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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the ConMed Integrated Systems Nurse's Assistant® O.R. Control System, 1.8. It focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics.

Crucially, this document does not contain information about acceptance criteria, device performance metrics, sample sizes, expert ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).

The document explicitly states: "Clinical testing is not required for this device." This indicates that the regulatory submission was based on non-clinical performance (e.g., electrical safety, electromagnetic compatibility) and a comparison of technological characteristics and intended use to previously cleared devices, rather than a study involving patient data or human readers.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Not available. The document does not specify performance acceptance criteria or report device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy). Its focus is on demonstrating safety and efficacy through equivalence to predicate devices and compliance with non-clinical standards.

2. Sample size used for the test set and the data provenance:

Not applicable. Clinical testing with a test set of data (patients/images) was not conducted or required for this device according to the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As no clinical testing was performed, there was no need for experts to establish ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. The document explicitly states "Clinical testing is not required for this device." An MRMC study would fall under clinical testing. Furthermore, this device is an O.R. control system, not an AI-powered diagnostic, so the concept of human readers improving with AI assistance is not relevant to its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. The device is an O.R. Control System; it's not an "algorithm" in the sense of an AI diagnostic. The document focuses on hardware, proprietary software, and its ability to route signals and control medical equipment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. No clinical ground truth data was used as clinical testing was not conducted. The assessment relied on a comparison of technical specifications and intended use against predicate devices.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that would typically be 'trained' on a dataset in the way a diagnostic AI is. Its software is proprietary, but its development would follow standard software engineering practices rather than machine learning training.

9. How the ground truth for the training set was established:

Not applicable. As above, the concept of a 'training set' and 'ground truth' for training is not relevant to this type of device according to the provided documentation.

In summary, the provided FDA 510(k) summary focuses entirely on demonstrating substantial equivalence through non-clinical means (technical specifications, intended use comparison, and compliance with general safety standards), explicitly stating that clinical testing was not required for this device.

Summary

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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

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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 (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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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:

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

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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, 1.8Nurse'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:

1. ConMed Integrated Systems Nurse's Assistant® 1.7 O.R. Control System - K060717
1. Stryker SwitchPoint Infinity System K033132
1. Karl Storz OR1 SCB Interface Control K070827

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Device Description: E.

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.

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Regulation Number and Section

§ 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.