The iVent™ 201 MR Conditional 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 invasive or non-invasive assistance via 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 MR Conditional ventilator is suitable for use in the ICU and all other hospital areas, including Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field, in all hospital-type facilities, alternate care sites, transport, emergency and in the home environment. The iVent™ 201 MR Conditional ventilator is MR Conditional.

The optional 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, excluding MR environments.

The iVent™ 201 MR Conditional ventilator is a restricted medical device intended for use by qualified, trained personnel under the direct supervision of a physician.

Device Description

The iVent™ 201 MR Conditional is a compact, portable, fully featured, microprocessorcontrolled 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 push buttons, 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.

Optional equipment:

Non-invasive pulse oximeter (not to be used in MR environments) .
. Remote Alarm Adapter

Testing has been performed according to ASTM F2052-06-e1 in 1.5 and 3.0 Tesla environments.

AI/ML Overview

The provided text describes a 510(k) submission for the VersaMed iVent™ 201 MR Conditional ventilator. This document focuses on demonstrating substantial equivalence to predicate devices, particularly regarding its functionality within a Magnetic Resonance (MR) environment.

Here's an analysis of the acceptance criteria and the study information present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of "acceptance criteria" in the format of specific performance metrics with target values and actual results for a clinical study on a disease. Instead, the focus is on the device's MR Conditional status and equivalence to predicate devices. The key "performance" aspect is the device's safe operation in MR environments, which is confirmed through a specific standard.

Acceptance Criterion (Implicit)	Reported Device Performance
Safe operation in MR environment (1.5 and 3.0 Tesla).	Testing performed according to ASTM F2052-06-e1.
Functionality in MR environment (up to 3.0 Tesla static field).	Device is "MR Conditional" for up to 3.0 Tesla static magnetic field.
Substantial equivalence to predicate ventilators (VersaMed iVent™ 201 - K061627 and Maquet SERVO-i - K063404) for intended use (continuous/intermittent ventilatory support for adult/pediatric patients in various modes).	"No significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices." (Differences primarily relate to MR environment use).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a "test set" in terms of patient data or clinical cases. The testing mentioned (ASTM F2052-06-e1) is a physical and electromagnetic compatibility standard for medical devices in MR environments. This standard typically involves testing the device itself, not a patient population. Therefore, there is no sample size of patients or images.
Data Provenance: Not applicable, as the testing is for device safety in an MR environment rather than a clinical data set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. The "ground truth" for MR Conditional status is established by adhering to an industry standard (ASTM F2052-06-e1) and demonstrating that the device meets its requirements for safe operation in specified MR environments. This does not involve expert readers or clinical ground truth.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The testing is based on objective measurements against a standard, not on subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI devices where the performance of human readers with and without AI assistance is compared. The iVent™ 201 MR Conditional is a ventilator, a life-support device, and its safety in an MR environment is assessed through engineering and physical standards, not through clinical reader studies.
Effect Size of Human Readers Improvement: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. This device is a physical medical device (ventilator), not an algorithm or AI software intended for standalone diagnostic performance. Its "standalone performance" relates to its mechanical and electrical operation, and its ability to function within an MR field without causing harm or malfunction, which is covered by the ASTM testing.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this submission is adherence to the ASTM F2052-06-e1 standard for testing medical devices in MR environments. This standard specifies test methods to evaluate potential hazards and effects (e.g., magnetic force, induced heating, artifact generation) when a medical device is exposed to MR fields. The device demonstrating compliance with this standard against predetermined thresholds effectively establishes its "MR Conditional" ground truth.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable.

