The Vest APX System (PVAPX1)

K233441 · Baxter Healthcare Corportation · BYI · Mar 22, 2024 · Anesthesiology

Device Facts

• Record ID: K233441
• Device Name: The Vest APX System (PVAPX1)
• Applicant: Baxter Healthcare Corportation
• Product Code: BYI · Anesthesiology
• Decision Date: Mar 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5665
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

High-frequency chest wall oscillation (HFCWO) device; mobilizes bronchial secretions. System comprises control unit, hoses, and inflatable garment. User inputs intensity (1-10) and frequency (5-20 Hz) via GUI; BLDC motor-driven air pulse generator (APG) creates oscillating positive pressure air pulses. Garment inflates/deflates against patient thorax; creates chest wall oscillations. Used in acute care, extended care, skilled nursing, home, and outpatient settings. Operated by physicians, professional healthcare providers, or patients. Magnetic hose connection facilitates use for patients with limited dexterity. Output is mechanical oscillation; assists in moving mucus to large airways for clearance via coughing or suctioning. Benefits include improved bronchial drainage and secretion clearance.

Clinical Evidence

Bench testing only. Evidence includes comparative pressure testing between subject and predicate garments (including 16"-19" Child XS size), usability testing per IEC 62366-1:2015 + A1:2020, electromagnetic compatibility (IEC 60601-1-2), and electrical safety (IEC 60601-1). Biocompatibility confirmed per ISO 10993-1:2018.

Technological Characteristics

HFCWO system; BLDC motor-driven air pulse generator. Materials compliant with ISO 10993-1. Connectivity: Wi-Fi, USB. Electrical: 100-240 VAC, 50/60 Hz. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home use), IEC 62304 (software), ISO 13485 (quality), ISO 14971 (risk management).

Indications for Use

Indicated for pediatric (6 months+) to geriatric patients requiring airway clearance therapy due to retained secretions, difficulty with secretion clearance, or atelectasis caused by mucus plugging; also indicated 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 Systems (K142482)

Submission Summary (Full Text)

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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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2

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 ([e-mail]) or phone [phone] 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 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.

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

| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) Summary

#### Submitter:

| Company Name:<br>Address:<br>Telephone Number: | Baxter Healthcare Corporation<br>One Baxter Parkway<br>Deerfield, Illinois 60015<br>1-800-422-9837 |
|------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Prepared and Submitted by:<br>Title: | Steven Co<br>Regulatory Manager, Global Regulatory Affairs |
| Contact Person: | Steven Co |
| Title:<br>Telephone:<br>Email: | Regulatory Manager, Global Regulatory Affairs<br>224-948-1812<br>[e-mail] |
| 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 Airway<br>Clearance Systems | Hill-Rom Services<br>Private Limited | K142482 | May 7, 2015 |

### DESCRIPTION OF THE DEVICE:

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).

# INDICATIONS FOR USE:

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.

