This AC (adaptor with DC converter) or battery-pack powered nebulizer is housed in a plastic case. Dimensions are 4.96"(II) x 2.80° (V) x 1.46"(I) x 1.46"(I) and weighs 4 ounces. It consists of a piezoelectric element driven by a microprocessor with dedicated software. The batteries are rechargeable via an AC power supply (100-240 VAC, 50-60 Hz). The external battery pack is made up of 2 lithium polymer cells.

The following is the method of acrosol generation:

Step 1: Ultrasonic energy is created and focused by a concave piezoelectric element, located within the generator, to a point at the base of the medication chamber that is located at the top of the generator.

Step 2: The focused ultrasonic energy forms a liquid fountain that is driven up through the guide tube inside the nebulizer head. Upon exiting the tube, the energized liquid fountain generates cavitation of acrosol particles and the liquid medication is converted into an aerosol.

Step 3: The forces associated with the fountain generate an air draft whereby air is drawn into the nebulizer head via the air vents. The aerosolized medicine is carried by this air draft, through the nebulizer's chimney and out through the nebulizer's mouthpiece opening.

Step 4: Non aerosolized liquid medication returns back into the medication chamber for re-generation through the guide tube.

AI/ML Overview

Here's the analysis of the provided text regarding the MyNeb Nebulizer, Model RDD100:

Acceptance Criteria and Device Performance Study

Based on the provided 510(k) summary, the MyNeb Nebulizer's acceptance criteria and performance are established through demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. No clinical studies are mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Intended Use	Convert liquid medication into aerosol for inhalation by the patient.	The MyNeb nebulizer is designed and functions to convert liquid medication into aerosol for inhalation. It achieves this through a piezoelectric element creating ultrasonic energy, forming a liquid fountain, generating aerosol particles via cavitation, and an air draft for delivery. This functionality is considered "basically the same" as predicate devices.
Electrical Safety	Compliance with relevant electrical safety standards for medical devices.	The device "conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing recommendations, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993)." Specific test results are not detailed but compliance is asserted.
Mechanical/Environmental	Durability, stability, and operational integrity under specified environmental conditions (e.g., temperature, humidity, shock, vibration).	The device "conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing recommendations, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993)." Specific test results are not detailed.
Electromagnetic Compatibility (EMC)	No undue electromagnetic interference with other devices, and proper functioning in the presence of expected EMI.	The device "conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing recommendations, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993)." It "meet[s] Environmental Safety and EMC requirements." Specific test results are not detailed.
Performance Characteristics	Similar compressor operating pressure and flow ranges to predicate devices; efficient aerosol generation.	The MyNeb's aerosol generation method (piezoelectric element) is explicitly compared to the MABISMist II, noting its use of a piezoelectric element for energy generation. The document states, "Performance characteristics are basically the same" as the predicate devices, implying comparable aerosol output and delivery efficiency. It's noted that all three units (MyNeb and predicates) are lightweight. Although specific pressure and flow ranges are mentioned for predicates, direct values for MyNeb are not provided, only a general "similar" comparison.
Design	Portability (lightweight), power options (AC/battery).	Dimensions: 4.96"(II) x 2.80"(V) x 1.46"(I); weighs 4 ounces. Powered by AC (adaptor with DC converter) or battery-pack (2 lithium polymer cells, rechargeable). Unit is described as "lightweight" and comparable to predicates. The housing is plastic.
Material Safety	Biocompatibility of materials in contact with medication/patient (not explicitly stated, but implied for medical devices).	Not explicitly discussed in the provided text. Usually addressed under general manufacturing practices and material specifications, which are not detailed in this summary. However, the mention of adhering to "FDA's DCRND 'Reviewer Guidance for Home Use Respiratory Devices'" would imply compliance with material safety for home use devices.

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

Sample Size for Test Set: Not applicable (N/A) for human subjects. The testing was non-clinical, focusing on the device itself.
Data Provenance: N/A. The data originates from internal device testing (electrical, mechanical, environmental, EMC) performed by the manufacturer or a contracted lab to conform to FDA guidance. No patient-derived data is involved.

