PRECISION LIQUID OXYGEN SYSTEM

K103324 · Precision Medical, Inc. · BYJ · Apr 21, 2011 · Anesthesiology

Device Facts

• Record ID: K103324
• Device Name: PRECISION LIQUID OXYGEN SYSTEM
• Applicant: Precision Medical, Inc.
• Product Code: BYJ · Anesthesiology
• Decision Date: Apr 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5655
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Precision Medical, Inc. Easy Mate 6+6 is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The Easy Mate 6+6 deliver 100% oxygen at 5 Conserved settings or 6 continuous flow settings. The device is intended to be used as ambulatory source of oxygen both inside and outside of the patient's home.

Device Story

Easy Mate 6+6 is a portable liquid oxygen system; functions as an ambulatory oxygen source for patients with respiratory difficulties. Device consists of a vacuum-insulated cryogenic container, pressure relief valve, and pneumatic conserver. Liquid oxygen stored under pressure is warmed via a heat exchange system to transition into a gaseous state for patient delivery. Delivers 100% oxygen at 5 conserved settings or 6 continuous flow settings. Filled by connecting to a larger stationary liquid oxygen reservoir. Operated by the patient or caregiver in home or ambulatory settings. Mechanical device; contains no electrical components. Provides supplemental oxygen to improve patient mobility and respiratory support.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified through mechanical and climatic testing.

Technological Characteristics

Vacuum-insulated cryogenic container; pneumatic conserver; mechanical heat exchange system. No electrical components. Portable form factor. Intended for use with stationary liquid oxygen reservoir filling systems.

Indications for Use

Indicated for patients requiring supplemental oxygen due to difficulty extracting oxygen from ambient air. Administered via nasal cannula. Intended for ambulatory use in home and clinical settings.

Regulatory Classification

Identification

A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.

Predicate Devices

• Precision Medical 2200 liquid oxygen system (K041122)

Submission Summary (Full Text)

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Liquid system 510K 6+6

# APR 2 1 2011 510(k) Summary Precision Medical, Inc. Easymate 6+6

103324

## Submitter Information

Submitter

Precision Medical, Inc. 300 Held Drive Northampton, Pa. 18067

FDA registration number:

Contact

2523148

James Parker Quality Assurance Manager

Tel: Fax: [phone] Extensions 228 (610)-262-6080

Preparation Date: April 6, 2011

Device Name

Easy Mate 6+6

Proprietary Name: Common Name: Classification Name: Precision Liquid Oxygen System Portable Liquid Oxygen Unit Portable Liquid Oxygen Unit (73 BYJ) as per CFR 868.5655

Class II Device

### Predicate Device Equivalence

Precision Medical, Inc. is claiming substantial equivalence to the Precision Medical 2200 liquid oxygen system K041122

#### Intended Use

The Precision Medical, Inc. Easy Mate 6+6 is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The Easy Mate 6+6 deliver 100% oxygen at 5 Conserved settings or 6 continuous flow settings. The device is intended to be used as ambulatory source of oxygen both inside and outside of the patient's home.

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### Device Description

The Precision Medical, Inc. Easy Mate 6+6 consists of a Vacuum insulated cryogenic container that includes a pressure relief valve and a pneumatic conserver. The vacuum insulated container allows oxygen to be stored in a liquid state under pressure. When the control valve is positioned to deliver, liquid oxygen inside the container is warmed and changes to gaseous state. The gas is than allowed to be released to the patient at the set rate. The device is intended to be used with a larger stationary liquid Oxygen reservoir, where it is filled by a connection that allows the portable Device to be filled by the larger reservoir. The Precision Medical Inc Easy Mate 6+6 Is a mechanical device containing no electrical components.

## Comparison of Technological Characteristics

and the Easy Mate 6+6 include a vacuum insulated cryogenic The Easy Mate container heat exchange system, and a pneumatic conserver Both devices are intended only as sources of supplemental oxygen and are not intended to be lifesupporting devices.

### Summary of Performance Testing

The Precision Medical, Inc. Easy Mate 6+6 has successfully passed tests in the following areas;

Mechanical / Climatic

Device Performance

#### Conclusions

In Summary, Precision Medical, Inc. has demonstrated that the Precision Medical, Inc. Easy Mate 6+6 is safe and effective. The combined testing and analysis of results provides assurance that the device meet the specifications and is safe and effective for the intended use.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

APR 2 1 2011

Re: K103324

Trade/Device Name: Precision Medical, Inc. Easy Mate 6+6 Regulation Number: 21 CFR 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: April 7, 2011 Received: April 8, 2011

Dear Mr. Parker:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for.

Anthony D. Watson, B.S., M.S., M.B.A. 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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#### 510 (k) number 103324

Device Name: Precision Medical, Inc. Easy Mate 6+6 Indications for use:

The Precision Medical, Inc. Easy Mate 6 + 6 are intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. These patients would normally receive the oxygen via a nasal cannula. The systems delivers 100% oxygen at different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home.

(Please do not write below this line- continue on another page if needed) Concurrence of CDRH, office of device Evaluation (ODE)

Prescription Use: X (Per 21 CFR 801.109) Or

Over the counter use (Optional Format 1-2-9)

signature

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K183324