The intended use of the Advanced Respiratory 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. The Advanced Respiratory modified 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.

Device Description

The Advanced Respiratory modified Vest™ Airway Clearance System is a high-frequency chest wall oscillator for enhancing the mobilization of bronchial secretions. The device is designed for use in applications where patients are unable to manually operate the device output functions, e.g. organ donor procurement centers. The primary components of the Advanced Respiratory modified Vest™ Airway Clearance System include an air-pulse generator, an inflatable vest and connecting tubing. 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 donor patient creating high-frequency chest wall oscillation that results in the mobilization of bronchial secretions. The air output pulses are set at a fixed frequency (13 Hertz) and pressure (equal to a dial setting of 6 on the predicate device).

AI/ML Overview

The provided document describes a 510(k) premarket notification for a modified medical device, the Modified Vest™ Airway Clearance System. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a previously legally marketed device (predicate device), not necessarily to prove absolute efficacy or performance of the device in a clinical setting through extensive studies meeting rigorous acceptance criteria often associated with AI/software devices.

Therefore, the information requested might not be fully available or directly applicable in the format expected for AI/software-based medical devices or typical performance studies. I will extract what is available and highlight where information is missing or not applicable to this type of regulatory submission.

Acceptance Criteria and Device Performance

The "acceptance criteria" in this context is the concept of substantial equivalence to the predicate device. The performance testing aimed to demonstrate that the modifications did not negatively impact the device's safety and effectiveness compared to the predicate, and that when set to comparable parameters, their performance was equivalent.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functional Equivalence (Pressure)	Statistical equivalence of vest pressure output between modified and predicate device when predicate controls are adjusted to match the modified device's settings (fixed frequency: 13 Hz, fixed pressure: dial setting 6).	A paired t-test on 15 vest pressure comparisons (using 5 standard size vests) yielded a calculated t-value of 0.34. This is "well within the t critical value for statistical equivalence with an alpha of .05 of ± 2.145," indicating statistical equivalence.
Safety Standard Compliance	Compliance with UL 544, "Standard for Safety" for Medical and Dental Equipment (same standard as predicate).	The modified Vest System is listed to UL 544.
Electromagnetic Compatibility (EMC)	Compliance with FCC Part 15 testing.	The modified Vest system passed FCC Part 15 testing.
European EMC/Electrical Safety Standard	Compliance with European Standard EN 60601-1-2 testing.	The modified Vest system passed European Standard EN 60601-1-2 testing.
Physical Characteristics (Dimensions/Weight)	Overall dimensions or weight of the modified device should be the same as the predicate.	The overall dimensions or weight of the modified device is the same as the predicate.
Component Compatibility	The vest components used with the modified system should be the same as those used with the predicate device.	The vest components that are used with the modified Vest System is the same as the vests used with the predicate device.
Indications for Use Equivalence	The intended use and indications for use of the modified device must be the same as the predicate device, as described by the American Association for Respiratory Care (AARC) Clinical Practice Guideline (1991).	The intended use of the modified Vest™ Airway Clearance System is the same as the predicate device. Indications include promoting airway clearance/improving bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician's choice, particularly for retained secretions, difficulty with secretion clearance, or atelectasis caused by mucus plugging. Also indicated for collecting mucus for diagnostic evaluation.

Study Details (Applicable to this 510(k) submission)

Sample size used for the test set and the data provenance:
- Sample Size: 15 vest pressure comparisons were performed, using all 5 of the standard size vests.
- Data Provenance: Not explicitly stated, but clinical studies for de novo approval are usually associated with specific sites. For a 510(k) demonstrating equivalence, it's likely internal lab testing or a controlled environment. The document is from Advanced Respiratory, located in Minnesota, USA, suggesting a US-centric provenance for the testing. It is a prospective comparison test of the modified device against the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes a physical device comparison, not an expert-driven ground truth assessment for a diagnostic or AI algorithm. Therefore, "experts" in the sense of clinical reviewers establishing ground truth are not applicable. The ground truth was based on objective physical measurements (pressure output) and compliance with established engineering and safety standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on challenging cases, typically in diagnostic imaging or clinical assessments where ground truth is subjective or requires expert interpretation. This study involved objective physical measurements and engineering compliance.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a physical medical device (high-frequency chest wall oscillator), not an AI/software diagnostic tool, and it does not involve human "readers" or AI assistance in interpretation. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially applicable/Re-interpreted: The "standalone" performance here refers to the device's ability to maintain its specified physical parameters (frequency and pressure output) and comply with safety standards. The document states the modified device's air output pulses are "set at a fixed frequency (13 Hertz) and pressure (equal to a dial setting of 6 on the predicate device)." The performance testing then verified this output against the predicate device when the predicate was similarly adjusted. So, the device's own output was tested. This is not "algorithm only" in the AI sense, but rather "device only" performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission was based on objective physical measurements (vest pressure output, frequency settings), engineering specifications, and adherence to established safety and electrical standards (UL 544, FCC Part 15, EN 60601-1-2). The comparison was to the predicate device's measured performance under matching conditions.
The sample size for the training set:
- Not applicable. This is a physical device undergoing modification and substantial equivalence demonstration, not an AI model that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. As no training set was involved for an AI model.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for Advanced Respiratory. The logo consists of a black diamond shape with a white "O" inside of it. To the right of the diamond shape, the words "Advanced Respiratory" are written in a serif font, with "Advanced" on the top line and "Respiratory" on the bottom line.

