DUAL HEATED INFANT VREATHING CIROUITS

K103767 · Fisher & Paykel Healthcare, Ltd. · BZE · Apr 16, 2012 · Anesthesiology

Device Facts

• Record ID: K103767
• Device Name: DUAL HEATED INFANT VREATHING CIROUITS
• Applicant: Fisher & Paykel Healthcare, Ltd.
• Product Code: BZE · Anesthesiology
• Decision Date: Apr 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5270
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The RT265 and RT266 infant breathing circuits are intended to deliver humidified breathing gases for administration to an infant patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Thus humidifies gases via heated breathing circuit may be indicated for patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases. These gases may be delivered by facemask or through bypassing the upper airways, for example use of an endotracheal tube.

Device Story

Dual-heated infant breathing circuits; function as conduits for delivery of humidified breathing gases to infant patients. Inspiratory and expiratory limbs contain integrated heater wires to minimize condensate formation. Used in clinical settings for patients requiring mechanical ventilation or positive pressure breathing assistance via facemask or endotracheal tube. Operated by healthcare professionals. Output is delivery of temperature-maintained, humidified gas to patient airway. Benefits include prevention of respiratory tract damage/irritation and desiccation of secretions caused by dry medical gases.

Clinical Evidence

Bench testing only. Comparative performance testing against predicate devices (RT235/RT236) included pneumatic testing, single fault and fire prevention, patient leakage current, and duration of use testing.

Technological Characteristics

Dual-heated breathing circuit with heater wires in both inspiratory and expiratory limbs. Materials modified in expiratory limb compared to predicate. Class II device (21 CFR 868.5270).

Indications for Use

Indicated for infant patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases. RT265 for flow rates > 4 L/min; RT266 for flow rates 0.3–4 L/min.

Regulatory Classification

Identification

A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.

Predicate Devices

• Fisher & Paykel Healthcare RT235 and RT236 Dual Heated Neonatal Breathing Circuits (K034026)

Submission Summary (Full Text)

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#### 510(k) Summary 5 K 10376"

APR 1 6 2012

Image /page/0/Picture/5 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line in a bold, sans-serif font, with a large ampersand between the two words. The word "HEALTHCARE" is on the second line in a similar font, but slightly smaller, and underlined.

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

. .

| Contact person | Stéphanie Elvin |
|---------------------|------------------------------------------------------------------------------------------------|
| Date prepared | 21 December 2010 |
| Trade name | RT265 and RT266 Dual Heated Infant Breathing Circuits1 |
| Common name | Heated Breathing Circuit |
| Classification name | Breathing System Heater<br>Class II (21 CFR § 868.5270), product code BZE |
| Predicate device | K034026 Fisher & Paykel Healthcare RT235 and RT236 Dual Heated<br>Neonatal Breathing Circuits2 |

1 Referred to throughout this document as RT265 and RT266

2 Referred to throughout this document as RT235 and RT236

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#### Description 5.1

The RT265 and RT266 dual heated infant breathing circuits are classified as 'Breathing System Heater' according to 21 CFR \$868.5270.

Infant breathing circuits form part of the respiratory humidification system in which the inspiratory limb delivers humidified gas to the patient and the expiratory limb carries the expired gas away from the patient. Heater wires in the inspiratory and expiratory limb minimise the formation of condensate.

#### 5.2 Intended use

The RT265 and RT266 infant breathing circuits are intended to deliver humidified breathing gases for administration to an infant patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Thus humidifies gases via heated breathing circuit may be indicated for patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases. These gases may be delivered by facemask or through bypassing the upper airways, for example use of an endotracheal tube.

#### Indications for use 5.3

The dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of infant patients, and to maintain the temperature of humidified inspired gas. The RT265 is used for flow rates greater than 4 L/min, and the RT266 is for flow rates between 0.3 and 4 L/min.

#### Technological characteristics comparison 5.4

The RT265 and RT266 are dual-heated breathing circuits, unchanged from the predicate devices (RT235 and RT236). This means that there is a heater wire in both the inspiratory and expiratory limb.

The inspiratory limb is identical in all aspects to that of the predicate device. The expiratory limb is of a different design to that of the predicate, reflecting the change in material.

The intended use of the RT265 and RT266 is the same as the predicate devices.

#### Non-clinical tests 5.5

Comparative performance testing of the RT265 and RT266 with the predicate breathing circuits RT235 and RT236, such as pneumatic testing, single fault and fire prevention, patient leakage current, performance and duration of use testing were performed. Testing showed that the relevant features of each predicate are substantially equivalent.

#### Conclusion 5.6

The RT265 and RT266 are substantially equivalent to the RT235 and RT236 breathing circuits. The comparison of features, performance, materials and intended use demonstrate that the RT265 and RT266 are at least as safe and effective for their intended purpose.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human form with three arms reaching upwards. To the left of the graphic, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Mr. Robert Petry Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place PO Box 14648 Auckland, New Zealand 1071

APR 1 6 2012

Re: K103767

Trade/Device Name: RT265 and RT266 Dual Heated Infant Breathing Circuits Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing system heater. Regulatory Class: II Product Code: BZE Dated: April 10, 2012 Received: April 11, 2012

Dear Mr. Petry:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Petry

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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 4

510(k) Number

Device Name

Fisher & Paykel Healthcare RT265 and RT266 Dual Heated Infant Breathing Circuits

The dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of infant patients, and to maintain the temperature of humidified inspired gas. The RT265 is used for flow rates greater than 4 L/min, and the RT266 is for flow rates between 0.3 and 4 L/min.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

L. Schultheis

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

510(k) Number: K103767