(57 days)
Not Found
No
The summary describes a system for displaying and monitoring ventilator data remotely, but there is no mention of AI or ML being used for analysis, prediction, or interpretation of the data. The focus is on data transmission, display, and alarm annunciation.
No
Explanation: The device is intended to monitor and display ventilator data and alarms, supplementing primary monitoring procedures, rather than directly treating or preventing a disease or condition. It is a monitoring and data display system, not a therapeutic intervention.
No
Explanation: The device provides a secondary display of ventilator data and remote monitoring/alarm surveillance. It explicitly states it is "intended to supplement and not replace any part of the current device monitoring procedures," indicating it does not independently diagnose. Its function is to display existing data, not to interpret or infer a medical condition.
Yes
The device description explicitly states "IISIS software provides continuous display of ventilator data" and "IISIS is accessed and displays ventilator data and waveforms through web-based technology," indicating it is a software-based system for monitoring and displaying data from existing ventilators. While it interfaces with hardware (ventilators), the device itself is described as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that IISIS is for monitoring mechanically ventilated patients and displaying ventilator data. It is a secondary display and remote monitoring tool. This is related to patient monitoring and data management, not the examination of specimens derived from the human body.
- Device Description: The description focuses on software that interfaces with ventilators to display and store data and alarms. It does not mention any analysis of biological samples or in vitro tests.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening based on in vitro tests.
The device's function is to provide a secondary display and remote monitoring of data generated by a ventilator, which is a life support device used directly on the patient. This falls under the category of patient monitoring and data management systems, not in vitro diagnostics.
N/A
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.
Product codes
MOD
Device Description
IISIS software provides continuous display of ventilator data at a central station and remote workstations. IISIS utilizes wireless technology to interface with most critical care and home care ventilators that have RS-232, Ethernet, or nurse call. IISIS is accessed and displays ventilator data and waveforms through web-based technology. IISIS provides real-time alarm annunciation, displays and stores ventilator settings, parameters, and ventilator waveforms as a secondary tool to the primary ventilator alarm and data display.
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
central monitoring station on mechanically ventilated patients in a hospital or hospital type environment.
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)
Validation testing was provided that confirms that IISIS V 1.0 performs all input functions, output functions and all required actions according to the functional requirements specified in the Software Requirements Specification.
To ensure performance to specifications, Federal Regulations and User Requirements: Software Development Practices The Validation and Verification Process have been followed. Procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validation, and maintenance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
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.(b)
Classification. Class II (performance standards).
0
OCT 1 3 2005
.
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 |
| 410-694-9450 (v) | |
| 410-694-8092 (f) | |
| Device Trade Name: | IISIS |
| Device Common | |
| Name: | Accessory to continuous ventilator (respirator) |
| Classification Name: | Class II, 868.5895, 73 MOD |
| Substantially | |
| Equivalent To: | Bernoulli Ventilator Management System |
| (K011861) | |
| Cardiopulmonary Corp. | |
| 200 Cascade Boulevard | |
| Milford, CT 06460 | |
| Device Description: | IISIS software provides continuous display of ventilator |
| data at a central station and remote workstations. IISIS | |
| utilizes wireless technology to interface with most | |
| critical care and home care ventilators that have RS-232, | |
| Ethernet, or nurse call. IISIS is accessed and displays | |
| ventilator data and waveforms through web-based | |
| technology. IISIS provides real-time alarm | |
| annunciation, displays and stores ventilator settings, | |
| parameters, and ventilator waveforms as a secondary | |
| tool to the primary ventilator alarm and data display. | |
| Indications for 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. | |
| Technological | |
| Comparison to | |
| Predicate Device: | The proposed and the predicate devices are both |
| software programs that are used to provide a secondary | |
| display of ventilator data to the central monitoring | |
| station and to provide remote monitoring and alarm | |
| surveillance. The proposed and predicate software can | |
| be operated from a personal computer. The IISIS | |
| software has substantially equivalent features and | |
| specifications. | |
| Non-Clinical | |
| Performance Data: | Validation testing was provided that confirms that IISIS |
| V 1.0 performs all input functions, output functions and | |
| all required actions according to the functional | |
| requirements specified in the Software Requirements | |
| Specification. |
To ensure performance to specifications, Federal
Regulations and User Requirements:
Software Development Practices The Validation and Verification Process have
been followed. Procedures specify individuals
within the organization responsible for
developing and approving product
specifications, coding, testing, validation, and
maintenance. |
| Adverse Effects on
Health: | The potential hazards are identified in the Hazard
Analysis and are controlled by:
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
safety risks and performs in accordance with its
intended use as well as the Bernoulli Ventilator
Management System device currently on the market.
InnoVision Medical Technologies, LLC considers
features of the IISIS V 1.0 to be substantially equivalent
to the features of Bernoulli Ventilator Management
System (K011861). |
1
Table 2 – (Section 2) 510(k) Premarket Notification Summary
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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 (240) 276-0120. 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 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