(57 days)
No
The summary describes a system for routing audio/video signals and controlling equipment in an operating room, with no mention of AI or ML capabilities.
No
The device primarily routes audio and video signals and performs auxiliary control functions for other equipment, rather than directly treating a condition or disease. It is an "adjunct display" and control system for other medical devices used in surgery.
No
The device is described as an O.R. Control System that routes audio and video signals and performs auxiliary control functions for activating, adjusting and monitoring settings of compatible medical and non-medical equipment. It is intended for use in an operating room for video-assisted surgery and as an adjunct display of interventional techniques. It does not perform any diagnostic functions like analyzing patient data to determine the presence or nature of a disease or condition.
No
The device description explicitly states it is composed of "off-the-shelf audio/video hardware components" in addition to proprietary software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Nurse's Assistant® O.R. Control System, 1.8 is described as a system for routing audio and video signals, controlling equipment settings, and providing teleconferencing capabilities within an operating room. Its function is to manage and integrate various pieces of equipment during surgical procedures.
- Lack of Specimen Analysis: There is no mention of this device collecting, preparing, or analyzing any specimens from the human body. Its purpose is operational control and signal management, not diagnostic testing based on biological samples.
Therefore, the intended use and device description clearly indicate that this system is for managing the operating room environment and equipment, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Nurse's Assistant® O.R. Control System, 1.8 is a programmable electrical medical system that is intended to provide trained staff with a centralized user interface from which to route audio and video signals, and to perform auxiliary control functions for activating, adjusting and monitoring certain settings of compatible medical and non-medical equipment.
The Nurse's Assistant® O.R. Control System, 1.8 is Indicated for use in an operating room for video assisted surgery during minimally invasive and traditional open procedures in all surgical specialities. The System is also used as an adjunct display of interventional techniques and provides teleconferencing capability through an optional interface.
Product codes
GCJ, OCS
Device Description
The Nurse's Assistant® O.R. Control System, 1.8, is a modification of an existing device that is composed of off-the-shelf audio/video hardware components, proprietary software that runs on a non-Windows based operating system and a touch panel interface with an intuitive graphical user interface. The Nurse's Assistant® System 1.8 communicates with interconnected devices through standard data communication protocols which allows the adjustment of equipment settings and routing of audio/video signals from one location in the operating room.
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
trained staff; operating room
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
Clinical testing is not required for this device.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of stylized lines and curves.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ConMed Integrated Systems Mr. C. Jeff Lipps Director, Regulatory Affairs and Quality Assurance 1815 NW 169th Place, Suite 4020 Beaverton, OR 97006
JUL 27 2015
K091648 Trade/Device Name: Nurse's Assistant® O.R. Control System, 1.8 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, OCS Dated (Date on orig SE ltr): July 22, 2009 Received (Date on orig SE ltr): July 28, 2009
Dear Mr. Lipps,
Re:
This letter corrects our substantially equivalent letter of August 5, 2009.
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 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
1
Page 2 -
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 (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
2
INTENDED USE / INDICATIONS FOR USE
Co91648
510(K) #: K091648
Device Name: Nurse's Assistant® O.R. Control System, 1.8
Intended Use /Indications for Use:
The Nurse's Assistant® O.R. Control System, 1.8 is a programmable electrical medical system that is intended to provide trained staff with a centralized user interface from which to route audio and video signals, and to perform auxiliary control functions for activating, adjusting and monitoring certain settings of compatible medical and non-medical equipment.
The Nurse's Assistant® O.R. Control System, 1.8 is Indicated for use in an operating room for video assisted surgery during minimally invasive and traditional open procedures in all surgical specialities. The System is also used as an adjunct display of interventional techniques and provides teleconferencing capability through an optional interface.
Prescription Use (Part 21 CFR 801.109 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)
Mil Ra Bancurition Coroneur CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091648
Page 1 of 1
3
Ka.91648
Page. 1 of 2
AUG 0 5 2009
22 July 2009
Nurse's Assistant® O.R. Control System, 1.8 510(k) #: K091648
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Integrated Systems is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Nurse's Assistant® O.R. Control System, 1.8.
Manufacturer: A.
ConMed Integrated Systems 1815 NW 169th Place, Suite 4020 Beaverton, OR, USA 97006 FDA Establishment Registration Number: 3031835
Company Contact: в.
C. Jeff Lipps Director of Regulatory Affairs and Quality Assurance 503-614-1106 Phone 503-614-1109 Fax
C. Device Name:
| Trade Name: | Nurse's Assistant® O.R. Control System, 1.8
Nurse's Assistant® System 1.8 |
|------------------------|------------------------------------------------------------------------------|
| Common Name: | Surgical Control Center |
| Classification Names: | 876.1500 – Endoscope and accessories |
| Proposed Class/Device: | Class II |
| Product Codes: | GCJ, KOG |
D. Predicate/Legally Marketed Devices:
-
- ConMed Integrated Systems Nurse's Assistant® 1.7 O.R. Control System - K060717
-
- Stryker SwitchPoint Infinity System K033132
-
- Karl Storz OR1 SCB Interface Control K070827
4
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Page 2 of 2
Device Description: E.
The Nurse's Assistant® O.R. Control System, 1.8, is a modification of an existing device that is composed of off-the-shelf audio/video hardware components, proprietary software that runs on a non-Windows based operating system and a touch panel interface with an intuitive graphical user interface. The Nurse's Assistant® System 1.8 communicates with interconnected devices through standard data communication protocols which allows the adjustment of equipment settings and routing of audio/video signals from one location in the operating room.
Intended Use:
The Nurse's Assistant® O.R. Control System, 1.8, is a programmable electrical medical system that is intended to provide trained staff with a centralized user interface from which to route audio and video signals, and to perform auxiliary control functions for activating, adjusting and monitoring certain settings of compatible medical and non-medical equipment.
Indications for Use:
The Nurse's Assistant® O.R. Control System, 1.8, is indicated for use in an operating room for video assisted surgery during minimally invasive and traditional open procedures in all surgical specialties. The System is also used as an adjunct display of interventional techniques and provides teleconferencing capability through an optional interface.
Device Technological Characteristics to Predicate Devices: E.
The Nurse's Assistant® O.R. Control System, 1.8, has the same intended use and technological characteristics as the predicate devices.
Performance Standards, Voluntary Standards, Clinical Testing: ુ.
There are no applicable mandatory performance standards established for this type of device. The Nurse's Assistant® O.R. Control System, 1.8, complies with UL 60601-1, 1st Edition and EN 60601-1-2 and additional voluntary consensus standards detailed in the submission. Clinical testing is not required for this device.
H. Conclusion:
The technological differences between the Nurse's Assistant® O.R. Control System, 1.8, the Nurse's Assistant® 1.7 O.R. Control System, Stryker Switchpoint Infinity and Karl Storz OR1 SCB Interface Control raise no new concerns for safety or efficacy. The Nurse's Assistant® O.R. Control System, 1.8 is substantially equivalent to the identified predicate devices.
Image /page/4/Picture/14 description: The image shows a black square with a white crescent shape inside. The crescent shape is positioned in the upper left corner of the square and curves downward and to the right. The image is simple and abstract, with a high contrast between the black background and the white shape.