(128 days)
The Smiths Medical Thera-Heat™ Heated Humidifier device is intended to warm and add humidity to the breathing gases that are administered to the patient. The humidifier is indicated for patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases. The Smiths Medical Thera-Heat™ Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers.
Inspiratory heated limb: An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and noninvasive breathing systems.
Inspiratory and Expiratory heated limbs: An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway and to warm the breathing gases on return from the patient to the ventilator when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.
The Thera-Heat™ Heated Humidifier system is a respiratory gas humidifier according to 21 CFR §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to add moisture and if applicable, heat to breathing gases prior to administration to a patient. Indirect heating is used by the Thera-Heat™ to provide an evaporated water content to dry breathing gases.
Respiratory gas humidifiers are used by clinicians to raise the water content of gases delivered to patients. Gases available for medical use do not always have sufficient moisture and may damage or irritate the respiratory tract or desiccate tracheobronchial secretions of patients whose airways have been bypassed. The Thera-Heat™ Heated Humidifier system warms and adds water vapor to the inspired gas by heating water within the humidification chamber as the dry gas passes over the warmed water.
The humidification chamber is an auto-fill style that contains an integral float valve at the water filling port. The float valve regulates the water level inside the chamber to maintain a constant water level. The water supply (liquid reservoir) is a pre-filled sterile water reservoir that connects to a filling port on the humidification chamber. When the liquid reservoir is empty, the caregiver will exchange it with a new one. After the gas is warmed and humidified it is channeled to the breathing tube for delivery to the patient.
The system can be operated using a conventional breathing tube (non-heated) in both limbs, or a heated breathing tube in the inspiratory limb only, or a heated breathing tube in both limbs. The heating of the humidification chamber and the power supplied to the heated breathing tube is provided by the controller unit. The purpose of the heated breathing tube is to regulate the gas temperature from the humidification chamber to the patient, reducing condensation and pooling of water, and the means of controlling the relative humidity by maintaining a temperature gradient between the humidification chamber and the delivered airway temperature. The caregiver sets the controller unit to the desired patient airway temperature, and then sets a humidity index value, which is limited in range by the controller based on the desired patient airway temperature. The control unit will maintain the selected temperature for the patient airway and the humidification chamber output temperature based on the humidity index value.
Accessories for the Thera-Heat™ Heated Humidifier include the humidification (water) chambers, temperature probes, interface cables and brackets.
Heated Wire Ventilator Breathing Circuits: A heated Wire Ventilator Breathing Circuit is a disposable device compromised of 22mm corrugated plastic tubing, 22 mm plastic tube connectors, and an electrical heater-wire harness subassembly. After the gas is warmed and humidification chamber it is delivered through the inspiratory limb of the breathing circuit to the patient. Heating of the breathing tube is provided and controlled by the heated humidifier. The heated wire breathing circuits may be comprised of a dual limb or single limb circuit. The purpose of the heated wire ventilator breathing circuits is to maintain or raise the gas temperature to or above the dew point reducing or eliminating water condensation and/or pooling of water in the breathing circuit. Other accessories such as exhalation valves, water traps, etc. can be added in to the overall assembly creating different product variations.
The provided text describes a 510(k) premarket notification for the "Thera-Heat™ Heated Humidifier and Heated Wire Ventilator Breathing Circuits." The focus of this submission is on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment, which are typical for studies validating AI/ML medical devices, is not explicitly detailed or applicable in this context.
Here's an analysis based on the available information:
-
Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of quantitative acceptance criteria for device performance. Instead, it states that the device "complies with the performance and safety standards ASTM F1690 (USA) and ISO 8185 for active humidification" with two noted exceptions. The reported "performance" is primarily compliance with these standards.
