(160 days)
This device is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing. The patient population includes adults, pediatrics, and infants that are spontaneously breathing. The product is a prescriptive device intended to be used in hospital setting.
Pneumatic jet nebulizer that aerosolizes medication by driving a high pressure gas through the jet stem across the one piece jet immersed in the solution.
The provided text describes the safety and effectiveness summary for the CareFusion AirLife Small Volume Nebulizer (K123527). This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail values. Instead, it presents performance data for "Aerosol Characterization" across various parameters for three common aerosolized medications (Albuterol Sulfate, Budesonide Suspension, and Cromolyn Sodium) at different flow rates. The implied acceptance is that these values demonstrate substantial equivalence to the predicate devices and are suitable for the intended use. The performance data is detailed in the table below:
| Drug Description | Aerosol Characteristic | Recommended Nebulizer Set Flow Rate 8 ± 1 LPM (Tested at 7 LPM) | Recommended Nebulizer Set Flow Rate 8 ± 1 LPM (Tested at 8 LPM) | Recommended Nebulizer Set Flow Rate 8 ± 1 LPM (Tested at 9 LPM) |
|---|---|---|---|---|
| Albuterol Sulfate (2.5 mg/3 ml or 2500 µg) | MMAD (µm)2 | 4.5 ± 0.1 µ | 3.8 ± 0.1 µ | 3.5 ± 0.1 µ |
| GSD3 | 2.1 ± 0.04 | 2.1 ± 0.02 | 2.1 ± 0.05 | |
| Extra-fine particles (< 1 µm)4 | 5.9 ± 0.3% (67 ± 5 µg) | 7.1 ± 0.3% (75 ± 2 µg) | 7.6 ± 0.4% (74 ± 4 µg) | |
| Fine particles (< 5 µm)4 | 52 ± 2% (582 ± 27 µg) | 59 ± 1% (626 ± 12 µg) | 64 ± 2% (619 ± 24 µg) | |
| Coarse particles (> 5 µm)4 | 48 ± 2% (547 ± 31 µg) | 41 ± 1% (438 ± 23 µg) | 36 ± 2% (354 ± 17 µg) | |
| Respirable particles (1-5 µm)4 | 46 ± 2% (515 ± 24 µg) | 52 ± 1% (551 ± 12 µg) | 56 ± 2% (545 ± 23 µg) | |
| Total mass of drug (in nebulizer)5 | 2500 µg | 2500 µg | 2500 µg | |
| Total Delivered Mass of Aerosol6 | 45 ± 2% (1129 ± 38 µg) | 42 ± 1% (1064 ± 25 µg) | 39 ± 1% (973 ± 23 µg) | |
| Average Treatment Time (minutes)7 | 3.4 ± 0.1 | 3.0 ± 0.1 | 2.7 ± 0.1 | |
| Budesonide Suspension (0.50 mg/2 ml or 500 µg) | MMAD (µm)2 | 5.6 ± 0.1 µ | 5.1 ± 0.1 µ | 4.7 ± 0.2 µ |
| GSD3 | 1.9 ± 0.03 | 1.9 ± 0.04 | 1.9 ± 0.1 | |
| Extra-fine particles (< 1 µm)4 | 4.8 ± 1.6% (11 ± 4 µg) | 4.7 ± 0.6% (9.4 ± 1.1 µg) | 7.0 ± 1.1% (13 ± 2 µg) | |
| Fine particles (< 5 µm)4 | 39 ± 2% (87 ± 6 µg) | 45 ± 2% (92 ± 2 µg) | 50 ± 3% (93 ± 3 µg) | |
| Coarse particles (> 5 µm)4 | 61 ± 2% (134 ± 10 µg) | 55 ± 2% (112 ± 8 µg) | 50 ± 3% (95 ± 8 µg) | |
| Respirable particles (1-5 µm)4 | 35 ± 2% (78 ± 6 µg) | 41 ± 1% (83 ± 2 µg) | 43 ± 2% (80 ± 23 µg) | |
| Total mass of drug (in nebulizer)5 | 500 µg | 500 µg | 500 µg | |
| Total Delivered Mass of Aerosol6 | 44 ± 2% (222 ± 14 µg) | 41 ± 2% (205 ± 9 µg) | 38 ± 1% (188 ± 7 µg) | |
| Average Treatment Time (minutes)7 | 1.9 ± 0.1 | 1.9 ± 0.1 | 1.7 ± 0.1 | |
| Cromolyn Sodium (20 mg/2 ml or 20000 µg) | MMAD (µm)2 | 4.7 ± 0.2 µ | 3.9 ± 0.1 µ | 3.5 ± 0.1 µ |
| GSD3 | 2.0 ± 0.02 | 2.0 ± 0.02 | 2.0 ± 0.02 | |
| Extra-fine particles (< 1 µm)4 | 9.7 ± 1% (617 ± 57 µg) | 11 ± 1% (648 ± 31 µg) | 13 ± 1% (675 ± 49 µg) | |
| Fine particles (< 5 µm)4 | 50 ± 2% (3170 ± 180 µg) | 58 ± 1% (3320 ± 150 µg) | 64 ± 3% (3310 ± 220 µg) | |
| Coarse particles (> 5 µm)4 | 50 ± 2% (3220 ± 290 µg) | 42 ± 1% (2360 ± 140 µg) | 36 ± 3% (1900 ± 250 µg) | |
