(110 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a heated wire breathing circuit, with no mention of AI or ML technologies.
No
This device is a breathing circuit, which acts as a conduit for breathing gases and helps maintain gas temperature, but it does not directly provide therapy. It is intended to be used with ventilators, which are therapeutic devices.
No
The device is a heated wire breathing circuit designed to warm and humidify breathing gases for patients, functioning as a conduit for ventilation. It does not collect or analyze data to diagnose a medical condition.
No
The device description clearly outlines physical components such as corrugated plastic tubing, plastic tube connectors, and an electrical heater wire harness subassembly. It is a hardware device with electrical and mechanical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The described device is a heated wire breathing circuit. Its function is to warm and humidify breathing gases delivered to a patient's airway. It acts as a conduit for these gases.
- Lack of Diagnostic Testing: The description does not mention any testing of biological samples or any diagnostic purpose. The device's role is purely in the delivery and conditioning of breathing gases.
Therefore, this device falls under the category of a respiratory support device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The disposable heated wire circuit is a heated wire breathing circuit intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. The disposable heated wire circuit is indicated for use by a single adult or pediatric patient in the home, hospital and/or institutional settings. It may be used for both invasive and non-invasive ventilation.
Product codes (comma separated list FDA assigned to the subject device)
BZE
Device Description
The Respironics heated wire breathing circuit is a disposable device compromised of 15 or 22 mm corrugated plastic tubing, and 22 mm plastic tube connectors, and an electrical heater wire harness subassembly. The Respironics disposable heated wire circuit consists of a single limb single lumen smooth interior tube (15 or 22 mm diameter) containing 2 heater wires that are located in the tubing construction of which the tube is formed having a supporting structure; the tube is spiral and the wire has a single loop form. After the gas is warmed and humidified in the water chamber it is delivered through the breathing circuit to the patient. Heating of the breathing tube is provided and controlled by a compatible heated humidifier. This disposable heated wire circuit is designed to be used with the HC500 Fisher and Paykel humidifier. The heating wires are physically separated from the lumen of the tubing. As such, there is no direct contact between the heating wires and the air flow. When a voltage is applied, a current flows through the heating wires. Due to the wire resistance, heat is dissipated through the wall of the tube construction into the air flow in the lumen of the tubing.
There are four types of disposable breathing circuits:
- l . Disposable Pediatric, Heated Wire Active Circuit
-
- Disposable Adult, Heated Wire Active Circuit
-
- Disposable Pediatric, Heated Wire Passive Circuit
-
- Disposable Adult, Heated Wire Passive Circuit
The purpose of the heated wire breathing circuits is to maintain or raise the gas temperature to or above the dew point thus reducing or eliminating water condensation and/or pooling of water in the breathing circuit.
The Respironics disposable heated wire breathing circuit has standard cuffs on both the machine-end cuff and mask-end cuff. As such, the disposable heated wire breathing circuit can be connected to heated humidifiers and flow generators that have standard male outlet connectors. The Respironics disposable heated wire breathing circuit is intended for incorporation into ventilator devices and is intended to act as a conduit for the breathing gasses delivered from the humidifier to the patient. It can also be used in conjunction with supplemental Oxygen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway (Invasive & Non-invasive)
Indicated Patient Age Range
Adult or pediatric patient. Pediatric (>= 5kg) to Adult.
Intended User / Care Setting
Environment of use: home, institutional, nursing, extended care, and clinical sleep lab settings.
Operators: Patients, Lay caregivers (includes family members of patients and aides), Nurses, Respiratory therapists, Physicians and Home care providers.
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
Non-clinical testing of the Respironics Disposable Heated Wire Breathing Circuit have been conducted including mechanical, electrical, and temperature accuracy under environmental conditions, and test standards for electromagnetic immunity. These include Resistance to Flow, Compliance, Compressible Volume and Wire Resistance. All materials used in the heated wire breathing circuit and humidification chambers have been evaluated according to tests outlined in ISO 10993-1.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This device has been tested to appropriate ISO and IEC standards and other applicable requirements passing all test protocols. The Respironics disposable heated wire circuit was designed and tested according to guidance outlined in:
- FDA's Draft Reviewer Guidance for Premarket Notification Submissions -Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices (November 1993);
- FDA's Draft Reviewer Guidance for Ventilators July 1995; and
As suggested by FDA's November 1993 publication entitled "Reviewer Guidance for Premarket Notification Submissions - Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices" and "Draft Reviewer Guidance for Ventilators July 1995" the Respironics disposable heated wire circuit was tested in accordance with the applicable voluntary standards. The Respironics disposable heated wire circuit met the required performance criteria and functioned as intended.
