CIRCUIT GUARD

K982239 · Arc Medical, Inc. · CAH · Aug 14, 1998 · Anesthesiology

Device Facts

• Record ID: K982239
• Device Name: CIRCUIT GUARD
• Applicant: Arc Medical, Inc.
• Product Code: CAH · Anesthesiology
• Decision Date: Aug 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Indications for Use

To reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.

Device Story

Circuit Guard is a thin-walled polyethylene sleeve attached to a filter/HME housing; designed to be pulled over the breathing circuit wye and tubing. Device acts as a physical barrier to reduce gross contamination of circuit components during use in hospital, OR, anesthesia, or ICU environments. Operated by clinicians; provides a protective covering for the patient end of the circuit. Benefits patient by minimizing external contamination of breathing circuit components.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Thin-walled polyethylene sleeve; attached to filter/HME housing; single-use; non-powered; manual operation.

Indications for Use

Indicated for use in hospital, OR, anesthesia, and ICU settings to reduce gross contamination on the patient end of breathing circuits, ventilator circuits, and resuscitators. Intended for single use.

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

• ARC Filter and Filter / HME (K903056A, K903058A)
• Concord-Portex Steri-Cath (K902383)

Submission Summary (Full Text)

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

K982239

# Non-Confidential Summary of Safety and Effectiveness

page 1 of 2 June 23, 1998

ARC Medical, Inc. 322 Patterson Ave. Scottsdale, GA 30079

AUG 1 4 1998

Tel - [phone] Fax - [phone]

Official Contact:

Proprietary or Trade Name: Common/Usual Name: Classification Name: Device: Predicate Devices:

Harold B. Norris - President Circuit Guard Bacteria Filter accessory Bacterial filter, breathing circuit Circuit Guard ARC Filter and Filter / HME - K903056A, K903058A, Concord-Portex - Steri-Cath - K902383.

# Device Description:

The Circuit Guard is a thin-wall sleeve which when attached to a Filter / HME housing, is pulled over the breathing circuit wye and tubing to cover these items to reduce gross contamination of the circuit components. It is viewed to be similar the intended use of a sleeved suction catheter. This is a modification of our ARC Filter and ARC Filter / HME.

## Intended Use:

র মাহমুদ

Indicated Use --

Environment of Use --

To reduce gross contamination on breathing circuit by covering the patient end of the circuit. Hospital, OR, anesthesia, ICU

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

# Non-Confidential Summary of Safety and Effectiveness

page 2 of 2

### June 23, 1998

| Attribute | ARC<br>Circuit Guard | ARC<br>Filter/<br>Filter/HME<br>K903056A<br>K903058A | Concord-<br>Portex<br>Steri-Cath<br>K902383 |
|---------------------------------------------------------------------|----------------------|------------------------------------------------------|---------------------------------------------|
| Use | | | |
| Intended to reduce gross<br>contamination on a surface | Yes | -- | Yes |
| Used with breathing circuits,<br>ventilator circuits, resuscitators | Yes | Yes | -- |
| Environment of use - Hospital, OR,<br>anesthesia, ICU | Yes | Yes | Yes |
| Indicated for single use | Yes | Yes | Yes |
| Design | | | |
| Placed in the breathing circuit | Yes | Yes | Yes |
| Incorporates a thin-walled<br>protective sleeve | Yes | -- | Yes |
| Performance Standards / Specifications | | | |
| None applicable for proposed<br>modification | Yes | -- | Yes |
| Materials | | | |
| Sleeve - Polyethylene | Yes | -- | Yes |

Differences between Other Legally Marketed Predicate Devices ----------

The proposed modification to the ARC products does not alter their original intended uses. There is no significant differences between the intended device and the predicate devices.

. 189

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

Image /page/2/Picture/3 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes that resemble human profiles or faces, stacked on top of each other.

AUG 1 4 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Harold B. Norris ARC Medical, Inc. 322 Patterson Avenue Scottdale, GA 30079

K982239 Re: Circuit Guard Regulatory Class: II (two) Product Code: 73 CAH Dated: June 23, 1998 Received: June 25, 1998

Dear Mr. Norris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

#### Page 2 - Mr. Harold B. Norris

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## INDICATIONS FOR USE

Page 1 of 1

Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

| 510(k) Number: | K982239 | (To be assigned) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------|------------------|
| | Modification to K903056A and K903058A | |
| Device Name: | Circuit Guard | |
| Intended Use : | To reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve. | |

Concurrence of CDRH, Office of Device Evaluation (ODE)

11 11

Waste Kernel

(Division Sign-Off) Division of Cardiova and Neurological D 510(k) Number

Prescription Use (Per CFR 801.109)

Over-the-counter use