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 audio and 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" & 32" Radiance flat panel displays, Sony LMD-2140MD 21" flat panel display, Sony UP-51MD or Sony UP-51MDU video printers, Sony SVO-9500MD VCR, ProVation™ procedure documentation device, Skytron Stellar Series Surgical Lights, optional Surgeon's Assistant™ accessory touch panel and an audio/video conferencing interface.

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, nasopharynqoscopy, ear endoscopy and sinusoscopy.

Device Description

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "Nurse's Assistant® 1.7 O.R. Control System (1.7C)". This submission is for a modification to an existing device, and its primary purpose is to demonstrate substantial equivalence to previously marketed predicate devices.

Crucially, the document does NOT contain information about specific acceptance criteria or performance studies in the way one would typically find for a new artificial intelligence or diagnostic device. Instead, the "study" mentioned refers to the testing performed to demonstrate substantial equivalence to predicate devices rather than meeting specific performance metrics against a defined ground truth.

Here's an breakdown based on the information available:

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

Acceptance Criteria: Not explicitly defined in terms of measurable performance metrics (e.g., sensitivity, specificity, accuracy). The implicit "acceptance criteria" is demonstrating substantial equivalence to predicate devices, meaning it operates in a similar manner and has similar safety and effectiveness.
Reported Device Performance: The document states: "Tests performed on the Modification to Nurse's Assistant® 1.7 O.R. Control System demonstrate substantial equivalence to the predicate devices listed above." No specific numerical performance results are provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The type of testing done is focused on the control system's functionality and safety, not on diagnostic performance with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable/not provided. The device is a surgical control system, not an AI or diagnostic tool that requires expert-established ground truth for performance evaluation in the typical sense. The 'ground truth' for such a device would relate to its functional specifications and safe operation, which are evaluated through engineering tests and adherence to standards.

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

This information is not applicable/not provided for the same reasons as point 3.

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. This type of study is not relevant to a surgical control system. The device's purpose is to act as a centralized user interface for OR equipment, not to assist human readers in interpreting images or data.

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

The device itself is a "computerized control system" designed for "operating room (OR) staff with a simple, centralized user interface". It is inherently a human-in-the-loop system. While functional tests of its components would be done standalone, the overall system's purpose is to be used by humans. The document does not detail specific standalone vs. human-in-the-loop performance studies as one would typically see for AI-driven diagnostic devices.

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

For this type of device (a control system), the "ground truth" would be its adherence to engineering specifications, safety standards, and functional requirements. For example, does it correctly actuate the specified equipment settings? Does it route audio/video as intended? These are verified through engineering and functional testing, not typically through pathology or expert consensus on clinical cases.

8. The sample size for the training set

This information is not provided and is generally not applicable to this type of device. The Nurse's Assistant 1.7 O.R. Control System is a hardware/software control system, not an AI model that undergoes "training" with a dataset in the machine learning sense.

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

This information is not applicable for the reasons stated in point 8.

Summary

{0}------------------------------------------------

Nurse's Assistant® 1.7 O.R. Control System (1.7C) 510(k) #: ____________________________________________________________________________________________________________________________________________________________________

March 15, 2006

Разе, fr

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 Modification to the Nurse's Assistant® 1.7 O.R. Control System (1.7C).

A. Submitter:

ConMed Integrated Systems Registration Number: 3031835

в. 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

C. 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:

1. ConMed Integrated Systems Modification to Nurse's Assistant 1.7 O.R. Control System - K052740
1. Stryker SwitchPoint Infinity™ Control System K033132
1. Computer Motion, Inc. Modification to HERMES® O.R. Control Center - K024294

Image /page/0/Picture/16 description: The image shows the text "001 * CONFIDENTIAL". The text is in a bold, sans-serif font. The word "CONFIDENTIAL" is in all caps and is larger than the "001 *" text. The background is white.

{1}------------------------------------------------

K060717

Page 2 of 2

Intended Use / Indications for Use: 4. ui

Substantial Equivalence / Device Technological Characteristics and F. 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 ConMed Integrated Systems predicate device Modification to Nurse's Assistant 1.7 O.R. Control System (1.7B) (K050829), Stryker SwitchPoint Infinity Control System (K033132) and Computer Motion's Modification to HERMES O.R. Control Center (K024294).

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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2006

ConMed Integrated Systems c/o Mr. C. Jeff Lipps Director of Regulatory Affairs and Quality Assurance 1815 NW 169th Place, Suite 4020 Beaverton, Oregon 97006

Re: K060717

Trade/Device Name: Modification to Nurse's Assistant® 1.7 O.R. Control System (1.7C) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 18, 2006 Received: April 19, 2006

Dear Mr. Lipps:

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. Iisting of devices, good manufacturing practice, 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 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

{3}------------------------------------------------

Page 2 -- Mr. C. Jeff Lipps

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. 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.ida.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sex Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K060717

Indications for Use

510(K) # (if known): /( 06 0 7 / 7

Device Name: Modification to Nurse's Assistant® 1.7 O.R. Control System (1.7C)

Indications for Use:

The Nurse's Assistant® 1.7 Q.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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ XXX (Part 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)	0169
Division of General, Restorative, and Neurological Devices	CONFIDENTIAL
510(k) Number	K000717

Page 1 of 1

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.