(88 days)
VentStar Dual Heated / VentStar Heated: Disposable inspiratory heated breathing circuit with humidifier chamber for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and adult patients with a body weight of at least 40 kg (88 lbs).
VentStar Heated (N) / VentStar Heated (N) basic: Disposable inspiratory heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and neonatal patients with a body weight of up to 5 kg (11 lbs).
Infinity ID Breathing Circuit Heated (N): Inspiratory heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for moping moistened breathing gas between the humidifier and neonates with a body weight of up lo 5 kg (11 Ibs) Intended for single-use only. Breathing circuit with integrated transponder. The transponder serves as a carrier of product-specific data for processing by Dräger Infinity ID equipment.
Infinity ID Breathing Circuit Dual Heated / Infinity ID Breathing Circuit Heated: Heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidfier and adults with a body welght of at least 40 kg (88 moration broaining goo Doching circuit with integrated transponder. The transponder. The transponder serves as a carrier of product-specific data for processing by Dräger Infinity ID equipment.
The 510(k) comprises heated breathing gas hose systems including a humidifier chamber for the ventilation of neonatal or adult patients in Intensive Care Units. The hose systems consist of two breathing hoses (inspiratory and expiratory limb) with an additional y- piece.
Inside the inspiratory and in case of the dual heated systems also in the expiratory limb of the hose system there is a heating wire which can be connected to a Fisher & Paykel humidifier MR850 to heat up the breathing gas to minimise condensation. An expiratory limb without heating wire includes a water trap. There are additional sensor ports where the temperature sensors of the Fisher & Paykel humidifier MR850 (e.g. Fisher & Paykel 900MR868) can be placed in.
In case of the neonatal system, the hose is equipped with an incubator extension for use inside an incubator.
The Infinity ID heated breathing circuits are based on the heated breathing circuits additionally equipped with an RFID identification tag. The tag stores characteristics of the breathing hose (e.g. patient type, hose diameter, resistance and compliance values, manufacturing date and shelf life) and is automatically be readout when connected to the outlets of a ventilator device which supports this function.
The provided document (K102618) describes heated breathing circuits manufactured by Dräger Medical AG & Co. KG. The summary of testing indicates that the device has undergone performance evaluations; however, it does not provide specific quantitative acceptance criteria or detailed study results that would allow for a precise filling of the table requested.
Therefore, many sections of your request cannot be fully answered with the information given. I will extract what is available and indicate where information is missing.
Acceptance Criteria and Device Performance Study for Dräger Heated Breathing Circuits (K102618)
The provided document describes the safety and performance testing for Dräger's VentStar Heated and Infinity ID Breathing Circuit Heated devices. However, explicit quantitative acceptance criteria and detailed quantitative performance results are not presented in a traditional "acceptance criteria vs. reported performance" format. The document generally states that "product performance is given within the range the device can be used by clinicians" and that "the technological characteristics and the results of the performance data demonstrated that the heated breathing hoses issued no new risks." This suggests a qualitative assessment of performance against design specifications or clinical utility rather than specific numerical thresholds.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter Tested | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical and Thermal Safety | Implicitly, compliance with relevant electrical and thermal safety standards (e.g., IEC 60601 series, or specific standards for heated breathing circuits) to ensure patient and user safety. | "Electrical and thermal safety" testing was performed. Specific results and acceptance values are not provided. The conclusion states that "no new risks" were identified. |
| Inspiratory Limb Performance | Implicitly, maintenance of gas flow, temperature, and humidity characteristics within clinically acceptable ranges for inspiration. | "Inspiratory... limb performance" testing was performed. Specific results and acceptance values are not provided. The conclusion indicates "product performance is given within the range the device can be used." |
| Expiratory Limb Performance | Implicitly, maintenance of gas flow, temperature, and humidity characteristics within clinically acceptable ranges for expiration, including condensation management. | "Expiratory limb performance" testing was performed. Specific results and acceptance values are not provided. The conclusion indicates "product performance is given within the range the device can be used." |
| System Compatibility | Successful functional integration and performance when connected to Dräger ventilators and the Fisher & Paykel MR850 humidifier. | "System Compatibility with Dräger ventilators and humidifier MR850" was tested. Specific results are not provided, but the device is cleared for use with these components. |
| Biocompatibility (Materials) | Compliance with ISO 10993-1 for biological evaluation of medical devices to ensure materials are non-toxic and biocompatible. | "All materials used have been evaluated acc. to tests outlined in ISO 10993-1." Specific test results are not provided. |
| RFID Functionality | (For Infinity ID models) Accurate storage and automatic readout of product-specific data (patient type, hose diameter, resistance, compliance, manufacturing date, shelf life) by Dräger Infinity ID equipment. | The device is "additionally equipped with an RFID identification tag. The tag stores characteristics... and is automatically be readout when connected to the outlets of a ventilator device which supports this function." Specific test results for RFID accuracy/reliability are not provided. |
Missing Information: Detailed quantitative acceptance criteria (e.g., temperature ranges, flow rates, humidity levels, specific electrical thresholds) and corresponding numerical performance data are not available in this document.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document mentions "the following testing has been performed on the breathing systems," but does not list the number of units tested for each type of assessment.
