The Vest APX System is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. 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 Vest APX System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation.

The Vest APX System may be used for the pediatric population (6 months and older) to geriatric population.

Device Description

The Vest APX System is a high-frequency chest wall oscillation device designed to be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of The Vest APX System consist of a control unit, hoses, and an inflatable garment. Oscillating positive pressure air pulses are applied to the garment by the control unit. The Blower provides the baseline pressure to the system. The user will input the different intensity from 1 -10 on the Graphical User Interface (GUI) and the blower will produce different static pressure based on speed. The air pulse generator (APG) provides the air pulsations (oscillations) based on the frequency input (ranging from 5 to 20 Hertz) provided by user via the GUI. The APG is driven by the Brushless Direct Current (BLDC) motor.

The resulting pressure pulses cause the garment to inflate and deflate against the chest of the patient, creating high-frequency chest wall oscillation and mobilization of bronchial secretions. This form of airway clearance therapy is referred to as high-frequency chest wall oscillation (HFCWO).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "The Vest APX System." This document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, "The Vest Airway Clearance Systems." The basis for this determination is a comparison of technological characteristics and performance data.

However, the document does not contain specific acceptance criteria, reported device performance metrics in a quantitative table format, details about a usability study beyond mentioning it, or information about sample size for test sets or training sets, ground truth establishment, or multi-reader multi-case studies as requested in the prompt. The "performance data" section only lists compliance with certain electromagnetic compatibility and safety standards, and biocompatibility.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, sample size for test sets or training sets, data provenance, number of experts, adjudication methods, details of MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The information primarily focuses on demonstrating substantial equivalence through similar intended use, indications for use, and technological characteristics, particularly through non-clinical testing.

Here's a summary of what is available regarding testing:

Nonclinical Tests Performed:

Comparative pressure testing for the subject and predicate garments: This test would likely compare the pressure outputs or profiles generated by both the new device (The Vest APX System) and the predicate device (The Vest Airway Clearance Systems) when used with their respective garments. The goal would be to demonstrate similar functional performance in terms of pressure application for airway clearance.
Usability testing per IEC 62366-1:2015 + A1:2020: This indicates that a usability study was conducted following international standards for medical device usability. The purpose is to evaluate if the device can be used safely and effectively by its intended users.
Additional comparative pressure testing for the 16"-19" Child XS Garment with the subject and predicate devices: This specific comparative pressure test focuses on a particular garment size (Child XS) to ensure equivalent performance for this pediatric population.

Performance Data / Compliance:

The Vest APX System meets the following standards:

IEC 60601-1-2 Edition 4.1 2020-09 (Electromagnetic Disturbances)
ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (General requirements for basic safety and essential performance)
IEC 60601-1-11 Edition 2.1 2020-07 (Requirements for medical electrical equipment in home healthcare environment)
ISO 10993-1:2018 (Biological evaluation of medical devices - Biocompatibility)

What is NOT provided in the text:

A specific table of acceptance criteria (e.g., minimum pressure output, maximum deviation, specific usability scores).
Quantitative reported device performance to compare against acceptance criteria.
Sample sizes for any of the tests (e.g., how many garments were tested for pressure, how many users in the usability study).
Data provenance for any test data.
Details on ground truth for any test (e.g., what was the "gold standard" for pressure measurements).
Any information regarding experts involved in establishing ground truth or adjudication.
Details about a multi-reader multi-case study (this device is a physical therapy device, not an AI diagnostic tool, so such a study would not be applicable).
Standalone performance (again, not an AI diagnostic tool).
Information on training sets, as this is not a machine learning or AI device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 22, 2024

Baxter Healthcare Corportation Steven Co Regulatory Affairs Manager One Baxter Parkway Deerfield, Illinois 60015

Re: K233441

Trade/Device Name: The Vest APX System (PVAPX1) Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: Class II Product Code: BYI Dated: February 28, 2024 Received: February 28, 2024

Dear Steven Co:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,
John S.	Digitally signed by
Bender -S	John S. Bender -S
	Date: 2024.03.22
	16:44:18 -04'00'

for Ethan Nyberg, Ph.D.

