Used to conduct a sample of the subject's breathing to a gas measurement device (capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation. The device is to be used with monitors using Microstream™ technology.

o Microstream™ Luer Adult Oral-Nasal Sampling Line Used whenever the physician needs to collect a sample of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation.

Device Description

Similar to their predicates, the Microstream non-intubated sampling line/Filter Line family is intended to conduct CO2 from the patient's breath to a gas measurement device (Capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation (when connected to an O2 source).

The proposed devices are a modification of their predicates' material compounds (not made with DEHP or PHT materials), a change of dryer location to off the patient's face, and the integration of softer face-contacting tubes, mainly to enhance patient comfort, increase flexibility and reduce smell.

The proposed devices are sampling lines which are intended to be used with Capnograph monitors using Microstream technology. These sampling lines incorporate a luer connector with a recognition system:

Microstream™ Advance Neonatal-Infant Nasal Filter Line with O2 Tubing .
. Microstream™ Advance Pediatric Oral-Nasal Filter Line with O2 Tubing
Microstream™ Advance Adult Oral-Nasal Filter Line with O2 Tubing .

In addition, this sampling line which is intended to be used with any Capnograph monitor is proposed:

Microstream™ Luer Adult Oral-Nasal Sampling Line .

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing and related products). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a clinical study establishing new performance metrics.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, provenance of data) are not applicable in this context, as this submission relies on bench testing and biocompatibility assessments to show the new device is as safe and effective as existing ones.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The "Substantial Equivalence Table" on page 6-7 serves as the primary source for acceptance criteria (implicitly, the values of the predicate devices) and the reported performance of the new devices.

Feature	Acceptance Criteria (Predicate Device K010024, K011536, or K013845)	Reported Device Performance (Microstream™ Advance Neonatal-Infant, Pediatric, Adult, or Luer Adult)
Intended Population	Adults and pediatrics (K010024)	Neonatal-Infant
	Adult, intermediate, or pediatric (K011536)	Pediatric
	Adult, intermediate, or pediatric (K013845)	Adult
Single Patient Use	Yes	Yes
Patient Interface	Nasal Cannula (K010024)	Same as K010024 (Nasal Cannula)
	Oral Nasal Cannula (K011536)	Same as K011536 (Oral Nasal Cannula)
	Oral Nasal Cannula (K013845)	Same as K013845 (Oral Nasal Cannula)
Biocompatibility	ISO 10993-1	ISO 10993-1, ISO 18562-1
Dehumidifier/Dryer	- (K010024, K011536, K013845)	+ (Neonatal-Infant)
		+/- (Pediatric, Adult)
		- (Luer Adult)
Rise time	≤200 msec @ 50ml/min sample flow rate, sea level, RT minimal background= 50msec (K010024, K011536)	≤260 msec @ 50ml/min sample flow rate, sea level, RT minimal background= 50msec (Neonatal-Infant)
	≤200 msec for 2m; ≤260 msec for 4m @50ml/min sample flow rate, sea level, RT minimal background= 50msec (Pediatric)
	200 msec @ 50ml/min sample flow rate, sea level, RT minimal background=50msec (Adult)
	≤200 msec @ 50ml/min sample flow rate, sea level. ≤100msec @ 180ml/min. RT background= 50msec (K013845)	200 msec @ 50ml/min sample flow rate, sea level. ≤100msec @ 180ml/min RT background = 50msec (Luer Adult)
Pressure Drop - CO2 sampling set	40mbar @ 50ml/min, sea level (K010024, K011536)	≤75[mbar] @ 50ml/min, sea level (Neonatal-Infant, Pediatric (max 4m length), Adult)
	≤70mbar @ 180ml/min, sea level (K013845)	≤70[mbar] @ 180ml/min sea level (Luer Adult)
Pressure Drop - O2 line	≤135mBar @ 8L/min, at sea level (K010024, K011536, K013845)	225mBar @ 3L/min, at sea level (Neonatal-Infant)
		≤110mBar @ 5L/min, at sea level (Pediatric, Adult)
		≤80mBar @ 5L/min, at sea level (Luer Adult)
Leak Tightness	Was not provided under the 510k submission (K010024, K013845)	≤2[mbar/sec] @ 100[mbar] vacuum
	≤10mbar/sec (K011536)	≤2[mbar/sec] @ 100[mbar] vacuum
Tensile Strength	Was not provided under the 510k submission (K010024, K011536, K013845)	CO2 line: Withstand a pull test of 1kg. O2 line: Withstand a pull test of 2kg (Neonatal-Infant)
		Withstand a pull test of 2kg (Pediatric, Adult, Luer Adult)

2. Sample size used for the test set and the data provenance

N/A. This submission indicates the use of "bench testing" and "biocompatibility assessment" rather than clinical test data or real-world patient data. The purpose is to demonstrate that the physical and material properties of the new devices are substantially equivalent to existing ones.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. Ground truth from experts is not relevant for bench testing and biocompatibility assessments of physical properties.

