(37 days)
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.
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.
The provided 510(k) summary for the PARI Hydrate V describes a non-clinical study to demonstrate substantial equivalence to predicate devices, rather than a study against explicit acceptance criteria with reported device performance in the format typically used for AI/ML-based device evaluations. The summary focuses on comparing the device's technical characteristics and performance to existing, legally marketed humidifiers.
Therefore, the following analysis is based on interpreting the provided information in the context of a 510(k) submission for a non-AI/ML medical device, where the "acceptance criteria" are implied by performance equivalence to predicate devices and adherence to relevant standards.
Acceptance Criteria and Study Details
The PARI Hydrate V is a respiratory gas humidifier. For such a device, the primary performance characteristic is its ability to warm and add moisture to breathing gases effectively and safely. The acceptance criteria are implicitly defined by the performance of the predicate devices and adherence to international standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a non-AI/ML device, the "acceptance criteria" are based on equivalence to predicate devices and relevant industry standards (ISO 8185). The reported device performance is stated as being "comparable to the predicates."
| Acceptance Criteria (Implied) | Reported Device Performance (PARI Hydrate V) |
|---|---|
| Humidifier Output: Gravimetric output across various flow rates, equivalent to predicate devices (PARI Hydrate G, Fisher & Paykel MR 850) and meeting ISO 8185 standards. | "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." |
| Safety and Effectiveness: Meets performance requirements without raising new concerns regarding safety or effectiveness. | "PARI Hydrate V meets performance requirements and raises [no] safety or effectiveness [concerns]." (Presumed typo in original: "raises of safety or effectiveness" likely means "raises no new concerns of safety or effectiveness.") |
2. Sample Size Used for the Test Set and Data Provenance
The summary describes "non-clinical testing" which typically involves bench testing rather than patient data.
- Sample Size: Not explicitly stated but refers to "a gravimetric test standard for humidifier output across the range of flows." This implies multiple measurements were taken at different flow rates to demonstrate consistent performance. The "sample" in this context would likely be the device itself and a series of test conditions.
- Data Provenance: Bench test data. Not applicable in terms of country of origin or retrospective/prospective as it doesn't involve patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. For a non-clinical bench test of a humidifier, the "ground truth" is typically established by objective physical measurements (e.g., gravimetric analysis for humidity output) using calibrated laboratory equipment, not by human expert assessment. The testing would have been conducted by engineers or technicians in a laboratory setting.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Performance is determined by objective measurements against a standard.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often in conjunction with AI assistance. The PARI Hydrate V is a therapeutic device, and its performance is assessed via engineering and physical tests.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device does not incorporate an AI algorithm. Its performance is inherent to its physical design and operation.
7. Type of Ground Truth Used
- Objective Measurements: The ground truth for the device's performance (humidification output) was established through objective gravimetric measurements according to a "test standard for humidifier output," likely following the procedures outlined in ISO 8185. This involves precisely measuring the mass of water added to a gas stream over time.
- Predicate Device Performance: The ground truth for comparative purposes was the established performance of the legally marketed predicate devices (PARI Hydrate G and Fisher & Paykel MR 850), as well as the requirements of ISO 8185.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML device and therefore does not have a "training set" in the computational sense. Its design and development would have involved engineering principles and prototype testing, but not machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as above.
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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.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 (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 (301) 443-6597 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:
Page of
(Posted November 13, 2003)
Page 4.1
§ 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).