Intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a gas measurement device for measuring the percentage of CO2 in the patient's exhaled breath. The set is intended for single patient use only. Intended population: Intubated Adult- Pediatric patients.

Device Description

Similar to their predicates the devices are non-sterile, disposable, single patient use, intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a device for measuring the percentage of CO2 in the patient's exhalation when connected to a capnograph.

The device's main components are PVC tubing, airway adapter and a luer connector.

Microstream™ Advance Adult-Pediatric Intubated Filter Line can be used only with Microstream™ capnography technology.

Microstream™ Luer Adult-Pediatric Intubated Sampling Line can be used with any capnograph with a luer connection.

An Accessory (extension line) to the proposed devices: Microstream™ Advance Filter Line, MRI is composed of PVC tubing and a luer connector. It is Intended to be used when longer tubing is required to allow CO2 sampling for environments such as an MRI suite. The straight tubing is then connected to the FilterLine/ Sampling Line end from one side and from the other side to the monitor, which is placed outside of MRI suite.

The main reason for this submission is the modification of the CO2 tubing to material not made with phthalates.

AI/ML Overview

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Microstream Luer Adult-Pediatric Intubated Sampling Line and Microstream Advance Adult-Pediatric Intubated Filter Line.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text outlines performance tests conducted, but it merges the acceptance criteria with the performance results. For clarity, I will present the acceptance criteria based on the "Same as predicate" statements and the performance reported when new criteria were established for the modified devices.

Feature	Acceptance Criteria (Based on Predicate or New)	Reported Device Performance
Biocompatibility	ISO 10993-1 and FDA guidance (Cytotoxicity, Sensitization, Irritation, Risk Assessment for prolonged use >24 hours-30 days)	Conducted according to ISO 10993 and FDA guidance. Results demonstrated safe use.
Pressure Drop	Microstream Luer: ≤70 mBar @ 180 ml/min, sea level	≤70 mBar @ 180 ml/min, sea level
	Microstream Advance: ≤75 mBar @ max 4m length; 50 ml/min, sea level	≤75 mBar @ max 4m length; 50 ml/min, sea level
	Accessory (MRI): ≤75 mBar @ 50 ml/min, sea level	≤75 mBar @ 50 ml/min, sea level
Leak Tightness	2 mBar/sec leak rate @ 100 mBar under pressure (Same as K980324/K980327)	Met (Identical to K980324/K980327, implying 2 mBar/sec leak rate @ 100 mBar under pressure)
Tensile Strength	Pull test of at least 2 kg (Same as K980324/K980327)	Met (Identical to K980324/K980327, implying pull test of at least 2 kg)
Mode of Operation	Luer: For use with any Capnograph with luer connection	Met
	Advance: For use with Microstream Capnography technology	Met
Single Patient Use	Yes (Same as predicates)	Met
Tubing Material	Made without phthalates (New requirement for modified device)	Met (Modified to entirely without phthalates)

2. Sample Size Used for the Test Set and Data Provenance:

The document states that "Bench testing was conducted to ensure the devices' performance." This implies physical testing of the devices. However, the specific sample size (number of units tested) for the bench tests is not explicitly mentioned in the provided text.

The data provenance is laboratory-based bench testing of the physical devices. There is no indication of country of origin for the data or whether it was retrospective or prospective in the context of patient data, as this was a bench study.

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

This information is not applicable as the study described is a bench performance study and not a clinical study with a test set requiring expert ground truth establishment. The "ground truth" for these tests would be the established engineering and ISO standards for device performance (e.g., specific tensile strength, pressure drop limits).

4. Adjudication Method for the Test Set:

This information is not applicable as the study is a bench performance study and does not involve adjudication by experts for clinical outcomes or image interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable as the device is a physical medical device (sampling line) and not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the device is a physical medical device and does not have an algorithm for standalone performance.

7. The Type of Ground Truth Used:

For this bench study, the "ground truth" refers to established engineering standards, regulatory requirements (e.g., ISO 10993 for biocompatibility), and performance specifications derived from the predicate devices. For example, for tensile strength, the ground truth is "at least 2kg," and for leak tightness, "2 mBar/sec leak rate @ 100 mBar."

