The Cloud 1 Humidification System is intended to warm and humidify gas before it is delivered to the airway of a patient requiring mechanical ventilation or ventilatory assistance.

Device Description

The Cloud 1 Humidification System is used to deliver heat energy and humidity to a patient's proximal airway in those instances where the patient's natural mechanisms of heat retention and humidification are bypassed by intubation. The system consists of a humidifier that creates water vapor at an elevated temperature and mixes the vapor with air from a ventilator and a specialized breathing circuit including a heating element in either the inspiratory limb or both the inspiratory and expiratory limbs. The water content of the air exiting the humidifier is close to saturation at a desired proximal airway temperature. The breathing circuit heater adds heat energy to the air/vapor mixture as it travels from from the humidifier to the patient's proximal airway and, optionally, from the patient's airway to the ventilator expiratory valve. By reducing the temperature loss in the breathing tube, condensation of water vapor (rainout) is minimized resulting in safer operation and reduced clinical maintenance of the system.

The proposed system is a dual microprocessor controlled system with multiple redundant alarm and system check features. The humidification system uses the Vapor Phase transfer chamber concept that provides a physical separation between the water compartment and the vapor compartment by means of a hydrophobic membrane. This separation assures that a large bolus of liquid water cannot enter the patient's breathing circuit due to tipping of the humidifier. The construction of the chamber's membrane and the relatively high operating temperature allows the use of low cost distilled water instead of sterile water as is more commonly used in humidifiers.

The proposed system uses a breathing circuit heater assembly that supports heater elements in the center of the inspiratory air flow with a polymer web. The heater elements are placed such that they cannot touch the wall of the breathing circuit tube, reducing the chance for the heater melting through the tube wall and creating a circuit leak. Locating the heater elements at the center of the tube optimizes heat transfer to the airflow, reducing the operating temperature of the heater elements, further reducing chance of melting the breathing tube. The heater element employs straight wires instead of the more conventional spiral wound wires to reduce the risk of hot spot formation due to uneven spiral pitch winding and subsequent melting of the heater assembly and/or breathing circuit tube.

The support web serves as a structure to connect and support temperature sensors (thermistors), two extending to the proximal end of the heater assembly and another at the distal end of the heater assembly. The proximally located sensors measure proximal airway temperature (PAT) while the distally located sensor measures the chamber output temperature (COT). Additional conductive wires are extruded in the assembly support ribbon to electrically connect the PAT sensors to a cable assembly molded in the distal end. The cable assembly plugs into the humidifie/heated wire controller.

AI/ML Overview

The provided text describes a medical device, the "CLOUD 1 Humidification System," and its 510(k) submission for market clearance. However, the document does not contain detailed acceptance criteria, a specific study protocol, or quantitative data demonstrating how the device meets acceptance criteria. It primarily focuses on comparing the device's performance characteristics and safety features to predicate devices in a qualitative manner.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria with numerical targets. Instead, it describes performance in comparative terms to predicate devices.

Acceptance Criteria	Reported Device Performance
Humidity Delivery	"In most flow/setpoint conditions, the RSP system delivered humidity closer to saturation than either of the competitors' systems."
Safety Features	"The RSP system provides greater safety by using a dual PAT sensor and tracking error detection, redundant latching high and low PAT alarms, redundant power switches for both the heater platen and the circuit heater, redundant latching platen overtemperature sensing and alarming, and tertiary safety with a platen thermal fuse in addition to the safety benefits of the transfer chamber and improved circuit heater constructions."
Physical Separation (preventing water bolus)	"The humidification system uses the Vapor Phase transfer chamber concept that provides a physical separation between the water compartment and the vapor compartment by means of a hydrophobic membrane. This separation assures that a large bolus of liquid water cannot enter the patient's breathing circuit due to tipping of the humidifier."
Breathing Circuit Heater Safety	"The heater elements are placed such that they cannot touch the wall of the breathing circuit tube, reducing the chance for the heater melting through the tube wall... The heater element employs straight wires instead of the more conventional spiral wound wires to reduce the risk of hot spot formation..."
Water Type Usage	"The construction of the chamber's membrane and the relatively high operating temperature allows the use of low cost distilled water instead of sterile water as is more commonly used in humidifiers."

