MINIMATE COMPRESSOR

K051691 · Precision Medical, Inc. · BTI · Dec 9, 2005 · Anesthesiology

Device Facts

• Record ID: K051691
• Device Name: MINIMATE COMPRESSOR
• Applicant: Precision Medical, Inc.
• Product Code: BTI · Anesthesiology
• Decision Date: Dec 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide compressed air for a hand held medication small volume nebulizer. Not for continuous use. Use must be limited to maximum 30 minute intervals.

Device Story

The MiniMate compressor is a portable device designed to provide an oil-free air supply to a hand-held small volume nebulizer. It consists of a 1/30 hp electrical motor, a self-lubricating piston-type compressor, and a protective housing that reduces noise and dampens vibration. The device is intended for intermittent use, with operation limited to 30-minute intervals. It is not a life-supporting device. The compressor provides the necessary airflow to aerosolize medication for patient inhalation. It is intended for use in clinical or home settings to assist in respiratory therapy.

Clinical Evidence

Bench testing only. The device successfully passed mechanical, climatic, and electrical performance testing.

Technological Characteristics

Piston-type compressor; 1/30 hp electric motor; self-lubricating (oil-free air supply); protective housing for noise reduction and vibration dampening; portable form factor.

Indications for Use

Indicated for patients requiring compressed air for a hand-held small volume nebulizer. Not intended for life support or continuous use; limited to 30-minute intervals.

Regulatory Classification

Identification

A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

Predicate Devices

• Precision Medical Care Mist compressor (K923324)

Submission Summary (Full Text)

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510K Precision Medical PM5

K051691

#### DEC 9 2005

## 510(k) Summary

# Precision Medical, Inc. Portable Liquid Oxygen System

#### Submitter Information

| Submitter | Precision Medical, Inc.<br>300 Held Drive<br>Northampton, Pa.<br>18067 |
|-------------------|------------------------------------------------------------------------|
| Contact | James Parker<br>Quality Assurance Manager |
| Tel:<br>Fax: | (610)-262-6090 Extensions 228<br>(610)-262-6080 |
| Preparation Date: | June 20, 2005 |

#### Device Name

| Proprietary Name: | Minimate compressor |
|-----------------------|---------------------------------|
| Common Name: | Portable Nebulizer Compressor |
| Classification Name: | Compressor, Air , Portable/73BT |
| Device classification | Class II |
| Classification Number | 868.6250 |

#### Predicate Device Equivalence

Precision Medical, Inc. is claiming substantial equivalence to Precision Medical Care Mist compressor/ K923324/A

#### Device Description

The compressor is made up of three basic sections

- l. Electrical motor
- 2. Compressor
- 3. Housing

A 1/30 hp electrical motor drives the air compressor.

The compressor is a piston type, which is self lubricating, thus providing a oil free, air supply to the nebulizer.

The housing provides protection for the components, reduces noise, and dampens the vibration from the compressor. The housing also protects the end user from the components of the device.

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### Intended Use

To provide compressed air for a hand held medication small volume nebulizer. Not for continuous use. Use must be limited to maximum 30 minute intervals.

#### Comparison of Technological Characteristics

Precision Medical Inc is claiming equivalence to the Precision Medical, Inc. Care mist compressor Summary of Performance Testing

The Precision Medical, Inc. Minimate compressor PM5 successfully passed tests in the following areas; Mechanical / Climatic Electrical Device Performance

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### Conclusions

In Summary, Precision Medical, Inc. has demonstrated that the Precision Medical, Minimate compressor PM5 system is safe and effective. The combined testing and analysis of results provides assurance that the device meets it's specifications and is safe and effective for it's intended use.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle, with the words oriented to follow the circular shape.

DEC 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Parker Quality Assurance Manager Precision Medical, Incorporated 300 Held Drive Northampton, Pennsylvania 18067

Re: K051691

Trade/Device Name: Precision Medical, Inc. MiniMate Compressor Regulation Number: 21 CFR 868.6250 Regulation Name: Portable Nebulizer Compressor Regulatory Class: II Product Code: BTI Dated: November 3, 2005 Received: November 4, 2005

Dear Mr. Parker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have to row and have determined the device is substantially equivalent (for the relevelocal above and have acteringlosure) to legally marketed predicate devices marketed in multions for ass batter to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Antendinent, or to do roos 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 approvisions of the Act. The general controls provisions of the Act include controls provisions or 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 If your device is classinod (200 a0010). Existing major regulations affecting (1 Nr.), it har be casyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Parker

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 modifine and regulations and regulations administered by other Federal agencies. of the Act of ally I ederal bake is requirements, including, but not limited to: registration r our mast compry was a many (21 CFR Part 801); good manufacturing practice alla listing (21 OF Fire at 807), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in the quality sion 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) This letter will and w yourse even 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), rf you desire specific at no of Compliance at [phone]. 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 may overn 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,

Gyette y. Michin Omd.

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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12/8/2005510KPMCopy of 510kPM5compressor120805.doc

# Indications for Use

510 (k) number (if known)

Device Name: Precision Medical, Inc.MiniMate compressor

### Indications for use:

The Precision Medical, Inc. Minimate compressor is intended to provide The Precision Medical, "the "Minimate" ". The device is intended to be used Comprossed un 10 a this not intended as a life supporting device.

Prescription Use _X (Part 21 CFR 801 Subpart D) And /Or

Over the counter use (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)

hum Saliom

(Division Sign-Off) (Division Sign-Old)
Division of Anesthesiology, General Hospital. Division Control, Dentai Devices

510(k) Number