PALL ULTIPOR ANESTHESIA BREATHING SYSTEM

K013093 · Pall Medical · CAH · Aug 1, 2002 · Anesthesiology

Device Facts

• Record ID: K013093
• Device Name: PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
• Applicant: Pall Medical
• Product Code: CAH · Anesthesiology
• Decision Date: Aug 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

The Pall Ultipor Anesthesia Breathing Circuit System with a Breathing System Filter ("BSF") 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 facemask or by a connection to an artificial airway, such as an endotracheal tube or laryngeal mask. The Pall Ultipor 25 BSF minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%.

Device Story

Anesthesia breathing circuit system; connects anesthesia gas machine to patient via facemask or artificial airway. Includes breathing system filter (BSF) to minimize viral/bacterial contamination (99.999% efficiency). Components include patient kit (BSF, mask, elbow) and machine kit (reservoir bag, inspiratory/expiratory tubing, gas monitoring line). Used in clinical anesthesia settings; operated by healthcare professionals. Patient kit is single-use; machine kit components (excluding gas monitoring line) are cleared for 24-hour/multiple-patient use. Gas monitoring line also validated for 24-hour/multiple-patient use. System facilitates safe gas delivery while reducing cross-contamination risk.

Clinical Evidence

Bench testing only. Data provided to demonstrate 99.999% bacterial/viral filtration efficiency and durability of gas monitoring lines for 24-hour/multiple-patient use.

Technological Characteristics

Breathing circuit system comprising patient kit (BSF, mask, elbow) and machine kit (reservoir bag, tubing, gas monitoring line). BSF provides 99.999% filtration efficiency. Components designed for 24-hour/multiple-patient use (excluding single-use patient kit components).

Indications for Use

Indicated for patients requiring medical gas administration during anesthesia via oronasal facemask or artificial airway (endotracheal tube or laryngeal mask).

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

• Zefon Anesthesia Breathing System

Submission Summary (Full Text)

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AUG 0 1 2002

## K013093

## 510(k) Summary

| Submitted by | Pall Medical<br>2200 Northern Blvd.<br>East Hills, NY 11548-1209 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone] ext. 4341<br>Fax: [phone] |
| Contact Person: | Leonard S. Berman, Ph.D.<br>Director of Scientific Affairs |
| Date: | August 1, 2002 |
| Device Trade Name: | Pall Ultipor™ Anesthesia Breathing Circuit<br>System with Bacterial System filter |
| Common Name: | Breathing Circuit |
| Predicate Device: | Zefon Anesthesia Breathing System |
| Indications: | The Pall Ultipor Anesthesia Breathing Circuit<br>System ("Ultipor") with a Breathing System Filter<br>("BSF") is intended for use in the administration of<br>medical gases during anesthesia. The circuit<br>connects the anesthesia gas machine to the patient,<br>by means of an oronasal facemask or by a<br>connection to an artificial airway, such as an<br>endotracheal tube or laryngeal mask. The Pall<br>Ultipor 25 BSF minimizes viral and bacterial<br>contamination of the inspiratory and expiratory<br>limbs of the circuit with a minimum efficiency of<br>99.999%. Zefon Anesthesia Breathing System<br>("Zefon") has virtually the same indications. |
| Technological Characteristics: | Both the Ultipor and Zefon consist of a patient kit<br>and a machine kit. The components of the both<br>Ultipor's and Zefon's patient kits are: (1) the BSF;<br>(2) face mask; and (3) mask elbow. The components<br>of both Ultipor's and Zefon's machine kit are: (1)<br>the reservoir bag; (2) expiratory tubing; and (3)<br>inspiratory tubing. Ultipor and Zefon both have a<br>gas monitoring line; this line is a component of<br>Ultipor's machine kit and Zefon's patient kit. Both |
| Conclusion: | The device is substantially equivalent to the |
| | predicate. |

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devices' machine kits connect the inspiratory and expiratory ports of the anesthesia machine to their BSF. The respective components of both devices perform the same function(s).

In addition, all of the components of the Ultipor's and Zefon's patient kits are single use and all of the components of these devices' machine kits are for use up to 24 hours, which may include use on multiple patients ("24 hour/multiple patient use"). when used with their respective patient kits. The use of Ultipor's reservoir bag. expiratory/inspiratory tubing, and expiratory connector for up to 24 hours on multiple patients does not raise any new questions of safety or effectiveness because FDA has already cleared the same types of components for the same duration of use as part of the Zefon device. The gas monitoring line is the only component that has different durations of use in the Ultipor (24 hour/multiple use) than in the Zefon (single use). The 510(k) includes data showing the durability of the gas monitoring line for 24 hour/multiple use. Thus, the use of Ultipor's gas monitoring lines for multiple uses for up to 24 hours does not raise any new questions of safety or effectiveness when compared to the cleared predicate.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 01 2002

Pall Medical C/O Mr. Jonathan S. Kahan Partner Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109

Re: K013093

> Trade/Device Name: Pall Ultipor Anesthesia Breathing System Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: May 6, 2002 Received: May 9, 2002

Dear Mr. Kahan:

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. Kahan

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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,

Timo 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: Pall Ultipor Anesthesia Breathing Circuit System

Indications for Use:

The Pall Ultipor Anesthesia Breathing Circuit System with a Breathing System Filter ("BSF") 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 facemask or by a connection to an artificial airway, such as an endotracheal tube or laryngeal mask. The Pall Ultipor 25 BSF minimizes viral and bacterial contamination of the inspiratory and expiratory limbs of the circuit with a minimum efficiency of 99.999%.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

6HWesterholm

ision Sign-Off Division of Dental, Infection Control. and General Hospital Device 510(k) Number

Prescription Use (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)