KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION

K083598 · KARL STORZ Endoscopy-America, Inc. · ODA · May 29, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K083598
• Device Name: KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: ODA · Gastroenterology, Urology
• Decision Date: May 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Karl Storz VOICE1® SCB R-UI Speech Control Application is indicated for use in speech control of Karl Storz-designated devices and peripherals in conjunction with the Karl Storz SCB® R-UI software.

Device Story

VOICE1® SCB R-UI Speech Control Application is a software-based tool operating in the background of the Karl Storz SCB R-UI system. It accepts voice commands from the user via microphone input; processes these commands to control endoscopic and ancillary surgical equipment (e.g., light sources, cameras, insufflators, pumps, documentation systems, environmental controls) connected to the SCB network. The device is used in the operating room by surgical staff to adjust device parameters hands-free. By enabling speech-based control, it allows surgeons and staff to manage surgical equipment without manual interaction, potentially improving workflow efficiency and maintaining sterile fields.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and bench testing of the software application.

Technological Characteristics

Software application designed for the Karl Storz OR1® Control Computer and SCB R-UI software. Components include a speech recognition engine, software bus, and graphical/auditory user interfaces. Operates as a networked control system for endoscopic peripherals.

Indications for Use

Indicated for speech control of Karl Storz-approved devices and peripherals in conjunction with Karl Storz SCB® R-UI software in a surgical environment.

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

• Karl Storz SCB R-UI Speech Control Option SCO (K003113)

Reference Devices

• Karl Storz SCB R-UI SCO (K994348)

Submission Summary (Full Text)

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K083598 page 1 of 2

MAY 2 9 2009

Image /page/0/Picture/2 description: The image shows the logo for Karl Storz Endoscopy. The logo is black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ ENDOSCOPY" in smaller letters. There is a line underneath the phrase "KARL STORZ ENDOSCOPY".

# 510(k) SUMMARY

| Sponsor/Submitter: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe<br>Culver City, CA 90230-7600<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Crystal Dizol<br>Regulatory Affairs Specialist<br>Email: [e-mail] |
| Date of Submission: | December 5, 2008 |
| Device Trade Name: | Karl Storz VOICE1® SCB R-UI Speech Control Application |
| Common Name: | Endoscopic central control unit |
| Classification Name: | Endoscope and accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | ODA |
| Predicate Device(s): | Karl Storz SCB R-UI Speech Control Option SCO (K003113) |
| Device Description: | The Karl Storz VOICE1® SCB R-UI Speech Control Application is an<br>independent application that works in the background of the SCB R-UI.<br>VOICE1® recognizes commands spoken by the user and sends<br>corresponding commands to the SCB R-UI system, enabling the user to<br>control endoscopic and other ancillary surgical equipment and adjust<br>device parameters entirely by speech control. |
| Indications for Use: | The Karl Storz VOICE1® SCB R-UI Speech Control Application is<br>indicated for use in speech control of Karl Storz-approved devices and<br>peripherals in conjunction with the Karl Storz SCB® R-UI software. |
| Technological<br>Characteristics: | The Karl Storz VOICE1® SCB R-UI Speech Control Application is<br>software designed for use with the Karl Storz OR1® Control Computer<br>and Karl Storz SCB R-UI software. VOICE1 has a speech recognition<br>component, a software bus, and graphical and auditory user interfaces. |
| Summary of<br>Subtantial<br>Equivalence: | The Karl Storz VOICE1® SCB R-UI Speech Control Application is<br>substantially equivalent to the predicate device since the basic functions<br>user interactions, and device types controlled are similar. The minor<br>differences between the Karl Storz VOICE1® SCB R-UI Speech Control<br>Application and the predicate device raise no new issues of safety and<br>effectiveness. For a comparison between the Karl Storz VOICE1® SCB<br>R-UI Speech Control Application and the predicate device, refer to the<br>attached substantial equivalence chart. |

Att: Substantial Equivalence Table for Karl Storz VOICE1® SCB R-UI Speech Control Application

:

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STORZ ENDOSCOPY

UBSTANTIAL EQUIVALENCE TABLE FOR KARL STORZ VOICE1® SCB R-JI SPEECH CONTROL APPLICATION

| Device | | Karl Storz SCB R-UI SCO<br>(K994348) |
|--------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Device Type | Karl Storz VOICE1®<br>SCB R-UI Speech Control Application | Software to provide voice control of SCB<br>networked devices |
| User Input | | Microphone, Touch-screen |
| | | Light sources: Xenon 175, Xenon 300 |
| | | Cameras: Tricam SL, Telecam SL |
| Devices<br>Controlled | | Insufflators: Electronic Endoflator, Thermoflator |
| | | Image processors: Reverse Video |
| | | Pumps: Hamou Endomat, Hamou Micro-<br>Hysteroflator, Uropump, Unimat 45 |
| | | Lithotriptors: Calcusplit |
| | | Insufflators: Electronic Endoflator, Thermoflator |
| | Documentation Systems: AIDA 2.x, AIDA DVD-M,<br>AIDA Compact II | |
| | Environmental Devices: Media Control (Room<br>Light, Surgical Light, Telephone) | |
| Added Functions | | No new functions added to controlled devices |
| Other Software<br>Requirements | | SCB R-UI Software must be installed |
| Intended use | | For use in conjunction with Karl Storz SCB R-UI<br>software to provide speech control of compatible<br>devices connected to the SCB network |

K083598 Hgegfz

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle, with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Crystal K. Dizol Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 2151 E. Grand Avenue EL SEGUNDO CA 90245

# MAY 2 9 2009

Re: K083598

> Trade Name: VOICE1® SCB R-UI Speech Control Application Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODA Dated: May 25, 2009 Received: May 27, 2009

Dear Ms. Dizol:

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 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); 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.

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Page 2

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 one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

[signature]

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number (if known): Not yet assigned

Karl Storz VOICE1® SCB R-Ul Speech Control Application Device Name:

Indications for Use:

The Karl Storz VOICE1® SCB R-UI Speech Control Application is indicated for use in speech control of Karl Storz-designated devices and peripherals in conjunction with the Karl Storz SCB® R-UI software.

Prescription Use:
(21 CFR 801 Subpart D) AND/OR Over-The-Counter Use:
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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