Proneb Max

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration". January 23, 2020 PARI Respiratory Equipment, Inc. Michael Judge VP. Regulatory 2412 PARI Way Midlothian, Virginia 23112 Re: K191270 Trade/Device Name: Proneb Max Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: December 20, 2019 Received: December 23, 2019 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, James J. Lee Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191270 Device Name Proneb Max Indications for Use (Describe) The PARI Proneb Max is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers with patients for whom doctors have prescribed medication. It is intended for adult and pediatric patients 2 years and older, and may be used in hospital-type facilities, nursing homes, sub-acute institutions and home environments. Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | |---------------------------------------------------------------------------------------| | <span style="font-family: Arial;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Summary: PRONEB MAX – K191270 – PARI Respiratory Equipment, Inc. #### 1. Submitter Michael Judge Name: Address: PARI Respiratory Equipment, Inc. 2412 Pari Way Midlothian, VA 23112 Phone: (804) 253-7274, ext. 269 Fax: (804) 253-0260 Email: mike.judge@pari.com #### 2. Device Name a. Name of Device: Proneb Max Common or Usual Name: Compressor Classification Name: Nebulizer, Direct Patient Interface (21 CFR 868.5630) Regulatory Class: II Product Code: CAF There are no other variants or model numbers of this device. #### Legally Marketed Predicate Device 3. Primary Predicate Device PARI Vios, K092918, Product Code CAF - Reference Device b. Proneb Ultra, K002862, Product Code BTI #### 4. Device Description The Proneb Max is a tabletop air compressor for use with jet nebulizers, which aerosolize liquid medications for inhalation by patients with respiratory diseases and conditions. The Proneb Max is to be used with adult and pediatric patients ages 2 years and older, and is intended for sale by prescription only. It may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments. It is provided non-sterile. The Proneb Max compressor creates an airflow that travels to the nebulizer through tubing. The nebulizer is attached to the compressor for its operation. The Proneb Max compressor is constructed of (1) Teflon; (2) ABS; (3) PBT GF30 and, has the following principal internal subcomponents: (1) cylinder/valve system; (2) piston rod/piston sealing: (3) a patient interface (on/off switch): (4) motor 120V/60Hz: (5) power cord/wire harness; and (6) hoses. Energy source for the device is provided by connection to a 120V/60 Hz mains power source. #### 5. Mechanism of Action The Proneb Max's mode of action is permanent, i.e., once the on/off switch on the compressor is pressed, the compressor generates compressed air for nebulization until the switch on the compressor is turned off. There is no additional functionality such as a pause function or output adjustment, or auto-shutoff. Nebulization is accomplished as follows: A PARI inhalation system consists of a PARI compressor (such as the subject device), and a PARI nebulizer with mouthpiece or optional accessories, e.g., a mask. The compressor functions as a source of compressed air for the nebulizer. The Proneb Max compressor is powered by a shaded pole, C-frame motor powered by 120V mains via an integrated power cord. This motor drives an oil-free, reciprocating piston pump which draws ambient air in and forces compressed air out of the compressor air outlet for use by a nebulizer cup. #### 6. Indications for Use The Proneb Max is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers with patients for whom doctors have prescribed medication for nebulization. It is intended for adult and pediatric patients 2 years and older, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments. {4}------------------------------------------------ ## Comparison of Technological Characteristics with the Predicate Device Table 1. Substantial Equivalence Comparison 7. | PRODUCT | Proneb Max | | | PARI Vios | | | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-----------| | DEVICE<br>CLASSIFICATION | CAF, Nebulizer (direct patient interface)<br>21 CFR 868.5630 | | | CAF, Nebulizer (direct patient interface)<br>21 CFR 868.5630 | | | | 510K NO. | K191270 | | | K092918 | | | | MANUFACTURER<br>(REG. NO.) | PARI Respiratory Equipment, Inc.