(175 days)
Yes
The device description explicitly states that the application "recognizes commands spoken by the user," which is a core function of speech recognition technology. While not explicitly stating "AI" or "ML," speech recognition systems commonly utilize machine learning algorithms for accurate voice command processing. The predicate device also indicates a "Speech Control Option," further supporting the use of speech recognition technology.
No
The device is a speech control application that enables users to control surgical equipment and adjust device parameters through voice commands. It does not directly treat or diagnose any medical condition, nor does it deliver any therapeutic intervention. Its function is purely operational for controlling other medical devices.
No
The device is a speech control application that enables users to control surgical equipment and adjust device parameters by voice. It does not perform any diagnostic functions like analyzing medical images or patient data to identify diseases or conditions.
Yes
The device is described as an "independent application" that works in the background of existing software (SCB R-UI) and controls devices by recognizing spoken commands and sending corresponding commands. This functionality is purely software-based, acting as an interface and control layer. While it interacts with hardware (endoscopic and surgical equipment), the device itself, as described, is the software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for speech control of surgical equipment and adjusting device parameters. This is a control function for medical devices used during a procedure, not for analyzing biological samples in vitro to diagnose or monitor a medical condition.
- Device Description: The description confirms it's a speech recognition application that controls other medical devices. It doesn't mention any interaction with biological samples or diagnostic testing.
- Lack of IVD Characteristics: The document lacks any mention of typical IVD elements such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Diagnostic or monitoring purposes
- Specific analytes or biomarkers
- Performance metrics related to diagnostic accuracy (sensitivity, specificity, etc.)
Therefore, the Karl Storz VOICE1® SCB R-UI Speech Control Application is a medical device used for controlling other medical devices, not an in vitro diagnostic device.
No
The letter does not mention a Predetermined Change Control Plan (PCCP) at all, let alone explicitly state that one has been reviewed, approved, or cleared by the FDA for this specific device.
Intended Use / Indications for Use
The Karl Storz VOICE1® SCB R-UI Speech Control Application is indicated for use in speech control of Karl Storz-approved devices and peripherals in conjunction with the Karl Storz SCB® R-UI software.
Product codes (comma separated list FDA assigned to the subject device)
ODA
Device Description
The Karl Storz VOICE1® SCB R-UI Speech Control Application is an independent application that works in the background of the SCB R-UI. VOICE1® recognizes commands spoken by the user and sends corresponding commands to the SCB R-UI system, enabling the user to control endoscopic and other ancillary surgical equipment and adjust device parameters entirely by speech control.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Karl Storz SCB R-UI Speech Control Option SCO (K003113)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Karl Storz SCB R-UI SCO (K994348)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
600 Corporate Pointe
Culver City, CA 90230-7600
Phone: (310) 338-8100
Fax: (310) 410-5519 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Crystal Dizol
Regulatory Affairs Specialist
Email: cdizol@ksea.com |
| 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
independent application that works in the background of the SCB R-UI.
VOICE1® recognizes commands spoken by the user and sends
corresponding commands to the SCB R-UI system, enabling the user to
control endoscopic and other ancillary surgical equipment and adjust
device parameters entirely by speech control. |
| Indications for Use: | The Karl Storz VOICE1® SCB R-UI Speech Control Application is
indicated for use in speech control of Karl Storz-approved devices and
peripherals in conjunction with the Karl Storz SCB® R-UI software. |
| Technological
Characteristics: | The Karl Storz VOICE1® SCB R-UI Speech Control Application is
software designed for use with the Karl Storz OR1® Control Computer
and Karl Storz SCB R-UI software. VOICE1 has a speech recognition
component, a software bus, and graphical and auditory user interfaces. |
| Summary of
Subtantial
Equivalence: | The Karl Storz VOICE1® SCB R-UI Speech Control Application is
substantially equivalent to the predicate device since the basic functions
user interactions, and device types controlled are similar. The minor
differences between the Karl Storz VOICE1® SCB R-UI Speech Control
Application and the predicate device raise no new issues of safety and
effectiveness. For a comparison between the Karl Storz VOICE1® SCB
R-UI Speech Control Application and the predicate device, refer to the
attached substantial equivalence chart. |
Att: Substantial Equivalence Table for Karl Storz VOICE1® SCB R-UI Speech Control Application
:
ﺒ 1
1
STORZ ENDOSCOPY
UBSTANTIAL EQUIVALENCE TABLE FOR KARL STORZ VOICE1® SCB R-JI SPEECH CONTROL APPLICATION
| Device | | Karl Storz SCB R-UI SCO
(K994348) |
|--------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Device Type | Karl Storz VOICE1®
SCB R-UI Speech Control Application | Software to provide voice control of SCB
networked devices |
| User Input | | Microphone, Touch-screen |
| | | Light sources: Xenon 175, Xenon 300 |
| | | Cameras: Tricam SL, Telecam SL |
| Devices
Controlled | | Insufflators: Electronic Endoflator, Thermoflator |
| | | Image processors: Reverse Video |
| | | Pumps: Hamou Endomat, Hamou Micro-
Hysteroflator, Uropump, Unimat 45 |
| | | Lithotriptors: Calcusplit |
| | | Insufflators: Electronic Endoflator, Thermoflator |
| | Documentation Systems: AIDA 2.x, AIDA DVD-M,
AIDA Compact II | |
| | Environmental Devices: Media Control (Room
Light, Surgical Light, Telephone) | |
| Added Functions | | No new functions added to controlled devices |
| Other Software
Requirements | | SCB R-UI Software must be installed |
| Intended use | | For use in conjunction with Karl Storz SCB R-UI
software to provide speech control of compatible
devices connected to the SCB network |
K083598 Hgegfz
2
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.
3
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) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 (800) 638-2041 or (240) 276-3150 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
4
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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