PRECISION BLENDER

K053232 · Precision Medical, Inc. · BZR · Jan 10, 2006 · Anesthesiology

Device Facts

• Record ID: K053232
• Device Name: PRECISION BLENDER
• Applicant: Precision Medical, Inc.
• Product Code: BZR · Anesthesiology
• Decision Date: Jan 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5330
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Precision Medical Inc. Air and oxygen blender is designed to dispense a continuous and precise blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients. The exact FIO2 blend of gases corresponds to the dialed in Fractional Concentration of Oxygen (FiO2) setting indicated by the control face.

Device Story

Precision Medical Blender is a gas mixing device for hospital use by qualified personnel under physician direction. It receives pressurized medical air and oxygen (30-75 psi) as inputs; internal mechanism blends gases to a precise FiO2 (21-100%) based on user-dialed control face settings. Output is a continuous flow of blended gas delivered via outlet ports to patients. Available in high-flow (up to 120 lpm) and low-flow (up to 30 lpm) models. Includes an integrated alarm system that triggers at 80 dB if inlet gas pressure differential exceeds 6 psi. Device assists clinicians in providing controlled oxygen therapy; benefits include precise titration of oxygen concentration for respiratory support.

Clinical Evidence

Bench testing only. Performance testing evaluated mechanical and climatic device performance, including flow accuracy, pressure drop, and alarm functionality. No clinical data provided.

Technological Characteristics

Mechanical gas blender; pneumatic operation. Two models: PM 5200 (high flow) and PM 5300 (low flow). Oxygen range 21-100%; accuracy ±3% of full scale. Inlet pressure 30-75 psi; requires air/O2 pressure within 10 psi. Integrated pressure differential alarm (80 dB at 1 foot). Dimensions: 3.5" x 2.25" x 5.25". Weight: 2.25 lbs. Operating temperature 59°F to 104°F. No software or electronic components.

Indications for Use

Indicated for delivery of blended air and oxygen in hospital settings to infant, pediatric, and adult patients. Oxygen concentrations adjustable from 21% to 100%. Not intended as a life-supporting device.

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

• Bio-Med Blender (K925982)

Submission Summary (Full Text)

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# 510(k) Summary

# Precision Medical, Inc. Blender

# 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: | November 17, 2005 |
| Device Name | |
| Proprietary Name: | Precision Blender |
| Common Name: | Oxygen Blender |
| Classification Name:<br>Two models: | Blender, Oxygen Unit (73 BYJ) as per CFR 868.5330 |
| Low flow Blender | PM 5300 flow, range 0 to 30 liters per minute |

#### High flow blender PM 5200 flow, range 2 to 120 liters per minute

# Predicate Device Equivalence

Precision Medical, Inc. is claiming substantial equivalence to the Bio-Med Blender 510K # K925982

## Device Description

The Precision Medical, Inc. Air and 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 air/oxygen mixtures is required.

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# Intended Use

The Precision Medical Inc. Air and oxygen blender is designed to dispense a continuous and precise blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients. The exact FIO2 blend of gases corresponds to the dialed in Fractional Concentration of Oxygen (FiO2) setting indicated by the control face.

| Manufacturer | BIO-Med Blender | Precision Medical, Inc. |
|---------------------------|--------------------------------------------------------|--------------------------------------------------------|
| Dimensions | H 3 ½ "x W 2 ¼" D 2 ⅞ " | H 3 ½ " W 2 ¼ " 5 ¼ " |
| Weight | 2 ¼ lbs | 2 ¼ lbs |
| Oxygen % Range | 21 to 100% | 21 to 100% |
| Accuracy | ± 3% of full scale | ± 3% of full scale |
| Supply Pressure | 30-75 psi air + O2 must be within 10 psi of each other | 30-75 psi air + O2 must be within 10 psi of each other |
| Max Flow (High Flow) | ≥ 120 lpm @60% setting at 50psi inlet pressures | ≥ 120 lpm @60% setting at 50psi inlet pressures |
| Pressure Drop (high flow) | ≤ 6 psi at 50 psi inlet pressure and 40 lpm flow | ≤ 6 psi at 50 psi inlet pressure and 40 lpm flow |
| Alarm/Bypass Reset | When inlet gas pressure differential is ≤ 6 psi | When inlet gas pressure differential is ≤ 6 psi |
| Alarm intensity | 80 db at 1 foot | 80 db at 1 foot |
| Operating temperature | 59° 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 | BIO-Med Blender | Precision Medical, Inc. |
|--------------------------|-------------------------------------------------------|-------------------------------------------------------|
| Max Flow ( Low Flow) | $\geq$ 30 lpm @60% setting at 50psi inlet pressures | $\geq$ 30 lpm @60% setting at 50psi inlet pressures |
| Pressure Drop (low flow) | $\leq$ 6 psi at 50 psi inlet pressure and 10 lpm flow | $\leq$ 6 psi at 50 psi inlet pressure and 10 lpm flow |

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# Summary of Performance Testing

The Precision Medical, Inc. Blender will successfully pass tests in the following areas; Mechanical / Climatic Device Performance

### Conclusions

In Summary, Precision Medical, Inc. has demonstrated that the Precision Medical, Inc. oxygen blender is safe and effective. The combined testing and analysis of results provides assurance that the device meets the specifications and is safe and effective for the intended use.

## Risk Analysis

Precision Medical, Inc. is using International Standard ISO 14971 Medical Devices Application of Risk management to medical devices Risk analysis has been completed for this device. This document will be updated and released as part of design control.

#### Design control

Precision Medical, Inc. is in compliance with 21 CFR 820.30 for design control. The design inputs/outputs matrix has been developed using form PMF 202. These documents will be completed before the release of the product.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN I 0 2006

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

Re: K053232

Trade/Device Name: Precision Medical, Inc Blender Regulation Number: 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR Dated: November 17, 2005 Received: November 18, 2005

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 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. 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); 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.

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 Office 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 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,

Sygite Y. Michael Oms.

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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510 (k) number (if known)

Device Name: Precision Medical, Inc.Blender

#### Indications for use:

The Precision Medical, Inc. Blender Oxygen System is intended to deliver blended air and oxygen in a Hospital setting. Oxygen concentrations can be dialed in from 21% to 100%. 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)

Smitte Y. Michie Omd.

Oral, Dental Devices