Acceptance Criteria (Standards Compliance) Reported Device Performance IEC60601-1 (Safety) Complies UL60601-1 (Safety) Complies CAN/CSA 22.2 No.60601.1 (Safety) Complies IEC60601-1-2 (Electromagnetic Compliance) Complies IEC60601-1-4 (Software Compliance) Complies (to the acceptance of Underwriters Laboratories) ASTM F1690 (USA) (Active Humidification) Complies with exceptions: * Clause 51.6.2: Generates a high priority alarm if airway temperature is $\ge$ 41°C. * Clause 51.8 part C: Cannot reduce airway temperature sufficiently when airflow is instantaneously increased from minimum to maximum rated flow in a non-heated circuit, allowing airway temperature to exceed 43°C for 30 seconds. An alarm is generated, and heating stops. A warning label and operational manual notice are provided. ISO 8185 (Active Humidification) Complies with exceptions: * Clause 51.6.2: Generates a high priority alarm if airway temperature is $\ge$ 41°C. * Clause 51.8 part C: Cannot reduce airway temperature sufficiently when airflow is instantaneously increased from minimum to maximum rated flow in a non-heated circuit, allowing airway temperature to exceed 43°C for 30 seconds. An alarm is generated, and heating stops. A warning label and operational manual notice are provided. (As per ASTM F1690, which likely references similar performance metrics). -
Sample Size and Data Provenance (for test set):
The document does not detail specific "test sets" in the context of clinical or performance data for an AI/ML device. The testing conducted was "non-clinical testing...covering mechanical, electrical, and software for functional performance and temperature accuracy under environmental conditions and tests standards." This implies laboratory or bench testing, not patient data. -
Number of Experts and Qualifications (for ground truth):
Not applicable. The ground truth for this device is based on compliance with established engineering and medical device safety standards (IEC, UL, CSA, ASTM, ISO), not expert consensus on diagnostic or clinical outcomes from a test set of data. -
Adjudication Method:
Not applicable. No expert adjudication method is mentioned as this is not a study involving human interpretation of data for medical diagnosis. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states "Clinical Data: Not required." This indicates that no human-in-the-loop clinical study comparing human performance with and without AI assistance was conducted or deemed necessary for this 510(k) submission. -
Standalone (Algorithm Only) Performance:
"Standalone performance" in the context of an AI/ML algorithm is not applicable here. The device is a physical medical device (humidifier and breathing circuits). Its performance was assessed through non-clinical laboratory testing against engineering and safety standards. -
Type of Ground Truth Used:
The "ground truth" for this submission is compliance with international and national safety and performance standards for respiratory gas humidifiers and breathing circuits (e.g., IEC60601-1, UL60601-1, CAN/CSA 22.2 No.60601.1, IEC60601-1-2, IEC60601-1-4, ASTM F1690, ISO 8185). -
Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set. The device is a hardware system. -
How the Ground Truth for the Training Set Was Established:
Not applicable. As this is not an AI/ML device, there is no training set or ground truth established in that manner. The "ground truth" for its design and manufacturing is adherence to established engineering principles and regulatory standards.
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K071958 Page 1 of 4
smiths medical
bringing technology to life
Smiths Medical ASD Inc. Critical Care Division 160 Weymouth Street Rockland, MA 02370, USA
T: +1 781 878 8011 F: +1 781 878 8201
SECTION 5, 510(k) Summary
Company Information:
Smiths Medical ASD, Inc. 160 Weymouth Street Rockland, MA 02370 (781) 878-8011, ext 7904 Contact: Christine A. Lloyd Regulatory Affairs Specialist
Summary Prepared: November 21, 2007
NOV 2 1 2007
Product Name:
Trade Name: Thera-Heat™ Heated Humidifier and Heated WireVentilator Breathing Circuits
Common Name: Respiratory Gas Humidifier and Heated Wire Ventilator Breathing Circuits.
Classification Name: Humidifier, Respiratory Gas Heater (21 CFR 868.5450, Product Code BTT) & Breathing System (21 CFR 868.5270, Product Code BZE)
Predicate Device(s):
K913368, (Fisher & Paykel Electronics Ltd.) Models MR700/MR720/MR730 Dual Servo Respiratory Humidifier ACC ---
K000697, JCardinal Health (formerly Allegiance Healthcare Corp), Airlife® Heated Ventilator and Anesthesia Breathing Circuits
Device Description:
Thera-Heat™ Heated Humidifier
The Thera-Heat™ Heated Humidifier system is a respiratory gas humidifier according to 21 CFR §868.5450. A respiratory gas humidifier is identified by the Food and Drug Administration (FDA) as a therapeutic device that is intended to add moisture and if applicable, heat to breathing gases prior to administration to a patient. Indirect heating is used by the Thera-Heat™ to provide an evaporated water content to dry breathing gases.
Respiratory gas humidifiers are used by clinicians to raise the water content of gases delivered to patients. Gases available for medical use do not always have sufficient moisture and may damage or irritate the respiratory tract or desiccate tracheobronchial secretions of patients whose airways have been bypassed. The Thera-Heat™ Heated Humidifier system warms and adds
{1}------------------------------------------------
water vapor to the inspired gas by heating water within the humidification chamber as the dry gas passes over the warmed water.
The humidification chamber is an auto-fill style that contains an integral float valve at the water filling port. The float valve regulates the water level inside the chamber to maintain a constant water level. The water supply (liquid reservoir) is a pre-filled sterile water reservoir that connects to a filling port on the humidification chamber. When the liquid reservoir is empty, the caregiver will exchange it with a new one. After the gas is warmed and humidified it is channeled to the breathing tube for delivery to the patient.
The system can be operated using a conventional breathing tube (non-heated) in both limbs, or a heated breathing tube in the inspiratory limb only, or a heated breathing tube in both limbs. The heating of the humidification chamber and the power supplied to the heated breathing tube is provided by the controller unit. The purpose of the heated breathing tube is to regulate the gas temperature from the humidification chamber to the patient, reducing condensation and pooling of water, and the means of controlling the relative humidity by maintaining a temperature gradient between the humidification chamber and the delivered airway temperature. The caregiver sets the controller unit to the desired patient airway temperature, and then sets a humidity index value, which is limited in range by the controller based on the desired patient airway temperature. The control unit will maintain the selected temperature for the patient airway and the humidification chamber output temperature based on the humidity index value.
Accessories for the Thera-Heat™ Heated Humidifier include the humidification (water) chambers, temperature probes, interface cables and brackets.
