(74 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description is purely mechanical.
Yes
The device is intended to treat newborns and infants with RDS or who are recovering from RDS, which is a therapeutic purpose.
No
The device is described as providing CPAP (Continuous Positive Airway Pressure) for treatment, not for diagnosing conditions.
No
The device description explicitly states it consists of a "Driver and NCPAP Prongs," which are hardware components.
Based on the provided information, the SensorMedics Infant Flow System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide CPAP (Continuous Positive Airway Pressure) to treat newborns and infants with RDS. This is a therapeutic intervention applied directly to the patient, not a test performed on a sample taken from the patient.
- Device Description: The description mentions a Driver and NCPAP Prongs, which are components of a respiratory support system, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the SensorMedics Infant Flow System is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SensorMedics Infant Flow System, consisting of a Driver and NCPAP Prongs, is intended to provide CPAP for use in hospitals to treat newboms and infants with RDS or who are recovering from RDS.
Product codes
BZD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
newboms and infants
Intended User / Care Setting
hospitals
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
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 30 1998
Mr. Paul L. Kittinger Director, Requlatory Affairs SensorMedics 22705 Savi Ranch Parkway Yorba Linda, CA 92887-4645
Re: K974303 SensorMedics Infant Flow System Regulatory Class: II (two) Product Code: BZD Dated: November 11, 1997 Received: November 17, 1997
Dear Mr. Kittinger:
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 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, qood 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 regulations 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 Regulation (QS) for Medical Devices: General regulation (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 Reqister. 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 regulations.
1
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 regulation (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.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
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): K974303
DEVICE NAME:
Infant Flow System
INDICATIONS FOR USE:
The SensorMedics Infant Flow System, consisting of a Driver and NCPAP Prongs, is intended to provide CPAP for use in hospitals to treat newboms and infants with RDS or who are recovering from RDS.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
John Westenshausen
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of Cardiovascular, Respiratory, Over-The-Counter-Use __________
and Neurological Devices (Optional Format (1-2-96)
| 510(k) Number | __________ |
|---|---|
| --------------- | ------------ |