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.

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
1. Disposable Adult, Heated Wire Active Circuit
1. Disposable Pediatric, Heated Wire Passive Circuit
1. 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.

AI/ML Overview

Acceptance Criteria and Study for Respironics Disposable Heated Wire Circuits (K110398)

This submission describes a medical device, the Respironics Disposable Heated Wire Circuits, which is a breathing circuit designed to warm and/or humidify breathing gases for patients. The application for clearance is an Abbreviated 510(k), indicating reliance on recognized standards and predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Respironics Disposable Heated Wire Circuits are not explicitly stated in a quantitative table within the provided document. Instead, the submission demonstrates substantial equivalence to predicate devices by showing similar values for key performance characteristics and compliance with recognized standards.

The criteria for acceptance are implicitly derived from the comparison to predicate devices and adherence to the listed standards. The reported device performance is that the Respironics Disposable Heated Wire Circuits achieved "passing all test protocols" for general requirements.

Here's a table summarizing the comparison to predicate devices, which serves as the basis for demonstrating equivalence and thus, meeting implicit acceptance criteria:

Feature/Function	Predicate Device: Plastiflex Healthcare Hybernite Rainout Control System (K100104)	Predicate Device: Intersurgical Heated Wire Breathing System (K092129)	Predicate Device: Fisher & Paykel Respiratory Humidifier (K983112)	Respironics Disposable Heated Wire Circuits (New Device)	Similarity/Difference	Impact on Safety and Effectiveness
Common or usual name	Heated Breathing Tube, Breathing system heater	Heated Breathing Tube, Breathing system heater	Respiratory humidifier with accessories (including heated wire circuits)	Heated Breathing Tube, Breathing system heater	Similar	No impact
Classification	Class II	Class II	Class II	Class II	Same	No impact
Classification Panel	Anesthesiology	Anesthesiology	Anesthesiology	Anesthesiology	Same	No impact
Product Code	BZE - heater, breathing system w/wo controller	BZE - heater, breathing system w/wo controller	BTT - humidifier, respiratory gas	BZE - heater, breathing system w/wo controller	Same	No impact
CFR Regulation Number	21 CFR 868.5270	21 CFR 868.5270	21 CFR 868.5270 & 21 CFR 868.5450	21 CFR 868.5270	Same	No impact
Intended Use	Provide warmed and/or humidified breathing gases; non-invasive ventilation; home or sleep-lab setting; single adult patient	Warm breathing gases before entering patient's airway (general definition)	Add moisture to, and sometimes to warm, breathing gases; all settings; mechanical ventilation etc.	Provide warmed and/or humidified breathing gases; invasive & non-invasive ventilation; home, hospital, institutional settings; single adult or pediatric patient	N/A (Similar)	No impact
Anatomical Sites	Non-invasive	Not Specified	Invasive & Non-invasive	Invasive & Non-invasive	Same	No impact
Target Patient Population	Adult	Any patient using a heated humidifier	Any patient using a heated humidifier	Pediatric (>= 5kg) to Adult	Similar	No impact
Environment of Use	Home or Sleep Lab Setting	Hospital Setting	Home, Institution/Hospital Setting, Extended Care and Clinical Sleep settings	Home, Institution/Hospital Setting, Extended Care and Clinical Sleep settings	Same	No impact
Sterility	Non-Sterile	Not Specified	Non-Sterile	Non-Sterile	Similar	No impact
Compatible with Humidifiers	Universal	For use with Intersurgical model humidifiers	For use with F&P model humidifiers	For use with F&P 500	Similar	No impact
Breathing Gases Specified	Air & Supplemental Oxygen	Not Specified	Air & Supplemental Oxygen	Air & Supplemental Oxygen	Similar	No impact
Standard Polymeric Materials	Yes	Yes	Yes	Yes	Similar	No impact
Tube Diameter	15 and 22 mm configurations	22mm	15 and 22 mm configurations	15 and 22 mm configurations	Similar	No impact
Tube Length	~1.5 m	~1.5 m	1.5 m	1.83 m	Same	No impact
Power Source	Separate	Incorporated (humidifier controlled)	Incorporated (humidifier controlled)	Incorporated (humidifier controlled)	Similar	No impact
Heating Wire	Encased	Encased	Encased	Encased	Same	No impact
Wire Resistance (ohms)	Not specified	14.7 Ins & 11.9 Exp	Not specified	30 +/- 5%	Similar	No impact
Active Controller	No – Power source controlled	No - Humidifier Controlled	No – Humidifier Controlled	No – Humidifier Controlled	Similar	No impact
Standards of Conformity	ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, IEC 60601-1-2, AAMI/ANSI/ISO 10993-1, ISO 14971	ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, IEC 60601-1-2, AAMI/ANSI/ISO 10993-1	ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, IEC 60601-1-2, AAMI/ANSI/ISO 10993-1, ISO 14971	ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, IEC 60601-1-2, AAMI/ANSI/ISO 10993-1, ISO 14971	Similar	No impact
Electrical Safety	IEC 60601-1 compliant	IEC 60601-1 compliant	IEC 60601-1 compliant	IEC 60601-1 compliant	Same	No impact

