(267 days)
The Fisher & Paykel HC550 System is designed for use with artificial ventilation systems. Portable volume ventilation systems, pressure support ventilation and Continuous Positive Airway Airway Pressure (CPAP) systems may incorporate an HC550 to provide therapeutic levels of warm humidified air to adult patients with artificial airways or through mask ventilation.
The operating flow range is 5 to 120L/min depending on the patient interface.
The HC550 is designed for use in long term care facilities or the home under the prescription of a qualified medical professional.
The Fisher & Paykel Healthcare HC550 System is designed to condition gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.
The HC550 System consists of the following components:
- . HC550 Respiratory Humidifier
- . Accessories:
- a) Breathing circuit (compatible adult breathing circuits as cleared in K983112, K020332, K034026, K103767, K122432)
- b) Humidification Chamber (as cleared in K9341401 and K913368)
- c) Heaterwire Adaptor (as cleared in K073706)
- d) Temperature/Flow Probe (as cleared in K983112)
- RT008 Air Entrainer (optional oxygen therapy accessory) (as cleared in K953711) e)
The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a humidification chamber.
A dryline tube (part of the breathing circuit) transports respiratory gases from a flow source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified.
The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube may be electrically heated by means of a heater-wire placed internally to the tube, which is controlled by the HC550 respiratory humidifier.
The expiratory limb of the breathing circuit transports expired gas from patient. In the case of a dual-heated breathing circuit, this limb may also be heated in the same manner as the inspiratory limb.
If a heated breathing circuit is used, the heaterwire adaptor provides electrical energy from the respiratory humidifier to the heaterwire in the breathing circuit.
Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.
HC550 System Acceptance Criteria and Study Details
This document describes the acceptance criteria and corresponding study results for the HC550 System, a respiratory gas humidifier. The information is extracted from the provided 510(k) Notification K132017.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the HC550 System are based on compliance with the ISO 8185:2007 standard for humidification systems. The device's performance is compared to these requirements.
| Acceptance Criteria (from ISO 8185:2007) | Reported Device Performance (HC550 System) |
|---|---|
| Humidity performance (for non-invasive mode): ≥ 10 mg/L over recommended flow ranges | ≥ 10 mg/L over the recommended flow ranges |
| Humidity performance (for invasive mode): ≥ 33 mg/L over recommended flow ranges | ≥ 33 mg/L over the recommended flow ranges |
| Enthalpy: < 194 kJ/kg dry gas | < 194 kJ/kg dry gas |
2. Sample Size and Data Provenance for Test Set
The document does not explicitly state a specific sample size for a "test set" in the context of clinical studies. The performance evaluation was conducted through bench testing to demonstrate compliance with ISO 8185:2007.
- Sample Size for Test Set: Not applicable in the context of a clinical test set. Performance was evaluated through bench testing.
- Data Provenance: Bench testing results, derived from laboratory experiments, not patient data. No country of origin for specific data is stated, but the submission is from Auckland, New Zealand.
- Retrospective/Prospective: Not applicable, as no clinical study with patient data was performed.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. Ground truth was established by international standards (ISO 8185:2007) for device performance, not expert consensus on an annotated dataset.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable, as no clinical study requiring adjudication of expert opinions was conducted. Performance was judged against predefined engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.
- Effect Size of AI vs. without AI assistance: Not applicable, as this is a medical device and not an AI-assisted diagnostic or treatment system.
6. Standalone Performance Study
- Standalone Performance Study: Yes, a standalone performance study was done in the form of bench testing. The algorithm (or device in this case) was tested against established international standards (ISO 8185) to assess its functional performance independently. The results are presented in the table above, demonstrating the device's ability to meet the humidity and enthalpy requirements specified by the standard.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was international standard compliance (ISO 8185:2007). This standard sets quantifiable performance requirements for respiratory gas humidifiers.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not utilize machine learning or AI models that require a "training set." Its design and performance are based on engineering principles and compliance with established standards.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as no training set was used.
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HC550 System
510(k) Notification
510(k) Summary 5
MAR 2 5 2014
5-1
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15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com
| Contact person/submitter | Elizabeth Goldstein |
|---|---|
| Date prepared | 26 March 2014 |
| Contact details | Address: 15 Maurice Paykel PlaceEast TamakiAuckland 2013, New Zealand |
| Telephone: +64 9 574 0100 | |
| Fax: +64 9 574 0148 | |
| Trade name | HC550 System |
| Common name | Respiratory gas humidifier |
| Classification name | Respiratory gas humidifierII (21 CFR §868.5450), product code BTT |
| Predicate device | K073706 Respiratory Humidifier, Model 850 |
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5.1 Device Description
The Fisher & Paykel Healthcare HC550 System is designed to condition gases for patients by raising the delivered water vapor content (humidity) and temperature of the gases.
