(151 days)
The NE-C802 Compressor Nebulizer System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (3 year old and greater) and adult patients in the home, hospital, and sub-acute settings.
The Omron Model NE-C802 is a standard nebulizer compressor system with an integral compressor and handheld, pneumatic nebulizer intended for general purpose use. It is powered by standard AC. This is a modification of the NE-C801 cleared under K110860.
Acceptance Criteria and Device Performance for Omron NE-C802 Compressor Nebulizer System
The Omron NE-C802 Compressor Nebulizer System is substantially equivalent to its predicate device, the Omron NE-C801 (K110860). The modifications made to the NE-C802, primarily involving minor changes to the nebulizer design and compressor design for smaller size and lighter weight, do not alter the intended use or fundamental scientific technology. Therefore, clinical investigation was not deemed necessary to validate these changes.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on demonstrating substantial equivalence to the predicate device, NE-C801 (K110860), across various performance characteristics. The reported device performance for the NE-C802 is compared directly to the NE-C801.
| Characteristic | Acceptance Criteria (Predicate NE-C801) | Reported Device Performance (NE-C802) | Notes |
|---|---|---|---|
| Compressor | Roller - 4 valves | Roller – 3 valves | Design change, but performance is viewed as substantially equivalent. |
| Power | DC 12V | DC 6V | Changed for smaller, lighter design, but performance is viewed as substantially equivalent. |
| Operating pressure & flow from compressor | < 54 Kpa, > 2.54 lpm | < 52 Kpa, > 1.2 lpm | While the flow rate is lower, the overall performance (e.g., particle size, delivery rate) is considered substantially equivalent. |
| Nebulizer Design | Standard pneumatic nebulizer | Design change to some components to improve airflow | Still pneumatic; principle of operation is the same. |
| Delivery Rate | 0.3 ml / min | 0.25 ml / min | Slightly lower, but the particle characterization results are directly compared and found substantially equivalent. |
| Particle Size (MMAD in µm) @ 15L/min | Pulmicort: 4.89; Intal: 3.33; Salbutamol: 3.38 | Pulmicort: 4.43; Intal: 3.78; Salbutamol: 3.25 | Compared across three drugs. The statistical analysis of variance and mean difference showed non-significance (p-value), indicating substantial equivalence. |
| Particle Size (MMAD in µm) @ 32L/min | Pulmicort: 4.37; Intal: 2.79; Salbutamol: 2.72 | Pulmicort: 4.08; Intal: 3.37; Salbutamol: 2.94 | Compared across three drugs. The statistical analysis of variance and mean difference showed non-significance (p-value), indicating substantial equivalence. |
| GSD @ 5 lpm | Pulmicort: 2.2; Intal: 2.4; Salbutamol: 2.7 | Pulmicort: 2.4; Intal: 2.8; Salbutamol: 2.9 | Differences in GSD were noted but deemed not to raise new questions of safety or efficacy. Statistical analysis done with 99% confidence interval. |
| GSD @ 2 lpm | Pulmicort: 2.32; Intal: 2.7; Salbutamol: 2.89 | Pulmicort: 2.55; Intal: 3.2; Salbutamol: 3.4 | Differences in GSD were noted but deemed not to raise new questions of safety or efficacy. Statistical analysis done with 99% confidence interval. |
| Total Delivered Dose (ug) @ 5 lpm | Pulmicort: 395; Intal: 13567; Salbutamol: 7650 | Pulmicort: 385; Intal: 12993; Salbutamol: 7483 | Minor differences, but comparison suggests substantial equivalence in clinical impact for drug delivery. |
| Total Delivered Dose (ug) @ 2 lpm | Pulmicort: 378; Intal: 12533; Salbutamol: 7716 | Pulmicort: 392; Intal: 12992; Salbutamol: 7494 | Minor differences, but comparison suggests substantial equivalence in clinical impact for drug delivery. |
| Total Delivered Dose Fraction (%) @ 5 lpm | Pulmicort: 80%; Intal: 69%; Salbutamol: 78% | Pulmicort: 76%; Intal: 65%; Salbutamol: 74% | Differences in delivered dose fraction were found to be substantially equivalent. |
