments andAccessories used with the da Vinci and da Vinci S surgicalsystems. The Cleaning System when used in accordance withits labeling provides an automated cleaning method as part ofthe re-processing sequence for the EndoWrist Instruments andAccessories.
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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3/3

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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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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:

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

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.