OCT - 9 2001

Kol2928

Advanced Respiratory 1020 West County Road F St. Paul, Minnesota 55126 www.thevest.com

651-490-1468

800-426-4224

651-234-1209

Formerly American Biosystems, Inc

13 August 2001

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. LarsonManager of Quality Systems and Regulatory AffairsAdvanced Respiratory1020 West County Road FShoreview, MN 55126Phone: (651) 234-1211 Fax: (651) 234-1527
Contact person:	Eric J. Larson
Name of Device:	Modified Vest™ Airway Clearance System
Classification:	Powered Percussor, Class II
Predicate Device:	ABI Vest™ Airway Clearance System, 510(K) number: K993629

Description of Device:

ENCLOSURE E-SUMMARY OF SAFETY & EFFECTIVENESS PREMARKET NOTIFICATION 510(K) ADVANCED RESPIRATORY PAGE

Your source fo

The
Vest

Airway Clearance System

So everyone can breathe a little easier.14

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SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

Intended Use:

The intended use of the modified 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™ Airway Clearance System is substantially equivalent to the previously cleared ABI Vest™ Airway Clearance System (a.k.a. ThAIRapy® Vest System) (K993629), which 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. The reason for this submission is to modify the predicate device to set the frequency and pressure at optimal values and add software that controls the therapy time duration and pause duration between therapy sessions.

Performance Testing:

The modifications have been compared to safety and effectiveness previously established by the market-cleared Vest System predecessor. A paired t-test on 15 vest pressure comparisons using all 5 of the standard size vests depicts that the modified Vest system and predicate Vest system are equivalent when the predecessor controls are adjusted to the set parameters of the modified vest system. The calculated t-value of .34 for the 15 comparisons is well within the t critical value for statistical equivalence with an alpha of .05 of ± 2.145.

The modified Vest System is listed to U.L. 544, "Standard for Safety" for Medical and Dental Equipment, the same standard as the predecessor is listed.

The modified Vest system also passed FCC Part 15 testing and European Standard EN 60601-1-2 testing

The overall dimensions or weight of the modified device is the same as the predicate

The vest components that are used with the modified Vest System is the same as the vests used with the predicate device

Conclusion:

Comparison testing of the modified model to the predicate Vest System demonstrates that the performance and safety is equivalent to the predicate with the controls adjusted to the set parameters of the modified system, i.e., frequency at 6 Hz and pressure to dial setting of 6.

ENCLOSURE E-SUMMARY OF SAFETY &EFFECTIVENESS PREMARKET NOTIFICATION 510(K) ADVANCED RESPIRATORY

PAGE

119

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 92001

Advanced Respiratory c/o Mr. Ned Devine Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, MI 49548

Re: K012928

ABI Vest™ Airway Clearance System Regulation Number: 868.5665 Regulation Name: Powered Percussor Regulatory Class: II (two) Product Code: 73 BYI Dated: September 24, 2001 Received: September 25, 2001

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 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.

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

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Page 2 - Mr. Ned Devine

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 rordlict 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) I mb letter with and wy of substantial equivalence of your device 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

V. Outh Tell

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known)______________________________________________________________________________________________________________________________________________________

Device Name: Modified Vest™ Airway Clearance System

Indications for use:

1. 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)

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

Division of Cardiovascular & Respiratory Devices
510(k) Number K012428

Regulation Number and Section

§ 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).