No clinical tests have been performed on the Respironics Disposable Heated Wire Breathing Circuit as not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).
0
KID348
Respironics Disposable Heated Wire Circuits
JUN - 1 2011 Premarket Notification -- Abbreviated 510(k)
Section 5.0 510(k) Summary
17
Administrative Information and Device Identification
:
| Name and address of the submitter, contract manufacturer and sponsor of the 510(k) submission: | Submitter: |
|---|---|
| Respironics, Inc. | |
| 1740 Golden Mile Highway | |
| Monroeville, PA 15146 | |
| Fax: 724-387-7490 | |
| Contract Manufacturer: | |
| WILAmed GMBH | |
| Aurachhoehe 5 7 | |
| Kammerstein, Bayern, 91126, Germany | |
| Fax: 049-9178-996778 | |
| United States Agent: | |
| Regulatory Insight, Inc. | |
| Kevin Walls | |
| 5401 S. Cottonwood CT | |
| Greenwood Village, CO 80121 USA | |
| Office: 720-962-5412 | |
| Fax: 720-962-5413 | |
| Email: kevin@reginsight.com | |
| FDA registration number of the manufacturer of the new device: | Submitter: |
| 2518422 (Establishment Registration Number) | |
| Contract Manufacturer: | |
| 9615827 (Establishment Registration Number) | |
| 10033146 (Owner/Operator Number) | |
| Official contact person for all correspondence: | Joseph E. Olsavsky |
| Sr. Regulatory Affairs Manager | |
| Philips Respironics | |
| 1740 Golden Mile Highway | |
| Monroeville, PA 15146 | |
| Office: 724-387-7562 | |
| Fax: 724-387-7490 | |
| Email: joseph.olsavsky@philips.com | |
| Date Prepared: | February 10, 2011 |
| Device Name: | Respironics Disposable Heated Wire Circuits |
| Trade or Proprietary name of new | Disposable Pediatric, Heated Wire Active Circuit USA |
| device: | Disposable Adult, Heated Wire Active Circuit USA |
| Disposable Pediatric, Heated Wire Passive Circuit USA | |
| Disposable Adult, Heated Wire Passive Circuit USA | |
| Common or usual name of the | |
| device: | Heated Breathing Tube |
| Philips/Respironics model number: | 1076043, 1076044, 1076045, 1076046 |
| Classification of new device: | Class II |
| Classification of the predicate | |
| device: | Class II |
| Classification Panel: | Anesthesiology |
| Panel Code: | BZE - Breathing system, heater |
| CFR Regulation Number: | 21 CFR 868.5270 |
| a) Identification. A breathing system heater is a device | |
| that is intended to warm breathing gases before they | |
| enter a patient's airway. The device may include a | |
| temperature controller. | |
| (b) Classification. Class II (performance standards). | |
| Predicate Device Name(s) and | |
| 510(k) numbers: | 1. Plastiflex Healthcare Hybernite Rainout Control |
| System - K100104 date of concurrence 04/14/2010) |
- Intersurgical Heated Wire Breathing System -
K092129 (date of concurrence 05/18/2010) - Fisher & Paykel Respiratory Humidifier - K983112
(date of concurrence 11/10/1996) |
| Reason for submission: | New Device |
1
Description of Device:
The Respironics heated wire breathing circuit is a disposable device compromised of 15 or 22 mm corrugated plastic tubing, and 22 mm plastic tube connectors, and an electrical heater wire harness subassembly. The Respironics disposable heated wire circuit consists of a single limb single lumen smooth interior tube (15 or 22 mm diameter) containing 2 heater wires that are located in the tubing construction of which the tube is formed having a supporting structure; the tube is spiral and the wire has a single loop form. After the gas is warmed and humidified in the water chamber it is delivered through the breathing circuit to the patient. Heating of the breathing tube is provided and controlled by a compatible heated humidifier. This disposable heated wire circuit is designed to be used with the HC500 Fisher and Paykel humidifier. The
2
heating wires are physically separated from the lumen of the tubing. As such, there is no direct contact between the heating wires and the air flow. When a voltage is applied, a current flows through the heating wires. Due to the wire resistance, heat is dissipated through the wall of the tube construction into the air flow in the lumen of the tubing.
