The Vest® Airway Clearance Systems is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice or treatment. Indications for this form of therapy are described by the American Association of Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy. 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 Vest® Airway Clearance 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.

Device Description

The Vest® Airway Clearance System consists of an inflatable garment attached to an Air Pulse Generator that rapidly inflates and deflates the inflatable garment. This causes the chest wall to be gently compressed and released, which creates airflow within the lungs. This process moves the mucus toward the large airways where it can be cleared by coughing or suctioning. This type of Airway Clearance Therapy is referred to as High Frequency Chest Wall Oscillation (HFCWO).

The system consists of an Air Pulse Generator, connecting hose, and multiple styles and sizes of garments. The garments are single patient, multi-use.

AI/ML Overview

The provided text is a 510(k) Summary for the Hill-Rom "The Vest® Airway Clearance Systems (Model 105)". This document states that the new device is substantially equivalent to a previously cleared predicate device (K024309) and therefore does not include a study demonstrating the new device meets specific acceptance criteria based on clinical outcomes or performance metrics like accuracy, sensitivity, or specificity. Instead, the focus is on comparative non-clinical bench testing to prove equivalence.

Therefore, much of the requested information, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, is not applicable in the context of this 510(k) submission as it relies on substantial equivalence to a predicate device rather than novel performance demonstration.

However, I can extract the information provided regarding the testing performed to support substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim based on non-clinical testing rather than clinical performance metrics, the "acceptance criteria" here refer to the successful completion and comparison of non-clinical tests to demonstrate that modifications do not raise new safety or effectiveness concerns compared to the predicate device.

Acceptance Criteria (Success of Test)	Reported Device Performance (Outcome)
- Comparative Pressure mapping	Demonstrated equivalent performance between the proposed Air Pulse Generator and garments and the predicate Vest® Airway Clearance System (K024309).
- Environmental and Mechanical testing	Demonstrated that the modifications (software update, additional garment styles, locking connecting hose) do not raise new safety or risks compared to the predicate.
- Electrical Safety (Various Standards)	Compliance with ANSI/AAMI ES60601-1:2005/(R)2012, C1:2009/(R)2012, A2:2010/(R)2012, IEC 60601-1:2005+CORR,1 (2006) + CORR. 2 (2007), EN 60601-1:2006 +CORR: 2010, CAN/CSA-C22.2 No. 6060101 (2008), EN 60601-102: 2007.
- Electromagnetic Compatibility (EMC)	Compliance with 47 CFR FCC Part 15B:2012 (CLASS B), ETSI EN 300 328 V1.7.1:2006, ETSI EN 301 489-1 V1.9.2:2011, ETSI EN 301 489-17 V2.2.1:2012.
- Biocompatibility Review	Biocompatibility testing was not needed as materials are identical to the predicate and do not have direct or indirect contact with patient skin or tissue.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "comparative non-clinical bench testing." The tests performed are listed in the table above and in the "Non-clinical Testing Summary" section of the 510(k) summary (page 6 of the document). These tests were conducted to demonstrate that the updated device, with its minor modifications, performs equivalently to the predicate device and does not introduce new safety or effectiveness risks.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this 510(k) submission. The document describes non-clinical bench testing, which typically does not involve human sample sizes or data provenance in the same way clinical studies do. The testing involved comparing the proposed device components (Air Pulse Generator, connecting hose, garments) with the predicate device.

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)

This information is not applicable. The ground truth for this type of non-clinical bench testing is based on engineering specifications and compliance with established standards, not expert clinical interpretation.

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

This information is not applicable as the testing is non-clinical bench testing against engineering standards.

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

This information is not applicable. The device is an airway clearance system, not an AI-powered diagnostic device, and therefore MRMC studies are not relevant to its clearance.

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

This information is not applicable. The device is a physical medical device, not an algorithm, so standalone performance in this context is not relevant.

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

The "ground truth" for this submission are the established engineering specifications and international standards (e.g., IEC 60601-1, FCC Part 15B, etc.) that the device must meet, and the performance characteristics of the predicate device (K024309), which the new device aims to be substantially equivalent to.

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning device that requires a training set.

