(7 days)
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.
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.
This document is a 510(k) premarket notification for a medical device (Ventilator). These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies with acceptance criteria, ground truth, and statistical analyses of algorithm performance, as would be common for AI/ML device submissions.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly available within the provided text.
Based on the provided text, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria and reported device performance in the way an AI/ML submission would. Instead, it states compliance with voluntary performance standards and highlights modifications that indicate improved capabilities or ranges compared to the predicate.
| Criterion Type | Acceptance Criteria (Implicit from Predicate & Standards) | Reported Device Performance (iVent 201) |
|---|---|---|
| General Performance | Compliance with 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." (General statement of compliance) |
| Low Tidal Volume Setting | 100ml (on cleared predicate) | 50ml (new) |
| Maximum Respiratory Rate | 50 BPM (on cleared predicate) | 80 BPM (new) |
| Maximum Inspiratory Pressure | 60 cmH2O (on cleared predicate) | 80 cmH2O (new) |
| Maximum PEEP Setting | 20 cmH2O (on cleared predicate) | 40 cmH2O (new) |
| Maximum PSV Setting | 30 cmH2O (on cleared predicate) | 60 cmH2O (new) |
| I:E Ratio Inspiratory Time Range | 0.3-3 seconds (for 1:4 to 2:1 ratio on cleared predicate) | 0.2-3 seconds (for 1:4 to 2:1 ratio on new device) |
| Trigger Sensitivity (lpm) | 2-9 lpm (on predicate) | 1-20 lpm (new) |
| Trigger Sensitivity (cmH2O) | -1 to -8 cmH2O (on predicate) | 0.5 to 20 cmH2O (new) |
| Intended Use | Continuous or intermittent ventilatory support for patients >= 10kg requiring mechanical ventilation. Suitable for intra-hospital, home, alternative-site, transport, emergency. | Same as predicate. |
| Safety and Effectiveness | No significant differences from predicate that affect safety or effectiveness. | Stated as substantially equivalent. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable. This is a ventilator, not an AI/ML diagnostic device with a "test set" in the context of imagery or other data. The "testing" referred to is non-clinical performance and safety testing against engineering specifications and voluntary standards. No specific sample sizes for such tests are provided in this summary.
- Data Provenance: Not applicable in the context of "data" for a test set. The non-clinical testing would have been conducted by the manufacturer, VersaMed Medical Systems Inc., likely at their facilities or certified labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" establishment in the AI/ML sense for this type of device. The verification of the device's performance against specifications would be done through engineering tests, calibration, and safety assessments.
4. Adjudication method for the test set
- Not applicable. No adjudication method is mentioned, as there is no "test set" requiring human interpretation or consensus.
5. 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 is a hardware medical device (ventilator), not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study is not relevant and was not performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a ventilator, which is a standalone machine. Its performance parameters are assessed directly (e.g., airflow, pressure, tidal volume delivery accuracy) rather than through separate algorithm-only performance. It operates with human input (setting parameters) but its core function is mechanical ventilation, not an algorithm providing diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For a ventilator, the "ground truth" for performance would be its physical output and functional accuracy compared to its specified engineering parameters and relevant performance standards (e.g., "does it deliver 50ml tidal volume when set to 50ml?" This is measured directly, not compared to human labels or pathology).
8. The sample size for the training set
- Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth to establish for it.
{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 ..
§ 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).