(59 days)
Not Found
No
The document describes a mechanical device for airway clearance and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device provides airway clearance therapy and is indicated for conditions like retained secretions, difficulty with secretion clearance, and atelectasis caused by mucus plugging, clearly falling under therapeutic applications.
No
The device is designed for therapy (airway clearance) and not for diagnosing a condition. While it can be used to collect mucus for diagnostic evaluation, its primary function is therapeutic.
No
The device description explicitly states the primary components are an air-pulse generator and an inflatable vest, which are hardware components.
Based on the provided information, this device is not primarily an IVD (In Vitro Diagnostic).
Here's why:
- Primary Intended Use: The main intended use is to provide airway clearance therapy through external manipulation of the thorax. This is a therapeutic function, not a diagnostic one.
- Mechanism of Action: The device works by applying oscillating pressure to the chest wall to mobilize secretions. This is a physical therapy mechanism.
- Diagnostic Mention: While the intended use mentions that the system is also indicated for external manipulation to promote airway clearance for the purpose of collecting mucus for diagnostic evaluation, this is a secondary function and the device itself is not performing the diagnostic test on the mucus. It's facilitating the collection of a sample that might be used for a diagnostic test.
In summary: The device's core function is therapeutic (airway clearance). The mention of collecting mucus for diagnostic evaluation is a potential outcome or application of the therapy, not the primary diagnostic function of the device itself. Therefore, it does not fit the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The intended use of the Advanced Respiratory Vest Airway Clearance System is to promote airway clearance or improve bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment. The indications typically follow the Clinical Practice Guideline published by the American Association for Respiratory Care (AARC) 1991. In addition, the device is also indicated for the purpose of collecting mucus for diagnostic evaluation.
The intended use of the Modified Vest™ Airway Clearance System is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy (1991). 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 purposes of collecting mucus for diagnostic evaluation.
Product codes (comma separated list FDA assigned to the subject device)
BYI
Device Description
The Advanced Respiratory Vest™ Airway Clearance System is a high-frequency chest wall oscillator designed to be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of The Vest™ Airway Clearance System include an air-pulse generator and an inflatable vest. Oscillating positive pressure air pulses are applied to the vest by the air-pulse generator. The resulting pressure pulses cause the vest to inflate and deflate against the chest of the user creating high-frequency chest wall oscillation and mobilization of bronchial secretions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The Modified Advanced Respiratory Vest™ Airway Clearance System was compared to the predicate model The Vest™ ThAIRapy System (K993629). Functional and performance comparisons were made and it is concluded that the device that is the subject of this 510(k) is substantially equivalent to the predicate device.
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/1 description: The image shows the logo for Advanced Respiratory. The logo consists of a black diamond shape with a white "O" inside of it on the left. To the right of the diamond is the text "Advanced Respiratory" in a serif font, with "Advanced" on top of "Respiratory".
651-490-1468 800-426-4224 Fax 651-234-1209
Advanced Respiratory 1020 West County Road F St. Paul, Minnesota 55126 www.thevest.com
Formerly American Biosystems, Inc
FEB 2 1 2003
l 1 December 2002
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990.
| Submitter: | Eric J. Larson
Manager of Quality Systems and Regulatory Affairs
Advanced Respiratory, Inc.
1020 W. County Road F
Shoreview, MN 55126
Phone: (651) 234-1211 Fax: (651) 234-1527 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Eric J. Larson |
| Name of Device: | Modified VestTM Airway Clearance System |
| Classification: | Powered Percussor, Class II |
| Predicate Device: | The VestTM Vest System, 510(K) number: K012928, K993629 |
Description of Device:
The Advanced Respiratory Vest™ Airway Clearance System is a high-frequency chest wall oscillator designed to be used in a wide variety of settings for enhancing the mobilization of bronchial secretions. The primary components of The Vest™ Airway Clearance System include an air-pulse generator and an inflatable vest. Oscillating positive pressure air pulses are applied to the vest by the air-pulse generator. The resulting pressure pulses cause the vest to inflate and deflate against the chest of the user creating high-frequency chest wall oscillation and mobilization of bronchial secretions.
Your source for
Image /page/0/Picture/13 description: The image shows the logo for "The Vest Airway Clearance System". The words "The Vest" are in a stylized font, with "The" being smaller and above "Vest". Below this, in a smaller, simpler font, are the words "Airway Clearance System". The logo is in black and white.
So everyone can breathe a little easier
1
SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
Intended Use:
The intended use of the Advanced Respiratory Vest Airway Clearance System is to promote airway clearance or improve bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice of treatment. The indications typically follow the Clinical Practice Guideline published by the American Association for Respiratory Care (AARC) 1991. In addition, the device is also indicated for the purpose of collecting mucus for diagnostic evaluation.
Comparison of Technological Characteristics:
The Modified Vest™ System is equivalent to Advanced Respiratory's previously cleared LINK Vest™ Airway Clearance System (K012928) and its Vest™ Airway Clearance System (a.k.a. ThAIRapy® Vest System) (K993629) in that the new model is intended to promote airway clearance or improve bronchial drainage by enhancing the mobilization of bronchial secretions when external manipulation of the thorax is the physician's choice of treatment. All devices have reciprocating bellows that generate the air pulses. The same vests will be used on the new device as were available for the predicate devices. Operator controls remain consistent with predicate devices. The user can adjust air pulse frequency and pressure. The reason for this submission is to due to the change from analog to digital control of device frequency and pressure. The predicate device contains analog potentiometers that were rotated to control device frequency and pressure. The new device has momentary switches that are depressed to send a digital signal for microprocessor control of frequency and pressure.
Performance Testing:
The Modified Advanced Respiratory Vest™ Airway Clearance System was compared to the predicate model The Vest™ ThAIRapy System (K993629). Functional and performance comparisons were made and it is concluded that the device that is the subject of this 510(k) is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three stripes representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2003
Advanced Respiratory C/O Mr. Ned E. Devine Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K024309
Trade/Device Name: The Vest™ Airway Clearance System Regulation Number: 868.5665 Regulation Name: Powered Percussor Regulatory Class: II Product Code: BYI Dated: February 6, 2003 Received: February 7, 2003
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.
3
Page 2 - Mr. Devine
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runne:
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a white background with several small, black, horizontal lines scattered across it. The lines vary in length and thickness, and they are not arranged in any particular pattern. The overall impression is one of randomness and sparseness.
INDICATIONS FOR USE STATEMENT
ENCLOSURE F-INDICATIONS FOR USE STATEMENT-PREMARKET NOTIFICATION 510(K) ADVANCED RESPIRATORY, INC. PAGE
ﻬﺎ ﻓﻬﻮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ
5
510(K) Number (if known)_ _ Ko24300
Device Name: Modified Vest™ Airway Clearance System
Indications for use:
The intended use of the Modified Vest™ Airway Clearance System is the same as the predicate device, which is to provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy (1991). 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 purposes of collecting mucus for diagnostic evaluation.
-
- Bronchial Hygiene Guidelines Committee, American Association for Respiratory Care. AARC clinical practice guideline: postural drainage therapy. Respiratory Care 1991; 36: 1418 - 1426.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) √
Avestin
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K024309
OR
Over the Counter Use__________________________________________________________________________________________________________________________________________________________
34