8. The Sample Size for the Training Set:

This information is not applicable as the study is a bench performance study of a physical device and does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as in point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

Oridion Medical 1987 Ltd. Dalia Givony Regulatory and Clinical Affairs Manager 7 Hamarpe Street P.O. Box 45025 Jerusalem, 9777407 Il

Re: K181467

Trade/Device Name: Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: December 30, 2018 Received: January 2, 2019

Dear Dalia Givony:

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

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Todd D. Courtney -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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Traditional 510K submission for Intubated CO2 Sampling Lines

001 Indications for Use Statement

K181467

Device Name:

Microstream™ Luer Adult-Pediatric Intubated Sampling Line Microstream™ Advance Adult-Pediatric Intubated Filter Line

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X (Per 21 CFR 801.109)

Over-The-Counter Use

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510K Summary

DATE THIS SUMMARY WAS PREPARED

Feb 07, 2019

SUBMITTER NAME AND ESTABLISHMENT ADDRESS:

Oridion Medical 1987 Ltd. 7 HaMarpe Street, P.O. Box 45025, Jerusalem 9777407, Israel

ESTABLISHMENT REGISTRATION NUMBER

8044004

CONTACT PERSON:

Dalia Givony Regulatory & Clinical Affairs Consultant Hativat Golani 2 Modiin, Israel, 7172157 Tel: +972-8-9721157 Dalia@daliag.com

PRODUCTS TRADE NAME

Microstream™ Luer Adult-Pediatric Intubated Sampling Line Microstream™ Advance Adult-Pediatric Intubated Filter Line

COMMON: Intubated CO2 Sampling Lines

CLASSIFICATION:

Product Classification: CCK Class II

This device is a capnograph accessory. It is classified as follows:

21 CFR 868.1400, carbon dioxide gas analyzer.

This device is classified identically to the cleared predicate device K980324 and K980327 (reference device).

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PREDICATE DEVICE:

Microstream FilterLine OR/EMS cleared under K980324

REFERENCE DEVICE:

Microstream FilterLine ICU cleared under K980327

DEVICE DESCRIPTION:

The device's main components are PVC tubing, airway adapter and a luer connector.

Microstream™ Advance Adult-Pediatric Intubated Filter Line can be used only with Microstream™ capnography technology.

Microstream™ Luer Adult-Pediatric Intubated Sampling Line can be used with any capnograph with a luer connection.

The main reason for this submission is the modification of the CO2 tubing to material not made with phthalates.

INDICATIONS FOR USE:

Intended to conduct a sample of the patient's breathing from a ventilator or

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anesthesia machine to a gas measurement device for measuring the percentage

of CO2 in the patient's exhaled breath. The set is intended for single patient use only. Intended population: Intubated Adult- Pediatric patients.

COMPARISON TO PREDICATE:

Feature	Microstream™™FilterLineOR/EMS -K980324(predicate)	Microstream™™FilterLine ICU-K980327(referencepredicate)	Microstream™™ LuerAdult-Pediatric IntubatedSampling Line	Microstream™™AdvanceAdult-PediatricIntubatedFilter Line	Accessory:Microstream™™Advance FilterLine, MRI.
Mode ofoperation	For use withMicrostreamCapnographytechnology	For use withMicrostreamCapnographytechnology	For use with anyCapnograph with luerconnection	Same asK980327	Same asK980324
Single patientuse	Yes	Yes	Yes	Yes	Yes
Biocompatibility	ISO 10993-1	ISO 10993-1	ISO 10993-1	ISO 10993-1	ISO 10993-1
Tubing Length	2 m	2 m	2m	2m/4m	9m
Tubing material	Made withphthalates	Made withphthalates	Made withoutphthalates	Madewithoutphthalates	Made withoutphthalates
Dehumidifiertubing	N/A	Nafion	N/A	Same asK980327	N/A
Pressure Drop	Not specified	Not specified	≤70mBar@180ml/min,sea level	≤75[mbar] @max 4mlength;50[mL/min],sea level	≤75[mbar]@50[mL/min],sea level
Leak Tightness	2 mBar/secleak rate @100mBarunderpressure	2 mBar/secleak rate @100mBarunderpressure	Same as K980324	Same asK980327	Same asK980324
TensileStrength	Pull test of atleast 2kg	Pull test of atleast 2kg	Same as K980324	Same asK980327	Same asK980324

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CLINICAL/ NON-CLINICAL:

The devices are composed from the following main patient contacting components: CO2 tubing (PVC), dehumidifier (Nafion) and air way connector (ABS). Biocompatibility testing, according to ISO 10993 and FDA guidance, which include cytotoxicity, sensitization and irritation as well as risk assessment, were conducted to assess the safe use of the proposed modified devices as externally communicating device with indirect contact with tissue, for prolonged use (>24 hours-30 days).

PERFORMANCE DATA:

Bench testing was conducted to ensure the devices' performance and to demonstrate similarity to the predicate devices. This bench testing includes mainly pressure drop, tensile strength, and leak tightness.

CONCLUSION:

The results show that the proposed devices are substantially equivalent to their predicates with no different questions of safety and effectiveness.

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).