(453 days)
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Not Found
No
The provided text describes a device for adding moisture to an HME system and does not mention any AI or ML components or functionalities.
Yes
The device is described as making it "possible to feed additional moisture into the system" when a patient has a "moisture deficit," indicating a direct therapeutic action to address a physiological deficiency.
No
The device is described as an HME-Booster™ that provides additional moisture to the system, optimizing the output of an HME. Its function is to support therapeutic humidity delivery, not to diagnose a condition.
No
The description explicitly mentions a "Booster heating element" and a "Booster T-piece," indicating the device includes hardware components beyond just software.
Based on the provided text, the HME-Booster™ 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 about a person's health.
- HME-Booster™ Function: The description clearly states the HME-Booster™ is used to add moisture to a breathing system during anesthesia and ICU care, specifically when an HME alone is insufficient. It directly interacts with the breathing circuit and the patient's airway, not with a specimen taken from the patient.
The intended use and function of the HME-Booster™ are related to respiratory support and humidification, which falls under the category of medical devices used for patient care, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The HME-Booster™ makes it possible to feed additional moisture into the system during rne innie Dooter - manoon p specifically when the use of an HME alone is no longer adequate due to a patient's moisture deficit. Only use the Booster T-piece when the Booster heating element is used. The HME-Booster™ can be used with HME's for anesthesia and HME's for ICU, at flow rates between 2L and 12L per minute. The HMEanoother and hime sole purpose of optimizing the output of the HME. It can only be used at any time in combination with an HME. Not for use with pediatric applications, where at any time in combination or equal to 250 ml and the body weight is less than 20 kg.
Product codes
BTT
Device Description
HME-Booster™
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not for use with pediatric applications, where at any time in combination or equal to 250 ml and the body weight is less than 20 kg.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of three curved lines that resemble a bird in flight, symbolizing growth and progress.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2000
Mr. Charles A. Burt Requlatory Affairs Manager King Systems Corporation 15011 Herriman Boulevard Noblesville, IN 46060
K990614 Re: HME-Booster™ Requlatory Class: II (two) 73 BTT Product Code: Dated: March 28, 2000 Received: April 3, 2000
Dear Mr. Burt:
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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements regulatory action. 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 regulations.
1
Page 2 - Mr. Charles A. Burt
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 diagnostic 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/dsma/dsmamain.html".
Sincerely yours,
Mark N. Milhum
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section #3
Device name: HME-Booster™.
Indications For Use:
The HME-Booster™ makes it possible to feed additional moisture into the system during rne innie Dooter - manoon p specifically when the use of an HME alone is no longer adequate due to a patient's moisture deficit. Only use the Booster T-piece when the Booster heating element is used. The HME-Booster™ can be used with HME's for anesthesia and HME's for ICU, at flow rates between 2L and 12L per minute. The HMEanoother and hime sole purpose of optimizing the output of the HME. It can only be used at any time in combination with an HME. Not for use with pediatric applications, where at any time in combination or equal to 250 ml and the body weight is less than 20 kg.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 868.5450)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Mark n Milkerm
For Division Sign-Off)
aw of Cardiovascular, Respiratory,
Cardiovascular, Respiratory,
ical Devices
(k) Number K990614