| Respirable particles (1-5 µm)4 | 40 ± 1% (2550 ± 150 µg) | 47 ± 1% (2660 ± 120 µg) | 51 ± 2% (2640 ± 190 µg) | |
| Total mass of drug (in nebulizer)5 | 20000 µg | 20000 µg | 20000 µg | |
| Total Delivered Mass of Aerosol6 | 32 ± 2% (6380 ± 390 µg) | 28 ± 2% (5680 ± 240 µg) | 26 ± 2% (5220 ± 400 µg) | |
| Average Treatment Time (minutes)7 | 3.1 ± 0.1 | 1.7 ± 0.1 | 1.6 ± 0.1 |
Study Proving Device Meets Criteria:
The study demonstrating the device meets the criteria is a "Performance Test Summary" presented in the document, specifically focusing on Biocompatibility, Simulated Life-Time, and Aerosol Characterization.
- Biocompatibility: Performed according to ISO 10993-1. "Cytotoxicity, Sensitization and Irritation studies were concluded with satisfactory results."
- Simulated Life-Time: "No performance degradation was observed for at least 50 treatments."
- Aerosol Characterization: This was the primary performance test, using a Cascade Impactor (NGI) per USP 34 <1601> chilled to 5 °C with an extraction flow of 15 lpm for three common aerosolized medications. The results are detailed in the table above and described as showing the device "meets all performance requirements, and is substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not explicitly state the sample size (number of nebulizers tested) for the aerosol characterization or simulated lifetime tests. The values provided are "Mean and 95% confidence interval of the mean," which implies multiple measurements were taken, but the exact N is not given.
- Data Provenance: The document does not specify the country of origin of the data. The tests are non-clinical (laboratory-based) and are likely performed in-house or by a contracted lab. The study is prospective in the sense that the tests were conducted specifically for this submission to assess the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable for this type of device and study. The "ground truth" for the performance tests (biocompatibility, simulated lifetime, aerosol characterization) is based on established scientific methods, standards (e.g., ISO 10993-1, USP 34 <1601>), and laboratory measurements, not on expert consensus from medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the study did not involve human interpretation or adjudication of results in the traditional sense of clinical studies. Performance metrics were derived from physical measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. This was a non-clinical performance study of a medical device (nebulizer), not an AI diagnostic or assistive device. Therefore, no MRMC study, human reader improvement, or AI assistance was involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in essence. The performance tests conducted (biocompatibility, simulated lifetime, aerosol characterization) are standalone evaluations of the device's physical and functional properties, independent of human interaction or interpretation beyond performing the tests according to established protocols. There is no "algorithm" in the sense of AI here, but the device's performance was assessed directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance testing is based on objective physical measurements and adherence to recognized standards and protocols. For example:
- Biocompatibility: Conformance to ISO 10993-1.
