(10 days)
Not Found
No
The description focuses on mechanical oscillation and does not mention any AI/ML components or functionalities.
Yes
The device is designed to treat a medical condition (airway clearance and bronchial drainage) and is indicated for use when external chest manipulation is the physician's treatment of choice, signifying a therapeutic purpose.
No
The device description indicates it is a treatment device designed 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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 device works by applying mechanical force (oscillating air pulses) to the chest wall. It does not involve analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- No mention of in vitro testing: The description focuses on the mechanical action of the device on the patient's chest. There is no mention of any tests performed on samples outside of the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Electromed SmartVest® Airway Clearance System, Model TL is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
Product codes (comma separated list FDA assigned to the subject device)
BYI
Device Description
The proposed SmartVest® Airway Clearance System, Model TL is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport. The primary components of the SmartVest® 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed SmartVest® Airway Clearance System, Model TL was tested and compared to the predicate Medpulse® Respiratory Vest System Model 2000 ez (K040367). Testing included measuring the pressure imparted to the chest wall of both the proposed and predicate systems. 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 (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.
MedPulse® Respiratory Vest System, Model 2000 ez 510(K) number: K040367
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
§ 868.5665 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
DEC I 2005
002 Sixth Avenue N V7 New Pradue MN 55071 Phone, 952-768-9299 - Fax: 951-768-1941
510(k) SUMMARY
| Date: | October 15, 2005 |
|---|---|
| Submitter: | Chet Sievert |
| Regulatory Representative | |
| 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: | Electromed SmartVest® Airway Clearance System, |
| Model TL | |
| Classification: | Powered Percussor, Class II |
| Predicate Device: | MedPulse® Respiratory Vest System, Model 2000 ez |
| 510(K) number: K040367 |
Description of Device:
The proposed SmartVest® Airway Clearance System, Model TL is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport. The primary components of the SmartVest® 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.
Intended Use:
The Electromed SmartVest® Airway Clearance System, Model TL is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
1
510(k) SUMMARY (continued)
Comparison of Technological Characteristics:
The proposed SmartVest® Airway Clearance System, Model TL has the same technological characteristics and principles of operation as Electromed's previously cleared Medpulse® Respiratory Vest System Model 2000 ez (K040367). The proposed SmartVest® System will continue to use the same method of generating pressurized airpulses 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 in the same manner as the predicate system.
The first reason for this submission is due to a component change to the Air-Pulse Generator's pneumatic diaphragm. The proposed change reduces the size of the pneumatic diaphragm and therefore the Generator's over-all size. The second proposed change is to add several features to the Generator Control Panel that required software changes. These features allow the user to view the Control Panel in multiple directions during use and a Sleep Mode that automatically shuts off the device if left unattended.
A Vest that is dedicated for hospital use and additional Vest sizes were also added to the product line. In addition, a softer vest lining is proposed to accommodate user comfort.
Performance Testing:
The proposed SmartVest® Airway Clearance System, Model TL was tested and compared to the predicate Medpulse® Respiratory Vest System Model 2000 ez (K040367). Testing included measuring the pressure imparted to the chest wall of both the proposed and predicate systems. 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 SmartVest® Airway Clearance System, Model TL 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 SmartVest® Airway Clearance System, Model TL is substantially equivalent to the proposed Medpulse® Respiratory Vest System Model 2000 ez (K040367).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its wings and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
DEC I 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Electromed, Incorporated C/O Mr. Neil Devine Responsible Third Party Official Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K053248
Trade/Device Name: Electromed Smartvest® Airway Clearance System, Model TL Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: II Product Code: BYI Dated: October 18, 2005 Received: November 21, 2005
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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.
3
Page 2 - Mr. Devine
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 (QS) 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely vours.
Soufite y. Michin Omd
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
510(k) Submission Electromed, Inc.
October 15, 2005 SmartVest® Airway Clearance System, Model TL
VII. Indications for Use Statement
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ELECTROMED SMARTVEST® AIRWAY CLEARANCE SYSTEM, MODEL TL
Indications For Use:
The Electromed SmartVest® Airway Clearance System, Model TL is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
Prescription Use × (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)
Aun Sucion
: Station Sign-Off) Circsion of Anesthesioingy, General Hospital, innection Control, Dental Devices
Number: K053148