ClearLine IV™ is intended for detection and automatic removal of air in intravenous (IV) lines during administration of IV solutions, blood, and blood products. It is indicated for use in critical care areas such as the operating room (OR), postanesthesia care unit (PACU), and intensive care unit (ICU). ClearLine IV™ is placed between the patient and the V source and can be used with or without fluid warmers.

Device Description

The ClearLine IV™ is a modification to the predecessor device, the AirPurge™ System. Both devices consist of two main components, the control unit and the sterile, single-use disposable cartridge. The control unit is mounted to the I.V. pole using a pole clamp attached to the back of the control unit. The disposable cartridge is loaded onto the control unit and connected to the infusion line between the infusion source and the patient. During infusion, air entering the cartridge will be detected by an ultrasonic sensor in the control unit, which will automatically close the patient line and divert the fluid flow containing the air to the waste collection bag. A second ultrasonic sensor in the control unit monitors the line to the waste collection bag. When both sensors detect liquid again, flow to the patient is resumed.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called ClearLine IV™, an automated air removal system for IV lines. It focuses on demonstrating the device's substantial equivalence to a predicate device (AirPurge™ System) through non-clinical testing.

However, the document does not contain information related to a study that proves the device meets acceptance criteria through the analysis of "reported device performance" in the context of an AI/ML-based medical device evaluating images or data with human experts.

The "acceptance criteria" and "device performance" described in the document relate to functional requirements of a mechanical/electronic device (e.g., air sensor response time, minimal detectable air volume, flow rates, software functions, electrical safety, biocompatibility, sterilization validation, package integrity, and human factors).

Therefore, it's not possible to extract the requested information (table of acceptance criteria with reported device performance for an AI/ML output, sample sizes for test/training sets in an AI/ML context, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, type of ground truth used for AI, etc.) from the provided text.

The document explicitly states under "J. Clinical Testing": "Clinical testing was not required to support this 510(k)." This further indicates that the device's validation did not involve studies with human subjects or expert readers interpreting data in a clinical performance setting as would be expected for an AI/ML medical device.

In summary, the provided text does not contain the information necessary to describe an AI/ML device's acceptance criteria and the study that proves it meets those criteria in the manner requested by the prompt.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 25, 2018

ClearLine MD % Sheila Hemeon-Heyer Founder and President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002

Re: K171954

Trade/Device Name: ClearLine IVTM Regulation Number: 21 CFR 880.5445 Regulation Name: Intravascular Administration Set, Automated Air Removal System Regulatory Class: Class II Product Code: OKL Dated: December 22, 2017 Received: December 26, 2017

Dear Ms. Sheila Hemeon-Heyer:

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.

{1}------------------------------------------------

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Tina
Kiang-S

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K171954

Device Name

ClearLine IV™

Indications for Use (Describe)

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted per the requirements of 21 CFR 807.92.

A.	Submitter:	Heyer Regulatory Solutions LLC
		P.O. Box 2151
		Amherst, MA 01004-2151
		Contact: Sheila Hemeon-Heyer
		Sheila@heyer-regulatory.com

B. Manufacturer/ ClearLine MD 300 Trade Center, Suite 5400 510(k) Applicant: Woburn, MA 01801 Contact: Rick Romeo VP Operations, Quality and Regulatory Affairs (781) 933-6500 rromeo@clearlinemd.com
C. Date Prepared: January 16, 2018

D. Device Name and Classification Information:

Trade Name:	ClearLine IV™
Classification Name:	Intravascular Administration Set, Automated Air
	Removal System
Regulation:	21 CFR 880.5445
Product Code:	OKL
Review Panel:	General Hospital
Class:	II

DEN080009, AirPurge™ System E. Predicate Device(s):

F. Summary Device Description:

{4}------------------------------------------------

Both the ClearLine IV™ and AirPurge™ have the same air detection and removal response time of less than 60 msec. Both devices can detect air bubbles as small as 25 µL with fluid volume loss per purge of 0.1 mL at a typical flow rate of 300 mL/hr.

