The PARI O-PEP is intended for use as a Positive Expiratory Pressure Device, and is designed to help patients improve secretion clearance. The PARI O-PEP is intended for adult and pediatric patients ages 5 and older, for use in home, hospital, and sub-acute institutions.

Device Description

The PARI O-PEP (Oscillating Positive Expiratory Pressure) is a small, single patient use, reusable oscillating PEP therapy device. The PARI O-PEP is a respiratory therapy device designed for temporary application to mobilize secretions or mucous in the lower respiratory tract, strengthen the respiratory tract and alleviate shortness of breath. The patient exhales repeatedly into the device against a movable ball, causing a vibration that is transmitted to the lungs. This causes the deeper respiratory tract to open. By doing this, secretions are mobilized and able to move up the airways. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the PARI O-PEP device based on the provided text, using the requested format.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against predefined acceptance criteria from a comprehensive clinical trial. Therefore, much of the requested information regarding detailed study design, ground truth establishment, expert adjudication, or MRMC studies for AI devices is not applicable or not present in this type of submission. The performance assessment here is primarily non-clinical and comparative.

Acceptance Criteria and Device Performance (Based on Non-Clinical Comparative Testing)

The "acceptance criteria" for the PARI O-PEP, in the context of this 510(k) submission, are primarily defined by its ability to perform comparably to its predicate device (Flutter D and Flutter) in key functional metrics: oscillatory frequency and expiratory resistance. Biocompatibility and cleaning efficacy are also established.

Table 1: Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Proxy: Substantial Equivalence to Predicate)	Reported Device Performance (PARI O-PEP vs. Predicate Flutter/Flutter D)
Expiratory Resistance	Produce comparable expiratory pressure levels to the predicate Flutter device across a range of flow rates (5-30 LPM) and angular positions (0 and 30 degrees).	"PARI O-PEP expiratory pressure level was compared to the predicate Flutter device across a range of flow rates between 5 and 30 LPM and angular positions of 0 and 30 degrees, and was found to be substantially equivalent to the predicate device for all variables."
Oscillating Frequency	Produce comparable oscillation frequencies to the predicate Flutter device across a range of flow rates (5-30 LPM) and angular positions (0 and 30 degrees).	"PARI O-PEP oscillating frequency was compared to the predicate Flutter device across a range of flows between 5 and 30 LPM and angular positions of 0 and 30 degrees, and was found to be substantially equivalent to the predicate device for all variables." "Oscillation frequency of PARI O-PEP device is comparable to predicate Flutter across a range of flow rates between 5 and 30 LPM."
Biocompatibility	Meet requirements of ISO 10993-1, -5, -10.	"Testing demonstrates that the subject device meets requirements in accordance with: ISO 10993-1, ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and skin sensitization)."
Cleaning Efficacy	Meet requirements for cleaning of a reusable medical device in accordance with recognized guidelines (e.g., AAMI TIR No. 30, 2011).	"Testing demonstrates that the subject device meets requirements for cleaning of a reusable medical device in accordance with recognized guidelines, including: AAMI TIR No. 30, 2011: A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices."

Study Details (Non-Clinical Comparative Testing)

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of devices. The testing involved comparing the PARI O-PEP device against the predicate Flutter device across a "range of flow rates between 5 and 30 LPM and angular positions of 0 and 30 degrees." This suggests multiple measurement points for each device.
- Data Provenance: The data is from non-clinical laboratory testing performed by the manufacturer, PARI Respiratory Equipment, Inc. The country of origin for the data is not specified, but it would be expected to be where PARI conducts its testing, likely the USA given their address. The data is prospective in the sense that the tests were specifically conducted for this 510(k) submission to demonstrate equivalence.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This was a non-clinical, objective performance test comparing physical properties (pressure, frequency) of devices, not a diagnostic device requiring expert interpretation of results. The "ground truth" was the measured performance of the predicate device under controlled conditions.
Adjudication Method for the Test Set:
- Not Applicable. No human adjudication was involved in comparing the physical performance parameters of the devices. The comparison was based on direct measurements.
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:
- No. This device is a mechanical respiratory therapy device, not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI" are not relevant.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical medical device, not an algorithm or AI system.
The Type of Ground Truth Used:
- For the performance tests (expiratory resistance, oscillating frequency): The "ground truth" was the measured physical performance of the legally marketed predicate device (Flutter/Flutter D) under standardized laboratory conditions. The PARI O-PEP's performance was measured and compared against these established values.
- For biocompatibility and cleaning efficacy: The "ground truth" was adherence to established regulatory standards (ISO 10993 series and AAMI TIR No. 30).
The Sample Size for the Training Set:
- Not Applicable. This is a non-AI, mechanical device. There is no concept of a "training set." The device itself is manufactured based on engineering design.
How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set for a mechanical device, there is no ground truth to establish for it in this context.