| Total Delivered Dose Fraction (%) @ 2 lpm | Pulmicort: 81%; Intal: 64%; Salbutamol: 79% | Pulmicort: 78%; Intal: 65%; Salbutamol: 75% | Differences in delivered dose fraction were found to be substantially equivalent. |
| Respirable Fraction (0.5-5 um) (%) @ 5 lpm | Pulmicort: 55%; Intal: 59%; Salbutamol: 59% | Pulmicort: 50%; Intal: 60%; Salbutamol: 56% | Differences in respirable fraction were found to be substantially equivalent. |
| Respirable Fraction (0.5-5 um) (%) @ 2 lpm | Pulmicort: 58%; Intal: 62%; Salbutamol: 60% | Pulmicort: 54%; Intal: 64%; Salbutamol: 57% | Differences in respirable fraction were found to be substantially equivalent. |
| Total Respirable Dose (0.5-5 um) (ug) @ 5 lpm | Pulmicort: 2.17; Intal: 80.13; Salbutamol: 44.9 | Pulmicort: 1.93; Intal: 78.27; Salbutamol: 41.63 | Differences in total respirable dose were found to be substantially equivalent. |
| Total Respirable Dose (0.5-5 um) (ug) @ 2 lpm | Pulmicort: 2.39; Intal: 77.86; Salbutamol: 46.24 | Pulmicort: 2.12; Intal: 82.4; Salbutamol: 43.03 | Differences in total respirable dose were found to be substantially equivalent. |
| Dimensions | 142 mm (W) x 98 mm (H) x 72 mm (D) | 85mm (W) x 43mm (H) x 115mm (D) | Smaller and lighter, which is a stated modification, but does not impact safety or efficacy. |
| Weight (without battery) | 270 gm | 190 gm | Lighter, which is a stated modification, but does not impact safety or efficacy. |
| Reservoir Size | 7 ml | 10 ml | Increased, but does not impact safety or efficacy, potentially improving user convenience. |
| Indications for Use | Pneumatic nebulizer for respiratory disorders | Pneumatic nebulizer for respiratory disorders | Identical, with clarification for pediatric population (3 years and older). |
| Environment of Use | Home, Hospital, Sub-acute Institutions | Home, Hospital, Sub-acute Institutions | Identical. |
| Patient Population | Pediatric and adult | Pediatric (3 years and older) and adult | Identical, with clarification for pediatric population (3 years and older). |
| Contraindications | None | None | Identical. |
| Materials in Patient Contact | ABS, Polypropylene and PVC | Polypropylene and PVC | The materials in the gas and fluid pathway are identical or considered equivalent in terms of safety. The use of these materials has been determined safe by FDA. |
| Standards Met | IEC60601-1:1988 +A1:1991+A2:1995, IEC60601-1-2:2007, ISO10993-1:2009, ISO10993-5:2009, ISO10993-10:2009 | IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-11:2007, IEC 62366:2007, ISO10993-1:2009, ISO10993-5:2009, ISO10993-10:2010 | Updated to newer versions of standards where applicable, demonstrating continued compliance with relevant safety and performance requirements. |
| Operating Conditions | 10°C to 40°C, 30% to 85% RH | 10°C to 40°C, 30% to 85% RH | Identical. |
| Storage Conditions | -20°C to 60°C, 10% to 95% RH | -20°C to 60°C, 10% to 95% RH | Identical. |
| Power Source | AC | AC | Identical. |
| Nebulizer Components Cleanable | Yes | Yes | Identical. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical or large-scale comparative studies. Instead, the performance testing focuses on bench testing and laboratory measurements to demonstrate substantial equivalence.
- Particle Characterization Test: This test involved 3 devices for 3 runs with 3 different drugs. This implies a total of 9 measurements per parameter.
- Data Provenance: The data is generated from bench testing conducted by Omron Healthcare, Inc. (the manufacturer). The country of origin of the data is not explicitly stated, but it is implied to be internal testing by the US-based company or its contracted labs. The data is retrospective in the sense that it was conducted for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the ground truth for these types of technical performance tests (e.g., particle size, flow rates) is established by using calibrated scientific instruments and standardized testing methodologies, not by expert consensus in a clinical setting.