There are four types of disposable breathing circuits:
- l . Disposable Pediatric, Heated Wire Active Circuit
-
- Disposable Adult, Heated Wire Active Circuit
-
- Disposable Pediatric, Heated Wire Passive Circuit
-
- Disposable Adult, Heated Wire Passive Circuit
The purpose of the heated wire breathing circuits is to maintain or raise the gas temperature to or above the dew point thus reducing or eliminating water condensation and/or pooling of water in the breathing circuit.
The Respironics disposable heated wire breathing circuit has standard cuffs on both the machine-end cuff and mask-end cuff. As such, the disposable heated wire breathing circuit can be connected to heated humidifiers and flow generators that have standard male outlet connectors. The Respironics disposable heated wire breathing circuit is intended for incorporation into ventilator devices and is intended to act as a conduit for the breathing gasses delivered from the humidifier to the patient. It can also be used in conjunction with supplemental Oxygen.
The environment of use for the disposable heated wire breathing circuit will be for in the home, institutional, nursing, extended care, and clinical sleep lab settings.
Operators of the disposable heated wire breathing circuit are expected to be: Patients, Lay caregivers (includes family members of patients and aides), Nurses, Respiratory therapists, Physicians and Home care providers.
The disposable heated wire breathing circuit is intended to be used with ventilators that provide both pressure support and volume modes of therapy.
Other accessories such as water traps, etc. can be added in to the overall assembly creating different product variations.
Comparison of Device Technological Characteristics to Predicate Devices:
The Respironics Disposable Heated Wire Circuits have the following similarities to those predicate devices listed in this submission which previously received 510(k) concurrence; the Respironics Disposable Heated Wire Circuits:
- Has the same intended use, .
- Uses the same operating principle, .
3
- Incorporates the same basic heated wire breathing circuit design elements for use with . ventilator devices including physical interfaces; and performance characteristics;
- . Incorporates similar materials & is ISO 10993 compliant;
- ls manufactured utilizing similar manufacturing processes; and .
- Complies with similar electrical, mechanical, chemical and performance standards .
According to FDA's Draft Reviewer Guidance for Premarket Notification Submissions -Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices (November 1993), the following characteristics for the submitted device and consistent with the predicate devices are identified below:
- The Respironics disposable heated wire breathing circuit is not an implantable device. ●
- The Respironics disposable heated wire breathing circuit is intended for life support or . life sustaining applications.
- The Respironics disposable heated wire breathing circuit is not sold as sterile. ●
- The Respironics disposable heated wire breathing circuit is a single-patient-use device. .
- The Respironics disposable heated wire breathing circuit must be prescribed by a . physician.
- The Respironics disposable heated wire breathing circuit does not contain a drug or . biological as a component.
- The Respironics disposable heated wire breathing circuit is not a kit. .
- The Respironics disposable heated wire breathing circuit is not software driven. .
- The Respironics disposable heated wire breathing circuit is electrically operated_ .
The intended use of the Respironics heated wire breathing circuit is comparable to the referenced predicate dcvices. The comparison of the data shows similar values for the key performance characteristics. The Respironics disposable heated wire circuit shows similar values for compliance, volume, resistance to flow, wire resistance and tube length and connectivity.
The reason for the Abbreviated 510(k) promarket notification submission for Respironics Disposable Heated Wire circuit is that this is a new device.
The new device as designed and manufactured does not raise any new issues of safety and effectiveness.
4
emarket Notification -- Abbreviated 510(k
he following table compares the Respironics Disposable Heated Wire Circuits with the legally marketed predicate dev
Table 12-1 Comparison of Respirants Disposable Heated Circuits with Platified Croup NV Hybernite Rainout Cyntrol System
| Feature/Function | New device: Respironics
Disposable Heated Wire
Circuits | Predicate Device: Plastiflex
Healthcare Hybernite
Rainout Control System
(K100104) | Predicate Device:
Intersurgical Heated Wire
Breathing System
(K092129) | Fisher & Paykel
Respiratory Humidifier
(K983112) | Similarity/
Difference | Impact on
safety and
effectiveness |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Common or usual
name of the device | Heated Breathing Tube,
Breathing system heater | Heated Breathing Tube,
Breathing system heater | Heated Breathing Tube,
Breathing system heater | Respiratory humidifier with
accessories (including
heated wire circuits) | Similar.
