(44 days)
The HC238 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.
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 provides positive air pressure. The fan speed is directly related to air pressure, and is open at a humidification chamber at the front of the device. The second functional unit of the HC238 is a heated passover humidifier. The water is contained in the humidifying chamber and is heated on a heaterplate at the front of the unit. Humidified air is delivered from the blower assembly via a port at the back of the chamber. The chamber connects directly to the breathing tube.
Here's an analysis of the provided 510(k) summary regarding the HC238 CPAP Humidifier, focusing on acceptance criteria and supporting studies:
This 510(k) submission (K050904) for the Fisher & Paykel Healthcare Ltd HC238 CPAP Humidifier does not contain information about clinical acceptance criteria or studies with human subjects that prove the device meets specific performance thresholds related to its clinical efficacy in a statistical manner. This is explicitly stated in the document: "(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."
Instead, the submission relies on demonstrating substantial equivalence to a predicate device (HC234 CPAP Humidifier, K040941) through non-clinical testing and shared technological characteristics.
Therefore, for your specific request, I can only provide information based on the non-clinical testing described and the regulatory pathway taken.
1. A table of acceptance criteria and the reported device performance
Since no specific clinical acceptance criteria with quantitative thresholds are provided, and no clinical performance data from human studies are reported, the table below reflects the non-clinical compliance and performance goals based on applicable standards.
| Acceptance Criterion (Non-Clinical) | Reported Device Performance |
|---|---|
| Mechanical safety compliance | Complies with relevant requirements (implied by submission) |
| Electrical safety compliance | Complies with IEC 60601-1 |
| Thermal safety compliance | Complies with relevant requirements (implied by submission) |
| Environmental conditions compliance | Complies with relevant requirements (implied by submission) |
| Electromagnetic compatibility (EMC) compliance | Complies with IEC 60601-1-2 |
| Functional verification | Meets design and performance functional requirements |
| Performance (general) | Meets design and performance functional requirements |
| Performance & Safety (CPAP Devices) | Complies with ISO 17510-1 |
| Humidification Systems Performance & Safety | Complies with "key international - and - 607 requirements from particular standards for humidification systems" (specific standard numbers are partially obscured but generally referencing relevant standards for humidifiers) |
| Delivered pressure maintenance (software feedback) | Implemented to maintain delivered pressure for instances of mouth or resource feedback, ambient air density, and dynamic changes in flow. |
| Delivered pressure measurement & display | Functional measurement and display (implied as a modification to predicate) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No human test subjects were used for clinical verification studies. The "test set" for non-clinical studies would typically refer to the specific units of the device tested in a laboratory setting. The number of devices tested is not specified, but it's standard practice to test multiple units to ensure reproducibility and compliance.
- Data Provenance: Not applicable. No human data was collected. Non-clinical testing data would originate from laboratory experiments conducted by Fisher & Paykel Healthcare Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical ground truth was established through expert consensus as no clinical studies were performed. Ground truth for non-clinical testing is typically defined by engineering specifications, regulatory standards, and accepted measurement techniques.
4. Adjudication method for the test set
- Not applicable. No human expert adjudication was performed for clinical outcomes. Compliance with standards and functional requirements in non-clinical testing is determined by engineers and quality assurance professionals against pre-defined specifications and test protocols.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a CPAP humidifier, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical/electronic medical device, not an algorithm. Therefore, no standalone algorithm performance study was done.
7. The type of ground truth used
- For the non-clinical tests, the "ground truth" was based on:
- Regulatory Standards: Specific requirements outlined in standards like IEC 60601-1, IEC 60601-1-2, and ISO 17510-1.
- Engineering Specifications: Internal design and performance specifications for the device.
- Predicate Device Performance: The HC238 was compared to the predicate HC234 CPAP Humidifier (K040941) to demonstrate substantial equivalence in intended use, fundamental technological characteristics, and manufacturing process.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning product; therefore, there is no "training set" in that context. If "training set" refers to the data used to design and refine the device, it would involve extensive engineering development, component testing, and prototype evaluation. The specific "sample size" of developmental units or data is not provided.
9. How the ground truth for the training set was established
- Not applicable in the context of AI/ML. For traditional medical device development, the "ground truth" during the design and development ("training") phase is established through:
- User Needs Analysis: Understanding the requirements of patients and healthcare providers.
- Regulatory Requirements: Adhering to applicable standards and regulations from the outset.
- Benchmarking: Evaluating existing similar products (like the predicate device) to understand performance expectations.
- Engineering Principles: Applying established principles of fluid dynamics, heat transfer, electrical engineering, etc., to design components and systems.
- Iterative Testing: Repeated testing of components and prototypes against design specifications to ensure they meet intended performance and safety metrics.
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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 (301) 443-6597 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
§ 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).