CPAP HUMIDIFIER, MODEL HC238JHU

K050904 · Fisher & Paykel Healthcare, Ltd. · BZD · May 25, 2005 · Anesthesiology

Device Facts

• Record ID: K050904
• Device Name: CPAP HUMIDIFIER, MODEL HC238JHU
• Applicant: Fisher & Paykel Healthcare, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: May 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HC238 series CPAP humidifier is used to assist with patient breathing while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is by the delivery of Continuous Positive Airway Pressure (CPAP) in order to prevent airway obstruction. The addition of heated respiratory humidification relieves the drying and irritating effects which may arise from use of a CPAP system. The HC238 CPAP humidifier is for use on adult, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep laboratory.

Device Story

HC238 CPAP Humidifier provides non-invasive Continuous Positive Airway Pressure (CPAP) therapy with integrated heated passover humidification. Device consists of a motorized fan assembly and a heated humidification chamber. Fan speed adjusts to maintain pressure; device incorporates pressure feedback software to compensate for air density changes, mouth leaks, or dynamic breathing patterns. Output includes delivered pressure measurement and display. Used by adult patients in home or sleep lab settings to prevent airway obstruction and mitigate drying effects of CPAP therapy. Healthcare providers use output to monitor therapy efficacy.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated through non-clinical bench testing, including mechanical, electrical, and thermal safety, electromagnetic compatibility (EMC), and functional performance verification against international standards.

Technological Characteristics

Non-invasive CPAP flow generator with integrated heated passover humidifier. Features motorized fan assembly and heater plate. Software-controlled pressure feedback loop for dynamic pressure maintenance. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and ISO 17510-1 (CPAP performance).

Indications for Use

Indicated for adult, spontaneously breathing (non-ventilator dependent) patients with Obstructive Sleep Apnea (OSA) for use at home or in a sleep laboratory.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• HC234 CPAP Humidifier (K040941)

Submission Summary (Full Text)

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K050904

Fisher & Paykel Healthcare Ltd

06 April 2005

HC238 CPAP Humidifier - 510(k)

MAY 2 5 2005

## 510(k) Summary of Safety and Effectiveness Information

HC238 CPAP Humidifier Model No. / Name: Noncontinuous ventilator (IPPB) - BZD Classification Name: Anesthesiology Devices, 21 CFR §868.5905 (Class II) Fisher & Paykel, HC234 CPAP Humidifier, K040941 Predicate Device:

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92:

(a)(1) - (a)(3) Refer to information above and concluding this summary.

#### (a)(4) Description of the Devices

The HC238 CPAP Humidifier is a non-invasive Continuous Positive Airway Pressure flow generator, incorporating a Heated Respiratory Humidifier.

The HC238 is comprised of two functional units. One is a motorised fan assembly that The TO200 is comprised of the fan speed is directly related to air pressure, and is provides positive an prossure. The fan open is at a a humidification chamber at the front of the device.

The second functional unit of the HC238 is a heated passover humidifier. The water is The second Turnelonar and of the The The rior on a heaterplate at the front of the unit. Contained in the numblifieding than blower assembly via a port at the back of the chamber. The chamber connouts directly to the breathing tube condensation in cooler operating conditions.

### (a)(5) Statement of the Intended Use

The HC238 series CPAP humidifier is used to assist with patient breathing while sleeping, The HC230 senes of treating Obstructive Sleep Apnea (OSA). This is by the delivery of for the purpose of treating Obstructive Group in order to prevent airway obstruction. The Continuous Fositive Arivay Tresours (S. A.) therapy relieves the drying and irritating adultion of neated roupinater), which may arise from use of a CPAP system.

The HC238 CPAP humidifier is for use on adult, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep laboratory.

