CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER
Device Facts
| Record ID | K133516 |
|---|---|
| Device Name | CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER |
| Applicant | Flexicare |
| Product Code | CCK · Anesthesiology |
| Decision Date | Apr 30, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1400 |
| Device Class | Class 2 |
Indications for Use
CO2 Monitoring lines are intended to connect from a patient interface CO2 sampling port to the expired gas monitor.
Device Story
Single-patient-use, small-diameter PVC tubing with luer lock connectors; used to transport exhaled breath from a patient interface to a gas analyzer (e.g., capnograph). Optional 0.45µm hydrophobic filter prevents water vapor transfer to the analyzer. Operated in hospital settings by clinicians. Device relies on the external gas analyzer's pump to draw gas through the line. Output is the delivery of gas samples to the analyzer for CO2 monitoring. Benefits include facilitating continuous respiratory gas monitoring for patient safety.
Clinical Evidence
Bench testing only. Testing included visual/dimensional inspection, resistance to flow (at 100ml/min and 300ml/min), leakage, CO2 monitoring performance, tensile testing (40N), and accelerated aging (ASTM F1980). Biocompatibility testing performed per ISO 10993-3, 5, and 10. All samples passed pre-determined acceptance criteria.
Technological Characteristics
Flexible PVC tubing; ABS luer connectors; 2.0m or 3.0m lengths; 1.2mm ID / 2.7mm OD. Optional 0.45µm hydrophobic filter. Non-sterile, single-use. Compliant with ISO 594-2 (BS EN 1707:1997) and ISO 10993-3&5. No software, electronics, or energy source.
Indications for Use
Indicated for any patient requiring gas monitoring. Used to connect a patient interface CO2 sampling port to an expired gas monitor in a hospital setting.
Regulatory Classification
Identification
A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.
Predicate Devices
- Intersurgical - CO2 Monitoring line and CO2 monitoring line with filter (K122075)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for "Flexicare". The logo is in black and white and features a stylized "F" with two curved lines above it. The word "Flexicare" is written in a bold, sans-serif font to the right of the "F". Below the word "Flexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller font.
#### 510(k) Summary
Trade name
C.F.R Section: Device tvpe: Product Code:
Manufacturer:
Regulatory Affairs Contact:
Christopher Watkins Quality Requlatory & Technical Director Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, Mid. Glam. CF45 4ER. United Kingdom
CO2 monitoring line & CO2 monitoring line with filter
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Telephone:
Date Summary Prepared:
Common Name:
Classification:
Predicate Device
Description:
00 44 1443 471 593
22nd April 2014
CO2 monitoring line
Class 2
K133516
сск
21 CFR 868.1400.
Flexicare Medical Limited
Cynon Valley Business Park Mountain Ash, Mid. Glam. CF45 4ER. United Kingdom
Intersurgical - CO2 Monitoring line and CO2 monitoring line with filter, which was cleared for marketing by 510(k) No K122075
Flexicare's CO2 monitoring line is single patient use, small diameter tubing intended to be connected to a luer lock connector on a patient interface to allow for gas sampling from a patients exhaled breath by gas sampling equipment. The Gas monitoring/analysing device will feature a pump, which draws expired breath from the patient through the monitoring line and into the gas analyser.
Flexicare's CO2 monitoring line is available with or without a 0.45um hydrophobic filter, which prevents the transfer of water vapour down the monitoring line and into the gas sampling equipment.
Flexicare's CO2 monitoring lines feature clear construction to aid visual inspection of the device.
The CO2 monitoring line is a single patient use device, designed for use with one patient over a single course of treatment. The CO2 monitoring line is supplied in a sealed poly bag in a non sterile state and is not to be sterilized.
The Flexicare CO2 monitoring lines feature 2M & 3M length tubes.
# APR 3 0 2014
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Image /page/1/Picture/0 description: The image shows the logo for Flexicare. The logo is black and white and features a stylized "F" followed by the word "lexicare" in a bold, sans-serif font. Below the word "lexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller font.
