(267 days)
No
The description mentions a microprocessor with embedded software for control, but there is no mention of AI, ML, or related concepts. The control appears to be based on feedback from temperature and flow probes, which is standard control system technology, not AI/ML.
Yes
The device is described as providing "therapeutic levels of warm humidified air" for adult patients connected to ventilation systems, indicating its role in patient treatment.
No
The device is a respiratory humidifier designed to condition gases for patients receiving artificial ventilation, CPAP, or pressure support ventilation. It provides therapeutic levels of warm humidified air, but it does not perform any diagnostic function.
No
The device description clearly outlines multiple hardware components including a respiratory humidifier, breathing circuits, humidification chamber, heaterwire adaptor, and temperature/flow probe. While it mentions embedded software, the device is fundamentally a hardware system with software control.
Based on the provided text, the Fisher & Paykel HC550 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- HC550 Function: The HC550 System is designed to condition gases (warm and humidify air) for patients receiving respiratory support through artificial ventilation or mask ventilation. It directly interacts with the patient's respiratory system, not with specimens taken from the patient.
- Intended Use: The intended use clearly states it's for providing warm humidified air to adult patients with artificial airways or through mask ventilation, used in conjunction with ventilation systems. This is a therapeutic function, not a diagnostic one.
Therefore, the HC550 System falls under the category of a respiratory support device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
BTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Long term care facilities or the home under the prescription of a qualified medical professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
The HC550 is compliant with the same product standards (or equivalent product standards) as the predicate device, MR850. Compliance of the subject device, HC550 System, and the predicate device, MR850, to the same device standards supports substantial equivalence of these products.
Testing to ISO 8185:2007 supports performance of the subject device in accordance with the intended use and substantial equivalence to the predicate device. 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.
Biocompatibility:
The HC550 System was assessed for biocompatibility in accordance with ISO 10993-1 and 510(k) Memorandum - #G95-1. The method of assessing biocompatibility of the subject device is identical to the method of assessing biocompatibility of the predicate device. 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 are identical to those of the predicate device and no new patient-contacting accessories are presented.
Clinical Tests:
Not applicable - no clinical testing was performed with respect to the HC550 System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Humidity performance (for non-invasive mode): >= 10 mg/L over the recommended flow ranges (as required by ISO 8185)
Humidity performance (for invasive mode): >= 33 mg/L over the recommended flow ranges (as required by ISO 8185)
Enthalpy:
§ 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).
0
HC550 System
510(k) Notification
510(k) Summary 5
MAR 2 5 2014
5-1
Image /page/0/Picture/5 description: The image shows the logo for Fisher & Paykel. The words "Fisher & Paykel" are on the top line, with an ampersand between the two words. The word "Healthcare" is on the second line, in all caps.
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 Place |
| East Tamaki | |
| Auckland 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 humidifier |
| II (21 CFR §868.5450), product code BTT | |
| Predicate device | K073706 Respiratory Humidifier, Model 850 |
1
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.
2
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 of | |
| heat & humidity to inspired | ||
| respiratory gases | Addition of therapeutic levels of heat | |
| & humidity to inspired respiratory | ||
| gases | ||
| Patient population | Patients requiring mechanical | |
| ventilation or positive pressure | ||
| breathing assistance, via face non- | ||
| invasive or invasive | Patients requiring mechanical | |
| ventilation or positive pressure | ||
| breathing assistance, via face non- | ||
| invasive or invasive | ||
| Environment for use | Long term care facilities or the | |
| home | ||
| Note: The power output of the | ||
| HC550 has been software limited | ||
| for 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 Healthcare | |
| humidification chambers | Fisher & Paykel Healthcare | |
| humidification chambers | ||
| Breathing circuit - Adult | • Single-heated | • Single-heated |
| • Dual-heated | • Dual-heated | |
| • Non-heated | • Non-heated |
Table 2 HC550 and MR850 accessories comparison summary
3
| Device feature | HC550 (modified) | MR850 (predicate) |
|---|---|---|
| Breathing circuit - Infant/Neonatal | None | Single-heated Dual-heated Non-heated |
| Electrical adaptor | Fisher & Paykel Healthcare Dual | |
| Limb Smart Adaptor and Single | ||
| Limb Smart Adaptor | Fisher & Paykel Healthcare Dual | |
| Limb Smart Adaptor and Single | ||
| Limb Smart Adaptor | ||
| Temperature / flow probe | Fisher & Paykel Healthcare | |
| Temperature / Flow Probes | Fisher & Paykel Healthcare | |
| Temperature / Flow Probes | ||
| Oxygen therapy | RT008 Air Entrainer | RT008 Air Entrainer |
| Mounting accessories | Fisher & Paykel Healthcare | |
| ventilator brackets | Fisher & Paykel Healthcare | |
| ventilator 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.
4
| 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 recommended | |
| flow ranges | ||
| (as required by ISO 8185) | ≥ 10 mg/L over the recommended | |
| flow ranges | ||
| (as required by ISO 8185) | ||
| Humidity performance | ||
| (for invasive mode) | ≥ 33 mg/L over the recommended | |
| flow ranges | ||
| (as required by ISO 8185) | ≥ 33 mg/L over the recommended | |
| flow ranges | ||
| (as required by ISO 8185) | ||
| Enthalpy | FF PSC Publicitions: Services (301) 441-6740 |
9
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