(245 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical components and testing, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Vest® Airway Clearance Systems is intended to provide airway clearance therapy". The device's mechanism of action (High Frequency Chest Wall Oscillation to clear mucus) also aligns with the definition of a therapeutic intervention.
No.
The device is intended for airway clearance therapy, although it can be used to collect mucus for diagnostic evaluation, its primary function is therapeutic, not diagnostic.
No
The device description explicitly states that the system consists of an Air Pulse Generator, connecting hose, and multiple styles and sizes of garments, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to provide airway clearance therapy through external manipulation of the thorax. While it mentions the possibility of collecting mucus for diagnostic evaluation, this is a secondary function and the device itself is not performing a diagnostic test on the collected sample.
- Device Description: The device is a mechanical system that applies physical force to the chest wall. It does not involve reagents, assays, or analysis of biological samples in the way that an IVD does.
- Performance Studies: The performance studies described are focused on the mechanical and electrical safety and equivalence of the device to a predicate device, not on the accuracy or performance of a diagnostic test.
An In Vitro Diagnostic device is defined as a medical device that is intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This device does not fit that definition.
N/A
Intended 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.
Product codes
BYI
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.
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 to geriatric population
Intended User / Care Setting
Critical care, in-patient 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)
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 ●
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
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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.
1
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
2
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)
| XX Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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FORM FDA 3881 (8/14)
3
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510(k) Summary Page 1 of 5
| Date Prepared | 4-May-15 | |
|---|---|---|
| Hill-Rom Services Pte Ltd | ||
| 1 Yishun Ave 7 | ||
| Singapore, 768923, Singapore | Tel - 011 - 65 65945215 | |
| Fax - 011 - 65 65945201 | ||
| Official Contact: | Christina M. Miracle | |
| 1069 State Route 46 East | ||
| Batesville, IN 47006 | ||
| Tel – 812-931-3590 | ||
| 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 | |
| 21 CFR 868.5665 | ||
| 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
4
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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
System | Predicate
Vest® Airway Clearance System
(K024309) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CFR
Classification | 868.5665 | 868.5665 |
| Classification | BYI | BYI |
| Classification name | Percussor, Powered-Electric | Percussor, Powered-Electric |
| 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. | 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. |
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510(k) Summary Page 3 of 5 4-May-15
| | Proposed Vest® Airway Clearance
System | Predicate
Vest® Airway Clearance System
(K024309) |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environments of Use | Critical care, in-patient acute care,
extended care and skilled nursing
facility care, home care, outpatient /
ambulatory care, pulmonary
diagnostic (bronchoscopy)
laboratory. | Critical care, in-patient acute care,
extended care and skilled nursing
facility care, home care, outpatient /
ambulatory care, pulmonary
diagnostic (bronchoscopy)
laboratory. |
| Patient Population | Pediatric to geriatric population | Pediatric to geriatric population |
| Systems consists of | Air Pulse Generator
Connecting hose (60") locking / non-
locking
Garments of various styles and sizes
Chest (permanent)
Full Vest (Permanent / SPU / C3)
Wrap Vest (Permanent / SPU) | Air Pulse Generator
Connecting hose (60-80") non-locking
Garments of various styles and sizes
Chest (permanent)
Full Vest (Permanent / SPU) |
| Software Modes | Manual (Normal)
Bluetooth™ - Yes
Operational modes:
Programmable
Cough Pause®
Ramp | Manual (Normal)
Operational modes:
Manual mode |
| 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 – 230 VAC, 50 / 60 Hz
5.0 A max
Power plug – NEMA 5-15P (3 pin) |
| Mechanical safety | UL/EN/IEC 60601-1 and CAN/CSA
C22.2 No. 601.1 | UL/EN/IEC 60601-1 and CAN/CSA
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.