(59 days)
The HC234 CPAP Humidifier is used to assist with patient breathing while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA) by the delivery of Continuous Positive Airway Pressure (CPAP) in order to prevent airway obstruction. The addition of heated respiratory humidification to this therapy relieves the drying and irritation to the patient airways that may arise from use of a CPAP system.
The HC234 CPAP Humidifier is for use on adult, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep laboratory.
The HC234 CPAP Humidifier is a non-invasive Continuous Positive Airway Pressure flow generator, incorporating a Heated Respiratory Humidifier.
The HC234 is comprised of two functional units. One is a motorised fan assembly that provides positive air pressure, and is controlled by software. The fan output is ducted to a humidification chamber at the front of the device.
The second functional unit of the HC234 is a heated passover humidifier. The water is contained in the humidification chamber positioned on a heaterplate at the front of the unit. The chamber connects to the patient breathing tube. Ambient temperature is monitored in order to reduce breathing tube condensation in cooler operating conditions.
The provided text is a 510(k) summary for the HC234 CPAP Humidifier and does not contain information on acceptance criteria or a study proving the device meets those criteria in a way that would allow for the detailed table and study specifics requested.
Specifically, the document states:
- "Non-clinical testing of the HC234 CPAP Humidifier has been carried out covering mechanical, electrical, and electromagnetic compatibility, functional verification, and performance."
- "The HC234 is designed to meet the requirements of the IEC 60601-1 general electromedical and IEC 60601-1-11, and UL 60601-1. It complies with performance and safety requirements of ISO 8185 standard for humidifiers."
- "Clinical verification studies on the HC234 CPAP Humidifier were not required in order to demonstrate the safety, effectiveness, and performance of the device."
Since clinical studies were not required and only non-clinical testing for compliance with standards was performed, an acceptance criteria table detailing specific performance metrics (like sensitivity, specificity, accuracy) and a study report with details like sample size, ground truth, expert opinions, or MRMC studies for device performance as typically seen for AI/diagnostic devices are not available in this document.
Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document focuses on regulatory compliance with established standards (IEC, UL, ISO) rather than a comparative performance study with explicit acceptance criteria and results against those criteria.
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27 April, 2004
JUN 1 0 2004
Image /page/0/Picture/4 description: The image contains a sequence of characters that appear to be handwritten. The sequence is "K040941". The characters are written in a bold, dark ink, which makes them stand out against the white background. The handwriting style is simple and legible.
510(k) Summary of Safety and Effectiveness Information
HC234 CPAP Humidifiers Model No. / Name:
Noncontinuous ventilator (IPPB) - BZD Classification Name: Anesthesiology Devices, 21 CFR §868.5905 (Class II)
Fisher & Paykel, HC200 CPAP Humidifier, K973161 Predicate Devices:
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 HC234 CPAP Humidifier is a nor-invasive Continuous Positive Airway Pressure flow generator, incorporating a Heated Respiratory Humidifier.
The HC234 is comprised of two functional units. One is a motorised fan assembly that provided The HU234 is comprised on two functional unless on a messure, and is controlled by software. positive an pressure. The fan oped is a circuly to a humidification chamber at the front of the device.
The second functional unit of the HC234 is a heated passover humidifier. The water is contained in the I he second functional unit of the Hoze4 to a heaterplate at the front of the unit. The chamber connects numiditicallon chamber positioned on a neaton the chamber. Ambient temperature is monitored in order to reduce breathing tube condensation in cooler operating conditions.
(a)(5) Statement of the Intended Use
The HC234 CPAP humidifier is used to assist with patient breathing while sleeping, for the purpose of I he HC234 CFAF numilian is asca to assist the the the delivery of Continuous Positive Airway Pressure treating Oustinctive Sieep Apined (OST). This is the title of heated respiratory humidfication to the (CPAP) in ofder to prevent anway obserts on the patient airways that may anse from use of a CPAP system.
The HC234 CPAP humidifier is for use on adult patients, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep laboratory.
