(250 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties and mechanical integrity of a breathing system filter. There is no mention of any computational analysis, algorithms, or learning processes.
No.
The filtering of breathing gases is considered a life-support function, but the device itself does not directly treat a disease or condition; it prevents the transmission of infectious agents.
No
Explanation: The device is described as a filter intended to reduce the transmission of bacteria and viruses during anesthesia or assisted respiration. While it has a port for monitoring exhaled CO2, the device itself performs a filtration function, not a diagnostic one.
No
The device description clearly outlines physical components (housing, filter pack, luer port) and performance studies focus on physical characteristics and material properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce the transmission of bacteria and viruses to/from a patient during anesthesia" and for use with breathing systems. This describes a device that physically filters gases within a breathing circuit.
- Device Description: The description details a physical filter with housing, a filter pack, and connectors for a breathing system. It also mentions a luer port for monitoring patient exhaled CO2, which is a physiological measurement, not an in vitro diagnostic test.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health or condition. Its function is purely mechanical filtration.
- Performance Studies: The performance studies focus on the physical and filtration characteristics of the device (filtration efficiency, pressure drop, leakage, material safety), not on the accuracy or reliability of a diagnostic test.
IVD devices are designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the breathing circuit connected to the patient) and its purpose is to prevent the transmission of pathogens, not to diagnose a condition.
N/A
Intended Use / Indications for Use
Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are single patient for use on a single patient for up to 24hrs and are available in Adult size. FlepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.
Product codes (comma separated list FDA assigned to the subject device)
CAH
Device Description
Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to reduce the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration
Flexicare's HepaShield Bacterial Viral Breathing System Filters consist of a top/bottom housing, pleated paper filter pack and a luer port cap. The Female luer-lock port allows connection of a luer-terminating monitoring line for 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 HepaShield Bacterial Viral Breathing System Filters feature a 22mm Male and a 15mm Female conical. The machine side features a 22mm Female and a 15mm Male conical.
All conical connectors comply with dimensions stated within BS EN ISO 5356-1 standard.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in Adult sizes.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in a both Sterile and non-sterile state, packaged in individually sealed polybags, or blister trays (if sterile).
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
trained personnel / hospital environments
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)
Summary of Nonclinical Testing: Flexicare's HepaShield Bacterial Viral Breathing System Filter has been evaluated in accordance with standards listed in table:
Tests performed include: Visual Inspection, Compliance testing, Pressure drop, Gas Leakage, Conical Connector compliance, Leak testing, Drop testing, Cytotoxicity, Irritation, Sensitization, Systemic toxicity, Material Mediated Pyrogenicity, Bacterial Endotoxin, Particulate emissions (gas pathway), VOC emissions (gas pathway), Gauging tests on luer, Liquid leakage from luer, Air leakage from luer, Luer separation force, Luer unscrewing torque, Luer ease of assembly, Luer resistance to overriding, Luer testing for stress cracking, Shelf life testing, Filter integrity, Pressure Drop, Housing Leakage. All tests passed.
Key results: The results of this testing show that Flexicare's HepaShield Bacterial Viral Breathing System Filter passes all performance tests and perform at least as well as the marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial/ Viral Filtration efficiency/ filter integrity (Fresh): BFE - 99.99999%, VFE - 99.9999%
Salt Method filtration efficiency: 99.89%
Leakage per BS EN ISO 23328-2/ BS EN ISO 9360-1:
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 23, 2020
Flexicare Medical Limited Joel Biddle Regulatory Manager Cynon Vallev Business Park Mountain Ash, cf45 4er UK
Re: K191909
Trade/Device Name: HepaShield Bacterial Viral Breathing System Filter Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: Class II Product Code: CAH Dated: February 19, 2020 Received: February 24, 2020
Dear Joel Biddle:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K191909
Device Name HepaShield Bacterial Viral Breathing System Filter
Indications for Use (Describe)
Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are single patient for use on a single patient for up to 24hrs and are available in Adult size. FlepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image is a logo for "flexicare". The logo is in blue and consists of a stylized letter "f" with three curved lines above it. Below the word "flexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller font size. The logo is clean and modern, and the blue color gives it a sense of trustworthiness and reliability.
510(k) Summary
K191909
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 Fax: 00 44 1443 474 222
Summary prepared on: March 16th, 2020. Device Name:
Trade Name: HepaShield Bacterial Viral Breathing System Filter
Common/Usual Name: Breathing circuit bacterial filter.
Classification Name: Breathing circuit bacterial filter: 21 CFR 868.5260
Product Codes: CAH (Breathing circuit bacterial filter)
Predicate Device:
Pall's Ultipor 25 Bacterial Viral Breathing System Filter (K013093)
Device Description:
Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to reduce the transmission of bacteria and viruses to and from a patient who requires aesthesia, artificial respiration or other types of assisted respiration
Flexicare's HepaShield Bacterial Viral Breathing System Filters consist of a top/bottom housing, pleated paper filter pack and a luer port cap. The Female luer-lock port allows connection of a luer-terminating monitoring line for 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 HepaShield Bacterial Viral Breathing System Filters feature a 22mm Male and a 15mm Female conical. The machine side features a 22mm Female and a 15mm Male conical.
