(48 days)
The HC604 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 to this therapy relieves the drying and irritating effects on the patient airways, which may arise from use of a CPAP system.
The HC604 CPAP Humidifier is for use on adult, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep laboratory.
The HC604 CPAP Humidifier is a non-invasive Continuous Positive Airway Pressure flow generator, incorporating a Heated Respiratory Humidifier and a heated respiratory breathing circuit.
The HC604 is comprised of two main functional units. One is a motorised fan assembly that provides positive air pressure, which can be adjusted from 4 to 20cm H₂O as prescribed by a physician. The fan speed is directly related to air pressure, and is controlled by software. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second functional unit of the HC604 is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heaterplate at the front of the unit. The chamber connects directly to the blower assembly via a port at the back of the chamber. Ambient temperature is monitored in order to reduce breathing tube condensation in cooler operating conditions. Condensation is further reduced by the heated breathing tube which connects to the outlet port on the fop of the unit.
Here's an analysis of the provided text regarding the HC604 CPAP Humidifier's acceptance criteria and studies, organized according to your request:
Acceptance Criteria and Device Performance Study
The provided document describes the substantial equivalence of the HC604 CPAP Humidifier to a predicate device (HC234 CPAP Humidifier) for 510(k) clearance. It does not present a study with specific acceptance criteria metrics and numerical results for that device's performance. Instead, it relies on demonstrating compliance with recognized standards and similarity to a legally marketed predicate.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, specific numerical acceptance criteria and a table of direct performance for the HC604 CPAP Humidifier are not provided in the document. The document states that the device "meets the requirements" of various standards and that its "technological characteristics... are equivalent" to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance (Implicitly Met) |
|---|---|---|
| Safety | IEC 60601-1 (General Electromedical Standards) | Device meets requirements of IEC 60601-1 |
| UL 60601-1 (USA deviations) | Device complies with UL 60601-1 | |
| ISO 8185 (Humidifier Standards) | Device complies with ISO 8185 | |
| ASTM F1690 (Humidifier Standards) | Device complies with ASTM F1690 | |
| Effectiveness/Performance | Technological equivalence to HC234 CPAP Humidifier | Stated as equivalent to HC234 in key aspects: Type, Heaterplate power usage, Control method, Ambient temperature sensor, Operating pressure range (4 to 20 cm H2O), Proportional start pressure algorithm, User interface, Manual altitude adjustment, Double insulated design, Reusable humidification chamber option |
| Functional verification | "Functional verification" studies carried out | |
| Performance verification | "Performance" studies carried out | |
| Electromagnetic Compatibility | Meets IEC 60601-1-2 EMC standards | |
| Mechanical Integrity | Mechanical safety | "Mechanical" tests carried out |
| Electrical Integrity | Electrical safety | "Electrical" tests carried out |
| Thermal Integrity | Thermal safety | "Thermal" tests carried out |
| Environmental Conditions | Environmental testing | "Environmental conditions" tests carried out |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify a sample size for any clinical test set because it explicitly states: "Clinical verification studies on the HC604 CPAP Humidifier were not required in order to demonstrate the safety, effectiveness, and performance of the device."
- Data provenance for non-clinical tests is implicitly from the manufacturer, Fisher & Paykel Healthcare, but no specific country of origin for the data or whether it was retrospective/prospective is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No clinical test set requiring expert ground truth assessment was performed. The evaluation was based on non-clinical testing and comparison to a predicate device.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC comparative effectiveness study was not done, as no clinical studies were performed or deemed necessary.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (CPAP Humidifier), not an AI algorithm. Its performance is intrinsic to the device's function, not an algorithm that operates independently or with a human in the loop in the context of interpretation or diagnosis.
7. The Type of Ground Truth Used
- For the non-clinical tests (mechanical, electrical, thermal safety, EMC, functional verification, performance), the "ground truth" was established based on compliance with recognized international and national standards (IEC 60601-1, UL 60601-1, IEC 60601-1-2, ISO 8185, ASTM F1690) and demonstrated equivalence to the predicate device's technological characteristics and intended use.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
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7 July 2004
AUG 3 1 2004
510(k) Summary of Safety and Effectiveness Information
HC604 CPAP Humidifier Model No. / Name:
Non-continuous ventilator (IPPB) - BZD Classification Name: Anesthesiology Devices, 21 CFR §868.5905 (Class II)
Fisher & Paykel Healthcare, HC234 CPAP Humidifier, K040941 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 Device
The HC604 CPAP Humidifier is a non-invasive Continuous Positive Airway Pressure flow generator, incorporating a Heated Respiratory Humidifier and a heated respiratory breathing circuit.
The HC604 is comprised of two main functional units. One is a motorised fan assembly that provides positive air pressure, which can be adjusted from 4 to 20cm H₂O as prescribed by a physician. The fan speed is directly related to air pressure, and is controlled by software. The blower assembly output connects directly to a humidification chamber at the front of the device.
