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.

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.

AI/ML Overview

The provided text describes the Electromed SmartVest® Airway Clearance System, Model TL, and its substantial equivalence to a predicate device, the MedPulse® Respiratory Vest System, Model 2000 ez. This is a medical device submission, not an AI/ML device, therefore, many of the requested categories (like number of experts, adjudication methods, MRMC study, sample size for training data, etc.) are not applicable.

Here's the information that can be extracted and inferred from the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Maintain identical indications and intended use as predicate device.	Adopted identical indications and intended use as the predicate device.
Maintain identical technological characteristics and principles of operation as predicate device.	Uses the same technological characteristics and principles of operation (dual acting pneumatic diaphragm technology) as the predicate device.
No change in output performance compared to predicate device.	Functional performance testing demonstrated no change in output performance.
No new safety issues compared to predicate device.	Electrical safety tests demonstrated no new safety issues.
Ability to adjust air pulse frequency and pressure amplitude.	User can adjust air pulse frequency and pressure amplitude in the same manner as the predicate system.
Ability to view Control Panel in multiple directions.	New feature added to the Control Panel allows viewing in multiple directions.
Inclusion of a "Sleep Mode" function.	New "Sleep Mode" automatically shuts off the device if unattended.
Addition of a hospital-dedicated vest and additional vest sizes.	A vest dedicated for hospital use and additional vest sizes were added.
Softer vest lining for user comfort.	Softer vest lining proposed to accommodate user comfort.
Pressure imparted to the chest wall comparable to predicate device.	Measured pressure imparted to the chest wall of both proposed and predicate systems (implicitly found to be comparable or acceptable).

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 distinct "test set" sample size for patients or data. The performance testing section mentions: "Testing included measuring the pressure imparted to the chest wall of both the proposed and predicate systems." This implies testing was done on the physical devices themselves, likely in a laboratory or simulated environment, rather than on a patient population.

Therefore, information on:

Sample size for the test set: Not specified, as the testing focuses on device performance and safety rather than clinical efficacy evaluated on a patient cohort in this type of submission.
Data provenance: Not applicable in the context of clinical patient data, as the tests described are technical device performance evaluations. The device manufacturer is Electromed, Inc., based in New Prague, MN, USA, implying the testing would have occurred domestically.
Retrospective or prospective: Not applicable for device performance 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)

Not applicable. This device is a powered percussor, not an AI/ML diagnostic or prognostic tool. The "ground truth" here is established by engineering and safety standards, and by comparison to the predicate device's established performance. Experts involved would be engineering and regulatory professionals, but their number and specific qualifications in the context of "ground truth for a test set" are not relevant or provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of expert opinions on medical images or clinical outcomes.

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant for this type of device submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission is implicitly:

Engineering specifications and performance standards for powered percussors.
The established, safe, and effective performance of the predicate device (MedPulse® Respiratory Vest System Model 2000 ez).
Compliance with electrical safety standards.
The indications for use of the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires training data.

9. How the ground truth for the training set was established

Not applicable. As
this is not an AI/ML device, no training set or its ground truth establishment is relevant.

Summary

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K053248

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 SievertRegulatory RepresentativeElectromed, Inc.502 Sixth Avenue N.W.New Prague, MN 56071Phone: 952.758.9299Fax: 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 ez510(K) number: K040367

Description of Device:

Intended Use:

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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).

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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.

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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

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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:

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

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).