(14 days)
The Respironics H2 Heated Humidifier is an accessory for positive pressure ventilation systems to provide moisture to the patient circuit.
It is intended for use with adult patients (> 30 kg), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation.
The H2 Heated Humidifier is a microprocessor-controlled system that has been designed to moisten and warm the air from a positive pressure ventilation device and thus help to compensate for the drying effect. The device is intended for use with the standard patient circuit that is used to connect the device to the patient interface (mask) and to the positive pressure ventilation device.
It is a Respiratory Gas Humidifier (heated Passover type) according to 21 CFR 868.5450. Heat is used to provide an evaporated water content to dry breathing gases.
The H2 Heated Humidifier has a thermoplastic enclosure with dimensions of 5.5 in. high x 6.5 in. wide x 5.25 in. deep and weighs 1.24 lbs. (without the chamber fitted), 1.63 lbs. (with the chamber fitted), and 2.5 lbs. (with the chamber fitted and filled with water). The unit is compromised of a metal heater plate that is controlled from control electronics, contained in a plastic enclosure that is directly supplied with AC power. The heater plate is positioned in the front of the unit. The humidification chamber slides onto the heater plate and is held in place by a rim on the enclosure. The unit controls are located on the top panel.
Accessories for the H2 Heated Humidification chambers, breathing tubing and mounting arrangements.
The provided text is a 510(k) summary for the H2 Heated Humidifier. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not describe any clinical study proving the device meets acceptance criteria.
The information provided is largely focused on regulatory approval and device description, not performance testing results against specific acceptance criteria. Specifically, it mentions "design verification and validation testing" and "verification testing" regarding a baffle modification, but it does not detail:
- Acceptance criteria for performance metrics (e.g., specific humidity levels, temperature ranges, or other functional parameters).
- Any studies involving human subjects or animal models.
- The methodologies for setting ground truth, expert involvement, or sample sizes related to clinical performance.
Given this, I cannot answer most of your questions as the information is not present in the provided text.
Here's a breakdown of what can and cannot be answered based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific Performance Criteria (e.g., humidity output, temperature control, stability) | Not provided in the text. The text mentions "design verification and validation testing" and "verification testing" for a baffle modification, but specific numerical or qualitative acceptance criteria and corresponding performance metrics are not detailed. |
| Mitigation of water turbulence (for baffle modification) | "Verification testing has demonstrated that the addition of the baffle to the water chamber mitigated the water turbulence, which caused the water to spill into the patient circuit, observed at 30 cm H₂O under normal operating conditions and at 40 cm H2O under single fault conditions." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The text only refers to "design verification and validation testing" and "verification testing" without detailing the number of units or test conditions beyond specific pressure points for the baffle (30 cm H₂O and 40 cm H₂O).
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). This was likely internal engineering test data rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The testing described (baffle efficacy) appears to be engineering/laboratory testing, not involving expert interpretation of clinical data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically used in clinical studies for diagnostic accuracy, which is not described here.
5. 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. This type of study is irrelevant for a respiratory gas humidifier and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/algorithm-driven device in the sense of image analysis or diagnostic aid. The "software" mentioned is for device control, not for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the baffle modification, the ground truth was likely determined by physical observation (presence or absence of water splashing/spilling into the patient circuit) under controlled laboratory conditions, against engineering specifications.
8. The sample size for the training set
- Not applicable/Not provided. This device does not have a "training set" in the context of machine learning or AI models. The software is noted as "unchanged from the software provided in K012633," indicating pre-existing, validated control software.
9. How the ground truth for the training set was established
- Not applicable/Not provided. See point 8. The "ground truth" for the device's operational parameters would have been established through engineering design, specifications, and previous validation for predicate devices.
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Premarket Notification 510(k) Section 10 - 510(K) Summary
| Official Contact / Addressof Manufacturing facility | Zita A. YurkoManager, Regulatory AffairsRespironics Inc.1001 Murry Ridge LaneMurrysville, PA 15668 |
|---|---|
| Proprietary Name | H2 Heated Humidifier |
| Common/Usual Name | Respiratory Gas Humidifier |
| Classification Reference | 21 CFR 868.5450 |
| Classification | Class II |
| Appropriate Classification Panel | Anesthesiology Devices |
| Product Code | BTT - Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Predicate Devices | Respironics Heated Humidifier (K012633) |
| Fisher & Paykel HC100 Heated Humidifier (K915460) | |
| Reason for submission | Additional or expanded indications |
Substantial Equivalence
This premarket notification submission demonstrates that the H2 Heated Humidifier is substantially equivalent to a combination of the Respironics Heated Humidifier (K012633) and the Fisher & Paykel HC100 Heated Humidifier (K915460). The software in the H2 Heated Humidifier is unchanged from the software provided in K012633.
The design of the humidifier was verified through the use of design verification and validation testing. The Hazards Control Measures Traceability Matrix provided in Appendix B of the Risk Analysis assured that all hazards identified by the risk analysis were successfully mitigated.
©2002 Respironics Inc.
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This submission is seeking to extend the existing claims of the humiditier to include patients using mask applied positive pressure ventilation.
Indications for Use
The Respironics H2 Heated Humidifier is an accessory for positive pressure ventilation systems to provide moisture to the patient circuit.
It is intended for use with adult patients (> 30 kq), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation therapy.
Device Description
The H2 Heated Humidifier is a microprocessor-controlled system that has been designed to moisten and warm the air from a positive pressure ventilation device and thus help to compensate for the drying effect. The device is intended for use with the standard patient circuit that is used to connect the device to the patient interface (mask) and to the positive pressure ventilation device.
It is a Respiratory Gas Humidifier (heated Passover type) according to 21 CFR 868.5450. Heat is used to provide an evaporated water content to dry breathing gases.
The H2 Heated Humidifier has a thermoplastic enclosure with dimensions of 5.5 in. high x 6.5 in. wide x 5.25 in. deep and weighs 1.24 lbs. (without the chamber fitted), 1.63 lbs. (with the chamber fitted), and 2.5 lbs. (with the chamber fitted and filled with water). The unit is compromised of a metal heater plate that is controlled from control electronics, contained in a plastic enclosure that is directly supplied with AC power. The heater plate is positioned in the front of the unit. The humidification chamber slides onto the heater plate and is held in place by a rim on the enclosure. The unit controls are located on the top panel.
Accessories for the H2 Heated Humidification chambers, breathing tubing and mounting arrangements.
During the review of the Respironics Heated Humidifier (K012633) submission, a baffle was added to the inlet of the humidifier water chamber in order to minimize the amount of water being blown out of the humidifier at high flow conditions. Without the baffle, a positive pressure ventilation device operating at pressures > 20 cm H2O and flows < 325 LPM would cause the water in the chamber to splash and enter the outlet of the water chamber into the patient tubing. Verification testing has
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demonstrated that the addition of the baffle to the water chamber mitigated the water turbulence, which caused the water to spill into the patient circuit, observed at 30 cm H₂O under normal operating conditions and at 40 cm H2O under single fault conditions.
The software in the H2 Heated Humidifier is unchanged from the software provided in K012633.
(End of Section.)
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. The text is written in all capital letters.
JAN 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·Respironics, Incorporated C/O Mr. Ned Devine, Jr. Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K030090
Trade/Device Name: H2 Heated Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: January 10, 2003 Received: January 10, 2003
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 vour 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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runsey
Susan Runner, DDS, MA Interim 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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Page 1 of 1
14030090 510(k) Number (if known):
Device Name: H2 Heated Humidifier
Indications for Use:
The Respironics H2 Heated Humidifier is an accessory for positive pressure ventilation systems to provide moisture to the patient circuit.
It is intended for use with adult patients (> 30 kg), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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on of Anesthesiology, General Hospital, Infection Control,
510(k) Number:_
§ 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).