#### Part Numbers:
| Part Number | Product description |
|-------------|----------------------------------------------------------------------|
| 010-700U | CO2 MONITORING LINE WITH MALE/MALE CONNECTORS - 2M |
| 010-705U | CO2 MONITORING LINE WITH FEMALE/FEMALE CONNECTORS - 2M |
| 010-710U | CO2 MONITORING LINE WITH MALE/FEMALE CONNECTORS - 2M |
| 010-700XU | CO2 MONITORING LINE WITH MALE/MALE CONNECTORS - 3M |
| 010-700AU | CO2 MONITORING LINE WITH MALE/MALE CONNECTORS - 2M - WITH FILTER |
| 010-705AU | CO2 MONITORING LINE WITH FEMALE/FEMALE CONNECTORS - 2M - WITH FILTER |
| 010-710AU | CO2 MONITORING LINE WITH MALE/FEMALE CONNECTORS - 2M - WITH FILTER |
| 010-700XAU | CO2 MONITORING LINE WITH MALE/MALE CONNECTORS - 3M - WITH FILTER |
#### Sizing
| Part Number | Length (mm) | Tube OD (mm) | Tube ID (mm) |
|-------------|-------------|--------------|--------------|
| 010-700U | 2000 | 2.7 | 1.2 |
| 010-705U | 2000 | 2.7 | 1.2 |
| 010-710U | 2000 | 2.7 | 1.2 |
| 010-700XU | 3000 | 2.7 | 1.2 |
| 010-700AU | 2000 | 2.7 | 1.2 |
| 010-705AU | 2000 | 2.7 | 1.2 |
| 010-710AU | 2000 | 2.7 | 1.2 |
| 010-700XAU | 3000 | 2.7 | 1.2 |
Intended Use:
CO2 Monitoring lines are intended to connect from a patient interface CO2 sampling port to the expired gas monitor.
Substantial Equivalence
Flexicare's CO2 monitoring line & CO2 monitoring line with filter have the same intended use as predicate device:
Intersurgical - CO2 Monitoring line and CO2 monitoring line with filter, which was cleared for marketing by 510(k) No K122075
Both Flexicare's CO2 monitoring lines and Intersurgical CO2 monitoring lines are single patient use devices.
Neither Flexicare's CO2 monitoring lines or Intersurgical CO2 monitoring lines are life supporting or life sustaining.
Neither Flexicare's CO2 monitoring lines or Intersurgical CO2 monitoring lines use software, and are not electronically driven.
Both Flexicare's CO2 monitoring lines and Intersurgical CO2 monitoring lines are supplied non- sterile in individual poly bags.
Both Flexicare's CO2 monitoring lines and Intersurgical CO2 monitoring lines are designed for the same intended use in the same intended conditions.
Both Flexicare's CO2 monitoring lines and Intersurgical CO2 monitoring lines consist of 3-4 components made from injection molded & extruded plastics.
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Image /page/2/Picture/0 description: The image shows the logo for "Flexicare". The logo is black and white and features a stylized "F" with two curved lines. The word "Flexicare" is written in a bold, sans-serif font to the right of the "F". Below the word "Flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font.
Both Flexicare's CO2 monitoring lines and Intersurgical CO2 monitoring lines are supplied either with or without 0.45µm hydrophobic filters. Flexicare's hydrophobic filter appeared to be identical to the Intersurgical filters in appearance and product marking. It is likely they are sourced from the same supplier.
From the performance testing it was discovered both Flexicare's and the predicate device tubes are manufactured from flexible PVC, and that both devices feature male and female luers with the option of a hydrophobic filter.
