PULMODYNE CHF FLOW GENERATOR SYSTEM

K080256 · Pulmodyne · BYE · May 9, 2008 · Anesthesiology

Device Facts

• Record ID: K080256
• Device Name: PULMODYNE CHF FLOW GENERATOR SYSTEM
• Applicant: Pulmodyne
• Product Code: BYE · Anesthesiology
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Pulmodyne CHF Flow Generator is a venturi-based oxygen/air delivery device providing CPAP to spontaneously breathing adult patients. It connects to a wall oxygen source (60 psi) to generate high flows (up to 150 Lpm) with FiO2 between 28-100%. The device utilizes an air entrainment port with a filter, an on/off valve, and an in-line PEEP valve to establish circuit pressure. It interfaces with the patient via a face mask or ET tube. Used in hospital, sub-acute, or pre-hospital (EMS) environments by clinicians. The flow generator is reusable, while the circuit, mask, entrainment filter, and PEEP valve are single-patient use. The device assists in respiratory support by maintaining positive airway pressure, which can benefit patients with congestive heart failure or other respiratory distress requiring CPAP.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Venturi-type flow generator. Materials: Stainless steel and PVC (generator), PVC and silicone (mask), PE (tubing). Energy source: Compressed oxygen (60 psi). Connectivity: Standalone. Sterilization: Reusable generator component; disposable patient-contact components. Dimensions: 22 mm and 30 mm fittings.

Indications for Use

Indicated for spontaneously breathing adult patients requiring CPAP in hospital or pre-hospital (EMS) settings. Contraindicated in patients with facial lacerations, laryngeal trauma, recent tracheal or esophageal anastomosis, gastrointestinal bleeding or ileus, recent gastric surgery, basilar skull fracture, high risk of vomiting, emphysematous bulla, or hypovolemia.

Regulatory Classification

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.

Predicate Devices

• Caradyne - Whisperflow - K982283

Submission Summary (Full Text)

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K080256

**MAY - 9 2008**

### Non-Confidential Summary of Safety and Effectiveness

Page 1 of 4 6-May-08

| Pulmodyne<br>2055 Executive Dr.<br>Indianapolis, IN 46241 | Tel - [phone] |
|-----------------------------------------------------------|-------------------------------------------------------------------------|
| 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 Pressure<br>BYE - 868.5965 |
| Predicate Devices: | Caradyne - Whisperflow - K982283 |

#### Device Description:

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.

| Indications for Use: | To provide CPAP to spontaneously breathing adult patients in the<br>hospital 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 flow<br>WF 8500<br>K982283 | Proposed<br>Pulmodyne CHF<br>Flow Generator |
| Use | | |
| Intended for delivery of CPAP | Yes | Yes |
| Used with PEEP valves, CPAP mask and<br>circuit tubing | Yes | Yes |
| Environment - Hospital, sub-acute and<br>pre-hospital (EMS) | Yes | Yes |
| Design | | |
| Works by a venturi method to create a<br>vacuum to provide high flows | Yes | Yes |
| Has oxygen inlet fitting which attach to wall<br>oxygen source standard CGA or DISS fitting | Yes | Yes |
| Has an On / Off valve | Yes | Yes |
| Can adjust oxygen flow through the<br>venturi port | Yes | Yes |
| Has an air entrainment port with<br>22 mm ID inlet | Yes | Yes |
| Attribute | Variable / Adjustable | |
| | Whisper flow<br>WF 8500<br>K982283 | Proposed<br>Pulmodyne CHF<br>Flow Generator |
| Air entrainment port with particulate filter | Yes | Yes |
| Has a valve which adjusts the flow to the<br>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<br>or ET tube | Yes | Yes |
| Utilizes a standard PEEP valve to<br>establish the circuit pressure | Yes | Yes |
| Patient can entrain room air should<br>oxygen flow fail | Yes | Yes |
| One-way valve to prevent<br>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<br>PEEP valve, entrainment filter are<br>Disposable, single patient use | Yes | Yes |
| Accessories required -<br>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 flow<br>WF 8500<br>K982283 | Proposed<br>Pulmodyne CHF<br>Flow 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 -<br>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 [phone]. 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 [phone] or [phone] 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