(131 days)
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Not Found
No
The document describes a standard microprocessor-controlled ventilator with various ventilation modes and monitoring capabilities. There is no mention of AI, ML, or any adaptive algorithms that would typically indicate the presence of such technology. The "Adaptive Bi-Level" mode is a common ventilation strategy and does not inherently imply AI/ML.
Yes
The device is a ventilator, which provides ventilatory support for individuals requiring mechanical ventilation, making it a therapeutic device.
No.
The device is a ventilator used to provide ventilatory support. While it displays clinical data and has options for 'Diagnostic Software', its primary function is providing mechanical ventilation, not diagnosing medical conditions.
No
The device description clearly indicates the iVent101 is a physical ventilator with hardware components such as a turbine-powered air source, battery, flow/pressure sensors, and an LCD touch-screen. While it has software control and an optional software package, it is not solely software.
Based on the provided text, the iVent101 ventilator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, a congenital abnormality, to monitor therapeutic measures, or to determine compatibility with potential recipients.
- iVent101 Function: The iVent101 ventilator is a device that provides mechanical ventilatory support directly to a patient. It interacts with the patient's respiratory system, not with specimens derived from the patient.
- Intended Use: The intended use clearly states it provides "continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation." This is a direct therapeutic intervention, not a diagnostic test performed on a specimen.
Therefore, the iVent101 ventilator falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities:
- Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated ● Volume Control (PRVC)
- CPAP with Pressure Support
- Adaptive Bi-Level for either NIV or invasive ventilation.
The iVent101 ventilator is suitable for use in institution, home and portable settings.
Product codes (comma separated list FDA assigned to the subject device)
73 CBK, 73 NOU
Device Description
The iVent101 is a compact, portable, microprocessor-controlled ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation .A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. Internal flow and pressure are read through flow/pressure sensors. Clinical data [Tidal Volume, Rate, PIP, FiG2, Peak Flow, Inspiratory Time, I:E Minute Volume] are presented on machine screen.
All the operator actions are performed on the LCD touch-screen on the front panel, allowing rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.
The iVent101 can use external AC or DC power supply and contains an integrated battery.
The iVentiol is equipped with two configurations, which differs in the patient circuit type that connects to the machine. One configuration is to be used with a standard one limb patient circuit, and the second configuration is to be used with a standard dual limb patient circuit. The two configurations are incorporating the same infrastructure and can be easily replaced by the user.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
infants from 5 kg through adult patients
Intended User / Care Setting
institution, home and portable settings.
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
NOV 2 3 2009
Premarket Notification 510(k) Summary As required by section 807.92 The iVent101 Non-Confidential Summary of Safety and Effectiveness
Sales Mary of Safety and Effectiveness of Safety and Effectiveness of Sales
Submitter's Name:
GE HealthCare C/O Datex-Ohmeda PO Box 7550 Madison, WI 53707 USA Tel: 608-221-1551 Fax: 608-223-2496
Contact Person:
Ms. Adrienne Lenz, RAC Mr. Jim Raskob
Trade Name:
The iVent101
Classification:
| Name: | Continuous ventilator |
|---|---|
| Product code: | 73 CBK, 73 NOU |
| Classification panel: | 868-5895 |
| Class: | 2 |
| Panel: | Anesthesiology |
1
Device Description:
The iVent101 is a compact, portable, microprocessor-controlled ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation .A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. Internal flow and pressure are read through flow/pressure sensors. Clinical data [Tidal Volume, Rate, PIP, FiG2, Peak Flow, Inspiratory Time, I:E Minute Volume] are presented on machine screen.
All the operator actions are performed on the LCD touch-screen on the front panel, allowing rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.
The iVent101 can use external AC or DC power supply and contains an integrated battery.
The iVentiol is equipped with two configurations, which differs in the patient circuit type that connects to the machine. One configuration is to be used with a standard one limb patient circuit, and the second configuration is to be used with a standard dual limb patient circuit. The two configurations are incorporating the same infrastructure and can be easily replaced by the user.
Intended use:
The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities:
- Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated . Volume Control (PRVC)
- . CPAP with Pressure Support
- � Adaptive Bi-Level for either NIV or invasive ventilation.
The iVent101 ventilator is suitable for use in institution, home and portable settings.
2
Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES * USA" around the top half of the circle. The right side of the seal contains a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
VersaMed Medicatl Systems, Limited C/O Adrienne Lenz, RAC Director Datex-Ohmeda, Incorporated P.O. Box 7550 Madision, Wisconsin 53707-7550
Re: K092135
Trade/Device Name: The iVent101 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK, NOU Dated: October 28, 2009 Received: October 30, 2009
Dear Ms. Lenz:
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, 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 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.
NOV 2 3 2009
3
Page 2- Ms. Lenz
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
| 510(k) Number (if known): | K091335 |
|---|---|
| --------------------------- | --------- |
Device Name: The iVent101
Indications for Use:
The iVent101 ventilator [with single or dual limb configuration] is intended to provide continuous or intermittent ventilatory support for the care of invividuals who require mechanical ventilation. Specifically, the ventilator is applicable for infants from 5 kg through adult patients who require invasive or non-invasive support via the following ventilatory modalities:
- Assist/Control and SIMV with either Volume, Pressure, or Pressure Regulated ● Volume Control (PRVC)
- � CPAP with Pressure Support
- Adaptive Bi-Level for either NIV or invasive ventilation. .
The iVent101 ventilator is suitable for use in institution, home and portable settings.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schullther
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K092135
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