(57 days)
IISIS is 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.
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.
The provided document describes the IISIS software, an accessory to continuous ventilators, and its 510(k) premarket notification. The focus of the document is on establishing substantial equivalence to a predicate device, the Bernoulli Ventilator Management System, rather than on detailed performance metrics as would typically be found in direct medical device performance studies.
Therefore, many of the requested categories for acceptance criteria and study details cannot be fully satisfied from this document alone because it pertains to software validation rather than a clinical effectiveness study.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional Requirements) | Reported Device Performance |
|---|---|
| Performs all input functions according to the functional requirements specified in the Software Requirements Specification. | Validation testing was provided that confirms that IISIS V 1.0 performs all input functions. |
| Performs all output functions according to the functional requirements specified in the Software Requirements Specification. | Validation testing was provided that confirms that IISIS V 1.0 performs all output functions. |
| Performs all required actions (e.g., real-time alarm annunciation, displaying and storing ventilator settings, parameters, and waveforms) according to the functional requirements specified in the Software Requirements Specification and user requirements. | Validation testing was provided that confirms that IISIS V 1.0 performs all required actions. This includes providing continuous display of ventilator data at a central station and remote workstations, utilizing wireless technology to interface with critical care and home care ventilators, accessing and displaying ventilator data and waveforms through web-based technology, providing real-time alarm annunciation, and displaying and storing ventilator settings, parameters, and waveforms. The device is confirmed to perform to specifications, Federal Regulations, and User Requirements. The Validation and Verification Process has been followed in accordance with software development practices. |
| Does not introduce new potential safety risks. | The IISIS V 1.0 does not result in any new potential safety risks, as determined by a Hazard Analysis where potential hazards were identified and controlled (by designing controls, introducing protective measures, and/or warning users). |
| Performs in accordance with its intended use. | The IISIS V 1.0 performs in accordance with its intended use (as a secondary display of ventilator data for central monitoring and remote surveillance). |
| Is substantially equivalent to the predicate device (Bernoulli Ventilator Management System). | The IISIS V 1.0 is considered substantially equivalent to the Bernoulli Ventilator Management System (K011861) in terms of features and specifications, and performs similarly for providing secondary display of ventilator data and remote monitoring/alarm surveillance. |
Study Details (as inferable from the document):
-
Sample size used for the test set and the data provenance:
- The document mentions "Validation testing was provided" for software functions. This refers to software verification and validation activities rather than testing with patient data. It does not specify a "test set" in the context of clinical data or patient samples. Therefore, not applicable for patient/clinical data.
- Data Provenance: Not specified, as it's a software validation claim.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information is for software functional validation, not clinical ground truth establishment. Software requirements are established by a team (likely including subject matter experts) and validated against those requirements.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This refers to software functional validation, not clinical case adjudication.
-
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 document describes a software system as an accessory for continuous ventilators that provides a secondary display and alarm annunciation. It is not an AI-assisted diagnostic tool for which MRMC studies would typically be conducted.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device, IISIS V 1.0, is inherently a "standalone" software system in the sense that it operates independently to collect, display, and annunciate ventilator data. Its function is to supplement existing procedures and provide secondary information, not to make diagnostic or therapeutic decisions on its own. While it provides "real-time alarm annunciation," it explicitly states it is "intended to supplement and not replace any part of the current device monitoring procedures." Therefore, its performance is evaluated in its functional display and alarm capabilities. The "validation testing" confirms the algorithm's performance of its intended functions.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Functional Requirements and Specifications. The "ground truth" for the validation of IISIS V 1.0 is adherence to its "functional requirements specified in the Software Requirements Specification" and "User Requirements." This isn't a clinical ground truth but a validation against predefined software behavior.
-
The sample size for the training set:
- Not applicable. The document describes a software system that displays data and annunciates alarms, not a machine learning or AI model that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. No training set is mentioned or implied, as it's not an AI/ML device.
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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. Andrews410-694-9450 (v)410-694-8092 (f) |
| Device Trade Name: | IISIS |
| Device CommonName: | Accessory to continuous ventilator (respirator) |
| Classification Name: | Class II, 868.5895, 73 MOD |
| SubstantiallyEquivalent To: | Bernoulli Ventilator Management System(K011861)Cardiopulmonary Corp.200 Cascade BoulevardMilford, CT 06460 |
| Device Description: | IISIS software provides continuous display of ventilatordata at a central station and remote workstations. IISISutilizes wireless technology to interface with mostcritical care and home care ventilators that have RS-232,Ethernet, or nurse call. IISIS is accessed and displaysventilator data and waveforms through web-basedtechnology. IISIS provides real-time alarmannunciation, displays and stores ventilator settings,parameters, and ventilator waveforms as a secondarytool to the primary ventilator alarm and data display. |
| Indications for Use: | Intended to be used on a central monitoring station onmechanically ventilated patients in a hospital or hospitaltype environment. It is used to provide a secondarydisplay of the ventilator data to the central station and toprovide remote monitoring and alarm surveillance.IISIS is intended to supplement and not replace any partof the current device monitoring procedures. |
| TechnologicalComparison toPredicate Device: | The proposed and the predicate devices are bothsoftware programs that are used to provide a secondarydisplay of ventilator data to the central monitoring |
| station and to provide remote monitoring and alarmsurveillance. The proposed and predicate software canbe operated from a personal computer. The IISISsoftware has substantially equivalent features andspecifications. | |
| Non-ClinicalPerformance Data: | Validation testing was provided that confirms that IISISV 1.0 performs all input functions, output functions andall required actions according to the functionalrequirements specified in the Software RequirementsSpecification.To ensure performance to specifications, FederalRegulations and User Requirements:Software Development Practices The Validation and Verification Process havebeen followed. Procedures specify individualswithin the organization responsible fordeveloping and approving productspecifications, coding, testing, validation, andmaintenance. |
| Adverse Effects onHealth: | The potential hazards are identified in the HazardAnalysis 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 potentialsafety risks and performs in accordance with itsintended use as well as the Bernoulli VentilatorManagement System device currently on the market.InnoVision Medical Technologies, LLC considersfeatures of the IISIS V 1.0 to be substantially equivalentto the features of Bernoulli Ventilator ManagementSystem (K011861). |
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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.
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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
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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
§ 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).