The HC550 System consists of the following components:
- . HC550 Respiratory Humidifier
- . Accessories:
- a) Breathing circuit (compatible adult breathing circuits as cleared in K983112, K020332, K034026, K103767, K122432)
- b) Humidification Chamber (as cleared in K9341401 and K913368)
- c) Heaterwire Adaptor (as cleared in K073706)
- d) Temperature/Flow Probe (as cleared in K983112)
- RT008 Air Entrainer (optional oxygen therapy accessory) (as cleared in K953711) e)
The device consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a humidification chamber.
A dryline tube (part of the breathing circuit) transports respiratory gases from a flow source (e.g. ventilator) to the humidification chamber where the gases are heated and humidified.
The inspiratory limb of the breathing circuit transports the heated and humidified gases from the humidification chamber to the patient. The inspiratory tube may be electrically heated by means of a heater-wire placed internally to the tube, which is controlled by the HC550 respiratory humidifier.
The expiratory limb of the breathing circuit transports expired gas from patient. In the case of a dual-heated breathing circuit, this limb may also be heated in the same manner as the inspiratory limb.
If a heated breathing circuit is used, the heaterwire adaptor provides electrical energy from the respiratory humidifier to the heaterwire in the breathing circuit.
Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.
Note 1: The MR290 Autofeed Humidification Chamber was originally cleared for market under K934140. Since clearance, there have been two changes to the materials used to construct the device, as currently constructed (i.e. with materials which have been modified since under K934140) has been cleared for market under K131957.
5.2 Intended Use
HC550 System:
The Fisher & Paykel HC550 System is designed for use with artificial ventilation systems. Portable volume ventilation systems, pressure support ventilation and Continuous Positive Airway Pressure (CPAP) systems may incorporate an HC550 to provide therapeutic levels of warm humidified air to adult patients with artificial airways or through mask ventilation.
The operating flow range is 5 to 120L/min depending on the patient interface.
The HC550 is designed for use in long term care facilities or the home under the prescription of a qualified medical professional.
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5.2.1 Intended Use Comparison
The intended uses of the subject device, HC550 System, and the predicate device, MR850, are identical with the exception of the following:
- . The environment for use.
Table 1 provides a comparison of the intended use of the HC550 and MR850, where differences are highlighted in gray.
| Table 1 HC550 and MR850 intended use comparison summary | |||
|---|---|---|---|
| --------------------------------------------------------- | -- | -- | -- |
| Device feature | HC550 (modified) | MR850 (predicate) |
|---|---|---|
| Purpose and function | Addition of therapeutic levels ofheat & humidity to inspiredrespiratory gases | Addition of therapeutic levels of heat& humidity to inspired respiratorygases |
| Patient population | Patients requiring mechanicalventilation or positive pressurebreathing assistance, via face non-invasive or invasive | Patients requiring mechanicalventilation or positive pressurebreathing assistance, via face non-invasive or invasive |
| Environment for use | Long term care facilities or thehomeNote: The power output of theHC550 has been software limitedfor home use. Refer to $5.3. | Hospital |
Technological Characteristics Comparison 5.3
The electrical hardware of the subject device, HC550 System, and the predicate device, MR850, are identical and therefore the HC550 System is physically and electrically compatible with accessories designed for the MR850 system. However, although the MR850 may be used with adult, infant or neonatal breathing circuits, the HC550 System is being submitted for use with adult breathing circuit accessories.
Table 2 provides a comparison of the accessories for the HC550 and MR850, where differences are highlighted in gray.
