(252 days)
Not Found
No
The device description and intended use describe a purely mechanical venturi-type oxygen flow generator. There is no mention of any computational or algorithmic components, let alone AI/ML.
Yes
The device is described as providing CPAP (Continuous Positive Airway Pressure) to spontaneously breathing patients, which is a therapeutic intervention for respiratory support.
No
The device is described as an oxygen flow generator that provides CPAP pressure, which is a therapeutic function, not a diagnostic one. It delivers CPAP to spontaneously breathing patients but does not mention any role in detecting, identifying, or analyzing medical conditions.
No
The device description clearly states it is a "venturi type oxygen / air mixture delivery device" and mentions physical components like "standard in-line PEEP valves" and interfaces with the patient via a "face mask or ET tube," indicating it is a hardware device.
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 to spontaneously breathing patients. This is a therapeutic intervention applied directly to the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is described as an oxygen/air mixture delivery device that provides CPAP pressure. This is a medical device used for respiratory support, not for analyzing biological samples.
- 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 based on sample analysis.
In summary, the Whisperflow Oxygen Flow Generator is a medical device used for respiratory therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environment.
Product codes
73 BYE
Device Description
The Whisperflow Oxygen Flow Generator is a venturi type oxygen / air mixture delivery device which provides CPAP pressure at high flows to a spontaneously breathing patient. It can deliver up to 140 Lpm flow at a FiO2 between 28- 100%. It utilizes standard in-line PEEP valves to set the prescribed pressure and interfaces with the patient via a face mask or ET tube.
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
adult patient, adult patients
Intended User / Care Setting
Hospital and pre-hospital.
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)
K811393, K83150, K801883, K871851
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).
0
3/9/99
Image /page/0/Picture/1 description: The image shows the number "K 982283" on the left side. To the right of the number is a logo of three interlocking circles. Next to the logo is the word "caradyne" in bold, black letters.
Caradyne Limited Parkmore Business Centre Parkmore West Galway, Ireland.
Non-Confidential Summary of Safety and Effectiveness
page 1 of 5 June 25, 1998 Tel: +353 (0)91 709010 Fax: +353 (0)91 758929 Email: info@caradyne.com Internet: www.caradyne.com
| Caradyne, Ltd. | |
|---|---|
| Parkmore Business Park | |
| Parkmore West | |
| Galway, Ireland | |
| Tel - 011-353-91-709010 | |
| Fax - 011-353-91-758929 | |
| Official Contact: | John O'Dea, Ph.D., General Manager |
| Proprietary or Trade Name: | Whisperflow Oxygen Flow Generators and accessories |
| Common/Usual Name: | CPAP generator |
| Classification Name: | Breathing Attachment, Positive End Expiratory Pressure |
| Device: | Whisperflow Oxygen Flow Generators and accessories |
| Predicate Devices: | Vital Signs - Downs Flow Generators - K811393, K83150 |
| Vital Signs CPAP mask - K801883 | |
| EMS Mask - K871851 |
Device Description: 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
The Whisperflow Oxygen Flow Generator is a venturi type oxygen / air mixture delivery device which provides CPAP pressure at high flows to a spontaneously breathing patient. It can deliver up to 140 Lpm flow at a FiO2 between 28- 100%. It utilizes standard in-line PEEP valves to set the prescribed pressure and interfaces with the patient via a face mask or ET tube.
| Indicated Use -- | To provide CPAP to a spontaneously breathing adult patient. |
|---|---|
| Environment of Use -- | Hospital and pre-hospital. |
| Patient population -- | Spontaneously breathing adult patients. |
Comparison to Predicate Devices:
| Attribute | Variable / Adjustable
Vital Signs | | |
|--------------------------------------------------------------------------------------------------|--------------------------------------|----------------------------------------|------------------------------|
| | Whisperflow
WF 8500 | Model 9250
K821503
Vital Flow100 | |
| Use | | | |
| Intended for delivering of CPAP | Yes | Yes | |
| Attribute | Variable / Adjustable | | |
| | Whisperflow
WF 8500 | Model 9250
K821503 | Vital Signs
Vital Flow100 |
| Used with PEEP valves, CPAP mask
and circuit tubing | Yes | Yes | Yes |
| Environment Hospital /
pre-hospital (EMS) | Yes | Yes | Yes |
| Design | | | |
| Works by a venturi method to create a
vacuum to provide high flows | Yes | Yes | Yes |
| Has oxygen inlet fitting which attached
to wall oxygen source standard CGA or
DISS fitting | Yes | Yes | Yes |
| Has an On / Off valve | Yes | Yes | Yes |
| Can adjust oxygen flow | Yes | Yes | Yes |
| Has an air entrainment port with 22 mm ID inlet | Yes | Yes | Yes |
| Air entrainment port can have a standard
particulate / bacterial filter attached | Yes | Yes | Yes |
| Has a valve which adjusts the flow to
the venturi nozzle | Yes | No | Yes |
| Outlet port (22 mm) | Yes | Yes | Yes |
| Recommend an in-line oxygen analyzer | Yes | Yes | Yes |
| Recommend an in-line safety valve PEEP valve | Yes | Yes | Yes |
| Circuit is standard 22 mm tubing | Yes | Yes | Yes |
| Can have a humidifier placed in-line | Yes | Yes | Yes |
