(159 days)
The SCT 3000 Heated Humidifier is indicated for use with breathing circuits when healthcare professionals require humidified and /or heated gas being delivered to patients.
Servo-Controlled Tracking SCT 3000 heated humidifier is designed to provide heated, humidified gas to a patient whose own humidification system - the nose and upper airway - is compromised. The unit is used primarily during anesthesia or prolonged respiratory therapy to prevent damage to the upper airway and lungs caused by dry gas while helping to maintain the patient's body temperature stable. The whole system, including disposable humidification chambers, heated wire breathing circuits and no-wire (vent) circuits, achieves precise control of delivered gas temperature and humidity by a servo controlled mechanism. The SCT 3000 employs a feedback loop where the temperature input from the thermistors controls the heating elements. The SCT 3000 has two thermistors that provide analog input. This information, in turn, is used to control the amount of time that the two heating elements are cycled on/off. The SCT's microprocessor - the Intel P80C32, regulates this servo mechanism. the advanced design allows simple operation, sophisticated diagnostic routines and superior safety features to be built into the instrument, resulting in better performance and safer operation.
The provided text describes a 510(k) premarket notification for the Marquest SCT 3000 Heated Humidifier. The information focuses on demonstrating substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics of a device, especially not one using AI or machine learning. Therefore, I cannot fully complete the requested table and sections.
Here's an analysis based on the provided document, highlighting why certain questions cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or provide specific quantitative performance metrics for the new SCT 3000 Heated Humidifier in the way a study for a diagnostic AI device would. Instead, it relies on comparison to predicate devices, indicating equivalency in function and safety features.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated as AC) | Reported Device Performance (as presented in the document) |
|---|---|---|
| High Temperature Alarm | Distal Temperature > 1 degree C of Set Temp. (for SCT 3000) | Meets or exceeds; set at > 1 degree C (compared to predicate's > 2 degrees C) |
| Low Temperature Alarm | Distal Temperature < 4 degrees C of Set Temp. | Meets or exceeds; set at < 4 degrees C (same as predicate) |
| Maximum Heater Plate Temperature | 98 degrees C | 98 degrees C (compared to predicate's 110 degrees C) |
| Humidification Method | Pass Over Wick | Pass Over Wick (same as predicate) |
| Alarm Mute | 1 Minute | 1 Minute (compared to predicate's 3 minutes) |
| Safety Alarms | Visual Display of All Alarms | Visual Display of All Alarms (compared to predicate's Visual Display or Error Code Display) |
| Electrical Safety Standards | Compliance with UL 544, CSA C22.2 No. 125-M1984, ANSI Z79.9-1979 | Yes, meets all listed standards (same as predicate) |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document is a 510(k) submission for a heated humidifier, not an AI/ML device that uses test sets or data. The "test set" in this context refers to the device itself being tested for compliance with standards and functional equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of an AI/ML device, refers to verified labels or outcomes. For this medical device, safety and performance are assessed through engineering and regulatory testing against established standards and predicate device specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in studies where multiple human readers assess data, and a consensus mechanism is needed to establish ground truth or resolve discrepancies, common in diagnostic imaging studies for AI.
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:
- No. This is not an AI-assisted device. Therefore, no MRMC study comparing human readers with and without AI assistance would have been conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device, not an algorithm. Performance is assessed through engineering testing and compliance with regulatory standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be derived from:
- Engineering specifications and measurements: e.g., actual temperature readings, alarm activation thresholds.
- Compliance with recognized standards: UL 544, CSA C22.2 No. 125-M1984, ANSI Z79.9-1979.
- Comparison to predicate device performance: Demonstrating the new device performs equivalently or better on critical safety and functional aspects.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML model is involved.
Summary of the Study/Evidence:
The "study" presented here is a 510(k) premarket notification. The primary goal is to demonstrate "substantial equivalence" to legally marketed predicate devices (Marquest SCT 3000 - K903138 and Fisher & Paykel 730 Respiratory Humidifier - K913368).
The evidence provided focuses on:
- Device Description and Intended Use: Clearly outlining the function and purpose of the SCT 3000.
- Comparison Table (Attributes): A detailed comparison of the new SCT 3000 with its predicate devices across various attributes including:
- Indications for use (anesthesia, respiratory therapy)
- Targeted population (adult, pediatric, neonate)
- Circuit types (heated wire, no-wire, specific manufacturer circuits)
- Application types (single patient, reusable)
- Chamber types (low flow, high flow)
- Compatibility (ventilators, anesthesia systems)
- Design features (microprocessor control)
- Safety Features: High and low temperature alarms (with specific thresholds), maximum heater plate temperature, alarm mute duration, and safety alarm display.
- Performance Testing: Stating compliance with specific national and international electrical and medical device safety standards (UL 544, CSA C22.2 No. 125-M1984, ANSI Z79.9-1979).
The document explicitly states that "Any differences that do exist would not have an effect on the safety or effectiveness of the device," which is key to a 510(k) submission for substantial equivalence. The "study" is more of a regulatory compliance review of engineering specifications and testing against established standards and predicate device performance, rather than a clinical trial or AI evaluation study.
