ROADRUNNER, PEP THERAPY DEVICE

K991561 · Dhd Healthcare Corp. · BWF · Nov 10, 1999 · Anesthesiology

Device Facts

• Record ID: K991561
• Device Name: ROADRUNNER, PEP THERAPY DEVICE
• Applicant: Dhd Healthcare Corp.
• Product Code: BWF · Anesthesiology
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Roadrunner is a hand-held, single-patient-use device for secretion clearance and lung expansion. Patient exhales through device to generate vibrating positive expiratory pressure (PEP). Features include: inhalation without device removal; multi-spatial orientation operation; accommodation of low flow rates; external knob for frequency/pressure adjustment. Used in hospital or home settings under physician order. Benefits include improved secretion clearance, reduced need for postural drainage, airway opening, and prevention/reversal of atelectasis.

Clinical Evidence

Bench and human testing compared Roadrunner to Flutter and TheraPEP. Results showed Roadrunner met performance specifications and performed substantially equivalent to predicate devices in secretion clearance and lung expansion metrics.

Technological Characteristics

Hand-held PEP device; mechanical vibration mechanism; adjustable frequency/pressure via external knob; allows inhalation without removal; multi-spatial orientation capability; single-patient use.

Indications for Use

Indicated for patients with Cystic Fibrosis, COPD, asthma, lung diseases with secretory problems, and atelectasis. Patients must be capable of following instructions for PEP therapy. Prescription use only; suitable for hospital or home use after training.

Regulatory Classification

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.

Predicate Devices

• TheraPEP (K944900, K962749, K983467)
• Flutter (K940986, K946083)

Submission Summary (Full Text)

{0}------------------------------------------------

# 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: [phone] 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:

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.

#### 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

{1}------------------------------------------------

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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

{4}------------------------------------------------

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)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)