The technological characteristics of Flexicare's CO2 monitoring line and Intersurgical's CO2 monitoring line are very similar. These similarities are evident in the comparison table below.
| | Flexicare - CO2 monitoring line<br>K133516 | Intersurgical - CO2 Monitoring Line<br>K122075 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Intended use | | |
| Target<br>Population | Any patient from which gas monitoring is<br>required | Any patient from which gas monitoring is required |
| Indications for,<br>use | CO2 Monitoring lines are intended to<br>connect from a patient interface CO2<br>sampling port to the expired gas monitor. | The CO2 monitoring lines are intended to connect<br>from a CO2 sampling port to the expired gas<br>monitor |
| Place of use | Hospitals | Hospitals |
| Product labeling | CO2 monitoring line | CO2 monitoring line |
| Single use or re-<br>usable? | Single use | Single use |
| Design and<br>performance | | |
| Resistance to<br>flow | 8.8 mbar at 100ml/min flow<br>30.2 mbar at 300ml/min flow | 15.2 mbar at 100ml/min flow<br>51.2 mbar at 300ml/min flow |
| Leakage | <1.0ml/min | <1.0ml/min |
| Connectors | 2x luer lock connectors - male or female | 2x luer lock connectors- male or female |
| Outer diameter | 2.7mm | 3.05mm |
| Inner diameter | 1.2mm | 1.47mm |
| Lengths available | 2.0m, 3.0m | 0.7m, 1.8m, 2.45m, 3.0m |
| Standards | ISO 594-2 (BS EN 1707:1997) , ISO 10993-<br>3&5 | ISO 594-2 (BS EN 1707:1997) , ISO 10993-3&5 |
| Processes | Extrusion, injection moulding, adhesive<br>bonding | Extrusion, injection moulding, adhesive bonding |
| Colours | None - colourless | None - colourless |
| Energy<br>Used/delivered: | Gas is pulled away from the patient by a<br>pump in the gas sampling device | Gas is pulled from one end of the tube to the other<br>by a pump in the gas sampling device |
| Compatability : | Designed for use with gas monitoring<br>device (for example a Capnograph) with<br>luer connections to gas sampling tubing | Designed for use with gas monitoring device (for<br>example a Capnograph) with luer connections to<br>gas sampling tubing |
| Materials : | PVC (main line) and ABS (luer connectors) | PVC (main line) and Polycarbonate (luer<br>connectors) |
| Biocompatibility: | Compliant with ISO 10993-3&5 | Compliant with 10993-3&5 |
| Sterility: | Non sterile | Non sterile |
| Storage | Store in a cool, dry place out of direct sunlight | Store in a cool, dry place out of direct sunlight |
| Component<br>interactions | Tube – intact skin contact<br>Connector - intact skin contact ( whilst connecting to analyzing machine | Tube - intact skin contact<br>Connector - intact skin contact ( whilst connecting to analyzing machine |
| Intended use | Any patient from which gas monitoring is required | Any patient from which gas monitoring is required |
| Target<br>Population | Any patient from which gas monitoring is required | Any patient from which gas monitoring is required |
| Indications for<br>use | CO2 Monitoring lines are intended to connect from a patient interface CO2 sampling port to the expired gas monitor. | The CO2 monitoring lines are intended to connect from a CO2 sampling port to the expired gas monitor |
| Place of use | Hospitals | Hospitals |
| Product labeling | CO2 monitoring line + Hydrophobic filter | CO2 monitoring line + Hydrophobic filter |
| Single use or re-usable? | Single use | Single use |
| Design and<br>performance | | |
| Resistance to<br>flow | 30.0 mbar at 100ml/min flow<br>95.7 mbar at 300ml/min flow | 33.4 mbar at 100ml/min flow<br>114.5 mbar at 300ml/min flow |
| Leakage | <1.0ml/min | <1.0ml/min |
| Connectors | 2 x luer lock connectors - male or female (plus luer lock male to luer lock female connection between monitoring line and filter) | 2 x luer lock connectors - male or female (plus luer lock male to luer lock female connection between monitoring line and filter) |
| Outer diameter | 2.7mm | 3.05mm |
| Inner diameter | 1.2mm | 1.47mm |
| Length | 2.0m, 3.0m | 0.7m, 1.8m, 2.45m, 3:0m |
| Standards | ISO 594-2 (BS EN 1707:1997), ISO 10993-3&5 | ISO 594-2 (BS EN 1707:1997), ISO 10993-3&5 |
| Processes | Extrusion, injection moulding, adhesive bonding | Extrusion, injection moulding, adhesive bonding |
