(26 days)
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 is suitable for intra-hospital use, home and alternate-site use, transport and energy use.
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.
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. The ventilator is designed to treat a variety of clinical conditions. It can deliver oxygen-enriched air and may be used to administer nebulized medications by inhalation. The iVent™ 201 can use external AC or DC power supply and contains an internal battery. Its operation is controlled by the iVent™ 201 Software.
I am sorry, but the provided text is a 510(k) premarket notification letter and summary for a medical device (iVent™ 201 Portable Ventilator). This document confirms the device's substantial equivalence to a legally marketed predicate device, but it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding AI algorithms, ground truth establishment, or human reader performance.
Therefore, I cannot extract the information you requested about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily focuses on:
- Confirming the device's regulatory classification and substantial equivalence.
- Listing predicate devices.
- Specifying indications for use.
- Detailing compliance with voluntary performance standards (e.g., ASTM, ISO, EN).
- Describing the device and its remote alarm adapter.
- Stating that safety and performance testing were conducted to determine substantial equivalence.
It does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for specific tests.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies or AI-related performance.
- Standalone algorithm performance.
- Type of ground truth used for performance evaluation (beyond general safety and performance testing for regulatory submission).
- Sample size for a training set (as this is not an AI-enabled device validation).
- How ground truth for a training set was established.
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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: K011957
Trade/Device Name: iVent™ 201 Portable Ventilator Regulation Number: 868.5895 Regulatory Class: II (Two) Product Code: 73 CBK Dated: June 19, 2001 Received: June 22, 2001
Dear Jerome Korten:
This letter corrects our substantially equivalent letter of July 18, 2001. 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, 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 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 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 yours.
Clus
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): K011957
Device Name: iVent™ 201 Portable Ventilator (formally SmartVent 201)
Indications for Use:
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 is suitable for intra-hospital use, home and alternate-site use, transport and energy use.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K011957
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
fth
510(k) Number
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JUL 1 8 2001
510(k) Summary iVent™ 201 Portable Ventilator with Remote Alarm Adapter 510(k) Number K011957
510(K) SUMMARY
A 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990. This 510(k) Summary meets the requirements identified in 21 C.F.R. §807.92.
Submitter's Name:
VersaMed Ltd .. Atidim Industrial Park, Bldg.2 P.O.B. 58135 Tel-Aviv 61580, Israel
Contact Person:
Ken Raichman VersaMed Ltd .. Atidim Industrial Park, Bldg.2 P.O.B. 58135 Tel-Aviv 61580, Israel Tel: 972-3-649-6822 Fax: 972-3-649-6823 E-mail: ken@versamed.co.il
Trade Name:
iVent™ 201 Portable Ventilator
Classification Name:
Continuous Ventilator
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Classification:
The FDA has classified these devices as a class II device (product code 73 CBK) and are reviewed by the Anesthesiology, Respiratory, and Defibrillator Devices Group.
Predicate Devices:
The iVentil 201 Portable Ventilator with Remote Alarm adapter is substantially equivalent to the iVett™ 201 Portable Ventilator K981668
Performance Standards:
No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act. However, the Went™ 201 Portable Ventilator complies with the following voluntary standards: ASTM F1100-90, ASTM F1246-91, MIL-STD-810E, ISO 10651-1, ISO 10651-2, ISO 10651-3, EN 60601-1, EN 60601-1-2.
Indication for Use:
The iVentM 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 is suitable for inter-hospital use, home and alternatesite use, transport and emergency use.
The iVentilator 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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Intended Use of the Alarm Adapter: The Remote Alarm adapter is a device designed to connect the iVent 201 to a Central or Remote Alarm unit, such as a LIFECARE Remote Alarm Unit or similar device, for registration of the iVent 201 alarm output by a Central or Remote Alarm System.
Device Description:
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. The ventilator is designed to treat a variety of clinical conditions. It can deliver oxygen-enriched air and may be used to administer nebulized medications by inhalation. The iVent™ 201 can use external AC or DC power supply and contains an internal battery. Its operation is controlled by the iVent™ 201 Software.
Description of Remote Alarm Adapter: The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central or Remote Alarm unit of the Hospital. The Adapter consists of a relay circuit, which meets the activating requirements of the Central or Remote Alarm unit. The iVent 201 with Remote Alarm Adapter will activate the Central or Remote Alarm unit for any major or medium priority alarm event that occurs on the iVent201.
Substantial Equivalence:
Based on a series of safety and performance testing we believe that the iVent™ 201 with Remote Alarm Adapter is substantially equivalent to its predicate devices cited above without raising new safety and/or effectiveness issues.
§ 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).