SERVO GUARD, MODEL 64 81 290 EH88E

K030071 · Maquet, Inc. · CAH · Apr 26, 2004 · Anesthesiology

Device Facts

• Record ID: K030071
• Device Name: SERVO GUARD, MODEL 64 81 290 EH88E
• Applicant: Maquet, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Apr 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Servo Guard is an efficient bacterial and viral filter for applications in respiratory care and anestheria. The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment.

Device Story

Servo Guard is a disposable, single-use bacterial and viral filter for respiratory care and anesthesia circuits. Device placed in inspiratory or expiratory limbs of breathing circuits to reduce cross-contamination between patient and equipment. Operated by qualified medical personnel in clinical settings. Provides mechanical filtration of gases; no electronic or software components.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Disposable, single-use bacterial/viral filter for breathing circuits. Mechanical filtration principle. Compatible with both inspiratory and expiratory limbs. No energy source, software, or connectivity.

Indications for Use

Indicated for adult, pediatric, and infant populations requiring respiratory care or anesthesia. Intended for use by qualified medical personnel only to reduce cross-contamination between patient and equipment.

Regulatory Classification

Identification

A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.

Predicate Devices

• Siemens Main Flow Bacteria Filter (K871366)
• End expiratory filter, Model RT020 (K002839)

Submission Summary (Full Text)

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APR 2 6 2004

Servo Guard -510(k) Sun

| | Document Type<br>Traditional 510(k) | Section-Page<br>E-2 |
|-----------------------|-------------------------------------|---------------------|
| mmary & Certification | Doc-ID<br>EVU-108704 - 01 | |

### 510 (k) Summary as required by section 807.92(c)

## Subscribers Name & Address

Maquet Critical Care AB Röntgenvägen 2 SE-171 95 Solna, Sweden Tel: + 46 8 730 7300 Fax: + 46 8 730 7838

Contact Person and Official correspondent: Veronica Ekstroem, Regulatory Affairs

Official Correspondent:

Jamie Yieh, Regulatory Affairs Manager Maquet Inc. , 1140 Route 22 East, Suite 202, Bridge water, NJ 08807

#### Trade Name

Servo Guard Part No 64 81 290 EH88H

#### Device Classification

| Common Name | Classification<br>Number | Class | Regulation Number |
|-----------------------------------|--------------------------|-------|-------------------|
| Breathing Circuit Bacteria Filter | | II | 21 CFR 868.5260 |

#### Predicate Device Identification

| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|----------------------------------------------------------------|----------|
| Siemens Main Flow Bacteria Filter | K871366 |
| End expiratory filter, Model RT020 | K002839 |

#### Device Description (for detailed description see Section F)

The Servo Guard is an efficient bacterial and viral filter for applications in respiratory care and anesthesia. The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment.

Maquet Critical Care AB

#### COMPANY CONFIDENTIAL

Traditional 510(k) ServoGuard

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| MAQUET | Document Type<br>Traditional 510(k) | Section-Page<br>E-3 | |
|---------------------------------------------|-------------------------------------|---------------------|-----------|
| Object/Subject | | Doc-ID | Issue no. |
| Servo Guard -510(k) Summary & Certification | | EVU-108704 | 01 |

#### Intended Use of the Device:

The Servo Guard is an efficient bacterial and viral filter for applications in respiratory care and anestheria. The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment.

# Summary of technological characteristics of Device and Predicate Device:

The dimensions of the three devices are different. The Servo Guard filter has a more efficient bacterial/viral filtration than the predicate devices. The Servo guard may be used both on the inspiratory and the expiratory limbs of the breathing circuit, while the RT020 only can be used on the expiratory side.

#### COMPANY CONFIDENTIAL

Maquet Critical Care AB

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes above three wave-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 2004

Mr. Jamie Yieh Maquet Medical, Inc. 1140 Route 22E Suite 202 Bridgewater, New Jersey 08807

Re: K030071

Tradc Name: Servo Guard Model 64 81 290 EH88E Regulation Number: 868.5260 Regulation Name: Bacterial Breathing Circuit Filter Regulatory Class: II Product Code: CAH Dated: March 3, 2004 Received: March 8, 2004

Dear Mr. Yieh:

We have reviewed your Section 510(k) premarket notification of intent to market the device refercnced 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.

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 requircments, including, but not limited to: registration and listing (21

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Page 2 - Mr. Jamie Yieh

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/dsma/dsmamain.html.

Sincerely yours.

Clus
Chia-Lin Pi, Ph.D.

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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| | Document Type<br>Traditional 510(k) | Section-Page<br>H-2 | |
|--------------------------------------|-------------------------------------|---------------------|-----------|
| Object/Subject | | Doc-ID | Issue no. |
| Servo Guard- Indicated Use Statement | | EVU-108704 | - 01 |

#### 510(k) Number (if known):

Device Name: Servo Guard

Indications For Use:

The Servo Guard is a disposable single-use device that provides filtration for reducing possible cross contamination between patient and equipment. The device is intended for adult, pediatric and infant populations. The device is indicated for use by qualified medical personnel only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Cotury

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

510(k) Number: K030071

Maquet Critical Care AB

#### COMPANY CONFIDENTIAL

Traditional SIO(k) ServoGuard