Summary

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K073694
page 1 of 3

510(k) Summary Non-Confidential Summary of Safety and Effectiveness Page 1 of 3 29-May-08

Versalvied Medical Systems2 Blue Hill Plaza, Bldg. 2Pearl River, NY 10965	Tel - 845-770-2840 x 101Fax - 845-770-2850	MAY 30 200
-----------------------------------------------------------------------------------	------------------------------------------------	------------

S. Deler - VP Quality Assurance and Regulatory Affairs

Proprietary or Trade Name:	VersaMed iVent™ 201 MR Conditional
Common/Usual Name:	Ventilator, continuous, facility use
Classification Name:	Ventilator, continuous, facility use
Device:	iVent™ 201 MR Conditional
Predicate Devices:	VersaMed iVent™ 201 - K061627Maquet SERVO-I - K063404

Device Description:

Optional equipment:

Non-invasive pulse oximeter (not to be used in MR environments) .
. Remote Alarm Adapter

Testing has been performed according to ASTM F2052-06-e1 in 1.5 and 3.0 Tesla environments.

Indications for Use:

The iVen™ 201 MR Conditional 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 invasive or non-invasive assistance via 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 .

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510(k) Summary Non-Confidential Summary of Safety and Effectiveness Page 2 of 3 29-May-08

The optional 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, excluding MR environments.

The iVent™ 201 MR Conditional ventilator is a restricted medical device intended for use by qualified, trained personnel under the direct supervision of a physician.

Patient Population:	Adult and pediatric
Environment of Use:	ICU and all other hospital areas, including Magnetic Resonance(MR) environment, not to exceed a 3.0 Tesla static magnetic field, inall hospital-type facilities, alternate care sites, transport,emergency and in the home environment.
Features	Predicates	Proposed DeviceVersaMed iVentTM 201 MRConditional
Indications for useAlready cleared	The iVentTM 201 is a portable, computer controlled, electrically powered intensive careventilator intended to provide continuous or intermittent ventilatory support for the care ofindividuals who require mechanical ventilation. Specifically, the ventilator is applicable foruse with adult through pediatric patients, who require invasive or non-invasive assistancevia the following general modes of ventilatory support, as prescribed by an attendingphysician:Assist/Control (Pressure Controlled or Volume Controlled) SIMV (Pressure Controlled or Volume Controlled) CPAP/PSV The iVentTM 201 ventilator (with or without the non-invasive Pulse Oximeter option) issuitable 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-invasivePulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rateand is suitable for use in all above mentioned areas, excluding MR environments.	Same plus MR environment(MR Conditional)
Expanded Indicationsfor Use	The iVentTM 201 ventilator is a restricted medical device intended for use by qualified,trained personnel under the direct supervision of a physician.VersaMed - K061627Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.Maquet - K063404	Magnetic Resonance (MR)environment, not to exceed a 3.0Tesla static magnetic field. MRConditional
Environment of Use	MR environments - Not to exceed 3.0 TeslaK063404 - Maquet SERVO-i	SameNot to exceed 3.0 Tesla
Patient Population	Adult and pediatrics - K061627	Same
Contraindications	None	Same
MR Testing	ASTM F2502 not known (K063404)	ASTM F2502-06-el

Differences Between Other Legally Marketed Predicate Devices

The VersaMed iVent™ 201 MR Conditional ventilator system is viewed as substantially equivalent to the following predicate devices – VersaMed iVent™ 201 - K061627 and Maquet SERVO-i - K063404.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is black and white, and the text is in a simple sans-serif font. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2008

VersaMed Medical Systems, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, FL 34134-2958

Re: K073694

Trade/Device Name: iVent™ 201 MR Conditional Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 15, 2008 Received: May 19, 2008

Dear Mr. Dryden:

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. Dryden

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 vours.

Clues

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 Statement

Page 1 of 1

510(k) Number:	K073694 (To be assigned)
Device Name:	iVent™ 201 MR Conditional

Indications for Use:

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

The optional 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, excluding MR environments.

The iVent™ 201 MR Conditional ventilator is a restricted medical device intended for use by qualified, trained personnel under the direct supervision of a physician.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mi Thul

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

510(k) Number: Ko73694

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).