<br>(2954963) | | | PARI Respiratory Equipment, Inc.<br>(2954963) | | | | INDICATIONS FOR USE | The Proneb Max is a tabletop, AC-<br>powered air compressor intended to<br>provide a source of compressed air for use<br>with jet nebulizers. It is intended for adult<br>and pediatric patients 2 years and older,<br>and may be used in hospitals, hospital-<br>type facilities, nursing homes, sub-acute<br>institutions and home environments. | | | The PARI Vios is a tabletop, AC powered<br>air compressor intended to provide a<br>source of compressed air for use with jet<br>nebulizers. The PARI Vios is intended for<br>adult and pediatric patients for use in<br>hospital, clinic, or home environments. | | | | Environment of use | Home care, nursing home, sub-acute<br>institution, or hospital | | | Hospital, Clinic, or home environments | | | | Target Population | Adult and pediatric patients 2 years and<br>older | | | Adult and pediatric patients | | | | Prescription Use | Rx Only | | | Rx Only | | | | METHOD OF OPERATION | | | | | | | | Technology Used | Piston-driven, oil-free, reciprocating air<br>compressor. AC powered, shaded pole<br>motor, polymer cylinder, Teflon piston<br>seal, ABS housing. | | | Piston-driven, oil-free, reciprocating air<br>compressor. AC powered, shaded pole<br>motor, polymer cylinder, Teflon piston<br>seal, ABS housing. | | | | Function | Provision of compressed air for use with<br>jet nebulizers. | | | Provision of compressed air for use with<br>jet nebulizers. | | | | PERFORMANCE | | | | | | | | | Proneb Max / LC Plus | | | Proneb Ultra / LC Plus | | | | | Atrovent | Sultanol | Pulmicort | Atrovent | Sultanol | Pulmicort | | Mean values<br>MMAD (µm) | 4.1 | 4.0 | 6.1 | 4.1 | 3.8 | 6.0 | | GSD (µm) | 2.2 | 2.2 | 1.8 | 2.2 | 2.2 | 1.8 | | Fine Particle<br>Fraction (%) | 58 | 59 | 35 | 58 | 61 | 36 | | Fine Particle<br>Dose (µg) | 121 | 712 | 122 | 125 | 710 | 127 | {5}------------------------------------------------ | PRODUCT | Proneb Max | PARI Vios | |----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------| | ELECTRICAL RATINGS | | | | Power Wattage | 98 W, under normal load | 80 W, under normal load | | AC Power Supply Input | 120 VAC / 60 Hz | 120 VAC / 60 Hz | | Classification According To<br>IEC 60601-1 | | | | Type of electric shock<br>protection | Protection Class II | Protection Class II | | Degree of protection from<br>electric shock of the part used<br>(nebulizer) | Type BF | Type BF | | Degree of protection<br>against water ingress in<br>accordance with EN 60529<br>(IP rating) | IP 21 | No protection | | Degree of protection when<br>used in the presence of<br>flammable mixtures of<br>anesthetics with air, with<br>oxygen, or with nitrous oxide | No protection | No protection | | Operating Mode | Continuous operation | Continuous operation | | MECHANICAL | | | | Dimensions<br>Compressor (L/W/H) | 7.28 x 5.1 x 5.9 in | 6.5 x 6.5 x 3.75 in. | | Weight (approx.) | 3.74 lb. | 3 lb. | | STERILIZATION | | | | | Does not require sterilization and is not<br>shipped as a sterile product | Does not require sterilization and is not<br>shipped as a sterile product | #### Proneb Max and Primary Predicate PARI Vios a. The Proneb Max and primary predicate PARI Vios are identical in purpose, function, core technology and energy source. That is, they are portable, single-patient use, compressors that generate compressed air for jet nebulize liquid medications. They are to be used with adult and pediatric patients for whom doctors have prescribed medication, i.e. they are for prescription use only. Note that the patient population is more clearly defined for the subject device. Energy source for the devices are provided by a connection to a mains power source, via power cord. The Proneb Max and the PARI Vios are technologically equivalent for the following reasons; (1) the performance of the jet nebulizer is dependent on the volumetric flow rate of the jet nozzle generated by