(449 days)
The Smiths Medical Thera-Heat™ Heated Humidifier 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.
A Neonate 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 non-invasive breathing systems.
A Neonate Heated Wire Ventilator 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 humidificr according to a 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 warm and add humidity to the breathing gases that are administered to the patient. 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. The water supply (liquid reservoir) is a prefilled 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 Adult versions only) in both limbs, or a heated breathing tube in the inspiratory limb only (Adult and Neonate versions), or a heated breathing tube in both limbs (Adult and Neonate versions). The purpose of the heated breathing tube is to regulate the gas temperature from the humidification chamber to the patient thereby reducing condensation and pooling of water and controlling the relative humidity. Thera-Heat™ Heated Humidifier sets and controls the heating of the humidification chamber and the breathing tube. The caregiver first sets the unit to the desired patient temperature and then sets a humidity value that is scaled by the controller based on the desired patient temperature. Thera-Heat™ Heated Humidifier will maintain the selected temperature at the patient and the humidification chamber output temperature based on the humidity value.
Accessories for the Thera-Heat™ Heated Humidifier include the humidification (water) chambers, temperature probes, interface cables and brackets.
A Heated Wire Ventilator Breathing Circuit is a disposable device compromised of 10 mm corrugated plastic tubing, 22 mm plastic tube connectors, and an electrical heaterwire harness subassembly. After the gas is warmed and humidified in the water 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 Thera-Heat™ Heated Humidifier. The breathing circuits may be comprised of a dual limb (Adult and Neonate versions) or single limb circuit (Adult versions only). 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 water traps, etc. can be added in to the overall assembly creating different product variations.
The provided text describes the Thera-Heat™ Heated Humidifier and Neonate Heated Wire Ventilator Breathing Circuits. It outlines functional performance, safety standards, and electromagnetic compliance. However, it does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance specific to a new AI/medical device's performance metrics (like sensitivity, specificity, or accuracy) and a study that proves it meets said criteria.
Here's a breakdown of what can be extracted and what information is missing based on your request:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the given text. The document states that the Thera-Heat™ Heated Humidifier meets safety and performance standards like UL60601-1/IEC 60601-1, CAN/CSA C22.2 No. 60601.1, IEC60601-1-2, IEC60601-1-4, ASTM F1690 (USA), and ISO8185. It also mentions that the device "meets the safety requirements" and "complies with the performance and safety standards." However, it does not present specific quantitative acceptance criteria (e.g., "temperature output must be within +/- 0.5°C") and then report the device's measured performance against those criteria.
The only specific performance detail mentioned is an exception: "Clause 51.6.2 the Thera-Heat™ generates a high priority alarm in the event that the airway temperature is at or above 41℃. This event does cause the Thera-Heat™ to generate an alarm and stops the heating of the humidification chamber and the heated circuit." This describes a safety mechanism, not a general performance metric.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided. The document states "Non-clinical testing of the Thera-Heat™ Heated Humidifier and Neonate Heated Wire Ventilator Breathing Circuits have been conducted including mechanical, electrical, and software for functional performance, temperature accuracy under environmental conditions, and test standards for electromagnetic immunity." It does not specify the sample sizes (e.g., number of units tested, number of test runs) or the nature of the data (e.g., laboratory simulations, animal studies, human data). It also does not mention data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided. This section is typically relevant for studies involving human interpretation or expert consensus for ground truth establishment (e.g., in diagnostic AI). For a hardware device like a humidifier, "ground truth" would likely refer to measurements from calibrated instruments, not expert consensus on interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. Adjudication methods are usually relevant for studies where there's subjectivity in ground truth determination, often involving multiple experts (e.g., in medical image analysis). This is not applicable to the type of non-clinical testing described.