- Aerosol Characterization: Data obtained using a Cascade Impactor (NGI) per USP 34 <1601>, which is a direct measurement method for particle size distribution and drug delivery.
8. The sample size for the training set:
Not applicable. This study does not involve a "training set" as it is not a machine learning or AI model development. It's a physical device being evaluated for performance against established standards.
9. How the ground truth for the training set was established:
Not applicable for the same reason as point 8.
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K 123527
Image /page/0/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a circular emblem on the left and the word "CareFusion" on the right. The emblem contains a stylized image of two figures embracing within a shield-like shape.
ک(۵ (κ) Summary of Safety and Effectiveness
APR 2 5 2013
Summary of 510(k) safety and effectiveness in accordance with 21 CFR 807.92.
SUBMITTER INFORMATION
| Name | CareFusion | ||||
|---|---|---|---|---|---|
| Address | 1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA | ||||
| Phone number | (847) 473-7208 | ||||
| Fax number | (847) 473-7774 | ||||
| EstablishmentRegistration Number | 8030673 | ||||
| Name of contact person | Erika Fernandez | ||||
| Date prepared | November 14, 2012 |
NAME OF DEVICE
| Trade or proprietary name | AirLife Small Volume Nebulizer |
|---|---|
| Common or usual name | Small Volume Nebulizer |
| Classification name | Nebulizer |
| Classification panel | 73 Anesthesiology |
| Regulation | Class II per 21CFR §868.5630, Product code CAF |
| Legally marketed device(s) to which equivalence is claimed | K023602: AirLife Misty Max 10 NebulizerK962879: NebuTech HDN |
| Device description | Pneumatic jet nebulizer that aerosolizes medication by driving ahigh pressure gas through the jet stem across the one piece jetimmersed in the solution. |
| Intended use | This device is intended to be used to aerosolize liquid medicationinto gases that are delivered directly to the patient for breathing.The patient population includes adults, pediatrics, and infantsthat are spontaneously breathing. The product is a prescriptivedevice intended to be used in a hospital setting. |
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Image /page/1/Picture/0 description: The image shows the logo for CareFusion. The logo consists of a circular icon on the left and the word "CareFusion" on the right. The icon contains a stylized image of a shield with a heart inside of it.
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THEPREDICATE DEVICE | ||
|---|---|---|
| Proposed Device | Predicate Device | |
| Intended Use | This device is intended to be usedto aerosolize liquid medication intogases that are delivered directly tothe patient for breathing.The patient population includesadults, pediatrics, and infants thatare spontaneously breathing. | This device is intended to be used tospray liquids in aerosol form intogases that are delivered directly to thepatient for breathing. Its use isindicated whenever a physician orhealthcare professional administers orprescribes medical aerosol products toa patient using a Misty Max 10nebulizer. This product is a singlepatient use, non-sterile prescriptivedevice and is designed to be used ineither a hospital or homecareenvironment. |
| Indications for Use | This device is intended to be usedto aerosolize liquid medication intogases that are delivered directly tothe patient for breathing. Its use isindicated when a licensedhealthcare professional prescribesor administers medical aerosols toa patient using a small volumenebulizer. The patient populationincludes adults, pediatrics, andinfants that are spontaneouslybreathing. The product is a single-patient; non-sterile, disposable,prescriptive device intended to beused in hospital setting. | The AirLife Misty Nebulizer is apneumatic nebulizer which nebulizesspecific drugs for inhalation by apatient. The patient populationincludes infant, pediatric and adultpatients. Its use is indicated whenevera physician or healthcare professionaladminister or prescribes medicalaerosol products to a patient using asmall volume nebulizer. This productis a single patient use, non-sterileprescriptive device and is designed tobe used in either a hospital orhomecare environment. |
| Patient Population | adult, pediatric, infant | Same |
| Type of Device | DisposableNon-SterileSingle-Patient Use | Same |
| Core Technology | Pneumatic Jet | Same |
| Type of Gas Source | Compressed Air or Oxygen | Same |
| Nebulizer drive flow rates (LPM) | $8 \pm 1$ LPM | 6-10 LPM |
| Maximum Fill Capacity (mL) | 10 mL | Same |
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Performance Data
Summary of non-clinical tests conducted for determination of substantial equivalence
Performance Test Summary
1. Biocompatibility
.