F&P
clearance
covers a
system
(humidifier
- heated
wire
circuit) | No impact on
safety and
effectiveness |
| Classification | Class II | Class II | Class II | Class II | Same | No impact on
safety and
effectiveness |
| Classification
Panel | Anesthesiology | Anesthesiology | Anesthesiology | Anesthesiology | Same | No impact on
safety and
effectiveness |
| Product Code: | BZE- heater, breathing
system w/wo controller | BZE- heater, breathing
system w/wo controller | BZE- heater, breathing
system w/wo controller | BTT - humidifier,
respiratory gas | Same | No impact on
safety and
effectiveness |
| CFR Regulation
Number | 21 CFR 868.5270
a) Identification. A
breathing system
heater is a device
that is intended to
warm breathing
gases before they
enter a patient's | 21 CFR 868.5270
a) Identification. A
breathing system
heater is a device that
is intended to warm
breathing gases
before they enter a
patient's airway. The | 21 CFR 868.5270
a) Identification. A
breathing system
heater is a device
that is intended to
warm breathing
gases before they
enter a patient's | 21 CFR 868.5270
a) Identification. A
breathing system
heater is a device
that is intended to
warm breathing
gases before they
enter a patient's | Same | No impact on
safety and
effectiveness |
| 10(k) numbers: | | | | | | |
| Intended Use | airway. The device
may include a
temperature
controller. | device may include a
temperature
controller. | airway. The device
may include a
temperature
controller. | airway. The device
may include a
temperature
controller. | | |
| | (b) Classification. Class II
(performance standards). | (b) Classification. Class II
(performance standards). | (b) Classification. Class II
(performance standards). | (b) Classification. Class II
(performance standards). | | |
| | Not yet assigned
The disposable heated wire
circuit is a heated wire
breathing circuit intended to
provide warmed and/or
humidified breathing gases
before they enter a patient's
airway. The disposable
heated wire circuit is
indicated for use by a single
adult or pediatric patient in
the home, hospital and/or | K100104
The Hybernite Rainout
Control System is a heated
breathing circuit intended to
provide warmed and/or
humidified breathing gases
before entering the patient
airway. The Hybernite device
is intended for incorporation
into CPAP (continuous
positive airway pressure)
devices and is intended to act | K092129
Breathing system heaters
are defined as a device that
is intended to warm
breathing gases before they
enter the patient's airway. | 21 CFR 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. | K983112
The Fisher & Paykel
Healthcare MR 850
Humidifier is a Respiratory
Gas Humidifier as per 73
BTT, 21 CFR 868.5450. It
is intended to add moisture
to and warm breathing gases
for administration to a
patient. The MR850 is
intended to be used to warm
and add humidity to gases | N/A
No impact on
safety and
effectiveness |
| | | | | (b)Classification. Class II
(performance standards. | | N/A
Similar |
5
Premarket Notification -- Abbreviated 510(k)
Tab 5 Page 6 of 14
6
| Respironics Disposable Heated Wire Circuits | Premarket Notification -- Abbreviated 510(k) | |
|---|---|---|
| be used for both invasive and | ||
| non-invasive ventilation. | gasses delivered form the | |
| humidifier to the patient. | ||
| After the gas is warmed and | ||
| humidified in the humidifier, it | requiring mechanical | |
| ventilation, positive | ||
| pressure breathing | ||
| assistance or general |
.
| be used for both invasive and
non-invasive ventilation. | gasses delivered form the
humidifier to the patient.