The modifications resulting in the ClearLine™ IV are:

. Redesign of the cartridge for improved fluid flow
. Redesign of the user interface to provide more comprehensive information to the user

G. Indications for Use Statement:

ClearLine IV™ is intended for detection and automatic removal of air in intravenous (IV) lines during administration of IV solutions, blood, and blood products. It is indicated for use in critical care areas such as the operating room (OR), postanesthesia care unit (PACU), and intensive care unit (ICU). ClearLine IV is placed between the patient and the IV source and can be used with or without fluid warmers.

H. Technical Comparison with Predicate Device

The table below provides a side-by-side comparison of the modified to legally marketed device.

	Cleared DeviceAirPurge™ System(DEN080009)	Modified DeviceClearLine IV™	Same or Discussion ofDifferences
Indications forUse	The AirPurge™ is intended fordetection and automatic removalof air in intravenous (IV) linesduring administration ofintravenous solutions, blood andblood products. It is indicated foruse in the Operating Room andpost anesthesia care areas. TheAirPurge™ System is placeddistal to I.V. bags using gravityfeed or pressure, and may beused with or without fluidwarmers.	ClearLine IV™ is intended fordetection and automatic removalof air in intravenous (IV) linesduring administration of IVsolutions, blood, and bloodproducts. It is indicated for use incritical care areas such as theoperating room (OR), post-anesthesia care unit (PACU), andintensive care unit (ICU).ClearLine IV is placed betweenthe patient and the IV source andcan be used with or without fluidwarmers.	Clarification added thatdevice is used in criticalcare areas, including theICU. Clarification added toassure that the device isplaced between the patientand IV source
SystemComponents	Control unitSterile, single-use disposablecartridgeWaste outlet lineWaste collection bag	Control unitSterile, single-use disposablecartridgeWaste outlet lineWaste collection bag	Same
	Cleared DeviceAirPurge™ System(DEN080009)	Modified DeviceClearLine IV™	Same or Discussion ofDifferences
Air detectionand removalresponse time	Less than 60 msec	Less than 60 msec	Same
Minimaldetectable airvolume	25 µL	25 µL	Same
Flow rates forreliabledetection andair removal	1 mL/min to 600 mL/min	1 mL/min to 600 mL/min	Same
Fluid lossduring airremoval as afunction of flowrate	600 mL/min: ~10 mL300 mL/hr: ~0.1 mL	600 mL/min: ~10 mL300 mL/hr: ~0.1 mL	Same
Softwarecontrolled	Yes	Yes	Same
Indicators andalarms	Discrete LEDs with limitedcharacters	Status displayed on LCD andlonger text messages providemore descriptive information touser	Redesigned I/O enablesmore informativemessaging regarding devicestatus
Method ofdetecting air	Ultrasonic sensors	Ultrasonic sensors	Same
Patientcontactingmaterials(cartridge)	Medical grade polymers:PVCSANABSD	Medical grade polymers:PVCPolycarbonateMBS	Biocompatibility of all fluidpath materials confirmed bytesting conducted inconformance withapplicable ISO 10993standards.
CartridgeSterilization	EtO	EtO	Same
Power	AC line and rechargeable batteryoperation. Adapter rated at 15watts. AC Source: 100-240V, 50-60 Hz, 400 mA. 5 hours typicalbattery life on fully chargedbattery.	AC line and rechargeable batteryoperation. Adapter rated at 15watts. AC Source: 100-240V, 50-60 Hz, 400 mA. 5 hours typicalbattery life on fully chargedbattery.	Same
Control UnitDimensions	H 5.5 in (14 cm)W 5 in (13 cm)D 5 in (13 cm)	H 5.5 in (14 cm)W 5 in (13 cm)D 5 in (13 cm)	Same
Control UnitWeight (withbattery)	2.3 lbs (1.05 kg)	2.3 lbs (1.05 kg)	Same

{5}------------------------------------------------

{6}------------------------------------------------

l. Non-Clinical Testing

The following non-clinical testing was conducted for verification and validation of the system requirements and to support substantial equivalence under this 510(k). All testing met the pre-defined acceptance criteria and were considered to have passed.

