(203 days)
The Omron NE-U22 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings. It is not intended for use with Pentamidine.
Micro Air Vibrating Mesh Nebulizer (NE-U22) uses low frequency vibration to create aerosol and provide fine particles to the patient's lungs. The mesh plate has more than 6,000 holes to create low velocity aerosol. The VMT nebulizer is portable and quiet. This nebulizer is battery powered, 2 "AA" and it is lightweight. The batteries last approximately 40 treatments. This nebulizer provides precise drug delivery in a very short time. The metal alloy mesh cap is durable and resistant to corrosion.
This is a premarket notification for a medical device (a nebulizer), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and expert involvement is not applicable in the context of an AI/ML device submission.
The document describes the Omron Micro Air Vibrating Mesh Nebulizer (Model NE-U22) and asserts its substantial equivalence to a previously cleared predicate device (Omron NE-U04 - K923024).
Here's why the AI/ML specific questions cannot be answered from the provided text:
- No AI/ML Components: The device description explicitly states "Software driven: No". This confirms that the NE-U22 is a physical medical device and does not utilize artificial intelligence or machine learning.
- Substantial Equivalence: The 510(k) submission process for non-AI devices primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is done by comparing technical characteristics, indications for use, and performance claims, rather than through extensive clinical trials with ground truth established by experts or comparative effectiveness studies of AI assistance.
However, I can extract the relevant "acceptance criteria" and "reported device performance" in the context of this device's submission, based on the comparison with its predicate:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are implied by the performance characteristics of the predicate device, and "reported device performance" are the corresponding characteristics of the new device. The document explicitly states "There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices," implying that the NE-U22 meets or exceeds the performance of the NE-U04 in all relevant aspects.
| Feature / Acceptance Criteria (from Predicate NE-U04) | Reported Device Performance (NE-U22) |
|---|---|
| Indications for Use: aerosolize liquid medications for inhalation; not for Pentamidine; Pediatric and adult patient population; Home, Hospital, Sub-acute Institutions environment of use. | Same (Explicitly stated "Same" for Indications for Use). |
| Power source: Battery - 2 “AA” / AC Adapter AC 120V (60Hz/ DC 3 V | Same (Explicitly stated "Same"). |
| Nebulizing method: Vibrating mesh | Same (Explicitly stated "Same"). |
| Software driven: No | No (Explicitly stated "No"). |
| Materials in patient contact: Polypropylene | Identical (Explicitly stated "Identical"). |
| Standards met: IEC 60601-1, IEC 60601-1-2, UL 60601-1, FCC Part 15 Subpart B Class B, ISO 14971 | Same (Explicitly stated "Same"). This indicates meeting relevant electrical safety, electromagnetic compatibility, and risk management standards. |
| Drug delivery rate: <0.3 ml/min | 0.25 ml/min to 0.9 ml/min (This is a difference but the submission implies it's acceptable and does not negatively impact safety or effectiveness, potentially representing an improvement). |
| Reservoir size: 7 ml | 7 ml (Explicitly stated "Same"). |
| Nebulizer components cleanable: Yes | Yes (Explicitly stated "Yes"). |
| Operating conditions: 0°C to 45°C 30% to 85% RH | Same (Explicitly stated "Same"). |
| Storage conditions: -25°C to 70°C 10% to 90% RH | Same (Explicitly stated "Same"). |
| Dimensions (mm): 68(W) x 60(D) x 172(H) | 38(W) x 51(D) x 104(H) (This is a difference in size, implying a more compact design, which is generally viewed positively for portable devices). |
| Weight (kg) without battery: 148 gm | 97 grams without battery (This is a difference in weight, implying a lighter device, which is generally viewed positively for portable devices). |
Since the device is not an AI/ML product, the remaining questions are not applicable (N/A) for this submission.
2. Sample size used for the test set and the data provenance: N/A (No AI/ML features requiring a test set for algorithm performance assessment). The submission relies on comparative specifications and adherence to standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth required for AI/ML assessment).
4. Adjudication method for the test set: N/A (No test set for AI/ML assessment).
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: N/A (Not an AI-assisted device).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A (No algorithm).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A (No ground truth required for AI/ML assessment).
