(88 days)
Not Found
No
The document describes a heated breathing circuit with an RFID tag for identification and data storage. There is no mention of AI or ML algorithms for data processing, analysis, or decision-making. The RFID tag simply carries product-specific data.
No.
The device is a heated breathing circuit for conveying moistened breathing gas, not a therapeutic device itself. Its function is to facilitate the delivery of gas in a humidified state, primarily to minimize condensation and support the function of a humidifier, rather than to treat a specific medical condition.
No
The device is described as a heated breathing circuit with a humidifier chamber, designed to convey moistened breathing gas to patients. Its function is to facilitate ventilation, not to diagnose a medical condition.
No
The device description clearly details physical components such as breathing hoses, heating wires, humidifier chambers, and an RFID identification tag. These are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to convey moistened breathing gas to patients during ventilation. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is a breathing circuit with heating elements and a humidifier chamber. It facilitates the delivery of warmed and humidified air to the patient's lungs. This is a life support function, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Predicate Devices: The predicate devices are a respiratory humidifier and a humidification chamber, which are also therapeutic devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This breathing circuit does not perform any such function.
N/A
Intended Use / 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 conveying moistened breathing gas between the humidifier and neonates 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 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 humidifier and adults with a body weight of at least 40 kg (88 lbs). 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.
Product codes
BTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal or adult patients
Intended User / Care Setting
Intensive Care Units
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing has been performed on the breathing systems:
- Electrical and thermal safety
- Inspiratory and expiratory limb performance
- System Compatibility with Dräger ventilators and humidifier MR850
- Materials
- All materials used have been evaluated acc. to tests outlined in ISO 10993-1
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.
- All materials used have been evaluated acc. to tests outlined in ISO 10993-1
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073706, K033710, K020332, K983112, K934140
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. Above the word "Dräger" is the text "K102618". The text "K102618" is written in a handwritten style.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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 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 conveying moistened breathing gas between the humidifier and | |
| neonates 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 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 humidifier and adults with | |
| a body weight of at least 40 kg (88 lbs). 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. |
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Image /page/2/Picture/0 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is black and the background is white. The two dots above the "a" are also black.
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.
4
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
5
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: _