ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER

K973238 · Bill Olson Corp. · CAH · Mar 11, 1998 · Anesthesiology

Device Facts

• Record ID: K973238
• Device Name: ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER
• Applicant: Bill Olson Corp.
• Product Code: CAH · Anesthesiology
• Decision Date: Mar 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zefon Anesthesia Circuit with Bacterial Filter is intended for use in the administration of medical gases during anesthesia. The circuit connects the anesthesia gas machine to the patient by means of an oronasal face mask or by a connection to an artificial airway, such as an endotracheal tube. In the case of the Zefon circuit, a heat moisture exchange filter is included to minimize viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit.

Device Story

Zefon Anesthesia Circuit with Bacterial Filter facilitates delivery of medical gases from anesthesia machine to patient. Device connects to patient via oronasal face mask or artificial airway (endotracheal tube). Integrated heat moisture exchange (HME) filter minimizes viral and bacterial contamination within inspiratory and expiratory limbs of circuit. Used in clinical anesthesia settings by healthcare professionals. Benefits include gas delivery and reduction of cross-contamination risk.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Anesthesia circuit assembly including integrated heat moisture exchange (HME) bacterial filter. Designed for connection between anesthesia gas machine and patient airway interfaces (mask/endotracheal tube).

Indications for Use

Indicated for patients requiring administration of medical gases during anesthesia via oronasal face mask or artificial airway (e.g., endotracheal tube).

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 1998

Mr. Scott Ryan Bill Olson Corp. 5350 Southwest First Lane Ocala, FL 34474

Re : K973238 Zefon Anesthesia Circuit with Bacterial Filter Requlatory Class: II (two) Product Code: 73 CAH Dated: February 20, 1998 February 24, 1998 Received:

Dear Mr. Ryan:

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 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 A substantially equivalent determination assumes compliance to 895. 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.

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Page 2 - Mr. Scott Ryan

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/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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

Enclosure

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510(k) Number (if known): K973238

Device Name: Zefon Anesthesia Circuit with Bacterial Filter

Indications For Use:

The Zefon Anesthesia Circuit with Bacterial Filter is intended for use in the administration of medical gases during anesthesia. The circuit connects the anesthesia gas machine to the patient by means of an oronasal face mask or by a connection to an artificial airway, such as an endotracheal tube. In the case of the Zefon circuit, a heat moisture exchange filter is included to minimize viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Ruy

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1973238 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR :

Over-The-Counter Use

(Optional Format 1-2-96)

Exhibit 13