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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the PowerNebTM device, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence. This type of submission typically does not include detailed clinical study results or acceptance criteria in the same way a PMA (Pre-Market Approval) or a full clinical trial publication would. The focus here is on demonstrating that the new device is as safe and effective as existing legally marketed predicate devices. Therefore, direct "acceptance criteria" and "study proving device meets acceptance criteria" as might be found in a clinical trial report are not explicitly stated in this document.

The "Performance Testing" mentioned is comparative testing against predicate devices and particle size testing for the nebulizer component, not a full-scale clinical trial with predefined end-point acceptance criteria in the traditional sense.

Acceptance Criteria and Device Performance

Since explicit acceptance criteria for a "study proving the device meets the acceptance criteria" are not detailed in this 510(k) summary, the table below will instead reflect the comparative features to predicate devices, which serve as the implicit "acceptance" for substantial equivalence. The "Acceptance Criteria" column will list critical features where the proposed device is expected to be comparable or equivalent to its predicates. The "Reported Device Performance" will detail how the PowerNeb® aligns with these features.

Acceptance Criteria (Derived from Predicate Device Comparison)	Reported Device Performance (PowerNeb® Features)
Indications for Use: • Mobilization of endobronchial secretions • Lung expansion therapy • Treatment and prevention of atelectasis	• Mobilization of endobronchial secretions • Lung expansion therapy • Treatment and prevention of atelectasis • Also has the ability to provide supplemental oxygen when used with compressed oxygen.
Creates Positive Expiratory Pressure	Creates a positive expiratory pressure
Increases Patient Functional Residual Capacity (FRC)	Increases patient Functional Residual Capacity (FRC)
Creates Positive Inspiratory Pressure	Creates a positive inspiratory pressure
Percussive Mode Peak Pressures	Selector ring adjustable in percussive mode (CHFO™) to provide peak pressures ≤ 30 cmH2O.
Static Flow Mode Airway Pressures	Provides a clinician controlled flow in static flow mode (CPEP™) for positive airway pressures of 0-20 cmH2O.
Nebulization Feature	Nebulization is standard feature.
Ability to provide Percussive or Static Lung Inflation	Can provide a percussive or static lung inflation component.
Percussive Frequency Rate	Percussive frequency rate pre-set at 100 - 300 bpm.
Interface Circuit Type	Disposable, single-patient use interface circuit.

Study Details (Based on the 510(k) Summary)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Size: Not specified. The document mentions "comparative testing against the predicate devices" and "testing of particle sizes from the small-volume nebulizer," but does not provide details on the number of devices tested or the specific test protocols.
- Data Provenance: Not specified. It's likely these were internal laboratory or bench tests conducted by the manufacturer, Comedica, Inc. (Dallas, TX, USA). The document does not indicate the country of origin of data or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This was a 510(k) submission for a noncontinuous ventilator, not an imaging or diagnostic device requiring expert interpretation for ground truth. Performance would be assessed through objective measurements against engineering specifications and predicate device performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. This document describes performance testing of a mechanical device.
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. This device is a noncontinuous ventilator and does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in the sense that the device's performance was assessed independently. The document states, "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." This implies bench testing of the device's functional attributes. The device itself is described as "pneumatic in operation and does not incorporate any electronic parts or software," so there is no "algorithm" in the modern AI sense.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this type of device, "ground truth" would be established by:
  - Objective engineering measurements: Such as pressure measurements (cmH2O), flow rates, frequency (bpm), and particle size distribution for nebulization.
  - Comparison to predicate device specifications/performance: Demonstrating that the PowerNeb® operates within expected parameters analogous to the legally marketed predicate devices.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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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: (214) 324-9223 Fax: (214) 324-2433

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® (ProposedDevice)	IPV® (K895485)	EzPAP®(K991300)
Indications:• Mobilization ofendobronchial secretions• Lung expansion therapy• Treatment and prevention ofatelectasis	Indications:• Mobilization ofendobronchial secretions• Treatment and prevention ofatelectasis	Indications:• Mobilization ofendobronchial secretions• Treatment and prevention ofatelectasis
Creates a positive expiratorypressure	Creates a positive expiratorypressure	Creates a positive expiratorypressure
Increases patient FunctionalResidual Capacity (FRC)	Increases patient FunctionalResidual Capacity (FRC)	Increases patient FunctionalResidual Capacity (FRC)
Creates a positive inspiratorypressure.	Creates a positive inspiratorypressure.	Creates a positive inspiratorypressure.
Selector ring adjustable inpercussive mode (CHFOTM) toprovide peak pressures ≤ 30cmH2O.	Working pressure adjustable inpercussive mode (IPV®) toprovide peak pressures from 0to > 80 cmH2O.	No percussive mode.
Provides a clinician controlledflow in static flow mode(CPEPTM) for positive airwaypressures of 0-20 cmH2O.	No static flow mode.	Provides a clinician controlledflow in static flow mode(EzPAP®) for positive airwaypressures of 0-20 cmH2O.
Nebulization is standard feature.	Nebulization is standard feature.	Nebulization must be added.
Can provide a percussive orstatic lung inflation component.	Provides percussive componentonly.	Provides static component only.
Percussive frequency rate pre-set at 100 - 300 bpm.2	Clinician controlled percussivefrequency rate at 100 - 300bpm.3	No percussive frequency.
Disposable, single-patient useinterface circuit.	Non-disposable, re-usableinterface circuit.	Disposable, single-patient usedevice.

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:

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:

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 (240) 276-0115. 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 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:

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:

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
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.(b)
Classification. Class II (performance standards).