(17 days)
Not Found
No
The description focuses on centralized control and video routing, with no mention of AI/ML terms or capabilities.
No.
The device is a control system for operating room equipment, routing video, and managing settings, rather than directly treating a disease or condition.
No
The device is described as a computerized control system that provides a user interface to activate, adjust, and monitor OR equipment settings and route video. It does not perform any analysis or interpretation of medical data to diagnose a condition.
No
The device is described as a "computerized control system" that interacts with and controls various pieces of hardware (endoscopic cameras, light sources, insufflators, ESUs, displays, printers, VCRs, etc.). While it likely includes software, its primary function is to control and route signals between hardware components, making it a system that includes both hardware and software, not a software-only device.
Based on the provided information, the Nurse's Assistant® 1.7 O.R. Control System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route video from multiple sources to multiple destinations." This describes a system for managing and controlling other medical devices and video feeds within an operating room.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Lack of Specimen Analysis: The description of the Nurse's Assistant® 1.7 O.R. Control System does not mention any analysis of biological specimens (blood, tissue, etc.). Its function is to control and route information from other devices, not to perform diagnostic tests on patient samples.
Therefore, the Nurse's Assistant® 1.7 O.R. Control System falls under the category of a medical device used in the operating room for managing equipment and video, not an IVD device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route video from multiple sources to multiple destinations.
The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in an operating room for video assisted surgery. This includes minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques and traditional open procedures.
The Nurse's Assistant 1.7 O.R. Control System indicated for use with ConMed Linvatec IM3300 Endoscopic Camera, ConMed Linvatec LS7500 Xenon Light Source, ConMed Linvatec GS1002 40L Insufflator, ConMed Electrosurgery System 5000 Electrosurgery Unit (ESU), ConMed Linvatec VP-1500 Digital Capture Device, Getinge ALM Surgical Lamp Energix WPS, Getinge ALM PrismaVision PRV3 Surgical Light Camera, Berchtold Chromophare D-Series Surgical Lamps, Berchtold ChromoVision HR24 Surgical Light Camera, National Display Systems 15" & 18" Vector III and 19" Radiance flat panel displays, Sony LMD-2140MD 21" flat panel display, Sony UP-51MD or Sony UP-51MDU video printers, Sony SVO-9500MD VCR, and ProVation™ procedure documentation device.
The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharyngoscopy, ear endoscopy and sinusoscopy.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
Not Found
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
operating room (OR) 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests performed on the Modification to Nurse's Assistant® 1.7 O.R. Control System demonstrate substantial equivalence to the predicate devices listed above.
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.
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.
Not Found
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
Nurse's Assistant® 1.7B O.R. Control System 510(k) #: __ Kosz740
September 29, 2005
Page 1 of 2
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 a Special 510(k) Summary of Safety and Effectiveness for the Nurse's Assistant 9 1.7B O.R. Control System.
A. Submitter:
ConMed Integrated Systems Registration Number: 3031835
B. Company Contact:
C. Jeff Lipps Director of Regulatory Affairs and Quality Assurance 1815 NW 169th Place, Suite 4020 Beaverton, OR 97006 503-614-1106 Phone 503-614-1109 Fax
். Device Name:
| Proprietary Name: | Nurse's Assistant® 1.7 O.R. Control System |
|---|---|
| Trade Name: | Nurse's Assistant® 1.7 |
| Common Name: | Surgical Control Center |
| Classification Names: | 876.1500 - Endoscope and accessories |
| Proposed Class/Device: | Class II |
| Product Codes: | GCJ |
D. Predicate/Legally Marketed Devices:
-
- ConMed Integrated Systems Nurse's Assistant 1.7 O.R. Control System - K050829
-
- Computer Motion, Inc. HERMES O.R. Control Center K030240
CONFIDENTIAL 0014
1
Page 2 of 2
Intended Use / Indications for Use: E.
The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route video from multiple sources to multiple destinations.
The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in an operating room for video assisted surgery. This includes minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques and traditional open procedures.