the compressor. (2) The Proneb Max and PARI Vios have similar design and construction which consists of a 2-way valve, plastic cylinder, piston with Teflon seal, and an AC-powered shaded pole motor with mounting frame, all contained within an ABS housing. The technology and construction of the subject and predicate devices have no significant differences. #### b. Proneb Max and Proneb Ultra Reference Device The Proneb Max is intended to be PARI's successor product to its Proneb Ultra, currently branded as Vios Pro. Because Proneb Ultra was cleared under Product Code BTI, in this submission Proneb Ultra is listed as a reference device. Performance testing was conducted, comparing Proneb Ultra to the subject Proneb {6}------------------------------------------------ Max in support of the substantial equivalence claim. The Proneb Ultra reference device are both piston compressors with similar stroke volume and cycle frequency. (4) The Proneb Max and the Proneb Ultra are made of similar component materials and are driven by shaded pole motors of equivalent size and power range. Both the Proneb Max and the Proneb Ultra have identical compressor performance and intended usage. #### 8. Performance Data #### Gas Path Testing a. The emitted air quality of the Proneb Max was evaluated to determine whether it may produce potentially harmful gases, VOCs, or particulates, as follows: - 1) Ozone Gas Analysis - 2) Carbon Monoxide and Carbon Dioxide Gas Analysis - 3) ISO 18562-3, Volatile Organic Compounds Analysis* - 4) ISO 18562-2, EPA PM 2.5, Particular Matter Analysis *Note that VOC testing demonstrated emitted air quality using worst-case flow rates. The Proneb Max subject device met all acceptance criteria of the test. All air quality tests concluded that the subject device meets applicable standards. #### Electrical Safety and Electromagnetic Compatibility (EMC) b. Electrical safety and EMC testing were conducted on the Proneb Max compressor. Testing establishes that, with respect to electrical safety, the Proneb Max meets the applicable requirements of: { } } EC 60601-1; (2) IEC 60601-1-2; (3) IEC 60601-1-6; (4) IEC 60601-1-11;and (5) IEC 62366. ## NONCLINICAL PERFORMANCE TESTING Aerosol Characterization in accordance with FDA Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators and USP <1601>, as well as simulated use and mechanical testing was conducted as described below to demonstrate substantial equivalence. #### Aerosol Characterization C. Aerosol characterization (particle size distribution) by Next Generation Impactor was performed with the Proneb Max and the Proneb Ultra reference device, using PARI jet nebulizer cups. With respect to aerosol performance, with PARI jet nebulizer cups, the Proneb Max's: -MMAD (Mass Median Aerodynamic Diameter) is statistically equivalent to that of reference Proneb Ultra: -GSD (Geometric Standard Deviation) is statistically equivalent to that of the reference Proneb Ultra: -FPF (Fine Particle Fraction) is statistically equivalent to that of the reference Proneb Ultra; and, -FPD (Fine Particle Dose) is statistically equivalent to that of the reference Proneb Ultra. #### d. Simulated Use Test Testing was conducted to determine if the Proneb Max remained within specification over its stated useful life. The testing concluded that the device remained within the specifications stated in the IFU. #### e. Mechanical Testing #### 1) Packaging Drop Test A drop test was performed, based on ASTM D4169 (2016), DC 13, Assurance Level II to determine that the design and strength of the Proneb Max sales/transport packaging is sufficient for transport, storage and sales. The testing concluded that the packaging is satisfactory for the envisioned uses. #### 2) Environmental Conditions Test An environmental conditions test was conducted in order to define the device's optimal operating conditions of temperature and relative humidity for incorporation into the IFU. The testing established these environmental conditions. #### 9. Conclusion Based on the indications for use, technological characteristics, and performance of the device, we conclude that the Proneb Max is determined to be substantially equivalent to the predicate.