Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance metrics focus on physical properties and filtration efficiency, with no mention of AI or ML.

Therapeutic

Yes
The device is intended to reduce the transmission of bacteria and viruses to/from a patient and to maintain moisture levels in the patient's respiratory tract, specifically to prevent complications due to drying of the respiratory mucosa. These functions directly address health conditions or aim to prevent adverse physiological events.

Diagnostic

No

The device is an HME (Heat and Moisture Exchange) filter designed to reduce the transmission of bacteria and viruses and maintain moisture levels in a patient's respiratory tract during ventilation. It is a therapy device, not a diagnostic device, although it includes a luer port for monitoring exhaled CO2, which is a diagnostic function secondary to its primary therapeutic purpose.

SaMD (Software as a Medical Device)

No

The device is a physical filter with housing, filter pad, and HME media, not a software program.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The Flexicare ThermoShield HME Filter is a device that is part of a breathing system. Its primary functions are to filter bacteria and viruses from the air being breathed by the patient and to maintain moisture levels in the patient's respiratory tract.
No Sample Testing: The device does not perform any tests on samples taken from the patient's body. It interacts directly with the air being delivered to and exhaled by the patient.

Therefore, the Flexicare ThermoShield HME Filter is a respiratory support device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Flexicare's ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation.

An HMEF is normally positioned at the patient end of the breathing system between the circuit Y-piece and the catheter mount or patient airway device.

Flexicare's ThermoShield HME Filters are single use on a single patient for up to 24hrs and are available in Adult and Mini (pediatric) sizes.

Flexicare's ThermoShield HME Filters are designed to be used in pre-hospital and homecare environments by trained personnel.

Expert clinical judgment must be used in assessing patient humidification requirements.

Product codes (comma separated list FDA assigned to the subject device)

CAH

Device Description

Flexicare's ThermoShield HME Filters are designed to prevent the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration

Flexicare's ThermoShield HME Filters include a HME (Heat and Moisture Exchanger) Media in addition to a filter. The Inclusion of HME media is intended to help prevent complications due to drying of the respiratory mucosa, such as mucus plugging and endotracheal tube (ETT) occlusion. This is achieved by the HME media preventing a large amount of the water vapor from passing through the device.

Flexicare's ThermoShield HME Filters consist of a top/bottom housing, filter pad, HME media and a luer port cap. The Female luer-lock port allows monitoring of patient exhaled CO2 & is supplied with a tethered cap to seal port when not in use.

The patient side of the Flexicare's ThermoShield HME Filters feature a 22mm Male and a 15mm Female conical connector. The machine side features a 22mm Female and a 15mm Male conical connector.

All conical connectors comply with dimensions stated within BS EN ISO 5356-1: 2004

Flexicare's ThermoShield HME Fitters have rounded housing with no sharp edges. This reduces the risk of pressure marks on the patient.

Flexicare's ThermoShield HME Fitters are available in Adult and Mini (Pediatric) sizes.

Flexicare's ThermoShield HME Filters are supplied non sterile in individually sealed polybags.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's respiratory tract

Indicated Patient Age Range

Adult and Mini (pediatric)

Intended User / Care Setting

pre-hospital, hospital and homecare environments by trained personnel.

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 on Flexicare's Adult ThermoShield HME Filter. These Non-clinical tests included Visual inspection/comparison, HME moisture output, HME moisture loss, Compliance testing, Pressure drop, Conical connector compliance testing, Luer lock compliance testing, shelf life verification, Biocompatibility and Filtration efficiency. Testing demonstrated that the relevant features, design and performance of each manufacturer's device are substantially equivalent.

Verification tests were performed on Flexicare's Mini ThermoShield HME Filter. These Non-clinical tests included Visual inspection/comparison, HME moisture output, HME moisture loss, Compliance testing, Pressure drop, Conical connector compliance testing, Luer lock compliance testing, shelf life verification, Biocompatibility and Filtration efficiency. Testing demonstrated that the relevant features, design and performance of each manufacturer's device are substantially equivalent.