8. The sample size for the training set: N/A (No AI/ML training set).
9. How the ground truth for the training set was established: N/A (No AI/ML training set).
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Premarket Notification 510(k) Section 5 – 510(k) Summary
Non-Confidential Summary of Safety and EffectivenessFEB 2 3 2007
Page 1 of 2 15-Feb-07
| Omron Healthcare, Inc. | |
|---|---|
| 1200 Lakeside Dr. | |
| Bannockburn, IL 60015 | |
| Official Contact: | Ranndy Kellogg -- VP Marketing and ProductDevelopment |
| Proprietary or Trade Name: | Omron Micro Air Vibrating mesh nebulizer |
| Common/Usual Name: | Nebulizer |
| Classification Name: | Nebulizer (Direct Patient Interface) |
| Device: | Model NE-U22 |
| Predicate Devices: | Omron -- NE-U04 -- K923024 |
| Tel - 847-247-5609Fax - 847-680-6269 |
Device Description:
Micro Air Vibrating Mesh Nebulizer (NE-U22) uses low frequency vibration to create aerosol and provide fine particles to the patient's lungs. The mesh plate has more than 6,000 holes to create low velocity aerosol. The VMT nebulizer is portable and quiet. This nebulizer is battery powered, 2 "AA" and it is lightweight. The batteries last approximately 40 treatments. This nebulizer provides precise drug delivery in a very short time. The metal alloy mesh cap is durable and resistant to corrosion.
| Indications for Use: | |
|---|---|
| Indicated Use -- | The Omron NE-U22 is an ultrasonic (vibrating mesh)nebulizer system designed to aerosolize liquid medications forinhalation by the patient. |
| It is not intended for use with Pentamidine. | |
| Patient Population -- | Pediatric and adult |
| Environment of Use -- | Home, hospital, and sub-acute care settings. |
| Contraindications -- | None |
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 15-Feb-07
Device Attributes:
| Features | NE-U22 | NE-U04 |
|---|---|---|
| Indications for use | The Omron NE-U22 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medications for inhalation by the patient. It is not intended for use with Pentamidine. | Same |
| Environment of Use | Home, Hospital, Sub-acute Institutions | Same |
| Patient Population | Pediatric and adult | Same |
| Contraindications | None | Same |
| Power source | Battery - 2 “AA”AC Adapter AC 120V (60Hz/ DC 3 V | Same |
| Nebulizing method | Vibrating mesh | Same |
| Software driven | No | No |
| Materials in patient contact | Polypropylene | Identical |
| Standard met | IEC 60601-1, IEC 60601-1-2, UL 60601-1, FCC Part 15 Subpart B Class B, ISO 14971 | Same |
| Drug delivery rate | 0.25 ml/min to 0.9 ml/min | <0/3 ml/min |
| Reservoir size | 7 ml | 7 ml |
| Nebulizer components cleanable | Yes | Yes |
| Operating conditions | 0°C to 45°C 30% to 85% RH | Same |
| Storage conditions | -25°C to 70°C 10% to 90% RH | Same |
| Dimensions (mm) | 38(W) x 51(D) x 104(H) | 68(W) x 60(D) x 172(H) |
| Weight (kg) without battery | 97 grams without battery | 148 gm without battery |
Differences Between Other Legally Marketed Predicate Devices
The Model Micro Air Vibrating Mesh Nebulizer (NE-U22) is viewed as substantially equivalent to the following predicate device - Omron NE-U04 - K923024.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and its body forming a flowing shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2007
Mr. Ranndy Kellogg VP Marketing and Product Development Omron Healthcare, Incorporated 1200 Lakeside Drive Bannockburn, Illinois 60015-1243
Re: K062263
Trade/Device Name: Micro Air Vibrating Mesh Nebulizer Model - NE-U22 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 4, 2007 Received: February 6, 2007
Dear Mr. Kellogg:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Kellogg
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris Lins Pi-R
Chiu Lin, Ph.D. 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 Statement
Page 1 of 1
| 510(k) Number: | K062263 |
|---|---|
| Device Name: | Micro Air Vibrating Mesh nebulizer Model - NE-U22 |
| Indications for Use: | The Omron NE-U22 is an ultrasonic (vibrating mesh)nebulizer system designed to aerosolize liquid medicationsfor inhalation by the patient.The device may be used with pediatric and adult patients inthe home, hospital, and sub-acute care settings.It is not intended for use with Pentamidine. |
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mird Vele
Thickens, etc.
Bentonite, etc.
210000 K And
§ 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).