MEDICAL DEPOT POWER NEB 1

K012006 · Medical Depot, Inc. · CAF · Jul 13, 2001 · Anesthesiology

Device Facts

• Record ID: K012006
• Device Name: MEDICAL DEPOT POWER NEB 1
• Applicant: Medical Depot, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Jul 13, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Medical Depot is intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.

Device Story

Medical Depot Power Neb I is a medical-grade air compressor designed for home health care. It functions as a power source for pneumatic nebulizers; it converts electrical energy into compressed air. This compressed air drives the nebulizer to aerosolize liquid medication into a fine mist for patient inhalation. The device is operated by patients or caregivers in a home environment. By facilitating the delivery of respiratory medication, it assists in the management of respiratory disorders. The device utilizes a membrane compressor mechanism, distinguishing it from piston-based models.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Membrane-based air compressor; provides compressed air for pneumatic nebulization; home-use form factor; electrical power source.

Indications for Use

Indicated for children and adults suffering from respiratory disorders requiring aerosolized medication therapy via a pneumatic nebulizer in a home health care setting.

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

• Medical Depot Power Neb II (K00334)
• John Bunn Model 510 Medication Compressor (K86262)

Reference Devices

• Graham - Field Mini-Mist II

Submission Summary (Full Text)

{0}------------------------------------------------

# K012006

JUL 1 3 2001

## 510(K) SUMMARY (as required by 807.92(c))

| Submitter of 510(k): | Medical Depot, Inc.<br>55 Sea Lane<br>Farmingdale, NY 11735 | |
|----------------------|-------------------------------------------------------------------------|------------------------------|
| | Phone:<br>Fax: | 631-420-4134<br>631-420-4168 |
| Contact Person: | Harvey Diamond | |
| Date of Summary: | May 1, 2001 | |
| Trade Name: | Medical Depot Power Neb I | |
| Classification Name: | Nebulizer | |
| Predicate Device: | Medical Depot Power Neb II<br>John Bunn Model 510 Medication Compressor | K00334<br>K86262 |

### Device Comparison/Description:

The Medical Depot Nebulizer Device is the same as our Power Neb II except with a membrane rather than a piston compressor. It is also the same as the Graham - Field Mini-Mist II which was originally cleared by John Bunn Company and has the same compressor as this device.

### Intended Use:

The Medical Depot is intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized, wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUL 1 3 2001

Medical Depot, Inc. c/o Art Ward Regulatory and Marketing Services, Inc. 962 Allegro Lane Apollo Beach, FL 33572

Re: K012006

Medical Depot Power Neb I Regulation Number: 868.5630 Regulatory Class: II (two) Product Code: 73 CAF Dated: May 1, 2001 Received: June 27, 2001

#### Dear Mr. Ward:

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 regulation (21 CFR Part 820) and that, through periodic OS 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

{2}------------------------------------------------

### Page 2 - Mr. Art Ward

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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Arth A. CarhartL.

Yr James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known): K012006

Device Name: Medical Depot Power Neb I

### Indications For Use:

The Medical Depot is intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

- Aoh A. Cia U. fr. IED

Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)