The Altera" Nebulizer System is intended specifically for the aerosolization of Cayston" (aztreonam for inhalation solution) using vibrating membrane technology. The device is intended for adult and pediatric patients who have been prescribed Cayston, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

Device Description

The Altera™ Nebulizer System (hereinafter referred to as "Altera") is a drug specific version of the FDA-cleared eFlow Electronic Nebulizer, originally cleared in 510k No. K033833, and as modified in Special 510K No. K072670.

Both the Altera and the predicate eFlow are identical in purpose, function, core technology, basic design, materials and method of operation. They are single-patient use, reusable electronic nebulizers that employ micro-perforated vibrating membrane technology to aerosolize liquid medications. They are for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution, or hospital environment. Both devices are hand-held and portable, consisting of a control, or base unit and a nebulizer handset, connected with a connection cord. Power input for both the Altera and the predicate eFlow is provided by either four AA batteries or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country.

However, unlike the predicate eFlow the Altera is drug-specific, intended for use only with aztreonam for inhalation solution.

AI/ML Overview

The provided text describes the Altera™ Nebulizer System, a medical device, and its testing to demonstrate substantial equivalence to predicate devices, rather than a study proving it meets specific acceptance criteria in the manner of a clinical trial for a new therapeutic or diagnostic device. The device is a nebulizer, and the testing focuses on its physical performance and safety characteristics.

Therefore, many of the requested categories like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable in this context. The "ground truth" here relates to engineering specifications and performance benchmarks compared to predicate devices.

Here's an adaptation of the requested table and information, focusing on the available details from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Benchmarked or Defined)	Reported Device Performance (Altera™ Nebulizer System)
Device Equivalence	Substantial equivalence to legally marketed predicate devices (eFlow Electronic Nebulizer, PARI LC Star Nebulizer, I-Neb AAD System) in purpose, function, core technology, basic design, materials, method of operation, and safety/effectiveness.	The Altera is identical in purpose, function, core technology, basic design, materials, and method of operation to the predicate eFlow, and similar in intended use (drug-specific) to the I-neb AAD® System. The FDA found the device "substantially equivalent" to predicate devices.
Simulated Lifetime Testing - Aerosol Head	Aerosol Heads 25, 30, 35, and 45 must meet "TOR and MMD specifications of the different head sizes" following simulated lifetime use.	Aerosol Heads 25, 30, 35, and 45 met TOR and MMD specifications following simulated lifetime use.
Validation of Cleaning and Disinfection Methods	Nebulizer must be cleaned and disinfected effectively by the methods stated in the Instructions For Use (IFU). This includes both manual and automated cleaning methods, and chemical/home sterilizer disinfection methods.	Microbiological efficiency control tests confirmed the nebulizer can be cleaned and disinfected effectively by the methods stated in the IFU.
Aerosol Characterization (Particle Size Distribution)	Altera's MMAD, MMD, and GSD should be identical with or lower than predicate devices (eFlow and LC Star). Altera's RF, TM, and RM should be identical with or greater than predicate devices (eFlow and LC Star).	The Altera's MMAD, MMD, and GSD are identical with or lower than the predicate eFlow and LC Star. The Altera's RF, TM, and RM are identical with or greater than the predicate eFlow and LC Star.
Drug-Specific Aerosol Performance (with aztreonam)	The Altera's aerosol performance characteristics using aztreonam for inhalation solution should be measured and compared to the established commercial delivery system (eFlow Model 678G1002). The data for this predicate is found in the AZLI New Drug Application (NDA) 50-814.	Aerosol performance characteristics using aztreonam for inhalation solution were measured with the Andersen Cascade Impactor (ACI) method and compared to eFlow Model 678G1002 data, appearing in AZLI NDA 50-814. (The document implies this comparison demonstrated acceptable performance, as a conclusion of substantial equivalence was reached).
Environmental Safety (Airpath Testing)	No environmental safety issues (e.g., volatile organic compounds (VOCs), emitted particulates, and CO/CO2/Ozone gases) should be present.	Airpath testing was conducted to ensure no environmental safety issues with VOCs, emitted particulates, and CO/CO2/Ozone gases. (The document implies acceptable results as a conclusion of substantial equivalence was reached).
EMC and Electrical Safety	The control unit must meet applicable requirements of: IEC 60601-1-2; CAN/CSA C22.2 NO 601.1-M90; UL 1431. It must also have been subjected to stress testing per IEC/EN/DIN EN 60068-2-3, 60068-2-6, 60068-2-14, 60068-2-29, and 60068-2-64.	EMC and electrical safety validations were not re-performed for this submission because the Altera's controller is identical to the one cleared in 510K No. K072670, which previously met these requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of patient data or clinical images. The testing described is primarily engineering and performance-based for the device itself.

