(259 days)
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.
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.
The PARI Sinus 510(k) submission primarily relies on non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria in the traditional sense of a diagnostic or therapeutic efficacy study. Therefore, the "acceptance criteria" here refer to parity with predicate device performance in key engineering metrics, and the "study" is a series of non-clinical tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Predicate Device Performance Description | PARI Sinus Reported Performance |
|---|---|---|
| MMAD (Mass Median Aerodynamic Diameter) | Not explicitly stated, implied to be within acceptable range. Comparable to predicate devices. | "PARI Sinus is comparable to the predicate devices." |
| Total Mass (Aerosolized Drug Output) | Not explicitly stated, implied to be within acceptable range. Comparable to predicate devices. | "PARI Sinus is comparable to the predicate devices." |
| Vibrating Pressure Amplitude | "Acapella predicate both generate comparable low-amplitude vibrating pressure." | "PARI Sinus is comparable to the predicate devices." |
| Aerosolization Method | "reusable, air compressor-driven jet nebulizers which use the same method of aerosolization." | "reusable, air compressor-driven jet nebulizers which use the same method of aerosolization." |
| Compressor Type | "Proneb Ultra compressor are both piston-driven, oil-less air compressors powered by shaded pole AC motors." | "piston-driven, oil-less air compressors powered by shaded pole AC motors." |
| Operating Pressure | "produce comparable operating pressure." | "produce comparable operating pressure." |
| Drug/Air Path Materials | "similar to the predicate LC Sprint device." | "similar to the predicate LC Sprint device." |
Important Note: The acceptance criteria are implicitly defined as "comparable" to the predicate devices' performance, without specific numerical thresholds being provided in this summary. This is common for 510(k) submissions demonstrating substantial equivalence for devices of this nature.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of human subjects or distinct data samples for a clinical test set. The "test set" here refers to the device itself being tested in a lab setting.
- Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory environment, likely by the manufacturer, PARI Respiratory Equipment, Inc. No information on country of origin of data in a human context, or retrospective/prospective status is relevant here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This submission solely reports on non-clinical engineering and performance characteristics. There is no human interpretative element or "ground truth" established by experts in the context of clinical outcomes or images.
4. Adjudication Method for the Test Set
- Not Applicable. As there is no human interpretation or subjective assessment involved, an adjudication method for a test set is irrelevant for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. A MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not completed/is not required to show substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is a nebulizer system, not a software algorithm or AI-powered diagnostic tool. The concept of "standalone performance" for an algorithm is not relevant here.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Methods: The "ground truth" for the non-clinical tests would have been established by comparing the PARI Sinus's performance against industry standards, internal specifications, and the known performance metrics of the predicate devices. For example, MMAD is measured using established aerosol science methods.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not a machine learning model. There is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an algorithm, this question is not relevant.
In summary, the PARI Sinus 510(k) relies on demonstrating engineering comparability through non-clinical testing to legally marketed predicate devices, negating the need for clinical studies with human subjects or AI-specific evaluation metrics.
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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.
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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.
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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
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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)
§ 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).