(422 days)
Not Found
No
The summary describes a standard ventilator and pulse oximeter with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a ventilator, which provides continuous or intermittent ventilatory support for individuals requiring mechanical ventilation, directly addressing a health condition.
No
Explanation: The device is described as a ventilator for providing ventilatory support, and while it includes a pulse oximeter for monitoring oxygen saturation and pulse rate, its primary function is therapeutic (mechanical ventilation), not diagnostic.
No
The device description explicitly mentions hardware components like a "Non-invasive Pulse Oximeter board, MS-5" and its connection to sensors, indicating it is not software-only.
Based on the provided text, the iVent™ 201 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- iVent™ 201 Function: The iVent™ 201 is a ventilator. Its primary function is to provide mechanical ventilatory support to patients by assisting with breathing. It also includes a pulse oximeter for non-invasive monitoring of oxygen saturation and pulse rate.
- No Sample Analysis: The description of the iVent™ 201 and its intended use does not involve the analysis of samples taken from the body. It directly interacts with the patient's respiratory system and monitors physiological parameters non-invasively.
Therefore, the iVent™ 201 falls under the category of a life support or respiratory medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
CBK, NOU, DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients weighing at least 10 kg (22 lb.)
Intended User / Care Setting
qualified, trained personnel under the direction of a physician
intrahospital use, home and alternate-site use, transport and energy use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
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.
1
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
2
INDICATIONS FOR USE
510(k) Number (if known): K021981
Device Name: iVent™ 201 Portable Ventilator
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 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)
OR
Over the Counter Use
3
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.
4
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.
5
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:
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.
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.