The submission asserts that the new device "does not raise any new issues of safety and effectiveness" due to these similarities and successful performance testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers extensively to "performance testing" and "non-clinical testing" for the device, including mechanical, electrical, and temperature accuracy under environmental conditions, as well as electromagnetic immunity. However, specific sample sizes for these test sets are not provided within the given text.

The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin for the data provided. The studies were conducted by the manufacturer, Respironics, Inc. (Monroeville, PA, USA) and potentially their contract manufacturer, WILAmed GMBH (Kammerstein, Germany).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document describes a medical device (heated wire breathing circuits) and its performance based on bench testing and comparison to predicate devices and recognized standards. There is no mention of a "test set" requiring ground truth established by human experts in the context of diagnostic interpretation or clinical outcomes. Therefore, this question is not applicable to the information provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

As there is no mention of a test set requiring human expert adjudication (such as in an AI/diagnostic imaging study), this question is not applicable. The testing described is primarily bench testing against engineering standards and specifications.

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

This is not applicable as the device is a heated wire breathing circuit, not an AI or diagnostic imaging device that would involve human readers or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a medical accessory (heated wire breathing circuit) and does not involve an algorithm or AI. The performance testing refers to the physical and electrical characteristics of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is typically established by:

Engineering specifications: The device is designed to meet specific technical parameters (e.g., resistance to flow, temperature range, wire resistance).
Voluntary consensus standards: Compliance with international and national standards like ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, AAMI/ANSI/ISO 10993-1 constitutes the "truth" of its performance and safety in specific areas.
Predicate device characteristics: The performance of legally marketed predicate devices serves as a benchmark for comparison to demonstrate substantial equivalence.

There is no mention of ground truth derived from expert consensus, pathology, or outcomes data, as this is a non-clinical submission for a device component.

8. The sample size for the training set

This is not applicable as the device is a physical breathing circuit, not an AI or machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable as the device is a physical breathing circuit and does not involve a training set.

Summary

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KID348

Respironics Disposable Heated Wire Circuits

JUN - 1 2011 Premarket Notification -- Abbreviated 510(k)

Section 5.0 510(k) Summary

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 USADisposable Pediatric, Heated Wire Passive Circuit USADisposable Adult, Heated Wire Passive Circuit USA
Common or usual name of thedevice:	Heated Breathing Tube
Philips/Respironics model number:	1076043, 1076044, 1076045, 1076046
Classification of new device:	Class II
Classification of the predicatedevice:	Class II
Classification Panel:	Anesthesiology
Panel Code:	BZE - Breathing system, heater
CFR Regulation Number:	21 CFR 868.5270a) Identification. A breathing system heater is a devicethat is intended to warm breathing gases before theyenter a patient's airway. The device may include atemperature controller.(b) Classification. Class II (performance standards).
Predicate Device Name(s) and510(k) numbers:	1. Plastiflex Healthcare Hybernite Rainout ControlSystem - K100104 date of concurrence 04/14/2010)2. Intersurgical Heated Wire Breathing System -K092129 (date of concurrence 05/18/2010)3. Fisher & Paykel Respiratory Humidifier - K983112(date of concurrence 11/10/1996)
Reason for submission:	New Device

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Description of Device:

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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
1. Disposable Adult, Heated Wire Active Circuit
1. Disposable Pediatric, Heated Wire Passive Circuit
1. Disposable Adult, Heated Wire Passive Circuit

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.

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, .

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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.

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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: RespironicsDisposable Heated WireCircuits	Predicate Device: PlastiflexHealthcare HyberniteRainout Control System(K100104)	Predicate Device:Intersurgical Heated WireBreathing System(K092129)	Fisher & PaykelRespiratory Humidifier(K983112)	Similarity/Difference	Impact onsafety andeffectiveness
Common or usualname of the device	Heated Breathing Tube,Breathing system heater	Heated Breathing Tube,Breathing system heater	Heated Breathing Tube,Breathing system heater	Respiratory humidifier withaccessories (includingheated wire circuits)	Similar.F&Pclearancecovers asystem(humidifier+ heatedwirecircuit)	No impact onsafety andeffectiveness
Classification	Class II	Class II	Class II	Class II	Same	No impact onsafety andeffectiveness
ClassificationPanel	Anesthesiology	Anesthesiology	Anesthesiology	Anesthesiology	Same	No impact onsafety andeffectiveness
Product Code:	BZE- heater, breathingsystem w/wo controller	BZE- heater, breathingsystem w/wo controller	BZE- heater, breathingsystem w/wo controller	BTT - humidifier,respiratory gas	Same	No impact onsafety andeffectiveness
CFR RegulationNumber	21 CFR 868.5270a) Identification. Abreathing systemheater is a devicethat is intended towarm breathinggases before theyenter a patient's	21 CFR 868.5270a) Identification. Abreathing systemheater is a device thatis intended to warmbreathing gasesbefore they enter apatient's airway. The	21 CFR 868.5270a) Identification. Abreathing systemheater is a devicethat is intended towarm breathinggases before theyenter a patient's	21 CFR 868.5270a) Identification. Abreathing systemheater is a devicethat is intended towarm breathinggases before theyenter a patient's	Same	No impact onsafety andeffectiveness
10(k) numbers:
Intended Use	airway. The devicemay include atemperaturecontroller.	device may include atemperaturecontroller.	airway. The devicemay include atemperaturecontroller.	airway. The devicemay include atemperaturecontroller.
	(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 assignedThe disposable heated wirecircuit is a heated wirebreathing circuit intended toprovide warmed and/orhumidified breathing gasesbefore they enter a patient'sairway. The disposableheated wire circuit isindicated for use by a singleadult or pediatric patient inthe home, hospital and/or	K100104The Hybernite RainoutControl System is a heatedbreathing circuit intended toprovide warmed and/orhumidified breathing gasesbefore entering the patientairway. The Hybernite deviceis intended for incorporationinto CPAP (continuouspositive airway pressure)devices and is intended to act	K092129Breathing system heatersare defined as a device thatis intended to warmbreathing gases before theyenter the patient's airway.	21 CFR 868.5450Respiratory gas humidifier.(a)Identification. Arespiratory gas humidifier isa device that is intended toadd moisture to, andsometimes to warm, thebreathing gases foradministration to a patient.Cascade, gas, heated, andprefilled humidifiers areincluded in this generic typeof device.	K983112The Fisher & PaykelHealthcare MR 850Humidifier is a RespiratoryGas Humidifier as per 73BTT, 21 CFR 868.5450. Itis intended to add moistureto and warm breathing gasesfor administration to apatient. The MR850 isintended to be used to warmand add humidity to gases	N/ANo impact onsafety andeffectiveness
				(b)Classification. Class II(performance standards.		N/ASimilar

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Premarket Notification -- Abbreviated 510(k)

Tab 5 Page 6 of 14

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Respironics Disposable Heated Wire Circuits	Premarket Notification -- Abbreviated 510(k)
be used for both invasive andnon-invasive ventilation.	gasses delivered form thehumidifier to the patient.After the gas is warmed andhumidified in the humidifier, it	requiring mechanicalventilation, positivepressure breathingassistance or general

be used for both invasive andnon-invasive ventilation.	gasses delivered form thehumidifier to the patient.After the gas is warmed andhumidified in the humidifier, itis delivered through the heatedtubing to the patient. Thepurpose of the HyberniteRainout Control System is tomaintain or raise the gastemperature to or above thedew point (of the air exitingthe humidifier) reducing oreliminating watercondensation and/or poolingof water in the breathingcircuit, and problemsassociated with such. TheHybernite is indicated for usein the home or sleep-labsetting by a single adultpatient. It can also be used inconjunction with supplementalOxygen. Hybernite isindicated for non-invasiveventilation.	requiring mechanicalventilation, positivepressure breathingassistance or generalmedical gases. Gasesavailable for medical use donot contain sufficientmoisture and may damageor irritate the respiratorytract, or desiccate secretionsof patients whosesupraglottic airways havebeen bypassed. Heat is usedto increase the water outputof the humidifier.	Heated breathing tubes arealso utilized in order toincrease operatingefficiency and reduceexcessive water and heatloss.					heating wires	heating wires	heating wires			safety andeffectiveness
Anatomical Sites	Invasive & Non-invasive	Non-invasive	Not Specified(intended use includes anypatient using a heatedhumidifier which would beinclusive of Invasivepatients)	Invasive & Non-invasive	Same	No impact onsafety andeffectiveness	energy used and ordelivered	current flows through theheating wires. Due to the wireresistance, heat is dissipatedthrough the wall of the tubeconstruction into the air flowin the lumen of the tubing. Asa result, the air passingthrough the tubing is warmedto or above the dew point (ofthe air existing the humidifier)reducing or eliminating watercondensation and/or poolingof water in the breathingcircuit.	Due to the wire resistance,heat is dissipated through thewall of the tube constructioninto the air flow in the lumenof the tubing. As a result, theair passing through the tubingis warmed to or above the dewpoint (of the air existing thehumidifier) reducing oreliminating watercondensation and/or poolingof water in the breathingcircuit.	Rising of the delivered gastemperature from 37 to 40Cincreases its enthalpy.	Due to the wire resistance,heat is dissipated throughthe wall of the tubeconstruction into the airflow in the lumen of thetubing. As a result, the airpassing through the tubingis warmed to or above thedew point (of the airexisting the humidifier)reducing or eliminatingwater condensation and/orpooling of water in thebreathing circuit.	Same	No impact onsafety andeffectiveness
Target PatientPopulation	Pediatric (>= 5kg) to Adult	Adult	Any patient using a heatedhumidifier	Any patient using a heatedhumidifier	Same	No impact onsafety andeffectiveness	Reusable	The raising of the gastemperature does not exceed41C.	The raising of the gastemperature does not exceed40C.		The raising of the gastemperature does not exceed41C.	Similar	No impact onsafety andeffectiveness
Environment ofUse	Home, Institution/HospitalSetting, Extended Care andClinical Sleep settings	Home or Sleep Lab Setting	Hospital Setting	Home, Institution/HospitalSetting, Extended Care andClinical Sleep settings	Same	No impact onsafety andeffectiveness		Single Patient Use -Reusable	Single Patient Use - ReusableCleaning Regime: Mild soapand water after use.	Not Specified	Single Patient Use --Reusable	Similar	No impact onsafety andeffectiveness
Sterility	Non-Sterile	Non-Sterile	Not Specified	Non-Sterile	Similar	No impact onsafety andeffectiveness

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Premarket Notification -- Abbreviated 510(k)

{8}------------------------------------------------

Premarket Notification -- Abbreviated 510(k)

