The iVenf™ 201 is a portable, computer controlled, electrically powered intensive care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, 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 iVently 201 ventilator (with or without the non-invasive Pulse Oximeter option) is suitable for use in the ICU and all other hospital areas. in all hospital-type facilities. alternate-care sites, transport, emergency and in the home environment. The non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate and is suitable for use in all above mentioned areas.

The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician

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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the iVent™ 201 Portable Ventilator. It focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical trials or comprehensive performance testing against numerical targets.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, and ground truth establishment, typically found in a clinical study report for AI/CADe devices, is not present in this submission.

Here's a breakdown of what can be extracted and what cannot based on the provided text:

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

Not Available. The document does not provide a table of numerically defined acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity, latency) or corresponding reported performance metrics from a specific study. Instead, it references compliance with voluntary standards and general specifications.

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

Not Applicable / Not Available. This document describes a traditional medical device (ventilator) and its components, not an AI/CADe device. Therefore, there is no "test set" in the context of algorithm evaluation with patient data. The non-clinical testing mentioned is likely engineering verification and validation against design specifications and voluntary standards, not a data-driven performance evaluation.

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 / Not Available. As above, there is no "test set" or "ground truth" establishment in the context of expert review for an AI/CADe system.

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

Not Applicable / Not Available. No such adjudication method is mentioned or relevant for this type of device submission.

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

Not Applicable / Not Available. This device is a ventilator, not an AI-assisted diagnostic or CADe device. Therefore, MRMC studies and "human readers" are not relevant to its evaluation.

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

Not Applicable / Not Available. There is no standalone algorithm in the context of an AI device being evaluated. The device itself is a standalone medical device.

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

Not Applicable / Not Available. No "ground truth" in the AI/CADe sense is established or used for this type of device. Performance is generally verified against engineering specifications, simulated physiological models, and recognized standards.

8. The sample size for the training set

Not Applicable / Not Available. This device does not involve a "training set" as it is not an AI/machine learning product.

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

Not Applicable / Not Available. As there is no training set, this question is not relevant.

Summary of Relevant Information from the Document:

While the document does not fit the structure of an AI/CADe device submission, it does discuss device performance in terms of compliance with standards and equivalence:

Performance Standards: The iVent™ 201 portable ventilator complies with several voluntary standards: ASTM F 1100-90, ASTM F 1246-91, MIL-STD-810E, ISO 10651-112/3, IEC 60601-1, IEC 60601-2-12, IEC 60601-1-2, CAN/CSA-C22.2 No.601.1, ISO 9919, EN 865 (section 6).
Statement on Performance: "The non clinical testing results provides assurance that the device meets it's specifications and is safe and effective for its intended use."
Substantial Equivalence: The primary "proof" of meeting safety and effectiveness is through demonstration of substantial equivalence to a predicate device (iVent™ cleared under K053270). This equivalence is based on having the same intended use, environment for use, patient population, similar design, same technology, and identical materials, with only a "clarification to the indications statement without changing the scope."

Essentially, for this device, the "acceptance criteria" are the relevant voluntary standards and the ability to demonstrate substantial equivalence to a predicate device already deemed safe and effective by the FDA. The "study" proving it meets these "criteria" is the non-clinical testing mentioned and the formal argument for substantial equivalence presented in the 510(k) submission.

Summary

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K061627

JUN 2 9 2006

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 K053270

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 10651-112/3 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:

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Intended use:

The iVent™ 201 is a portable, computer controlled, electrically powered Intensive Care ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for use with adult through pediatric patients, 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 use in hospitals and hospital-type facilities, inter and intra-hospital use, home and alternate-care site use, in 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

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Substantial Equivalence:

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

· iVent™ cleared under K053270
The iVent 201 -portable ventilator in this submittal is the same device as the cleared device under K053270 except for the modification associated with this submittal:

clarification to the indications statement without changing the scope of the cleared device indications statement.

There are no significant differences between the iVent™ 201 portable ventilator in this submittal and the predicate device under K053270 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:

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.

Have the same environment for use:
in hospitals and hospital-type facilities, inter and intra-hospital use, home and alternate-care site use, in transport and emergency use.
Have the same patient populution :

3.1 this system can be used with adult and pediatric patients require Tidal Volume between 50-2000 ml.

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 seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2006

Mr. Jerry Korten Official Correspondent Versamed Medical Systems, Incorporated 2 Blue Hill Plaza, Bldg. 2, 3td floor Pearl River, New York 10965

Re: K061627

Trade/Device Name: iVent™ 201 Portable Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 29, 2006 Received: June 12, 2006

Dear Ms. 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 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 (240) 276-3150 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

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INDICATIONS FOR USE

510(k) Number (if known):

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

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)

Cuningham

of Anesthesiology, Gene Jon Control. Denta : I :mber

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).