This ultrasonic nebulizer is intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing for use by both the adult and pediatric populations.

Device Description

The ICEL Evolusonic Portable Ultrasonic Nebulizer has been developed with the patient's necessities in mind for the delivery of spray liquids in aerosol form into gases directly to the patient for breathing, for use by the adult and pediatric populations. The device runs on standard AC power and easily upgrades to battery operation (rechargeable battery or sold separately). It can be plugged into an electrical outlet using the AC/DC converter, and it can also be plugged directly into an automobile cigarette lighter for use when traveling.

AI/ML Overview

The provided text describes the submission for K983736 for the ICEL Evolusonic Portable Ultrasonic Nebulizer. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Description)	Reported Device Performance (Test Results)
Electrical and Environmental Tests (from FDA Reviewer Guidance)	Met all relevant requirements
Duration of operation from battery power	Met
Electrical power indicators	Met
Overcurrent protection	Met
Controls protection	Met
Connector protective compatibility	Met
Mechanical safety	Met
Mechanical shock resistance	Met
Vibration	Met
Fluid spill resistance	Met
Extreme operating and storage temperature/humidity	Met
EMI Testing (from FDA Reviewer Guidance)
Radiated and Conducted Electro-Magnetic Energy (Para. h7ia)	Passed
Magnetic Fields (Para. h7ia)	Passed
Electrical Evaluation (IEC 601-1 and Reviewer Guidance)
Dielectric Withstand (Para. (h)(4))	Passed
Leakage Current (Para. (h)(6))	Passed
Nebulizer Characterization Study	Passing Results

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. All testing described is non-clinical. The "samples" for the non-clinical tests would have been the ICEL Evolusonic Portable Ultrasonic Nebulizer devices, and the tests were performed in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective in the clinical sense, as no clinical studies were performed.

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

Not applicable. No ground truth in the clinical sense was established by experts for a test set, as no clinical studies were performed. The "ground truth" for the non-clinical tests was based on established engineering standards and guidelines (FDA Reviewer Guidance, IEC 601-1).

4. Adjudication Method for the Test Set

Not applicable. As no clinical studies were performed, there was no expert adjudication process for a test set.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were performed and none are submitted with this 510(k) submission."

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

Not applicable. This device is a physical medical device (an ultrasonic nebulizer), not an algorithm or AI. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this submission refers to compliance with safety and performance standards established by regulatory guidelines.

Electrical and Environmental Tests: Compliance with requirements outlined in the FDA's "Reviewer Guidance for Premarket Notification Submission" (November 1993 edition).
EMI Testing: Compliance with requirements outlined in the FDA's "Reviewer Guidance for Premarket Notification Submission" (Para. h7ia).
Electrical Evaluation: Compliance with IEC 601-1 and the FDA's "Reviewer Guidance for Premarket Notification Submission" (Para. (h)(4) and (h)(6)).
Nebulizer Characterization Study: Compliance with Federal Good Laboratory Practices (21 CFR Part 58 (FDA) or 40 CFR Part 160 (EPA)) and passing results according to established nebulizer characterization protocols.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical device, not an AI or algorithm that requires a "training set."

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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K983736

NOV 10 1998

EXHIBIT #1 PAGE 1 OF 4

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: 1983736

Submitter's Identification: 1.

Walter Azevedo Hormann Brasamerica Medical Equipment, Inc. 3046 Virginia Street Miami. FL 33133 Tel: (305) 567-0840

Date Summary Prepared: October 20, 1998

2. Name of the Device:

ICEL Evolusonic Portable Ultrasonic Nebulizer

3. Predicate Device Information:

The ICEL Evolusonic Portable Ultrasonic Nebulizer is substantially equivalent to the ICEL Ultrasonic Nebulizer Model PU 12000 Air and PU 12300 Air previously cleared under K#972371.

র্ব . Device Description:

The device runs on standard AC power and easily upgrades to battery operation (rechargeable battery or sold separately).