Sample Size: Not applicable in the traditional sense of a clinical test set. The "samples" would be units of the nebulizer components (e.g., "Aerosol Heads 25, 30, 35 and 45" for lifetime testing) or laboratory measurements. The exact number of units tested is not provided.
Data Provenance: The data appears to come from internal testing conducted by PARI Respiratory Equipment, Inc. ("PARI conducted simulated lifetime testing," "PARI performed an aerosol characterization"). The AZLI New Drug Application (NDA) 50-814 and an eFlow Electronic Nebulizer product description provided reference data for the drug-specific testing, implying external or previously established data points for comparison. The country of origin for the testing itself is not explicitly stated, but PARI Respiratory Equipment, Inc. is based in Midlothian, Virginia, suggesting US-based operations. The testing is retrospective in the sense that it relies on established engineering principles and comparisons to existing, cleared devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. "Ground truth" in this context is based on:

Established engineering specifications (e.g., TOR, MMD, GSD, RF, TM, RM values).
Microbiological testing standards for cleaning/disinfection efficacy.
Environmental safety standards for airpath testing (VOCs, particulates, gases).
International and national electrical and electromagnetic compatibility (EMC) safety standards (e.g., IEC 60601-1-2, UL 1431).
Performance data of legally marketed predicate devices and drug-specific NDA data.

These "ground truths" are objective measurements against regulatory and technical benchmarks, not subjective expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The testing methods described are objective and quantitative (e.g., cascade impaction, laser light scattering, microbiological efficiency control tests). They do not involve human interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where different human readers interpret medical images or data, and their performance is compared with and without AI assistance. The Altera™ Nebulizer System is a therapeutic device for drug delivery, not a diagnostic imaging or data interpretation system.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, in a sense, a "standalone" performance assessment of the device's physical and technical characteristics was done. The evaluations (simulated lifetime, cleaning validation, aerosol characterization, airpath testing, electrical/EMC safety) describe the device's inherent performance according to its design, independent of human interaction beyond basic operation according to IFU. There is no "algorithm" in the AI sense for which to measure standalone performance.

7. The Type of Ground Truth Used

The ground truth used for the Altera™ Nebulizer System is a combination of:

Engineering Specifications/Industry Standards: For properties like particle size distribution (MMAD, MMD, GSD, RF, TM, RM), device lifetime, and electrical/EMC safety.
Regulatory Standards: For cleaning/disinfection efficacy (microbiological efficiency).
Predicate Device Performance Data: Performance benchmarks derived from previously cleared devices (eFlow, LC Star, I-neb AAD System).
Existing Drug Application Data: Specific aerosol performance characteristics for aztreonam solution were benchmarked against data from AZLI New Drug Application (NDA) 50-814, which served as the "ground truth" for drug delivery efficacy.

8. The Sample Size for the Training Set

Not applicable. The Altera™ Nebulizer System is a mechanical/electronic device, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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K00380

SECTION 5: 510(K) SUMMARY

1. Submitter Information

Name:	PARI Respiratory Equipment, Inc	FEB 2 2 2010
Address:	2943 Oak Lake BoulevardMidlothian, Virginia 23112-3998
Phone:	804-253-7274 x810
FAX:	804-639-7244
Contact Name:	James L. McIntire Jr.
Date Prepared:	February 9, 2010
Device Name:
Common Name:	Nebulizer
Proprietary Name:	Altera™ Nebulizer System
Classification Name:	Nebulizer (Direct Patient Interface)
Regulation No.:	868.5630
Class:	Class II
Panel:	Anesthesiology
Product Code:	CAE

3. Device Description

However, unlike the predicate eFlow the Altera is drug-specific, intended for use only with aztreonam for inhalation solution.

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4. Intended Use

The Altera™ Nebulizer System is intended specifically for the aerosolization of Cavston™ (aztreonam for inhalation solution) using vibrating membrane technology. The device is intended for adult and pediatric patients who have been prescribed Cayston, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments..

5. Legally Marketed Predicate Devices

Manufacturer	Device	510(k) Number
PARI Innovative Manufacturers, Inc	eFlow Electronic Nebulizer	K033833,K072670
PARI Innovative Manufacturers, Inc	PARI LC Star Nebulizer	K963924
Respironics® Inc.	I-Neb AAD System	K042991

6. Technological Characteristics Compared to Predicate Devices

The Altera, eFlow, LC Star and I-NEB AAD System are all nebulizers used to aerosolize medication for inhalation.