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JUL 1 6 1997
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| Marquest Medical Products, Inc.1 1039 East Lansing CircleEnglewood, CO 80112 | Tel - (303) 790-4835Fax - (303) 799-0210 |
|---|---|
| Official Contact: | Thomas W. Dielmann,Vice President, Regulatory Affairs / Quality Assurance |
| Proprietary or Trade Name: | SCT 3000 Heated Humidifier |
| Common / Usual Name: | Heated Humidifier |
| Classification Name: | Respiratory Gas HumidifierSubsection 868.5450 |
| Intended Device: | SCT 3000 uses breathing circuits and humidificationchambers to precisely control the delivery of gastemperature and humidity to the patient. |
| Predicate Devices: | Marquest SCT 3000 - K903138Fisher & Paykel 730 Respiratory Humidifier - K913368 |
| Device Description /Indicated Use: | Servo-Controlled Tracking SCT 3000 heated humidifier isdesigned to provide heated, humidified gas to a patientwhose own humidification system - the nose and upperairway - is compromised. The unit is used primarily duringanesthesia or prolonged respiratory therapy to preventdamage to the upper airway and lungs caused by dry gaswhile helping to maintain the patient's body temperaturestable. |
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| Device Description /Indicated Use (continued): | The whole system, including disposable humidificationchambers, heated wire breathing circuits and no-wire (vent)circuits, achieves precise control of delivered gastemperature and humidity by a servo controlledmechanism.The SCT 3000 employs a feedback loop where thetemperature input from the thermistors controls the heatingelements. The SCT 3000 has two thermistors that provideanalog input. This information, in turn, is used to controlthe amount of time that the two heating elements are cycledon/off. The SCT's microprocessor - the Intel P80C32,regulates this servo mechanism. the advanced design allowssimple operation, sophisticated diagnostic routines andsuperior safety features to be built into the instrument,resulting in better performance and safer operation. |
|---|---|
| Targeted Population: | Adult, neonate, and pediatric |
| Environment of Use: | Hospital, anesthesia, ICU, respiratory therapy, homehealthcare |
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘ
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Comparison to Predicate Devices:
| Attribute | MarquestSCT 3000 | Fisher & PaykelMR 730 |
|---|---|---|
| UseIndicated for anesthesia | Yes | Yes |
| Indicated for respiratory therapy | Yes | Yes |
| Population - adult, pediatric, neonate | Yes | Yes |
| Indicated for use only with specificmanufacturers heated circuits | Yes | Yes |
| Use with heated wire circuits | Yes | Yes |
| Use with no-wire circuits | Yes | Yes |
| Single patient use applications | Yes | Yes |
| Reusable circuits application | Yes | Yes |
| Heated wire operation | Yes | Yes |
| No-wire operation | Yes | Yes |
| For use with low flow chambers | Yes | Yes |
| For use with high flow chambers | Yes | Yes |
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Comparison to Predicate Devices:
| Attribute | MarquestSCT 3000 | Fisher & PaykelMR 730 |
|---|---|---|
| Use (continued)For use with ventilators - with orwithout exhalation valves | Yes | Yes |
| For use with anesthesia systems | Yes | Yes |
| For use with various heated wirecircuit configurations | Yes | Yes |
| For use with various no-wirecircuit configurations | Yes | Yes |
| DesignMicroprocessor controlled | Yes | Yes |
| High Temperature Alarm | Yes - DistalTemperature> 1 degree Cof Set Temp. | Yes - DistalTemperature> 2 degrees Cof Set Temp. |
| Low Temperature Alarm | Yes - DistalTemperature< 4 degrees Cof Set Temp. | Yes - DistalTemperature< 4 degrees Cof Set Temp. |
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| Attribute | MarquestSCT 3000 | Fisher & PaykelMR 730 |
|---|---|---|
| Design (continued)Maximum Heater PlateTemperature | 98 degrees C | 110 degrees C |
| Humidification Method | Pass OverWick | Pass OverWick |
| Alarm Mute | 1 Minute | 3 Minutes |
| Other Features | Pause Mode | Standby Mode |
| Safety Alarms | Yes - VisualDisplay ofAll Alarms | Yes - VisualDisplay orError CodeDisplay |
| Performance TestingMeets UL 544, Medical and DentalEquipment / Patient Care Equipment | Yes | Yes |
| Meets CSA C22.2 No. 125-M1984,Electromedical Equipment | Yes | Yes |
| Meets ANSI Z79.9-1979, Humidifiersand Nebulizers for Medical Use | Yes | Yes |
Differences
Any differences that do exist would not have an effect on the safety or effectiveness of the device.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized graphic. The graphic depicts three human profiles facing right, layered on top of each other. The profiles are rendered in black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas W. Dielmann Marguest Medical Products, Inc. 11039 East Lansing Circle Englewood, Colorado 80112
JUL 16 1997
Re: K970478 SCT 3000 Heated Humidifier Requlatory Class: II (two) Product Code: 73 BTT Dated: May 28, 1997 Received: June 2, 1997
Dear Mr. Dielmann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Thomas W. Dielmann
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Marquest Medical Products, Inc. 11039 East Lansing Circle Englewood, Colorado 80112 U.S.A. 303 790 4835 phone 303 799 0210 fax
Section # 3
Labeling (continued)
C. Indications for Use Statement
Pursuant to the Notice of 2/6/96 regarding listing of Indications for Use on a separate sheet, the following is per that request.
| 510(k) Number K970478 (to be assigned) | ||
|---|---|---|
| Device Name: | SCT 3000 Heated Humidifier | |
| Indications for Use: | The SCT 3000 Heated Humidifier is indicated for use withbreathing circuits when healthcare professionals requirehumidified and /or heated gas being delivered to patients. | |
| Targeted Population: | Adult, neonate, and pediatric | |
| Environment of Use: | Hospital, anesthesia, ICU, respiratory therapy, homehealthcare | |
| Disposable / Reusable: | Reusable - Supplied Clean Non-Sterile |
Concurrence of CDRH, Office of Device Evaluation
or
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number __
Prescription Use
(per 21 CFR 801.109)
Over - The - Counter Use
§ 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).