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EXHIBIT #1 PAGE 2 OF 4

It can be plugged into an electrical outlet using the AC/DC converter, and it can also be plugged directly into an automobile cigarette lighter for use when traveling.

Intended Use: 5.

This ultrasonic nebulizer is intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing for use by both the adult and pediatric populations.

Comparison to Predicate Devices: ട.

The two (2) devices are identical with regard to theory of operations, indications for use and basic operating procedures. The primary difference (significant) between the two (2) models is the air flow function – The PU 12300 Air contains the air flow function inside the economatic module, whereas the Evolusonic has the air flow function built-in. The intensity controller is indicated by LED (high or low) lighted, whereas the Evolusonic is indicated by LED flashing. Power indication is indicated by LED for the PU 12300 Air, whereas the Evolusonic is indicated by LED flashing in green color, and , the timer for the PU12300 is indicated by LED high/low flashing, whereas the Evolusonic is indicated by LED flashing in an orange color. Software has not been affected. The electrical requirements, power consumption, ultrasonic operating frequency, particle size range and nebulization rate are identical between both devices.

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7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

(a) Following the methods described in the November, 1993, edition of the FDA's Reviewer Guidance for Premarket Notification Submission, the following electrical and environmental tests were conducted:
- -Duration of operation from battery power
  - -Electrical power indicators
  - -Overcurrent protection
  - -Controls protection
  - Connector protective compatibility -
  - -Mechanical safety
  - Mechanical shock resistance -
  - Vibration -
  - -Fluid spill resistance
  - -Extreme operating and storage temperature/humidity

Conclusion: The ICEL ultrasonic nebulizers tested met all relevant requirements of the tests listed in the Reviewer Guidance document, they did not present unsafe conditions.

(b) In addition, in accordance with the Reviewer Guidance document the following EMI testing was also performed:

Reviewer Guidance	Test Description	Test Results
Para. h7ia	Radiated andConducted Electro-Magnetic Energy	Passed
Para. h7ia	Magnetic Fields	Passed

An electrical evaluation in accordance with the Reviewer Guidance document and IEC 601-1 was performed on the power supply of the Reviewer Gulturities and
601-1 was performed on the power supply of the ICEL Nebulizer with the following conclusions:

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Exhibit #1 Page 4 of 4

Reviewer Guidance	Test Description	Test Results
Para. (h)(4)	Dielectric Withstand	Passed
Para. (h)(6)	Leakage Current	Passed

In addition a Nebulizer Characterization Study was performed with (c) passing results. The test was conducted in accordance with the Federal Good Laboratory Practices (21 CFR Part 58 (FDA) or 40 CFR Part 160 (EPA)]. All laboratory data which pertains to this study are recorded in Nelson Laboratories Data File Number 57738.

Discussion of Clinical Tests Performed: 8.

No clinical tests were performed and none are submitted with this 510(k) submission.

ல் Conclusions:

Based upon non-clinical testing performed and the results of such testing, we have demonstrated that the ICEL Evolusonic Portable Ultrasonic Nebulizer is as safe and effective and performs as well as our predicate device cited in this 510(k) Summary.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 1998

Ms. Susan D. Golstein-Falk Brasamerica Medical Equipment, Inc. c/o MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, NY 11021

Re: K983736 ICEL Evolusonic Portable Ultrasonic Nebulizer Regulatory Class: II (two) Product Code: 73 CAF Dated: October 20, 1998 Received: October 22, 1998

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Susan D. Golstein-Falk

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan
Thomas J. Callahan, Ph.D.

Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EXHIBIT #B

ー of Paqe

K4835 510(k) NUMBER (IF KNOWN):

ICEL Evolusonic Portable Ultrasonic Nebulizer DEVICE NAME :

INDICATIONS FOR USE:

This ultrasonic nebulizer is intended to spray liquids in aerosol form into gases that are This ultrasonic hebuilter is interrasa to opray in in adult and pediatric populations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)

Lanh Modoo 11-9-98
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K983736

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).