4. Adjudication Method for the Test Set
This is not applicable for the type of bench testing presented. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical images or patient outcomes, which are not part of this submission. The "adjudication" here is implied by the statistical analysis of the performance parameters demonstrating equivalence.
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 MRMC comparative effectiveness study was done. This device is a mechanical nebulizer system, not an AI-assisted diagnostic or therapeutic device. Therefore, a study of human readers improving with AI assistance is irrelevant and was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done. This device is a physical product (compressor nebulizer), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance characteristics (e.g., MMAD, GSD, delivered dose) is established through objective laboratory measurements using recognized scientific instruments and methods, such as an 8-stage cascade impactor for particle characterization. It is not based on expert consensus, pathology, or outcomes data, as those are relevant to clinical efficacy and safety, which were deemed unnecessary for this 510(k) given the substantial equivalence to the predicate.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device's evaluation. This is a hardware device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning model, there is no ground truth established for one.
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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized image of a human face in profile, with three overlapping profiles suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2014
Omron Healthcare, Incorporated C/O Mr. Paul Dryden ProMedic. Incorporated 24301 Woodsage Drive Bonita Springs, FL 34134-2958
Re: K141140
Trade/Device Name: Omron Compressor Nebulizer Systems -NE-C802 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: August 28, 2014 Received: August 29, 2014
Dear Mr. Dryden:
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. Dryden
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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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Indications for Use
510(k) Number (if known) K141140
Device Name NE-C802
Indications for Use (Describe)
The NE-C802 Compressor Nebulizer System is intended to provide ar to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (3 year old and greater) and adult patients in the home, hospital, and sub-acute settings.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| 510(k) Summary |
|---|
| Page 1 of 6 |
| 30-Apr-14 |
| Omron Healthcare, Inc. | |
|---|---|
| 1200 Lakeside Drive | Tel – 847-247-5626 |
| Bannockburn, IL 60015 USA | Fax – 847-680-6269 |
| Official Contact: | Renee Thornborough – Director, Quality & Regulatory |
| Proprietary or Trade Name: | NE-C802 |
| Common/Usual Name: | Nebulizer (direct patient interface) |
| Classification Name/Code: | CAF, Class 2, Nebulizer (direct patient interface)CFR 870.1130 |
| Device: | NE-C802 |
| Modified Device: | Omron – NE-C801 – K110860 |
Device Description:
The Omron Model NE-C802 is a standard nebulizer compressor system with an integral compressor and handheld, pneumatic nebulizer intended for general purpose use. It is powered by standard AC. This is a modification of the NE-C801 cleared under K110860.
The modifications to the device do not change the intended use of the predicate device. The modifications to the device do not alter the fundamental scientific technology. As there are no changes in hardware that will impact performance, there is no need to validate the changes through a clinical investigation.
Indications for Use:
The NE-C802 Compressor Nebulizer System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (3 year old and greater) and adult patients in the home, hospital, and sub-acute settings.
Contraindications:
None
Summary of Modifications:
The modifications to the device do not change the intended use of the predicate device. The modifications to the device do not alter the fundamental scientific technology. As there are no changes in hardware that will impact performance, there is no need to validate the changes through a clinical investigation.
Modifications:
- Minor changes to nebulizer design
- Changes to physical dimensions ●
- Change to compressor design to make it smaller and lighter weight ●
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510(k) Summary Page 2 of 6 30-Apr-14
There is no change in intended use, including patient population and environment of use. There is no change in contraindications.
Performance Testing:
Verification activities, as required by the risk analysis, for the modification were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met. Table 5.1 summarizes the difference, Table 5.2 equivalence comparison, and Table 5.3 the testing.
