(100 days)
Not Found
No
The summary describes a microprocessor-controlled ventilator with standard ventilation modes, controls, and a comprehensive alarm system. There is no mention of AI, ML, or any features that would typically indicate the use of such technologies for tasks like predictive analysis, automated parameter adjustments based on patient data patterns, or advanced diagnostic support beyond standard alarms.
Yes
The device is a ventilator, which provides ventilatory support to patients, directly treating a medical condition and maintaining vital functions.
No
The device provides ventilation support and monitoring, which are therapeutic and monitoring functions, not diagnostic ones.
No
The device description explicitly states it is a "pneumatically powered, microprocessor controlled ventilator" and the performance studies include "hardware, software, electrical safety, functional safety, EMC, packaging, and environmental" testing, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The e500 Ventilator is described as a device that provides ventilatory support and monitoring by assisting with breathing. It directly interacts with the patient's respiratory system.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is to deliver air and monitor respiratory parameters.
Therefore, the e500 Ventilator falls under the category of a life support or respiratory therapy device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The e500 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only.
The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital transport includes patient transport within the hospital or hospital-type facility.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The Newport e500 Wave Ventilator is a pneumatically powered, microprocessor controlled ventilator cleared through Premarket Notification.
Performance characteristics and clinical features support infant/pediatric (>20 mL) through adult patients.
Front panel controls allow trained operators to select ventilation controls under volume control, pressure control and volume target pressure control breath types in A/CMV, SIMV and SPONT modes.
A comprehensive alarm system is built-in to alert the user to violations of preset safety limits.
The alarms associated with the e500 meet or exceed standards of critical care ventilators and have been developed in compliance with ISO9703-1, ISO9703-2 and EN475. The alarms of the e500 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).
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
infant, pediatric, and adult patients
Intended User / Care Setting
hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.
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)
Comprehensive verification and validation testing was performed with the Newport e500 Wave Ventilators including; hardware, software, electrical safety, functional safety, EMC, packaging, and environmental. All test results met pre-defined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K030780, K051263, K041223, K984535
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
JUL 2 8 2006
ATTACHMENT 3, page 22 510(k) SUMMARY
A. Sponsor
Newport Medical Instruments, Inc.
1620 Sunflower Ave
Costa Mesa, California 92626
Telephone: (714) 427-5811
Fax: (714) 427-0839
Contact Person: Richard Waters
Vice President, Regulatory Affairs & Quality Assurance
B. Date Prepared
4/18/2006
். Device Name
Trade Name: Newport e500 Wave Ventilator
Classification Name: Continuous Ventilator
D. Device Description
The Newport e500 Wave Ventilator is a pneumatically powered, microprocessor controlled ventilator cleared through Premarket Notification.
Performance characteristics and clinical features support infant/pediatric (>20 mL) through adult patients.
Front panel controls allow trained operators to select ventilation controls under volume control, pressure control and volume target pressure control breath types in A/CMV, SIMV and SPONT modes.
A comprehensive alarm system is built-in to alert the user to violations of preset safety limits.
The alarms associated with the e500 meet or exceed standards of critical care ventilators and have been developed in compliance with ISO9703-1, ISO9703-2 and EN475. The alarms of the e500 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).
E. Intended Use
The e500 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a
1
ATTACHMENT 3, page 23
tidal volume of ≥ 20 mL. The device is prescription use only. The intended environments include hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.
F. Cleared/Predicate Device
Cleared Device
Newport e500 Ventilator, K030780
Predicate Devices
Drager EvitaXL K051263, July 12th, 2005
Maquet Servo-I Ventilator, K041223, July 29th, 2004
Puritan-Bennett 840, K984535, December 28, 1998
G. Summary of Substantial Equivalence
The Newport e500 Wave Ventilator is substantially equivalent to the cleared/predicate devices in intended use, physical characteristics, performance specifications and safety characteristics.
H. Testing
Comprehensive verification and validation testing was performed with the Newport e500 Wave Ventilators including; hardware, software, electrical safety, functional safety, EMC, packaging, and environmental. All test results met pre-defined acceptance criteria.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its wings and body. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2006
Mr. Richard Waters Vice President, Regulatory Affairs & Quality Assurance Newport Medical Instruments, Incorporated 1620 Sunflower Avenue Costa Mesa, California 92626
Re: K061094
Trade/Device Name: Newport e500 Wave Ventilator Regulation Number: 21 CFR 868,5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 12. 2006 Received: July 13, 2006
Dear Mr. Waters:
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 vour device in the Federal Register.
3
Page 2 - Mr. Waters
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,
Ching-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
4
ATTACHMENT 1, page 20 INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: _Newport e500 Wave Ventilator
Indications for Use:
The e500 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only.
The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital transport includes patient transport within the hospital or hospital-type facility.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Page 1_of 1_
(Posted November 13, 2003)
Aun. M. Wem
Sign-C)
n of Anesthesiology, General Hospital,
n Control, Dental Devices
KOCIO94