(310 days)
Not Found
No
The description focuses on the physical components and control mechanisms (keypad with buttons) for heating and humidifying gases, with no mention of AI or ML algorithms for control, analysis, or prediction.
Yes
The device is used to humidify and heat breathing gases for patients, which directly addresses a physiological need and prevents adverse health effects associated with dry gases. This falls under the definition of a therapeutic intervention.
No
The device, Humid-Heat™, is described as an active respiratory humidifier that heats and humidifies breathing gases supplied from a ventilator. Its purpose is to provide "physiologically optimized breathing gases" to patients, preventing issues like thickened mucus and trapped secretions. There is no mention of the device analyzing, detecting, or measuring any physiological parameters to diagnose a condition. Its function is therapeutic/supportive, not diagnostic.
No
The device description explicitly lists five main hardware components: the supply unit, the heater, the temperature probe, the HME, and the water feed set. It also mentions a keypad for control. This indicates it is a physical device with hardware, not software only.
Based on the provided information, the Humid-Heat™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Humid-Heat™ Function: The Humid-Heat™ directly interacts with the breathing gases supplied to a patient's respiratory system. It heats and humidifies these gases before they enter the body. It does not analyze any biological samples from the patient.
- Intended Use: The intended use clearly states it's for heating and humidifying breathing gases supplied from a ventilator to patients. This is a therapeutic and supportive function, not a diagnostic one.
Therefore, the Humid-Heat™ falls under the category of a respiratory support device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Humid-Heat™ is intended for use as an active respiratory humidifier to heat and humidify dry breathing gases supplied from a ventilator via an endotracheal tube, a tracheostomy tube, or a face mask to adult patients under intensive care or anesthesia.
Product codes
73 BTT
Device Description
Humid-Heat™ is an active respiratory humidifier that heats and humidifies dry breathing gases supplied from a ventilator via an endotracheal, tracheostomy tube or a face mask to adult patients under intensive care or anesthesia. Patients receive physiologically optimized breathing gases (37°C, 100% relative humidity) instead of the dry and cool breathing gases they would otherwise receive if connected directly to a ventilator. They thus avoid the thickened mucus, decreased cilia activity and secretions trapped in the lower airways that are often caused by exposure to cool, dry gases. By heating and humidifying the supplied breathing gases, Humid-Heat™ overcomes these problems and provides optimal conditions for long-term ventilation.
Heating and humidification take place close to the patient, thereby eliminating the problem of condensation in ventilator circuits. Humid-Heat™ does not require any water traps or heated wires and water consumption is reduced. Humid-Heat™ is suitable for use with volume and pressure-controlled ventilators.
The Humid-Heat™ consists of five main components: the supply unit, the heater, the temperature probe, the HME and the water feed set. It is controlled with a keypad consisting of four buttons; up/down buttons to set the minute volume of the ventilator, start button, stop button, and the power switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
intensive care or anesthesia
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
An extensive collection of tests have been conducted and successfully completed, including electrical safety (IEC 601-1), performance and environmental testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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SECTION 2. SUMMARY AND CERTIFICATION
A. 510(K) SUMMARY
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the Hudson RCI AB summary for the Humid-Heat™
| SUBMITTER'S NAME: | Hudson RCI AB (Formerly Louis Gibeck AB) |
|---|---|
| ADDRESS: | Box 711 |
| SE-194 27 Upplands Väsby | |
| Sweden | |
| CONTACT PERSON: | Constance Bundy |
| TELEPHONE NUMBER: | 612-574-1976 |
| FAX NUMBER: | 612-571-2437 |
| DATE OF SUBMISSION: | November 1, 1999 |
Identification of device 1.
Proprietary Name: Humid-Heat™ Common Name: Respiratory gas humidifier Classification Status: Class II per regulations 868.5450 Product Codes: 73 BTT
Equivalent devices 2.
Hudson RCI AB believes the Humid-Heat™ is substantially equivalent to Fisher & Paykel Dual Servo Controlled Heated Respiratory Humidifiers, cleared for marketing under 510(k) K913368.