Heated Wire Ventilator Breathing Circuits
A heated Wire Ventilator Breathing Circuit is a disposable device compromised of 22mm corrugated plastic tubing, 22 mm plastic tube connectors, and an electrical heater-wire harness subassembly. After the gas is warmed and humidification chamber it is delivered through the inspiratory limb of the breathing circuit to the patient. Heating of the breathing tube is provided and controlled by the heated humidifier. The heated wire breathing circuits may be comprised of a dual limb or single limb circuit. The purpose of the heated wire ventilator breathing circuits is to maintain or raise the gas temperature to or above the dew point reducing or eliminating water condensation and/or pooling of water in the breathing circuit. Other accessories such as exhalation valves, water traps, etc. can be added in to the overall assembly creating different product variations.
Indications for Use:
Thera-Heat™ Heated Humidifier
The Smiths Medical Thera-Heat™ Heated Humidifier device is intended to warm and add humidity to the breathing gases that are administered to the patient. The humidifier is indicated for patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases
{2}------------------------------------------------
The Smiths Medical Thera-Heat™ Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers.
Inspiratory heated limb
An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and noninvasive breathing systems.
Inspiratory and Expiratory heated limbs)
An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway and to warm the breathing gases on return from the patient to the ventilator when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.
Technological Characteristics:
The technological characteristics of the Thera-Heat™ Heated Humidifier are equivalent to the predicate device; Fisher & Paykel Electronics Ltd, Models MR700/MR720/MR730 Dual Servo Respiratory Humidifier ACC per K913368. The Thera-Heat™ is equivalent to the Fisher & Paykel humidifiers in terms of:
| Type: | Active Heated Humidifier |
|---|---|
| Humidification method: | Passover humidification |
| Configuration: | Humidification chamber, heated wire or non-heated breathingcircuits, and a dual sensor temperature probe to monitor thehumidification chamber output temperature and temperature ofthe airway proximal to the patient connection port. |
| Control: | Comparable range of temperature and humidity adjustments |
| Control method: | Software controlled using a microcontroller |
Non-Clinical Data:
Non-clinical testing of the Thera-Heat™ Heated Humidifier has been carried out covering mechanical, electrical, and software for functional performance and temperature accuracy under environmental conditions and tests standards for electromagnetic immunity.
The Thera-Heat™ Heated Humidifier meets the safety requirements of IEC60601-1, UL60601-1, and CAN/CSA 22.2 No.60601.1. It meets the electromagnetic compliance requirements of IEC60601-1-2 and the software compliance of IEC60601-1-4 to the acceptance of Underwriters Laboratories. The Thera-Heat™ Heated Humidifier complies with the performance and safety
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standards ASTM F1690 (USA) and ISO 8185 for active humidification with the following two exceptions. Clause 51.6.2 the Thera-Heat™ generates a high priority alarm in the event that the airway temperature is at or above 41°C. Clause 51.8 part C, the Thera-Heat™ cannot reduce the airway temperature sufficiently when the air flow is increased (instantaneously) from the minimum rated flow to the maximum rated flow and the airway temperature is being regulated through a non-heated (non-wire) breathing circuit. This event does cause the Thera-Heat™ to generate an alarm and stops the heating of the humidification chamber however it cannot prevent the airway temperature from exceeding 43°C for 30 seconds (ISO8185 clause 51.8); this is because energy in the water was created for the lower flow. We have placed a warning label on the outside of the device and in the operator's manual to provide some risk control over this situation for the user.
Clinical Data:
Not required
Conclusion:
The standards compliance and product performance testing conducted demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.
Very truly yours,
SMITHS MEDICAL ASD, INC.
Nudesthe A. Lloyd
Christine A. Lloyd Regulatory Affairs Specialist
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2007
Ms. Christine Lloyd Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 160 Weymouth Street Rockland, Massachusetts 02370
Re: K071958
Trade/Device Name: Thera-Heat™ Heated Humidifier and Heated Wire Ventilator Breathing Circuits Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT, BZE Dated: November 16, 2007 Received: November 19, 2007
Dear Ms. Lloyd:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Lloyd
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suon Chno
Chiu Lin, Ph.D.
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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SECTION 4, Indications for Use Statement
Indications for Use
510(k) Number (if known): K071958 Device Name: Thera-Heat™ Heated Humidifier
Indications for Use:
The Smiths Medical Thera-Heat™ Heated Humidifier device is intended to warm and add humidity to the breathing gases that are administered to the patient. The humidifier is indicated for patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases
The Smiths Medical Thera-Heat™ Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers.
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)
_(acting B.C.)
(Division Sign-Off)
Page 1 of 1
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K071952
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SECTION 4, Indications for Use Statement
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Heated Wire Ventilator Breathing Circuits
Indications for Use:
Inspiratory heated limb
An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and noninvasive breathing systems.
Inspiratory and Expiratory heated limb
An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway and to warm the breathing gases on return from the patient to the ventilator when used with the Thera-Heat™ Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.
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)
(Acting B.C.)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K671958
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).