The CO2 Sampling lines are the single patient, disposable device intended for monitoring expired gases from the patient.
Environment of use – hospital, sub-acute, and pre-hospital settings.
Patient population – Patients requiring expired gas monitoring.

Device Description

Barbaras Development Inc. CO2 Sampling lines are the accessories in breathing system and intended for sampling of exhaled gases for monitoring, typically end-tidal CO2.

The Barbaras Development Inc. CO2 sampling lines are used to connect between the patient's end of the breathing system and the distant analyzer, such as the capnograph monitor, along this tube, the patient's breath is continuously sampled. the gas sampling is exhaust only and there is no gas flow back to patient.

The Barbaras Development Inc. CO2 Sampling Lines are a disposable, single patient use that allow to sample of patients exhaled gases. It consists of flexible extruded plastic tubes with and standard connectors on each end. We will present several different configurations like have the filter or without filter in the middle which have been tested and compared to predicates.

The Barbaras Development Inc. CO2 Sampling Lines are offered in the following models: 0184 CO2 Sampling line, 0184T CO2 Sampling line, 0139 CO2 Sampling line, 0182 CO2 Sampling line.

Gas sampling devices are not specific to a particular exhaled gas monitor. Almost all gas sampling line are connected to the monitor via a standard luer fitting, whether it is a female or male fitting.

AI/ML Overview

The provided FDA 510(k) clearance letter details the clearance of CO2 Sampling lines manufactured by Barbaras Development Inc. The clearance is based on substantial equivalence to a predicate device, Tylenol Medical Instruments Co., Ltd - K181981 - CO2 sampling line, and a reference device, ProMedic – Gas Sampling Lines – K023579.

It's important to note that this document is a 510(k) summary for a medical device that is an accessory (CO2 sampling lines) and not an AI/ML powered diagnostic or prognostic tool. Therefore, many of the requested elements, such as MRMC studies, effect size of AI assistance, standalone algorithm performance, number of experts for ground truth, adjudication methods, and training set details, are not applicable to this type of device and are not present in the provided text. The evaluation focuses on physical characteristics, material compatibility, and basic performance parameters against established standards.

Here's the breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes "Non-Clinical Testing Summary" and "Performance testing" categories, indicating that these were the acceptance criteria for the device. The reported performance is generally stated as "performed equivalent to the predicate" and "All testing demonstrated that the subject devices are substantially equivalent to the predicate." No specific numerical results are provided in this summary.

Acceptance Criteria Category	Specific Tests/Criteria	Reported Device Performance
Material/Design	Biocompatibility (Cytotoxicity, Sensitization, Irritation)	Similar to predicate, met ISO 10993 testing requirements for skin contact (limited duration < 24 hours). The gas sampling line is exhaust only with no gas flow back to the patient.
Mechanical/Physical	Age testing	Performed equivalent to the predicate.
	Mechanical testing	Performed equivalent to the predicate.
	Luer Fitting	Meets ISO 80369-7. (Predicate used ISO 594-2, but subject device meets the updated standard)
	Flow / leaks	Meets ISO 80601-2-55. (Referred to as "Back pressure (Resistance to flow)" in the subject device's testing)
	Strength of bonds	Performed equivalent to the predicate. (Referred to as "Bond strength (Tensile strength of connections)" in the subject device's testing)
	Tensile Strength	Performed equivalent to the predicate. (Referred to as "Bond strength (Tensile strength of connections)" in the subject device's testing)
Functional Equivalence	Indications for Use	Similar to predicate, both monitor exhaled gases.
	Environment of Use	Identical to predicate (hospital, sub-acute, pre-hospital).
	Patient Population	Similar to predicate (pediatrics to adults/neonates).
	Duration of Use	Similar to predicate (single patient, disposable, less than 24h).
	Prescriptive	Similar; both are prescription devices.
	Mode of Operation	Similar (conduit from patient interface to monitor).
	Gas sampling connection	Similar (Luer slip fit or luer lock).
	Sampling tubing specs	Subject device IDs (1.0 & 1.5 mm) fall within range of predicate (1.10 mm) and reference (1.27 mm & 1.524 mm). Lengths differ but are generally comparable as sample lines.
	Materials	Similar (PVC tubing, Polypropylene/ABS connectors).

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

The document does not specify the sample size used for the non-clinical testing (test set) or any specific data provenance beyond the general statement that testing was performed.

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

Not applicable. This device is a passive accessory (CO2 sampling line) and does not involve subjective interpretation or diagnosis by experts to establish a "ground truth" as would be the case for an AI-powered diagnostic device. Its performance is measured against engineering standards and functional equivalence.