.
Biocompatibility tests on the finished product were performed according to ISO 10993-1. Cytotoxicity, Sensitization and Irritation studies were concluded with satisfactory results.
2. Simulated Life-Time
No performance degradation was observed for at least 50 treatments
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| Drug Description | Aerosol Characteristic | Recommended Nebulizer Set Flow Rate 8 ± 1 LPM | ||
|---|---|---|---|---|
| 7 LPM | 8 LPM | 9 LPM | ||
| Albuterol Sulfate(AdrenergicBronchodilator,Beta-2agonist).Typical dose2.5 mg/3 ml(0.083% byvolume) or 2500 µgof drugsubstance. | MMAD (µm)2 | 4.5 ± 0.1 µ | 3.8 ± 0.1 µ | 3.5 ± 0.1 µ |
| GSD3 | 2.1 ± 0.04 | 2.1 ± 0.02 | 2.1 ± 0.05 | |
| Extra-fine particles (< 1 µm)4 | 5.9 ± 0.3%67 ± 5 µg | 7.1 ± 0.3%75 ± 2 µg | 7.6 ± 0.4%74 ± 4 µg | |
| Fine particles (< 5 µm)4 | 52 ± 2%582 ± 27 µg | 59 ± 1%626 ± 12 µg | 64 ± 2%619 ± 24 µg | |
| Coarse particles (> 5 µm)4 | 48 ± 2%547 ± 31 µg | 41 ± 1%438 ± 23 µg | 36 ± 2%354 ± 17 µg | |
| Respirable particles (1-5 µm)4 | 46 ± 2%515 ± 24 µg | 52 ± 1%551 ± 12 µg | 56 ± 2%545 ± 23 µg | |
| Total mass of drug (in nebulizer)5 | 2500 µg | 2500 µg | 2500 µg | |
| Total Delivered Mass of Aerosol6 | 45 ± 2%1129 ± 38 µg | 42 ± 1%1064 ± 25 µg | 39 ± 1%973 ± 23 µg | |
| Average Treatment Time (minutes)7 | 3.4 ± 0.1 | 3.0 ± 0.1 | 2.7 ± 0.1 | |
| BudesonideSuspension(Corticosteroid).Typical dose0.50 mg/2 ml or500 µg of drugsubstance. | MMAD (µm)2 | 5.6 ± 0.1 µ | 5.1 ± 0.1 µ | 4.7 ± 0.2 µ |
| GSD3 | 1.9 ± 0.03 | 1.9 ± 0.04 | 1.9 ± 0.1 | |
| Extra-fine particles (< 1 µm)4 | 4.8 ± 1.6%11 ± 4 µg | 4.7 ± 0.6%9.4 ± 1.1 µg | 7.0 ± 1.1%13 ± 2 µg | |
| Fine particles (< 5 µm)4 | 39 ± 2%87 ± 6 µg | 45 ± 2%92 ± 2 µg | 50 ± 3%93 ± 3 µg | |
| Coarse particles (> 5 µm)4 | 61 ± 2%134 ± 10 µg | 55 ± 2%112 ± 8 µg | 50 ± 3%95 ± 8 µg | |
| Respirable particles (1-5 µm)4 | 35 ± 2%78 ± 6 µg | 41 ± 1%83 ± 2 µg | 43 ± 2%80 ± 23 µg | |
| Total mass of drug (in nebulizer)5 | 500 µg | 500 µg | 500 µg | |
| Total Delivered Mass of Aerosol6 | 44 ± 2%222 ± 14 µg | 41 ± 2%205 ± 9 µg | 38 ± 1%188 ± 7 µg | |
| Average Treatment Time (minutes)7 | 1.9 ± 0.1 | 1.9 ± 0.1 | 1.7 ± 0.1 | |
| Cromolyn Sodium(NonsteroidalAnti-asthmaMedication).Typical dose20 mg/2 ml or20000 µg ofdrug substance. | MMAD (µm)2 | 4.7 ± 0.2 µ | 3.9 ± 0.1 µ | 3.5 ± 0.1 µ |
| GSD3 | 2.0 ± 0.02 | 2.0 ± 0.02 | 2.0 ± 0.02 | |
| Extra-fine particles (< 1 µm)4 | 9.7 ± 1%617 ± 57 µg | 11 ± 1%648 ± 31 µg | 13 ± 1%675 ± 49 µg | |
| Fine particles (< 5 µm)4 | 50 ± 2%3170 ± 180 µg | 58 ± 1%3320 ± 150 µg | 64 ± 3%3310 ± 220 µg | |
| Coarse particles (> 5 µm)4 | 50 ± 2%3220 ± 290 µg | 42 ± 1%2360 ± 140 µg | 36 ± 3%1900 ± 250 µg | |
| Respirable particles (1-5 µm)4 | 40 ± 1%2550 ± 150 µg | 47 ± 1%2660 ± 120 µg | 51 ± 2%2640 ± 190 µg | |
| Total mass of drug (in nebulizer)5 | 20000 µg | 20000 µg | 20000 µg | |
| Total Delivered Mass of Aerosol6 | 32 ± 2%6380 ± 390 µg | 28 ± 2%5680 ± 240 µg | 26 ± 2%5220 ± 400 µg | |