- Data Provenance: The manufacturer is Dräger Medical AG & Co. KG, based in Lübeck, Germany. The data would therefore be prospective product development and validation testing conducted by the manufacturer, likely in Germany.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable or not provided in the document. The testing described appears to be engineering and biocompatibility validation, not clinical studies requiring a ground truth established by medical experts in the traditional sense of diagnostic accuracy algorithms. Performance is likely measured against engineering specifications and relevant international standards.
4. Adjudication Method for the Test Set
This is not applicable as the tests performed are primarily engineering and compliance checks, not diagnostic interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or at least not described in this document. This typically applies to AI systems assisting human readers in diagnostic tasks, which is not the nature of this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable in the context of this device. The heated breathing circuits are passive disposables designed to work in conjunction with other medical equipment (humidifiers, ventilators) and human clinicians. They do not involve an AI algorithm operating independently.
7. Type of Ground Truth Used
The "ground truth" for this device's performance would be defined by:
- Engineering Specifications: Design tolerances and intended operational parameters for temperature, flow, humidity, and material integrity.
- International Standards: Compliance with ISO standards (e.g., ISO 10993-1 for biocompatibility) and other relevant safety and performance mandates for medical devices (e.g., electrical safety standards).
- Clinical Requirements: The ability to effectively humidify and convey breathing gas to patients within clinically acceptable and safe ranges, as determined by medical device regulations and established clinical practice.
8. Sample Size for the Training Set
This is not applicable. This device is not an AI algorithm trained on data; it is a physical medical device (breathing circuit).
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------DEC: 1 0 2010
Applicants Name and Address:
Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany
Manufacturer Name and Address:
Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany
Establishment Registration Number :
9611500
Contact Person:
Ulrich Schröder Director Regulatory & Clinical Affairs
Tel. No.: 011 49 (451) 882-3648 Fax No .: 011 49 (451) 882-3018
Applicants US Contact Person
Joyce Kilrov Vice President, Processes, Quality & Requlatory
Tel. No .: (215) 660-2626 Fax No .: (215) 721-5424
Date submission was prepared:
2010/09/03
Device Name:
Common Usual Name: Heated Breathing Circuits Proprietary Name: VentStar Heated / Infinity ID Breathing Circuit Heated Product Code: BTT Classification Name: humidifier, respiratory gas, (direct patient interface) 21 CFR 868.5450 Regulation Number: Class: 11
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| 510(k) number | Trade name | Company |
|---|---|---|
| K073706 | Respiratory Humidifier, Model MR850, heated system RT200, RT225, RT212 | Fisher & Paykel Healthcare, Ltd. |
| K033710 | ||
| K020332 | ||
| K983112 | ||
| K934140 | MR290 single use humidification chamber | Fisher & Paykel Healthcare, Ltd. |
Legally Marketed Devices to which Substantial Equivalence is claimed:
Device Description:
The 510(k) comprises heated breathing gas hose systems including a humidifier chamber for the ventilation of neonatal or adult patients in Intensive Care Units. The hose systems consist of two breathing hoses (inspiratory and expiratory limb) with an additional y- piece.
Inside the inspiratory and in case of the dual heated systems also in the expiratory limb of the hose system there is a heating wire which can be connected to a Fisher & Paykel humidifier MR850 to heat up the breathing gas to minimise condensation. An expiratory limb without heating wire includes a water trap. There are additional sensor ports where the temperature sensors of the Fisher & Paykel humidifier MR850 (e.g. Fisher & Paykel 900MR868) can be placed in.
In case of the neonatal system, the hose is equipped with an incubator extension for use inside an incubator.
The Infinity ID heated breathing circuits are based on the heated breathing circuits additionally equipped with an RFID identification tag. The tag stores characteristics of the breathing hose (e.g. patient type, hose diameter, resistance and compliance values, manufacturing date and shelf life) and is automatically be readout when connected to the outlets of a ventilator device which supports this function.
Intended Use:
| Device Name | Intended Use |
|---|---|
| VentStar Dual Heated/ VentStar Heated | Disposable inspiratory heated breathing circuit with humidifier chamber forconnection to a Fisher & Paykel MR850 humidifier, for conveying moistenedbreathing gas between the humidifier and adult patients with a body weight ofat least 40 kg (88 lbs). |
| VentStar Heated (N) /VentStar Heated (N)basic | Disposable inspiratory heated breathing circuit for connection to a Fisher &Paykel MR850 humidifier, for conveying moistened breathing gas between thehumidifier and neonatal patients with a body weight of up to 5 kg (11 lbs). |
| Infinity ID BreathingCircuit Heated (N) | Inspiratory heated breathing circuit for connection to a Fisher & Paykel MR850humidifier, for conveying moistened breathing gas between the humidifier andneonates with a body weight of up to 5 kg (11 lbs). Intended for single-use only.Breathing circuit with integrated transponder. The transponder serves as acarrier of product-specific data for processing by Dräger Infinity ID equipment. |
| Infinity ID BreathingCircuit Dual Heated /Infinity ID BreathingCircuit Heated | Heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier,for conveying moistened breathing gas between the humidifier and adults witha body weight of at least 40 kg (88 lbs). Intended for single-use only. Breathingcircuit with integrated transponder. The transponder serves as a carrier ofproduct-specific data for processing by Dräger Infinity ID equipment. |
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Summary of Testing
The following testing has been performed on the breathing systems:
- Electrical and thermal safety -
- Inspiratory and expiratory limb performance ー
- System Compatibility with Dräger ventilators and humidifier MR850 -
- ﺖ Materials
- o All materials used have been evaluated acc. to tests outlined in ISO 10993-1
Conclusion:
The intended use and general construction as the predicate devices remain the same. The design of the heated breathing circuits is identical in fit, form and function to marketed products named in the table above.
It has been shown that product performance is given within the range the device can be used by clinicians.
The technological characteristics and the results of the performance data demonstrated that the heated breathing hoses issued no new risks during design verification and validation which could question device use.
In accordance with the Federal Food and Cosmetic Act and 21 CFR Part 807, based on the information provided in this premarket notification Dräger Medical AG & Co. KG concludes that the heated breathing circuits are safe, effective and substantially equivalent to the predicate devices as described in this application.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles an abstract caduceus or a stylized representation of human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Draeger Medical AG & Company KG C/O Ms. Joyce Kilroy Draeger Medical System, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969
DEC 1 0 2010
Re: K102618
Trade/Device Name: VentStar Heated / Infinity ID Breathing Circuit Heated Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: September 3, 2010 Received: September 13, 2010
Dear Ms. Kilrov:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Kilroy
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, 1 please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. 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
DEC 1 0 2010
510(k) Number: K102618
Device Name: VentStar Heated / Infinity ID Breathing Circuit Heated
Indications for Use:
VentStar Dual Heated / VentStar Heated
Disposable inspiratory heated breathing circuit with humidifier chamber for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and adult patients with a body weight of at least 40 kg (88 lbs).
VentStar Heated (N) / VentStar Heated (N) basic
Disposable inspiratory heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and neonatal patients with a body weight of up to 5 kg (11 lbs).
Infinity ID Breathing Circuit Heated (N)
Inspiratory heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for moping moistened breathing gas between the humidifier and neonates with a body weight of up lo 5 kg (11 Ibs) Intended for single-use only. Breathing circuit with integrated transponder. The transponder serves as a carrier of product-specific data for processing by Dräger Infinity ID equipment.
Infinity ID Breathing Circuit Dual Heated / Infinity ID Breathing Circuit Heated
Heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidfier and adults with a body welght of at least 40 kg (88 moration broaining goo Doching circuit with integrated transponder. The transponder. The transponder serves as a carrier of product-specific data for processing by Dräger Infinity ID equipment.
AND/OR
Prescription Use (Part 21 CFR 801 Subpart D) 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 Eyaluation (ODE)
L. Schutte
(Division Sign-Off) Division of Anesthesiology, General പ്രശ്യമപ്പും 1 Infection Control, Dental Devices
4102618 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).