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 information is not provided. An MRMC study is relevant for evaluating the impact of AI on human performance in diagnostic tasks. The Thera-Heat™ device is a humidifier, not a diagnostic AI system, so this type of study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/provided in the requested context. The device is a physical humidifier with software control. Its "standalone performance" is what the non-clinical testing already assesses (mechanical, electrical, software for functional performance). There isn't an "algorithm only" component separate from the device's function in the way an AI diagnostic algorithm would be.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this device, the "ground truth" for the non-clinical testing would have been established through objective measurements using calibrated instruments and reference standards. For example, temperature accuracy would be compared against a known, accurate temperature measurement device. Electromagnetic compliance would be verified against established test standards (e.g., IEC60601-1-2). Functional performance would be assessed against engineering specifications. The document doesn't explicitly state "calibrated instruments" but this is the implied method for such device testing.
8. The sample size for the training set:
This information is not provided. "Training set" is primarily relevant for machine learning algorithms. While the device has "Software... controlled using a microcontroller," there's no indication that it utilizes machine learning requiring a distinct training set. The software's performance would be validated through traditional software testing and verification methods, not typically a "training set" in the AI sense.
9. How the ground truth for the training set was established:
This information is not provided/not applicable for the same reasons as point 8.
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smiths medical
bringing technology to life
510(k) Summary
Company Information:
Smiths Medical ASD, Inc. 160 Weymouth Street Rockland, MA 02370 (781) 878-8011, ext 7904 Contact: Christine Lloyd Regulatory Affairs Specialist
Smiths Medical ASD Inc. Critical Care Division 160 Weymouth Street Rockland, MA 02370, USA T: +1 781 878 8011 F: +1 781 878 8201 www.smiths-medical.com
OCT 2 0 2010
Summary Prepared: October 13, 2010
Product Name:
| Trade Name: | Thera-Heat™ Heated Humidifier and Neonate Heated WireVentilator Breathing Circuits |
|---|---|
| Common Name: | Respiratory Gas Humidifier and Heated Wire Ventilator BreathingCircuits. |
| Classification Name: | Humidifier, Respiratory Gas Heater (21 CFR 868.5450, ProductCode BTT) & Breathing System (21 CFR 868.5270, Product CodeBZE) |
Predicate Device(s):
- · K071958. Thera-Heat™ Heated Humidifier, model RC70000, and Adult Heated Wire Ventilator Breathing Circuits, models, RC70050 and RC70052
- · K073706. (Fisher & Paykel Healthcare) models RT130 and RT131 High Performance Circuits
- · K913368. (Fisher & Paykel Electronics Ltd.) models MR700/MR720/MR730 Dual Servo Respiratory Humidifier ACC
- · K000697, Allegiance Healthcare Corporation a subsidiary of Cardinal Health, Inc, Airlife® Heated Ventilator and Anesthesia Breathing Circuits, model 7582-452.
Device Description:
Thera-Heat™ Heated Humidifier
The Thera-Heat™ Heated Humidifier system is a respiratory gas humidificr according to a 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 warm and add humidity
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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. The water supply (liquid reservoir) is a prefilled 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 Adult versions only) in both limbs, or a heated breathing tube in the inspiratory limb only (Adult and Neonate versions), or a heated breathing tube in both limbs (Adult and Neonate versions). The purpose of the heated breathing tube is to regulate the gas temperature from the humidification chamber to the patient thereby reducing condensation and pooling of water and controlling the relative humidity. Thera-Heat™ Heated Humidifier sets and controls the heating of the humidification chamber and the breathing tube. The caregiver first sets the unit to the desired patient temperature and then sets a humidity value that is scaled by the controller based on the desired patient temperature. Thera-Heat™ Heated Humidifier will maintain the selected temperature at the patient and the humidification chamber output temperature based on the humidity value.
Accessories for the Thera-Heat™ Heated Humidifier include the humidification (water) chambers, temperature probes, interface cables and brackets.
Neonate Heated Wire Ventilator Breathing Circuits
A Heated Wire Ventilator Breathing Circuit is a disposable device compromised of 10 mm corrugated plastic tubing, 22 mm plastic tube connectors, and an electrical heaterwire harness subassembly. After the gas is warmed and humidified in the water 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 Thera-Heat™ Heated Humidifier. The breathing circuits may be comprised of a dual limb (Adult and Neonate versions) or single limb circuit (Adult versions only). 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
Page 2 of 4
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circuit. Other accessories such as 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
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
A Neonate 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 non-invasive breathing systems.