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

Number of Experts: Not applicable. Ground truth, in the context of clinical outcomes or diagnostic accuracy, is not relevant here as no clinical studies were performed.
Qualifications of Experts: Not applicable. The "ground truth" for the non-clinical tests was established by adhering to recognized testing standards and FDA guidance documents, which are assessed by engineers and regulatory specialists.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no human interpretation or decision-making on test "cases" that would require adjudication. Device performance against technical specifications and regulatory guidance was assessed directly.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Reader Improvement

MRMC Study: No, an MRMC comparative effectiveness study was explicitly stated as "Not Applicable" for this 510(k) submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Standalone Performance: While the device operates automatically (non-human-in-the-loop) once initiated, the term "standalone" usually refers to AI/algorithm performance. This device is a nebulizer, a mechanical medical device with embedded software for control, not an AI diagnostic algorithm. Its "standalone performance" refers to its efficacy in aerosol generation as described, which was assessed through non-clinical testing.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device's safety and effectiveness relies on compliance with established engineering and safety standards, as well as FDA guidance documents. Specifically, "Reviewer Guidance for Premarket Notification Submissions (November 1993)" and "Reviewer Guidance for Home Use Respiratory Devices" served as the benchmarks for determining acceptable performance in electrical, mechanical, environmental, and EMC testing. The "truth" is whether the device meets these pre-defined, objective engineering metrics.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a medical device, not an AI/machine learning model that requires a training set of data.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of medical device.

Summary

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DEC 20 2005

EXHIBIT #1

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 Part 807.92.

The assigned 510(k) number is: K053203

1. Submitter's Identification:

Respironics New Jersey, Inc. 41 Canfield Road Cedar Grove, NJ 07009

Contact: Lauren R. Ziegler, Senior Manager, Quality, Regulatory and Clinical Affairs Date Summary Prepared: October 3, 2005

2. Name of the Device:

MyNeb Nebulizer, Model RDD100 Common Name or Classification Name (21 CFR Part 807.87) of Device: Nebulizer, 21 CFR Part 868.5630

3. Predicate Device Information:

MABISMist II., K990506, Pari Trek with LC+, K960675 and K935540

4. Device Description:

The following is the method of acrosol generation:

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Step 4: Non aerosolized liquid medication returns back into the medication chamber for re-generation through the guide tube.

Image /page/1/Figure/3 description: This image shows a diagram of a nebulizer head. The diagram labels the different parts of the nebulizer head, including the cover, mouthpiece, chimney, air vent, medication chamber, energy formation point, body, generator, base, electronics board, on/off button, connector, piezoelectric element, PEEK film, guide tube, and aerosol formation. The nebulizer head is a device that is used to deliver medication to the lungs.

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Image /page/2/Picture/0 description: The image shows a black and white photograph of a complex mechanical or optical device. The device appears to be a combination of lenses, tubes, and supporting structures. The device is set against a dark background, which makes it difficult to discern the exact details of its construction.

MyNeb Aerosol Generation

5. Intended Use:

MyNeb is an AC or battery-pack powered nebulizer designed to convert liquid medication into acrosol for inhalation by the patient.

6. Comparison to Predicate Devices:

The subject (MyNeb) and predicate devices (MABISMist II, K990506; Pari Trek with 1.C+, K960675 and K935540) are indicated for the same intended use, are electrically powered, meet Environmental Safety and EMC requirements, and have similar compressor operating pressure and flow ranges. The MABISMist II. like the MyNeb, uilizes a piezoelectric element to achieve energy generation. Performance characteristics are basically the same, and all three units are fightweight.

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

When used as intended. MyNeb conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing recommendations, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993). Testing information demonstrating safety and effectiveness of the My Neb nebulizer in the

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intended environment of use is or will be supported by testing that was corducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.

8. Discussion of Clinical Tests Performed:

Not Applicable

9. Conclusions:

We have demonstrated that the MyNeb Nebulizer, Model RDD100 is as safe and effective as predicate devices presently on the market, based on electrical, mechanical, environmental and EMC testing results outlined in the FDA DCRND November 1993 Draft *Reviewer Guidance for Premarket Notification Submissions". We also adhered to FDA's DCRND "Reviewer Guidance for Home Use Respiratory Devices``.

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Image /page/4/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 with its wings spread, representing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2005

Intertek Testing Services C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 70 Codman Hill Road Boxborough, Massachusetts 01719

Re: K053203

Trade/Device Name: MyNeb Nebulizer, Model RDD100 Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: December 14, 2005 Received: December 15, 2005

Dear Mr. Lehtonen:

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. Lehtonen

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syfate y. Michie Orns.

Chia Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Exhibit B

Indications for Use

K053 203

510(k) Number (if known):

Device Name: MyNeb Nebulizer, Model RDD100

Indications for Use: MyNeb is an AC or battery-pack powered nebulizer designed to convert liquid medication into aerosol for inhalation by the patient.

Prescription Use X (Per 21 CFR 801 Subpart D)

Over -The-Counter Use ાર (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)

Page 1 of 1

Amy Saliom

(Division Sinn-Off) Division of Asesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K053203

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).