The use of DHD Roadrunner improves clearance of secretions
The use of DHD Roadrunner may reduce the need for postural drainage
DHD Roadrunner facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems
The DHD Roadrunner may be used to prevent or reverse atelectasis

Device Description

The DHD Roadrunner is indicated for use as a single patient use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when a patient exhales through the device.

AI/ML Overview

The provided text describes the DHD Roadrunner, a Positive Expiratory Pressure (PEP) device, and its substantial equivalence to predicate devices, but it does not explicitly state specific acceptance criteria or provide a detailed study report that proves the device meets those criteria with numerical performance metrics. Instead, it broadly claims that the device "met its specifications" and was "substantially equivalent."

Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific quantitative values from the provided text.

However, I can extract the available information regarding the "Summary of Studies" and other relevant details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (e.g., Pressure Range, Flow Rate, Vibration Frequency)	Reported Device Performance
Not explicitly stated in the provided text. The document broadly claims the device "met its specifications."	Not explicitly stated in the provided text. The document broadly claims the device "met its specifications" and was "substantially equivalent to the predicates." The study compared Roadrunner to Flutter and against its own performance specifications.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document mentions "bench & human testing" but does not provide the number of participants or samples.
Data Provenance: Not specified (e.g., country of origin). The document implies the testing was conducted by DHD Healthcare Corporation. It's unclear if the "human testing" involved a retrospective or prospective study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a mechanical medical device, not a diagnostic algorithm. Ground truth for performance would typically be established through engineering specifications, physical measurements, and clinical outcomes/physiological effects, rather than expert consensus on interpretations of data.

4. Adjudication method for the test set

Not applicable. As a mechanical device performance evaluation, adjudication would typically involve adherence to test protocols and measurement standards rather than expert consensus on interpretations.

5. 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

Not applicable. This is a medical device, not an AI or imaging diagnostic tool. An MRMC study is inappropriate for evaluating a PEP device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a physical, human-operated medical device. The concept of "standalone" performance (algorithm only) does not apply. The device's performance is inherently tied to a human user's exhalation. The "bench testing" component could be considered "standalone" in the sense of evaluating the device's physical output independent of a patient, but this is a different context than algorithm performance.

7. The type of ground truth used

The ground truth for the device's performance is implied to be based on:

Engineering Specifications: The device "met its specifications."
Comparison to Predicate Devices: Performance was compared to the Flutter® and TheraPEP® devices to establish "substantial equivalence" in terms of mechanisms (creating vibrating positive expiratory pressure) and intended physiological effects (secretion clearance, airway opening, preventing/reversing atelectasis). The predicates' established performance and safety serve implicitly as a form of ground truth for what is considered an effective PEP device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device.

Summary

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DHD HEALTHCARE

Image /page/0/Picture/2 description: The image shows the text "K991561" above the word "ROADRUNNER". The text is written in a simple, sans-serif font. The numbers are handwritten and slightly uneven. The word "ROADRUNNER" is in all caps and is bolded.

NOV 1 0 1999

510(k) Summary

Submitter:

DHD Healthcare Corporation 125 Rasbach Street Canastota, NY 13032

Contact: Larry Weinstein, Technology Manager 315-697-2221 Phone: 315-697-5191 Fax:

Device Name:

Product Code Name: Trade name: Common Name: Classification Name: Roadrunner To Be Determined Positive Expiratory Pressure (PEP) Device Incentive Spirometer - 868.5690

Predicate Devices:

TheraPEP® (1) : K944900, K962749, K983467 DHD Healthcare 125 Rasbach Street Canastota NY 13032

Flutter® (2) : K946083 K940986, K946083 Scandipharm Incorporated 22 Inverness Center Pkwy Birmingham. Alabama 35242

Device Description:

Intended Use:

Positive Expiratory Pressure (PEP) Therapy

Technological Characteristics Compared to Predicate:

Roadrunner. TheraPEP and Flutter are all PEP devices providing positive expiratory pressure. Roadrunner and Flutter offer the added vibration feature during exhalation. All three devices improve secretion clearance, reduce the need for postural drainage, facilitate the opening of airways, and prevent or reverse atelectasis. Roadrunner offers some additional features over Flutter by allowing inhalation without removing the device from the patient's mouth, allowing the device to perform in any spatial orientation, accommodating patients with very low flowrates and allowing patients to adjust frequency and pressure with the use of an external knob.

Summary of Studies:

The bench & human testing compares Roadrunner to Flutter and against its own performance specifications. Roadrunner is compared to DHD's TheraPEP®(2) device as a marketed PEP device with similar claims. In each test or comparison, the

ROADRUNNER

CONFIDENTIAL

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Roadrunner Device was shown to be substantially equivalent to the predicates and met its specifications.

Conclusion Drawn from Studies

For the indications for use, the DHD Roadrunner performs substantially equivalent to the predicate devices, Flutter® and TheraPEP®. In the opinion of DHD, it is substantially equivalent to the predicate devices and does not adversely affect safety and effectiveness compared to the predicate devices.

============================================================================================================================================================================== (1) TheraPEP® is a registered trademark of DHD Healthcare Corporation.

(2) Flutter® is a registered trademark of VarioRaw Percutive, a Scandipharm Company.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the head of the eagle is facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 0 1999

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

Re: K991561 Roadrunner, PEP Therapy Device Requlatory Class: II (two) Product Code: 73 BWF Dated: August 12, 1999 Received: August 13, 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 requlations affecting your device can be found in the Code of Federal Regulations, 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 regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register. 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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Page 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 regulation (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,

Jeanette Weichhaus fec,

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K991561 510(k) Number (if known):_

Device Name: Roadrunner

Indications For Use:

1 - Purpose:

The DHD Roadrunner is indicated for use as a Positive Expiratory Pressure (PEP) Device.

2 - Claims:

The use of DHD Roadrunner improves clearance of secretions 프
The use of DHD Roadrunner may reduce the need for postural drainage 트
DHD Roadrunner facilitates opening of airways in patients with Cystic Fibrosis, COPD, 트 asthma, and lung diseases with secretory problems
. The DHD Roadrunner may be used to prevent or reverse atelectasis
3 Target Patient Population

Patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis. All patients must be capable of following instructions for Positive Expiratory Pressure Therapy.

4 - Intended Environment For Use

Labeling reflects the statement: "Federal (USA) Law restricts this device to sale by or on the 피 order of a physician."
May be used in hospital as well as the home after a period of training. 트

5 - Legally Marketed Predicate Device(s):

DHD TheraPEP (K944900, K962749, K983467) 미
l Scandipharm Flutter (K940986, K946083)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Leann Auweterh

(Division Sign-C Division of Cardiovascular, R and Neurological Der 510(k) Number

Prescription Use_ 人 (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).