The DHD TheraPEP® is intended for use as a Positive Expiratory Pressure Device for patients suffering from Cystic Fibrosis, lung diseases with secretory problems, and to prevent or reverse atelectasis. The device may be used in conjuction with aerosol drug therapy.
The DHD TheraPEP is intended for use as a Positive Expiratory Pressure (PEP) device. It may also be used simultaneously with aerosol drug delivery using a nebulizer or Metered Dose Inhaler (MDI) with spacer.

Device Description

The DHD TheraPEP® is a single-patient-use Respiratory Therapy device. The standard system consists of a resistor, pressure range indicator, pressure port adapter, and mouthpiece. The mask may be substituted for the mouthpiece. Pressure monitoring is optional, and the pressure port adapter is removable.
Air and aerosolized drugs are drawn in through the inlet of TheraPEP, which is opposite the mouthpiece end of the device. The air and aerosolized drug passes by the inlet valve which baffles out some of the medication, primarily large diameter particles of aerosolized drug which can not be absorbed by the patient's lung tissue. The air and respirable diameter particles of the aerosolized drug continue undeterred past the inlet device and through the device past the mouthpiece and into the patient's body. As the user begins exhaling, the inlet valve closes, forcing all of the air from the lungs out the selected orifice in the selector dial.
The MDI with spacer or Nebulizer may be connected directly or by means of an adapter to the 22mm O.D. inlet end (opposite mouthpiece end) of the TheraPEP device. Positive Expiratory Pressure (PEP) occurs during exhalation and aerosol drug delivery occurs during inspiration. Use of an MDI Spacer and/or Nebulizer requires the same technique of breathing for inhalation and breath hold as does PEP therapy. A patient would be instructed by a clinician to take in a larger than normal breath for PEP Therapy or Aerosol Drug delivery followed by a short breath hold prior to exhalation. PEP occurs during exhalation and helps prolong exhalation plus keeps airways open longer thereby helping to move secretions, increase the transpulmonary pressure gradient, and resolve atelectasis.

AI/ML Overview

The provided text describes modifications to the TheraPEP device and studies conducted to support an added claim regarding its use with aerosol drug therapy. However, it does not detail specific "acceptance criteria" in the form of numerical performance targets (e.g., minimum sensitivity or specificity) or a formal "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or screening device.

Instead, the studies summarized aim to demonstrate substantial equivalence to existing devices and that the added claim does not negatively impact safety and effectiveness. The "acceptance criteria" here appear to be more about demonstrating equivalency and non-inferiority in terms of drug delivery characteristics, rather than meeting predefined performance thresholds for a new clinical outcome.

Here's an attempt to extract and present the information based on the provided text, acknowledging its limitations regarding explicit acceptance criteria and a structured "proving" study:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly list numerical "acceptance criteria" in the traditional sense for a diagnostic or screening device (e.g., specific thresholds for sensitivity, specificity, or accuracy). Instead, the performance evaluation in this submission focuses on demonstrating equivalence in drug delivery performance to predicate devices and that the new configurations (with nebulizer and MDI spacer) do not negatively impact performance.

The implicit acceptance criteria seem to be:

No significant difference in aerosolized drug delivery when the TheraPEP is used with MDIs (with spacer) or SVNs, compared to existing market products or the predicate device.
No statistically significant difference in total drug mass delivered or respirable drug mass delivered for different medications when compared to the predicate device in combination with nebulizers.
The added claim (combination with aerosol drug delivery) will not adversely affect the safety and effectiveness of the TheraPEP device.

Therefore, the "reported device performance" is largely framed in terms of "no difference" compared to predicate devices or current market offerings.

Acceptance Criteria (Implicit)	Reported Device Performance
No significant difference in albuterol drug delivery for MDI with Ace® spacer, with or without TheraPEP® connected.	No difference in albuterol drug delivery for MDI with the Ace® spacer, with or without the TheraPEP® attached in place of the Ace® mouthpiece, for either CFC or HFA formulations of albuterol.
No significant difference in albuterol drug delivery with various SVNs (Misty Neb, Salter, Uni-Heart) between TheraPEP® and Resistex®.	No difference in albuterol drug delivery with the Misty Neb, the Salter or the Uni-Heart nebulizers between the TheraPEP® and the Resistex®.
No statistically significant difference in total drug mass delivered or respirable drug mass delivered for Intal® or Alupent® between TheraPEP® and Resistex® when attached to various nebulizers (Misty Neb, Salter, Uni-Heart).	No difference statistically in either total drug mass delivered, or respirable drug mass delivered, with Intal® (cromolyn sodium) or with Alupent® (metaproterenol sulfate) between the TheraPEP® and the Resistex devices attached to any of the three brands of nebulizer. (Note: Larger amounts were recovered with TheraPEP®, but this did not achieve statistical significance due to small sample size and nonparametric testing.)
The added claim (device combined with aerosol drug delivery) will not adversely affect safety and effectiveness.	The conclusions state that the added claim for PEP therapy combined with aerosol drug delivery will not adversely affect the safety and effectiveness of the TheraPEP device when utilized for this application.

Study Information Details:

Sample size for the test set and data provenance:
- Phase I Testing: Not explicitly stated for each comparison, but the overall context of 510(k) submissions for such devices often involves in vitro laboratory testing rather than human subject trials. The phrasing "various products currently on the market" suggests comparative testing.
- Phase II Testing: "small sample size (n=3)" was explicitly mentioned for the comparison between TheraPEP® and Resistex® for Intal® and Alupent® drug delivery.
- Data Provenance: The studies appear to be laboratory-based in vitro evaluations of particle size distribution using cascade impaction measurement. Therefore, there is no "country of origin of the data" or "retrospective/prospective" context in the typical clinical study sense.
Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable as the studies were in vitro laboratory tests measuring particle size distribution and drug mass, not clinical evaluations requiring human expert interpretation for ground truth. The "ground truth" was established by the physical measurements themselves.
Adjudication method for the test set:
- Not applicable. The studies involved quantitative physical measurements, not human interpretation requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This was not an MRMC study. The studies evaluated device performance in terms of drug delivery characteristics, not reader performance with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The studies were "standalone" in that they evaluated the physical performance of the device and its compatibility with other components (nebulizers, MDIs) without human operation or interpretation as a variable in the outcome measurements. This aligns with the "algorithm only" concept for a physical device, where its intrinsic function is tested.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these studies was based on quantitative physical measurements using a cascade impactor to determine particle size distribution and total drug mass delivered. This is an objective measurement rather than an interpretive or clinical ground truth.
The sample size for the training set:
- Not applicable. These were in vitro verification and validation studies, not machine learning model development. Therefore, there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable, as there was no training set.

Summary

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APR 2 1991

K983467

510(k) SUMMARY As Required by 807.92(c)

9-23-98

1. Submitter: DHD Healthcare 125 Rasbach Street Canastota. NY 13032
  Phone: 315-697-2221 315-697-5191 Fax:

Jean Wallace, Manager, Regulatory Affairs Contact:

2. Device Name

TheraPEP® Kits Trade Name ー .
. Common name -Positive Expiratory Pressure (PEP) Kit with Nebulizer
Incentive Spirometer 868.5690 . Classification name -
1. RESISTEX® 510(K) K954492 Predicate Device:
Device Description The DHD TheraPEP® is a single-patient-use Respiratory Therapy 4. device. The standard system consists of a resistor, pressure range indicator, pressure port adapter, and mouthpiece. The mask may be substituted for the mouthpiece. Pressure monitoring is optional, and the pressure port adapter is removable.

Air and aerosolized drugs are drawn in through the inlet of TheraPEP, which is opposite the mouthpiece end of the device. The air and aerosolized drug passes by the inlet valve which baffles out some of the medication, primarily large diameter particles of aerosolized drug which can not be absorbed by the patient's lung tissue. The air and respirable diameter particles of the aerosolized drug continue undeterred past the inlet device and through the device past the mouthpiece and into the patient's body. As the user begins exhaling, the inlet valve closes, forcing all of the air from the lungs out the selected orifice in the selector dial.