Description of the Device ર્જ
Humid-Heat™ is an active respiratory humidifier that heats and humidifies dry breathing gases supplied from a ventilator via an endotracheal, tracheostomy tube or a face mask to adult patients under intensive care or anesthesia. Patients receive physiologically optimized breathing gases (37°C, 100% relative humidity) instead of the dry and cool breathing gases they would otherwise receive if connected directly to a ventilator. They thus avoid the thickened mucus, decreased cilia activity and secretions trapped in the lower airways that are often caused by exposure to cool, dry gases. By heating and humidifying the supplied breathing gases, Humid-Heat™ overcomes these problems and provides optimal conditions for long-term ventilation.
Heating and humidification take place close to the patient, thereby eliminating the problem of condensation in ventilator circuits. Humid-Heat™ does not require any water traps or heated wires and water consumption is reduced. Humid-Heat™ is suitable for use with volume and pressure-controlled ventilators.
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The Humid-Heat™ consists of five main components: the supply unit, the heater, the temperature probe, the HME and the water feed set. It is controlled with a keypad consisting of four buttons; up/down buttons to set the minute volume of the ventilator, start button, stop button, and the power switch.
Intended use 4.
The Humid-Heat™ is intended for use as an active respiratory humidifier to heat and humidify dry breathing gases supplied from a ventilator via an endotracheal tube, a tracheostomy tube, or a face mask to adult patients under intensive care or anesthesia.
Technological characteristics, comparison to predicate device. ਪੰਜ
Like the predicate devices, the Humid-Heat™ is intended to add moisture to, and to warn, the breathing gases for administration to a patient.
| Characteristic | Predicate device: Fisher &
Paykel MR850, K983112 | Humid-Heat ™ |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To warm and add humidity to
gases delivered to patients
requiring mechanical
ventilation. | Same |
| Airway Temperature
output | 30-39° C marked
29-40° C actual | 37° C± 2° C |
| Moisture output | At least 30 mg H2O/L if
temperature of gas delivered
to patient is set to 37° C for a
given continuous flow. | 44 mg H2O/L active VT 800 ml
30 mg H2O/L passive VT 800 ml |
| Technical background | The warmth and moisture are
supplied by passing the
breathing gas over heated
water while the temperature
of the gas flowing through the
breathing circuit is
maintained by a heated wire. | The supply unit pumps external
water onto a wick in the HME.
The water on the wick is
evaporated by an electrical
heater. |
| Ventilator systems | Mechanical ventilation or
positive pressure breathing
assistance | Volume and pressure-controlled
ventilators |
| Passive humidification | Maximal 20 mg H2O/L | 30 mg H2O/L passive VT 800 ml |
Comparison table
6. Discussion of performance testing.
An extensive collection of tests have been conducted and successfully completed, including electrical safety (IEC 601-1), performance and environmental testing.
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7. Conclusion
1.00
It is the conclusion of Hudson RCI AB that the Humid-Heat™ is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
1999 - 1999
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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" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 2000
Hundson RCI AB c/o Ms. Constance G. Bundy 6470 Riverview Terrace Fridley, MN 55432
K993773 Re : Hudson RCI AB Humid-Heat™ Regulatory Class: II (two) Product Code: 73 BTT August 17, 2000 Dated: August 18, 2000 Received:
Dear Ms. Bundy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is che device foreioned (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 In actoration with anoou therefore, market the device, subject to the general controls provisions of the Act. The general controls enc general 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 II yours 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 Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this conse 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 regulations.
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Page 2 - Ms. Constance G. Bundy
This letter will allow you to begin marketing your device as described inis lecter will arrow you co icention. The FDA finding of substantial in your 510 (x) promainsice to a legally marketed predicate device equivalence of your device of a region and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling II you destre bpooriis and additionally 809.10 for in vitro reguration (=vices), please contact the Office of Compliance at Graghosere devices // plonally, for questions on the promotion and (Jor) 53 1010. Hauter, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (901) 37 1000 by reference to premarket notification" (21 CFR 807.97). firstranding by rereation on your responsibilities under the Act may ocher general information of Small Manufacturers Assistance at its be obtained from the 22138-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
James B. Dillard III
Director
Directbr Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
B. INDICATIONS FOR USE
510(k) Number K993773
Device Name: Humid-Heat™
Indications for Use:
The Humid-Heat™ is an active respiratory humidifier that heats and humidifies dry rile fruinid-riour - 18 an actro respirator via an endotracheal tube, a tracheostomy tube, or a face mask to adult patients under intensive care or anesthesia.
(Please do not write below this line - continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K993773 |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) | |
| OR | |
| Over the Counter Use |