| Colours | None - colourless | None - colourless |
| Energy<br>Used/delivered: | Gas is pulled away from the patient by a pump in the gas sampling device | Gas is pulled from one end of the tube to the other by a pump in the gas sampling device |
| Compatability : | Designed for use with gas monitoring device (for example a Capnograph) with luer connections to gas sampling tubing | Designed for use with gas monitoring device (for example a Capnograph) with luer connections to gas sampling tubing |
| Materials : | PVC (main line) and ABS (luer connectors) | PVC (main line) and Polycarbonate (luer connectors) |
| Biocompatibility: | Compliant with ISO 10993-3&5 | Compliant with ISO 10993-3&5 |
| Sterility: | Non sterile | Non sterile |
| Storage | Store in a cool, dry place out of direct sunlight | Store in a cool, dry place out of direct sunlight |
| Component<br>interactions | Tube – intact skin contact<br>Connector - intact skin contact (whilst connecting to analyzing machine | Tube - intact skin contact<br>Connector - intact skin contact (whilst connecting to analyzing machine |
| Filter - intact skin contact (whilst<br>connecting to analyzing machine | Filter - intact skin contact (whilst connecting to<br>analyzing machine | |
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Image /page/3/Picture/0 description: The image shows the logo for "Flexicare". The logo has a stylized "F" on the left side, followed by the word "lexicare" in a sans-serif font. Below the word "lexicare" is the text "TOTAL QUALITY - TOTAL CARE" in a smaller font.
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Image /page/4/Picture/0 description: The image shows the logo for Flexicare. The logo consists of a stylized letter "f" followed by the word "lexicare" in a serif font. Below the word "lexicare" is the phrase "TOTAL QUALITY : TOTAL CARE" in a smaller, sans-serif font.
From the table above it is evident that the CO2 monitoring line devices from both manufacturers have very similar technological characteristics. Both devices feature the same number of components, have been made using the same manufacturing methods, have been manufactured from the same (or very similar) materials and critical dimensions (tube ID, Luer dimensions) are identical. Any differences between the Flexicare and Intersurgical devices are stated below with justifications.
#### Differences
Both devices are simple products, comprising of 3 components each (4 each if with filter). There are very little differences between the two devices. Below are the only differences discovered.
The luer connectors of the Intersurgical predicate device are Polycarbonate, while Flexicare's luers are ABS. This difference in material is not crucial as both materials are amorphous polymers and have similar properties including high clarity, hardness, high impact strength and very low mould shrinkage.
The only other difference between the devices is that the Intersurgical sample has a frosted finish tube, which is purely a surface finish difference.
| Test | Standard / Pre-determined<br>Acceptance Criteria | Outcome |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------|
| Visual inspection | Pre-determined Acceptance Criteria | All samples pass |
| Resistance to flow | Pre-determined Acceptance Criteria | All samples pass |
| Dimensional inspection. Length, ID, OD | Pre-determined Acceptance Criteria | All samples pass |
| Leakage | Pre-determined Acceptance Criteria | All samples pass |
| Performance - CO2 monitoring | Pre-determined Acceptance Criteria | All samples pass |
| Tensile testing | Pre-determined Acceptance Criteria | All samples pass |
| Luer connectors - Dimensional,<br>leakage, connection, stress cracking | ISO 594-1 / BS EN 20594-1:1994<br>ISO 594-2 (superseded by BS EN<br>1707:1997) | All samples pass |
| Accelerated age testing | ASTM F1980 | All samples pass |
| Cytotoxicity, Irritation, sensitization | BS EN ISO 10993-10:2010<br>BS EN ISO 10993-5:2009 | All samples pass |
| Genotoxicity | BS EN ISO 10993-3:2009 | All samples pass |
Non Clinical Tests Performed:
All the tests that were carried out on Flexicare's CO2 monitoring line are listed in the table above.
