HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM

K082541 · Medi Nuclear Corp., Inc. · CAF · Nov 26, 2008 · Anesthesiology

Device Facts

• Record ID: K082541
• Device Name: HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM
• Applicant: Medi Nuclear Corp., Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Nov 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Miniaturized nebulizer attached to valved manifold; utilizes Breath-Enhancement technology to increase aerosol mist output during patient inhalation. Device accepts liquid medication for nebulization; requires external drive gas (air/oxygen) at 6-8 LPM. Optional filter attachment available at air exit port. Used in hospitals, home care, schools, and long-term care facilities by patients or caregivers. Provides aerosolized medication to pulmonary system; enhances drug delivery efficiency compared to standard nebulization. Benefits patient by facilitating effective administration of prescribed respiratory medications.

Clinical Evidence

Bench testing only. Performance comparison provided for particle size (MMAD), aerosol generation rate (static and enhanced), and dead volume against the predicate device.

Technological Characteristics

Miniaturized nebulizer with valved manifold; Breath-Enhancement technology. Drive gas: 6-8 LPM (Air/Oxygen). MMAD: 1.5 um. Dead volume: 0.72 ml. Materials: currently used in similar FDA-cleared nebulizers. No software or electronic components.

Indications for Use

Indicated for adult and pediatric patients requiring aerosolized medication delivery to the pulmonary system via physician-prescribed nebulization.

Regulatory Classification

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.

Predicate Devices

• PARI LC Star Nebulizer (K061381)
• PARI LC Star Nebulizer (K963924)

Submission Summary (Full Text)

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## SECTION V.

K082541

page 1 of 1

# 510(k) SUMMARY Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System

| Manufacturer: | Medi/Nuclear Corporation, Inc.<br>4610 Littlejohn Street<br>Baldwin Park, CA 91706 | NOV 26 2008 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Regulatory Affairs Contact: | Jerry Schoen | |
| Telephone: | [phone] | |
| 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<br>miniaturized nebulizer attached to a valved manifold. During patient<br>inhalation, aerosol mist being generated from the nebulizer is<br>substantially increased through Breath-Enhancement technology, and<br>configuration is such that a filter can be added to the air exit port if so<br>desired. | |
| Intended Use: | The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is<br>indicated to aerosolize medication approved for nebulization and<br>prescribed by a physician. This Healthline MEDICATOR®/RediNeb®<br>Aerosol Drug Delivery System is intended for adult and pediatric<br>patients consistent with the indications for delivery of aerosolized<br>medication to/or through the patient's pulmonary system. | |
| | The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is for<br>patient use in all areas where the administration of medication by<br>aerosol means is warranted. This includes hospital/institutional<br>settings, home care use, schools, and long term care facilities. | |
| Substantial Equivalence: | Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System<br>is substantially equivalent to the PARI LC Star nebulizer. | |
| Summary of Testing: | All materials used in the fabrication of the Healthline<br>MEDICATOR®/RediNeb® Aerosol Drug Delivery System is currently<br>in use in the manufacture of similar nebulizer devices and have FDA<br>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<br>(static) | 0.26 ml/min. | 0.23 ml/min. |
| Aerosol Generation Rate<br>(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

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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.

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#### 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 [phone]. 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 [phone] or [phone] 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

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### 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