The Went™ 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 putients weight 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 Puise 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 coptivessor vontilators. A turbine-powered air source and a rechargeable internal battery provide freedam 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. Alam 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 (Cleared under K 021981): The Noninvasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interfor. The iVent 201 systems provide DC power and isolation to the board from the mains power and ground.
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 (cleared under K 011957): 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 is a Fragment of a 510(k) premarket notification and an FDA clearance letter for a medical device (iVent™ 201 Portable Ventilator). It does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would typically be found in a clinical study report or a more comprehensive technical summary.

The document focuses on demonstrating substantial equivalence to predicate devices and adherence to voluntary performance standards, rather than providing the results of a specific performance study against defined acceptance criteria for the device itself.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the requested questions based on the provided text. The document states that "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act," but it does mention compliance with voluntary standards like ASTM and ISO. However, it doesn't specify what the acceptance criteria derived from these standards were, nor does it provide the results of testing against those criteria in a format suitable for the requested table.

Here's what can be extracted and what cannot:

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

Cannot provide. The document states "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act." While it lists voluntary standards (e.g., ASTM F 1100-90, ISO 10651-1/2/3), it does not detail specific acceptance criteria derived from these standards or present test results against them. Compliance with these standards is mentioned as a general statement rather than specific performance data.

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

Cannot provide. The document does not describe a specific performance test or clinical study with a test set. It focuses on substantial equivalence based on design, intended use, and technology rather than clinical performance 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 / Cannot provide. No test set or ground truth establishment process is described in the provided text.

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

Not applicable / Cannot provide. No test set or adjudication process is described in the provided text.

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 device is a ventilator, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

Not applicable. This device is a physical medical device (ventilator), not an algorithm or AI. Performance would be assessed through engineering and bench testing, as well as potentially clinical trials for safety and effectiveness, but not in the "standalone algorithm" sense. The document does not detail specific performance studies.

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

Not applicable / Cannot provide. No ground truth establishment is described as part of a performance study.

8. The sample size for the training set

Not applicable. This device is a mechanical ventilator; there is no "training set" in the context of machine learning or AI models with the provided information.

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

Not applicable. See point 8.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices and compliance with voluntary standards for a physical medical device (ventilator). It does not contain the detailed performance study data, acceptance criteria, or ground truth information typical of a submission for an AI/algorithm-based device.

Summary

{0}------------------------------------------------

VersaMed Medical Systems Inc. 2 Blue Hill Plaza Bldg. 2 Pearl River, NY 10965 USA

K042468

Non-Confidential Summary of Safety and Effectiveness

Summary of Safety and Effectiveness

Submitter's Name:

NOV 17 2004

VersaMed Medical System Inc.

Contact Person:

Mr. Dean McBeth Tel: 845 770 8240 Fax: 845 770 8250

Trade Name:

iVent™ 201

Classification Name:

Anesthesiology

Classification:

CBK, DQA, NOU.

{1}------------------------------------------------

Predicate Devices:

The iVent™ 201 Portable Ventilator is substantially equivalent to:

· iVent™ 201with pulse oximeter cleared under K021981
· iVent™ 201 with remote alarm cable cleared under K011957

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 ISO 9919 EN 865 (section 6)

Device Description:

Description of Non- invasive Pulse Oximeter (Cleared under K 021981): The Noninvasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interfor. The iVent 201 systems provide DC power and isolation to the board from the mains power and ground.

{2}------------------------------------------------

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 (cleared under K 011957): 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.

Substantial Equivalence:

The iVent™ 201 is viewed as substantially equivalent to the following predicate devices K 021981 iVent™ TM 201 with pulse oximeter and K 011957 iVent™201 with remote alarm cable.

There are no significant differences between the iVent™ 201 portable ventilator and the predicate devices that affect the safety or effectiveness of the intended device as compared to the predicate devices. The iVent 201 is viewed as substantially equivalent to the predicate devices 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.
1. 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

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2004

Mr. Jerry Korten President and CEO VersaMed Medical System, Incorporated 2 Blue Hill Plaza P.O. Box 1512 Pearl River, New York 10965

Re: K042468

Trade/Device Name: iVent™ 201 Portable Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: October 22, 2004 Received: October 25, 2004

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 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.

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.

{4}------------------------------------------------

Page 2 - Mr. Korten

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/dsma/dsmamain.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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K042468

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 with Non-invasive Puise 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.

Prescription Use - Required V Over-The-Counter Use - Not allowed AND/OR (Part 21 CFR 801 Subpart D) (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)

Aury Juliant

(Division Sign-Off) Division of Anesthesiology Infection Control, Denta

510(k) Number: K042468

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).