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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the PARI Hydrate G and its acceptance criteria, structured as requested:

Acceptance Criteria and Device Performance for PARI Hydrate G

Acceptance Criteria Category	Specific Criteria/Test Description	Reported Device Performance
Performance Comparability	Device performance should be comparable to legally marketed predicate devices, specifically "Active High Flow Gas Humidification systems" (Vapotherm 2000i and AquinOx P50000) in terms of humidification output.	The PARI Hydrate G employs "similar materials, similar air, water, and power inputs, and delivers similar outputs compared to the predicate devices." Its "Capillary Force Vaporization technology... results in comparable humidification output to the predicate devices."
Standard Compliance	Compliance with ISO 8185 for humidifier output.	The 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 device is reported as "comparable to the predicates," implying compliance with the applicable parts of ISO 8185 related to humidifier output comparability.
Safety and Effectiveness	The device should meet performance requirements and raise no new issues of safety or effectiveness when compared to the predicate devices.	"PARI Hydrate G meets performance requirements and raises no new issues of safety or effectiveness." This is a conclusive statement from the submission. The FDA's substantial equivalence determination further corroborates that the device does not raise new safety or effectiveness concerns compared to existing legally marketed devices.

Study Details:

The provided submission, K070107 for the PARI Hydrate G, describes a non-clinical test summary rather than clinical studies.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not specified. The submission mentions a "gravimetric test standard for humidifier output across the range of flows" but does not give specific numbers of test samples (e.g., number of devices tested, number of readings taken).
- Data Provenance: Not specified. The testing was reported by PARI Innovative Manufacturers, Inc., based in Midlothian, VA, suggesting it was likely conducted in the US, but this is not explicitly stated. It was a non-clinical, in-vitro comparison rather than data from patients. The nature of the testing (comparing output) implies it was prospective for the specific purpose of the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This was an engineering/performance comparison against existing devices and an international standard (ISO 8185), not a clinical assessment requiring expert-established ground truth. The "ground truth" here would be the measured physical properties (humidification output) of the device and predicate devices, as well as the ISO standard specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies for human interpretation or assessment, which was not performed here. The performance was measured directly.
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 MRMC study was done. This device is a medical device (humidifier) and not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not an algorithm-only device. Performance testing was done on the physical device itself in a standalone manner (without patient interaction for this specific regulatory requirement). The "standalone" performance here refers to the device's ability to produce comparable humidification output in laboratory conditions.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the non-clinical testing was based on:
  - Measured humidification output of the predicate devices.
  - Specifications/requirements of ISO 8185 for humidifier output.
  - The principle that "Active High Flow Gas Humidification systems" should produce comparable humidification output, regardless of the specific technology.
The sample size for the training set:
- Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no "training set."
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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K070107

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

Indications For Use

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.

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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.

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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

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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

Page 4.1

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).