4. Adjudication Method for the Test Set

Not applicable. There is no "ground truth" established by experts that would require an adjudication method for this type of device. Performance is determined by objective physical and functional tests against industry standards.

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

Not applicable. This letter is for a CO2 sampling line, which is a physical accessory, not an AI-powered medical device.

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

Not applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used

The "ground truth" for this device's performance evaluation is established through objective engineering standards and performance specifications (e.g., ISO 80369-7 for luer fittings, ISO 80601-2-55 for flow/leaks, and ISO 10993 for biocompatibility) and comparative functional equivalence to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML or algorithm-based device.

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

Not applicable. This device does not involve a training set.

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov

June 4, 2025

Barbaras Development Inc.
℅ Paul Dryden
President
ProMedic, LLC
131 Bay Point Dr. NE
St. Petersburg, Florida 33704

Re: K251216
Trade/Device Name: 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
Regulation Number: 21 CFR 868.1400
Regulation Name: Carbon Dioxide Gas Analyzer
Regulatory Class: Class II
Product Code: CCK
Dated: April 16, 2025
Received: April 18, 2025

Dear Paul Dryden:

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 (the 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 available 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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K251216 - Paul Dryden Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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K251216 - Paul Dryden Page 3

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley Q. Quinn -S

Bradley Quinn
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K251216

Device Name: 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line

Indications for Use (Describe):

The CO2 Sampling lines are the single patient, disposable device intended for monitoring expired gases from the patient.

Environment of use – hospital, sub-acute, and pre-hospital settings.

Patient population – Patients requiring expired gas monitoring.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Page 5

510(k) Summary

Page 1 of 5

Date Prepared: 16-Apr-25

Sponsor: Barbaras Development Inc.
3567 OLD CONEJO RD
Newbury Park, CA 91320

Sponsor Contact: Matthew Baile
Tel: 805-499-9194 & +86 186 7690 0100

Submission Correspondent: Paul Dryden
ProMedic, LLC

Proprietary or Trade Name: 0184 CO2 Sampling line, 0184T CO2 Sampling line, 0139 CO2 Sampling line, 0182 CO2 Sampling line

Common/Usual Name: CO2 Sampling Line

Classification Name: Analyzer, gas, carbon-dioxide, gaseous-phase (accessories)

Product Code: CCK

Predicate Device: Tylenol Medical Instruments Co., Ltd - K181981- CO2 sampling line

Common/Usual Name: CO2 Sampling Line

Classification Name: Analyzer, gas, carbon-dioxide, gaseous-phase (accessories)

Product Code: CCK

Reference Device: ProMedic – Gas Sampling Lines – K023579

Common/Usual Name: CO2 Sampling Line

Classification Name: Analyzer, gas, carbon-dioxide, gaseous-phase (accessories)

Product Code: CCK

Device Description

Barbaras Development Inc. CO2 Sampling lines are the accessories in breathing system and intended for sampling of exhaled gases for monitoring, typically end-tidal CO2.

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510(k) Summary
Page 2 of 5

The Barbaras Development Inc. CO2 Sampling Lines are offered in the following models: 0184 CO2 Sampling line, 0184T CO2 Sampling line, 0139 CO2 Sampling line, 0182 CO2 Sampling line.

Principle of Operation

The subject device is a gas sampling line that connects between the patient and the sampling monitor. The monitor uses vacuum to pull a small sample of expired gas from the patient through the breathing circuit. It is a conduit for a gas sample to be taken from the patient directly to the gas monitor.

Indications for Use:

The CO2 Sampling lines are the single patient, disposable device intended for use when monitoring patient expired gases.

Environment of use – hospital, sub-acute, and pre-hospital settings.

Patient population – Patients requiring expired gas monitoring.

Patient Population: Patients requiring expired gas monitoring.

Environments of use: Hospital, sub-acute, and pre-hospital settings.

Substantial Equivalence Discussion

The table below compares the key features of the proposed CO2 sampling lines with the identified predicate, K181981 and it demonstrates that the subject devices can be found to be substantially equivalent. The reference device – Gas Sampling Lines – K023579 – has the same size ID as the largest subject device ID. It also lists lines with in-line filter.

In summary, it can be concluded that substantial equivalence is met based on the following discussions:

Indications for Use –
The indications for use are similar for the proposed device when compared to the predicate.
Discussion – Each device is indicated for use sampling expired gases.

Technology and construction –
The design, configurations, shape, size, etc. are equivalent to the predicate and reference.

Discussion of Differences –
The design incorporates a simple means to interface with the patient interfaces with sampling ports such as breathing/ventilator circuit. There are virtually no differences between the proposed devices

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510(k) Summary
Page 3 of 5

and the predicate. Any difference in performance does not raise any different risk concerns compared to the predicate or reference.

