The PARI Vios is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The PARI Vios is intended for adult and pediatric patients for use in hospital, clinic, or home environments.

Device Description

The PARI Vios nebulizer compressor is a small, lightweight AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The device is non-sterile and prescriptionuse only.

AI/ML Overview

The provided documentation describes the PARI Vios nebulizer compressor, but it does not contain information related to acceptance criteria for an AI/ML powered device or a study involving such a device.

Instead, it's a 510(k) summary for a medical device (a nebulizer compressor) that compares its performance to predicate devices. The "performance" mentioned refers to physical characteristics of the nebulizer compressor itself, not the performance of an algorithm or AI.

Therefore, I cannot provide answers to the requested categories (acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC, standalone, ground truth, training set) as they are relevant to AI/ML device studies, which are not detailed in this submission.

Here's a breakdown of what is provided, as it relates to the general concept of device performance:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" with numerical targets. Instead, it states that the PARI Vios's performance is "comparable to the predicate devices" for the following metrics:

Acceptance Criteria (Implied: Comparable to Predicate)	Reported Device Performance (PARI Vios)
Total Output Rate (TOR)	Comparable to the predicate devices
MMD (Mass Median Diameter)	Comparable to the predicate devices
Volume % <5 µm	Comparable to the predicate devices
Operating Pressure	Comparable to the predicate devices

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document mentions "tested with various nebulizers" but does not specify sample sizes for these tests, or any details about the provenance of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The device in question is a hardware compressor. "Ground truth" in the context of expert assessment for AI/ML is not relevant here. The performance metrics (TOR, MMD, etc.) are objective physical measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication is typically used to resolve discrepancies in expert-derived ground truth, which is not the case for objective physical measurements.

5. 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

This information is not applicable/not provided. An MRMC study is relevant for AI-assisted diagnostic devices. This submission concerns a nebulizer compressor. The document explicitly states: "Clinical testing was not completed/is not required to show substantial equivalence."

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

This information is not applicable/not provided. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance metrics (TOR, MMD, Volume % <5 µm, Operating Pressure) are objective physical measurements derived from testing the device itself, likely using standardized laboratory procedures.

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not applicable/not provided. There is no mention of a training set or ground truth establishment for such a set.

Summary

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K092918

FEB - 4 2010

PARI Vios 510(k) Submission 510(k) Summary

Submitter Information

Name:	PARI Respiratory Equipment, Inc.
Address:	2943 Oak Lake Blvd.Midlothian, VA 23112
Phone Number:	804-253-7274 x269
Fax Number:	804-639-7244
Contact Name:	Michael Judge
Date Prepared;	September 18, 2009

Device Name

Common Name:	Nebulizer Compressor
Trade Name:	PARI Vios
Classification Name:	Nebulizer (Direct Patient Interface), §868.5630, Product Code CAF

Legally Marketed Predicate Device(s)

Manufacturer	Device	510(k) Number
PARI Respiratory Equipment, Inc.	Trek S Nebulizer Compressor	K061381
PARI Respiratory Equipment, Inc.	Proneb Ultra	K002862

Device Description

Indications For Use

Technological Characteristics Compared to Predicate Devices

The PARI Vios, PARI Proneb Ultra, and PARI Trek.S are all air compressors intended to provide a source of compressed air for use with jet nebulizers. All three devices are piston-driven, oil-free, reciprocating air compressors.

PARI Vios employs similar materials compared to the predicate devices, including a polymenc cylinder and housing, Teflon piston seal, and silicone valves. PARI Vios is similar to the Proneb Ultra compressor regarding the fan-cooled shaded pole AC motor, integrated carry handle, and front-panel air outlet and filter access. Operating pressure and jet flow produced by the PARI Vios is comparable to the predicates.

Non-Clinical Test Summary

PARI Vios was tested with various nebulizers to compare performance to the predicate devices, including:

Total Output Rate: PARI Vios TOR is comparable to the predicate devices. #
MMD: PARI Vios MMD is comparable to the predicate devices .
Volume % <5 µm: PARI Vios is comparable to the predicate devices ..
Operating Pressure: PARI Vios is comparable to the predicate devices I

Clinical Performance Summary

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

Conclusions from Testing

PARI Vios meets performance requirements and raises no new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Mr. Michael Judge Director of Quality Assurance/Regulatory Affairs PARI Respiratory Equipment, Incorporated 2943 Oak Lake Boulevard Midlothian, Virginia 23112

FEB - 4 2010

Re: K092918

Trade/Device Name: PARI Vios Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: January 11, 2010 Received: January 12, 2010

Dear Mr. Judge:

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.

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Page 2 - Mr. Judge

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): N/A

Device Name: PARI Vios

Indications for Use:

Prescription Use XXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: KD 92918

Page of (Posted November 13, 2003)

Page 4.1

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).