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 Portable Oximeter is suitable for intrahospital use, home and alternate-site use, transport and energy 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 speqification, limits.

Device Description

The Non-invasive Pulse Oximeter board, MS-5, connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interface. The iVent201 provides DC power and isolates the board from the mains power and ground.

AI/ML Overview

The provided text describes the regulatory filing for the iVent™ 201 Portable Ventilator with Pulse Oximeter, but it does not contain the detailed information required to fill out the table and answer all the questions regarding acceptance criteria and the study that proves the device meets them.

Specifically, the text mentions "Acceptance criteria for compliance with the standards is detailed in Section 3, part E (Compliance)" but this section is not provided. It also discusses risk analysis for hardware and software but doesn't explicitly link these to performance claims or specific studies with sample sizes, ground truth, or expert qualifications.

Here's what can be extracted and what is missing:

Information Present:

Device Name: iVent™ 201 Portable Ventilator with Pulse Oximeter
Predicate Device (for Pulse Oximeter): MASIMO CSD-1050, Masimo Set 2000, cleared under K990966
Voluntary Standards:
- ISO 9919 Pulse Oximeters for Medical Use Specifications
- UL 544 Standard for Medical and Dental Equipment
- Council Directive -93/42/EEC
- IEC 601-1-4 Medical Electrical Equipment Programmable electrical medical systems
- EN 865 Pulse Oximeters Particular Specifications
- IEC 60601-1 (for medical safety)
Risk Analysis Areas: Leakage current, SpO2 power source failure, SpO2 Alarms, EMC interference (ventilator on oximeter, oximeter on ventilator, integrated unit on external devices and vice versa), loss of communication, out of range inputs.
Mention of Testing (but no details):
- "interference of the Ventilator on the Pulse Oximeter, which is checked by Masimo"
- "interference of the Pulse Oximeter on the Ventilator which is checked Versamed's software validation procedure"
- "interference of the integrated unit on external devices and vise versa, which is checked by an independent accredited testing agent."
- "The software risks addressed are loss of communication and out of range inputs. These are checked as part of Versamed's Software Test Procedure for validation of the software."
Indications for Use (Pulse Oximeter): Non-invasive monitoring of oxygen saturation and pulse rate of adult and pediatric patients.

Missing Information (Crucial for the Request):

Specific Acceptance Criteria: While standards are listed, the document does not provide specific numerical or qualitative acceptance criteria (e.g., SpO2 accuracy within +/-X%, pulse rate accuracy within +/-Y bpm).
Reported Device Performance: No actual performance data (e.g., measured accuracy values) is given.
Study Details:
- Sample size for test set
- Data provenance (country, retrospective/prospective)
- Number of experts
- Qualifications of experts
- Adjudication method
- MRMC study details (effect size)
- Standalone algorithm performance
- Type of ground truth used
- Sample size for training set
- How ground truth for training set was established

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Specific to Pulse Oximeter performance and safety)	Reported Device Performance (from the study)
*Not specified in the provided text.* However, based on the standards (ISO 9919, EN 865), typical criteria would include: - SpO2 accuracy within a certain % range (e.g., ±2% between 70-100% SpO2) - Pulse rate accuracy within a certain BPM range (e.g., ±3 BPM) - Alarm functionality testing - Electromagnetic compatibility (EMC) compliance - Safety standards (IEC 60601-1, UL 544) compliance	*Not specified in the provided text.* The document states "Acceptance criteria for compliance with the standards is detailed in Section 3, part E (Compliance)", but this section is not available here. No numerical performance results are provided.

Answers to Specific Questions:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Information not provided. The document vaguely mentions "Versamed's software validation procedure" and "an independent accredited testing agent" for EMC, but no details on sample size or data provenance.

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 / Information not provided. For a pulse oximeter, ground truth for SpO2 and pulse rate is typically established through direct measurement or comparison with a gold standard device, not expert consensus on interpretations. No details are given on how the ground truth was established for any performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable / Information not provided. This method is typically used for subjective evaluations where multiple readers/experts interpret images or data. For objective measurements like SpO2 and pulse rate, it's not relevant.

