IISIS, VERSION 1.0

K052244 · Innovision Medical Technologies, LLC · MOD · Oct 13, 2005 · Anesthesiology

Device Facts

• Record ID: K052244
• Device Name: IISIS, VERSION 1.0
• Applicant: Innovision Medical Technologies, LLC
• Product Code: MOD · Anesthesiology
• Decision Date: Oct 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator data to the central station and to provide remote monitoring and alarm surveillance. IISIS is intended to supplement and not replace any part of the current device monitoring procedures.

Device Story

IISIS V 1.0 is a software-based secondary monitoring tool for mechanically ventilated patients. It interfaces with critical care and home care ventilators via RS-232, Ethernet, or nurse call connections. The system collects ventilator settings, parameters, and waveforms, transmitting them to a central station and remote workstations. Operated by clinicians in hospital environments, the software displays real-time data and alarm annunciations via a web-based interface. It functions as a supplementary tool to primary ventilator displays, providing remote surveillance to assist clinical decision-making and improve patient monitoring oversight without replacing primary monitoring procedures.

Clinical Evidence

Bench testing only. Validation testing confirmed that IISIS V 1.0 performs all input/output functions and required actions per the Software Requirements Specification. Development followed established software validation and verification practices.

Technological Characteristics

Software-based secondary display system. Interfaces with ventilators via RS-232, Ethernet, or nurse call. Web-based technology for data visualization. Operates on standard personal computers. No specific hardware materials or energy sources defined beyond standard computing infrastructure.

Indications for Use

Indicated for mechanically ventilated patients in hospital or hospital-type environments requiring secondary display of ventilator data and remote alarm surveillance.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• Bernoulli Ventilator Management System (K011861)

Submission Summary (Full Text)

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

OCT 1 3 2005

.

K052244

## Section 2 - 510(k) Premarket Notification Summary (as required by 807.92 (j))

| Submitter: | InnoVision Medical Technologies, LLC |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | August 5, 2005 |
| Contact Person(s): | Patricia L. Andrews<br>410-694-9450 (v)<br>410-694-8092 (f) |
| Device Trade Name: | IISIS |
| Device Common<br>Name: | Accessory to continuous ventilator (respirator) |
| Classification Name: | Class II, 868.5895, 73 MOD |
| Substantially<br>Equivalent To: | Bernoulli Ventilator Management System<br>(K011861)<br>Cardiopulmonary Corp.<br>200 Cascade Boulevard<br>Milford, CT 06460 |
| Device Description: | IISIS software provides continuous display of ventilator<br>data at a central station and remote workstations. IISIS<br>utilizes wireless technology to interface with most<br>critical care and home care ventilators that have RS-232,<br>Ethernet, or nurse call. IISIS is accessed and displays<br>ventilator data and waveforms through web-based<br>technology. IISIS provides real-time alarm<br>annunciation, displays and stores ventilator settings,<br>parameters, and ventilator waveforms as a secondary<br>tool to the primary ventilator alarm and data display. |
| Indications for Use: | Intended to be used on a central monitoring station on<br>mechanically ventilated patients in a hospital or hospital<br>type environment. It is used to provide a secondary<br>display of the ventilator data to the central station and to<br>provide remote monitoring and alarm surveillance.<br>IISIS is intended to supplement and not replace any part<br>of the current device monitoring procedures. |
| Technological<br>Comparison to<br>Predicate Device: | The proposed and the predicate devices are both<br>software programs that are used to provide a secondary<br>display of ventilator data to the central monitoring |
| | station and to provide remote monitoring and alarm<br>surveillance. The proposed and predicate software can<br>be operated from a personal computer. The IISIS<br>software has substantially equivalent features and<br>specifications. |
| Non-Clinical<br>Performance Data: | Validation testing was provided that confirms that IISIS<br>V 1.0 performs all input functions, output functions and<br>all required actions according to the functional<br>requirements specified in the Software Requirements<br>Specification.<br><br>To ensure performance to specifications, Federal<br>Regulations and User Requirements:<br>Software Development Practices The Validation and Verification Process have<br>been followed. Procedures specify individuals<br>within the organization responsible for<br>developing and approving product<br>specifications, coding, testing, validation, and<br>maintenance. |
| Adverse Effects on<br>Health: | The potential hazards are identified in the Hazard<br>Analysis and are controlled by:<br>Designing controls directed at the cause and/or Introducing protective measures and/or Warning the Users. |
| Conclusions: | The IISIS V 1.0 does not result in any new potential<br>safety risks and performs in accordance with its<br>intended use as well as the Bernoulli Ventilator<br>Management System device currently on the market.<br>InnoVision Medical Technologies, LLC considers<br>features of the IISIS V 1.0 to be substantially equivalent<br>to the features of Bernoulli Ventilator Management<br>System (K011861). |

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

Table 2 – (Section 2) 510(k) Premarket Notification Summary

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

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA". The text is arranged in a circular fashion around the eagle.

OCT 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innovision Medical Technologies, LLC Ms. Patricia L. Andrews Corporate Operations Coordinator 1302 Concourse Drive Suite 302 Linthicum, Maryland 21090

Re: K052244

Trade/Device Name: IISIS, VERSION 1.0 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: II Product Code: MOD Dated: October 3, 2005 Received: October 4, 2005

Dear Ms. Andrews:

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 the Feach F 600, Drog, May, therefore, market the device, subject to the general approvisions 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.

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 (1 vir 1), it is a 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.

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

Page 2 - Ms. Andrews

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 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

OR

Device Name: IISIS V. 1.0

## INDICATIONS FOR USE: Intended Use:

Indications For Use:

IISIS is intended to be used on a central monitoring station on mechanically ventilated patient and to provide IISIS is intenced to be used on a central momoring stancer of the ventilator data to the central station and oprovide of the ourgent de type environment. It is used to provide a scondary display of the ventials and not replace any part of the current device monitoring procedures.

Prescription Use _ X Per 21 CFR 801.109

Over-the Counter Use _________________________________________________________________________________________________________________________________________________________

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qurle

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K052244

Confidential