(288 days)
The Electromed Medpulse™ RespiratoryVest System is designed specifically to deliver I its Lievency chest wall oscillation to promote airway clearance and improve bronchial drainage. The Medpulse™ Respiratory Vest System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
The Medpulse™ Respiratory Vest System is a high frequency chest wall oscillation device designed to aid in bronchial mucus clearance. The system consists of an air-pulse generator, an inflatable vest and air connection tubing. Alternating positive pressure air pulses are delivered to the inflatable vest via the air-pulse generator. Rapidly alternating positive pressure air pulses result in the inflation and deflation of the vest which frequency chest wall oscillation to the patient and thus enhances clearance of mucus from the lungs. The frequency of the air-pulses, time settings and amount of pressure are operator controlled according to physician's prescription.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medpulse™ Respiratory Vest System:
The provided document set is a 510(k) submission for the Medpulse™ Respiratory Vest System. It's important to note that 510(k) submissions don't typically involve extensive clinical trials with human subjects or detailed performance metrics like sensitivity/specificity for AI devices. Instead, they focus on demonstrating "substantial equivalence" to a predicate device already on the market.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (ThAIRapy® Vest System) regarding: | "The Electromed Medpulse™ System was functionally compared and performance tested against the predicate ThAIRapy® System which resulted in a demonstration of substantial equivalence regarding pressure amplitude, pulse frequency, pressure waveform shape, and thus performance." |
| - Form | "The Medpulse™ System and the ThAIRapy® System were comparitavely tested and found to be substantially equivalent with regard to form..." |
| - Fit | "The Medpulse™ System and the ThAIRapy® System were comparitavely tested and found to be substantially equivalent with regard to...fit..." |
| - Function | "The Medpulse™ System and the ThAIRapy® System were comparitavely tested and found to be substantially equivalent with regard to...function." |
| - Intended Use | "Electromed, Inc. believes that their Medpulse™ Respiratory Vest System is substantially equivalent to the Predicate system with regard to...intended use." |
| - Pressure Amplitude | Demonstrated substantial equivalence |
| - Pulse Frequency | Demonstrated substantial equivalence |
| - Pressure Waveform Shape | Demonstrated substantial equivalence |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for performance testing. The "performance testing" described is a functional comparison against a predicate device, not a human clinical trial involving a "test set" in the context of device performance metrics like sensitivity/specificity. The data provenance is not specified, but it's implied to be from Electromed, Inc.'s own internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this 510(k) submission. There was no "ground truth" to establish for a "test set" in the way it would be for an AI or diagnostic device. The comparison was functional and technical against a known predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. No adjudication method is mentioned because there was no clinical "test set" requiring expert review for ground truth establishment.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices that interact with human readers (e.g., radiologists interpreting images). The Medpulse™ Respiratory Vest System is a physical therapy device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. The Medpulse™ Respiratory Vest System is a physical device, not an algorithm. Its "performance" is inherent in its mechanical operation and its ability to deliver specified oscillation parameters.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this submission was the established performance and technical characteristics of the predicate device, the ThAIRapy® Vest System. The aim was to show that the Medpulse™ system matched these established characteristics. There was no clinical ground truth established through expert consensus, pathology, or outcomes data for this specific submission's performance testing.
8. The sample size for the training set
This information is not applicable. The Medpulse™ Respiratory Vest System is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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1977 510(k) Submission ELECTROMED, INC. Medpulse™ Respiratory Vest System
K982889
August 6, 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990.
Submitter: Electromed, Inc. 14920 Minnetonka Ind. Rd. Minnetonka, MN 55345 Phone# (612) 932-9387 Contact: Chet Sievert, Jr., Regulatory Consultant
Device Name: Proprietary Name: MedpulseTM Respiratory Vest System Common Name: Powered Percussor Classification: Powered Percussor-Electric (21 CFR 868.5665) Class II
Predicate Device: ThAIRapyR Vest System, #K884098
Description of Device:
The Medpulse™ Respiratory Vest System is a high frequency chest wall oscillation device designed to aid in bronchial mucus clearance. The system consists of an air-pulse generator, an inflatable vest and air connection tubing. Alternating positive pressure air pulses are delivered to the inflatable vest via the air-pulse generator. Rapidly alternating positive pressure air pulses result in the inflation and deflation of the vest which frequency chest wall oscillation to the patient and thus enhances clearance of mucus from the lungs. The frequency of the air-pulses, time settings and amount of pressure are operator controlled according to physician's prescription.
Intended Use:
The Intended Use of the Medpulse™ Respiratory Vest System is to provide high frequency chest wall oscillation to promote respiratory mucus clearance where external manipulations of the chest is the physician's treatment of choice.
Commarisons of Technological Characteristics:
The Medpulse™ System and the ThAIRapy® System were comparitavely tested and found to be substantially equivalent with regard to form, fit and function. Both systems utilize similar technologies which deliver pulsed compressed air to the vest at similiar frequencies and pressures.
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Performance Testing:
The Electromed Medpulse™ System was functionally compared and performance tested against the predicate ThAIRapy® System which resulted in a demonstration of substantial equivalence regarding pressure amplitude, pulse frequency, pressure waveform shape, and thus performance.
Conclusion:
Electromed, Inc. believes that their Medpulse™ Respiratory Vest System is substantially equivalent to the Predicate system with regard to form, fit, function and intended use.
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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 body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1999
Mr. Chet Sievert, Jr. Electromed, Inc. 14920 Minnetonko Industrial Road Minnetonka, MN 55345
Re: K982889 Medpulse™ Respiratory Vest System Requlatory Class: II (two) Product Code: 73 BYI Dated: April 29, 1999 Received: April 30, 1999
Dear Mr. Sievert:
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 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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Page 2 - Mr. Chet Sievert, Jr.
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,
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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Device Name: Medpulse™ Respiratory Vest System
Indications for Use
The Electromed Medpulse™ RespiratoryVest System is designed specifically to deliver I its Lievency chest wall oscillation to promote airway clearance and improve bronchial drainage. The Medpulse™ Respiratory Vest System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
Arh. A. Ciarlousli.
(Division Sign-Off) Division of Cardiovascular and Neurological Device 510(k) Number .
Prescriptions use
801.109
OTC
§ 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).