Vortex is a new spacer/holding chamber designed to assist patients using metered dose inhalers (MDI) for aerosolized drug delivery. Vortex may provide enhanced drug delivery, ease of use and ability to clean/disinfect the device.

Vortex is a reusable device consisting of an aluminum cylinder with an elastomeric fitting on one end to accept metered dose inhalers and a valved mouthpiece on the other end to interface with the patient. The elastomeric fitting may be removed for cleaning and/or replacement.

Vortex will be available as a stand-alone item and will also be available packaged with a mask.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Vortex compared to Aerochamber)	Reported Device Performance (Vortex)
Drug Delivery (Respirable Drug)	Comparable to or greater than Aerochamber.	Respirable drug delivered through Vortex is "comparable to . or greater than Aerochamber."
Fit with MDI Elbows	Not explicitly stated as a comparative criterion, but implied to fit all.	Vortex "fit all MDI elbows evaluated."
Inhalation Resistance	Comparable to or less than Aerochamber, and less than 250 pascal at 30 lpm flow.	"Comparable to or less than Aerochamber. All results are less than 250 pascal at 30 lpm flow."
Exhalation Resistance	Comparable to or less than Aerochamber, and less than 250 pascal at 30 lpm flow.	"Comparable to or less than Aerochamber. All results are less than 250 pascal at 30 lpm flow."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes for the "test set" (i.e., the number of devices or experimental replicates used in the non-clinical testing). It only states that "Testing to compare Vortex to Aerochamber was conducted."

The data provenance is retrospective, as the testing was conducted for the purpose of a 510(k) submission to demonstrate substantial equivalence to an already legally marketed device. The country of origin of the data is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable as the provided document describes non-clinical performance testing of a medical device (a valved holding chamber/spacer), not a diagnostic or AI-driven system that requires expert-established ground truth. The "ground truth" here is objective physical measurements (e.g., drug delivery, resistance).

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Adjudication methods are typically relevant for subjective assessments or when multiple experts review the same data, which is not the case for this non-clinical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not completed/is not required to show substantial equivalence." MRMC studies typically involve human readers and clinical outcomes.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device (Vortex valved holding chamber) is a physical medical device, not an algorithm or AI system. Its performance is measured directly, not through an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's performance assessment was based on objective physical measurements and established testing methodologies. For example:

Drug delivery: Measured quantitatively according to FDA guidance.
Fit with MDI elbows: An objective assessment of physical compatibility.
Inhalation and exhalation resistance: Measured quantitatively using instruments (e.g., in pascal at a specific flow rate).

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The performance testing was conducted on the physical device itself.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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VORTEX 510(k) Submission 510(k) Summary

MAY 0 9 2002

Submitter Information

Name:	PARI Innovative Manufacturers, Inc.
Address:	13800 Hull Street RoadMidlothian, Virginia 23112
Phone Number:	804-639-7235
FAX Number:	804-639-7244
Contact Name:	Lawrence Weinstein
Date Prepared:	February 14, 2002

Device Name

Common Name:	Holding Chamber/Spacer
Proprietary Name:	Vortex®
Classification Name:	Nebulizer (Direct Patient Interface)

Legally Marketed Predicate Device

Aerochamber Monaghan Medical (and/or Trudell Medical) Plattsburgh, NY

K992917; K930574; K900576; K900557; K884803; K872037; K822437

Device Description

Vortex will be available as a stand-alone item and will also be available packaged with a mask.

Intended Use

ve orex is indicated for use as a spacer/valved holding chamber for use in delivery of aerosol medication with metered dose inhalers.

Technological Characteristics Compared to Predicate Device

Vortex and Aerochamber are both valved holding chambers used to aid in the delivery of MDI v often and released include a cylindrical chamber to allow the MDI drug plume to expand nrior to inhalation by the patient. In addition, both make use of inhalation and exhalation valves to reduce coordination related problems with MDI actuation.

Vortex and Aerochamber make use of thermoplastic components and elastomeric valves and MDI adapters. However, Vortex makes use of a non-electrostatic (anodized aluminum) cylinder to reduce the likelihood of drug deposition on the cylinder.

Non-clinical Test Summary

Testing to compare Vortex to Aerochamber was conducted. Characteristics evaluated include:

Drug delivery (per FDA guidance): Respirable drug delivered through Vortex is comparable to . or greater than Aerochamber.
Fit with MDI elbows: Vortex fit all MDI elbows evaluated. .

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VORTEX 510(k) Submission

510(k) Summary

Inhalation and exhalation resistance: Inhalation and exhalation resistance for Vortex is comparable . to or less than Aerochamber. All results are less than 250 pascal at 30 lpm flow.

Clinical Performance Summary

Clinical testing was not completed/is not required to show substantial equivalence.

Conclusions from Testing

Vortex performance is comparable to Aerochamber for all items tested.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing right, arranged in a stacked formation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2002

Pari Innovative Manufacturers, Inc .. c/o Robert Mosenkis CITECH 5200 Butler Pike Plymouth Metting, PA 19462

K020944 Re:

Vortex Valved Holding Chamber Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II (two) Product Code: 73 CAF Dated: April 24, 2002 Received: April 25, 2002

Dear Mr. Mosenkis:

This letter corrects our substantially equivalent letter of May 9, 2002 regarding the indications for use of your device. Our letter incorrectly limited your device to use in military environments.

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 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). 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 additional controls. Existing major regulations affecting your

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Page 2 - Mr. Robert Mosenkis

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 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 continue 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 and additionally 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. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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VORTEX 510(k) Submission Intended Use

D209V4 510(k) Number (if known): {

Device Name: _Vortex™ Valved Holding Chamber

Indications for Use:

Vortex is indicated for use as a spacer/valved holding chamber for use in delivery of aerosol medication with metered dose inhalers.

(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 _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

signature

on Douly

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).