4. Adjudication method for the test set

N/A. Adjudication methods are typically used in clinical studies involving interpretation by multiple readers. This submission relies on objective physical measurements and material testing.

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

N/A. This device is a passive CO2 sampling line, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.

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

N/A. This is a hardware device; there is no "algorithm" in the sense of AI or image analysis.

7. The type of ground truth used

The "ground truth" for this type of submission is based on engineering specifications and established standards (e.g., ISO 10993 for biocompatibility, and the performance characteristics of the predicate devices for physical parameters like rise time, pressure drop, leak tightness, and tensile strength).

8. The sample size for the training set

N/A. There is no "training set" in the context of this traditional 510(k) submission, as it does not involve machine learning or AI.

9. How the ground truth for the training set was established

N/A. As there is no training set, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.

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

Re: K181624

Trade/Device Name: Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing. Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: February 5, 2019 Received: February 8, 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.

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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 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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K181624

Traditional 510K submission for Non-Intubated CO2 Sampling Lines

001 Indications for Use Statement

(This document is not confidential)

June 18, 2018

Indications for Use:

Microstream™ Advance Neonatal-Infant Nasal Filter Line with O2 Tubing .
Microstream™ Advance Pediatric Oral-Nasal Filter Line with O2 Tubing ●
Microstream™ Advance Adult Oral-Nasal Filter Line with O2 Tubing 0

(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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510 (k) Summary

510(k) Number: K181624

DATE THIS SUMMARY WAS PREPARED

March 14, 2019

Products Trade Name:

Microstream™ Advance Neonatal-Infant Nasal Filter Line with O2 Tubing Microstream™ Advance Pediatric Oral-Nasal Filter Line with O2 Tubing Microstream™ Advance Adult Oral-Nasal Filter Line with O2 Tubing Microstream™ Luer Adult Oral-Nasal Sampling Line

Common:

Non-Intubated CO2 Sampling Line

Establishment Registration Number

8044004

Establishment Address:

Oridion Medical 1987 Ltd. 7 Hamarpe Street, POB 45025, 9777407 Jerusalem

Contact Person:

Dalia Givonv Regulatory & Clinical Consulting +972-8-9721157 dalia@daliag.com

Classification:

Product Classification: 73CCK Class II

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

21 CFR 868.1400, carbon dioxide analyzer.

Predicate Devices:

O2/CO2 NASAL FILTERLINE cleared under K010024

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MICROSTREAM 02/CO2 ORAL NASAL FILTERLINE cleared under K011536 MAC-Line O2/CO2 ORAL NASAL CANNULA SAMPLE LINE cleared under K013845

Device description:

Microstream™ Advance Neonatal-Infant Nasal Filter Line with O2 Tubing .
. Microstream™ Advance Pediatric Oral-Nasal Filter Line with O2 Tubing
Microstream™ Advance Adult Oral-Nasal Filter Line with O2 Tubing .

In addition, this sampling line which is intended to be used with any Capnograph monitor is proposed:

Microstream™ Luer Adult Oral-Nasal Sampling Line .

Intended Use/Indications for Use:

Microstream™ Advance Neonatal-Infant Nasal Filter Line with O2 Tubing .
. Microstream™ Advance Pediatric Oral-Nasal Filter Line with O2 Tubing
Microstream™ Advance Adult Oral-Nasal Filter Line with O2 Tubing .

Used to conduct a sample of the subject's breathing to a gas measurement device (capnograph) while simultaneously administering supplemental oxygen

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projected near the nose and mouth for inhalation. The device is to be used with monitors using Microstream™ technology.

Microstream™ Luer Adult Oral-Nasal Sampling Line . Used whenever the physician needs to collect a sample of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation.

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Substantial equivalence table

