The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek S is intended for adult and pediatric patients.

Device Description

The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

AI/ML Overview

The provided document, K060357, describes a 510(k) submission for the PARI Trek™ S nebulizer compressor. This device is a nebulizer compressor, which is a mechanical device, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as ground truth, expert adjudication, MRMC studies, training set, etc.) are not applicable in this context.

The submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical performance summaries.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Performance)	Reported Device Performance (PARI Trek™ S)
Total Output Rate (TOR)	Comparable to predicate devices
Mass Median Diameter (MMD)	Comparable to predicate devices
Volume % < 5 um	Comparable to predicate devices

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

Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of devices tested. It refers generally to "PARI Trek™ S was tested with various nebulizers."
Data Provenance: The testing appears to have been conducted by the manufacturer, PARI Innovative Manufacturers, Inc., in the context of their 510(k) submission. No information on country of origin of data or whether it was retrospective or prospective is explicitly stated for this non-clinical testing, though it would implicitly be prospective testing for the new device.

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

Not applicable. This device is a mechanical nebulizer compressor, and its performance was evaluated against technical specifications (e.g., airflow, particle size distribution when paired with nebulizers) rather than medical interpretations requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this involves technical performance metrics, not diagnostic interpretations requiring adjudication.

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?

Not applicable. This is not an AI/ML powered device, and no human reader studies are mentioned or relevant for its substantial equivalence demonstration.

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

Not applicable. This is not an AI/ML powered device.

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

The "ground truth" for the non-clinical tests would be the established scientific and engineering principles for measuring nebulizer compressor performance (e.g., standards for measuring Total Output Rate, Mass Median Diameter, and particle size distribution). The comparison was made against the performance of legally marketed predicate devices, implying those predicate devices' performance serves as a benchmark for "comparable" criteria.

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device, so there is no training set involved.

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

Not applicable. As this is not an AI/ML powered device, there is no training set or ground truth establishment relevant to AI/ML.

Summary

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K060357

5 2006 APR

PARI rek™ S 510(k) submission 510(k) Summary

Submitt r Information PARI Innovative Manufacturers, Inc. Name: 2943 Oak Lake Blvd. Address Midlothian, VA 23112 804-253-7274 x269 Phone N imber: 804-639-7244 Fax Nun ber: Contact lame: Michael Judge December 19, 2005 Date Pre ared:

Device Name
Common Name:		Nebulizer compressor
Proprietary Name:		PARI Trek™ S
Classification Name:		Nebulizer (Direct Patient Interface), 21 CFR 868.5630, Product Code CAF

Legally Marketed Predicate Device(s)

Manufa turer	Device	510(k) Number
PARI Ir ovative Manufacturers, Inc.	Walkhaler Portable Compressor	K960675
PARI Ir. ovative Manufacturers, Inc.	Proneb® Ultra	K002862

Device | escription

The Trel MS nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of comp ssed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatic patients. The dev e is non-sterile, prescription-use only, intended for use in bospital, clinic, or home environments.

Intende Use

The Tre TM S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of comp ssed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatic patients.

Technol gical Characteristics Compared to Predicate Device

PARI Ti :k™ S, PARI Proneb® Ultra, and PARI Walkhaler® are all air compressors intended to provide a source o compressed air for use with jet nebulizers. All three devices are piston-driven, oil-free reciproc ting air compressors.

PARI Ti :k™ S employs similar materials compared to the predicate devices, including a polymer cylinder and hou ng, Teflon piston seal and silicon valves. PARI Trek™ S is similar to the Walkhaler® compres or regarding the DC motor, AC-to-DC adapter, and optional battery pack for portable use. Operati 3 pressure and jet flow produced by the PARI Trek™ S is comparable to the predicates.

Non-Cli rical Test Summary

PARI T km S was tested with various nebulizers to compare performance to the predicate devices, includin :

Tot 1 Output Rate: PARI Trek™ S TOR is comparable to the predicate devices D
a MN D: PARI Trek™ S MMD is comparable to the predicate devices
Voi me % < 5 um: PARI TrekTM S is comparable to the predicate devices l

Clinical Performance Summary

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

Conclu: ons from Testing

PARI I x™ S meets performance requirements and raises no new issues of safety or effectiveness.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The logo is black and white.

5 2006 APR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert Mosenkis Citech 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K060357

Trade/Device Name: Trek S Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: March 27, 2006 Received: March 28, 2006

Dear Mr. Mosenkis:

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 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.

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Page 2 - Mr. Robert Mosenkis

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-2022. 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,

Smith. Y. Michael Davis

Chiu Lin, Ph.D 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

Kolo 35

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

Device Name: Trck S

・・

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)

llion like m

gy, General Hospital,
Control Dental Devices

Page of (Posted November 13, 2003)

5.1

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).