All conical connectors comply with dimensions stated within BS EN ISO 5356-1 standard.
4
Image /page/4/Picture/0 description: The image shows the logo for Flexicare. The logo is blue and features a stylized "F" followed by the word "lexicare." Below the word "lexicare" is the phrase "TOTAL QUALITY - TOTAL CARE." The logo is clean and professional, and the blue color gives it a sense of trustworthiness.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in Adult sizes.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are available in a both Sterile and non-sterile state, packaged in individually sealed polybags, or blister trays (if sterile).
Indications For Use:
Flexicare's HepaShield Bacterial Viral Breathing System Filters are intended to reduce the transmission of bacteria and viruses to/from a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired.
Flexicare's HepaShield Bacterial Viral Breathing System Filters are single use devices for use on a single patient for up to 24hrs and are available in Adult size. Flexicare's HepaShield Bacterial Viral Breathing System Filters are designed to be used in hospital environments by trained personnel.
Technoloqical Characteristic Comparison Table:
The table below shows the similarities and differences between the Flexicare's HepaShield Bacterial Viral Breathing System Filter and the predicate device manufactured by Pall.
| | Flexicare's HepaShield Breathing System
Filter | Pall's Ultipor 25 Breathing System Filter |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K191909 | K013093 |
| Components | Filter housing top
Filter housing bottom
Filter Media pack
Tethered luer port cap
Outer shrink sleeve | Filter housing top
Filter housing bottom
Filter Media pack
Tethered luer port cap |
| Assembly Method | Ultrasonic welded housing | Ultrasonic welded housing |
| Target population | Adult | Adult |
| Emergency use | Yes | Yes |
| Environment of use | Hospital | Hospital |
| Patient use/Duration of use | Single use, disposable, and .
ANSI/AAMI ST72:2011, | Pass |
| Particulate emissions (gas
pathway) | EN ISO 18562-2:12017 | Pass |
| VOC emissions (gas pathway) | EN ISO 18562-3:2017 | Pass |
| Gauging tests on luer | | Pass |
| Liquid leakage from luer | | Pass |
| Air leakage from luer | | Pass |
| Luer separation force | BS EN ISO 80369-7:2016 | Pass |
| Luer unscrewing torque | | Pass |
| Luer ease of assembly | | Pass |
| Luer resistance to overriding | | Pass |
| Luer testing for stress cracking | | Pass |
| Shelf life testing | Standards included within this table | Pass |
| Filter integrity | Based on ASTM F2101 (Nelson Labs Protocol) | Methodology only, no pass
criteria within standard. |
| | BS EN ISO 23328-1 (2008) | Methodology only, no pass
criteria within standard. |
| Pressure Drop | BS EN ISO 23328-2 (2009) | Methodology only, no pass
criteria within standard |
| Housing Leakage | BS EN ISO 23328-2(2009) | Methodology only, no pass
criteria within standard |
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Image /page/8/Picture/0 description: The image shows the logo for "flexicare" in blue. The logo features a stylized "f" with three curved lines above the word "flexicare". Below the word "flexicare" is the text "TOTAL QUALITY - TOTAL CARE".
* Pre-determined Acceptance Criteria - Visual inspection
Criteria: Product packaging must remain sealed & undamaged. All components of devices must be free of flash, cracking, warping, discoloration or contamination.
Methodology: Visual inspection under normal or corrected vision of device packaging (inspection of panels, seams and welds for unsealed areas/openings, pint quality, tares) and assembled device (inspection of device for cracking, warping, discolouration, cosmetic defects, flash and contamination within material).
Flexicare's HepaShield Bacterial Viral Breathing System Filter 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's HepaShield Bacterial Viral Breathing System Filter passes all performance tests and perform at least as well as the marketed predicate device.
Consensus Standards
The recognized consensus standard for devices classified through FDA product code CAH are:
- ISO 5356-1: 2004 Anaesthetic And Respiratory Equipment Conical Connectors: ● Part 1: Cones And Sockets.
- EN ISO 18652: 2017 Biocompatibility Evaluation Of Breathing Gas Pathways In ● Healthcare Applications
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Image /page/9/Picture/0 description: The image shows the logo for Flexicare. The logo is blue and features a stylized "F" with three curved lines. The word "Flexicare" is written in a sans-serif font to the right of the "F". Below the word "Flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrates that the Flexicare HepaShield Bacterial Viral Breathing System Filter device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Pall's Ultipor 25 Bacterial Viral Breathing System Filter (K013093). .