Table 5.1 - Description of the modifications of the New Model NE-C802 vs. the Predicate
| Features | New modelNE-C802 | Predicate (K110860)NE-C801 |
|---|---|---|
| Compressor | Roller – 3 valves | Roller - 4 valves |
| Power | DC 6V | DC 12V |
| Operating pressure and flow from compressor | < 52 Kpa> 1.2 lpm | < 54 Kpa> 2.54 lpm |
| Nebulizer design | Design change to some nebulizercomponents to improve air flowbut still pneumatic and principle ofoperation is the same | |
| Delivery rate | 0.25 ml / min | 0.3 ml / min |
| Particle size (MMAD) in um | @ 15L/minPulmicort - 4.43 $\mu$ mIntal – 3.78 $\mu$ mSalbutamol - 3.25 $\mu$ m | @ 15L/minPulmicort - 4.89 $\mu$ mIntal – 3.33 $\mu$ mSalbutamol - 3.38 $\mu$ m |
| @ 32L/minPulmicort – 4.08 $\mu$ mIntal - 3.37 $\mu$ mSalbutamol – 2.94 $\mu$ m | @ 32L/minPulmicort - 4.37 $\mu$ mIntal - 2.79 $\mu$ mSalbutamol - 2.72 $\mu$ m | |
| Non-significance of Variance and mean difference (p value) | ||
| Dimensions (mm) | 85mm (W) x 43mm (H) x 115mm (D) | 142 mm (W) x 98 mm (H) x 72 mm (D) |
| Weight (kg) without battery | 190 gm | 270 gm |
| Reservoir size | 10 ml | 7 ml |
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510(k) Summary Page 3 of 6 30-Apr-14
| Features | New | Predicate (K110860) |
|---|---|---|
| NE-C802 | NE-C801 | |
| Indications for use | The NE-C802 Compressor NebulizerSystem is intended to provide air to thepneumatic nebulizer in order to aerosolizemedications for inhalation by the patientfor respiratory disorders. | The NE-C801 Compressor NebulizerSystem is intended to provide air to thepneumatic nebulizer in order to aerosolizemedications for inhalation by the patientfor respiratory disorders. |
| Environment of Use | Home, Hospital, Sub-acute Institutions | Same |
| Patient Population | Pediatric (3 years and older) to adult | Pediatric and adult |
| Contraindications | None | None |
| Pneumatic compressor | Yes | Yes |
| Pneumatic nebulizer | Yes | Yes |
| Software driven | No | No |
| Materials in patientcontact | Polypropylene and PVC | ABS, Polypropylene and PVC |
| Patient Interface | Mouthpiece or mask | Mouthpiece or mask |
| Standards met | IEC 60601-1:2005 | IEC60601-1:1988 +A1:1991+A2:1995 |
| IEC 60601-1-2:2007 | IEC60601-1-2:2007 | |
| IEC 60601-1-11:2007 | ||
| IEC 62366:2007 | ISO10993-1:2009 | |
| ISO10993-1:2009 | ISO10993-5:2009 | |
| ISO10993-5:2009 | ISO10993-10:2009 | |
| ISO10993-10:2010 | ||
| Nebulizer componentscleanable | Yes | Yes |
| Operating conditions | 10°C to 40°C 30% to 85% RH | Same |
| Storage conditions | -20°C to 60°C 10% to 95% RH | Same |
| Power Source | AC | AC |
Table 5.2 - Comparison and Equivalence of New Model NE-C802 and the Predicate
The differences between the proposed device and the predicates are:
- Physical size
- A modification to nebulizer
It is our view that these are not significant differences that affect the safety or effectiveness of the intended device as compared to the predicate device.
Table 5.3 - Particle Characterization results
A series of aerosol performance tests were performed using an 8 stage cascade impactor at a sampling flow rate of 15 1/min equipped with a USP <601> induction port throat. Aerosol was sampled directly from the outlet. A summary of results is listed below with intervals given for a 99% confidence level.