Inspiratory and Expiratory heated limb
A Neonate 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 Thera-Heat™ Heated Humidifier and Neonate Heated Wire Ventilator Breathing Circuit is an active heated humidifier which employs passover humidification to the breathing gases that are administered to the patient. The Thera-Heat™ Heated Humidifier system consists of a humidification chamber, heated wire (Adult and Neonate versions) or non-heated breathing circuits (Adult versions only), and a dual sensor temperature probe to monitor the humidification chamber output temperature and temperature of the airway proximal to the patient connection port. Temperature and humidity is controlled over the comparable range. Software is controlled using a microcontroller.
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The characteristics of the Thera-Heat™ Heated Humidifier and Neonate Heated Wire Ventilator Breathing Circuit are substantially equivalent to the above specified predicate devices based on intended use, indications for use, operational characteristics, fundamental technological characteristics, and performance characteristics. A detailed side-by-side comparison of the Thera-Heat™ Heated Humidifier and Neonate Heated Wire Ventilator Breathing Circuit is included in this premarket notification.
Non-Clinical Data:
Non-clinical testing of the Thera-Heat™ Heated Humidifier and Neonate Heated Wire Ventilator Breathing Circuits have been conducted including mechanical, electrical, and software for functional performance, temperature accuracy under environmental conditions, and test standards for electromagnetic immunity.
The Thera-Heat™ Heated Humidifier meets the safety requirements of UL60601-1/IEC 60601-1, and CAN/CSA C22.2 No. 60601.1. The device also meets the electromagnetic compliance requirements of IEC60601-1-2, and software compliance requirement of IEC60601-1-4 to the acceptance of Underwriters Laboratories and complies with the performance and safety standards including ASTM F1690 (USA) and ISO8185 for active humidification with the following exception. Clause 51.6.2 the Thera-Heat™ generates a high priority alarm in the event that the airway temperature is at or above 41℃. This event does cause the Thera-Heat™ to generate an alarm and stops the heating of the humidification chamber and the heated circuit. We have described this behavior in the operator's manual Alarm section.
Clinical Data:
Not required
Conclusion:
Based on the similarities in indication for use, design features, and functional features the Thera-Heat™ Heated Humidifier and Neonate Heated Wire Ventilator Breathing Circuits have been shown to be substantially equivalent to the current legally marketed predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Christine Lloyd, RAC Regulatory Affairs Specialist Smiths Medical North Carolina 160 Weymouth Street Rockland, MA 02370
OCT 2 0 2010
Re: K092256
Trade/Device Name: Thera-Heat™ Heated Humidifier and Neonate Heated Wire Ventilator Breathing Circuits Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT, BZE Dated: October 14, 2010 Received: October 18, 2010
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. 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. 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); 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 yours,
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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Indications for Use
OCT 2 0 2010
510(k) Number (if known): K092256
Device Name: Thera-Heat™ Heated Humidifier
Indications for Use:
The Smiths Medical Thera-Heat™ Heated Humidifier 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.
Y Schutte
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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)
Page 1 of 1
Smiths Medical Confidential Response to FDA request for Additional Information dated April 26, 2010 for K092256
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K09225 6 UCI 2 0 2010
Indications for Use
510(k) Number (if known): K092256
Device Name: Neonate Heated Wire Ventilator Breathing Circuits
Indications for Use:
Inspiratory heated limb
A Neonate 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 non-invasive breathing systems.
Inspiratory and Expiratory heated limb
A Neonate Heated Wire Ventilator 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.
L. Schult
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
4092256 510(k) Number: -
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)
Page 1 of 1
Confidential Smiths Medical Response to FDA request for Additional Information dated April 26, 2010 for K092256
§ 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).