The MDI with spacer or Nebulizer may be connected directly or by means of an adapter to the 22mm O.D. inlet end (opposite mouthpiece end) of the TheraPEP device. Positive Expiratory Pressure (PEP) occurs during exhalation and aerosol drug delivery occurs during inspiration. Use of an MDI Spacer and/or Nebulizer requires the same technique of breathing for inhalation and breath hold as does PEP therapy. A patient would be instructed by a clinician to take in a larger than normal breath for PEP Therapy or Aerosol Drug delivery followed by a short breath hold prior to exhalation. PEP occurs during exhalation and helps prolong exhalation plus keeps airways open longer thereby helping to move secretions, increase the transpulmonary pressure gradient, and resolve atelectasis.

5. Intended Use

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6. Technological Information

No basic technological changes as this submission is to add a claim and nebulizer components that are currently available in the market place.

7. Summary of Studies

The purpose of Phase I was to complete particle size distribution data using cascade impaction measurement, for the effect of expiratory resistance on metered dose inhaler (MDI) and small volume nebulizer (SVN) delivery of aerosolized albuterol (Proventil® and Proventil HFA) by metered dose inhaler (MDI) and aerosolized albuterol (Proventil®) by SVN. These tests were conducted using various products currently on the market such as the 1) Ace® Aerosol Cloud Enhancer MDI Spacer, reference 510(k) K953206, and three brands of SVN's, Airlife Misty Neb, Salter Neb and the Vortran Uni-Heart using albuterol sulfate (Proventil®), solution for inhalation.

The purpose of Phase II evaluation testing was to complete particle size distribution data using cascade impaction measurement, for the effect of expiratory resistance on small volume nebulizer (SVN) delivery of aerosol medication. Specifically, the effect of two expiratory resistance devices (TheraPEP, Resistex) on nebulized drug delivery was investigated usinq metaproterenol (Alupent®) and cromolyn sodium (Intal ®). This represents follow-up measures to the previous project testing MDI and nebulizer delivery of albuterol (Proventil®) with expiratory resistance.

8. Conclusions Drawn from Studies

The conclusions drawn from this evaluation were that there is no difference in albuterol drug delivery for MDI with the Ace® spacer, with or without the TheraPEP® attached in place of the Ace® mouthpiece, for either the CFC or the HFA formulations of albuterol. The results reported also indicate that there is no difference in albuterol drug delivery with the Misty Neb, the Salter or the Uni-Heart nebulizers between the TheraPEP® and the Resistex®.

Additional conclusions drawn indicate that there is no difference statistically in either total drug mass delivered, or respirable drug mass delivered, with Intal® (cromolyn sodium) or with Alupent® (metaproterenol suffate) between the TheraPEP® and the Resistex devices attached to any of the three brands of nebulizer (Misty Neb, Salter, Uni-Heart). In each individual trial, larger amounts of total and respirable drug mass, for both drugs, were recovered with the TheraPEP® compared to the Resistex® device. However, the greater drug delivery with the TheraPEP® did not achieve statistical significance with the small sample size (n=3) and with the conservative nonparametric Wilcoxon statistic.

The added claim (the device may be combined with aerosol drug delivery) for PEP therapy will not adversely affect the safety and effectiveness of the TheraPEP device when utilized for this application.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1999 APR

Mr. Larry Weinstein DHD Healthcare One Madison Street Wampsville, NY 13163

Re: K983467 TheraPEP® II (two) Requlatory Class: Product Code: 73 BWF January 15, 1999 Dated: Received: January 19, 1999

Dear Mr. Weinstein:

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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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 assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements 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.

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Paqe 2 - Mr. Larry Weinstein

This letter will allow you to begin 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 requlation (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

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Addendum - TheraPEP®510(k) Submission - K983467 Section 2 Intended Use Statement

TheraPEP® (Positive Expiratory Pressure Therapy (PEP) Device) Device Name:

1 . Indications For Use:
The DHD TheraPEP is intended for use as a Positive Expiratory Pressure (PEP) device. It may also be used simultaneously with aerosol drug delivery using a nebulizer or Metered Dose Inhaler (MDI) with spacer.

Atl. A. Ciarkows L.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.5690 Incentive spirometer.

(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).