Compatible withmultiplehumidifiers(standardconnectors)	For use with F&P 500	Universal	For use with Intersurgicalmodel humidifiers	For use with F&P modelhumidifiers	Similar	No impact onsafety andeffectiveness
Breathing GasesSpecified	Air & Supplemental Oxygen	Air & Supplemental Oxygen	No t Specified	Air & SupplementalOxygen	Similar	No impact onsafety andeffectiveness
StandardBreathing CircuitPolymericmaterials	Yes	Yes	Yes	Yes	Similar	No impact onsafety andeffectiveness
Tube Diameter	15 and 22 mm configurations	15 and 22 mm configurations	22mm	15 and 22 mmconfigurations	Similar	No impact onsafety andeffectiveness
Tube Length	1.83 m	~1.5 m	~1.5 m	1.5 m	Same	No impact onsafety andeffectiveness
Power Source	Incorporated (humidifiercontrolled)	Separate	Incorporated (humidifiercontrolled)	Incorporated (humidifiercontrolled)	Similar	No impact onsafety andeffectiveness
Heating Wire	Encased	Encased	Encased	Encased	Same	No impact onsafety andeffectiveness
Wire Resistance(ohms)	30 +/- 5%	Not specified	14.7 Ins & 11.9 Exp	Not specified	Similar	No impact onsafety andeffectiveness
Active Controller	No – Humidifier Controlled	No – Power source controlled	No - Humidifier Controlled	No – Humidifier Controlled	Similar	No impact onsafety andeffectiveness
Standards ofConformity/Performance	ISO 5367 – Breathing tubesintended for use withanesthetic apparatus andventilatorsISO 5356-1- Anesthetic andrespiratory equipment –Conical connectors: Part 1:	ISO 5367 – Breathing tubesintended for use withanesthetic apparatus andventilatorsISO 5356-1 - Anesthetic andrespiratory equipment –Conical connectors: Part 1:	ISO 5367 – Breathing tubesintended for use withanesthetic apparatus andventilatorsISO 5356-1 – Anestheticand respiratory equipment –Conical connectors: Part 1:	ISO 5367 – Breathing tubesintended for use withanesthetic apparatus andventilatorsISO 5356-1 – Anestheticand respiratory equipment –Conical connectors: Part 1:	Similar	No impact onsafety andeffectiveness

Tab 5 Page 9 of 14

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remarket Notification -- Abbreviated 510(k

ISO 8185 – Respiratoryhumidification systems –requirements (as applicableto breathing tubes).	IEC 60601-1: Medicalelectrical equipment – Part 1:General requirements forbasic safety and essentialperformance	IEC 60601-1-2 MedicalElectrical Equipment Part 1-2: Collateral Standard:ElectromagneticCompatibility –Requirements and Tests	AAMI/ANSI/ISO 10993-1Biological Evaluation ofMedical Devices – Part 1:Evaluation and Testing	ISO 14971 Medical devices -Application of riskmanagement to medicaldevices.	ISO 5367 compliant		ISO 10993		No impact onsafety andeffectiveness
ISO 8185 – Respiratoryhumidification systems –requirements (as applicable tobreathing tubes).	IEC 60601-1: Medicalelectrical equipment – Part 1:General requirements forbasic safety and essentialperformance	IEC 60601-1-2 MedicalElectrical Equipment Part 1-2: Collateral Standard:ElectromagneticCompatibility –Requirements and Tests	AAMI/ANSI/ISO 10993-1Biological Evaluation ofMedical Devices - Part 1:Evaluation and Testing		ISO 5367 compliant		ISO 10993		Same
ISO 8185 – Respiratoryhumidification systems –requirements (as applicableto breathing tubes).	IEC 60601-1: Medicalelectrical equipment – Part1: General requirements forbasic safety and essentialperformance	IEC 60601-1-2 MedicalElectrical Equipment Part 1-2: Collateral Standard:ElectromagneticCompatibility –Requirements and Tests	AAMI/ANSI/ISO 10993-1Biological Evaluation ofMedical Devices - Part 1:Evaluation and Testing		ISO 5367 compliant		ISO 10993		No impact onsafety andeffectiveness
ISO 8185 - Respiratoryhumidification systems -requirements (as applicableto breathing tubes).	IEC 60601-1: Medicalelectrical equipment - Part1: General requirements forbasic safety and essentialperformance	IEC 60601-1-2 MedicalElectrical Equipment Part 1-2: Collateral Standard:ElectromagneticCompatibility -Requirements and Tests	AAMI/ANSI/ISO 10993-1Biological Evaluation ofMedical Devices - Part 1:Evaluation and Testing	ISO 14971 Medical devices- Application of riskmanagement to medicaldevices.	ISO 5367 compliant		ISO 10993 compliant		Same
Compliance (mlpa)						Resistance to Flow(mb)²	Tube Volume (ml)	Biocompatibility

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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 compliantIEC 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 And1

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

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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.

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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

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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

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

Regulation Number and Section

§ 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).