After the gas is warmed and
humidified in the humidifier, it
is delivered through the heated
tubing to the patient. The
purpose of the Hybernite
Rainout Control System is to
maintain or raise the gas
temperature to or above the
dew point (of the air exiting
the humidifier) reducing or
eliminating water
condensation and/or pooling
of water in the breathing
circuit, and problems
associated with such. The
Hybernite is indicated for use
in the home or sleep-lab
setting by a single adult
patient. It can also be used in
conjunction with supplemental
Oxygen. Hybernite is
indicated for non-invasive
ventilation. | requiring mechanical
ventilation, positive
pressure breathing
assistance or general
medical gases. Gases
available for medical use do
not contain sufficient
moisture and may damage
or irritate the respiratory
tract, or desiccate secretions
of patients whose
supraglottic airways have
been bypassed. Heat is used
to increase the water output
of the humidifier. | Heated breathing tubes are
also utilized in order to
increase operating
efficiency and reduce
excessive water and heat
loss. | | | | | heating wires | heating wires | heating wires | | | safety and
effectiveness |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------|---------------------------------------------|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------|
| Anatomical Sites | Invasive & Non-invasive | Non-invasive | Not Specified
(intended use includes any
patient using a heated
humidifier which would be
inclusive of Invasive
patients) | Invasive & Non-invasive | Same | No impact on
safety and
effectiveness | energy used and or
delivered | current flows through the
heating wires. Due to the wire
resistance, heat is dissipated
through the wall of the tube
construction into the air flow
in the lumen of the tubing. As
a result, the air passing
through the tubing is warmed
to or above the dew point (of
the air existing the humidifier)
reducing or eliminating water
condensation and/or pooling
of water in the breathing
circuit. | Due to the wire resistance,
heat is dissipated through the
wall of the tube construction
into the air flow in the lumen
of the tubing. As a result, the
air passing through the tubing
is warmed to or above the dew
point (of the air existing the
humidifier) reducing or
eliminating water
condensation and/or pooling
of water in the breathing
circuit. | Rising of the delivered gas
temperature from 37 to 40C
increases its enthalpy. | Due to the wire resistance,
heat is dissipated through
the wall of the tube
construction into the air
flow in the lumen of the
tubing. As a result, the air
passing through the tubing
is warmed to or above the
dew point (of the air
existing the humidifier)
reducing or eliminating
water condensation and/or
pooling of water in the
breathing circuit. | Same | No impact on
safety and
effectiveness |
| Target Patient
Population | Pediatric (>= 5kg) to Adult | Adult | Any patient using a heated
humidifier | Any patient using a heated
humidifier | Same | No impact on
safety and
effectiveness | Reusable | The raising of the gas
temperature does not exceed
41C. | The raising of the gas
temperature does not exceed
40C. | | The raising of the gas
temperature does not exceed
41C. | Similar | No impact on
safety and
effectiveness |
| Environment of
Use | Home, Institution/Hospital
Setting, Extended Care and
Clinical Sleep settings | Home or Sleep Lab Setting | Hospital Setting | Home, Institution/Hospital
Setting, Extended Care and
Clinical Sleep settings | Same | No impact on
safety and
effectiveness | | Single Patient Use -
Reusable | Single Patient Use - Reusable
Cleaning Regime: Mild soap
and water after use. | Not Specified | Single Patient Use --
Reusable | Similar | No impact on
safety and
effectiveness |
| Sterility | Non-Sterile | Non-Sterile | Not Specified | Non-Sterile | Similar | No impact on
safety and
effectiveness | | | | | | | |
7
Premarket Notification -- Abbreviated 510(k)
8
Premarket Notification -- Abbreviated 510(k)
| Compatible with
multiple
humidifiers
(standard
connectors) | For use with F&P 500 | Universal | For use with Intersurgical
model humidifiers | For use with F&P model
humidifiers | Similar | No impact on
safety and
effectiveness |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------|
| Breathing Gases
Specified | Air & Supplemental Oxygen | Air & Supplemental Oxygen | No t Specified | Air & Supplemental
Oxygen | Similar | No impact on
safety and
effectiveness |
| Standard
Breathing Circuit
Polymeric
materials | Yes | Yes | Yes | Yes | Similar | No impact on
safety and
effectiveness |
| Tube Diameter | 15 and 22 mm configurations | 15 and 22 mm configurations | 22mm | 15 and 22 mm
configurations | Similar | No impact on
safety and
effectiveness |
| Tube Length | 1.83 m | ~1.5 m | ~1.5 m | 1.5 m | Same | No impact on
safety and
effectiveness |
| Power Source | Incorporated (humidifier
controlled) | Separate | Incorporated (humidifier
controlled) | Incorporated (humidifier
controlled) | Similar | No impact on
safety and
effectiveness |
| Heating Wire | Encased | Encased | Encased | Encased | Same | No impact on
safety and
effectiveness |
| Wire Resistance
(ohms) | 30 +/- 5% | Not specified | 14.7 Ins & 11.9 Exp | Not specified | Similar | No impact on
safety and
effectiveness |
| Active Controller | No – Humidifier Controlled | No – Power source controlled | No - Humidifier Controlled | No – Humidifier Controlled | Similar | No impact on
safety and
effectiveness |
| Standards of
Conformity/Perfor
mance | ISO 5367 – Breathing tubes
intended for use with
anesthetic apparatus and
ventilators
ISO 5356-1- Anesthetic and
respiratory equipment –
Conical connectors: Part 1: | ISO 5367 – Breathing tubes
intended for use with
anesthetic apparatus and
ventilators
ISO 5356-1 - Anesthetic and
respiratory equipment –
Conical connectors: Part 1: | ISO 5367 – Breathing tubes
intended for use with
anesthetic apparatus and
ventilators
ISO 5356-1 – Anesthetic
and respiratory equipment –
Conical connectors: Part 1: | ISO 5367 – Breathing tubes
intended for use with
anesthetic apparatus and
ventilators
ISO 5356-1 – Anesthetic
and respiratory equipment –
Conical connectors: Part 1: | Similar | No impact on
safety and
effectiveness |
Tab 5 Page 9 of 14
.