| Connects to patient interface - mask or ET tube | Yes | Yes | Yes |
| Utilizes a standard PEEP valve to
establish the circuit pressure | Yes | Yes | Yes |
| Patient can entrain room air should
oxygen flow fail | Yes | Yes | Yes |
| Attribute | Variable / Adjustable | Vital Signs | |
| | Whisperflow
WF 8500 | Model 9250
K821503 | Vital Flow100 |
| Mask has a one-way valve to prevent
rebreathing, if no oxygen flow | Yes | Yes | Yes |
| Flow generator can be EO gas sterilized | Yes | Yes | Yes |
| Accessories required - | | | |
| CPAP mask | Yes | Yes | Yes |
| Particulate filter at air entrainment port | Yes | Yes | Yes |
| 22 mm tubing | Yes | Yes | Yes |
| Head strap for mask | Yes | Yes | Yes |
| Various connectors | Yes | Yes | Yes |
| PEEP valves | Yes | Yes | Yes |
| Performance Standards / Specifications | | | |
| Oxygen input pressure 60 psi | Yes | Yes | Yes |
| Output flow range up to 140 Lpm | Yes | Yes | Yes |
| Fittings 22 mm | Yes | Yes | Yes |
| Range of Oxygen (FiO2) | 28-100% | 33-100% | 33-100% |
Registered in Ireland: 270891 Registered Office 2 Harbourmaster Place Custom House Dock Dublin 1
1
(continued)
page 2 of 5
June 25, 1998
2
page 3 of 5
June 25, 1998
| Materials and the comments of the comments of the comments of | and the contraction of the comments of the country of the count | |||
|---|---|---|---|---|
| Whisperflow generator - Stainless steel, PVC | Yes | Yes | Yes | |
| CPAP mask - PVC and silicone | Yes | Yes | Yes |
3
page 4 of 5
June 25, 1998
| Attribute | Whisperflow
WF 8530 | Vital Signs
Model 9200
K811393 |
|--------------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------|
| Use | | |
| Intended for delivering of CPAP | Yes | Yes |
| Used with PEEP valves, CPAP mask
and circuit tubing | Yes | Yes |
| Environment Hospital /
pre-hospital (EMS) | Yes | Yes |
| Design | | |
| Works by a venturi method to create a
vacuum to provide high flows | Yes | Yes |
| Has oxygen inlet fitting which attached
to wall oxygen source standard CGA or
DISS fitting | Yes | Yes |
| Has an air entrainment port with 22 mm ID inlet | Yes | Yes |
| Air entrainment port can have a standard
particulate / bacterial filter attached | Yes | Yes |
| Outlet port which is 22 mm | Yes | Yes |
| Recommend an in-line oxygen analyzer | Yes | Yes |
| Recommend an in-line safety valve PEEP valve | Yes | Yes |
| Circuit is standard 22 mm tubing | Yes | Yes |
| Can have a humidifier placed in-line | Yes | Yes |
| Connects to patient interface - mask or ET tube | Yes | Yes |
| Utilizes a standard PEEP valve to
establish the circuit pressure | Yes | Yes |
| Patient can entrain room air should
oxygen flow fail | Yes | Yes |
| Mask has a one-way valve to prevent
rebreathing if no oxygen flow | Yes | Yes |
| Attribute | Fixed Flow
Whisperflow
WF 8530 | Vital Signs
Model 9200
K811393 |
| Flow generator can be EO gas sterilized | Yes | Yes |
| Accessories required - | | |
| CPAP mask | Yes | Yes |
| Particulate filter for air entrainment port | Yes | Yes |
| 22 mm tubing | Yes | Yes |
| Head strap for mask | Yes | Yes |
| Various connectors | Yes | Yes |
| PEEP valves | Yes | Yes |
| Performance Standards / Specifications | | |
| Oxygen input pressure 60 psi | Yes | Yes |
| Output flow range up to 140 Lpm dependent | | |
| of PEEP pressure | Yes | Yes |
| Fittings 22 mm | Yes | Yes |
| Oxygen (FiO2) % | 28% | 33% |
| Materials | | |
| Whisperflow generator - Stainless steel, PVC | Yes | Yes |
| CPAP mask - PVC and silicone | Yes | Yes |
| | | |
4
page 5 of 5
June 25, 1998
Differences between Other Legally Marketed Predicate Devices =================================================================================================================
The differences between the Whisperflow generators and CPAP mask and the predicates are:
-
- CPAP mask is a ribbed cushion design versus an air cushion design.
-
- The Whisperflow generators have a wider range of FiO2 which may help in weaning patients from the ventilator.
There are no other significant differences between the intended device and the predicate devices.
5
Image /page/5/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 human figure with three faces in profile, connected by flowing lines. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1999
Mr. Paul E. Dryden Caradyne, Ltd. c/o Promedic, Inc. 6329 W. Waterview Court McCordsville, IN 46055
K982283 Re: Whisperflow Oxygen Flow Generator - Adjustable Model WF 85 Regulatory Class: II (two) Product Code: 73 BYE January 26, 1999 Dated: January 27, 1999 Received:
Dear Mr. Dryden:
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 A substantially equivalent determination assumes compliance to 895. 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 requlation may result in assumptions. In addition, FDA may publish further announcements regulatory action. 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.
6
Paqe 2 - Mr. Paul E. Dryden
This letter will allow you to beqin 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
7
TONSFORTIST
Page 1 of 1
Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.
K982283_______________________________________________________________________________________________________________________________________________________________________ (To be assigned) 510(k) Number:
Device Name:
Whisperflow Oxygen Flow Generator system
Intended Use :
To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environment.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lurk Modoo
Lath Modon 9-2
9-21- 78
Prescription Use
(Per CFR 801.109)
✓
or
Over-the-counter use