| Device feature | HC550 (modified) | MR850 (predicate) |
|---|---|---|
| Humidification chamber | Fisher & Paykel Healthcarehumidification chambers | Fisher & Paykel Healthcarehumidification chambers |
| Breathing circuit - Adult | • Single-heated | • Single-heated |
| • Dual-heated | • Dual-heated | |
| • Non-heated | • Non-heated |
Table 2 HC550 and MR850 accessories comparison summary
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| Device feature | HC550 (modified) | MR850 (predicate) |
|---|---|---|
| Breathing circuit - Infant/Neonatal | None | Single-heated Dual-heated Non-heated |
| Electrical adaptor | Fisher & Paykel Healthcare DualLimb Smart Adaptor and SingleLimb Smart Adaptor | Fisher & Paykel Healthcare DualLimb Smart Adaptor and SingleLimb Smart Adaptor |
| Temperature / flow probe | Fisher & Paykel HealthcareTemperature / Flow Probes | Fisher & Paykel HealthcareTemperature / Flow Probes |
| Oxygen therapy | RT008 Air Entrainer | RT008 Air Entrainer |
| Mounting accessories | Fisher & Paykel Healthcareventilator brackets | Fisher & Paykel Healthcareventilator brackets |
The HC550 and MR850 have identical physical characteristics, with minor aesthetic differences.
Table 3 provides a comparison of the physical descriptions of the HC550 and MR850, where differences are highlighted in gray.
| Device feature | HC550 (modified) | MR850 (predicate) |
|---|---|---|
| Height | 140 mm (5.5 in) | 140 mm (5.5 in) |
| Weight | 2.8 kg (6.2 lb) | 2.8 kg (6.2 lb) |
| Finger guard (color) | White | Blue |
| Lens | 2 button design | 3 button design |
| (Button location and opacity) | Opaque display | Clear display |
Table 3 HC550 and MR850 physical descriptions comparison summary
The heating hardware and electrical specifications of the HC550 and MR850 are identical, however the power has been software limited for use in the home.
Table 4 provides a comparison of the functional characteristics of the HC550 and MR850, where differences are highlighted in gray.
| Table 4 HC550 and MR850 functional characteristics comparison summary | ||
|---|---|---|
| Device feature | HC550 (modified) |
| Device feature | HC550 (modified) | MR850 (predicate) |
|---|---|---|
| Heater-plate | Aluminum 100 mm Ø | Aluminum 100 mm Ø |
| Voltage | 115 Vac | 115 Vac |
| Frequency | 50 or 60 Hz | 50 or 60 Hz |
| Current | 2.0 A maximum | 2.0 A maximum |
| Power | 150 W | 150 W |
| · (Software limited to 105W) |
Non-Clinical Tests 5.4
The HC550 is compliant with the same product standards (or equivalent product standards) as the predicate device, MR850.
Table 5 provides a comparison of the product standards for the HC550 and MR850.
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| Standard | HC550 (Modified device) | MR850 (Predicate device) |
|---|---|---|
| ISO 8185: 1997 | Compliant with ISO 8185:1997 | Compliant with ISO 8185:1997 |
| IEC 60601-1: 1988 | Compliant with IEC 60601-1:1998+A1:1991 +A2:1995 | Compliant with IEC 60601-1:1998+A1:1991 +A2:1995 |
| IEC 60601-1-2 | Compliant with IEC 60601-1-2:2007 | Compliant with IEC 60601-1-2:2001 |
Table 5 HC550 and MR850 functional characteristics comparison summary
Compliance of the subject device, HC550 System, and the predicate device, MR850, to the same device standards supports substantial equivalence of these products.
In addition, testing to ISO 8185:2007, the particular standard for humidification systems, supports performance of the subject device in accordance with the intended use (i.e. to heat and humidify gases) and substantial equivalence to the predicate device, MR850. As summarized in Table 6 below, the humidity output of both the subject device, HC550 System, and the predicate device, MR850, meets the performance requirements and the enthalpy requirements as specified in ISO 8185:2007 and therefore the performance of the devices is substantially equivalent.
| Standard | HC550 (Modified device) | MR850 (Predicate device) |
|---|---|---|
| Humidity performance(for non-invasive mode) | ≥ 10 mg/L over the recommendedflow ranges(as required by ISO 8185) | ≥ 10 mg/L over the recommendedflow ranges(as required by ISO 8185) |
| Humidity performance(for invasive mode) | ≥ 33 mg/L over the recommendedflow ranges(as required by ISO 8185) | ≥ 33 mg/L over the recommendedflow ranges(as required by ISO 8185) |
| Enthalpy | < 194 kJ/kg dry gas(as required by ISO 8185) | < 194 kJ/kg dry gas(as required by ISO 8185) |
Table 6 HC550 and MR850 functional characteristics comparison summary
5.4.1 Biocompatibility
The HC550 System was assessed for biocompatibility in accordance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing and 510(k) Memorandum - #G95-1 Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'.
The method of assessing biocompatibility of the subject device, HC550 System, is identical to the method of assessing biocompatibility of the predicate device, MR850.
