PARI HYDRATE V

K072982 · Pari Innovative Manufacturers, Inc. · BTT · Nov 29, 2007 · Anesthesiology

Device Facts

• Record ID: K072982
• Device Name: PARI HYDRATE V
• Applicant: Pari Innovative Manufacturers, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Nov 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The PARI Hydrate V is intended to warm and add moisture to breathing gases to patients requiring mechanical ventilation, positive pressure breathing assistance or general medical gases for administration to infant, pediatric, and adult patients. The Hydrate V is intended for use in homes, hospitals, and sub-acute institutions.

Device Story

PARI Hydrate V is a respiratory gas humidifier; provides heated, evaporated water content to dry breathing gases. Uses Capillary Force Vaporization technology; heater draws liquid through porous medium to generate humidity. Device connects to breathing circuit for gas delivery to patient. Used in homes, hospitals, and sub-acute institutions. Operated by clinicians or patients. Output is warmed, humidified gas; helps maintain airway moisture during ventilation or gas therapy.

Clinical Evidence

No clinical data. Bench testing only; performance compared to predicate devices using gravimetric test standards for humidifier output across flow ranges per ISO 8185.

Technological Characteristics

Active gas humidification system. Uses Capillary Force Vaporization technology (heater-driven liquid transport through porous medium). Dimensions/materials not specified. Standalone device. Complies with ISO 8185 performance requirements.

Indications for Use

Indicated for infant, pediatric, and adult patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gas administration for warming and humidification.

Regulatory Classification

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.

Predicate Devices

• PARI Hydrate G (K071707)
• Fisher & Paykel Healthcare, Ltd. MR 850 Heated Humidifier (K033710)

Submission Summary (Full Text)

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## PARI Hydrate V 510(k) Submission 510(k) Summary

| Submitter Information | | | |
|-----------------------|---------------------------------------------------------|-------------|--|
| Name: | PARI Innovative Manufacturers. Inc. | | |
| Address: | 2943 Oak Lake Blvd.<br>Midlothian, VA 23112 | | |
| Phone Number: | 804-253-7274 x269 | | |
| Fax Number: | 804-639-7244 | | |
| Contact Name: | Michael Judge | | |
| Date Prepared: | June 15, 2007 | NOV 29 2007 | |
| Device Name | | | |
| Common Name: | Humidifier | | |
| Proprietary Name: | PARI Hydrate V | | |
| Classification Name: | Humidifier, Respiratory Gas (Direct Patient Interface). | | |

### Legally Marketed Predicate Device(s)

| Manufacturer | Device | 510(k) Number |
|-------------------------------------|--------------------------|---------------|
| PARI Innovative Manufacturers, Inc. | PARI Hydrate G | K071707 |
| Fisher & Paykel Healthcare, Ltd. | MR 850 Heated Humidifier | K033710 |

21 CFR 868.5450, Product Code BTT

#### Device Description

The Hvdrate V is a Respiratory Gas Humidifier which provides heated evaporated water content to dry breathing gases using Capillary Force Vaporization technology. A breathing circuit is used to deliver the heated and humidified gas to the patient.

#### Indications For Use

The PARI Hydrate V is intended to warm and add moisture to breathing gases to patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases for administration to infant, pediatric, and adult patients. The Hydrate V is intended for use in homes, hospitals, and sub-acute institutions.

#### Technological Characteristics Compared to Predicate Device

PARI Hydrate V, PARI Hydrate G and Fisher & Paykel MR 850 are all Active Gas Humidification systems, used to add moisture and warmth to breathing gases for administration to patients.

PARI Hydrate V employs similar materials, similar air, water, and power inputs, and delivers similar outputs compared to the predicate devices. The Capillary Force Vaporization technology used in the Hydrate V, although slightly different than the heated plate concept used by the predicate MR 850, is identical to that used in the PARI Hydrate G and 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 V 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 and is not required to show substantial equivalence.

#### Conclusions from Testing

PARI Hydrate V meets performance requirements and raises of safety or effectiveness.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - (USA)" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2007

PARI Innovative Manufacturers, Incorporated C/O Daniel W. Lehtonen Senior Staff Engineer- Medical Devices Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K072982

Trade/Device Name: PARI Hydrate V Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: November 14, 2007 Received: November 15, 2007

Dear Mr. Lehtonen:

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. Lehtonen

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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 V

Indications for Use:

The PARI Hydrate V is intended to warm and add moisture to breathing gases to patients requiring mechanical ventilation, positive pressure breathing assistance or general medical gases for administration to infant, pediatric, and adult patients. The Hydrate V is intended for use in homes, hospitals, and sub-acute 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)

Muit Zarl

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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*(Posted November 13, 2003)*

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