DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER

K122075 · Intersurgical, Inc. · CCK · Dec 20, 2012 · Anesthesiology

Device Facts

• Record ID: K122075
• Device Name: DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER
• Applicant: Intersurgical, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Dec 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The CO2 monitoring lines are intended to connect from a CO2 sampling port to the expired gas monitor.

Device Story

Single-use, small-diameter PVC tubing; connects CO2 sampling port on face mask or breathing circuit to external capnograph or gas monitoring device. Available with or without hydrophobic filter to prevent water transfer into monitoring equipment. Operates via external pump within gas monitoring device, which pulls patient breath samples through tubing. Used in hospital settings by clinicians. Output is gas sample delivered to monitor for analysis; enables real-time CO2 monitoring for patient respiratory assessment.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including resistance to flow, leakage, connector durability (ISO 594-2:1998), and static water load. Biocompatibility evaluated per ISO 10993-1 and G95-1.

Technological Characteristics

Materials: PVC (tubing), PC/ABS (connectors), Nylon (filter media). Design: Small-diameter tubing with luer lock connectors. Energy: Passive (gas flow driven by external monitor pump). Sterility: Non-sterile. Biocompatibility: ISO 10993 compliant. Connectivity: Mechanical luer interface.

Indications for Use

Indicated for patients requiring gas monitoring during their breathing cycle, connecting a CO2 sampling port to an expired gas monitor.

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

• Catheter Research Inc., Disposable Gas Sampling Lines (K946044)

Submission Summary (Full Text)

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# Section 5 510(k) Summary of Safety and Effectiveness

DEC 2 0 2012

Name: INTERSURGICAL INCORPORATED Address: 417 Electronics Parkway Liverpool, NY 13088 Date: December 19, 2012 Contact Person: Michael Zalewski - Assistant VP - RA/CS Phone Number: 315-451-2900 Fax Number: 315-451-3696

Trade Name: C02 Monitoring Line and C02 Monitoring Line with Filter

Common Name: C02 Monitoring Line and C02 Monitoring Line with Filter

Classification: 21 CFR 868.1400, Classification Name: Analyzer, Gas, Carbon Dioxide, Gaseous Phase - Accessory - Classification Product Code: CCK

#### Predicate Device:

Catheter Research Inc., Disposable Gas Sampling Lines, K946044. The CRI monitoring lines are designed for connection between a gas monitoring device and a patient interface device in which gas monitoring is required. CRI gas sampling lines are available with or without a hydrophobic filter for the prevention of water transfer along the sampling line and into the gas sampling equipment.

# Description:

# C02 Monitoring Line and Monitoring Line with Filter

The monitoring line tubing is single use, small diameter tubing intended to be connected to a port on a face mask or breathing circuit to allow for gas sampling from a patient's breath by gas sampling equipment. When used with a face mask the line connects between the female luer lock connector on the mask and a capnograph or similar gas monitoring device. The gas monitoring device will have a pump which pulls air from inside mask, along the monitoring line and into the gas monitoring equipment. The monitoring line is available with or without a hydrophobic filter, which prevents the transfer of water down the monitoring line and into the gas sampling equipment.

#### Indications for Use:

The CO2 monitoring lines are intended to connect from a CO2 sampling port to the expired gas monitor

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# Section 5 510(k) Summary of Safety and Effectiveness (cont.)

# Technological Characteristics Summary:

The intended use of the Intersurgical C02 Monitoring Line and Monitoring Line with Filter is comparable to the referenced predicate devices. The comparison of the data shows similar values for the key performance characteristics. Proposed devices show similar values for resistance to flow, leakage, connectors, outer diameter, inner diameter and static water load.