Assistant Director

DHT1C: Division of Sleep Disordered

Breathing, Respiratory and

Anesthesia Devices

OHT1: Office of Ophthalmic, Anesthesia,

Respiratory, ENT and Dental Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K233441

Device Name The Vest APX System (PVAPX1)

Indications for Use (Describe)

The Vest APX System may be used for the pediatric population (6 months and older) to geriatric population.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter:

Company Name:Address:Telephone Number:	Baxter Healthcare CorporationOne Baxter ParkwayDeerfield, Illinois 600151-800-422-9837
Prepared and Submitted by:Title:	Steven CoRegulatory Manager, Global Regulatory Affairs
Contact Person:	Steven Co
Title:Telephone:Email:	Regulatory Manager, Global Regulatory Affairs224-948-1812Steven_Co@baxter.com
Date Prepared:	March 22, 2024

IDENTIFICATION OF THE DEVICE:

Common Name: Powered Percussor Trade/Device Name: The Vest APX System Classification Panel: Anesthesiology Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulatory Class: Class II Product Code: BYI

Table 1. Model Number(s) for The Vest APX System

Model Number	Name
PVAPX1	The Vest APX System

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PREDICATE DEVICE:

Device	Company	Predicate 510(k)	Clearance Date
The Vest AirwayClearance Systems	Hill-Rom ServicesPrivate Limited	K142482	May 7, 2015

DESCRIPTION OF THE DEVICE:

INDICATIONS FOR USE:

The Vest APX System may be used for the pediatric population (6 months and older) to geriatric population.

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

Baxter Healthcare Corporation has made modifications to the predicate device, The Vest Airway Clearance Systems. The subject device, The Vest APX System, has the same technological characteristics as the predicate device. The proposed modifications to the subject device do not raise different questions of safety and effectiveness. A summary of the technological characteristics of the subject device in comparison to those of the predicate device is provided in Table 3.

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Features	Predicate DeviceThe Vest AirwayClearance SystemsCleared under K142482	Subject DeviceThe Vest APX System	Assessment ofDifferences
Manufacturer	Hill-Rom ServicesPrivate Limited	Same	N/A
Product Code	BYI	Same	N/A
Classification Name	Percussor, Powered-Electric	Same	N/A
Regulation Number	868.5665	Same	N/A
Intended Use	The Vest AirwayClearance System wasdeveloped to provideeffective AirwayClearance Therapy. Thesystem consists of aninflatable garmentattached to an Air PulseGenerator that rapidlyinflates and deflates theinflatable garment. Thiscauses the chest wall tobe gently compressedand released, whichcreates airflow with in thelungs. This processmoves the mucus to wardthe large a irwa ys where itcan be cleared bycoughing or suctioning.This type of AirwayClearance Therapy isreferred to as HighFrequency Chest WallOscillation (HFCWO).	Same	N/A
Indications for Use	The Vest AirwayClearance System, Model105 & Model 205 isintended to providea irway clearance therapywhen externalmanipulation of thethorax is the physician'schoice or treatment.Indications for this formof therapy are describedby the AmericanAssociation of	The Vest APX System isintended to providea irway clearance therapywhen externalmanipulation of thethorax is the physician'schoice of treatment.Specific indications forexternal manipulation ofthe thorax includeevidence or a suggestionof retained secretions,evidence that the patient	SimilarThe subject deviceremoved outdatedAARC clinical practiceguidelines referenceincluded in thepredicate indications foruse.The subject deviceclarifies the intendedpatient population.
Features	Predicate DeviceThe Vest AirwayClearance SystemsCleared under K142482	Subject DeviceThe Vest APX System	Assessment ofDifferences
	Respiratory Care(AARC) in the ClinicalPractices Guidelines forPostural DrainageTherapy. According toAARC guidelines,specific indications forexternal manipulation ofthe thorax includeevidence or a suggestionof retained secretions,evidence that the patientis having difficulty withthe secretion clearance,or presence of atelectasiscaused by mucusplugging. In addition,The Vest® AirwayClearance System is alsoindicated for externalmanipulation of thethorax to promote airwayclearance or improvebronchial drainage forthe purposes of collectingmucus for diagnosticevaluation.	is having difficulty withthe secretion clearance,or presence of atelectasiscaused by mucusplugging. In addition,The Vest APX System isalso indicated forexternal manipulation ofthe thorax to promoteairway clearance orimprove bronchialdrainage for thepurposes of collectingmucus for diagnosticevaluation.The Vest APX Systemmay be used for thepediatric population (6months and older) togeriatric population.
Environments of Use	Acute care, extended careand skilled nursingfacility care, home care,outpatient /ambulatorycare, pulmonarydiagnostic(bronchoscopy)laboratory.	Same	N/A
Intended Population	Pediatric to geriatricpopulation	Pediatric population (6months and older) togeriatric population.	SimilarThe subject devicespecifies the intendedpediatric population.
Standard Compliance	21 CFR 820ISO 13485: 2016ISO 14971: 2019	21 CFR 820ISO 13485: 2016ISO 14971: 2019	Similar
	Predicate DeviceThe Vest AirwayClearance SystemsCleared under K142482	Subject DeviceThe Vest APX System	Assessment ofDifferences
Features	IEC 60601-1: 2005 + A1:2012IEC 60601-1-2: 2014IEC 60601-1-6: 2010 +A1: 2013IEC 62366-1: 2015IEC 60601-1-11: 2015IEC 62304: 2006 + A1:2015ANSI/AAMI ES60601-1:2005/(R)2012 +A1:2012,C1:2009/(R)2012 +A2:2010/(R)2012ANSI/AAMI HA60601-1-11:201547 CFR FCC Part15B:2012 (CLASS B)ISO 10993-1:2018ISO 15223-1:2021ISO 20417:2021	IEC 60601-1: 2005 +A1: 2012 + A2:2020IEC 60601-1-2: 2014 +A1:2020IEC 60601-1-6: 2010 +A1:2013 + A2:2020IEC 62366-1:2015 +A1:2020IEC 60601-1-11:2015 +A1:2020IEC 62304: 2006 +A1 :2015ANSI/AAMI ES60601-1:2005/A2:2021ANSI/AAMI HA60601-1-11:2015/A1:202147 CFR FCC Part 15Subpart B47 CFR FCC Part 15Subpart C47 CFR FCC Part 15Subpart EIEEE/ANSI C63.27:201747 CFR §2.1091ISO 10993-1:2018ISO 15223-1:2021ISO 20417:2021
Sterile	No	Same	N/A
Non-Pyrogenic	Yes	Same	N/A
Single Use	No	Same	N/A
Configuration forhome care	Model 105 includes acarrying case.	Model PVAPX1HCincludes a carrying case	Same
Configuration foracute care	Model 205 includes acart and advancedsoftware settings for useby a physician or	Model PVAPX1 ACincludes a cart andadvanced softwaresettings for use by aphysician or	Same
Features	Predicate DeviceThe Vest AirwayClearance SystemsCleared under K142482	Subject DeviceThe Vest APX System	Assessment ofDifferences
	professional health careprovider	professional health careprovider
Generator	Air Pulse Generator	Same	N/A
Hose	Connecting hose (60")mechanicalinterlock/friction fit	Connecting hose (60").Hose to control unit usesmagnetic forceconnection. Hose togarment uses friction fit	SimilarThe differentconnection mechanismallows an easierconnection option forusers with limiteddexterity.
Garment Offerings	Chest (Permanent)Full Vest (Permanent /SPU / C3)Wrap Vest (Permanent /SPU)	Full Vest(Disposable/Reusable)Wrap Vest(Disposable/Reusable)	SimilarThe difference isconsolidation of thegarments types offered,the size range options isthe same.
Technology ofOscillations	Pneumatic - a ir driven bycontrol unitinflates/deflates thegarment air bladder	Same	N/A
ElectricalSpecifications	100 - 230 VAC, 50 / 60Hz3.4 A @ 100 VAC / 2.0A @ 230 VACPower plug – NEMA 1-15P (2 pin)	100-240 VAC,50 / 60Hz3.5 A @ 100 VACPower plug - NEMA 1-15P (2 pin)	Similar
Connectivity	Bluetooth	Wi-FiUSB	Similar