Altera and the predicate eFlow both use micro-perforated vibrating membrane technology to generate the aerosol. The predicate LC Star is a compressor-driven jet nebulizer, while the predicate I-neb® AAD® System uses vibrating mesh technology to generate its aerosol.

The Altera and the predicate I-neb AAD® System have similar intended uses in the restrictive application of the devices to medications that are specifically approved for them.

The Altera and eFlow make use of identical materials and design for the nebulizer, as compared to the LC Star, and also use a similar two valve system to provide breath enhanced aerosol delivery.

7. Summary of Performance Testing

Simulated Lifetime Testing - Aerosol Head થ.

PARI conducted simulated lifetime testing of the series' Aerosol Heads 25, 30, 35 and 45. The results of the testing were that Aerosol Heads 25, 30, 35 and 45 met TOR and MMD specifications of the different head sizes following a simulated lifetime use.

Simulated Lifetime Testing - Validation of Cleaning and Disinfection Methods b.

Microbiological efficiency control tests were conducted in order to validate the nebulizer cleaning and disinfection methods in the IFU. Testing involved validation of both manual and automated cleaning methods, and a chemical disinfectant as well as a home sterilizer disinfection method. The testing concluded that the nebulizer can be cleaned and disinfected effectively by use of the methods stated in the IFU.

Aerosol Characterization Testing c.

PARI performed an aerosol characterization (particle size distribution) of the Altera in comparison with the predicate devices eFlow and LC Star. Testing was done by two

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methods: cascade impaction (Eight-Stage Anderson Cascade Impactor) and laser light scattering (Malvern MastersizerX). With respect to aerosol performance the Altera's MMAD. MMD and GSD is identical with or lower than the predicates eFlow and LC Star. The Altera's RF, TM and RM identical with or greater than the predicates eFlow and LC Star.

Drug-Specific Testing d.

The Altera's aerosol performance characteristics using aztreonam for inhalation solution were measured with the Andersen Cascade Impactor (ACI) method of eFlow Model 678G1002 as the aztreonam for inhalation solution commercial delivery system. These data appear in the AZLI New Drug Application (NDA) 50-814, and in 000,6004,PDR,01,02 eFlow® Electronic Nebulizer USA Model 678G 1002 "Product Description, Comparability Analysis with eFlow Model 78G 1004, and Discussion Regarding use as the Aztreonam Lysine for Inhalation

Airpath Testing e.

Although Altera is not compressor-driven, airpath testing was nonetheless conducted to ensure there are no environmental safety issues with the series involving volatile organic compounds (VOCs), emitted particulates and CO/CO2/Ozone gases.

EMC and electrical safety validations were not performed for this submission because the Altera's controller is identical to that cleared in 510K No. K072670. Previous testing established that, with respect to EMC and electrical safety in their intended operational environment, the control unit met the applicable requirements of: IEC 60601-1-2; CAN/CSA C22.2 NO 601.1-M90, and; UL 1431. Further, they have been subjected to IEC/EN/DIN EN 60068-2-3, 60068-2-6, 60068-2-14, 60068-2-29, and 60068-2-64 with respect to stress testing.

8. Conclusion

Based upon the above information the Altera Nebulizer System is substantially equivalent to the predicate devices, and raises no new issues of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of a caduceus, a symbol often associated with medicine and healthcare.

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

Mr. James L. McIntire Jr. eFlow Regulatory PARI Respiratory Equipment, Incorporated 2943 Oak Lake Boulevard Midlothian, Virginia 23112

Re: K100380

Trade/Device Name: Altera™ Nebulizer System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 9, 2010 Received: February 16, 2010

FEB 2 2 2010

Dear Mr. McIntire:

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. McIntire

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 yours.

Anthom U.S.m

Anthony D. Watson, B.S., M.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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Altera™ Nebulizer System

Indications For Use: The Altera" Nebulizer System is intended specifically for the aerosolization of Cayston" (aztreonam for inhalation solution) using vibrating membrane technology. The device is intended for adult and pediatric patients who have been prescribed Cayston, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.

L. Schulte

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: 400380

Image /page/5/Picture/7 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Part 21 CFR 801 Subpart D)" in a smaller font. There is a large "X" above a line to the right of the words "Prescription Use". The text indicates that the image is related to prescription drug regulations.

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 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).