NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM

K050829 · Conmed Integrated Systems (Cmis) · GCJ · May 6, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050829
• Device Name: NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
• Applicant: Conmed Integrated Systems (Cmis)
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Nurse's Assistant® 1.7 is intended to be used to route video from multiple sources to multiple destinations, to be used to turn on and off power to specific 110 volt receptacles within the OR, and to be used to adjust specific operating parameters of video displays, analog or digital recording, communication and playback equipment, endoscopic cameras, endoscopic light sources, surgical lamps, observation cameras, surgical cameras and operating room lights.

Device Story

Nurse's Assistant® 1.7 is a computerized control system for operating rooms (OR). It provides a touch panel interface for OR staff to manage OR equipment. Inputs include video signals from various sources and power control signals for 110V receptacles. The system routes video to multiple destinations and adjusts operating parameters for video displays, recording equipment, communication devices, endoscopic cameras, light sources, and surgical lamps. Used in ORs by surgical staff to centralize equipment control; facilitates workflow during minimally invasive and open surgical procedures. Benefits include streamlined equipment management and improved control over surgical environment parameters.

Clinical Evidence

Bench testing only.

Technological Characteristics

Computerized control system featuring a touch panel interface. Functions include video routing, power switching for 110V receptacles, and parameter adjustment for surgical peripheral equipment. System is designed for integration within an operating room environment.

Indications for Use

Indicated for use in an operating room for video assisted surgery, including minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques, and traditional open procedures. Applicable to general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharyngoscopy, ear endoscopy, and sinusoscopy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Val Med Nurse's Assistant O.R. Control System (K010754)
• Olympus Integrated Endosurgery System EndoALPHA (K981993)
• Karl Storz OR1 (KSEA SCB-ACC) (K023704)

Submission Summary (Full Text)

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

March 28, 2005

K050829

Page 1 of 2

# SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and In accordance with the roquil offects Systems is hereby submitting the 510(k) 21 CFR 607.92, Oonlined Intogrator of Stems of Stems of Statent® 1.7 O.R. Control System.

#### Submitter: A.

ConMed Integrated Systems Registration Number: 3031835

### Company Contact: B.

C. Jeff Lipps Director of Regulatory Affairs and Quality Assurance 1815 NW 169th Place, Suite 4020 Beaverton, OR 97006 503-614-1106 Phone [phone] Fax

#### Device Name: C.

D.

| Trade Name: | Nurse's Assistant® 1.7 O.R. Control System |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Surgical Control Center |
| Classification Names: | 1. 876.1500 – Endoscope and accessories<br>2. 878.4580 – Surgical lamp<br>3. 884.1720 – Gynecological laparoscope and<br>accessories |
| Proposed Class/Device: | Class II |
| Product Codes: | GCJ, KOG, FET, FSY, HET, FTA |
| Predicate/Legally Marketed Devices: | |

- 1. Val Med Nurse's Assistant O.R. Control System K010754
- 2. Olympus Integrated Endosurgery System EndoALPHA K981993
- 3. Karl Storz OR1 (KSEA SCB-ACC) K023704

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K050829

Page 2 of 2

#### Device Description: E.

The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that provides operating room (OR) staff with a simple touch panel interface from which to activate, adjust and monitor certain settings of equipment located in the OR.

## Intended Use:

The Nurse's Assistant® 1.7 is intended to be used to route video from multiple sources to multiple destinations, to be used to turn on and off power to specific 110 volt receptacles within the OR, and to be used to adjust specific operating parameters of video displays, analog or digital recording, communication and playback equipment, endoscopic cameras, endoscopic light sources, surgical lamps, ebservation cameras, surgical cameras and operating room lights.

### Indications for Use:

The Nurse's Assistant® 1.7 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 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 г. Comparison to Predicate Device(s):

The Nurse's Assistant® 1.7 O.R. Control System has similar indications for use, intended use and technological characteristics as the predicate devices; Val Med Nurse's Assistant O.R. Control System - K010754, Olympus Integrated Endosurgery System EndoALPHA - K981993 and Karl Storz OR1 (KSEA SCB-ACC) - K023704.

The technological characteristics of the Nurse's Assistant® 1.7 are equivalent to the predicate devices listed above.

Tests performed on the Nurse's Assistant® 1.7 demonstrate substantial equivalence to the predicate devices listed above.

### Conclusion:

The Nurse's Assistant® 1.7 is substantially equivalent to the predicate devices in terms of safety, effectiveness, and performance.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features the department's name encircling a symbol. The symbol consists of three stylized human figures, representing the department's focus on health and well-being. The figures are connected and appear to be moving forward.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 6 2005

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

Re: K050829

Trade/Device Name: 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: April 30, 2005 Received: May 2, 2005

Dear Mr. Lipps:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use battler in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the to May 2011-12-11 accordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merestere, mains of the Act include requirements for annual registration, listing 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 it may be subject to bash of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA can oo found in the announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actives and i Drimination that your device complies with other requirements of the Act that I Dri has made a cond regulations administered by other Federal agencies. You must or any I cach stututed and regirements, 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 (21 CFR Part 820); and if applicable, the electronic form in the qualisy by rovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. C. Jeff Lipps

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin manisting of substantial equivalence of your device to a legally prematics notification. "The PDF inturlig gour 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 If you ucate specific advise in 90% 276-0115 . Also, please note the regulation entitled, Colliact the Office of Compunation in (21CFR Part 807.97). You may obtain Misolanding by relevelee to promance no promance in the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or Manufacturers, International and Colisa.http://www.fda.gov/cdrh/industry/support/index.html.

Sineerely yours,

E. K.

Miriam C. Provost, Ph.D. 8 Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K050829

## INTENDED USE / INDICATIONS FOR USE

510(K) # (if known): K050829

Device Name: Nurse's Assistant® 1.7 O.R. Control System

## Intended Use /Indications for Use:

The Nurse's Assistant® 1.7 is intended to be used to route video from multiple The Narse's Assistant - 1.7 % intentions, to be used to turn on and off power to specific 110 volt receptacles within the OR, and to be used to adjust specific operating voil receptables within the US , analog or digital recording, communication and parameters of viaoo displayer, andoscopic light sources, surgical playback equipmont, chaosespurgical cameras and operating room lights.

The Nurse's Assistant® 1.7 is indicated for use in an operating room for video The Nurse 3 Aoolotatis includes minimally invasive procedures in all surgical assisted surgery. This molders wif interventional techniques and traditional open procedures.

The Nurse's Assistant® 1.7 is indicated for use in general, cardiovascular, ENT, The Nurse 3 / Solotant - 1. Tastic, obstetrics, gynecology, and orthopedic surgery, gastroenterology, drology, placeral cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, genefanyngoscopy, ear endoscopy and sinusoscopy.

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