SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G

K023745 · Sechrist Industries, Inc. · DTX · Jan 17, 2003 · Cardiovascular

Device Facts

• Record ID: K023745
• Device Name: SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
• Applicant: Sechrist Industries, Inc.
• Product Code: DTX · Cardiovascular
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Sechrist Model 3500CP-G Air/Oxygen Mixer is to enable qualified personnel to mix medical grade air and medical grade oxygen at operator selected ratios, for delivery to patients through various types of respiratory care and heart bypass oxygenation equipment.

Device Story

Precision pressure regulation and proportioning device; inputs pressurized medical grade air and oxygen (nominal 50 psi, range 30-70 psi) via D.I.S.S. inlet connections; mixes gases at operator-selected ratios; provides mixed gas via two outlets; configured with zero to three flowmeters; accessories include air and oxygen hoses; used in clinical settings for respiratory care and cardiopulmonary bypass; operated by qualified healthcare personnel; output enables precise gas delivery for patient ventilation or oxygenation; benefits include controlled gas concentration for patient support.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Precision pressure regulation and proportioning device; D.I.S.S. inlet connections; operates at 30-70 psi; two gas outlets; zero to three flowmeters; manufactured per ISO 9001 and ISO 13485 quality standards.

Indications for Use

Indicated for use by qualified personnel to mix medical grade air and oxygen at operator-selected ratios for delivery to patients via respiratory care or cardiopulmonary bypass oxygenation equipment.

Regulatory Classification

Identification

A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.

Predicate Devices

• Sechrist Air/Oxygen Mixer (K802226)
• Sechrist Air/Oxygen Mixer (K992503)
• Sechrist Air/Oxygen Mixer (K841789)
• Modified Sarns Membrane Oxygenator (K863902)
• Portable Bypass System, Model 1000 (K901253)

Submission Summary (Full Text)

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

K623745

#### 510(k) SUMMARY

#### Device Name:

JAN 1 7 2003

| Classification Name: | Breathing Gas Mixer |
|----------------------|------------------------------------|
| Common Name: | Gas Mixer |
| Proprietary Name: | Sechrist 3500CP-G Air/Oxygen Mixer |

### Devices to which

| Equivalence is Claimed: | K802226 Sechrist Air/Oxygen Mixer |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K992503 Sechrist Air/Oxygen Mixer |
| | K841789 Sechrist Air/Oxygen Mixer (Shiley, Inc.) |
| | K863902 Modified Sarns Membrane Oxygenator (Sarns, Inc./3M) |
| | K901253 (PBS) Portable Bypass System, Model 1000<br>Bio-Medicus |
| Contact: | Greg Godfrey, Vice President,<br>Quality Assurance & Regulatory Affairs<br>4225 E. La Palma Ave.<br>Anaheim, CA 92807<br>Phone: [phone]<br>Fax: [phone] |

### Indications for Use:

The intended use of the Sechrist Model 3500CP-G Air/Oxygen Mixer is to enable qualified personnel to mix medical grade air and medical grade oxygen at operator selected ratios, for delivery to patients through various types of respiratory care and heart bypass oxygenation equipment.

## Device Description:

The Sechrist Model Series 3500CP-G Air/Oxygen Mixer is a precision pressure regulation and proportioning device which is intended to mix medical grade air and medical grade oxygen. The mixer receives pressurized air and oxygen, at a nominal 50 psi, via Diameter Index Safety System (D.I.S.S.) inlet connections. The unit will operate satisfactorily with inlet pressures of 30 to 70 psi, providing the pressures are within 20 psi of one another. Two outlets for the mixed gas are provided. The air/oxygen mixers are configured with zero to three flowmeters. Accessories include air and oxygen hoses.

## Performance Standards:

A performance standard regulation under Section 514 of the Food, Drug and Cosmetic Act has not been promulgated for this device type. However, the device is designed and manufactured in accordance wit the following national and international standards:

| ISO 9001 | Quality Assurance Standard |
|-----------|------------------------------------------|
| ISO 13485 | Quality System Standard, Medical Devices |

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

## 510(k) SUMMARY

Application of ISO 9001 to manufacture of medical devices EN 46001 21 CFR 820 Quality System Regulation

### Summarv of Substantial Equivalence:

The Sechrist 3500CP-G (3500/3500HL Model Series) was originally cleared under 510(k)'s K802226 and K992503 to mix Medical Grade Air and Medical Grade Oxygen at operator selected ratios, for delivery through various types of respiratory care equipment.

The indications for use were revised to include the use of the 3500CP-G Sechrist Air/Oxygen Mixer to provide mixed Medical Grade Air and Medical Grade Oxygen for cardiopulmonary bypass purposes. This use was previously cleared for the Sechrist Air/Oxygen Mixer under 510(k) Numbers K841789, by Shiley, Inc., K863902, by Sarns Inc., and K901253, Bio-Medicus.

### Conclusion:

The device is substantially equivalent to the devices previously cleared under the above referenced 510(k) numbers.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

Sechrist Industries, Inc. c/o Mr. Greg Godfrey 4225 E. La Palma Avenue Anaheim, CA 92807

Re: K023745

Sechrist 3500CP-G Air/Oxygen Mixer Regulation Number: 21 CFR 870.4300 Regulation Name: CPB Gas Control Unit Regulatory Class: Class II (two) Product Code: DTX Dated: November 4, 2002 Received: November 7, 2002

Dear Mr. Godfrey:

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.

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

Page 2 – Mr. Greg Godfrey

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]. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Voleg Till
Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use Statement

510(k) Number (if known): __

Sechrist 3500CP-G Air/Oxygen Mixer Device Name:

Indications for Use:

The intended use of the Sechrist Model 3500CP-G Air/Oxygen Mixer is to enable qualified personnel to mix medical grade air and medical grade oxygen at operator selected ratios, for delivery to patients through various types of respiratory care and heart bypass oxygenation equipment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

OR

Over-The-Counter

(Optional Format 1-1-96

Odetteer

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K023745