HELIO2 BLENDER

K090781 · Precision Medical, Inc. · BZR · Aug 13, 2009 · Anesthesiology

Device Facts

• Record ID: K090781
• Device Name: HELIO2 BLENDER
• Applicant: Precision Medical, Inc.
• Product Code: BZR · Anesthesiology
• Decision Date: Aug 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Precision Medical, Inc. Heliox Blender Oxygen System is intendcd to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium. The blender is not intended as a life supporting device.

Device Story

Precision Medical HeliO2 Blender delivers blended Helium-Oxygen gas mixtures in hospital settings. Device accepts pressurized Helium and Oxygen gas inputs; internal blending mechanism mixes gases based on user-dialed concentration settings. Output is a controlled Heliox/Oxygen mixture for patient delivery. Operated by qualified/trained personnel under physician direction. Device features include alarm/bypass reset for inlet pressure differentials. Not intended for life support. Benefits include precise control of gas concentration for therapeutic delivery.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Mechanical gas blender. Dimensions: 3.5" x 2.25" x 5.25". Weight: 2.75 lbs. Supply pressure: 30-75 psi (inlet pressures must be within 10 psi of each other). Accuracy: ± 3% of full scale. Alarm/bypass reset: ≤ 6 psi differential. Operating temperature: 59°F to 104°F. No software or electronic components.

Indications for Use

Indicated for hospital patients requiring delivery of blended Helium and oxygen. Oxygen concentrations adjustable 20-100% for 20/80 O2/He mixtures and 30-100% for 30/70 O2/He mixtures. Not for life support.

Regulatory Classification

Identification

A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.

Predicate Devices

• Precision Medical, Inc. oxygen blender (K053232)

Submission Summary (Full Text)

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K090781

# 510(k) Summary

# Precision Medical, Inc. Blender

#### Submitter Information

| Submitter | Precision Medical, Inc.<br>300 Held Drive<br>Northampton, Pa.<br>18067 | AUG 1 3 2009 |
|-----------------------|---------------------------------------------------------------------------------|--------------|
| Contact | James Parker<br>Quality Assurance Manager | |
| Tel:<br>Fax:<br>Email | (610)-262-6090 Extensions 228<br>(610)-262-6080<br>[e-mail] | |
| Preparation Date: | March 20, 2009 | |
| Device Name | | |

| Proprietary Name: | HeliO2 Blender |
|----------------------|------------------------------------------------------|
| Common Name: | Helium- Oxygen Blender |
| Classification Name: | Blender, HeliO2 Unit (BZR) as per CFR 868.5330 |
| Two models: | |
| Low flow Blender | PM 5470/5480 flow, range 2 to 30 liters per minute |
| High flow blender | PM 5580/5570 flow, range 15 to 120 liters per minute |

# Predicate Device Equivalence

510K # K053232

Precision Medical, Inc. is claiming substantial to Precision Medical, Inc. oxygen blender same as oxygen blender except air fitting has been replaced with helium male fitting and scale on dial has been altered to add the Helium to the concentration.

### Four models will be marketed

- 1. Low flow HeliO2 uses 70/30 helium to oxygen mixture
- 2. Low Flow HeliO2 uses 80/20 helium to oxygen mixture
- 3. Hi Flow HeliO2 uses 70/30 helium to oxygen mixture
- 4. Hi Flow HeliO2 uses 80/20 helium to oxygen mixture.

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## Device Description

The Precision Medical, Inc. Heliox/oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of Heliox/oxygen mixtures are required.

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### Intended Use

The Precision Medical, Inc. Heliox Blender Oxygen System is intendcd to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium.

The blender is not intended as a life supporting device.

| Manufacturer | Precision Medical, Inc.<br>Heliox/oxygen blender | Precision Medical, Inc.<br>air/oxygen blender |
|---------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Dimensions | H 3 ½ " W 2 ¼ " 5 ¼ " | H 3 ½ " W 2 ¼ " 5 ¼ " |
| Weight | 2 ¾ lbs | 2 ¾ lbs |
| Oxygen % Range | 20 to 100% and 30 to 100% | 21 to 100% |
| Accuracy | ± 3% of full scale | ± 3% of full scale |
| Supply Pressure | 30-75 psi Heliox + O2 must<br>be within 10 psi of each<br>other | 30-75 psi air + O2 must be<br>within 10 psi of each other |
| Max Flow (High Flow) | ≥ 120 lpm @60% setting at<br>50psi inlet pressures | ≥ 120 lpm @60% setting at<br>50psi inlet pressures |
| Pressure Drop (high flow) | ≤ 3 psi at inlet pressures<br>from 30-90 psi and at<br>30lpmflow rate at 60%<br>FiO2 | ≤ 6 psi at 50 psi inlet<br>pressure and 40 lpm flow |
| Alarm/Bypass Reset | When inlet gas pressure<br>differential is ≤ 6 psi | When inlet gas pressure<br>differential is ≤ 6 psi |
| Alarm intensity | ≥80 db at 1 foot | 80 db at 1 foot |
| Operating temperature | 59°F to 104°F | 59°F to 104°F |

## Table of Comparisons to Predicate Device

The low flow model has the same characteristics as listed above, with the Max flow and the pressure drop being the only differences.

| Manufacturer | Precision Medical, Inc.<br>Heliox/oxygen blender | Precision Medical, Inc.<br>air/oxygen blender |
|--------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------|
| Max Flow ( Low Flow) | $\ge$ 30 lpm @60% setting at<br>50psi inlet pressures | $\ge$ 30 lpm @60% setting at<br>50psi inlet pressures |
| Pressure Drop (low flow) | $\le$ 2 psi at 30-90 psi inlet<br>pressure and 10 lpm flow<br>Rate at 60%FiO2 | $\le$ 6 psi at 50 psi inlet<br>pressure and 10 lpm flow |

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

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

AUG 1 3 2009

Re: K090781

Trade/Device Name: Helium-Oxygen Blender Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR Dated: August 10, 2009 Received: August 11, 2009

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.

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 (QS) 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Arthur Dimock

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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#### 510 (k) number K090781

Device Name: Precision Medical, Inc. Helium-Oxygen Blender

# Indications for use:

The Precision Medical, Inc. Heliox Blender Oxygen System is intended to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium.

The blender is not intended as a life supporting device.

Prescription Use X (Per 21 CFR 801.109) Or

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

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

L. Schutter

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

510(k) Number: K090781