The second functional unit of the HC604 is a heated passover humidifier. The water is contained in a humidification chamber positioned on a heaterplate at the front of the unit. The chamber connects directly to the blower assembly via a port at the back of the chamber. Ambient temperature is monitored in order to reduce breathing tube condensation in cooler operating conditions. Condensation is further reduced by the heated breathing tube which connects to the outlet port on the fop of the unit.
(a)(5) Statement of the Intended Use
This HC604 CPAP humidifier is used to assist with patient breathing while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is done by the delivery of Continuous Positive Airway Pressure (CPAP) in order to prevent airway obstruction. The addition of heated respiratory humidification to the device relieves the drying and irritating effects on the patient airways which may arise from use of a CPAP system. The HC604 CPAP humidifier is for use on adult patients.
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(a)(6) Technological Characteristics Summary
The technological characteristics of the Fisher & Paykel Healthcare HC604 CPAP Humidifier are equivalent to the Fisher & Paykel Healthcare HC234 CPAP Humidifier.
The HC604 is equivalent to the HC234 in the following ways:
- Type (non-invasive Continuous Positive Airway Pressure flow generator, . incorporating a Heated Respiratory Humidifier)
- . Heaterplate power usage
- Control method (electronic) .
- Ambient temperature sensor .
- Operating pressure range (4 to 20 cm H2O) .
- Proportional start pressure algorithm .
- User interface, with push buttons and an LCD display .
- Manual altitude adjustment .
- Double insulated design .
- Reusable humidification chamber option ●
The HC604 differs from the HC234 in the following ways;
- Includes a heated breathing tube connected to the device, reducing condensation . or "rain-out" to form in the tube
- Modified chamber design ●
- Some new materials used in the heated breathing tube .
- Performance increase in comparative humidity and temperature output ●
(b)(1) Discussion of the Non-Clinical Tests
Non-clinical testing of the HC604 CPAP Humidifier has been carried out covering mechanical, electrical and thermal safety, environmental conditions and electromagnetic compatibility, functional verification, and performance.
The HC604 meets the requirements of the IEC 60601-1 general electromedical and IEC 60601-1-2 EMC standards, and the relevant USA deviations to these in UL 60601-1. It complies with performance and safety requirements of the ISO 8185 and ASTM F1690 particular standards for humidifiers.
(b)(2) Discussion of the Clinical Tests
Clinical verification studies on the HC604 CPAP Humidifier were not required in order to demonstrate the safety, effectiveness, and performance of the device.
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510(k) Summary continued - Fisher & Paykel, HC604 CPAP Humidifier
(b)(3) Conclusions Demonstrating Safety, Effectiveness and Performance
The testing carried out for the HC604 CPAP Humidifier indicates that it meets design and The tosting carried out requirements. The proposed device meets the requirements of international and USA medical electrical equipment standards for safety, and key performance and safety requirements from particular standards for humidification systems.
This information indicates that the HC604 CPAP Humidifier is equivalent to the predicate device in terms of safety, effectiveness and performance.
signed:
James Thompson
te: 7/7/04
James Thompson Fisher & Paykel Healthcare Ltd
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2004
Mr. James Thompson Regulatory Affairs Engineer-OSA Fisher & Paykel Healthcare, Limited 15 Maurice Paykel Place, East Tamaki P.O. Box 14-348, Panmure, Auckland, NEW ZEALAND 1701
Re: K041900
Trade/Device Name: HC604 CPAP Humidifer Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 8, 2004 Received: July 14, 2004
Dear Mr. Thompson:
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 Amendinens, of to do rood Cosmetic Act (Act) that do not require approval of a premarket the Federal F 000; Drag, Drag, therefore, market the device, subject to the general approvial applisions of the Act. The general controls provisions of the Act include controls provided 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 11 your do ree is classified to such additional controls. Existing major regulations affecting (1 wr 1, 1 mm of tound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of rouhish further announcements concerning 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 I lease be ad rised that 12 a determination that your device complies with other requirements modi that I Drimb mass and regulations administered by other Federal agencies. or the Fee of any I with all the Act's requirements, including, but not limited to: registration r od intine (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and libeling (21 CF 1 read in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form in all quadis tion 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) rms reter notification. The FDA finding of substantial equivalence of your device to a premiter tiottreation - In 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), If you desire specific at 1.0 x . pliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj count of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
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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7 July 2004
510(k) Number:
KOY1900
HC604 CPAP Humidifier Device Name:
INDICATIONS FOR USE:
The HC604 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 to this therapy relieves the drying and irritating effects on the patient airways, which may arise from use of a CPAP system.
The HC604 CPAP Humidifier is for use on adult, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep laboratory.
Prescription Use
and/or
Over-the-Counter Use_
(Part 21 CFR 801 subpart D)
(Part 21 CFR 801 subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ann Sylvon
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De 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).