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "the performance of the system was tested and compared," but no details on the testing methodology or data generation are provided.

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

Not applicable. The document describes "non-clinical data" and comparisons to predicate devices, not studies involving expert-established ground truth for a test set.

4. Adjudication method for the test set

Not applicable, as no test set with expert ground truth or adjudication is 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

Not applicable. This device is a humidification system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and not mentioned.

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

Not applicable, as this is a medical device, not an algorithm, and the concept of "standalone performance" in this context refers to the device's functional operation. The text indicates the device's functional performance was tested ("performance of the system was tested"), but it's not "algorithm only."

7. The type of ground truth used

For the "Non-Clinical Data" described, the "ground truth" seems to be derived from instrumental measurements of humidity output, temperature control, and safety feature functionality, compared against the performance of predicate devices. It is not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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MAY 2 4 399

K983862

Section 2 - Summary and Certification

PREPARATION DATE OF SUMMARY

October 27, 1998

TRADE NAME

CLOUD 1 Humidification System

COMMON NAME

Humidifier and Breathing Circuit Heater Controller

PRODUCT CLASSIFICATION

Class II, per 868.5450 Product Code: 73BTT

PREDICATE DEVICES

Intertech/Inspiron Vapor Phase Model 009500 "Advanced" Humidifier Intertech/Inspiron Vapor Phase Model 009300 "Plus" Humidifier Intertech/Inspiron Vapor Phase Model 009900 Heated Wire Controller Fisher Paykell Model MR630 Humidifier Marquest Model SCT 3000 Humidifier RCI Model 380-88

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DESCRIPTION

INDICATIONS FOR USE

Humidifiers and heated circuit controllers are intended to be used on intubated patients who require supplemental heat and humidity to prevent hypothermia and drying of the tracheobronchial tract.

CONTRAINDICATIONS, PRECAUTIONS, and WARNINGS

Contraindications, cautions, and warnings are detailed in the product labeling.

TECHNICAL CHARACTERISTICS

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NON-CLINICAL DATA

The performance of the system was tested and compared to the performance of the Fisher Paykell and Marquest systems. In most flow/setpoint conditions, the RSP system delivered humidity closer to saturation than either of the competitors' systems. The RSP system provides greater safety by using a dual PAT sensor and tracking error detection, redundant latching high and low PAT alarms, redundant power switches for both the heater platen and the circuit heater, redundant latching platen overtemperature sensing and alarming, and tertiary safety with a platen thermal fuse in addition to the safety benefits of the transfer chamber and improved circuit heater constructions.

CONCLUSION

The testing performed and comparison to predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices.

Sudan Shizzawa

Gordon Shigezawa Director of Research and Development

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal are three stylized profiles of human faces, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 1999

Mr. Gordon Shigezawa Director of Research and Development SIMS/Respiratory Support Products, Inc. 2552 McGaw Avenue Irvine, CA 92614

Re : K983862 Trade Name: Cloud 1 Humidification System Regulatory Class: II (two) Product Code: BTT Dated: March 8, 1999 Received: March 12, 1999

Dear Mr. Shiqezawa:

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 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). 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 requlation 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

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Page 2 - Mr. Shigezawa

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.

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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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, "Misbrandinq by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Atl. A. Ciarlow L.

/. 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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Page_1__of_1_

510(k) Number (if known):___ K983862

Device Name: Cloud 1 Humidification System

Indications For Use:

The Cloud 1 Humidification System is intended to warm and humidify gas before it is delivered to the airway of a patient requiring mechanical ventilation or ventilatory assistance.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Arle A. Ciarhansti.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number . 983862

Regulation Number and Section

§ 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).