| | CO2 Monitoring Line | Gas Sampling Line |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | | K946044 |
| Intended Use: | | |
| Target population | Any patient from which gas<br>monitoring is required | Any patient from which gas<br>monitoring is required |
| Indications for use | The C02 monitoring lines are<br>intended to connect from a C02<br>sampling port to the expired gas<br>monitor. | The gas sampling lines are<br>intended to connect from a port<br>in the face mask breathing<br>circuit to the expired gas<br>monitor. |
| Where used | Hospitals | Hospitals |
| Product Labelling | CO2 Monitoring Line | Gas Sampling Line |
| Single Use or Reusable? | Single Use | Single Use |
| Design and Performance: | | |
| Resistance to Flow | 8.1mbar at 100ml/min flow<br>20.7ml/min at 300ml/min flow | 12.5mbar at 100ml/min flow<br>35.9ml/min at 300ml/min flow |
| Leakage | <1.0ml/min | <1.0ml/min |
| Connectors | 2 x Luer Lock connectors | 2 x Luer Lock connectors |
| Outer Diameter | 3.05mm | 2.95mm |
| Inner Diameter | 1.47mm | 1.34mm |
| Energy Used/Delivered: | Gas is pulled from one end of<br>the tube to the other by a pump<br>in the gas sampling device | Gas is pulled from one end of<br>the tube to the other by a pump<br>in the gas sampling device |
| Compatibility: | Designed for use with gas<br>monitoring device (for example<br>a capnograph) with luer<br>connections to gas sampling<br>tubing | Designed for use with gas<br>monitoring device (for example<br>a capnograph) with luer<br>connections to gas sampling<br>tubing |
| Materials: | PVC (main line) and PC (luer<br>connectors) | PVC (main line) and ABS (luer<br>connectors) |
| Biocompatibility: | Compliant with ISO 10993 | Compliant with ISO 10993 |
| Sterility: | Non-sterile | Non-sterile |
| | CO2 Monitoring Line + filter | Gas Sampling Line + filter<br>K946044 |
| Intended Use:<br>Target population | Any patient, from which gas monitoring is required during the patient's breathing cycle | Any patient from which gas monitoring is required during the patient's breathing cycle |
| Indications for use | The C02 monitoring lines are intended to connect from a C02 sampling port to the expired gas monitor. | The gas sampling lines are intended to connect from a port in the face mask breathing circuit to the expired gas monitor. |
| Where used | Hospitals | Hospitals |
| Product Labelling | CO2 Monitoring Line<br>2.45m + hydrophobic filter | Gas Sampling Line + filter |
| Single Use or Reusable? | Single Use | Single Use |
| Design and Performance:<br>Resistance to Flow | 26.3mbar at 100ml/min flow<br>82:0mbar at 300ml/min flow | 14.6mbar at 100ml/min flow<br>47.3mbar at 300ml/min flow |
| Leakage | <1.0ml/min | <1.0ml/min |
| Connectors | 2 x Luer Lock connectors (plus luer lock Male to Luer lock Female connection between monitoring line and filter) | 2 x Luer Lock connectors (plus luer lock Male to Luer lock Female connection between monitoring line and filter) |
| Outer Diameter | 3.05mm | 2.95mm |
| Inner Diameter | 1.47mm | 1.34mm |
| Static water load | Does not allow passage of water past filter media | Does not allow passage of water past filter media |
| Energy Used/Delivered: | Gas is pulled from one end of the tube to the other 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 |
| Compatibility: | Designed for use with gas monitoring device (for example a capnograph) with luer connections for gas sampling tubing | Designed for use with gas monitoring device (for example a capnograph) with luer connections for gas sampling tubing |
| Materials: | PVC (main line), ABS (luer connectors and filter housing) and Nylon (filter media) | PVC (main line) and ABS (luer connectors) |
| Biocompatibility: | Compliant with ISO 10993 | Compliant with ISO 10993 |
| Sterility: | Non sterile | Non sterile |

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Section 5 510(k) Summary of Safety and Effectiveness (cont.)

4

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# Section 5 510(k) Summary of Safety and Effectiveness (cont.)

# Summary of Testing:

Nonclinical tests submitted to demonstrate substantial equivalence for the Monitoring Lines and Monitoring Lines with Filter include resistance to flow, leakage, connectors, outer diameter, inner diameter and static water load. All materials used in the C02 Monitoring Lines and Monitoring Lines with Filter have been evaluated according to tests outlined in ISO 10993-1 and meet the requirements of Bluebook Memo, General Program Memorandum G95-1 biocompatibility testing for cytotoxicity, sensitization, and irritation. The monitoring line and hydrophobic filter conform to clauses 4.2 to 4.7 of ISO 594-2:1998, which are considered the 'functional' aspects of the luer lock design, ranging from separation and assembly forces to durability.

### Substantial Equivalence:

Intersurgical Incorporated has demonstrated that the proposed devices are safe and effective. They are considered to be substantially equivalent to the currently marketed predicate devices which have been previously reviewed for market clearance by the FDA.

#### K122075

# Premarket Notification [510(k)] Number

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

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

## December 20, 2012

Mr. Michael Zalewski Vice President-RA/OA/CS Intersurgical, Incorporated 417 Electronics Parkway LIVERPOOL NY 13077

Re: K122075

Trade/Device Name: Line and C02 Monitoring Line with Filter Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK . . Dated: December 4, 2012 Received: December 11, 2012

# Dear Mr. Zalewski:

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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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be devices that I Dr over device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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, 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthong Lo m

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Section 4 Indications for Use Statement

510(k) Number (if known): K122075

Device Name:

C02 Monitoring Line and C02 Monitoring Line with Filter

Indications For Use:

The CO2 monitoring lines are intended to connect from a CO2 sampling port to the expired gas monitor.

Prescription Use XXX (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)

Lester W. Schultheis Jr

2012.12.19 16:44:53-05.00,

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

12075 510(k) Number,