(253 days)
No
The description focuses on mechanical and electronic control of airflow and pressure, with no mention of AI/ML terms or capabilities.
Yes
The device is described as "intended for the provision of Bi-Level CPAP (SiPAP) to produce a sigh" and "indicated for the treatment of Newborn and Infant patients," which clearly states its therapeutic purpose.
No
The device is described as providing "Bi-Level CPAP (SiPAP) to produce a sigh" and is indicated for "treatment" of patients, which points to a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it includes hardware components like an enclosure, solenoid valve, and piggybacks onto an existing hardware unit (Infant Flow Driver Unit).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing Bi-Level CPAP (SiPAP) to newborn and infant patients for respiratory support. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system for delivering augmented flow and pressure for breathing support. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There are no mentions of analyzing blood, urine, tissue, or any other biological samples. The device interacts directly with the patient's respiratory system.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Infant Flow Plus System consisting of a Driver and Generator plus NCPAP Prongs and Masks, is intended for the provision of a Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in hospitals, hospital-type facilities and intra-hospital transport environments and is indicated for the treatment of newborn and infant patients.
Product codes
CBK
Device Description
The Infant Flow Plus System is a factory-installed modification to the Infant Flow Plus System. It uses the existing manually operated air / oxygen mixer and CPAP flow control. An ancillary manual flow control with electronic control solenoid valve allows timed delivery of augmented flow and pressure. The modification is housed in a robust enclosure that is designed to "piggy back" on to the existing Infant Flow Driver Unit.
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
Newborn and Infant patients
Intended User / Care Setting
Hospitals, Hospital-type facilities and intra-Hospital transport environments
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)
The Infant Flow Plus System has been verified to be compliant with the requirements of the following standards:
- IEC60601-1, Medical Electrical Equipment. Part 1; General requirements . for safety, Second Edition, 1998; Amendment 1, 1991-11; Amendment 2, 1995-03
- IEC60601-1-2, Second Edition, 2001, Medical Electrical Equipment, Part 1; . General Requirements for Safety; Electromagnetic Compatibility -Requirements for Tests.
- IEC60601-1-4: 1996. Medical Electrical Equipment Part 1: General . requirements for safety: 4. Collateral Standard: Programmable electrical medical systems.
- UL 2601-1: Medical Electrical Equipment: General Requirements for . Safety,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K011516, K840865, K884521, K833982, 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
510(k) Notification Infant Flow Plus System June 2003
510(k) SUMMARY
031745
Date Summary Prepared
May 1st, 2002
COMPANY NAME AND ADDRESS
SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887 USA
CONTACT PERSON
Earl W. Draper Director QS/RA Telephone (714) 283-2228 (714) 283-8426 Fax:
DEVICE TRADE NAME
Infant Flow Plus ™
COMMON NAME
Bi-level Nasal CPAP
1
510(k) Notification Infant Flow Plus System June 2003
PREDICATE DEVICES
- Star Sync 1. Device Name: Classification: Class II Manufacturer: Infrasonics, Inc. 3911 Sorrento Valley Blvd. San Diego CA 92121-1402 K840865 & K884521 510(k) #:
-
- Device Name: Infant Flow System Classification: Class II Manufacturer: EME (Electro Medical Equipment) Ltd 60 Gladstone Place Brighton Sussex, BN2 3QD United Kingdom 510(k) #: K011516
-
- Device Name: Model IV-100B Infant Ventilator Classification: Class II Manufacturer: Sechrist 510(k)# K833982
-
- Device Name: Infant Flow System Classification: Class II Manufacturer Manufactured for SensorMedics by EME (Electro Medical Equipment) Ltd 60 Gladstone Place Brighton Sussex, BN2 3QD United Kingdom 510(k)# K991972
2
When compared to the predicate devices, the Infant Flow Plus System does not incorporate any significant change in intended use, method of operation, material or design that could affect the safety or effectiveness of the subject device.
DEVICE DESCRIPTION
The Infant Flow Plus System is a factory-installed modification to the Infant Flow Plus System. It uses the existing manually operated air / oxygen mixer and CPAP flow control. An ancillary manual flow control with electronic control solenoid valve allows timed delivery of augmented flow and pressure. The modification is housed in a robust enclosure that is designed to "piggy back" on to the existing Infant Flow Driver Unit.
INTENDED USE
The Infant Flow Plus System consisting of a Driver and Generator plus NCPAP Prongs and Masks, is intended for the provision of a Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in hospitals, hospital-type facilities and intra-hospital transport environments and is indicated for the treatment of newborn and infant patients.
PERFORMANCE DATA
The Infant Flow Plus System has been verified to be compliant with the requirements of the following standards:
- IEC60601-1, Medical Electrical Equipment. Part 1; General requirements . for safety, Second Edition, 1998; Amendment 1, 1991-11; Amendment 2, 1995-03
- IEC60601-1-2, Second Edition, 2001, Medical Electrical Equipment, Part 1; . General Requirements for Safety; Electromagnetic Compatibility -Requirements for Tests.
- IEC60601-1-4: 1996. Medical Electrical Equipment Part 1: General . requirements for safety: 4. Collateral Standard: Programmable electrical medical systems.
- UL 2601-1: Medical Electrical Equipment: General Requirements for . Safety,
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling three abstract human figures or shapes, arranged in a row.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FFB 1 3 2004
SensorMedics, Incorporated c/o Mr. Tom Gutierrez P.E. VIASYS Healthcare GmbH 1100 Bird Center Drive Palm Springs, California 92262
Re: K031745
Trade/Device Name: Infant Flow Plus Infant CPAP System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 11, 2003 Received: December 16, 2003
Dear Mr. Gutierrez:
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 111 (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 your device in the Fedcral Register.
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.
4
Page 2 - Mr. Tom Gutierrez P.E.
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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Susan Runn
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
5
510(k) Notification Infant Flow Plus System June 2003
INDICATIONS FOR USE STATEMENT
Applicant:
SensorMedics Corporation
510(k) Number:
Infant Flow Plus System Device Name:
The Infant Flow Plus System consisting of a Driver and Indications for Use: Generator plus NCPAP Prongs and Masks, is intended for the provision of Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in Hospitals, Hospital-type facilities and intra-Hospital transport environments and is indicated for the treatment of Newborn and Infant patients.
Yes (Per 21 CFR 801.109) Prescription Use:
Please Do Not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)
Prescription Use
or
OTC Use
Kthun
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number K031745