Summary

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

May 27, 2016

PARI Respiratory Equipment, Inc. Michael Judge VP, Operations and Regulatory Affairs 2412 Pari Way Midlothian, Virginia 23112

Re: K150044

Trade/Device Name: PARI O-PEP Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: Undated Received: April 27, 2016

Dear Michael 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.

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 of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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): K150044

Device Name: PARI O-PEP

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)

Page __ of (Posted November 13, 2003)

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PARI O-PEP Oscillating Positive Expiratory Pressure Device 510(k) Submission 510(k) Summary

Submitter Information

Name:Address:	PARI Respiratory Equipment, Inc.2412 PARI WayMidlothian, VA 23112
Phone Number:	804-253-7274 x269
Fax Number:	804-253-0260
Contact Name:	Michael Judge
Date Prepared:	May 26, 2016
Device Name
Common Name:	O-PEP (Oscillating Positive Expiratory Pressure) Device

Trade Name: PARI O-PEP

Classification Name: Spirometer, Therapeutic (Incentive), 21 CFR 868.5690, Product Code BWF

Legally Marketed Predicate Device(s)

Manufacturer	Device	510(k) Number
Aptalis Pharma	Flutter D	K972859 (primary)
Bradstreet Clinical Research Assoc., Inc.	Flutter	K946083

Device Description

Medical Condition Treated

The PARI O-PEP is intended to help patients with respiratory conditions clear mucus and secretions from their airways.

Indications For Use

Technological Characteristics Compared to Predicate Device

The PARI O-PEP is substantially equivalent to the predicate devices Flutter and Flutter D. Table 1 below is a summary of the comparison.

Features	ProposedPARI O-PEP	Primary PredicateFlutter DK972859	Secondary PredicateFlutterK946083
Indications for use	The PARI O-PEP isintended for use as aPositive ExpiratoryPressure Device, and isdesigned to help patientsimprove secretion	The efficacy of the FlutterD as a mucus clearancedevice for cystic fibrosispatients is based on itsability to 1) vibrate theairways (which loosens	The Flutter providespositive expiratorypressure (PEP) therapyfor patients withmucus-producingrespiratory conditions,
Product Code andRegulation No.
Prescription Use	Rx Only	Rx Only	Rx Only
Environment of Use	Home, Hospital, Sub-acute Institutions	Not indicated	Not indicated
Patient Population	PediatricAdult	Patients with mucus-producing respiratoryconditions – agerestrictions not specified	Patients with mucus-producing respiratoryconditions – agerestrictions not specified
Contraindications	Pneumothorax, rightventricular insufficiency,coughing up blood andtuberculosis.	Pneumothorax, overtright-sided heart failure.	Pneumothorax, overtright-sided heartfailure.
Software driven	No	No	No
Materials in patientcontact	Rigid injection-moldedpolymer - POM.	Rigid injection-moldedpolymer	Rigid injection-moldedpolymer
Oscillationfrequency	Oscillation frequency of PARI O-PEP device is comparable to predicate Flutteracross a range of flow rates between 5 and 30 LPM.
Expiratoryresistance	Pressure level of PARI O-PEP device is comparable to predicate Flutter across arange of flow rates between 5 and 30 LPM.
Cleaning anddisinfection	Cleaning only, soap andwater.	N/A	Cleaning only, soapand water.

Table 1

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Discussion of Differences

The design and intended use of the subject and predicate devices are similar, since both sets are oscillating resistance devices for prescription use, and aid patients with mucus secretion through the airways via Positive Expiratory Pressure. Product codes and regulation numbers for the subject device and predicate devices differ; however, devices under both regulations are used to transmit vibrations through the patient's chest wall to aid in freeing mucus and improving ventilation. Performance testing demonstrates that the PARI O-PEP and predicate Flutter D devices were tested to compare oscillation frequency and expiratory resistance. Results demonstrate that the PARI O-PEP device produces comparable oscillation frequencies across a range of flow rates and pressure ranges.

Non-Clinical Test Summary

PARI O- PEP was tested to compare performance to the predicate Flutter device and satisfy applicable guidance, including:

Expiratory resistance: PARI O-PEP expiratory pressure level was compared to the predicate Flutter device across a range of flow rates between 5 and 30 LPM and angular positions of 0 and 30 degrees, and was found to be substantially equivalent to the predicate device for all variables.
. Oscillating frequency: PARI O-PEP oscillating frequency was compared to the predicate Flutter device across a range of flows between 5 and 30 LPM and angular positions of 0 and 30 degrees, and was found to be substantially equivalent to the predicate device for all variables.
. Biocompatibility: Testing demonstrates that the subject device meets requirements in accordance with: ISO 10993-1: Biological Evaluation of medical devices – Part 1: Evaluation and testing within a ■
- risk management process
- . ISO 10993-5: Biological Evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
. Cleaning efficacy validation: Testing demonstrates that the subject device meets requirements for cleaning of a reusable medical device in accordance with recognized guidelines, including:
- 트 AAMI TIR No. 30, 2011: A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices

Clinical Performance Summary

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

Conclusion

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicates have been found to be substantially equivalent.

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).