(43 days)
Not Found
No
The description focuses on the physical mechanism of humidification (Capillary Force Vaporization) and performance testing against standards and predicate devices, with no mention of AI or ML terms or functionalities.
No.
The device warms and adds moisture to breathing gases but does not directly treat or diagnose a medical condition.
No
This device is a respiratory gas humidifier, which adds warmth and moisture to breathing gases. Its function is therapeutic, not diagnostic, as it does not gather or analyze data about the patient's health condition.
No
The device description clearly states it is a "Respiratory Gas Humidifier" which is a hardware device that provides heated evaporated water content.
Based on the provided information, the PARI Hydrate G is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "warm and add moisture to breathing gases for administration to infant, pediatric, and adult patients." This describes a device used on a patient to modify the air they breathe, not a device used to test samples from a patient (which is the core function of an IVD).
- Device Description: The description confirms it's a "Respiratory Gas Humidifier" that provides heated and humidified gas to the patient via a nasal cannula. This aligns with a therapeutic or supportive respiratory device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the PARI Hydrate G falls under the category of a respiratory therapy device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PARI Hydrate G is designed to warm and add moisture to breathing gases for administration to infant, pediatric, and adult patients. The Hydrate G is intended for use in homes, hospitals, and sub-acute institutions.
Product codes
BTT
Device Description
The Hydrate G is a Respiratory Gas Humidifier which provides heated evaporated water content to dry breathing gases using Capillary Force Vaporization technology. A nasal cannula is used to deliver the heated and humidified gas to the patient.
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
infant, pediatric, and adult patients
Intended User / Care Setting
homes, hospitals, and sub-acute institutions.
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
Non-Clinical Test Summary: PARI Hydrate G was tested to compare performance to the predicate devices and ISO 8185, using a gravimetric test standard for humidifier output across the range of flows. The subject device is comparable to the predicates.
Clinical Performance Summary: Clinical testing was not completed/is not required to show substantial equivalence.
Conclusions from Testing: PARI Hydrate G meets performance requirements and raises no new issues of safety or effectiveness.
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).
0
FEB 2 3 2007
PARI Hydrate G 510(k) Submission 510(k) Summary
. . . .
Submitter Information
PARI Innovative Manufacturers, Inc. Name: 2943 Oak Lake Blvd. Address: Midlothian, VA 23112 804-253-7274 x269 Phone Number: 804-639-7244 Fax Number: Michael Judge Contact Name: November 14, 2006 Date Prepared:
Device Name
Humidifier Common Name: PARI Hydrate G Proprietary Name: Humidifier, Respiratory Gas (Direct Patient Interface), Classification Name: 21 CFR 868.5450, Product Code BTT
Legally Marketed Predicate Device(s)
| Manufacturer | Device | 510(k) Number |
|---|---|---|
| Vapotherm, Inc. | Model 2000i | K042245 |
| Smiths Medical ASD, Inc. | AquinOx, model P50000 | K050314 |
Device Description
The Hydrate G is a Respiratory Gas Humidifier which provides heated evaporated water content to dry breathing gases using Capillary Force Vaporization technology. A nasal cannula is used to deliver the heated and humidified gas to the patient.
Indications For Use
The PARI Hydrate G is designed to warm and add moisture to breathing gases for administration to infant, pediatric, and adult patients. The Hydrate G is intended for use in homes, hospitals, and sub-acute institutions.
Technological Characteristics Compared to Predicate Device
PARI Hydrate G, AquinOx P50000 and Vapotherm 2000i are all Active High Flow Gas Humidification systems, used to add moisture and warmth to breathing gases for administration to patients.
PARI Hydrate G employs similar materials, similar air, water, and power inputs, and delivers similar outputs compared to the predicate devices. The Capillary Force Vaporization technology, although slightly different than the heated plate and vapor/membrane transpiration concepts used by the predicates, uses a heater to draw liquid through a porous medium resulting in comparable humidification output to the predicate devices.
Non-Clinical Test Summary
PARI Hydrate G was tested to compare performance to the predicate devices and ISO 8185, using a gravimetric test standard for humidifier output across the range of flows. The subject device is comparable to the predicates.
Clinical Performance Summary
Clinical testing was not completed/is not required to show substantial equivalence.
Conclusions from Testing
PARI Hydrate G meets performance requirements and raises no new issues of safety or effectiveness.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PARI Innovative Manufactures, Incorporated C/O Mr. Neil E. Devine Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road Twinsburg, Ohio 44087
FEB 2 3 2007
Re: K070107
Trade/Device Name: PARI Hydrate G Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: February 20, 2007 Received: February 21, 2007
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 -- Mr. Devine
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): N/A
Device Name: PARI Hydrate G
Indications for Use:
The PARI Hydrate G is designed to warm and add moisture to breathing gases for administration to The PART Tryurate O is designed to warm arts and material of a secure of one in homes, hospitals, and subacute institutions.
Prescription Use XXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Klaus Weber
sthesiology, General Hospi
Page of (Posted November 13, 2003)
510(k) Number: K070707
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