RT019 INSPIRATORY/EXPIRATORY FILTER

K050927 · Fisher & Paykel Healthcare, Ltd. · CAH · Aug 1, 2005 · Anesthesiology

Device Facts

• Record ID: K050927
• Device Name: RT019 INSPIRATORY/EXPIRATORY FILTER
• Applicant: Fisher & Paykel Healthcare, Ltd.
• Product Code: CAH · Anesthesiology
• Decision Date: Aug 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Indications for Use

The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter is intended for use between a ventilator and a breathing circuit. Its function is to remove microbiological and particulate matter from gases entering and/or exiting a breathing circuit. The RT019 is intended to be connected to the ventilator inspiratory and/or expiratory ports. It is not directional in terms of flow and is a single use device.

Device Story

RT019 Inspiratory/Expiratory Filter; placed between ventilator and breathing circuit; removes microbiological and particulate matter from gases. Device features dual-walled translucent thermoplastic enclosure; electrostatic, hydrophobic, depth-type filter media; 78 mm length; 67 mm diameter; 23 g mass. Non-directional flow; single-use. Used in clinical settings where mechanical ventilation is required. Protects patient and equipment by filtering gas flow.

Clinical Evidence

No clinical data; bench testing only. Device is identical to the predicate.

Technological Characteristics

Dual-walled translucent thermoplastic enclosure; electrostatic, hydrophobic, depth-type filter media. Dimensions: 78 mm length, 67 mm diameter. Mass: 23 g. Non-directional flow. Single-use.

Indications for Use

Indicated for use between a ventilator and a breathing circuit to remove microbiological and particulate matter from gases entering or exiting the circuit. Intended for connection to ventilator inspiratory and/or expiratory ports. Single-use device.

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

• RT020 End Expiratory Filter (K002839)

Submission Summary (Full Text)

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AUG 1 - 2005

K050927

Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: [phone] Facsimile: [phone] Website: www.fphcare.com

# 510(k) Summary of Safety and Effectiveness 1.4

Reneta Money Contact person

30 March 2005 Date prepared

RT019 Inspiratory/Expiratory Filter Trade name

Breathing Circuit Bacterial Filter Common name

Breathing Circuit Bacterial Filter (21 CFR 868.5260) Classification name

RT020 End Expiratory Filter K002839 Predicate device

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## Description of device 1.4.1

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The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter is classified as a The Fisher & Tayker Ticannoure N1009-12-1 CFR §868.5260. It is intended to be Blaced at the machine end of a ventilator breathing circuit, to remove microbiological and particulate matter from the gases in a breathing circuit.

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The RT019 filter has a dual-walled translucent thermoplastic enclosure with aligned connector ports and perpendicular filter media. Its total length is 78 mm (3.1 in) with a maximum cross section diameter of 67 mm (2.6 in), and a mass of 23 g (0.81 oz). It has maximuli Cross scetton Giameer of 07 mm (1:40 conical tapers. The filter uses an electrostatic, hydrophobic, depth-type filter media.

#### 1.4.2 Intended use

The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter is intended for use The Tisher & I ayker Hounteaus reservit. Its function is to remove microbiological and between a venthator and a breating and/or exiting a breathing circuit. The RT019 is intended to be connected to the ventilator inspiratory and/or expiratory ports. It is not directional in terms of flow and is a single use device.

## Technological characteristics summary 1.4.3

As the RT019 is identical to the predicate device in every physical aspect, it shares the same technological characteristics.

## Summary of testing: 1.4.4

No additional tests were performed on the RT019 filter as it is identical to the predicate device (RT020). A change in the indications for use does not affect the filter's safety, efficacy or performance.

# Conclusions demonstrating safety, effectiveness and performance 1.4.5

The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter is identical to the predicate device in every aspect including safety, effectiveness and performance.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 - 2005

Fisher & Paykel Healthcare, Limited c/o Reneta Money 15 Maurice Paykel Place P.O. Box 14-348, Panmure East Tamaki, Auckland NEW ZEALAND

Re: K050927

Trade/Device Name: RT019 Inspiratory/Expiratory Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: July 18, 2005 Received: July 21, 2005

Dear Ms. Money:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boodetermined 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 eonimer to Provision of Hay 2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Coometer For ( 100) was the device, subject to the general controls provisions of the Act. The I ou may, diereleve, mains 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 rr your device to such additional controls. Existing major regulations affecting your device can may or sations to back as a sateral 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 - Ms. Money

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a based on a suith other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a determination and regulations administered by other Federal agencies. You must or any Federal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sets CrK Fart 807), laocing (21 CFR Part 820); good if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Dections over device as described in your Section 510(k) I mis letter will anow you to begin manicemly your antial equivalence of your device to a legally premaired 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 If you desire specific acvice for your access to the regulation of the regulation entitled, Conder the Oriece of Compuners in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or 1011 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C. L.

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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# Indications for Use Statement 1.2

KUSO927 510(k) Number:

RT019 Inspiratory/Expiratory Filter Device Name:

The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Indications For Use: Filter is intended for use between a ventilator and a breathing circuit. Its function is to remove microbiological and particulate matter from gases entering and/or exiting a breathing circuit. The RT019 is intended to be connected to the ventilator inspiratory and/or expiratory ports. It is not directional in terms of flow and is a single use device.

Prescription Use

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aunf Sulean Koso927

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

510(k) Number: k050427