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

This information is not applicable as there is no training set for this type of device submission.

Summary

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

May 7, 2015

Hill-Rom Private Limited % Mr. Paul Dryden President ProMedic Inc. 24301 Woodsage Dr. Bonita Springs, FL 34134

Re: K142482

Trade/Device Name: The Vest® Airway Clearance System Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulatory Class: II Product Code: BYI Dated: April 3, 2015 Received: April 6, 2015

Dear Mr. Dryden:

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. 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.

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

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

Enclosure

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Indications for Use

510(k) Number (if known)

K142482

Device Name

The Vest® Airway Clearance Systems (Model 105)

Indications for Use (Describe)

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.

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FORM FDA 3881 (8/14)

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510(k) Summary Page 1 of 5

Date Prepared	4-May-15
Hill-Rom Services Pte Ltd1 Yishun Ave 7Singapore, 768923, Singapore	Tel - 011 - 65 65945215Fax - 011 - 65 65945201
Official Contact:	Christina M. Miracle1069 State Route 46 EastBatesville, IN 47006Tel – 812-931-3590Fax - 812-934-1675
Proprietary or Trade Name:	The Vest® Airway Clearance Systems (Model 105
Common/Usual Name:	Percussor, Powered-Electric
Classification Code/Name:	BYI – Powered Percussor21 CFR 868.5665Class 2
Predicate Devices:	K024309 - The Vest® Airway Clearance System

Device Description:

The system consists of an Air Pulse Generator, connecting hose, and multiple styles and sizes of garments. The garments are single patient, multi-use.

Indications for Use:

Patient Population:

The Vest® Airway Clearance System is applicable for a wide variety of settings as recommended by the AARC Guidelines, including: Critical care, in-patient acute care, extended care and skilled

510(k) Summary

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Page 2 of 5 4-May-15

nursing facility care, home care, outpatient / ambulatory care, pulmonary diagnostic (bronchoscopy) laboratory.

The Vest® Airway Clearance System can be used for the pediatric to geriatric population. The system accommodates use across the targeted population by providing a selection of garment sizes which is used along with the Air Pulse Generator.

Predicate Device Comparison:

The Vest® Airway Clearance Systems (Model 105) is substantially equivalent to the predicate device, Vest® Airway Clearance Systems (K024309). We present a summary of the comparison in Table 1.

Table 1 - Substantial Equivalence Comparative Table

	Proposed Vest® Airway ClearanceSystem	PredicateVest® Airway Clearance System(K024309)
CFRClassification	868.5665	868.5665
Classification	BYI	BYI
Classification name	Percussor, Powered-Electric	Percussor, Powered-Electric
Indications for Use	The Vest® Airway Clearance Systemsis intended to provide airway clearancetherapy when external manipulation ofthe thorax is the physician's choice ortreatment. Indications for this form oftherapy are described by the AmericanAssociation of Respiratory Care(AARC) in the Clinical PracticesGuidelines for Postural DrainageTherapy. According to AARCguidelines, specific indications forexternal manipulation of the thoraxinclude evidence or a suggestion ofretained secretions, evidence that thepatient is having difficulty with thesecretion clearance, or presence ofatelectasis caused by mucus plugging.In addition, the Vest® AirwayClearance System is also indicated forexternal manipulation of the thorax topromote airway clearance or improvebronchial drainage for the purposes ofcollecting mucus for diagnosticevaluation.	The Vest® Airway Clearance Systemsis intended to provide airway clearancetherapy when external manipulation ofthe thorax is the physician's choice ortreatment. Indications for this form oftherapy are described by the AmericanAssociation of Respiratory Care(AARC) in the Clinical PracticesGuidelines for Postural DrainageTherapy. According to AARCguidelines, specific indications forexternal manipulation of the thoraxinclude evidence or a suggestion ofretained secretions, evidence that thepatient is having difficulty with thesecretion clearance, or presence ofatelectasis caused by mucus plugging.In addition, the Vest® AirwayClearance System is also indicated forexternal manipulation of the thorax topromote airway clearance or improvebronchial drainage for the purposes ofcollecting mucus for diagnosticevaluation.

