(89 days)
No
The summary describes a physical medical device (a nasal mask) and its intended use with existing CPAP systems. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on equivalency to predicate devices based on physical function.
Yes
The device is intended to provide CPAP (Continuous Positive Airway Pressure) for newborns and infants with Respiratory Distress Syndrome (RDS), which is a treatment for a medical condition.
No
The device is a nasal CPAP mask intended to provide CPAP to newborns and infants with or recovering from RDS. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "silicone mask," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to provide CPAP (Continuous Positive Airway Pressure) with a nasal mask to treat newborns and infants with RDS or recovering from RDS. This is a therapeutic intervention applied directly to the patient, not a test performed on a sample taken from the body.
- Device Description: The device is described as a silicone mask that fits into a CPAP system. This is a physical interface for delivering air pressure, not a reagent, instrument, or system intended for use in the in vitro examination of specimens derived from the human body.
- 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 specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the SensorMedics Infant Flow Nasal CPAP Mask is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SensorMedics Infant Flow Nasal CPAP Mask is intended for use with the SensorMedics Infant Flow System, consisting of a Driver and NCPAP Generator. It is intended to provide CPAP with a nasal mask for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.
Product codes
73 BZD
Device Description
The SensorMedics Infant Flow Nasal CPAP Mask is a silicone mask that fits into the generator of the Infant Flow System in place of the standard nasal prongs.
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
newborns 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
Non-clinical testing of the Infant Flow System using the mask as compared to the prongs demonstrated no differences in safety or effectiveness.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Because there are no differences other than facial mounting and labeling between the SensorMedics Infant Flow System prongs and the SensorMedics Infant Flow Mask, no additional clinical tests were performed or submitted in the premarket notification. Refer to 510(k) numbers K960359 and K945740 for these data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K962848, K974303, K960359, K945740
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
Appendix 3: 510(k) Summary
Preparation Date: November 23, 1998
Company:
SensorMedics Corporation 22705 Save Ranch Parkway Yorba Linda, CA 92887 Telephone: (714) 283-2228 (714) 283-8411 Fax:
Contact:
Paul L. Kittinger Director, Regulatory Affairs
Proprietary Name:
Infant Flow Nasal CPAP Masks
Common Name:
Nasal CPAP Masks
Intended Use:
The SensorMedics Infant Flow Nasal CPAP Mask is intended for use with the SensorMedics Infant Flow System, consisting of a Driver and NCPAP Generator. It is intended to provide CPAP with a nasal mask for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.
Description:
The SensorMedics Infant Flow Nasal CPAP Mask is a silicone mask that fits into the generator of the Infant Flow System in place of the standard nasal prongs.
Clinical and Non-Clinical Tests of Equivalency:
The Infant Flow Mask is similar in purpose to the Hans Rudolph CPAP Mask (K962848) and provides the same function as the nasal CPAP prongs of the SensorMedics Infant Flow System (K974303) and Hamilton Aladdin CPAP System (K960359 and K945740).
Because there are no differences other than facial mounting and labeling between the SensorMedics Infant Flow System prongs and the SensorMedics Infant Flow Mask, no additional clinical tests were performed or submitted in the premarket notification. Refer to 510(k) numbers K960359 and K945740 for these data.
Non-clinical testing of the Infant Flow System using the mask as compared to the prongs demonstrated no differences in safety or effectiveness.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three lines representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all caps and is written in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 1999
Mr. Paul L. Kittinger SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887
Re : K984254 Infant Flow NCPAP Masks Regulatory Class: II (two) Product Code: 73 BZD Dated: November 23, 1998 Received: November 27, 1998
Dear Mr. Kittinger:
We have reviewed your Section 510(k) notification of intent to market we have referenced above and we have determined the device is ene as tially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encessare, or logo to May 28, 1976, the enactment date of the Incelstate Commerco press, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and in accordante with o 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, pisting 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 Existing major regulations affecting your device additional controls. 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 Failure to comply with the GMP regulation may result in assumptions. aegulatory 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 regulations.
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Page 2 - Mr. Paul L. Kittinger
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.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
3
510(k) NUMBER:
DEVICE NAME:
Infant Flow NCPAP Masks
1
INDICATIONS FOR USE:
The SensorMedics Infant Flow NCPAP Masks are intended for use with the The Gensonnedics Infant Flow System, consisting of a Driver and NCPAP Generator. SensorMedics Infrant Flow Bystoitt, a nasal mask for use in hospitals to treat it is intended to provide of P.P. Maran are recovering from RDS.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Mark Kramer | |
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| Prescription Use | |
| (Per 21 CFR 801.109) | 510(k) Number |
| K984254 | |
| Over-The-Counter-Use | |
| [Optional Format (1-2-96)] |
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