(252 days)
To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environment.
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.
The provided text describes a medical device, the Whisperflow Oxygen Flow Generator, and its comparison to predicate devices for FDA 510(k) clearance. However, it does NOT contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics typically associated with such studies (like statistical results, sample sizes for test/training sets, expert qualifications, or ground truth establishment).
The document is a "Non-Confidential Summary of Safety and Effectiveness" which focuses on establishing substantial equivalence to previously marketed devices. It primarily details:
- Device Description
- Intended Use
- Comparison of attributes with predicate devices (Vital Signs - Downs Flow Generators - K811393, K83150 and Vital Signs CPAP mask - K801883, EMS Mask - K871851). This comparison involves a qualitative check (Yes/No) for various design and performance attributes.
- Differences between the Whisperflow generators and predicate devices (ribbed cushion vs. air cushion mask design, wider FiO2 range)
Therefore, based solely on the provided text, I cannot complete the requested table and answer many of the questions.
Here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance (Based only on the provided comparison tables, which serve as an implicit set of functional/performance criteria for substantial equivalence)
Given that this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are implicitly met if the device performs comparably to the predicate devices across the listed attributes.
| Acceptance Criteria (Attribute from Predicate) | Reported Device Performance (Whisperflow WF 8500 / WF 8530) |
|---|---|
| Intended for delivering CPAP | Yes |
| Used with PEEP valves, CPAP mask, and circuit tubing | Yes |
| Environment: Hospital / pre-hospital (EMS) | Yes |
| Works by a venturi method to create a vacuum to provide high flows | Yes |
| Has oxygen inlet fitting (standard CGA or DISS) | Yes |
| Has an On / Off valve (WF 8500 only comparison) | Yes |
| Can adjust oxygen flow (WF 8500 only comparison) | Yes |
| Has an air entrainment port with 22 mm ID inlet | Yes |
| Air entrainment port can have a standard particulate / bacterial filter attached | Yes |
| Has a valve which adjusts the flow to the venturi nozzle (WF 8500 only comparison) | Yes (for WF 8500); No (for Vital Signs Model 9250); WF 8530 comparison table details this as "Fixed Flow" |
| Outlet port (22 mm) | Yes |
| Recommend an in-line oxygen analyzer | Yes |
| Recommend an in-line safety valve PEEP valve | Yes |
| Circuit is standard 22 mm tubing | Yes |
| Can have a humidifier placed in-line | Yes |
| Connects to patient interface - mask or ET tube | Yes |
| Utilizes a standard PEEP valve to establish the circuit pressure | Yes |
| Patient can entrain room air should oxygen flow fail | Yes |
| Mask has a one-way valve to prevent rebreathing if no oxygen flow | Yes |
| Flow generator can be EO gas sterilized | Yes |
| Accessories required (CPAP mask, filter, tubing, head strap, connectors, PEEP valves) | Yes (for all listed accessories) |
| Oxygen input pressure 60 psi | Yes |
| Output flow range up to 140 Lpm | Yes (WF 8500); Yes, dependent on PEEP pressure (WF 8530) |
| Fittings 22 mm | Yes |
| Range of Oxygen (FiO2) | 28-100% (Whisperflow WF 8500); 28% (Whisperflow WF 8530) (Note: Predicates listed as 33-100% or 33%) |
| Materials (Generator: Stainless steel, PVC; Mask: PVC and silicone) | Yes (for both generator and mask materials) |
Missing Information:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned. The document describes a comparison of attributes, not a clinical study with a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No "test set" in the context of expert review is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant. This is not an AI/imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant. This is not an AI/imaging device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of this 510(k) submission. "Ground truth" here is effectively the specifications and functional performance of the predicate devices.
- The sample size for the training set: Not relevant. This is not an AI device.
- How the ground truth for the training set was established: Not relevant. This is not an AI device.
Summary of the Study/Comparison:
The document presents a comparison of the Whisperflow Oxygen Flow Generators (WF 8500 and WF 8530 models) to multiple predicate devices (Vital Signs - Downs Flow Generators K811393, K83150 and Vital Signs CPAP mask K801883, EMS Mask K871851). This comparison is qualitative, checking for the presence or absence of various design, functional, and performance attributes. The FDA's letter (K982283) indicates that based on this comparison, the device was found substantially equivalent to legally marketed predicate devices. The study is effectively a desk-based comparison of specifications and intended use rather than a clinical trial or performance test with a specifically defined "acceptance criteria" and "test set" in the manner common for AI-driven diagnostic devices.
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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 / AdjustableVital Signs | ||
|---|---|---|---|
| WhisperflowWF 8500 | Model 9250K821503Vital Flow100 | ||
| Use | |||
| Intended for delivering of CPAP | Yes | Yes | |
| Attribute | Variable / Adjustable | ||
| WhisperflowWF 8500 | Model 9250K821503 | Vital SignsVital Flow100 | |
| Used with PEEP valves, CPAP maskand circuit tubing | Yes | Yes | Yes |
| Environment Hospital /pre-hospital (EMS) | Yes | Yes | Yes |
| Design | |||
| Works by a venturi method to create avacuum to provide high flows | Yes | Yes | Yes |
| Has oxygen inlet fitting which attachedto wall oxygen source standard CGA orDISS 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 standardparticulate / bacterial filter attached | Yes | Yes | Yes |
| Has a valve which adjusts the flow tothe 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 toestablish the circuit pressure | Yes | Yes | Yes |
| Patient can entrain room air shouldoxygen flow fail | Yes | Yes | Yes |
| Attribute | Variable / Adjustable | Vital Signs | |
| WhisperflowWF 8500 | Model 9250K821503 | Vital Flow100 | |
| Mask has a one-way valve to preventrebreathing, 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 |
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page 4 of 5
June 25, 1998
| Attribute | WhisperflowWF 8530 | Vital SignsModel 9200K811393 |
|---|---|---|
| Use | ||
| Intended for delivering of CPAP | Yes | Yes |
| Used with PEEP valves, CPAP maskand circuit tubing | Yes | Yes |
| Environment Hospital /pre-hospital (EMS) | Yes | Yes |
| Design | ||
| Works by a venturi method to create avacuum to provide high flows | Yes | Yes |
| Has oxygen inlet fitting which attachedto wall oxygen source standard CGA orDISS fitting | Yes | Yes |
| Has an air entrainment port with 22 mm ID inlet | Yes | Yes |
| Air entrainment port can have a standardparticulate / 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 toestablish the circuit pressure | Yes | Yes |
| Patient can entrain room air shouldoxygen flow fail | Yes | Yes |
| Mask has a one-way valve to preventrebreathing if no oxygen flow | Yes | Yes |
| Attribute | Fixed FlowWhisperflowWF 8530 | Vital SignsModel 9200K811393 |
| 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 |
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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.
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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
§ 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).