The SmartVest® Airway Clearance System, Model SQL 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.

Device Description

The modified Electromed SmartVest® Airway Clearance System, Model SQL is an electrically powered percussor device designed to deliver high frequency chest wall oscillation (HFCWO) to aid in freeing mucus deposits in the lungs in order to improve bronchial drainage under the order of a physician's prescription. The primary components of both the proposed modified and predicate HFCWO Airway Clearance Systems consist of an Air Pulse Generator, an Inflatable Vest, and an Air Hose that connects the Generator to the Inflatable Vest. The Air Pulse Generator produces small volumes of pressurized air pulses that are rapidly delivered to the Inflatable Vest via the Air Hose at a selected oscillatory frequency between 5-20 times per minute (Hz). The Inflatable Vest imparts the oscillatory air pulses as pressure forces to the patient's external chest wall. These pressurized air pulses promote transient increases in airflow within the lungs that loosens mucus sufficiently to facilitate expulsion by the patient when normal respiratory function is not capable.

AI/ML Overview

The Electromed SmartVest® Airway Clearance System, Model SQL, is an electrically powered percussor device designed to deliver high-frequency chest wall oscillation (HFCWO) to aid in freeing mucus deposits in the lungs. The primary components are an Air Pulse Generator, an Inflatable Vest, and an Air Hose. The Air Pulse Generator produces pressurized air pulses (5-20 Hz) delivered to the Inflatable Vest via the Air Hose, which then applies these oscillatory pulses to the patient's chest wall. This action promotes transient increases in airflow to loosen mucus, facilitating expulsion.

The provided documentation describes the acceptance criteria and the study that proves the device meets the acceptance criteria as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Device Performance (Modified SmartVest® Airway Clearance System, Model SQL)
Output Performance Equivalence to Predicate Device (SmartVest® Airway Clearance System, Model TL: K053248) for: - Air Pulse Pressure - Air Pulse Frequency - Treatment Time	Demonstrated equivalence between the modified and predicate devices for air pulse pressure, air pulse frequency, and treatment time through comparison performance testing.
Safety and Effectiveness (no new risks compared to predicate)	Formal risk analysis revealed no new risks. The modified device has identical indications for use, the same patient population, and the same fundamental scientific technology, not raising additional questions of safety or effectiveness.
Design Control Compliance (21 CFR 820)	All modification and design activities were conducted in conformance to 21 CFR 820.30 Design Control.
Design Verification (meeting design input requirements)	Design verification testing, including software, demonstrated that design output specifications met design input requirements.
Usability/Human Factors (enhanced user operation, less potential for errors)	Usability/human factors testing demonstrated enhanced user operation with less potential for errors compared to the predicate.
Electromagnetic Compatibility (EMC)	The modified design passed electromagnetic compatibility testing.
Electrical Safety	The modified design passed electrical safety testing and UL testing.
Compliance with Recognized Standards: - IEC 60601-1 3rd edition - IEC 60601-1-2 3rd edition - IEC 60601-1-6 3rd edition - IEC 60601-1-11 3rd edition - UL testing - ASTM D4169-09 DC13 (Performance Testing of Shipping Containers and Systems)	The device underwent and presumably passed testing in accordance with these standards. (The document states "Testing included" these and "The modified design passed... electrical safety testing and UL testing" and "Design verification testing... demonstrated that the design output specifications met the design input requirements" which implies passing criteria for these standards were met.)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state a specific "test set" sample size or data provenance in terms of country of origin or whether data was retrospective or prospective for the performance and safety testing. The studies mentioned are primarily engineering and usability tests comparing the modified device to its predicate.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This device modification primarily involved engineering and usability changes to an existing, cleared device. The "ground truth" was established through comparison testing against the predicate device's established performance, compliance with regulatory standards, and internal design controls, rather than through expert-adjudicated clinical data of patient outcomes.

4. Adjudication Method for the Test Set:

Not applicable. No clinical adjudication of results is mentioned, as the studies are focused on product performance, safety, and equivalence to a predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The documentation focuses on engineering, performance and safety testing of the device itself and its equivalence to a predicate, not on the comparative effectiveness of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a medical apparatus (a percussor) and not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance relies on several factors:

Predicate Device Performance: The primary ground truth for output performance (air pulse pressure, frequency, treatment time) was the performance of the legally marketed predicate device (SmartVest® Airway Clearance System, Model TL: K053248).
Regulatory Standards: Compliance with established electrical safety and medical device standards (e.g., IEC 60601 series, UL, ASTM) served as a ground truth for safety and general performance.
Design Input Requirements: The pre-defined design input requirements served as the ground truth for design verification.
Usability Principles: Principles of usability and human factors served as the ground truth for usability testing.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm requiring a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" for this physical device.

Summary

{0}------------------------------------------------

DEC 1 9 2013

ELECTROMED, INC.

Creating superior care through innovation®

SPECIAL 510(k) SUMMARY

This Special 510(k) Summary is submitted in accordance with 21 CFR 807.92.