The tests selected to be carried out in order to determine substantial equivalence would test the critical aspects of the each device's functionality.
The visual & dimensional inspections were carried out to ensure that the Flexicare device had the same number of components, the same general assembly, the same material type and was dimensionally the same as (or very similar to) the predicate device. Both manufacturers' devices were found to be very similar in appearance, assembly, materials and dimensions with critical dimensions such as tube ID being identical.
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Image /page/5/Picture/0 description: The image shows the logo for Flexicare. The logo is black and white and features a stylized "F" followed by the word "lexicare" in a bold, sans-serif font. Below the word "lexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller font.
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Resistance to flow testing was carried out to compare the level of resistance between Flexicare's CO2 monitoring line with Intersurgical's at the same flow rates. This aspect is critical as a higher resistance would restrict CO2 reaching the gas analyzer. Testing was carried out at 100ml/min and again at 300ml/min.
CO2 monitoring testing was carried out in order to assess whether the devices would detect CO2 from beneath the nostrils as this is the main purpose of the device. Samples were not assessed for % of CO2 detected as this depends on the patient-end device that the CO2 monitoring line is attached to. Both manufacturers' devices detected CO2 consistently, proving substantial equivalence.
Leak and tensile testing were also carried out as a leak or disconnection from sampling line to luer could result in less or no CO2 being drawn to the gas sampling device. Both Flexicare's and Intersurgical's devices passed the leak testing and withstood the pre-determined acceptance criteria of 40N tensile force without disconnection. This also proves substantial equivalence of the devices.
#### Conclusion
Flexicare's & Intersurgical's CO2 monitoring line & CO2 monitoring line with filter passed the performance testing when tested against methods and criteria from both pre-determined acceptance criteria test methods and relevant standards. The results of this testing show that the CO2 monitoring line & CO2 monitoring line with filter passes all performance tests that are critical to its substantially equivalent operation. In all tests the Flexicare device performed as well as or better than the Predicate device.
Flexicare's CO2 monitoring line & CO2 monitoring line with filter is substantially equivalent to, and performs as well as the marketed predicate device manufactured by Intersurgical.
Signature of contact Person:
Chris Watkins Quality Regulatory & Technical Director
euashano
Dated: 22-04-2014
-------End of 510k Summary----------------------------------------------------------------------------------------------------------------------------------------------------
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 30, 2014
Flexicare Medical Limited Christopher Watkins Ouality Regulatory and Technical Director Cynon Vallev Business Park Mountain Ash, Mid. Glamorgan CF45 4ER. United Kingdom
Re: K133516
Trade Name: CO2 Monitoring Line & CO2 Monitoring Line with Filter Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: March 26. 2014 Received: March 31, 2014
Dear Mr. Watkins:
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 - Mr. Watkins
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/ResourcesforYou/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,
Ticket Park Shah M.D.
Tejashri Purohit Sheth, MiD.
Clinical Deputy Director,
DAGRID/ODE/CDRH FOR
Erin Keith, M.S. Acting Division 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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Image /page/8/Picture/0 description: The image shows the logo for Flexicare. The logo consists of a stylized letter "f" with two curved lines above it, followed by the word "lexicare" in a bold, sans-serif font. Below the word "lexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller, sans-serif font.
## Indications for Use
510(k) Number (if known): _K133516
Page 1 of 1
CO2 monitoring line & CO2 monitoring line with filter Device Name:
Indications for Use:
CO2 Monitoring lines are intended to connect from a patient interface CO2 sampling port to the expired gas monitor.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Todd D. Cour
