Who is the manufacturer of RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS?

Respironics, Inc. filed the 510(k) submission for RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS (K110398).

What is the FDA product code for RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS?

BZE. It is classified under 21 CFR 868.5270 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS?

Plastiflex Healthcare Hybernite Rainout Control System (K100104); Intersurgical Heated Wire Breathing System (K092129); Fisher & Paykel Respiratory Humidifier (K983112).

Who can help prepare an FDA 510(k) submission like RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS

K110398 · Respironics, Inc. · BZE · Jun 1, 2011 · Anesthesiology

Device Facts

Record ID	K110398
Device Name	RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
Applicant	Respironics, Inc.
Product Code	BZE · Anesthesiology
Decision Date	Jun 1, 2011
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 868.5270
Device Class	Class 2
Attributes	Therapeutic, Pediatric

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 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 Story

Disposable heated wire breathing circuit; 15 or 22 mm corrugated plastic tubing with integrated heater wire harness. Input: breathing gases from compatible heated humidifier (e.g., Fisher & Paykel HC500). Operation: voltage applied to heater wires; wire resistance dissipates heat through tube wall into gas lumen; maintains gas temperature at or above dew point to prevent condensation/pooling. Output: warmed/humidified gas delivered to patient airway. Used in home, hospital, nursing, extended care, and sleep labs. Operated by patients, caregivers, nurses, respiratory therapists, or physicians. Enhances patient comfort and prevents airway irritation/desiccation by optimizing gas temperature and humidity. Compatible with standard ventilator interfaces and supplemental oxygen.

Clinical Evidence

No clinical data. Bench testing only. Testing included mechanical, electrical, and temperature accuracy under environmental conditions, resistance to flow, compliance, compressible volume, and wire resistance. Biocompatibility evaluated per ISO 10993-1.

Technological Characteristics

Corrugated plastic tubing (15/22 mm); integrated heater wire harness (electrically operated). Materials ISO 10993 compliant. Interfaces with standard male connectors. Non-sterile, single-patient-use. Complies with ISO 5367 (breathing tubes), ISO 5356-1 (connectors), ISO 8185 (humidification systems), and IEC 60601-1 (electrical safety).

Indications for Use

Indicated for single adult or pediatric (>= 5kg) patients requiring invasive or non-invasive ventilation in home, hospital, or institutional settings to deliver warmed/humidified breathing gases.

Regulatory Classification

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.

Predicate Devices

Plastiflex Healthcare Hybernite Rainout Control System (K100104)
Intersurgical Heated Wire Breathing System (K092129)
Fisher & Paykel Respiratory Humidifier (K983112)

Related Devices

K234032 — Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line · Medline Industries, LP · Jun 4, 2024
K201418 — Sunset Heated CPAP Tube · Sunset Healthcare Solutions, Inc. · Jan 29, 2021
K150900 — Flexicare Heated Wire Breathing Systems · Flexicare Medical, Ltd. · May 15, 2015
K253322 — Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) · Medline Industries, LP · Mar 25, 2026
K151461 — Hybernite RT · Plastiflex Group NV · Mar 24, 2016

Submission Summary (Full Text)

{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) 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 | {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 - 2. Disposable Adult, Heated Wire Active Circuit - 3. Disposable Pediatric, Heated Wire Passive Circuit - 4. 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}------------------------------------------------ | 011180 1 ) | |--------------------------------------------------------------------------------------| | t 1 1 t 1 | | ۲۵ 1 1 1 | | 4 1 tet A 3 1 l t ) 1 1 T 2 1 | | 1 0 1 1 1 C 3 ﻟ t 1 ( 1 Circ 2 1 1 1 | | 1 | | 1 1 C 1 1 +7 > 1 1 | | 1100 2 1 1 o C 3 t | | 1 œ 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…