The Vest Airway Clearance System

K142482 · Hill-Rom Services Private Limited · BYI · May 7, 2015 · Anesthesiology

Device Facts

• Record ID: K142482
• Device Name: The Vest Airway Clearance System
• Applicant: Hill-Rom Services Private Limited
• Product Code: BYI · Anesthesiology
• Decision Date: May 7, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5665
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

The Vest® Airway Clearance System (Model 105) provides High Frequency Chest Wall Oscillation (HFCWO) therapy. The system comprises an Air Pulse Generator, a connecting hose, and an inflatable garment. The generator rapidly inflates and deflates the garment, applying gentle compression and release to the chest wall to create airflow within the lungs, mobilizing mucus toward large airways for clearance via coughing or suctioning. Used in clinical settings (critical care, acute care, skilled nursing, pulmonary labs) and home care, the device is operated by clinicians or patients. The system includes programmable modes (Cough Pause®, Ramp) and Bluetooth™ connectivity. It is intended to assist patients with secretion clearance, potentially reducing mucus plugging and improving bronchial drainage.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included comparative pressure mapping of garments, environmental and mechanical testing, and compliance with electrical safety and electromagnetic compatibility standards (ANSI/AAMI ES60601-1, IEC 60601-1, FCC Part 15B, ETSI EN 300 328).

Technological Characteristics

System utilizes HFCWO via an Air Pulse Generator (100–230 VAC) and inflatable garments. Connectivity includes Bluetooth™. Safety standards met: UL/EN/IEC 60601-1, CAN/CSA C22.2 No. 601.1, and various ETSI standards for wireless/EMC. Materials are identical to the predicate and do not contact patient skin.

Indications for Use

Indicated for pediatric to geriatric patients requiring airway clearance therapy due to retained secretions, difficulty with secretion clearance, or atelectasis caused by mucus plugging, or for bronchial drainage to collect mucus for diagnostic evaluation.

Regulatory Classification

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.

Predicate Devices

• The Vest® Airway Clearance System (K024309)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

| | <b>XX</b> Prescription Use (Part 21 CFR 801 Subpart D) |
|--|--------------------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) Summary Page 1 of 5

| Date Prepared | 4-May-15 | |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--|
| Hill-Rom Services Pte Ltd<br>1 Yishun Ave 7<br>Singapore, 768923, Singapore | Tel - 011 - 65 65945215<br>Fax - 011 - 65 65945201 | |
| Official Contact: | Christina M. Miracle<br>1069 State Route 46 East<br>Batesville, IN 47006<br>Tel – 812-931-3590<br>Fax - 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 Percussor<br>21 CFR 868.5665<br>Class 2 | |
| Predicate Devices: | K024309 - The Vest® Airway Clearance System | |

#### 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.

#### Indications for Use:

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.

#### 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 Clearance<br>System | Predicate<br>Vest® Airway Clearance System<br>(K024309) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CFR<br>Classification | 868.5665 | 868.5665 |
| Classification | BYI | BYI |
| Classification name | Percussor, Powered-Electric | Percussor, Powered-Electric |
| Indications for Use | The Vest® Airway Clearance Systems<br>is intended to provide airway clearance<br>therapy when external manipulation of<br>the thorax is the physician's choice or<br>treatment. Indications for this form of<br>therapy are described by the American<br>Association of Respiratory Care<br>(AARC) in the Clinical Practices<br>Guidelines for Postural Drainage<br>Therapy. According to AARC<br>guidelines, specific indications for<br>external manipulation of the thorax<br>include evidence or a suggestion of<br>retained secretions, evidence that the<br>patient is having difficulty with the<br>secretion clearance, or presence of<br>atelectasis caused by mucus plugging.<br>In addition, the Vest® Airway<br>Clearance System is also indicated for<br>external manipulation of the thorax to<br>promote airway clearance or improve<br>bronchial drainage for the purposes of<br>collecting mucus for diagnostic<br>evaluation. | The Vest® Airway Clearance Systems<br>is intended to provide airway clearance<br>therapy when external manipulation of<br>the thorax is the physician's choice or<br>treatment. Indications for this form of<br>therapy are described by the American<br>Association of Respiratory Care<br>(AARC) in the Clinical Practices<br>Guidelines for Postural Drainage<br>Therapy. According to AARC<br>guidelines, specific indications for<br>external manipulation of the thorax<br>include evidence or a suggestion of<br>retained secretions, evidence that the<br>patient is having difficulty with the<br>secretion clearance, or presence of<br>atelectasis caused by mucus plugging.<br>In addition, the Vest® Airway<br>Clearance System is also indicated for<br>external manipulation of the thorax to<br>promote airway clearance or improve<br>bronchial drainage for the purposes of<br>collecting mucus for diagnostic<br>evaluation. |

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

| | Proposed Vest® Airway Clearance<br>System | Predicate<br>Vest® Airway Clearance System<br>(K024309) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environments of Use | Critical care, in-patient acute care,<br>extended care and skilled nursing<br>facility care, home care, outpatient /<br>ambulatory care, pulmonary<br>diagnostic (bronchoscopy)<br>laboratory. | Critical care, in-patient acute care,<br>extended care and skilled nursing<br>facility care, home care, outpatient /<br>ambulatory care, pulmonary<br>diagnostic (bronchoscopy)<br>laboratory. |
| Patient Population | Pediatric to geriatric population | Pediatric to geriatric population |
| Systems consists of | Air Pulse Generator<br>Connecting hose (60") locking / non-<br>locking<br>Garments of various styles and sizes<br>Chest (permanent)<br>Full Vest (Permanent / SPU / C3)<br>Wrap Vest (Permanent / SPU) | Air Pulse Generator<br>Connecting hose (60-80") non-locking<br>Garments of various styles and sizes<br>Chest (permanent)<br>Full Vest (Permanent / SPU) |
| Software Modes | Manual (Normal)<br>Bluetooth™ - Yes<br>Operational modes:<br>Programmable<br>Cough Pause®<br>Ramp | Manual (Normal)<br>Operational modes:<br>Manual mode |
| Electrical<br>Specifications | 100 – 230 VAC, 50 / 60 Hz<br>3.4 A @ 100 VAC / 2.0 A @ 230 VAC<br>Power plug – NEMA 1-15P (2 pin) | 100 – 230 VAC, 50 / 60 Hz<br>5.0 A max<br>Power plug – NEMA 5-15P (3 pin) |
| Mechanical safety | UL/EN/IEC 60601-1 and CAN/CSA<br>C22.2 No. 601.1 | UL/EN/IEC 60601-1 and CAN/CSA<br>C22.2 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.