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## 510(k) Summary continued - Fisher & Paykel, HC238 CPAP Humidifier

# (a)(6) Technological Characteristics and Comparison to Predicate Summary

The fundamental technological characteristics of the HC238 CPAP Humidifier are equivalent to the HC234 CPAP Humidifier predicate device listed above. The HC238 is equivalent in to the rozbox of intended use, fundamental technological characteristics and manufacturing process. Modifications to the predicate device include;

- Pressure feedback in software to maintain delivered pressure for instances of mouth or r resource roodback in combient air density and dynamic changes in flow due to patient breathing pattern.
- Delivered pressure measurement function and display -

## (b)(1)_Discussion of the Non-Clinical Tests

Non-clinical testing of the HC238 CPAP Humidifier has been carried out covering mechanical, electrical and thermal safety, environmental conditions and electromagnetic compatibility, functional verification, and performance.

The HC238 complies with the requirements of IEC 60601-1 general electromedical and IEC 60601-1-2 EMC standards. It complies with performance and safety requirements of ISO 17510-1 for CPAP devices.

### (b)(2) Discussion of the Clinical Tests

Clinical verification studies on the HC238 CPAP Humidifier were not required in order to demonstrate the safety, effectiveness, and performance of the device.

## (b)(3) Conclusions Demonstrating Safety, Effectiveness and Performance

The testing carried out for the HC238 CPAP Humidifier indicates that it meets design and performance functional requirements. The proposed device meets the requirements of international and USA medical electrical equipment standards for safety, and key international - and - 607 requirements from particular standards for humidification systems.

This information indicates that the HC238 CPAP Humidifier is equivalent to the predicate device in terms of safety, effectiveness and performance.

signed:

James Thompson

James Thompson Fisher & Paykel Healthcare Ltd

te: 23/5/05

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures connected at the head and flowing downward. The symbol is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2005

Mr. James Thompson Regulatory Affairs Manager Fisher & Paykel Healthcare, Limited 15 Maurice Paykel Place East Tamaki Auckland, New Zealand

Re: K050904

Trade/Device Name: HC238 CPAP Humidifier Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 6, 2005 Received: April 11, 2005

Dear Mr. Thompson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becated or >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> referenced above and have determined re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mierstale continetee pror to reay 20, 1778, and in accordance with the provisions of Amendinens, of to de vices that nave oost (Act) that do not require approval of a premarket the Federal Pood, Drug, and Oosment 1 100 (-10 (-16) - 10 (-1) - 1 ) - 1 the general approval application (1111). . The general controls provisions of the Act include confors provisions of the rion 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 II your device is classified (See above) into exontrols. Existing major regulations affecting g (PMA), it may be subject to such adulties was real Regulations, Title 21, Parts 800 to 898. In your device can be found in the Soucerning your device in the Federal Register.

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# Page 2 - Mr. Thompson

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualled of a boostantine complies with other requirements mean that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally I cuchar statutes and reguirements, including, but not limited to: registration You must comply with an the Fee b requirements (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), laboling (21 CFR Part 820), and if 1 CFR Part 820), and if requirents as set form in the quality bjoxems (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) This letter will anow you to begin mailering , but the squivalence of your device to a premarket notification. The PDA midning of backlession 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), If you desire specific advice for your do roo sa career of the regulation in the regulation prease contact the Other or Occapital premarket notification" (21CFR Part 807.97). You entitled, "Misoranding of releases in pour responsibilities under the Act from the may over belief general miremational and Consumer Assistance at its toll-free Division of Birman [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ques

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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Fisher & Paykel Healthcare Ltd

510(k) Number:

HC238 CPAP Humidifier Device Name:

INDICATIONS FOR USE:

The HC238 CPAP Humidifier is used to assist with patient breating while sleeping, for the The HC238 CPAP Hunlidiner is used to assist in by the delivery of Continuous purpose of treating Obstructive Sleep Aprila (Gori). I nioway obstruction. The addition offerting offerty of Positive Allway Pressure (OFAT) in order of relieves the syng and irritating effects of neated respiratory numidined.com see of a CPAP system.

The HC238 CPAP Humidifier is for use on adult, spontaneously breathing (non-ventilato dependant) patients at home or in the sleep laboratory.

Prescription Use (21 CFR 801 subpart D) and/or

Over-the-Counter Use (21 CFR 801 subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

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

510(k) Number: K250904