The Nurse's Assistant 1.7 O.R. Control System indicated for use with ConMed Linvatec IM3300 Endoscopic Camera, ConMed Linvatec LS7500 Xenon Light Source, ConMed Linvatec GS1002 40L Insufflator, ConMed Electrosurgery System 5000 Electrosurgery Unit (ESU), ConMed Linvatec VP-1500 Digital Capture Device, Getinge ALM Surgical Lamp Energix WPS, Getinge ALM PrismaVision PRV3 Surgical Light Camera, Berchtold Chromophare D-Series Surgical Lamps, Berchtold ChromoVision HR24 Surgical Light Camera, National Display Systems 15" & 18" Vector III and 19" Radiance flat panel displays, Sony LMD-2140MD 21" flat panel display, Sony UP-51MD or Sony UP-51MDU video printers, Sony SVO-9500MD VCR, and ProVation™ procedure documentation device.
The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharyngoscopy, ear endoscopy and sinusoscopy.
Substantial Equivalence / Device Technological Characteristics and ட் Comparison to Predicate Device(s):
The Modification to Nurse's Assistant® 1.7 O.R. Control System has the same intended use and similar indications for use as the predicate device ConMed Integrated Systems Nurse's Assistant 1.7 O.R. Control System (K050829) and Computer Motion's HERMES O.R. Control Center (K030240)..
The technological characteristics of the Modification to Nurse's Assistant® 1.7 O.R. Control System are equivalent to the predicate devices listed above.
Tests performed on the Modification to Nurse's Assistant® 1.7 O.R. Control System demonstrate substantial equivalence to the predicate devices listed above.
The Modification to Nurse's Assistant® 1.7 O.R. Control System is substantially equivalent to the predicate devices in terms of safety, effectiveness, and performance.
Page 2 of 2 0015
Image /page/1/Picture/13 description: The image shows the word "CONFIDENTIAL" in all caps. The letters are bold and black, and the background is white. The word is centered in the image.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of four stylized human figures, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
0CT 17 2005
C. Jeff Lipps Director, RA/QA ConMed Integrated Systems 1815 NW 169th Place, Suite 4020 Beaverton, Oregon 97006
Re: K052740
R032740
Trade/Device Name: Modification to Nurse's Assistant® 1.7 O.R. Control System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: September 29, 2005 Received: September 30, 2005
Dear Mr. Lipps:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use black in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the corner of Hay 2011 de need that have been that do not require approval of a premarket approval application (PMA). and Cosmetic For (110) interest the device, subject to the general controls provisions of the Act. The r ou may) attress, sinces, and include requirements for annual registration, listing of general one profice 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 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 r 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); 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- C. Jeff Lipps
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
2
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(K) # (if known): K052740
Device Name: Modification to Nurse's Assistant® 1.7 O.R. Control System
Indications for Use:
:
The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from intendou to provide open and monitor certain settings of equipment located in the OR and to route video from multiple sources to multiple destinations.
The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in an operating room The Nurse's Assisted surgery. This includes minimally invasive procedures in all surgical for video abonot cargenct display of interventional techniques and traditional open procedures.
The Nurse's Assistant® 1.7 O.R. Control System indicated for use with ConMed Linvatec The Natise S Assiblant - 1. Port ConMed Linvatec LS7500 Xenon Light Source, ConMed IM000 Endoooplo CanMed Electrosurgery System 5000 Electrosurgery System 5000 Electrosurgery Unit (ESU), ConMed Linvatec VP-1500 Digital Capture Device, Getinge ALM Surgical Lamp (ESO), OonMod Entration PRV3 Surgical Light Camera, Berchtold Chromophare D-Series Surgical Lamps, Berchtold ChromoVision HR24 Surgical Light Chromophare D Centre D Connell Land Systems 15 & 18 Vector III and 19 Radiance flat panel Oamera, Nationar Dioplay Of flat panel display, Sony UP-51MD or Sony UP-51MDU displays, Jony EMD END ENR, and ProVation™ procedure documentation device.
The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and cardiovasoular, ENT, gastronal thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharyngoscopy, ear endoscopy and sinusoscopy.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR 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)
signature
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K 052740