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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 Device<br>The Vest Airway<br>Clearance Systems<br>Cleared under K142482 | Subject Device<br>The Vest APX System | Assessment of<br>Differences |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hill-Rom Services<br>Private Limited | Same | N/A |
| Product Code | BYI | Same | N/A |
| Classification Name | Percussor, Powered-<br>Electric | Same | N/A |
| Regulation Number | 868.5665 | Same | N/A |
| Intended Use | The Vest Airway<br>Clearance System was<br>developed to provide<br>effective Airway<br>Clearance Therapy. The<br>system consists of an<br>inflatable garment<br>attached to an Air Pulse<br>Generator that rapidly<br>inflates and deflates the<br>inflatable garment. This<br>causes the chest wall to<br>be gently compressed<br>and released, which<br>creates airflow with in the<br>lungs. This process<br>moves the mucus to ward<br>the large a irwa ys where it<br>can be cleared by<br>coughing or suctioning.<br>This type of Airway<br>Clearance Therapy is<br>referred to as High<br>Frequency Chest Wall<br>Oscillation (HFCWO). | Same | N/A |
| Indications for Use | The Vest Airway<br>Clearance System, Model<br>105 & Model 205 is<br>intended to provide<br>a irway clearance therapy<br>when external<br>manipulation of the<br>thorax is the physician's<br>choice or treatment.<br>Indications for this form<br>of therapy are described<br>by the American<br>Association of | The Vest APX System is<br>intended to provide<br>a irway clearance therapy<br>when external<br>manipulation of the<br>thorax is the physician's<br>choice of treatment.<br>Specific indications for<br>external manipulation of<br>the thorax include<br>evidence or a suggestion<br>of retained secretions,<br>evidence that the patient | Similar<br>The subject device<br>removed outdated<br>AARC clinical practice<br>guidelines reference<br>included in the<br>predicate indications for<br>use.<br>The subject device<br>clarifies the intended<br>patient population. |
| Features | Predicate Device<br>The Vest Airway<br>Clearance Systems<br>Cleared under K142482 | Subject Device<br>The Vest APX System | Assessment of<br>Differences |
| | Respiratory Care<br>(AARC) in the Clinical<br>Practices Guidelines for<br>Postural Drainage<br>Therapy. According to<br>AARC guidelines,<br>specific indications for<br>external manipulation of<br>the thorax include<br>evidence or a suggestion<br>of retained secretions,<br>evidence that the patient<br>is having difficulty with<br>the secretion clearance,<br>or presence of atelectasis<br>caused by mucus<br>plugging. In addition,<br>The Vest® Airway<br>Clearance System is also<br>indicated for external<br>manipulation of the<br>thorax to promote airway<br>clearance or improve<br>bronchial drainage for<br>the purposes of collecting<br>mucus for diagnostic<br>evaluation. | is having difficulty with<br>the secretion clearance,<br>or presence of atelectasis<br>caused by mucus<br>plugging. In addition,<br>The Vest APX System is<br>also indicated for<br>external manipulation of<br>the thorax to promote<br>airway clearance or<br>improve bronchial<br>drainage for the<br>purposes of collecting<br>mucus for diagnostic<br>evaluation.<br>The Vest APX System<br>may be used for the<br>pediatric population (6<br>months and older) to<br>geriatric population. | |
| Environments of Use | Acute care, extended care<br>and skilled nursing<br>facility care, home care,<br>outpatient /ambulatory<br>care, pulmonary<br>diagnostic<br>(bronchoscopy)<br>laboratory. | Same | N/A |
| Intended Population | Pediatric to geriatric<br>population | Pediatric population (6<br>months and older) to<br>geriatric population. | Similar<br>The subject device<br>specifies the intended<br>pediatric population. |
| Standard Compliance | 21 CFR 820<br>ISO 13485: 2016<br>ISO 14971: 2019 | 21 CFR 820<br>ISO 13485: 2016<br>ISO 14971: 2019 | Similar |
| | Predicate Device<br>The Vest Airway<br>Clearance Systems<br>Cleared under K142482 | Subject Device<br>The Vest APX System | Assessment of<br>Differences |
| Features | IEC 60601-1: 2005 + A1:<br>2012<br>IEC 60601-1-2: 2014<br>IEC 60601-1-6: 2010 +<br>A1: 2013<br>IEC 62366-1: 2015<br>IEC 60601-1-11: 2015<br>IEC 62304: 2006 + A1:<br>2015<br>ANSI/AAMI ES60601-<br>1:2005/(R)2012 +<br>A1:2012,<br>C1:2009/(R)2012 +<br>A2:2010/(R)2012<br>ANSI/AAMI HA60601-<br>1-11:2015<br>47 CFR FCC Part<br>15B:2012 (CLASS B)<br>ISO 10993-1:2018<br>ISO 15223-1:2021<br>ISO 20417:2021 | IEC 60601-1: 2005 +<br>A1: 2012 + A2:2020<br>IEC 60601-1-2: 2014 +<br>A1:2020<br>IEC 60601-1-6: 2010 +<br>A1:2013 + A2:2020<br>IEC 62366-1:2015 +<br>A1:2020<br>IEC 60601-1-11:2015 +<br>A1:2020<br>IEC 62304: 2006 +<br>A1 :2015<br>ANSI/AAMI ES60601-<br>1:2005/A2:2021<br>ANSI/AAMI HA60601-<br>1-11:2015/A1:2021<br>47 CFR FCC Part 15<br>Subpart B<br>47 CFR FCC Part 15<br>Subpart C<br>47 CFR FCC Part 15<br>Subpart E<br>IEEE/ANSI C63.27:<br>2017<br>47 CFR §2.1091<br>ISO 10993-1:2018<br>ISO 15223-1:2021<br>ISO 20417:2021 | |
| Sterile | No | Same | N/A |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | No | Same | N/A |
| Configuration for<br>home care | Model 105 includes a<br>carrying case. | Model PVAPX1HC<br>includes a carrying case | Same |
| Configuration for<br>acute care | Model 205 includes a<br>cart and advanced<br>software settings for use<br>by a physician or | Model PVAPX1 AC<br>includes a cart and<br>advanced software<br>settings for use by a<br>physician or | Same |
| Features | Predicate Device<br>The Vest Airway<br>Clearance Systems<br>Cleared under K142482 | Subject Device<br>The Vest APX System | Assessment of<br>Differences |
| | professional health care<br>provider | professional health care<br>provider | |
| Generator | Air Pulse Generator | Same | N/A |
| Hose | Connecting hose (60")<br>mechanical<br>interlock/friction fit | Connecting hose (60").<br>Hose to control unit uses<br>magnetic force<br>connection. Hose to<br>garment uses friction fit | Similar<br>The different<br>connection mechanism<br>allows an easier<br>connection option for<br>users with limited<br>dexterity. |
| Garment Offerings | Chest (Permanent)<br>Full Vest (Permanent /<br>SPU / C3)<br>Wrap Vest (Permanent /<br>SPU) | Full Vest<br>(Disposable/Reusable)<br>Wrap Vest<br>(Disposable/Reusable) | Similar<br>The difference is<br>consolidation of the<br>garments types offered,<br>the size range options is<br>the same. |
| Technology of<br>Oscillations | Pneumatic - a ir driven by<br>control unit<br>inflates/deflates the<br>garment air bladder | Same | N/A |
| Electrical<br>Specifications | 100 - 230 VAC, 50 / 60<br>Hz<br>3.4 A @ 100 VAC / 2.0<br>A @ 230 VAC<br>Power plug – NEMA 1-<br>15P (2 pin) | 100-240 VAC,50 / 60<br>Hz<br>3.5 A @ 100 VAC<br>Power plug - NEMA 1-<br>15P (2 pin) | Similar |
| Connectivity | Bluetooth | Wi-Fi<br>USB | 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.