(156 days)
Not Found
No
The device description focuses on mechanical components (blower, air pulse generator, motor) and user-controlled inputs (intensity, frequency) without mentioning any adaptive algorithms, learning capabilities, or data analysis that would typically characterize AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Vest APX System is intended to provide airway clearance therapy" and is indicated for conditions like "retained secretions," "difficulty with the secretion clearance," or "presence of atelectasis caused by mucus plugging." These are therapeutic applications.
No
The "Intended Use / Indications for Use" section states: "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." This indicates that while the device's primary function is therapeutic (airway clearance), it can facilitate the collection of samples FOR diagnostic evaluation, but it does not perform the diagnosis itself.
No
The device description explicitly details hardware components such as a control unit, hoses, an inflatable garment, a blower, an air pulse generator, and a BLDC motor. This indicates it is a hardware-based medical device with a software interface (GUI).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide airway clearance therapy through external manipulation of the thorax. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a mechanical system that applies pressure to the chest wall. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample for diagnostic purposes. The device's function is purely physical therapy.
While the device is indicated for collecting mucus for diagnostic evaluation, the device itself is the tool for collecting the sample, not for performing the diagnostic evaluation on the sample. The diagnostic evaluation would be a separate process performed on the collected mucus, likely in a laboratory setting using IVD devices or methods.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BYI
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thorax
Indicated Patient Age Range
pediatric population (6 months and older) to geriatric population.
Intended User / Care Setting
Acute care, extended care and skilled nursing facility care, home care, outpatient /ambulatory care, pulmonary diagnostic (bronchoscopy) laboratory.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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).
1
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 (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
2
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)
| ☒ 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 Corporation
One Baxter Parkway
Deerfield, Illinois 60015
1-800-422-9837 |
|------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Prepared and Submitted by:
Title: | Steven Co
Regulatory Manager, Global Regulatory Affairs |
| Contact Person: | Steven Co |
| Title:
Telephone:
Email: | Regulatory Manager, Global Regulatory Affairs
224-948-1812
Steven_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 Airway | |||
| Clearance Systems | Hill-Rom Services | ||
| 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
The Vest Airway
Clearance Systems
Cleared under K142482 | Subject Device
The Vest APX System | Assessment of
Differences |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hill-Rom Services
Private 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 Airway
Clearance System was
developed to provide
effective Airway
Clearance Therapy. The
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 with in the
lungs. This process
moves the mucus to ward
the large a irwa ys 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). | Same | N/A |
| Indications for Use | The Vest Airway
Clearance System, Model
105 & Model 205 is
intended to provide
a irway 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 | The Vest APX System is
intended to provide
a irway 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 | Similar
The subject device
removed outdated
AARC clinical practice
guidelines reference
included in the
predicate indications for
use.
The subject device
clarifies the intended
patient population. |
| Features | Predicate Device
The Vest Airway
Clearance Systems
Cleared under K142482 | Subject Device
The Vest APX System | Assessment of
Differences |
| | 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. | 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. | |
| Environments of Use | Acute care, extended care
and skilled nursing
facility care, home care,
outpatient /ambulatory
care, pulmonary
diagnostic
(bronchoscopy)
laboratory. | Same | N/A |
| Intended Population | Pediatric to geriatric
population | Pediatric population (6
months and older) to
geriatric population. | Similar
The subject device
specifies the intended
pediatric population. |
| Standard Compliance | 21 CFR 820
ISO 13485: 2016
ISO 14971: 2019 | 21 CFR 820
ISO 13485: 2016
ISO 14971: 2019 | Similar |
| | Predicate Device
The Vest Airway
Clearance Systems
Cleared under K142482 | Subject Device
The Vest APX System | Assessment of
Differences |
| Features | IEC 60601-1: 2005 + A1:
2012
IEC 60601-1-2: 2014
IEC 60601-1-6: 2010 +
A1: 2013
IEC 62366-1: 2015
IEC 60601-1-11: 2015
IEC 62304: 2006 + A1:
2015
ANSI/AAMI ES60601-
1:2005/(R)2012 +
A1:2012,
C1:2009/(R)2012 +
A2:2010/(R)2012
ANSI/AAMI HA60601-
1-11:2015
47 CFR FCC Part
15B:2012 (CLASS B)
ISO 10993-1:2018
ISO 15223-1:2021
ISO 20417:2021 | IEC 60601-1: 2005 +
A1: 2012 + A2:2020
IEC 60601-1-2: 2014 +
A1:2020
IEC 60601-1-6: 2010 +
A1:2013 + A2:2020
IEC 62366-1:2015 +
A1:2020
IEC 60601-1-11:2015 +
A1:2020
IEC 62304: 2006 +
A1 :2015
ANSI/AAMI ES60601-
1:2005/A2:2021
ANSI/AAMI HA60601-
1-11:2015/A1:2021
47 CFR FCC Part 15
Subpart B
47 CFR FCC Part 15
Subpart C
47 CFR FCC Part 15
Subpart E
IEEE/ANSI C63.27:
2017
47 CFR §2.1091
ISO 10993-1:2018
ISO 15223-1:2021
ISO 20417:2021 | |
| Sterile | No | Same | N/A |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | No | Same | N/A |
| Configuration for
home care | Model 105 includes a
carrying case. | Model PVAPX1HC
includes a carrying case | Same |
| Configuration for
acute care | Model 205 includes a
cart and advanced
software settings for use
by a physician or | Model PVAPX1 AC
includes a cart and
advanced software
settings for use by a
physician or | Same |
| Features | Predicate Device
The Vest Airway
Clearance Systems
Cleared under K142482 | Subject Device
The Vest APX System | Assessment of
Differences |
| | professional health care
provider | professional health care
provider | |
| Generator | Air Pulse Generator | Same | N/A |
| Hose | Connecting hose (60")
mechanical
interlock/friction fit | Connecting hose (60").
Hose to control unit uses
magnetic force
connection. Hose to
garment uses friction fit | Similar
The different
connection mechanism
allows an easier
connection option for
users with limited
dexterity. |
| Garment Offerings | Chest (Permanent)
Full Vest (Permanent /
SPU / C3)
Wrap Vest (Permanent /
SPU) | Full Vest
(Disposable/Reusable)
Wrap Vest
(Disposable/Reusable) | Similar
The difference is
consolidation of the
garments types offered,
the size range options is
the same. |
| Technology of
Oscillations | Pneumatic - a ir driven by
control unit
inflates/deflates the
garment air bladder | Same | N/A |
| Electrical
Specifications | 100 - 230 VAC, 50 / 60
Hz
3.4 A @ 100 VAC / 2.0
A @ 230 VAC
Power plug – NEMA 1-
15P (2 pin) | 100-240 VAC,50 / 60
Hz
3.5 A @ 100 VAC
Power plug - NEMA 1-
15P (2 pin) | Similar |
| Connectivity | Bluetooth | Wi-Fi
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.