POWERNEB

K051964 · Comedica , Inc. · NHJ · Dec 1, 2005 · Anesthesiology

Device Facts

• Record ID: K051964
• Device Name: POWERNEB
• Applicant: Comedica , Inc.
• Product Code: NHJ · Anesthesiology
• Decision Date: Dec 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PowerNeb® is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.

Device Story

PowerNeb is a pneumatic, single-patient use device for secretion clearance, aerosol delivery, and lung volume recruitment. Device uses fixed venturi against user-set orifice to generate continuous high frequency oscillation (CHFO) waveform at 180-220 BPM; also provides continuous expiratory pressure (CPEP) mode. Operated by clinicians in clinical settings. Device connects to compressed oxygen source for supplemental oxygen delivery. Output consists of positive inspiratory and expiratory pressures to assist lung expansion and secretion mobilization. Benefits include improved airway clearance and atelectasis management. Device is purely pneumatic; contains no electronics or software.

Clinical Evidence

Bench testing only. Comparative performance testing against predicate devices (Bird IPV, EZ Pap) and particle size analysis of the integrated small-volume nebulizer were conducted to verify functional equivalence and ensure no adverse impact on nebulization performance.

Technological Characteristics

Pneumatic, non-electronic, non-software device. Single-patient use interface circuit. Features fixed venturi and user-set orifice for CHFO (180-220 BPM) and CPEP modes. Provides peak pressures ≤ 30 cmH2O. Includes small-volume nebulizer/mouthpiece and disposable manometer. Non-sterile; not intended for user sterilization.

Indications for Use

Indicated for patients requiring mobilization of endobronchial secretions, lung expansion therapy, or treatment/prevention of pulmonary atelectasis. Can provide supplemental oxygen when used with compressed oxygen.

Regulatory Classification

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.

Predicate Devices

• Bird (IPV) Noncontinuous Ventilator (K895485)
• EZ Pap (K991300)
• Vortran PercussiveNEB (K003684)

Submission Summary (Full Text)

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Appendix C Page 1 of 3

DEC 1 2005

K051964

# 510(k) Summary

## Submitter Information:

Comedica, Inc. 2201 Tucker Street, Suite 102 Dallas, TX 75214

## Contact:

Dee Faram, President Telephone: [phone] Fax: [phone]

## Date Prepared:

November 28, 2005

## Device Name & Classification:

Common Name: Noncontinuous Ventilator Trade Name(s): PowerNebTM Classification Name: Intermittent Positive Pressure Breathing Device Class II device per 21 CFR 868.5905 Panel: DCRND, Anesthesiology, Defibrillator Device Group Product Code: NHJ

## Predicate Device:

The PowerNeb® Noncontinuous Ventilator is substantially equivalent to the following devices:

Bird (IPV) Noncontinuous Ventilator, marketed by Percussionaire Corp. under K895485 and the EZ Pap, marketed by DHD Healthcare Corp. under K991300. Comparative pre-set percussive frequency is equivalent to the Vortran PercussiveNEB, marketed under K003684 (which was found to be substantially equivalent to the Bird IPV). A comparison of these devices is provided below.

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| PowerNeb® (Proposed<br>Device) | IPV® (K895485) | EzPAP®(K991300) |
|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Indications:<br>• Mobilization of<br>endobronchial secretions<br>• Lung expansion therapy<br>• Treatment and prevention of<br>atelectasis | Indications:<br>• Mobilization of<br>endobronchial secretions<br>• Treatment and prevention of<br>atelectasis | Indications:<br>• Mobilization of<br>endobronchial secretions<br>• Treatment and prevention of<br>atelectasis |
| Creates a positive expiratory<br>pressure | Creates a positive expiratory<br>pressure | Creates a positive expiratory<br>pressure |
| Increases patient Functional<br>Residual Capacity (FRC) | Increases patient Functional<br>Residual Capacity (FRC) | Increases patient Functional<br>Residual Capacity (FRC) |
| Creates a positive inspiratory<br>pressure. | Creates a positive inspiratory<br>pressure. | Creates a positive inspiratory<br>pressure. |
| Selector ring adjustable in<br>percussive mode (CHFOTM) to<br>provide peak pressures ≤ 30<br>cmH2O. | Working pressure adjustable in<br>percussive mode (IPV®) to<br>provide peak pressures from 0<br>to > 80 cmH2O. | No percussive mode. |
| Provides a clinician controlled<br>flow in static flow mode<br>(CPEPTM) for positive airway<br>pressures of 0-20 cmH2O. | No static flow mode. | Provides a clinician controlled<br>flow in static flow mode<br>(EzPAP®) for positive airway<br>pressures of 0-20 cmH2O. |
| Nebulization is standard feature. | Nebulization is standard feature. | Nebulization must be added. |
| Can provide a percussive or<br>static lung inflation component. | Provides percussive component<br>only. | Provides static component only. |
| Percussive frequency rate pre-<br>set at 100 - 300 bpm.2 | Clinician controlled percussive<br>frequency rate at 100 - 300<br>bpm.3 | No percussive frequency. |
| Disposable, single-patient use<br>interface circuit. | Non-disposable, re-usable<br>interface circuit. | Disposable, single-patient use<br>device. |

¹ In recent years an abundance of evidence has emerged to suggest that peak alveolar pressures of 30 cmH2O and less are safer than those higher than 30. E.g. see attached article, New England Journal of Medicine, May 4, 2000. 342(18):1301-1308.

² PercussiveNEB™ (K003684), which used IPV as a predicate, is also preset.

³ IPV® has just announced a model with pre-set frequency. Literature is not available at this writing.

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### Description:

The PowerNeb is a pneumatic, single-patient use device used to enhance secretion clearance, deliver aerosol, and recruit lung volumes. PowerNeb uses a fixed venture against a user-set orifice to create a continuous high frequency oscillation (CHFO) waveform at 180-220 breaths per minute (BPM). The PowerNeb can also deliver a continuous expiratory pressure (CPEP) when switched to CPEP mode.

This device is pneumatic in operation and does not incorporate any electronic parts or software. This device is non-sterile, and is not intended to be sterilized by the user. The PowerNeb is packaged with a a small-volume nebulizer/mouthpiece, and a disposable manometer, each of which has been previously 510k cleared.

#### Intended Use:

PowerNeb® is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.

#### Performance Testing

Performance testing includes comparative testing against the predicate devices, as well as testing of particle sizes from the small-volume nebulizer both with and without the PowerNeb, to determine any effects of the PowerNeb on the nebulizer's performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is black and white.

#### Public Health Service

DEC 1 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Comedica, Incorporated C/O Ms. Krista Oakes Principal Amica Solutions 2300 McDermott Road, Suite 200-207 Plano, Texas 75025

Re: K051964

Trade/Device Name: PowerNebTM Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NHJ Dated: October 25, 2005 Received: October 26, 2005

Dear. Ms. Oakes:

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 - Ms. Oakes

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 (OS) 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 J. Michie Omp.

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

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#### Indications for Use

510(k) # (if known): K051964

Device Name: PowerNeb TM

Indications for Use:

PowerNeb® is indicated for mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and also has the ability to provide supplemental oxygen when used with compressed oxygen.

Prescription Use x (21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aum Schom

Sign Sign Off) Colonion of Anesthesiology, General Hospital, Intection Control, Dental Device

510(%) Number: