(157 days)
No
The device description explicitly states it is an "electrically cycled hammer" with the "exact same function and operation" as a pneumatic predicate device, just with electronic cycling. There is no mention of AI, ML, or any complex data processing or learning capabilities.
Yes.
The device is intended to provide airway clearance therapy to treat conditions like retained secretions, difficulty with secretion clearance, or atelectasis caused by mucus plugging, which are clear therapeutic indications.
Yes
The device aids in collecting mucus for diagnostic evaluation, indicating a role in the diagnostic process.
No
The device description explicitly states it is an "electrically cycled hammer" and compares it to a pneumatically cycled percussor, indicating it is a physical device with electrical components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide airway clearance therapy through external manipulation of the thorax. This is a therapeutic intervention performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as an "electrically cycled hammer" used for percussing the thorax. This is a physical therapy device, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
While the device is indicated for collecting mucus for diagnostic evaluation, the device itself is the tool for collecting the sample, not the device that performs the diagnostic test on the sample. The diagnostic evaluation would be performed separately using an IVD device or method.
N/A
Intended Use / Indications for Use
The intended use of the Med Systems Electro Flo Percussor Model 5000 is to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Med Systems Electro Flo Percussor Model 5000is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
Product codes
BYI
Device Description
The Model 5000 "Electro Flo" Percussor is just an electrically cycled hammer. It has the exact same function and operation as the Model 2500 "Fluid Flo" percussor that our company has manufactured for hospitals since 10-23-82 under 510(k) number K802399. The "Fluid Flo" percussor is cycled by an oscillating pneumatic valve whereas the "Electro Flo" percussor is cycled electronically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thorax
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
After analyzing bench and electrical safety testing data, it is the conclusion of MED Systems that the Med Systems Electro Flo Percussor Model 5000 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K802399, K801982, K821265, K821570, K813438
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).
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NOV 2 1 2003
EXHIBIT 2 510(k) Summary of Safety and Effectiveness
MED SYSTEMS 2631 Ariane Drive San Diego, CA 92117 Phone 800.345.9061 Fax 858.483.9827 medsystems.com
June 9, 2003 Contact: Jim Davis, President
-
- Identification of the Device: Proprietary-Trade Name: Med Systems Electro Flo Percussor Model 5000 Classification Name: Powered Chest Percussor Product Code BYI Common/Usual Name: Powered Chest Percussor
-
- Equivalent legally marketed devices: This product is similar in function to the Model 2500 "Fluid Flo" percussor that our company has manufactured for hospitals since 10-23-82 under 510(k) number K802399. (Company formerly known as Medical Equipment Development Co., Inc.) as well as PURITAN BENNETT McSHIRLEY | K801982 and SOUTHWEST MEDICAL MFG. INC (STROM) K821265, K821570 K813438
-
- Indications for Use (intended use) : The intended use of the Med Systems Electro Flo Percussor Model 5000 is provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Med Systems Electro Flo Percussor Model 5000is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
(1). Bronchial Hygiene Guidelines Committee, American Association for Respiratory Care. AARC Clinical Practice Guideline: Postural Drainage Therapy. Respiratory Care 1991: 36: 1418 - 1426
-
- Description of the Device:. The Model 5000 "Electro Flo" Percussor is just an electrically cycled hammer. It has the exact same function and operation as the Model 2500 "Fluid Flo" percussor that our company has manufactured for hospitals since 10-23-82 under 510(k) number K802399. The "Fluid Flo" percussor is cycled by an oscillating pneumatic valve whereas the "Electro Flo" percussor is cycled electronically.
1
| Feature | Med Systems
2500 Fluid Flo
K802399 | PURITAN
BENNETT
McSHIRLEY
K801982 | SOUTHWEST
MEDICAL
MFG. INC
STROM
K821265,
K821570
K813438 | Med Systems
5000 Electro Flo
(This
submission) |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------|
| INDICATION
For USE | For respiratory
secretion
clearance for
COPD, cystic
fibrosis,
emphysema,
atelectasis and
other obstructive
lung conditions | SAME | SAME | SAME |
| Power and
Control | Pneumatic
Solenoid | Electric Solenoid | Electric Motor | Electronic
Solenoid |
| Speed | 5 to 15 Hz | 6 to 60 Hz | 5 to 60 Hz | 5 to 25 Hz |
| Weight | 1.5 pounds | 3 pounds | 5 pounds | 1.5 pounds |
| Energy source | Pneumatic | 120 v 60 Hz AC | 120 v 60 Hz AC | 120 v 60 Hz AC |
5. Substantial Equivalence Chart
-
- Conclusion
After analyzing bench and electrical safety testing data, it is the conclusion of MED Systems that the Med Systems Electro Flo Percussor Model 5000 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
- Conclusion
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and head. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2003
MED Systems C/O Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K031876
Trade/Device Name: Electro Flo Percussor, Model 5000 Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulation Class: II Product Code: BYI Dated: August 20, 2003 Received: August 25, 2003
Dear Mr. Kamm:
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, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Daniel Kamm, P.E.
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 of 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 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
Sincerely vours.
Chiu Lin, Ph.D.
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
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j) Indications for Use
510(k) Number_ ماركا (13) 510
Device Name: Med Systems Electro Flo Percussor Model 5000
Indications for Use:
The intended use of the Med Systems Electro Flo Percussor Model 5000 is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy (1) (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Med Systems Electro Flo Percussor Model 5000 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
(1). Bronchial Hygiene Guidelines Committee, American Association for Respiratory Care. AARC clinical practice guideline: postural drainage therapy. Respiratory Care 1991; 36: 1418 - 1426.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | X |
| OR | Over the Counter Use ______ |
| (Per 21 CFR 801.109) | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| 510(k) Number: | K031876 |
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