All equivalent components of the HC550 and MR850 Systems have been assessed as having identical patient contact and duration of contact. All patient-contacting accessories which are accessories to the subject device, HC550 System, are also accessories to the predicate device, MR850, i.e. all patient-contacting devices are identical and no new patient-contacting accessories are being presented as part of this 510(k) submission.
A summary of the biocompatibility assessments of the HC550 and MR850 is provided in Table 7 below.
| Systemcomponent | Summary ofbiocompatibility -HC550 (Modified device) | Summary ofbiocompatibility -MR850 (Predicatedevice) | Comments |
|---|---|---|---|
| Respiratoryhumidifier | Non-patient contact device(no biocompatibilitytesting required) | Non-patient contact device(no biocompatibilitytesting required) | Identical |
| Breathingcircuitaccessories | External communicatingdevice(tissue/bone/dentin);permanent contact | External communicatingdevice(tissue/bone/dentin);permanent contact | IdenticalAll breathing circuitsrecommended for use withthe HC550 and/or MR850have been previouslycleared. Biocompatibilitytesting for breathing circuit |
| Fisher & Paykel Healthcare | HC550 System | 510(k) Notification5-6 | |
| accessories is as per therelevant 510(k) submissions. | |||
| Refer to 510(k) K983112,K020332, K122432. | |||
| Humidificationchamberaccessories | External communicatingdevice(tissue/bone/dentin);permanent contact | External communicatingdevice(tissue/bone/dentin);permanent contact | IdenticalAll humidification chambersrecommended for use withthe HC550 and/or MR850have been previouslycleared. Biocompatibilitytesting for humidificationchamber accessories is asper the relevant 510(k)submissions. |
| Refer to 510(k) K934140',K913368. | |||
| Note 1: The MR290Autofeed HumidificationChamber was originallycleared for market underK934140. Since clearance,there have been two changesto the materials used toconstruct the device. Thedevice, as currentlyconstructed (i.e. withmaterials which have beenmodified since clearanceunder K934140) has been | |||
| Temperature /flow probeaccessories | Primarily non-patient contactFlow probe stem is an external communicating device (tissue/bone/dentin); permanent contact | Primarily non-patient contactFlow probe stem is an external communicating device (tissue/bone/dentin); permanent contact | IdenticalAll temperature/flow probesrecommended for use withthe HC550 and MR850 havebeen previously cleared.Biocompatibility testing fortemperature/flow probeaccessories is as per therelevant 510(k) submissions.Refer to 510(k) K983112. |
| Heater wireadaptor | Non-patient contact device(no biocompatibility | Non-patient contact device(no biocompatibility | Identical |
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Clinical Tests ર્ફ્ર ફંડ
Not applicable - no clinical testing was performed with respect to the HC550 System.
Conclusion 5.6
A comparison of the physical and functional characteristics and biocompatibility demonstrates technological equivalence, where only minor differences between the devices exist for aesthetic purposes a revised environment for use. In addition, the subject device is being presented with adult accessories only, whereas the predicate device is presented with adult and infant/neonatal accessories. The aforementioned differences do not affect safety or effectiveness of the subject device. The comparison of the intended purpose/function of the HC550 to the MR850 demonstrates that the systems are substantially equivalent in terms of clinical purpose.
Performance of these devices is supported by bench testing, which demonstrates equivalent performance in accordance with the particular standard for humidification systems, ISO 8185.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2014
Fisher & Paykel Healthcare Ltd. Elizabeth Goldstein Regulatory Affairs Specialist 15 Maurice Paykel Place East Tamaki Auckland, New Zealand
Re: K132017
Trade/Device Name: HC550 System Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: February 16, 2014 Received: February 18, 2014
Dear Ms. Goldstein:
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 - Ms. Elizabeth Goldstein
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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Erin I. Keith M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infectious Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K132017
Device Name HC550 System
Indications for Use (Describe) Indications for Use:
HC550 System:
The Fisher & Paykel HC550 System is designed for use with artificial ventilation systems. Portable volume ventilation systems, pressure support ventilation and Continuous Positive Airway Pressure (CPAP) systems may incorporate an HC550 to provide therapeutic levels of warm humidified air to adult patients with artificial airways or through mask ventilation.
The operating flow range is 5 to 120L/min depending on the patient interface.
The HCS50 is designed for use in long term care facilities or the home under the prescription of a qualified medical professional.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (9/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
FF PSC Publicitions: Services (301) 441-6740
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§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).