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510(k) Summary Page 3 of 5 4-May-15

	Proposed Vest® Airway ClearanceSystem	PredicateVest® Airway Clearance System(K024309)
Environments of Use	Critical care, in-patient acute care,extended care and skilled nursingfacility care, home care, outpatient /ambulatory care, pulmonarydiagnostic (bronchoscopy)laboratory.	Critical care, in-patient acute care,extended care and skilled nursingfacility care, home care, outpatient /ambulatory care, pulmonarydiagnostic (bronchoscopy)laboratory.
Patient Population	Pediatric to geriatric population	Pediatric to geriatric population
Systems consists of	Air Pulse GeneratorConnecting hose (60") locking / non-lockingGarments of various styles and sizesChest (permanent)Full Vest (Permanent / SPU / C3)Wrap Vest (Permanent / SPU)	Air Pulse GeneratorConnecting hose (60-80") non-lockingGarments of various styles and sizesChest (permanent)Full Vest (Permanent / SPU)
Software Modes	Manual (Normal)Bluetooth™ - YesOperational modes:ProgrammableCough Pause®Ramp	Manual (Normal)Operational modes:Manual mode
ElectricalSpecifications	100 – 230 VAC, 50 / 60 Hz3.4 A @ 100 VAC / 2.0 A @ 230 VACPower plug – NEMA 1-15P (2 pin)	100 – 230 VAC, 50 / 60 Hz5.0 A maxPower plug – NEMA 5-15P (3 pin)
Mechanical safety	UL/EN/IEC 60601-1 and CAN/CSAC22.2 No. 601.1	UL/EN/IEC 60601-1 and CAN/CSAC22.2 No. 601.1

Indications -

The proposed indications for use of providing airway clearance therapy when external manipulation of the thorax is the physician's choice or treatment and to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation.are identical to the predicate. Discussion: The indications for use are identical to the predicate Vest® Airway Clearance System (K024309).

Technology -

The design of the Vest® Airway Clearance System utilizing an Air Pulse Generator, connecting hose, and inflatable / deflatable garment is unchanged from the predicate.

Discussion: The design is identical with minor modifications to the connecting hose and addition of garment styles, but in all substantially equivalent to the predicate Vest® Airway Clearance System (K024309).

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510(k) Summary Page 4 of 5 4-May-15

Environment of Use -

The proposed environments of use are Critical care, in-patient acute care, extended care and skilled nursing facility care, home care, outpatient / ambulatory care, pulmonary diagnostic (bronchoscopy) laboratory which are identical to the predicate.

Discussion: The intended environments of use are identical to the predicate Vest® Airway Clearance System (K024309).

Patient Population -

The Vest® Airway Clearance System (K024309) is intended for pediatric to geriatric population. Discussion: The patient population is identical to the predicate Vest® Airway Clearance System (K024309).

Discussion of Differences -

The basic differences between the proposed device and the predicate are an update in software, addition of styles of garments and addition of a locking style connecting hose. Testing has demonstrated that these differences do not raise any new safety or risks and thus can be found to be substantially equivalent.

Non-clinical Testing Summary -

We performed comparative non-clinical bench testing to demonstrate that the Vest® Airway Clearance System and its modifications and additional garment styles and sizes perform equivalent to the predicate Vest® Airway Clearance System (K024309). These tests included:

Comparative Pressure mapping of garments with predicate and proposed Air Pulse ● Generator
Environmental and Mechanical testing ●
ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 ●
47 CFR FCC Part 15B:2012 (CLASS B)
IEC 60601-1:2005+CORR,1 (2006) + CORR. 2 (2007) ●
EN 60601-1:2006 +CORR: 2010 ●
CAN/CSA-C22.2 No. 6060101 (2008)
. EN 60601-102: 2007
ETSI EN 300 328 V1.7.1:2006
ETSI EN 301 489-1 V1.9.2:2011 ●
ETSI EN 301 489-17 V2.2.1:2012 ●

Biocompatibility of Materials -

The materials of the garments are not in direct or indirect contact with the patient skin or tissue. The materials are identical to the predicate as well.

Discussion: Biocompatibility testing is not needed.

510(k) Summary Page 5 of 5

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4-May-15

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.

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).