Date prepared: September 4, 2013

SUBMITTER

Electromed, Inc. 502 Sixth Ave. NW New Praque, MN 56071 Telephone: 952-758-9299

CONTACT INFORMATION

Chet Sievert Director of Regulatory and Clinical Affairs Telephone: 952-758-0384 direct 651-246-8621 cell Fax: 888-877-3371 E-mail: csievert@electromed.com

DEVICE INFORMATION

Trade Name: SmartVest® Airway Clearance System, Model SQL Common Name: Percussor, Powered-Electric

CLASSIFICATION

Regulation Number: 21 CFR 868.5665, Powered percusson Product Code: BYI Class: Il

Panel: Anesthesiology

�

PREDICATE DEVICE

SmartVest Airway Clearance System, Model TL: K053248

INDICATIONS FOR USE

The Indications for Use of the proposed modified device are identical to the legally marketed predicate device:

"The SmartVest Airway Clearance System, Model SQL 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."

Corporate Headquarters 500 Sixth Ave. N.W. New Prague, MN 56071 Phone: 952-758-9299 Fax: 952-758-1941 www.electromed.com

{1}------------------------------------------------

DEVICE DESCRIPTION

ﻧﮯ

DESCRIPTION OF THE CHANGES TO THE PREDICATE

Modifications were made to the Air Pulse Generator only. The modified generator was designed primarily to be smaller, quieter and lighter compared to the predicate. In addition, the following features were added to the predicate generator and two existing features were enhanced:

Child-lock option on treatment settings
Digital control of pressure settings ●
. On/Off switch
Enhanced ramping feature .
. Enhanced pause feature
More "user friendly" graphic user interface .

PERFORMANCE, FUNCTIONAL and SAFETY TESTING

Testing included:

Comparison output performance testing; proposed modified vs. predicate (air . pulse pressure, air pulse frequency and treatment time)
Design verification testing (including software) .
Design validation testing (usability/human factors) .
IEC 60601-1 3th edition, 60601-1-2 30 edition, 60601-1-6 30 edition, 60601-1-. 11 300 edition and UL testing
ASTM D4169-09 DC13. Standard Practice for Performance Testing of Shipping . Containers and Systems

COMPLETION OF DESIGN CONTROL ACTIVITIES

Managing and documenting the design process of making modifications to the predicate device was performed under Electromed's Quality System which is compliant with 21 CFR 820. All modification and design activities were conducted in conformance to 21 CFR 820.30 Design Control including documentation of all design and development activities including risk analysis, project planning, design

{2}------------------------------------------------

requirements, design specifications, design transfer, design changes, verification and validation procedures and formal design reviews. These design control activities and testing ensured that the design output specifications met the design input requirements as well as meeting the device's intended use and the needs of the user population.

SUBTANTIAL EQUIVALENCE

A formal risk analysis of the proposed modified generator design revealed no new risks compared to the predicate generator design. All material changes were to a type of material that has been used in other legally marketed devices. Design verification testing, including software testing, demonstrated that the design output specifications met the design input requirements. Comparison performance testing of the proposed modified generator and the predicate generator including measurements of the air pulse pressure, air pulse frequency and treatment time demonstrated equivalence between the two devices. Usability/human factors testing demonstrated enhanced user operation with less potential for errors compared to the predicate. The modified design passed electromagnetic compatibility testing, electrical safety testing and UL testing.

The modified design does NOT change the device's operating principle or mechanism of action. Compared to the predicate, the proposed modified device has the identical indications for use, the same patient population, equivalent output performance and the same fundamental scientific technology which in total does not raise additional questions of safety or effectiveness thus meeting the definition of substantial equivalence.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

December 19, 2013

Electromed, Incorporated Mr. Chet Sievert Director of Regulatory and Clinical Affairs 502 Sixth Avenue NW NEW PRAGUE MN 56071

Re: K132794

Trade/Device Name: SmartVent Airway Clearance System, Model SQL Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: Class II Product Code: BYI Dated: November 15, 2013 Received: November 20, 2013

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, subiect 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{4}------------------------------------------------

Page 2 - Mr. Sievert

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/8 description: The image contains a logo or emblem with the text "Teashri Purohit Sheth, M.D." and "Clinical Deputy Director." The logo also includes the acronym "DAGRID." The text and logo are surrounded by decorative elements, giving it a formal or official appearance. The word "FOR" is present in the lower right corner.

Erin I. Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Special 510k SmartVest® Airway Clearance System, Model SQL

Section 5. Indications for Use Statement

Indications for Use Statement

510(k) Number: K132794

Device Name: SMARTVEST® AIRWAY CLEARANCE SYSTEM, MODEL SQL

Indications for Use:

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

1993年09月 - 198 ﺔ ﺍﻟﻘﻠﻴﻤﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ 1 :

Anya C. Harry -S 2013.12.18 17:11:59 -05'00'

Regulation Number and Section

§ 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).