| Average Treatment Time (minutes)7 | 3.1 ± 0.1 | 1.7 ± 0.1 | 1.6 ± 0.1 |
3. Aerosol Characterization
³ Performance data using Cascade Impactor (NGI) per USP 34 <1601> chilled to 5 °C with an extraction flow of 15 lpm for three common aerosolized medications. Treatment time was defined as onset of audible sputtering plus one minute. Values represent the Mean and 95% confidence interval of the mean.
2 MMAD Is Mass Median Aerodynamic Diameter.
3 GSD is the Geometric Standard Deviation.
4 Values are the mass of drug substance delivered in the specified size range of aerosol particles and the mass represented as a percentage of the Total Delivered Mass of Aerosol.
5 Total mass of drug in nebulizer is the mass of drug substance placed in the nebulizer cup for typical dose listed.
6 The total delivered mass of aerosol is the mass of drug substance recovered from the cascade impactor after treatment time. The mass is stated in micrograms of drug substance and as a percentage of the total mass of drug substance placed in the nebulizer.
- 7 Treatment time, defined as onset of sputtering plus one minute, to deliver the aerosol masses starting with the initial mass of drug listed.
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Results and Conclusion
Based upon the information provided the proposed device is substantially equivalent to the predicate devices, and raises no new issues of safety and effectiveness
Summary of clinical tests conducted for determination of substantial equivalence and/or of clinical information
N/A - No clinical tests were conducted for this submission
Conclusions drawn from non-clinical and clinical data
The results of the non-clinical tests show that the small volume nebulizer meets all performance requirements, and is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2013
Ms. Erika Silva Fernandez Manager, Regulatory Affairs CareFusion 1500 Waukegan Road WAUKEGAN IL 60060
Re: K123527
Trade/Device Name: Small Volume Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 21, 2013 Received: March 26, 2013
Dear Ms. Fernandez:
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. Ilsting 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 - Ms. Fernandez
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kwame O. Ulmer -S for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Small Volume Nebulizer
or
Unknown at this time
This device is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing. The patient population includes adults, pediatrics, and infants that are spontaneously breathing. The product is a prescriptive device intended to be used in hospital setting.
Prescription Use X_
Over-The Counter Use _
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chan O. Lee -S
2013.04.24
16:11:51 -04'00' For LS
(Division Sign-Off) (Division Sign-Old)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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).