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510(k) Summary continued - Fisher & Paykel, HC234 CPAP Humidifier
(a){6) Technological Characteristics and Comparison to Predicate Summary
The fundamental technological characteristics of the HC234 CPAP Humidifier are equivalent to the HC200 CPAP Humidifier predicate device listed above. The HC234 is equivalent in terms of intended ITO20 Of the humantal technological characteristics and manufacturing process. Modifications to the predicate device include;
- Operating pressure range modified to 4-20 cmH2O 1
- Manual altitude adjustment function added -
- Double insulated product design .
- Ambient Tracking Plus™ function added to reduce condensation .
- Proportional Start Pressure function -
- Reduced operating noise level -
- Compliance monitoring function added .
- Option of reusable humidification chambers -
- Optional use with supplemental oxygen -
(b)(1) Discussion of the Non-Clinical Tests
Non-clinical testing of the HC234 CPAP Humidifier has been carried out covering mechanical, Northeal testing of the 11020-1011 and electromagnetic compatibility, functional verification, and performance.
The HC234 is designed to meet the requirements of the IEC 60601-1 general electromedical and IEC I ne HU234 is designed to meet the requirements of these in UL 60601-1. It complies with performance and safety requirements of ISO 8185 standard for humidifiers.
(b)(2) Discussion of the Clinical Tests
Clinical verification studies on the HC234 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 HC234 CPAP Humidifier indicates that it meets design and performance The lesting carred our of the rozes of A. The requirements of international and USA functional requirements. The propers for safety, and key performance and safety requirements from particular standards for humidification systems.
This information indicates that the HC234 CPAP Humidifier is equivalent to the predicate device in terms of safety, effectiveness and performance.
signed:
Je I
James Thompson Fisher & Paykel Healthcare Ltd
te: 27/5/04
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2004
Mr. James Thompson Regulatory Affairs Engineer Fisher & Paykel Healthcare, LTD. 15 Maurice Paykel Place, East Tamaki PO Box 14-348, Panmure Auckland, New Zealand
Re: K040941
Trade/Device Name: CPAP Humidifier, Model HC234 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator Regulatory Class: II Product Code: BZD Dated: April 6, 2004 Received: April 12, 2004
Dear Mr. Thompson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the relerenced above and have acternalosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to do rough and Cosmetic Act (Act) that do not require approval of a premarket the Foderal I vou, Drag, and Orou may, therefore, market the device, subject to the general approvat application (the Act. The general controls provisions of the Act include controls provisions of ar 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 If your device is classified (see a additional controls. Existing major regulations affecting (I Mrs), it may be success to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of roundsh further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA 3 issualled of a substains. In the complies with other requirements mean that FDA nas made a deceminations administered by other Federal agencies. of the Act of ally receiter statutes and regarments, including, but not limited to: registration You must comply with an the Her Fee Boog (21 CFR Part 801); good manufacturing practice and listing (21 CFR I art 607), labeling (21 CFR Pat 820); and if requirents as set form in the quality bjoctars (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) I mis letter will anow you to begal finding of substantial equivalence of your device to a premarket notification. - The PDF mixtis 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), If you desire specific advise to: Jour ace at (301) 594-4646. Also, please note the regulation prease contact the Other or Complian premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of 01 01 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Carls
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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K040941 510(k) Number:
HC234 CPAP Humidifier Device Name:
INDICATIONS FOR USE:
The HC234 CPAP Humidifier is used to assist with patient breathing while sleeping, for the The HC234 CPAP Humiditer Is Used to assist with pating by the delivery of Continuous purpose of treating Obstructive Sleep Aprile (on one by china The addition of heated Positive Airway Pressure (CPAP) in older to preven anvay obstration 110 allaboration 11 and 10 and 10 and 1
respiratory humidification to this therapy relieves the drying and respiratory numidinoutism <o m use of a CPAP system.
The HC234 CPAP Humidifier is for use on adult, spontaneously breathing (non-ventilator) The TICZJ4 Of All Tiamianon in the sleep laboratory.
Prescription Use
and/or
Over-the-Counter Use __
(Part 21 CFR 801 subpart D)
(21 CFR 807 subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qum Syluem
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number:
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).