Table 3. Device Comparison

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Table 3. Device Comparison

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Table 3. Device Comparison

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Table 3. Device Comparison

DISCUSSION OF NONCLINICAL TESTS:

Nonclinical testing has been performed to demonstrate that The Vest APX System is substantially equivalent to The Vest Airway Clearance Systems. These tests included:

. Comparative pressure testing for the subject and predicate garments
. Usability testing per IEC 62366-1:2015 + A1:2020
. Additional comparative pressure testing for the 16"-19" Child XS Garment with the subject and predicate devices

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Performance Data:

The Vest APX System meets the following electromagnetic compatibility and safety standards:

. IEC 60601-1-2 Edition 4.1 2020-09, "Medical Electrical Equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & . A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2]
IEC 60601-1-11 Edition 2.1 2020-07, "Medical Electrical Equipment-Part 1-11 General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment"

Biocompatibility:

The Vest APX System complies with the requirements of ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

CONCLUSION:

Substantial equivalence between The Vest APX System and the referenced predicate, The Vest Airway Clearance Systems, is demonstrated by:

Substantially equivalent indications statements
. Identical intended use statements
Substantially equivalent technological characteristics:
- Both employ air pulse generators -
- Both treat the same anatomic locations of the thorax -
- Both provide high frequency chest wall oscillations -

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The Vest APX System is substantially equivalent to The Vest Airway Clearance Systems. The differences in the control unit, garment and hose designs do not introduce any new risks or raise any new questions of safety or effectiveness.

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).