(259 days)
Not Found
No
The description focuses on the mechanical aspects of aerosol delivery (compressor, nebulizer, vibration) and does not mention any computational or data-driven features indicative of AI/ML.
Yes
The device is described as an "aerosol therapy device for delivery of prescribed medications to the upper airway," directly indicating its use in therapy.
No
The device is described as a compressor nebulizer system designed to aerosolize and deliver medication, not to diagnose conditions. Its intended use is for therapy, not diagnosis.
No
The device description clearly states it is a "compressor nebulizer system" and a "reusable aerosol therapy device," indicating it is a hardware device that aerosolizes medication.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aerosolize medication approved for nebulization and prescribed by a physician for delivery to the upper airways." This describes a therapeutic device used to deliver medication, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the mechanism of delivering aerosolized medication (aerosol flow and vibration) to the upper airway. It does not mention any analysis of biological samples.
- Lack of IVD Keywords: The document does not contain keywords typically associated with IVD devices, such as "specimen," "sample," "assay," "analyte," "diagnosis," "monitoring," or "screening."
- Performance Studies: The performance studies described focus on the physical characteristics of the aerosol delivery (MMAD, Total Mass, Vibrating pressure amplitude), which are relevant to a drug delivery device, not an IVD.
In summary, the PARI Sinus is a therapeutic device for delivering medication to the upper airways, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The PARI Sinus is a compressor nebulizer system, designed to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the upper airways. The PARI Sinus is intended for adult and pediatric patients consistent with the indications for aerosol medication, in homes, hospitals, and sub-acute institutions.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The PARI Sinus is a single patient use, reusable aerosol therapy device for delivery of prescribed medications to the upper airway. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments. The PARI Sinus utilizes a combination of aerosol flow and vibration to effectively deliver aerosolized medications to the upper airway.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper airways
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
homes, hospitals, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Summary: PARI Sinus was tested to compare performance to the predicate devices, including: MMAD: PARI Sinus is comparable to the predicate devices. . Total Mass: PARI Sinus is comparable to the predicate devices. Vibrating pressure amplitude: PARI Sinus 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 Sinus meets performance requirements and raises no new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061381, K002768, K002862, K060399
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
PARI Sinus 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: | August 18, 2009 |
MAY - 6 2010
Device Name
| Common Name: | Nebulizer |
|---|---|
| Trade Name: | PARI Sinus |
| Classification Name: | Nebulizer (Direct Patient Interface), §868.5630, Product Code CA |
Legally Marketed Predicate Device(s)
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| PARI Respiratory Equipment, Inc. | LC Star with Nasal Adapter | K061381 |
| DHD Healthcare Corp. | Acapella | K002768 |
| PARI Respiratory Equipment, Inc. | Proneb Ultra | K002862 |
| PARI Respiratory Equipment, Inc. | LC Sprint | K060399 |
Device Description
The PARI Sinus is a single patient use, reusable aerosol therapy device for delivery of prescribed medications to the upper airway. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments. The PARI Sinus utilizes a combination of aerosol flow and vibration to effectively deliver aerosolized medications to the upper airway.
Indications For Use
The PARI Sinus is a compressor nebulizer system, designed to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the upper airways. The PARI Sinus is intended for adult and pediatric patients consistent with the indications for aerosol medication, in homes, hospitals, and sub-acute institutions.
Technological Characteristics Compared to Predicate Devices
The PARI Sinus, LC Sprint, and LC Star with Nasal Adapter are reusable, air compressor-driven jet nebulizers which use the same method of aerosolization. The PARI Sinus compressor and the Proneb Ultra compressor are both piston-driven, oil-less air compressors powered by shaded pole AC motors, and produce comparable operating pressure. The PARI Sinus system and the Acapella predicate both generate comparable low-amplitude vibrating pressure which is applied to the upper airways.
The PARI Sinus uses drug/air path materials that are similar to the predicate LC Sprint device.
Non-Clinical Test Summary
PARI Sinus was tested to compare performance to the predicate devices, including:
- MMAD: PARI Sinus is comparable to the predicate devices. .
- . Total Mass: PARI Sinus is comparable to the predicate devices
- . Vibrating pressure amplitude: PARI Sinus 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 Sinus meets performance requirements and raises no new issues of safety or effectiveness.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael Judge Director, QA/RA PARI Respiratory Equipment, Incorporated 2943 Oak Lake Boulevard Midlothian, Virginia 23112
Re: K092560 Trade/Device Name: PARI Sinus Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: April 26, 2010 Received: April 30, 2010
MAY - 6 2010
Dear Mr. 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.
2
Page 2- Mr. Michael 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 vours.
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
3
Indications for Use
510(k) Number (if known): N/A
Device Name: PARI Sinus
Indications for Use:
The PARI Sinus is a compressor nebulizer system, designed to aerosolize medication approved for nebulization and prescribed by a physician for delivery to the upper airways. The PARI Sinus is intended for adult and pediatric patients consistent with the indications for aerosol medication, in homes, hospitals, and sub-acute institutions.
Prescription Use ΧΧΧ (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. Schulten
(Division Sign-Off) (Division Sign-con)
Division of Anesthesiology, General Hospital
Povision of Anest Beatel Devices Division Control, Dental Devices
510(k) Number: K092560
Page of (Posted November 13, 2003)