(54 days)
No
The description focuses on mechanical oscillation and does not mention any AI/ML components or functions.
Yes
The device is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage, which are therapeutic actions to enhance mucus transport as a physician's treatment.
No
The device is described as a treatment system designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage, not to diagnose a condition.
No
The device description explicitly lists hardware components: an Air-Pulse Generator, an Inflatable Vest, and a Vest/Generator Connector Hose. These are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. This is a physical therapy/treatment method applied externally to the patient's body.
- Device Description: The description details a system that applies mechanical force (oscillating air pulses) to the external chest wall. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- No mention of biological samples or analysis: The entire description focuses on the mechanical action of the device on the patient's body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform such analysis.
N/A
Intended Use / Indications for Use
The intended use of the Electromed MedPulse® Respiratory Vest System Model 2000ez is to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The MedPulse® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
Product codes
BYI
Device Description
The proposed MedPulse® Respiratory Vest System Model 2000ez is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The MedPulse® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport. The primary components of the MedPulse® System include an Air-Pulse Generator, an Inflatable Vest and Vest/Generator Connector Hose. The Air-Pulse Generator produces oscillating pressurized air-pulses that are delivered to the Inflatable Vest by the Vest/Generator Hose. The air-pulses produced by the Generator cause the Vest to rapidly inflate and deflate against the external chest wall of a patient to promote airway clearance by creating high-frequency chest wall oscillation (HFCWO) resulting in mobilization of bronchial secretions.
The reason for this submission is due to two component changes to the Air-Pulse Generator's motor. The first proposed change is to switch from a servo brush motor to a brushless motor. The motor's output performance will remain the same. A change to a brushless technology is intended to make the motor more reliable and have a longer life span. The second proposed change is to change the motor's frequency control from an analog component (i.e., potentiometer) to a digital control component. The change from analog to digital frequency control is considered to make the Air-Pulse Generator's motor more robust and reliable. The motor's digital frequency control also presents the opportunity to use the same component to control the Timer feature on the Control Panel that regulates the duration of treatment. This change allows the System to "remember" the user's previous settings for ease and more reliable use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The proposed MedPulse® Respiratory Vest System Model 2000ez was tested and compared to the predicate Medpulse® Respiratory Vest System Model 2000 (K982889). Functional performance and electrical safety tests were performed that demonstrated no change in output performance or safety issues to result from the changes proposed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5665 Powered percussor.
(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).
0
APR - 7 2004
Image /page/0/Picture/1 description: The image shows a series of alphanumeric characters, likely a code or identifier. The characters are "K0403657" and are oriented diagonally in the image. The text appears to be handwritten or printed with a slightly uneven quality.
ELECTROMED, INC.
502 Sixth Avenue N.W. New Prague, MN 56071 Phone: 952-758-9299 · Fax: 952-758-1941
February 7, 2004
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990.
| Submitter: | Chet Sievert
Regulatory Affairs
Electromed, Inc.
502 Sixth Avenue N.W.
New Prague, MN 56071
Phone: 952.758.9299
Fax: 952.758.1941 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Chet Sievert |
| Name of Device: | MedPulse® Respiratory Vest System
Model 2000ez |
| Classification: | Powered Percussor, Class II |
| Predicate Device: | MedPulse® Respiratory Vest System
Model 2000
510(K) number: K982889 |
Description of Device:
The proposed MedPulse® Respiratory Vest System Model 2000ez is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The MedPulse® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport. The primary components of the MedPulse® System include an Air-Pulse Generator, an Inflatable Vest and Vest/Generator Connector Hose. The Air-Pulse Generator produces oscillating pressurized air-pulses that are delivered to the Inflatable Vest by the Vest/Generator Hose. The air-pulses produced by the Generator cause the Vest to rapidly inflate and deflate against the external chest wall of a patient to promote airway clearance by creating high-frequency chest wall oscillation (HFCWO) resulting in mobilization of bronchial secretions.
1
Intended Use:
The intended use of the Electromed MedPulse® Respiratory Vest System Model 2000ez is to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The MedPulse® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
Comparison of Technological Characteristics:
The proposed MedPulse® Respiratory Vest System Model 2000ez has the same technological characteristics and principles of operation as Electromed's previously cleared Medpulse® Respiratory Vest System Model 2000 (K982889). The proposed MedPulse® System will continue to use the same method of generating pressurized air-pulses as the Predicate, i.e., by dual acting pneumatic diaphragm technology. The user of the Proposed System will continue to be able to adjust air pulse frequency and pressure amplitude as the Predicate System. The Inflatable Vest and Vest/Generator Connector Hose components of the Modified MedPulse® System will remain unchanged from the Predicate System.
The reason for this submission is due to two component changes to the Air-Pulse Generator's motor. The first proposed change is to switch from a servo brush motor to a brushless motor. The motor's output performance will remain the same. A change to a brushless technology is intended to make the motor more reliable and have a longer life span. The second proposed change is to change the motor's frequency control from an analog component (i.e., potentiometer) to a digital control component. The change from analog to digital frequency control is considered to make the Air-Pulse Generator's motor more robust and reliable. The motor's digital frequency control also presents the opportunity to use the same component to control the Timer feature on the Control Panel that regulates the duration of treatment. This change allows the System to "remember" the user's previous settings for ease and more reliable use.
Performance Testing:
The proposed MedPulse® Respiratory Vest System Model 2000ez was tested and compared to the predicate Medpulse® Respiratory Vest System Model 2000 (K982889). Functional performance and electrical safety tests were performed that demonstrated no change in output performance or safety issues to result from the changes proposed.
Substantial Equivalence:
The proposed MedPulse® Respiratory Vest System Model 2000ez has the identical indications and intended use, technological characteristics and principles of operation as the Predicate device. Functional performance and electrical safety testing have demonstrated no changes in safety or effectiveness. Thus, the proposed MedPulse® Respiratory Vest System Model 2000ez is substantially equivalent to the proposed Medpulse® Respiratory Vest System Model 2000 (K982889).
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 2004
Mr. Chet Sievert Regulatory Consultant Electromed, Incorporated 502 Sixth Avenue N.W. New Prague, MN 56071
Re: K040367
Trade Name: Medpulse Respiratory Vest System, Model 2000ez Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: II Product Code: BYI Dated: March 16, 2004 Received: March 19, 2004
Dear Mr. Sievert:
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, TDAravay, publish further announcements concerning your device in the Federal Register.
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 af 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
3
Page 2 - Mr. Chet Sievert
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 (301) 594-4646. 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/dsma/dsmamain.html.
for
Sincerely yours,
stt Wuttersheue
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
Enclosure
4
Indications for Use
510(k) Number: K040367
Device Name: MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000ez
Indications For Use:
The Electromed MedPulse® Respiratory Vest System Model 2000ez is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The MedPulse® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
JtW.h
sthesiology, General Hospital,
510(k) Number: K040367
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