(25 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML components or algorithms.
Yes
The device is intended to provide CPAP to treat newborns and infants with RDS or recovering from RDS, indicating a therapeutic purpose.
No
Explanation: The device provides CPAP (Continuous Positive Airway Pressure) to treat newborns and infants with respiratory distress syndrome (RDS) or who are recovering from RDS, indicating a therapeutic rather than diagnostic function.
No
The device description explicitly mentions a "pressure generator, Nasal CPAP Prongs and Masks," which are hardware components. The summary also refers to a "device circuit."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide CPAP (Continuous Positive Airway Pressure) to newborns and infants with respiratory distress. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description refers to a "pressure generator, Nasal CPAP Prongs and Masks," which are components of a respiratory support system, not diagnostic equipment.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a medical device used for treatment, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The SensorMedics SiPAP Infant Nasal CPAP Circuit, consisting of a pressure generator, Nasal CPAP Prongs and Masks, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.
Product codes
73 BZD
Device Description
Detailed description of the device circuit is contained in the SiPAP Infant Nasal CPAP Operator's Instructions.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Because there are no performance differences between the SensorMedics SiPAP Infant Nasal CPAP Circuit, the SensorMedics Infant Flow Circuit and the Hamilton Medical Aladdin Circuit, no additional clinical or non-clinical tests were performed or submitted in the premarket notification. Refer to 510(k) numbers s K960359 and K945740 for this data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K960359, K945740, K974303, K984254, K991972
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
Infant Flow System - Summary of Safety and Effectiveness
Company:
SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887 714 283-1830
Contact:
Paul Kittinger
Proprietary Name:
SiPAP Infant Nasal CPAP Circuit
Common Name:
Nasal CPAP Circuit
Intended Use:
The SensorMedics SiPAP Infant Nasal CPAP Circuit, consisting of a pressure generator, Nasal CPAP Prongs and Masks, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.
Description of the Device:
Detailed description of the device circuit is contained in the SiPAP Infant Nasal CPAP Operator's Instructions.
Clinical and Non-Clinical Tests of Equivalency:
The SiPAP Infant Nasal CPAP Circuit is the equivalent device circuit as the Infant Flow distributed by Hamilton Medical under the "Aladdin" name (510(k) #"s K960359 and K945740) and the Infant Flow distributed by SensorMedics under 510(k)'s K974303, K984254 and K991972.
Because there are no performance differences between the SensorMedics SiPAP Infant Nasal CPAP Circuit, the SensorMedics Infant Flow Circuit and the Hamilton Medical Aladdin Circuit, no additional clinical or non-clinical tests were performed or submitted in the premarket notification. Refer to 510(k) numbers s K960359 and K945740 for this data.
Appendix 7
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
JUL 2 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Earl Draper SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887-4645
Re: K012034
SiPAP Infant Nasal CPAP Circuit Regulation Number: 868.5905 Regulatory Class: II (two) Product Code: 73 BZD Dated: June 27, 2001 Received: June 29, 2001
Dear Mr. Draper:
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 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might
2
Page 2 - Mr. Earl Draper
have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4646. 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" (21CFR 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,
Q. Tell
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) NUMBER (IF KNOWN): K012034
DEVICE NAME:
SiPAP Infant Nasal CPAP Circuit
INDICATIONS FOR USE:
The SensorMedics SiPAP Infant Nasal CPAP Circuit, consisting of a pressure generator, Nasal CPAP Prongs and Masks, is intended to provide CPAP for use in hospitals to treat newborns 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)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format (1-2-96)
Oaktell
Division of Cardiovascular & Respiratory Devices
510(k) Number K012034
Appendix 6