(7 days)
Not Found
No
The description mentions a "microprocessor-controlled ventilator" and "Optional Waveform and Diagnostic Software package," but there is no mention of AI, ML, or related terms. The functionality described appears to be based on traditional control systems and data display.
Yes
The device is a ventilator intended to provide mechanical ventilation, which is a form of medical treatment to support respiration and is explicitly described as a "restricted medical device."
Yes
The device, specifically the "Non-invasive Pulse Oximeter" component, is intended for "non-invasive monitoring of oxygen saturation and pulse rate," which are diagnostic parameters. Additionally, the "Optional Waveform and Diagnostic Software package" actively displays "pressure and flow waveform data, loops, trends, and logged totals," indicating its use in diagnosing and monitoring patient conditions.
No
The device description clearly outlines hardware components such as a turbine-powered air source, rechargeable internal battery, control knob, pushbuttons, screen, and a non-invasive pulse oximeter board mounted internally. While there is an optional software package, the core device is a physical ventilator with integrated hardware.
Based on the provided information, the iVent™ 201 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a ventilator providing mechanical ventilatory support. This is a life-support device that directly interacts with the patient's respiratory system.
- Device Description: The description details a mechanical ventilator with features for controlling airflow, monitoring patient parameters (like oxygen saturation and pulse rate via the pulse oximeter), and providing alarms.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The iVent™ 201 does not perform any such analysis of biological specimens. The pulse oximeter measures physiological parameters directly from the patient's body, not from a specimen.
Therefore, the iVent™ 201 falls under the category of a medical device used for patient support and monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician:
- · Assist/Control (Pressure Controlled or Volume Controlled)
- · SIMV (Pressure Controlled or Volume Controlled)
- · CPAP/PSV
The iVent™ 201 ventilator with Non-invasive Pulse Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.
The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
Product codes
CBK, DQA, NOU.
Device Description
The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow 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.
Description of Non- invasive Pulse Oximeter: The Non-invasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interface. The iVent 201 systems provide isolated DC power.
The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit.
Description of remote Alarm Adaptor: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.
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
adult and pediatric patients weighing at least 10 kg (22 lb.)
Intended User / Care Setting
qualified, trained personnel under the direction of a physician; intra-hospital use, home and alternate-site use, transport and emergency use.
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
The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use.
Key Metrics
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
Premarket Notification 510(k) Section 3 -- Administrative requirements
SEP 2 3 2005
i Vent 201
VersaMed Medical Systems Inc. 2 Bluc Hill Plaza Bldg. 2 Pearl River, NY 10965 USA
Non-Confidential Summary of Safety and Effectiveness
Summary of Safety and Effectiveness
Submitter's Name:
VersaMed Medical System Inc.
Contact Person:
Mr. Jerry Korten Tel: 845 770 8240 Fax: 845 770 8250
Trade Name:
iVent™ 201 Portable Ventilator
Classification Name:
Anesthesiology
Classification:
CBK, DQA, NOU.
1
Predicate Devices:
The iVent™ 201 Portable Ventilator is substantially equivalent to:
Performance Standards:
No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the iVent™ 201 portable ventilator complies with the following voluntary standards: ASTM F 1100-90 ASTM F 1246-91 MIL-STD-810E ISO 10651-1/2/3 IEC 60601-1 IEC 60601-2-12 IEC 60601-1-2 CAN/CSA-C22.2 No.601.1 180 EN 865 (section 6)
The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use.
Device Description:
The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow 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.
Description of Non- invasive Pulse Oximeter: The Non-invasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and
2
other output information via a serial digital interface. The iVent 201 systems provide isolated DC power.
The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit.
Description of remote Alarm Adaptor: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.
Intended use:
The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician:
Assist/Control (Pressure Controlled or Volume Controlled) SIMV (Pressure Controlled or Volume Controlled) CPAP/PSV
The iVent™ 201 ventilator with Non-invasive Pulse Oximeter is suitable for interahospital use, home and alternate-site use, transport and emergency use. The Noninvasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.
The i™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
3
Substantial Equivalence:
The iVent™ 201 portable ventilator is viewed as substantially equivalent to the following predicate devices:
The iVent 201 -portable ventilator in this submittal is the same device as the cleared device under K042468 except for the modifications associated with this submittal:
-
The new low tidal volume setting is 50ml while it was 100ml on the cleared device.
-
The new maximum respiratory rate setting is 80BPM while 50BPM is the highest limit on the cleared device.
-
The new maximum Inspiratory pressure range is 80cmH2O, while 60 cmH2O is the highest limit on the cleared device.
-
The new maximum PEEP setting is 40 cmH2O, while 20 cmH2O is the highest setting on the cleared device.
-The new maximum setting for Pressure Support Ventilation (PSV) is 60 cmH2O, while 30 cmH2O is the highest setting on the cleared device.
-The new I:E ratio of 1:4 to 2:1 now covers a inspiratory time range of 0.2-3 seconds, while the previous I:E ratio of 1:4 to 2:1 covered an inspiratory time range of 0.3-3 seconds on the cleared device.
-The new trigger sensitivity is 1-20 lpm or 0.5 to 20 cmH2O, while a trigger sensitivity of 2-9 lpm or -1 to -8 cmH2O was on the predicate device.
There are no significant differences between the iVent™ 201 portable ventilator in this submittal and the predicate device under K042468 that affect the safety or effectiveness of the intended device as compared to the predicate devices. The iVent 201 portable ventilator is viewed as substantially equivalent to the predicate device since they:
1. Have the same intended use:
1.1 The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
4
-
- Have the same environment for use:
2.1 intra-hospital use, home and alternate-site use. transport and emergency use.
- Have the same environment for use:
-
- Have the same patient populution :
3.1 this system can be used with adult and pediatric patients weighing at least 10 kg (22 lb.).
- Have the same patient populution :
-
- Are similar in design
-
- Employ the same technology
-
- Are made of identical materials
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle symbol.
Public Health Service
SEP 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jerry Korten CEO and President VersaMed Medical Systems, Inc. 2 Blue Hill Plaza Bldg. 2, 300 Floor Pearl River, New York 10965
Re: K052554
Trade/Device Name: iVENT 201 PORTABLE VENTILATOR Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: II Product Code: CBK Dated: September 12, 2005 Received: September 16, 2005
Dear Mr. Korten:
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 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 mr ), it e 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 Eederal Register.
6
Page 2 - Mr. Korten
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 and insuits (s 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 yours,
Chiu Lin, Ph.D.
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
7
Premarket Notification 510(k) Section 3 - Administrative requirements
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
iVent™ 201 Portable Ventilator
Indications for Use:
The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician:
- · Assist/Control (Pressure Controlled or Volume Controlled)
- · SIMV (Pressure Controlled or Volume Controlled)
- · CPAP/PSV
The iVent™ 201 ventilator with Non-invasive Pulse Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.
The iVeur™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
Prescription Use × (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)
Ona Sefion
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
(Division Sign-Off 10(k) Number: Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ..