(42 days)
Not Found
No
The device description and performance studies focus on the physical components and basic functionality of a heated wire breathing system and humidification chamber. There is no mention of AI, ML, image processing, or any data-driven decision-making processes.
Yes
The device is described as connecting a patient's airway to a ventilator and humidification chamber to provide warmed and humidified respiratory gases, directly impacting the patient's physiological state during ventilation.
No
The device is a breathing system for mechanical ventilation, providing warmed and humidified air to patients. It does not perform any diagnostic function.
No
The device description clearly states it is comprised of disposable connectors, tubing, and heated wire assemblies, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Flexicare Heated Wire Breathing System and Humidification Chamber are used to deliver warmed and humidified respiratory gases directly to a patient's airway. They are part of a respiratory support system, not a system for analyzing biological samples.
- Intended Use: The intended use clearly states connecting a patient's airway to a ventilator and humidification chamber to provide respiratory gases. There is no mention of analyzing biological specimens.
Therefore, this device falls under the category of a respiratory support device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Flexicare Heated Wire Breathing Systems are intended for use to connect a patient's airway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Adult patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Adult (038-31-748U) size.
Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.
Product codes (comma separated list FDA assigned to the subject device)
BZE, BTT
Device Description
Flexicare Heated Wire Breathing Systems are sterile single patient use devices which form part of a respiratory humidification system. In this system the inspiratory limb delivers heated humidified gas to the patient and expiratory limb carries the expired gas away from the patient.
Flexicare Heated Wire Breathing Systems are supplied with an Auto-fill Humidification chamber. When in use a Humidfication Chamber holds a volume of water and is placed onto a heater unit and fills automatically from a suspended water source.
The air from the ventilator is passed through the Humidification Chamber, gaining heat and humidity. This air is then channeled through the Heated Wire Breathing System to the patient.
The inclusion of a heated wire within the lumen of both the System tubes the amount that the humidified air cools when travelling to/from the patient. This in turn reduces the amount of condensation and water build-up within the System.
Flexicare's Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Adult patients.
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
Adult
Intended User / Care Setting
Hospital environment
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)
Verification tests were performed to establish the safety and efficacy of Flexicare's 038-31- 748U Heated Wire Breathing System. These Non-clinical tests included Visual inspection/comparison, Dimensional inspection, Internal Volume, Heated wire resistance, resistance to flow, humidifier start up/compatibility, conical connector compliance, connector strength, leaking, drop testing, tensile strength, tube compliance, humidification output, shelf life verification, Electromagnetic Capability, Electrical Safety and Biocompatibility. Testing demonstrated that the relevant features, design and performance of each manufacturer's device are substantially equivalent.
Verification tests were performed to establish the safety and efficacy of Flexicare's Autofill Humidification Chamber. These Non-clinical tests included Visual inspection/comparison, Dimensional inspection, Internal Volume, resistance to flow, conical connector compliance, connector strength, leaking, tensile strength, compliance, humidification output, shelf life verification, Electromagnetic Capability, Electrical Safety and Biocompatibility. Testing demonstrated that the relevant features, design and performance of each manufacturer's device are substantially equivalent.
Summary of performance Testing: Flexicare's Heated Wire Breathing Systems have been evaluated in accordance with standards listed in table:
| Test | Standard / Pre-Determined
Acceptance Criteria | Outcome |
|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------|
| Visual inspection | Pre-Determined Acceptance Criteria | Pass |
| Dimensional inspection | Pre-Determined Acceptance Criteria | Pass |
| System internal volume | Pre-Determined Acceptance Criteria | Pass |
| Wire resistance | Pre-Determined Acceptance Criteria | Pass |
| Tubing resistance to flow | Pre-Determined Acceptance Criteria | Pass |
| MR850 start-up test/ system compatibility check | Pre-Determined Acceptance Criteria | Pass |
| Means of connection | ISO 5367:2000 | Pass |
| Tubing resistance to flow | Not Specified | Not Specified |
| Increase in flow with bending | Not Specified | Not Specified |
| Leakage | Not Specified | Not Specified |
| Compliance | Not Specified | Not Specified |
| Packaging Pouch Integrity | ASTM F1886-09
ASTM F88-09
ASTM F1929-12 | Pass |
| Conical Connector compliance | ISO 5356-1:2004 | Pass |
| Leak testing | Not Specified | Not Specified |
| Drop testing | Not Specified | Not Specified |
| Cytotoxicity, Irritation, Sensitization, Systemic
Toxicity, Genotoxicity, Implantation, Sub-Acute
Toxicity | 10993-10:2010
10993-5:2009
10993-3:2014
10993-6:2009 | Pass |
| Testing to ISO 5367, temp probe tensile testing,
temp port leaking | ISO 8185:2007 | Pass |
| Electromagnetic capability & Electrical safety
testing | BS EN 60601-1:2006
BS EN 60601-1-2:2007
IEC 60601-1:2005 +CORR.1:2006
CORR. 2:2007 | Pass |
All Samples passed the performance testing when tested against methods and criteria from both pre-determined acceptance criteria methods and relevant FDA Recognized standards. The results of this testing show that Flexicare Heated Wire Breathing Systems pass all performance tests and performs at least as well as the marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are depicted in a simple, line-art style. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2015
Flexicare Medical Ltd. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re: K150900
Trade/Device Name: Flexicare Heated Wire Breathing Systems Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: Class II Product Code: BZE, BTT Dated: April 30, 2015 Received: May 1, 2015
Dear Mr. Job:
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.
1
Page 2 - Mark Job
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known)
Device Name
Flexicare Heated Wire Breathing Systems
Indications for Use (Describe)
Flexicare Heated Wire Breathing Systems are intended for use to connect a patient's airway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Adult patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Adult (038-31-748U) size.
Type of Use (Select one or both, as applicable)
2 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 A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
Device Name
Flexicare Autofill Humidification Chamber
Indications for Use (Describe)
Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.
Type of Use (Select one or both, as applicable)
2 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 A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image is a logo for Flexicare. The logo has the word "flexicare" in blue and red, with the "flexi" in blue and the "care" in red. To the left of the word is a stylized "f" in red and blue. Below the word is the phrase "TOTAL QUALITY - TOTAL CARE" in red.
SECTION 4
510(k) Summary
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Image /page/5/Picture/0 description: The image shows the logo for Flexicare. The word "flexicare" is written in a stylized font, with the "f" in red and the rest of the word in blue. Above the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in red. The logo is simple and modern, and it conveys a sense of quality and care.
Cynon Valley Business Park, Mountain Ash, Mid Glamorgan. CF45 4ER UK. Tel: +44 (0)1443 474647 Fax: +44 (0)1443 474222 Customer Services: +44 (0)1443 471580 Purchasing Fax: +44 (0)1443 476332 Email: enquiries@flexicare.com www.flexicare.com
510(k) Summary
510(k) Sponsor, Contact Person and Date Summary Prepared:
Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, Mid. Glamorgan CF45 4ER. United Kingdom
Joel Biddle Compliance Engineer Telephone: 00 44 1443 474 647 Fax: 00 44 1443 474 222
Summary prepared on: May 2015
Device Name:
Trade Name: Flexicare Heated Wire Breathing Systems
Common/Usual Name: Heated Breathing System
Classification Name: Breathing System Heater: 21 CFR 868.5270
Product Codes: BZE (breathing system heater) and BTT (respiratory gas humidifier).
Legally Marketed Equivalent Device:
Flexicare's Adult Heated Wire Breathing Systems are substantially equivalent to Fisher & Paykel's Adult RT380 Heated Breathing Circuit cleared under K122432.
Flexicare's Autofill Humidification Chamber is substantially equivalent to Fisher & Paykel's MR290 Autofill Humidification chamber cleared under K934140.
Device Description:
Flexicare Heated Wire Breathing Systems are sterile single patient use devices which form part of a respiratory humidification system. In this system the inspiratory limb delivers heated humidified gas to the patient and expiratory limb carries the expired gas away from the patient.
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Image /page/6/Picture/0 description: The image is a logo for "flexicare". The logo has the word "flexicare" in blue and red letters. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in red letters.
Flexicare Heated Wire Breathing Systems are supplied with an Auto-fill Humidification chamber. When in use a Humidfication Chamber holds a volume of water and is placed onto a heater unit and fills automatically from a suspended water source.
The air from the ventilator is passed through the Humidification Chamber, gaining heat and humidity. This air is then channeled through the Heated Wire Breathing System to the patient.
The inclusion of a heated wire within the lumen of both the System tubes the amount that the humidified air cools when travelling to/from the patient. This in turn reduces the amount of condensation and water build-up within the System.
Flexicare's Heated Wire Breathing Systems are comprised of disposable connectors, tubing and heated wire assemblies. The systems are intended for Adult patients.
Intended Use:
Flexicare Heated Wire Breathing Systems are intended for use to connect a patient's airway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Adult patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Adult (038-31-748U) size.
Humidification Chambers are intended for use to hold water reguired to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.
Substantial Equivalence:
Flexicare's Heated Wire Breathing Systems have the same intended use as the predicate device.
Flexicare's Heated Wire Breathing Systems and the Predicate device are single patient use devices. Supplied in Adult sizes.
Neither manufacturer's devices are life supporting or life sustaining.
Patient Contact -
Skin Contact & Externally Communicating - Prolonged duration