All Samples passed the performance testing when tested against methods and criteria from predetermined acceptance criteria in-house test methods and relevant BS EN & ISO FDA recognized standards.

The results of this testing show that Flexicare's ThermoShield HME Filters pass all performance tests and performs at least as well as marketed predicate devices "Humid-Vent Filter Compact angled/ Humid-Vent Filter Compact Straight" and "Humid-Vent Filter Pedi" by Gibeck.

The conclusions drawn from the nonclinical performance testing demonstrate that Flexicare's ThermoShield HME Filters are as safe, as effective, as the legally marketed predicate devices "Humid-Vent Filter Compact angled/ Humid-Vent Filter Compact Straight" and "Humid-Vent Filter Pedi" by Gibeck.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Adult Filter:
BFE - 99.999%
VFE - 99.99%
Salt Method filtration efficiency - 98.90%
Moisture output (mg/L) - Vt 500 - 30.4mg H2O/L air
Moisture loss (mg/L) - Vt 500 - 6.8 mg H2O/L air
Pressure Drop/ Flow resistance:
Straight filters:
1.71cmH2O @ 30LPM
4.31cmH2O @ 60LPM
7.82cmH2O @ 90LPM
Housing Burst strength - >101kPa
Leakage per ISO 9360-1 6.4 - No leak at 101kPa
Compliance per ISO 9360-1 6.5 - Straight filters 14ml/kPa

Mini Filter:
BFE - 99.99%
VFE - 99.9%
Salt Method filtration efficiency - 97.71%
Moisture output (mg/L) - Vt 200 - 30.3mg H2O/L air
Moisture loss (mg/L) - Vt 200 - 6.9 mg H2O/L air
Pressure Drop/ Flow resistance:
Straight filters:
2.02cmH2O @ 30LPM
4.86cmH2O @ 60LPM
8.61cmH2O @ 90LPM
Housing Burst strength - >101kPa
Leakage per ISO 9360-1 6.4 - No leak at 101kPa
Compliance per ISO 9360-1 6.5 - Straight filters 10ml/kPa

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.

K964382, K952084

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

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 22, 2017

Flexicare Medical Limited % Mark Job Regulatory Technology Services, LLC 1394 25th Street North West Buffalo, Minnesota 55313

Re: K163300

Trade/Device Name: ThermoShield HME Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: March 08, 2017 Received: March 15, 2017

Dear Mr. Mark 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.

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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Sincerelv.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K163300

Device Name

ThermoShield HME Filter

Flexicare's ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation.

An HMEF is normally positioned at the patient end of the breathing system between the circuit Y-piece and the catheter mount or patient airway device.

Flexicare's ThermoShield HME Filters are single use on a single patient for up to 24hrs and are available in Adult and Mini (pediatric) sizes.

Flexicare's ThermoShield HME Filters are designed to be used in pre-hospital and homecare environments by trained personnel.

Expert clinical judgment must be used in assessing patient humidification requirements.

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)

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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:

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary

510(k) Sponsor, Contact Person and Date Summary Prepared:

Flexicare Medical Limited Cynon Valley Business Park Mountain Ash. CF45 4ER. United Kingdom

Joel Biddle Senior Compliance Engineer Telephone: 00 44 1443 474 647

Summary prepared on: March 18th, 2017.

Device Name:

Trade Name:	ThermoShield HME Filters
Common/Usual Name:	Breathing System Bacterial / Viral filter with HME
Classification Name:	Filter, Bacterial, Breathing-Circuit. 21 CFR 868.5260
Product Code:	CAH
Classification:	Class 2

There have been no prior submissions for the devices included within this submission.

Legally Marketed Equivalent Device:

Flexicare's ThermoShield HME Filters are substantially equivalent to:

Gibeck "Humid-Vent Filter Compact angled/ Humid-Vent ● Filter Compact Straight" which was cleared for marketing by 510(k) No K964382 for adult population.
And,
Gibeck "Humid-Vent Filter Pedi" which was cleared for marketing by 510(k) K952084 for pediatric population.

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Device Description: