(785 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, or related terms, nor does it describe functionalities typically associated with AI/ML in medical devices (like image analysis or complex predictive algorithms). The description focuses on standard ventilation capabilities.
Yes
The device is described as providing "positive pressure ventilation," which is a medical treatment. The intended use also specifies that it is for "neonatal, infant, pediatric and adult patients" within a "hospital environment" and by a "licensed practitioner," all of which point to a therapeutic purpose rather than diagnostic or other functions.
No
The device, Newport E100M, is described as providing positive pressure ventilation, which is a therapeutic function, not a diagnostic one. It's intended for treatment, not for identifying a disease or condition.
No
The intended use clearly describes a device providing "positive pressure ventilation," which is a hardware-based function. The lack of a device description doesn't negate this hardware function.
Based on the provided information, the Newport E100M is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device provides positive pressure ventilation for patients. This is a therapeutic intervention performed directly on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description (or lack thereof): While the description is "Not Found," the intended use is the primary indicator.
- Mentions of IVD-related terms: There are no mentions of analyzing samples, diagnosing conditions, or any other activities typically associated with IVD devices.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. The Newport E100M is a life support device used to assist breathing.
N/A
Intended Use / Indications for Use
The Newport E100M is intended to provide positive pressure ventilation for neonatal, infant, pediatric and adult patients, for use in the hospital environment. The device is intended for use by or at the direction of a licensed practitioner.
Product codes
73 CBK
Device Description
Not Found
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
neonatal, infant, pediatric and adult patients
Intended User / Care Setting
licensed practitioner / hospital environment
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird with three wing-like strokes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 1999
Ms. Karon Morell Newport Medical Instruments, Inc. 760 West 16th Street, Bldg. M Costa Mesa, CA 92627
Re : K972833 E100M Ventilator Requlatory Class: II (two) Product Code: 73 CBK Dated: June 25, 1999 Received: June 25, 1999
Dear Ms. Morell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Karon Morell
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): ___K972833
Device Name: Newport E100M
Indications For Use: The Newport E100M is intended to provide positive pressure ventilation for neonatal, infant, pediatric and adult patients, for use in the hospital environment. The device is intended for use by or at the direction of a licensed practitioner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
canno A Weitighouse Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Device
(Optional Format 3-10-98)