Feature	Predicate device:K010024O2/CO2 NASALFILTERLINE	Microstream™AdvanceNeonatal-InfantNasal Filter Linewith O2 Tubing	Predicate device:K011536MICROSTREAMO2/CO2 ORALNASALFILTERLINE	Microstream™Advance PediatricOral-Nasal FilterLine with O2Tubing	Microstream™Advance AdultOral-Nasal FilterLine with O2Tubing	Predicatedevice:K013845MAC-LineO2/CO2 OralNasalCannulasample line	Microstream™ Luer AdultOral-NasalSamplingLine
Intendedpopulation(non-intubated)	Adults andpediatrics	Neonatal-Infant	Adult, intermediateor pediatric	Pediatric	Adult	Adult, intermediateor pediatric	Adult
Single patientuse	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Patientinterface	Nasal Cannula	Same as K010024	Oral NasalCannula	Same as K011536	Same asK011536	Oral NasalCannula	Same asK013845
Biocompatibility	ISO 10993-1	ISO 10993-1ISO 18562-1	ISO 10993-1	ISO 10993-1,ISO 18562-1	ISO 10993-1ISO 18562-1	ISO 10993-1	ISO 10993-1ISO 18562-1
Dehumidifier/Dryer	-	+	-	+/-	+/-	-	-
Rise time	≤200 msec@50ml/min sampleflow rate, sea level,RT minimalbackground=50msec	≤260 msec @50ml/min sampleflow rate, sea level,RT minimalbackground=50msec	≤200 msec @50ml/min sampleflow rate, sea level,RT minimalbackground=50msec	≤200 for 2m;≤260 for 4m@50ml/min sampleflow rate, sea level,RT minimalbackground=50msec	200 msec @50ml/min sampleflow rate, sealevel, RT minimalbackground=50msec	≤200 msec @50ml/minsample flowrate, sea level.≤100msec @180ml/min.RTbackground= 50msec	200 msec @50ml/minsample flowrate, sealevel.≤100msec @180ml/min
Feature	Predicate device:K010024O2/CO2 NASALFILTERLINE	Microstream™AdvanceNeonatal-InfantNasal Filter Linewith O2 Tubing	Predicate device:K011536MICROSTREAMO2/CO2 ORALNASALFILTERLINE	Microstream™Advance PediatricOral-Nasal FilterLine with O2Tubing	Microstream™Advance AdultOral-Nasal FilterLine with O2Tubing	Predicatedevice:K013845MAC-LineO2/CO2 OralNasalCannulasample line	Microstream™ Luer AdultOral-NasalSamplingLine
							RTbackground =50msec
Pressure Drop-	CO2 sampling set:40mbar@ 50ml/min, sea level.O2 line: ≤135mBar@ 8L/min, at sealevel.	CO2 line:≤75[mbar] @ 50ml/min, sea level.02 line:225mBar@ 3L/min,at sea level.	CO2 sampling set:40mbar@ 50ml/min, sea level.O2 line: ≤135mBar@ 8L/min, at sealevel.	CO2 line:≤75[mbar] @50ml/min; sealevel; max 4mlength.02 line: ≤110mBar@ 5L/min, at sealevel	CO2 line:≤75[mbar] @50[ml/min; sealevel.02 line:≤110mBar @5L/min, at sealevel.	CO2 line:≤70mbar @180ml/min.sea level.02 line:≤135mBar @8L/min, at sealevel	CO2 line:≤70[mbar] @180ml/minsea level.O2 line:≤80mBar @5L/min, at sealevel
LeakTightness	Was not providedunder the 510ksubmission	≤2[mbar/sec] @100[mbar] vacuum.	≤10mbar/sec	≤2[mbar/sec] @100[mbar] vacuum	≤2[mbar/sec] @100[mbar]vacuum.	Was notprovidedunder the510ksubmission	≤2[mbar/sec]@ 100[mbar]vacuum
TensileStrength	Was not providedunder the 510ksubmission	CO2 line:Withstand a pulltest of 1kg.02 line: Withstanda pull test of 2kg	Was not providedunder the 510ksubmission	Withstand a pulltest of 2kg.	Withstand a pulltest of 2kg.	Was notprovidedunder the510ksubmission	Withstand apull test of2kg.

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Clinical/ Non-Clinical:

Biocompatibility was assessed according to ISO 10993, ISO 18562-1 and FDA guidance. The devices are intended for prolonged use (>24 hours-30 days) and composed of components for exhaled breath (CO2 tubing, dehumidifier), and components for inhaled breath (02 delivery tubing, cannula, connectors).

Components for exhaled breath (with tissue contact) were tested for Cytotoxicity, Sensitization, and Intracutaneous. Components for inhaled breath (externally communicating, indirect contact with tissue in the patient respiratory pathway) were tested for Cytotoxicity, Sensitization, Intracutaneous, Acute Systemic Toxicity, Pyrogenicity, Particulate, and Volatile Organic Compounds.

Performance data:

Bench testing was conducted to ensure the devices' performance and to demonstrate substantial equivalence to the predicates. This includes mainly pressure drop, tensile strength, leak tightness, rise time, resistance to kinking of the O2 Line, resistance to kinking of CO2 line, and O2 and CO2 connector mechanical testing.

Conclusion:

Biocompatibility testing as well as performance bench testing shows that the subject devices are substantially equivalent to their predicates without raising 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).