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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

Disclaimer: This document describes a medical device called "C02 Monitoring Line and C02 Monitoring Line with Filter." The "study" described is a submission for 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, rather than a clinical study establishing efficacy or a standalone algorithm performance study. Therefore, some of the requested categories (like MRMC studies, human reader improvement, and training set details) are not applicable or cannot be extracted from this type of regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in this document, but rather implied by the comparison to a predicate device. The performance is reported by comparing the new device's characteristics to those of the predicate device (K946044). The "acceptance criteria" here implicitly mean that the new device's performance for these characteristics should be comparable or substantially equivalent to the predicate device to justify market clearance.

Characteristic	Acceptance Criteria (Implied: Comparable to Predicate)	Reported Device Performance (CO2 Monitoring Line)	Reported Device Performance (CO2 Monitoring Line + Filter)	Predicate Device Performance (Gas Sampling Line, K946044)	Predicate Device Performance (Gas Sampling Line + Filter, K946044)
Intended Use	Same as predicate	Connect from C02 sampling port to expired gas monitor	Connect from C02 sampling port to expired gas monitor	Connect from port in face mask breathing circuit to expired gas monitor	Connect from port in face mask breathing circuit to expired gas monitor
Target Population	Same as predicate	Any patient from which gas monitoring is required	Any patient from which gas monitoring is required	Any patient from which gas monitoring is required	Any patient from which gas monitoring is required during the patient's breathing cycle
Where Used	Same as predicate	Hospitals	Hospitals	Hospitals	Hospitals
Single Use/Reusable	Same as predicate	Single Use	Single Use	Single Use	Single Use
Resistance to Flow	Comparable to predicate	8.1mbar at 100ml/min flow; 20.7mbar at 300ml/min flow (for non-filter)	26.3mbar at 100ml/min flow; 82.0mbar at 300ml/min flow (for filter)	12.5mbar at 100ml/min flow; 35.9mbar at 300ml/min flow (for non-filter)	14.6mbar at 100ml/min flow; 47.3mbar at 300ml/min flow (for filter)
Leakage	<1.0ml/min	<1.0ml/min	<1.0ml/min	<1.0ml/min	<1.0ml/min
Connectors	Same as predicate	2 x Luer Lock connectors	2 x Luer Lock connectors (plus luer lock Male to Female for filter)	2 x Luer Lock connectors	2 x Luer Lock connectors (plus luer lock Male to Female for filter)
Outer Diameter	Comparable to predicate	3.05mm	3.05mm	2.95mm	2.95mm
Inner Diameter	Comparable to predicate	1.47mm	1.47mm	1.34mm	1.34mm
Static Water Load	Does not allow water passage	Not applicable (for non-filter)	Does not allow passage of water past filter media	Not applicable (for non-filter)	Does not allow passage of water past filter media
Energy Used	Same as predicate	Gas pulled by pump in gas sampling device	Gas pulled by pump in gas sampling device	Gas pulled by pump in gas sampling device	Gas pulled by pump in gas sampling device
Compatibility	Same as predicate	Designed for use with gas monitoring device (e.g., capnograph)	Designed for use with gas monitoring device (e.g., capnograph)	Designed for use with gas monitoring device (e.g., capnograph)	Designed for use with gas monitoring device (e.g., capnograph)
Materials	Comparable to predicate	PVC (main line), PC (luer connectors)	PVC (main line), ABS (luer connectors & filter housing), Nylon (filter media)	PVC (main line), ABS (luer connectors)	PVC (main line), ABS (luer connectors)
Biocompatibility	Compliant with ISO 10993	Compliant with ISO 10993	Compliant with ISO 10993	Compliant with ISO 10993	Compliant with ISO 10993
Sterility	Same as predicate	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Luer Lock Conformance	Conform to ISO 594-2:1998 (clauses 4.2-4.7)	Conform to clauses 4.2-4.7 of ISO 594-2:1998	Conform to clauses 4.2-4.7 of ISO 594-2:1998	Not explicitly stated for predicate in this document, but implied by regulatory standard for such devices.	Not explicitly stated for predicate in this document, but implied by regulatory standard for such devices.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (which in this context is "substantial equivalence") is the nonclinical testing described in the document, specifically the "Summary of Testing" section.

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of lines tested) for each physical characteristic (resistance to flow, leakage, etc.). These are typically described in detailed test reports, not usually summarized in the 510(k) filing itself beyond stating that the tests were performed.
Data Provenance: The data appears to be prospective testing conducted by the manufacturer, Intersurgical Incorporated, on their new devices. The country of origin for the data is not specified, but the manufacturer is based in Liverpool, NY, USA. However, given the predicate is from "Catheter Research Inc.," it implies the predicate data is also likely from the US, or at least from a study accepted by the FDA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not applicable and not provided in this document. The "ground truth" for nonclinical performance characteristics like resistance to flow or leakage is established by validated testing methodologies and metrology, not by expert consensus. This is a technical device characteristic evaluation, not an diagnostic or interpretative one.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation of data (e.g., medical imaging, clinical symptoms) is involved, and discrepancies among observers need to be resolved to establish ground truth. For physical device performance tests, the outcome is typically measured objectively and does not require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This information is not applicable. This document describes a C02 monitoring line, which is a physical accessory for gas monitoring equipment, not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies, AI assistance, and human reader performance are not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. As stated above, this is a physical medical device accessory, not an algorithm or software-as-a-medical-device (SaMD).

7. Type of Ground Truth Used

The "ground truth" for the performance characteristics like resistance to flow, leakage, dimensions, and biocompatibility is established through objective physical measurements and standardized laboratory testing (e.g., in accordance with ISO standards) using established metrology and chemical/biological analysis. It is not based on expert consensus, pathology, or outcomes data in the traditional sense.

8. Sample Size for the Training Set

This information is not applicable and not provided. As this is not an AI/machine learning device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided. There is no training set for this type of device.

Summary

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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

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 gasmonitoring is required	Any patient from which gasmonitoring is required
Indications for use	The C02 monitoring lines areintended to connect from a C02sampling port to the expired gasmonitor.	The gas sampling lines areintended to connect from a portin the face mask breathingcircuit to the expired gasmonitor.
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 flow20.7ml/min at 300ml/min flow	12.5mbar at 100ml/min flow35.9ml/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 ofthe tube to the other by a pumpin the gas sampling device	Gas is pulled from one end ofthe tube to the other by a pumpin the gas sampling device
Compatibility:	Designed for use with gasmonitoring device (for examplea capnograph) with luerconnections to gas samplingtubing	Designed for use with gasmonitoring device (for examplea capnograph) with luerconnections to gas samplingtubing
Materials:	PVC (main line) and PC (luerconnectors)	PVC (main line) and ABS (luerconnectors)
Biocompatibility:	Compliant with ISO 10993	Compliant with ISO 10993
Sterility:	Non-sterile	Non-sterile
	CO2 Monitoring Line + filter	Gas Sampling Line + filterK946044
Intended Use: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 Line2.45m + hydrophobic filter	Gas Sampling Line + filter
Single Use or Reusable?	Single Use	Single Use
Design and Performance:Resistance to Flow	26.3mbar at 100ml/min flow82:0mbar at 300ml/min flow	14.6mbar at 100ml/min flow47.3mbar 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.)

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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 (800) 638-2041 or (301) 796-7100 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,

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
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.(b)
Classification. Class II (performance standards).