(34 days)
Not Found
No
The description mentions a microprocessor with dedicated software, which is common in many medical devices and does not inherently indicate AI/ML. There is no mention of learning, adaptation, or complex pattern recognition in the device's operation. The aerosol generation process is described as a deterministic physical process driven by ultrasonic energy.
Yes
The device is designed to convert liquid medication into an aerosol for inhalation by the patient, which is a therapeutic purpose.
No
Explanation: The device is a nebulizer designed to convert liquid medication into an aerosol for inhalation. Its purpose is to deliver medication, not to diagnose a medical condition.
No
The device is a nebulizer, which is a physical hardware device that converts liquid medication into aerosol. While it contains a microprocessor with dedicated software, the primary function and form factor are hardware-based.
Based on the provided information, the MyNeb device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MyNeb is designed to "convert liquid medication into aerosol for inhalation by the patient." This describes a device used for delivering medication directly to a patient's respiratory system.
- Device Description: The description details the mechanism of aerosol generation from liquid medication. This process is focused on drug delivery, not on analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment effectiveness.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. The MyNeb's function is to deliver a substance into the human body.
N/A
Intended Use / Indications for Use
MyNeb is an AC or battery-pack powered nebulizer designed to convert liquid medication into aerosol for inhalation by the patient.
Product codes
CAF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Tests Performed: 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 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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:
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.
1
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.
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.
2
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
3
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``.
4
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