Environment of Use –
The environments of use are identical to predicate.
Discussion –There are no differences in the requirements of each environment of use which would raise any new safety concerns when compared to the predicate.

Patient Population –
The patient population of pediatrics to adults is equivalent to the predicate. However, the population is dictated by the gas monitor indications to which the sample line is attached.
Discussion – The patient populations are equivalent to the predicate.

Non-Clinical Testing Summary –
We performed comparative testing of the appropriate performance functions and features.

The tests included:

Age testing
Mechanical testing
Luer Fitting per ISO 80369-7
Flow / leaks per ISO 80601-2-55
Strength of bonds
Tensile Strength

The results show that the subject devices performed equivalent to the predicate. All testing demonstrated that the subject devices are substantially equivalent to the predicate.

Substantial Equivalence Conclusion

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.

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510(k) Summary
Page 4 of 5

Table - Comparison of Subject vs. Predicate and Reference Devices

Attributes	Predicate DeviceTylenol Medical Instruments Co., LtdCO2 Sampling lineK181981	Subject Device0184 CO2 Sampling line0184T CO2 Sampling line0139 CO2 Sampling line0182 CO2 Sampling line	Reference DeviceProMedic, Inc.Gas Sampling LinesK023579	Comments
Indications for Use	The CO2 Sample Lines are intended to be used where exhaled gas is monitored.The intended population: Patients requiring expired gas monitoring, adult to pediatrics.The intended environment of use: Hospital-OR, sub-acute, and pre-hospital setting.	The CO2 Sampling lines are single patient, disposable device intended for use when monitoring patient expired gases.Environment of use – hospital, sub-acute, and pre-hospital settings.Patient population – Patients requiring expired gas monitoring.	The gas sampling lines are intended to connect from a port in the breathing circuit to the expired gas monitor.	All indicated to provide monitoring of exhaled gasesThe reference device is included only for the sampling tube ID specifications.
Environment of Use	Hospitals and / or sub-acute, pre-hospital	Hospital, sub-acute, clinic, physician offices, pre-hospital	Hospitals and / or sub-acute	Similar
Patient Population	Patient requiring sampling of expired gases	Patients requiring expired gas monitoring, adult to neonates	Not provided	Similar
Duration of Use	Single patient, disposable	Single patient, disposable	Single patient, disposable	Similar
Prescriptive	Yes	Yes	Yes	Similar
Sampling tubing specs	ID – 1.10 mmLength – 2 m	ID – 1.0 and 1.5 mmLength – 3~3.25m	ID – 0.050 inches (1.27mm) and 0.060 inches (1.524 mm) /Length – 8, 10, and 15 feet	The reference device has gas sampling lines cleared slightly above the maximum ID presented for the subject device.
Mode of Operation	Connector to sample from the patient Nasal cannula, nares connector or sampling Port Small bore tubing. Connects to expired gas monitor.	Monitoring exhaled gas via a gas sampling line connected from patient interface with sampling port to capnograph.	Connects to a port in the breathing circuit to the expired gas monitor.	Similar
Gas sampling connection	Luer slip fit or luer lock	Luer slip fit or luer lock	Luer slip fit or luer lock	Similar
Materials	Cannula and tubing - PVCConnectors – Polypropylene, ABS	Tubing - PVCConnectors – Polypropylene, ABS	Tubing – PVCConnectors – Not listed	Similar
Biocompatibility	Indirect contact and direct (skin) contact with the patientISO 10993 testing	Skin contact: Limited duration of use (< 24 hours)ISO 10993 testing	Not listed	Similar(Note: the gas sampling line is exhaust only and there is

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510(k) Summary
Page 5 of 5

Attributes	Predicate DeviceTylenol Medical Instruments Co., LtdCO2 Sampling lineK181981	Subject Device0184 CO2 Sampling line0184T CO2 Sampling line0139 CO2 Sampling line0182 CO2 Sampling line	Reference DeviceProMedic, Inc.Gas Sampling LinesK023579	Comments
	• Cytotoxicity• Sensitization• Irritation	• Cytotoxicity• Irritation• Sensitization		no gas flow back to patient.)Per the 4/6/24 clarification call skin contact was agreed as the only testing needed
Limited duration of use	Less than 24h	Less than 24h	Not listed	Similar
Performance testing	Resistance to flowTensile strength of connectionsLuer fitting testing per ISO594-2Age testing - EnvironmentalMechanical testing	Back pressure (Resistance to flow)Bond strength (Tensile strength of connections)Luer fitting testing per ISO80369-7Age testing - EnvironmentalMechanical testing	Not listed	Performance testingISO 80369-7 and ISO 80601-2-55

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).