The Pulmodyne CHF 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 150 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 Pulmodyne CHF Flow Generator incorporates several components:
Flow generator (two styles - fixed flow and variable flow) .
Patient interface mask .
PEEP valve .
Circuit / tubing and connectors .
Air entrainment filter .
The Pulmodyne CHF Flow Generator is multi-patient, reusable and can be cleaned while the other components: circuit, mask, entrainment filter, and PEEP valve are disposable, single patient use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pulmodyne CHF Flow Generator:

This document is a 510(k) Premarket Notification Summary for a medical device, specifically the Pulmodyne CHF Flow Generator. A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, the "study" referenced here is primarily a comparison to a predicate device to establish substantial equivalence.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate device, the Caradyne - Whisperflow - K982283. The Pulmodyne CHF Flow Generator demonstrates substantial equivalence by matching or exceeding these characteristics.

Attribute	Acceptance Criteria (Predicate: Whisperflow WF 8500 K982283)	Reported Device Performance (Proposed: Pulmodyne CHF Flow Generator)
Use
Intended for delivery of CPAP	Yes	Yes
Used with PEEP valves, CPAP mask and circuit tubing	Yes	Yes
Environment - Hospital, sub-acute and 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 attach to wall oxygen source standard CGA or DISS fitting	Yes	Yes
Has an On / Off valve	Yes	Yes
Can adjust oxygen flow through the venturi port	Yes	Yes
Has an air entrainment port with 22 mm ID inlet	Yes	Yes
Air entrainment port with particulate filter	Yes	Yes
Has a valve which adjusts the flow to the venturi nozzle	Yes	Yes
Outlet port (22 mm)	Yes	Yes
Option for an in-line oxygen analyzer	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
One-way valve to prevent rebreathing, if no gas flow	Yes (in mask)	Yes (in elbow)
Flow generator can be cleaned and is reusable	Yes	Yes
Other components -- circuit, mask, PEEP valve, entrainment filter are Disposable, single patient use	Yes	Yes
Accessories required
CPAP mask	Yes	Yes
Particulate filter at 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	Yes	Yes
Fittings - 22 and 30 mm	Yes	Yes
Range of Oxygen (FiO₂)	28-100%	28-100%
Materials
Generator	Stainless steel and PVC	Stainless steel and PVC
CPAP mask	PVC and silicone	PVC and silicone
Circuit tubing and connectors	PE	PE

Study Details

Given this is a 510(k) submission based on substantial equivalence, the "study" is primarily a comparison of the new device's specifications and features to those of the predicate device. There is no mention of a traditional efficacy or performance study involving patients or a test set in the provided summary.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a clinical test set. The "test" is a comparison of product specifications and design to a predicate device.
- Data Provenance: The data comes from the design specifications and materials of the proposed Pulmodyne CHF Flow Generator and is compared directly against the documented characteristics of the predicate device (Caradyne - Whisperflow - K982283), as presented by the manufacturer. This is likely an internal engineering and design comparison.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in this context, would be the established specifications and performance of the predicate device, which are typically determined by the predicate device manufacturer and accepted by the FDA. The submission itself is prepared by engineering/regulatory personnel from Pulmodyne.
Adjudication method for the test set:
- Not applicable. There's no clinical data or expert review of cases described. The comparison is based on objective device characteristics and features.
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:
- No MRMC study was done. This device is a mechanical CPAP flow generator, not an AI-powered diagnostic or assistive technology. Therefore, this type of study is entirely irrelevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this substantial equivalence submission is the established design, performance specifications, and intended use of the legally marketed predicate device (Caradyne - Whisperflow - K982283). The new device's characteristics are compared directly to these established features.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established:
- Not applicable. No training set is involved.

In summary: The provided document is a 510(k) summary, which demonstrates substantial equivalence of a new medical device to a previously cleared predicate device. It primarily relies on a direct comparison of design, materials, and performance specifications rather than a clinical trial with patient data or extensive "studies" in the traditional sense of diagnostic or therapeutic efficacy. The "acceptance criteria" are the features and performance of the predicate device, and the "study" is the detailed comparison showing that the new device meets or is equivalent to these criteria.

Summary

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K080256

MAY - 9 2008

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 4 6-May-08

Pulmodyne2055 Executive Dr.Indianapolis, IN 46241	Tel - (317) 246-5505
Official Contact:	Tami Lefevers, Quality Manager
Proprietary or Trade Name:	Pulmodyne CHF Flow Generator
Common/Usual Name:	CPAP flow generator
Classification Name:	Breathing Attachment Positive End Expiratory PressureBYE - 868.5965
Predicate Devices:	Caradyne - Whisperflow - K982283

Device Description:

Flow generator (two styles - fixed flow and variable flow) .

