The PARI PEP S is intended for use as a Positive Expiratory Pressure Device, and is designed to help patients exercise their lungs properly and improve secretion clearance. The PARI PEP S may be used by itself or in conjunction with aerosol drug therapy. The PARI PEP S is intended for adult and pediatric patients, for use in home, hospital, and sub-acute institutions.

Device Description

The PARI PEP S is a small, single patient use, reusable PEP therapy device for use as a stand alone PEP device or for use with aerosol drug delivery. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

AI/ML Overview

The provided information is for the PARI PEP S Positive Expiratory Pressure Device (K090829). This device is an Incentive Spirometer, which is a mechanical device, not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for training/test sets, ground truth establishment for AI/ML, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or provided in this 510(k) summary.

However, I will extract and present the relevant information that is available regarding its performance and the study details.

Acceptance Criteria and Device Performance:

The 510(k) summary indicates that the PARI PEP S was tested to compare its performance to predicate devices (PARI PEP and TheraPEP). The acceptance criteria are implicitly defined by "comparable to the predicate devices" for the tested parameters.

Acceptance Criteria (Implicit)	Reported Device Performance
Expiratory resistance comparable to predicate devices	PARI PEP S is comparable to the predicate devices.
Inspiratory resistance comparable to predicate devices	PARI PEP S is comparable to the predicate devices.

Study Details:

Sample size used for the test set and the data provenance: Not applicable. The testing described is a comparison of functional characteristics (resistance) rather than a clinical trial with patient data. No specific sample size for a "test set" of patient data is mentioned as clinical testing was not performed or required.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical outcomes or interpretations by experts is not relevant for this type of device comparison test.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept applies to clinical image interpretation or diagnostic performance, which is not relevant here.
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 a non-AI mechanical device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a non-AI mechanical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a mechanical device performance comparison. The "ground truth" here would be the measured physical properties of the predicate devices.
The sample size for the training set: Not applicable. This is a non-AI mechanical device.
How the ground truth for the training set was established: Not applicable. This is a non-AI mechanical device.

Additional Information from the 510(k) Summary:

Study Type: Non-Clinical Test Summary focused on comparing performance (expiratory and inspiratory resistance) of the PARI PEP S to legally marketed predicate devices (PARI PEP and TheraPEP).
Clinical Performance Summary: "Clinical testing was not completed/is not required to show substantial equivalence." This statement confirms that clinical studies, which would typically involve patient data and clinical endpoints, were not part of this submission for substantial equivalence.
Conclusion: "PARI PEP S meets performance requirements and raises no new issues of safety or effectiveness." This indicates that the comparative non-clinical testing was sufficient to demonstrate substantial equivalence to the predicate devices for the given indications for use.

Summary

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K090829

JUL 21 2009

PARI PEP S Positive Expiratory Pressure Device 510(k) Submission 510(k) Summary

Submitter Information

Name:	PARI Respiratory Eqiupment, 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:	March 6, 2009

Device Name

A 1 2 7 2 2 1 6 2 6 2 6 2 6 2 2 3 6 2 2 3 6 2 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3
Common Name:	PEP (Positive Expiratory Pressure) Device
Trade Name:	PARI PEP S
Classification Name:	Incentive Spirometer, 21 CFR 868.5690, Product Code BWF

Legally Marketed Predicate Device(s)

Manufacturer	Device	510(k) Number
PARI Respiratory Equipment, Inc.	PARI PEP	K972042
Smiths Medical, Inc.	TheraPEP	K983467

Device Description

Indications For Use

Technological Characteristics Compared to Predicate Device

The PARI PEP S. PARI PEP and TheraPEP are all fixed orifice, positive expiratory pressure devices where a choice of orifices are provided allowing a clinician to select the appropriate settings to accommodate a patient breathing pattern. All devices incorporate a one way valve to allow low resistance inhalation and exhalation through the selected restrictive orifice. All three devices include a pressure monitoring port to allow user or clinician monitoring of the expiratory pressure. PARI PEP and TheraPEP may all be used as stand alone devices or may be used in conjunction with aerosol therapy.

The PARI PEP S uses materials identical to the PARI PEP system.

Non-Clinical Test Summary

PARI PEP S was tested to compare performance to the predicate PARI PEP device, including:

Expiratory resistance: PARI PEP S is comparable to the predicate devices. 트
트 Inspiratory Resistance: PARI PEP S is comparable to the predicate devices

Clinical Performance Summary

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

Conclusions from Testing

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL 2 1 2009

Re: K090829

Trade/Device Name: PARI PEP S Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: II Product Code: BWF Dated: July 1, 2009 Received: July 2, 2009

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.

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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Runner, D.D.S., M.A

Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

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

Device Name: PARI PEP 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)

L. Schuler

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

510(k) Number: KD908629

Page of (Posted November 13, 2003)

Page 4.2

Regulation Number and Section

§ 868.5690 Incentive spirometer.

(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).