SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM

K050209 · Smith & Nephew, Inc. · GCJ · Nov 23, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050209
• Device Name: SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The Smith & Nephew Control Digital Operating Room System is indicated for use with compatible endoscopic and surgical equipment for centralized control of these devices and display of device status. The control system provides centralized touch panel and voice control of medical devices for use by the surgeon and O.R. staff.

Device Story

Computer-based system for centralized management of operating room equipment; inputs include touch panel activations and voice commands via wireless microphone; system components include Medical Device Controller, Medical Device Hub, Primary and Surgical Touch Panel Interfaces, Ethernet router, and AVB network hub; transforms user inputs into control signals for connected medical/non-medical devices; displays device settings and status on surgeon's monitor; used in OR by surgeons and staff; facilitates centralized workflow; improves efficiency by allowing remote control of multiple devices from a single interface.

Clinical Evidence

Bench testing only. Performance testing demonstrated equivalent outcomes for centralized and remote control of medical devices in the OR compared to predicate systems. Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, UL 60601-1, and CAN/CSA 22.2 No. 601.1 standards.

Technological Characteristics

Computer-based system; components include controller, hub, touch panel interfaces, Ethernet router, and AVB network hub. Connectivity via Ethernet/AVB network. Complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, UL 60601-1, and CAN/CSA 22.2 No. 601.1. Features touch panel and optional voice recognition engine.

Indications for Use

Indicated for use by surgeons and O.R. staff to provide centralized control and status display of compatible endoscopic and surgical equipment.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Olympus EndoALPHA Integrated Endosurgery System (K981993)
• HERMES Operating Room Control Center (K990691)
• Sidne™ System (K022393)

Submission Summary (Full Text)

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975 749 1000 973 749 1599 Fax www.smith-nephow.com

NOV 2 3 2005

We are smith&nephew
K050209

# SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

# Smith & Nephew Control Digital Operating Room System

Date Prepared: January 27, 2005

## A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

# B. Company Contact

Janice Haselton Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

# C. Device Name

| Trade Name: | Smith & Nephew Control Digital Operating Room System |
|----------------------|-------------------------------------------------------------------------------------------------------------|
| Common Name: | Endoscopes and accessories, Arthroscopes, Electrosurgical<br>cutting and coagulation device and accessories |
| Classification Name: | General and Plastic Surgery, Orthopedic,<br>Gastroenterology/Urology |

## D. Predicate Devices

The Smith & Nephew Control Digital Operating Room System is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Olympus EndoALPHA

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Integrated Endosurgery System, cleared in K981993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne™ System, cleared in K022393.

#### Description of Device E.

The proposed Smith & Nephew Control Digital Operating Room System is a computer based system that enables centralized status display and control of multiple medical and non-medical devices through touch panel activation or through an optional voice recognition feature. The primary system consists of a Medical Device Controller, Medical Device Hub, Primary Touch Panel Interface (TPI-P), Surgical Touch Panel Interface (TPI-S), Ethernet Router and AVB network hub and AVB Power Supply.

Optional components include:

- speech recognition engine ●
- a wireless microphone for speech recognition .
- a wireless touch screen interface that can be bagged and placed in the . sterile field
- . a display controller which allows device settings and conditions to be displayed on the surgeon's monitor

#### F. Intended Use

The Smith & Nephew Control Digital Operating Room System is indicated for use with compatible endoscopic and surgical equipment for centralized control of these devices and display of device status. The control system provides centralized touch panel and voice control of medical devices for use by the surgeon and O.R. staff.

## G. Comparison of Technological Characteristics

The Smith & Nephew Control Digital Operating Room System is substantially equivalent to the Olympus EndoALPHA Integrated Endosurgery System, cleared in K981993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne™ System, cleared in K022393 based on the following similarities:

- a central controller which monitors and controls various medical devices .
- a centralized control panel which displays various medical devices used in . the operating room
- remote control of various medical devices via a touch screen panel ●
- . voice activation and control of various medical devices used in the operating room

## H. Summary Performance Data

The performance testing conducted on the Smith & Nephew Control Digital. Operating Room System demonstrates substantial equivalence to the Olympus

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EndoALPHA Integrated Endosurgery System, cleared in K981993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne™ System. cleared in K022393 based on equivalent performance outcomes of centralized and remote control of medical devices in the O.R.

The Smith & Nephew Control Digital Operating Room System conforms to the following voluntary standards:

IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety (1988) + Amendment 1 (1991) + Amendment 2 (1995) (UL 2601-1)

IEC 60601-1-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, Safety Requirements for Medical Electrical Systems (1992) + Amendment 1 (1995), (2000)

IEC 60601-1-2 (2001-09) 2nd Edition Medical Electrical Equipment - Part I: General Requirements for Safety; Electromagnetic Compatibility - Requirements & Tests (2001)

UL 60601-1 (2003): Medical Electrical Equipment - Part 1: General Requirements for Safety

CAN/CSA 22.2 No. 601.1 Medical Electrical Equipment - Part 1: General Requirements for Safety (1990) + Supplement No. 1-94 (1994)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is presented in black and white.

NOV 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janice Haselton, Sr. Regulatory Affairs Specialist Smith & Nephew, Inc. 150 Minuteman Road Andover, Massachusetts 01810

Re: K050209

K030207
Trade/Device Name: Smith & Nephew Control Digital Operating Room System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 17, 2005 Received: October 18, 2005

Dear Ms. Haselton:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatinent date of the Medical Device Amendments, or to conninered print to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic recry there the device, subject to the general controls provisions of the Act. The 1 ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controls profice, 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 can be found in the concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toast of advised that I Dr o toseantes over device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I caeral statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or N in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualify of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Janice Haselton

This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier will anow you to ough finding of substantial equivalence of your device to a legally premarket notification "The 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 11 you desire specific daries in [phone] . Also, please note the regulation entitled, Contact the Ories of Companisemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,
Kaubere Invelun

Mark N. Melkersen Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):

1050209

Device Name: __ The Smith & Nephew Control Digital Operating Room System__

Indications For Use:

The Smith & Nephew Control Digital Operating Room System is indicated for use with compatible endoscopic and surgical equipment for centralized control of these devices and display of device status. The control system provides centralized touch panel and voice control of medical devices for use by the surgeon and O.R. staff.

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

Over-The-Counter Use ------

(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)

Barbara Buehler MXM
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

**510(k) Number** K050209