(85 days)
Not Found
No
The document describes a mechanical nebulizer system and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is described as an "Aerosol Drug Delivery System" used to "aerosolize medication approved for nebulization and prescribed by a physician" for delivery to the "pulmonary system." This aligns with the definition of a therapeutic device as it delivers medication for treatment.
No
The device is described as an "Aerosol Drug Delivery System" intended to "aerosolize medication." Its purpose is to administer medication to the patient's pulmonary system, not to diagnose a condition.
No
The device description clearly states it is a "miniaturized nebulizer attached to a valved manifold," indicating it is a physical hardware device for aerosol drug delivery, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aerosolize medication approved for nebulization and prescribed by a physician" and deliver it to the patient's pulmonary system. This is a therapeutic delivery system, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a nebulizer and manifold for delivering medication as an aerosol. It does not describe a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition, monitor a treatment, or screen for a disease.
The device is clearly intended for the administration of medication to a patient, which falls under the category of a therapeutic or drug delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is indicated to aerosolize medication approved for nebulization and prescribed by a physician. This Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System is intended for adult and pediatric patients consistent with the indications for delivery of aerosolized medication to/or through the patient's pulmonary system. The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is for patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools, and long term care facilities.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is a miniaturized nebulizer attached to a valved manifold. During patient inhalation, aerosol mist being generated from the nebulizer is substantially increased through Breath-Enhancement technology, and configuration is such that a filter can be added to the air exit port if so desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's pulmonary system
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools, and long term care facilities.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All materials used in the fabrication of the Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System is currently in use in the manufacture of similar nebulizer devices and have FDA approval for this type application. Note table below.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Particle Size (MMAD): 1.5 um
Aerosol Generation Rate (static): 0.23 ml/min.
Aerosol Generation Rate (enhanced): 0.42 ml/min.
Dead Volume: 0.72 ml
Drive Gas/Flow Rate: 6-8 LPM (Air/Oxygen)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SECTION V.
page 1 of 1
510(k) SUMMARY Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System
| Manufacturer: | Medi/Nuclear Corporation, Inc.
4610 Littlejohn Street
Baldwin Park, CA 91706 | NOV 26 2008 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Regulatory Affairs Contact: | Jerry Schoen | |
| Telephone: | (626) 960-9822 | |
| Date Summary Prepared: | August 22, 2008 | |
| Trade Name: | Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System | |
| Classification: | Class II per 21CFR 868.5630 | |
| Predicate Device: | PARI LC Star Nebulizer K061381 and K963924 | |
| Description: | The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is a
miniaturized nebulizer attached to a valved manifold. During patient
inhalation, aerosol mist being generated from the nebulizer is
substantially increased through Breath-Enhancement technology, and
configuration is such that a filter can be added to the air exit port if so
desired. | |
| Intended Use: | The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is
indicated to aerosolize medication approved for nebulization and
prescribed by a physician. This Healthline MEDICATOR®/RediNeb®
Aerosol Drug Delivery System is intended for adult and pediatric
patients consistent with the indications for delivery of aerosolized
medication to/or through the patient's pulmonary system. | |
| | The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is for
patient use in all areas where the administration of medication by
aerosol means is warranted. This includes hospital/institutional
settings, home care use, schools, and long term care facilities. | |
| Substantial Equivalence: | Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System
is substantially equivalent to the PARI LC Star nebulizer. | |
| Summary of Testing: | All materials used in the fabrication of the Healthline
MEDICATOR®/RediNeb® Aerosol Drug Delivery System is currently
in use in the manufacture of similar nebulizer devices and have FDA
approval for this type application. Note table below. | |
| Feature or Specification | Predicate PARI LC-Star | Healthline MEDICATOR®/RediNeb® |
|---|---|---|
| Particle Size (MMAD) | 2.0 um | 1.5 um |
| Aerosol Generation Rate | ||
| (static) | 0.26 ml/min. | 0.23 ml/min. |
| Aerosol Generation Rate | ||
| (enhanced) | 0.38 ml/min. | 0.42 ml/min. |
| Dead Volume | 1.0 ml | 0.72 ml |
| Drive Gas/Flow Rate | 6-8 LPM | 6-8 LPM |
| (Air/Oxygen) | (Air/Oxygen) | |
| Intended Use | Same | Same |
510(k) Premarket Notification
Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2008
Mr. Jerry Schoen, Chief Operating Officer Medi/Nuclear Corporation, Incorporated 4610 Littlejohn Street Baldwin Park, California 91706
Re: K082541
Trade/Devicc Name: MEDICATOR® / RediNeb® Regulation Number: 21 CFR 868.5630 Regulation Namc: Nebulizer Regulatory Class: II Product Code: CAF Dated: August 28, 2008 Received: September 2, 2008
Dear Mr. Schoen:
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.
2
Page 2 - Mr. Schoen
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Snute y. Mckee mas
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
3
Section IV.
Indications for Use Statement
510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________
Device Name: MEDICATOR® Aerosol Drug Delivery System is indicated to aerosolize medication approved for nebulization and prescribed by a physician. This Healthline medication nebulizer device is intended for adult and pediative by a "physical." This "Healthine medications for delivery of aerosolized medication to-or-through the patient's pulmonary system.
The MEDICATOR® /RediNeb® Nebulizer device is for patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools and long term care facilities.
R
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: Korasy,
Concurrence of CDRH, Office of Device Evaluation (ODE):
OR
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Co
Over-The-Counter Use ___________________
510(k) Premarket Notification Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System