Patient interface mask .
PEEP valve .
Circuit / tubing and connectors .
Air entrainment filter .

The Pulmodyne CHF Flow Generator is multi-patient, reusable and can be cleaned while the other components: circuit, mask, entrainment filter, and PEEP valve are disposable, single patient use.

Indications for Use:	To provide CPAP to spontaneously breathing adult patients in thehospital and pre-hospital (EMS) environment.
Patient Population:	Adults
Environment of Use:	Hospital, sub-acute institution, or pre-hospital (EMS)

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Non-Confidential Summary of Safety and Effectiveness

Page 2 of 4 6-May-08 ·

There are several conditions were therapeutic CPAP is Contraindications: contraindicated:

Patients who have:

Facial lacerations .
Laryngeal trauma .
Recent tracheal or esophageal anastomosis .
Gastrointestinal bleeding or ileus .
- Recent gastric surgery
Basilar skull fracture .
◆ Patients at high risk of vomiting
Emphysematous Bulla when an area of the lung may be brittle and present a risk . of bursting
Hypovolaemia low blood volume .

Attribute	Variable / Adjustable
	Whisper flowWF 8500K982283	ProposedPulmodyne CHFFlow Generator
Use
Intended for delivery of CPAP	Yes	Yes
Used with PEEP valves, CPAP mask andcircuit tubing	Yes	Yes
Environment - Hospital, sub-acute andpre-hospital (EMS)	Yes	Yes
Design
Works by a venturi method to create avacuum to provide high flows	Yes	Yes
Has oxygen inlet fitting which attach to walloxygen source standard CGA or DISS fitting	Yes	Yes
Has an On / Off valve	Yes	Yes
Can adjust oxygen flow through theventuri port	Yes	Yes
Has an air entrainment port with22 mm ID inlet	Yes	Yes
Attribute	Variable / Adjustable
	Whisper flowWF 8500K982283	ProposedPulmodyne CHFFlow Generator
Air entrainment port with particulate filter	Yes	Yes
Has a valve which adjusts the flow to theventuri nozzle	Yes	Yes
Outlet port (22 mm)	Yes	Yes
Option for an in-line oxygen analyzer	Yes	Yes
Circuit is standard 22 mm tubing	Yes	Yes
Can have a humidifier placed in-line	Yes	Yes
Connects to patient interface - maskor 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
One-way valve to preventrebreathing, if no gas flow	Yes in mask	Yes in elbow
Flow generator can be cleaned and is reusable	Yes	Yes
Other components -- circuit, maskPEEP valve, entrainment filter areDisposable, single patient use	Yes	Yes
Accessories required -CPAP mask	Yes	Yes
Particulate filter at air entrainment port	Yes	Yes
22 mm tubing	Yes	Yes
Head strap for mask	Yes	Yes
Various connectors	Yes	Yes
PEEP valves	Yes	Yes
Attribute	Variable / Adjustable
	Whisper flowWF 8500K982283	ProposedPulmodyne CHFFlow Generator
Performance Standards / Specifications
Oxygen input pressure 60 psi	Yes	Yes
Output flow range up to 140 Lpm	Yes	Yes
Fittings - 22 and 30 mm	Yes	Yes
Range of Oxygen (FiO₂)	28-100%	28-100%
Materials
Generator -Stainless steel and PVC	Yes	Yes
CPAP mask - PVC and silicone	Yes	Yes
Circuit tubing and connectors - PE	Yes	Yes

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Non-Confidential Summary of Safety and Effectiveness

Page 3 of 4
6-May-08

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Non-Confidential Summary of Safety and Effectiveness Page 4 of 4 6-May-08

Conclusion:

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tails, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2008

Pulmodyne C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

Re: K080256

Trade/Device Name: Pulmodyne CHF Flow Generator Regulation Number: 21 CFR 868.5965 Regulation Name: Positive End Expiratory Pressure Breathing Atachment Regulatory Class: II Product Code: BYE Dated: May 6, 2008 Received: May 7, 2008

Dear Mr. Dryden:

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 III (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 Federal Register.

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Page 2 - Mr. Dryden

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. 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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Sutte Y. Michael Omd.

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

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Indications for Use Statement

Page 1 of 1

510(k) Number: K080256 (To be assigned)

Pulmodyne CHF Flow Generator Device Name:

Indications for Use:

To provide CPAP to spontaneously breathing adult patients in the hospital and prehospital (EMS) environment.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off

(Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K080256

Regulation Number and Section

§ 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).