9
ت
remarket Notification -- Abbreviated 510(k
| ISO 8185 – Respiratory
humidification systems –
requirements (as applicable
to breathing tubes). | IEC 60601-1: Medical
electrical equipment – Part 1:
General requirements for
basic safety and essential
performance | IEC 60601-1-2 Medical
Electrical Equipment Part 1-
2: Collateral Standard:
Electromagnetic
Compatibility –
Requirements and Tests | AAMI/ANSI/ISO 10993-1
Biological Evaluation of
Medical Devices – Part 1:
Evaluation and Testing | ISO 14971 Medical devices -
Application of risk
management to medical
devices. | ISO 5367 compliant | | ISO 10993 | | No impact on
safety and
effectiveness |
|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------|-----------------------------|---------------------|------------------|---------------------------------------------|
| ISO 8185 – Respiratory
humidification systems –
requirements (as applicable to
breathing tubes). | IEC 60601-1: Medical
electrical equipment – Part 1:
General requirements for
basic safety and essential
performance | IEC 60601-1-2 Medical
Electrical Equipment Part 1-
2: Collateral Standard:
Electromagnetic
Compatibility –
Requirements and Tests | AAMI/ANSI/ISO 10993-1
Biological Evaluation of
Medical Devices - Part 1:
Evaluation and Testing | | ISO 5367 compliant | | ISO 10993 | | Same |
| ISO 8185 – Respiratory
humidification systems –
requirements (as applicable
to breathing tubes). | IEC 60601-1: Medical
electrical equipment – Part
1: General requirements for
basic safety and essential
performance | IEC 60601-1-2 Medical
Electrical Equipment Part 1-
2: Collateral Standard:
Electromagnetic
Compatibility –
Requirements and Tests | AAMI/ANSI/ISO 10993-1
Biological Evaluation of
Medical Devices - Part 1:
Evaluation and Testing | | ISO 5367 compliant | | ISO 10993 | | No impact on
safety and
effectiveness |
| ISO 8185 - Respiratory
humidification systems -
requirements (as applicable
to breathing tubes). | IEC 60601-1: Medical
electrical equipment - Part
1: General requirements for
basic safety and essential
performance | IEC 60601-1-2 Medical
Electrical Equipment Part 1-
2: Collateral Standard:
Electromagnetic
Compatibility -
Requirements and Tests | AAMI/ANSI/ISO 10993-1
Biological Evaluation of
Medical Devices - Part 1:
Evaluation and Testing | ISO 14971 Medical devices
- Application of risk
management to medical
devices. | ISO 5367 compliant | | ISO 10993 compliant | | Same |
| Compliance (mlpa) | | | | | | Resistance to Flow
(mb)² | Tube Volume (ml) | Biocompatibility | |
10
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| t |
arket Notification -- Abbrev
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | The first and the count of the first to the country of the first and the first and the many of the first and the may be and | . | ||||
|---|---|---|---|---|---|---|
| Electrical Safe | IEC 60601-1 compliant | 91-1 compliant | ||||
| IEC 6060 | EC 60601-1 compliant | EC 60601-1 compliant | Same | No impact or | ||
| safety and | ||||||
| effectiveness | ||||||
| . | Annual And Annual Commend Commend of Children Annual Property And | |||||
| 1 |
ﮯ ﮯ
of Comparison of Device Technological Characteristics to Predicate Dev
onics Disposable Heated Circuits are substantially equivalent to the predicate devices listed in this Summary and
s not raise any new issues of safety and effectiveness.