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, an MRMC comparative effectiveness study was not done. This type of study is for AI-assisted human interpretations, which is not relevant to a standalone medical device like a ventilator and pulse oximeter that provide direct measurements.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Yes, implicitly. A pulse oximeter is a standalone measurement device. However, the document does not provide the specific performance data from such a standalone evaluation. It references compliance with standards like ISO 9919, which would necessitate standalone performance testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Information not provided. For pulse oximetry, the ground truth for oxygen saturation and pulse rate is typically obtained from a reference method (e.g., arterial blood gas analysis, electrocardiogram) for accuracy testing, but this is not explicitly stated.

8. The sample size for the training set
* Not applicable / Information not provided. The device described is a hardware medical device with integrated software for control and measurement. It's not an AI/machine learning device that would typically involve a "training set" in the common sense.

9. How the ground truth for the training set was established
* Not applicable / Information not provided. (See answer to #8).

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or a bird in flight, composed of three curved lines that suggest wings and a body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2004 APR 1

Jerome Korten President and CEO Versamed Corporation 2 Blue Hill Plaza Pearl River, NY 10965

Re: K021981

Trade/Device Name: iVent™ 201 Portable Ventilator with Pulse Oximeter Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II (Two) Product Code: CBK, NOU, DQA Dated: May 12, 2003 Received: May 15, 2003

Dear Jerome Korten:

This letter corrects our substantially equivalent letter of August 13, 2003. 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 (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. Ilsting 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 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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

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): K021981

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 Portable Oximeter is suitable for intrahospital use, home and alternate-site use, transport and energy 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 speqification, limits.

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

Concurrence of CDRH, Office of Device Evaluation (Q

(ODE)

nesthesiology, General Ho ction Control, Denta

(Division Sign-Off)

510(k) Number: K021981

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K021981

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use

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AUG 1 3 2003

510(k) Summary

iVent™ 201 Portable Ventilator with Non-invasive Pulse Oximeter 510(k) Number KOZ |98 |

Submitter's Name:

VersaMed Ltd. Hasharon I ndustrial Park, Ornat Bkdg, P.O.B. 5011, Kadima 60920, Israel

Contact Person:

Ken Raichman VersaMed Ltd. Hasharon Industrial Park, Ornat Bkdg, P.O.B. 5011, Kadima 60920, Israel

Tel: 972-9-899 7775 Fax: 972-9-899 7776

Trade Name:

iVent™ 201 Pulse Oximeter

Classification Name:

Non-invasive Pulse Oximeter

Classification:

The FDA has classified these devices as a class II device (product code 74 DQA) and are reviewed by the Anesthesiology, Respiratory, and Defibrillator Devices Group.

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Predicate Devices:

The Non-invasive Pulse Oximeter for the itVent™ 201 Portable Ventilator is substantially equivalent to:

· MASIMO CSD-1050, 510(k) Masimo Set 2000, cleared under K990966

Performance Standards:

No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, to the best of our knowledge, the Non-invasive Pulse Oximeter, complies with the following voluntary standards:

ISO 9919 Pulse Oximeters for Medical Use Specifications; -
UL 544 Standard for Medical and Dental Equipment; Council Directive -93/42/EEC:
IEC 601-1-4 Medical Electrical Equipment Programmable electrical medical systems:
EN 865 Pulse Oximeters Particular Specifications. -

Versamed's iVent 201 with integrated Pulse Oximetry is designed to meet the FDA recognized Medical Safety standard IEC 60601-1 and the voluntary Pulse Oximetry standards ISO 9919 and EN 865.

Acceptance Criteria and Risk Analysis:

Acceptance criteria for compliance with the standards is detailed in Section 3, part E (Compliance).

Risk Analysis is addressed in Section 5 for hardware and Section 7 for Software.

The hardware risks addressed are leakage current. SpO2 power source failure, SpO2 Alarms and EMC interference. EMC interference is considered from three points: interference of the Ventilator on the Pulse Oximeter, which is checked by Masimo; interference of the Pulse Oximeter on the Ventilator which is checked Versamed's software validation procedure; and interference of the integrated unit on external devices and vise versa, which is checked by an independent accredited testing agent.

The software risks addressed are loss of communication and out of range inputs. These are checked as part of Versamed's Software Test Procedure for validation of the software.

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Indication for Use:

The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate of adult and pediatric patients.

Device Description:

Substantial Equivalence:

The MASIMO MS-5 Board is considered to be substantially equivalent to its predicate device (Masimo SET 2000, cleared under K990966) and cited above without raising new safety and/or effectiveness issues.

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).