(237 days)
Not Found
No
The document describes a system for controlling endoscopic equipment via voice, touch, or remote control, focusing on integration and user interface. There is no mention of AI, ML, image processing, or data analysis that would typically indicate the presence of AI/ML technology.
No
The device is described as controlling an operating system and various endoscopy devices. It does not perform any therapeutic action on a patient.
No
The device is described as controlling an operating system and various endoscopy devices. It doesn't perform any diagnostic function itself; instead, it facilitates the control of equipment used in diagnostic and therapeutic endoscopy.
No
The device description explicitly mentions controlling the system using a "remote control unit" and "touch screen monitor," which are hardware components. While software is involved in the control interface, the system includes physical hardware beyond a general-purpose computing platform.
Based on the provided information, the RIWO NET SYSTEM 5590 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "controlling an operating system by voice control, touch screen monitor or remote control unit in diagnostic and therapeutic endoscopy." This describes a system for managing and controlling other medical devices used during a procedure, not a device that performs tests on biological samples in vitro (outside the body).
- Device Description: The description reinforces this by explaining it provides "central user control of an endoscopic operating system" and controls "various endoscopy devices." This is about system management and control, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The RIWO NET SYSTEM 5590 does not fit this definition.
N/A
Intended Use / Indications for Use
The RIWO NET System 5590 is used for controlling an operating system by voice control, touch screen monitor or remote control unit in diagnostic and therapeutic endoscopy.
Product codes
ODA
Device Description
The RIWO NET System 5590 provides central user control of an endoscopic operating system using either voice or remote control from the sterile area or touch screen monitor. The RIWO NET System controls various endoscopy devices by uniform graphical user interface, such as light sources, cameras, insufflators, video recorders, etc.
Mentions image processing
Not Found
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)
No clinical tests performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K994231, K981993, K980787, K002328
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Richard Wolf Medical Instruments Corporation Robert L. Casarsa Quality Assurance Manager 353 Corporate Woods Parkway Vernon Hills, IL 60061
Re: K020255 Trade/Device Name: RIWO NET Operating Control System Model #5590 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODA Dated (Date on orig SE ltr): August 1, 2002 Received (Date on orig SE ltr): August 2, 2002
JUL 2,7, 2015
Dear Mr. Casarsa,
This letter corrects our substantially equivalent letter of September 18, 2002.
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
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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); medical device 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5.0 INDICATIONS FOR USE
510(k) Number (if known): -- K020255
Device Name: RIWO NET System 5590
Intended use:
The RIWO NET SYSTEM 5590 is used for controlling an operating system by voice control, touch screen monitor or remote control unit in diagnostic and therapeutic endoscopy.
(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 General, Restorative and Neurological Devices
510(k) Number K020255
OR
Over-The Counter
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Prescription Use Per 21 CFR 801 109
3
$\kappa_{0}255\sqrt{}$
SEP 1 8 2002
353 Corporate Woods Parkway Vernon Hills, II. 6006 i
Phone: 847-913-1113 Customer Service: 800-323-WOLF www.richard-wolf.com
Image /page/3/Picture/3 description: The image shows the logo for Richard Wolf Medical Instruments Corporation. The logo features the words "RICHARD WOLF" in bold, sans-serif font, with "RICHARD" stacked above "WOLF". To the right of the text is a square containing a stylized image of a wolf. Below the text is the phrase "Medical Instruments Corporation" in a smaller, sans-serif font.
12.0 510(k) Summary of Safety and Effectiveness
| Submitter: | |
|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | IL 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | January 22, 2002 |
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | (847) 913 1113 |
| FAX number (include area code): | (847) 913 0924 |
| Product Information: | |
| Trade name: | RIWO NET Operating Control System |
| Model number: | 5590.xxx |
| 32115.xxx | |
| Common name: | Operating Control System RIWO NET, remote and voice control, CAN bus |
| Classification name: | Endoscope and/or Accessories |
| Information on devices to which substantial equivalence is claimed: |
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 K994231 | 1 SIEMENS Integrated Operating System (SIOS) | 1 Siemens |
| 2 K981993 | 2 EndoALPHA Integrated Endosurgery System | 2 Olympus |
| 3 K980787 | 3 HERMES Operating Room Control Center | 3 Computer Motion |
| 4 | 4 Operation Room Control OR1/ SCB PC | 4 Karl Storz |
| 5 K002328 | 5 SIOS-Interface for Light Projector, Camera, Insufflator | 5 Richard Wolf |
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Description 1.0
The RIWO NET System 5590 provides central user control of an endoscopic operating system using either voice or remote control from the sterile area or touch screen monitor. The RIWO NET System controls various endoscopy devices by uniform graphical user interface, such as light sources, cameras, insufflators, video recorders, etc.
2.0 Intended Use
The RIWO NET SYSTEM 5590 is used for controlling an operating system by voice control, touch screen monitor or remote control unit in diagnostic and therapeutic endoscopy.
Technological Characteristics 3.0
The connected endoscopy devices communicate via CAN bus / RS-232 interface. All the connected devices can always be controlled conventional with their buttons furthermore. When they are connected to the master RIWO NET System 5590, the RIWO NET controller recognized the new device automatically and after run-up period, the slave device can be used in the RIWO NET System.
The speech recognition is speaker independent. Various languages are available.
The complete RIWO NET System with endoscopy devices is placed in a mobile trolley.
4.0 Substantial Equivalence
The submitted devices are substantial equivalent to devices by Siemens, Olympus, Computer Motion, and Karl Storz. The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness.
5.0 Performance Data
The submitted devices are conforming to the international standards UL-2601-1, IEC60601-1 with Aland A2. IEC 60601-1-1 with A1, IEC 60601-1-2.
6.0 Clinical Tests
By:
No clinical tests performed.
Conclusions Drawn 7.0
These devices are designed and tested to guarantee the safety and effectivencss, when used according to the instructions manual.
Robert Casasa
Robert L. Casarsa Quality Assurance Manager
Date: Jan 22, 2022
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