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Premarket Notification 510()
Section 5
| 310(k) SummaryPage 4 of 630-Apr-14 | ||||||
|---|---|---|---|---|---|---|
| Characteristic | Device NE-C802 (NEW) | Predicate Device - NE-C801 K110860 | ||||
| Pulmicort250 ug.ml | Intal10 mg/ml | Salbutamol5 mg/ml | Pulmicort250 ug.ml | Intal10 mg/ml | Salbutamol5 mg/ml | |
| MMAD (um)5 lpm | 4.89 | 3.33 | 3.38 | 4.43 | 3.78 | 3.25 |
| 2 lpm | 4.37 | 3.79 | 2.72 | 4.08 | 3.37 | 2.94 |
| GSD5 lpm | 2.4 | 2.8 | 2.9 | 2.2 | 2.4 | 2.7 |
| 2 lpm | 2.55 | 3.2 | 3.4 | 2.32 | 2.7 | 2.89 |
| Total Delivered Dose (ug)5 lpm | 385 | 12993 | 7483 | 395 | 13567 | 7650 |
| 2 lpm | 392 | 12992 | 7494 | 378 | 12533 | 7716 |
| Total Delivered Dose Fraction (%)5 lpm | 76% | 65% | 74% | 80% | 69% | 78% |
| 2 lpm | 78% | 65% | 75% | 81% | 64% | 79% |
| Respirable Fraction (0.5-5 um) (%)5 lpm | 50% | 60% | 56% | 55% | 59% | 59% |
| 2 lpm | 54% | 64% | 57% | 58% | 62% | 60% |
| Total Respirable Dose (0.5-5 um) (ug)5 lpm | 1.93 | 78.27 | 41.63 | 2.17 | 80.13 | 44.9 |
| 2 lpm | 2.12 | 82.4 | 43.03 | 2.39 | 77.86 | 46.24 |
510(k) Summar
ummary of result
NF-C802 was found to be substantially equivalent on all performance areas except as noted below. These differences are in GSD and Ultr
particle fraction. Neither of which
statistical analysis was done with a 99% confidence inter
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510(k) Summary Page 5 of 6 30-Apr-14
The Model NE-C802 is viewed as substantially equivalent to the predicate device because:
Indications -
The Indications for Use are as a general purpose nebulizer and compressor system which is identical to predicate - Omron NE-C801 (K110860).
Discussion - We have not changed the indications for use statement, only defined the pediatric population to 3 years and older, which has been a recent FDA request.
Technology -
The technology of the compressor is identical compressor technology to predicate - Omron NE-C801 (K110860). The technology of the pneumatic nebulization is identical nebulizer technology to predicate – Omron NE-C801 (K110860).
Discussion - The modifications to compressor, smaller and lighter weight has not changed the technology. As to the nebulizer changes, this is still a pneumatic nebulizer to aerosolize medications. The changes have been for simplification and efficiency of performance. The particle characterization performance demonstrates that the 2 devices perform substantially equivalent.
Materials -
The materials in the gas and fluid pathway are identical to predicate device, Omron NE-C801 (K110860).
Discussion - The materials are identical to our own predicate device are have the identical patient contact, exposure, and duration of use. The use of these materials has been determined to be safe by FDA under previous submission reviews.
Environment of Use -
The environment of use is - home, hospital and sub-acute care settings which are identical to predicate - Omron NE-C801 (K110860).
Discussion - There have been no changes in the environment of use and thus the proposed device can be found substantially equivalent to the predicate.
Patient Population -
The patient population is pediatric and adult which is identical to predicate - NE-C801 (K110860).
Discussion - We have not changed the patient population, but as requested by FDA, there are subsets of "pediatric" populations and we have added clarification of this in our indications for use. It is common practice that nebulizers may be used with patients that are 3 years and old, or can follow verbal instructions. Our added language does not alter the indications for use, but only to supports FDA's request for clarification of "pediatrics" population.
Non-clinical Testing -
We have performed a number of performance tests which are identical to those done with the predicate, Omron NE-C801 (K110860). These included:
- IEC 60601-1 ●
- IEC 60601-1-2
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510(k) Summary Page 6 of 6 30-Apr-14
- Cascade Impactor particle characterization testing with 3 devices for 3 runs with 3 drugs o
- Compressor testing
- VOC testing per EPA TO-15 o
- CO, CO2 testing EPA Part 60 o
- o Ozone testing per OSHA method ID 214
- PM25 testing per NIOSH NMAM 0600 O
- Cleaning
- Simulated life and age testing
- Mechanical testing ●
Discussion – The non-clinical testing demonstrated that the performance of the proposed device was equivalent to the predicate Omron NE-C801 (K110860).
Clinical Testing -
There was no clinical testing performed.
Substantial Equivalence Conclusion -
The proposed device has been found to be substantially equivalent to the predicate. Differences between the proposed device and the predicate do not raise new questions of safety or efficacy.
§ 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).