(190 days)
Not Found
No
The device description and claims focus on mechanical principles (vibrating positive expiratory pressure) for secretion clearance and lung expansion. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is used to treat conditions and symptoms such as improving secretion clearance, opening airways, and preventing/reversing atelectasis in patients with lung diseases, which falls under the definition of a therapeutic device.
No
The device is indicated for therapeutic purposes (secretion clearance, lung expansion, opening airways) rather than for diagnosing a condition.
No
The device description explicitly states it is a "hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when a patient exhales through the device," indicating it is a physical hardware device.
Based on the provided information, the DHD Roadrunner is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended use is as a Positive Expiratory Pressure (PEP) device for secretion clearance and lung expansion. This is a therapeutic and mechanical function, not a diagnostic one performed on in vitro samples.
- Device Description: The description details a hand-held device that creates vibrating positive expiratory pressure. This is a physical interaction with the patient's respiratory system, not an analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The DHD Roadrunner's function falls outside of this definition.
N/A
Intended Use / Indications for 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.
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
- 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
Product codes (comma separated list FDA assigned to the subject device)
73 BWF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
- Labeling reflects the statement: "Federal (USA) Law restricts this device to sale by or on the order of a physician."
- May be used in hospital as well as the home after a period of training.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench & human testing compares Roadrunner to Flutter and against its own performance specifications. Roadrunner is compared to DHD's TheraPEP® device as a marketed PEP device with similar claims. In each test or comparison, the Roadrunner Device was shown to be substantially equivalent to the predicates and met its specifications. For the indications for use, the DHD Roadrunner performs substantially equivalent to the predicate devices, Flutter® and TheraPEP®.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K944900, K962749, K983467, K946083, K940986
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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: 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:
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 (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
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):
(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)