ddressed by the Reviewer's Checklist are unchanged from the predicate devices identified in this submitta
.0 – Substantial Equivalence Discussion.
erformance Testing Summ
ce has been tested to appropriate ISO and IEC standards and other applicate requirements passing all test protocol
ics disposable heated wire circuit was designed and tested
Draft Reviewer Guidance for Premarket Notification Submissions - Anesthesiology and Respiratory Devices
of Cardiovascular,Respiratory, and Neurological Devices (November 199
Oraft Reviewer Guidance for Ventilators July 1995
as suggested by TDA's Noveller Denided "Reviewed with Premarket Nothical on Pomission Ancatesional Respiracy: Division Cariorscular, Ind Newsled I bevices with be with be
ical testing of the Respironics Disposable Heated Wire Breathing Chem Conducted including mech
11
narket Notification -- Abbreviated .
Resistance to Flow, Compressible Volume and Wire Resistance. All materials used in the heated wire breathing circular
See Section 9.0 Declarations of Conformity and Summary Reports, Section 17.0 Electronagnetic Compatibility and Electrical Safet
and Section 18.0 Performance Testing – Bench.
Clinical data
. No clinical tests have been performed on the Respironics Disposable Heated Wire Breathing Circu required.
12
Non-Clinical Testing:
This device has been tested to appropriate ISO and IEC standards and other applicable requirements passing all test protocols. The Respironics disposable heated wire circuit was designed and tested according to guidance outlined in:
-
FDA's Draft Reviewer Guidance for Premarket Notification Submissions -Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices (November 1993);
-
FDA's Draft Reviewer Guidance for Ventilators July 1995; and
As suggested by FDA's November 1993 publication entitled "Reviewer Guidance for Premarket Notification Submissions - Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory, and Neurological Devices" and "Draft Reviewer Guidance for Ventilators July 1995" the Respironics disposable heated wire circuit was tested in accordance with the applicable voluntary standards. The Respironics disposable heated wire circuit met the required performance criteria and functioned as intended.
Non-clinical testing of the Respironics Disposable Heated Wire Breathing Circuit have been conducted including mechanical, electrical, and temperature accuracy under environmental conditions, and test standards for electromagnetic immunity. These include Resistance to Flow, Compliance, Compressible Volume and Wire Resistance. All materials used in the heated wire breathing circuit and humidification chambers have been evaluated according to tests outlined in ISO 10993-1.
See Section 9.0 Declarations of Conformity and Summary Reports, Section 17.0 Electromagnetic Compatibility and Electrical Safety and Section 18.0 Performance Testing -Bench.
Statement of Safety and Effectiveness:
Analysis of comparison of design, function and features of the Respironics Disposable Heated Wire Breathing Circuit to the Plastiflex Healthcare Hybernite Rainout Control System -K100104 date of concurrence 04/14/2010); Intersurgical Heated Wire Breathing System . K092129 (date of concurrence 05/18/2010) and Fisher & Paykel Respiratory Humidifier -K983112 (date of concurrence 11/10/1996), together with the results of testing demonstrates the new device to be substantially equivalent to the predicate devices in terms of meeting performance criteria and functioning as intended.
Statement of Intended Use:
The disposable heated wire circuit is a heated wire breathing circuit intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. The disposable
・
13
heated wire circuit is indicated for use by a single adult or pediatric patient in the home, hospital and/or institutional settings. It may be used for both invasive and non-invasive ventilation.
Conclusion :
The Respironics Disposable Heated Circuits are substantially equivalent to the predicate devices listed in this Summary and the new device does not raise any new issues of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/14/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 image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Joseph E. Olsavsky Senior Manager-HRC Regulatory Affairs Respironics, Incorporated Sleep & Home Respiratory Group 1740 Golden Mile Highway Monroeville, Pennsylvania 15146
JUN - 1 2011
Re: K110398
Trade/Device Name: Respironics Disposable Heated Wire Circuits Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: II Product Code: BZE Dated: May 11, 2011 Received: May12, 2011
Dear Mr. Olsavsky:
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.
15
Page 2- Ms. Olsavsky
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.
N for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
16
Premarket Notification -- Abbreviated 510(k)
Section 4.0 Indications for Use
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Disposable Heated Wire Circuits
The disposable heated wire circuit is a heated wire breathing circuit intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. The disposable heated wire circuit is indicated for use by a single adult or pediatric patient in the home, hospital and/or institutional settings. It may be used for both invasive and non-invasive ventilation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110398