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.

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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the iVent™ 201 Portable Ventilator, seeking to establish substantial equivalence to predicate devices. It states that the device complies with voluntary performance standards and mentions "non clinical testing results provides assurance that the device meets its specifications and is safe and effective for its intended use." However, it does not provide specific quantitative acceptance criteria or detailed study results for device performance.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies cannot be extracted from the provided text.

Here's a summary of what can be inferred:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or provide a table of reported device performance against such criteria. It generally states: "The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not mentioned in the document. The testing described is "non-clinical," implying bench testing rather than studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as the testing described is non-clinical.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as the testing described is non-clinical.

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

Such a study was not performed or mentioned. This device is a ventilator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This concept is not applicable to a ventilator. The document describes the device's functionality as a standalone ventilator.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For "non clinical testing," the ground truth would typically be established by engineering specifications, calibration standards, and established mechanical/electrical measurement techniques. No details are provided.

8. The sample size for the training set

Not applicable, as this is a medical device, not an AI/machine learning model that typically has "training sets." The assessment is based on non-clinical testing of the device itself.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary of available information related to performance and standards:

The document states that a "non-clinical testing" was performed and that the device complies with several voluntary performance standards. These standards implicitly set performance criteria that the device must meet.

Voluntary Performance Standards the iVent™ 201 portable ventilator complies 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
ISO 9919
EN 865 (section 6)

Study proving the device meets acceptance criteria:

The document broadly states: "The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use." No specific study name, methodology, or detailed results are provided beyond this general statement. The 510(k) submission relies on demonstrating substantial equivalence to predicate devices and compliance with recognized voluntary standards rather than providing detailed clinical study results in this particular summary.

Summary

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K053270

Premarket Notification 510(k) Section 3 – Administrative requirements JAN 2 7 2006

iVent 201

VersaMed Medical Systems Inc. 2 Blue 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.

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Predicate Devices:

The iVent™ 201 Portable Ventilator is substantially equivalent to:

· iVent™ cleared under K052554
TBIRD VELA cleared under K032451

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 ISO 9919 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:

Description of Non- invasive Pulse Oximeter: The Non-invasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse waveform, and

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other output information via a serial digital interface. The iVent 201 systems provide isolated DC power.

Intended use:

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 iTM 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.

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Substantial Equivalence:

The iVent™ 201 portable ventilator is viewed as substantially equivalent to the following predicate devices;

· iVent™ cleared under K052554
· TBIRD VELA cleared under K032451

The iVent 201 -portable ventilator in this submittal is the same device as the cleared device under K052554 except for the modifications associated with this submittal:

-The incorporation of the ability to deliver 7LPM oxygen gas flow to an external nebulizer that is gated to the occurrence of a breath into the i Vent 201 device.
ﺖ The incorporation of the ability to measure static compliance using inspiratory hold and the ability to measure auto PEEP using end expiratory hold into the iVent 201 device.

There are no significant differences between the iVent™ 201 portable ventilator in this submittal and the predicate device under K052554 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:
  I.I The iVent™ 201 is a portable, computer controlled, clectrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

2. Have the same environment for use:

2.1 intra-hospital use, home and alternate-site use, transport and emergency use.

1. Have the same patient populution :
  3.1 this system can be used with adult and pediatric patients weighing at least 10 kg (22 lb.).
1. Are similar in design
1. Employ the same technology
1. Are made of identical materials

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure in profile, with three curved lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2006

Mr. Jerry Korten VersaMed Medical Systems, Incorporated CEO & President 2 Blue Hill Plaza Building 2 Pearl River, New York 10965

Re: K053270

Trade/Device Name: iVent™ 201 Portable Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 5, 2006 Received: January 6, 2006

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 prìor 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 such 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.

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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 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 yours,

Qive

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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Premarket Notification 510(k) Section 3 - Administrative requirements

i Vent 201

INDICATIONS FOR USE

510(k) Number (if known): KO5 3270

Device Name:

iVent™ 201 Portable Ventilator

Indications for Use:

· Assist/Control (Pressure Controlled or Volume Controlled)
· SIMV (Pressure Controlled or Volume Controlled)
· CPAP/PSV

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.

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)

Cilia Myloom

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices

510(k) Number: K053270

Regulation Number and Section

§ 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).