(501 days)
Not Found
No
The device description and performance studies focus on mechanical properties and comparisons to a predicate device, with no mention of AI or ML.
Yes
The device is intended to help patients improve secretion clearance, mobilize secretions or mucous, strengthen the respiratory tract, and alleviate shortness of breath, which are therapeutic benefits.
No
The device is described as a therapy device designed to mobilize secretions and strengthen the respiratory tract, not to diagnose a condition.
No
The device description clearly states it is a "small, single patient use, reusable oscillating PEP therapy device" that the patient exhales into, causing a vibration. This describes a physical hardware device, not software.
Based on the provided information, the PARI O-PEP is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a Positive Expiratory Pressure Device designed to help patients improve secretion clearance. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details how the device works by creating vibrations during exhalation to mobilize secretions. This is a physical therapy mechanism, not a method for analyzing biological samples.
- No mention of biological samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue). The PARI O-PEP interacts directly with the patient's respiratory system during breathing.
- No mention of diagnostic testing: The purpose is to treat a condition (secretion clearance), not to diagnose a disease or condition.
Therefore, the PARI O-PEP falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
BWF
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.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
lower respiratory tract, lungs, airways
Indicated Patient Age Range
adult and pediatric patients ages 5 and older
Intended User / Care Setting
home, hospital, and sub-acute institutions.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Test Summary:
- 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: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of a caduceus-like symbol with three figures representing health and human services. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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.
1
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
2
Indications for Use
510(k) Number (if known): K150044
Device Name: PARI O-PEP
Indications for Use:
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.
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)
3
PARI O-PEP Oscillating Positive Expiratory Pressure Device 510(k) Submission 510(k) Summary
Submitter Information
| Name:
Address: | PARI Respiratory Equipment, Inc.
2412 PARI Way
Midlothian, 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
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.
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
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.
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 | Proposed
PARI O-PEP | Primary Predicate
Flutter D
K972859 | Secondary Predicate
Flutter
K946083 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The PARI O-PEP is
intended for use as a
Positive Expiratory
Pressure Device, and is
designed to help patients
improve secretion | The efficacy of the Flutter
D as a mucus clearance
device for cystic fibrosis
patients is based on its
ability to 1) vibrate the
airways (which loosens | The Flutter provides
positive expiratory
pressure (PEP) therapy
for patients with
mucus-producing
respiratory conditions, |
| Product Code and
Regulation No. | | | |
| Prescription Use | Rx Only | Rx Only | Rx Only |
| Environment of Use | Home, Hospital, Sub-
acute Institutions | Not indicated | Not indicated |
| Patient Population | Pediatric
Adult | Patients with mucus-
producing respiratory
conditions – age
restrictions not specified | Patients with mucus-
producing respiratory
conditions – age
restrictions not specified |
| Contraindications | Pneumothorax, right
ventricular insufficiency,
coughing up blood and
tuberculosis. | Pneumothorax, overt
right-sided heart failure. | Pneumothorax, overt
right-sided heart
failure. |
| Software driven | No | No | No |
| Materials in patient
contact | Rigid injection-molded
polymer - POM. | Rigid injection-molded
polymer | Rigid injection-molded
polymer |
| Oscillation
frequency | Oscillation frequency of PARI O-PEP device is comparable to predicate Flutter
across a range of flow rates between 5 and 30 LPM. | | |
| Expiratory
resistance | Pressure level of PARI O-PEP device is comparable to predicate Flutter across a
range of flow rates between 5 and 30 LPM. | | |
| Cleaning and
disinfection | Cleaning only, soap and
water. | N/A | Cleaning only, soap
and water. |
Table 1
4
5
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.