a. Performance testing to verify the following functional requirements
- i. System start-up upon inserting the cartridge and closing the controller door
- ii. Cartridge priming
- iii. Cartridge leak testing
- iv. Air sensor response time (ultrasound sensors) at low and high flow rates
- v. Air detection to solenoid reaction time at low and high flow rates
- vi. Detection and removal of air bubbles ≥ 25 µl at low and high flow rates when infusing water and blood, with and without a fluid warmer
- vii. Detection and removal of air bubbles ≥ 25 µl at low and high flow rates when infusing lipids
- viii. System operation when the unit is tilted in any of four directions (forward, backward, left, right)
- ix. System operation when used with in-line filters and small diameter extension tubing
- x. System operation when used with infusion and syringe pumps
- xi. System power and battery requirements
- xii. Solenoid life expectancy testing
b. Software verification and validation testing of all software requirements including:
- i. Controller start-up self-test
- ii. Software monitoring of system operation
- iii. Controller interface operations, including alarm situations (high and medium priorities)
c. Electrical safety testing in conformance with IEC/EN 60601-1:2006 + A1:2013 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
d. Electromagnetic compatibility testing in conformance with IEC 60601-1-2:2007 General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests and IEC 60601-1-2:2014 for Special Environments (immunity to low frequency equipment found in the OR such as electrosurgery and RFID)
e. Sterilization validation for the sterile cartridge
- i. Validation of the EtO sterilization cycle according to ISO 11135 to an SAL of 10-6
- ii. EtO residuals testing according to ISO 10993-7:2008
- iii. LAL testing according to USP <85>

{7}------------------------------------------------

f. Biocompatibility testing on the finished, sterilized cartridge (fluid contacting pathway) in compliance with ISO 10993 and FDA's guidance, "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," June 16, 2016. Device is categorized as externally communicating, prolonged contact, indirect blood contacting.
- ISO 10993-5:2009: Cytotoxicity MEM elution test i.
- ii. ISO 10993-10:2010: Sensitization: guinea pig maximization
- iii. ISO 10993-10:2010: Intracutaneous reactivity in rabbits
- ISO 10993-11:2006: Acute systemic toxicity in mice iv.
- ISO 10993-11:2006 and USP <151> Pyrogen Test: Material-V. mediated pyrogenicity test in rabbits
- i. ISO 10993-4:2002 and ASTM F756-13: Direct contact and indirect contact hemolysis testing
- ISO 10993-4:2002: Complement activation testing ii.
- iii. ISO 10993-18:2005: Chemical characterization and toxicological risk assessment
Package validation testing of cartridge pouches after 2X EtO sterilization g. was conducted at time 0, after environmental conditioning per ISTA 2A and distribution conditioning per ASTM D4169-16, and after accelerated aging per ASTM F1980-16. Tests conducted included:
- i. Seal strength test according to ASTM F88/F88M-15
- ii. Bubble leak test according to ASTM F2096-11
h. Cartridge integrity and functionality testing was also conducted on samples that had been subjected to the 2X sterilization, environmental, distribution, and aging conditions. Tests conducted included:
- i. Cartridge leak test
- ii. Verification of bubble detection and removal at low and high flow rates
i. A summative human factors study and Human Factors Engineering Report per FDA's guidance on "Applying Human Factors and Usability Engineering to Medical Devices," February 3, 2016.

J. Clinical Testing

Clinical testing was not required to support this 510(k).

K. Conclusion

The information and testing presented in this 510(k) demonstrate that the ClearLine IV™ is substantially equivalent to the predicate device, the AirPurge™ System.

Regulation Number and Section

§ 880.5445 Intravascular administration set, automated air removal system.

(a)
Identification. An intravascular administration set, automated air removal system, is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the intravascular fluid. The device may include an air identification mechanism, software, an air removal mechanism, tubing, apparatus to collect removed air, and safety control mechanisms to address hazardous situations.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Provide an argument demonstrating that all reasonably foreseeable hazards have been adequately addressed with respect to the persons for whose use the device is represented or intended and the conditions of use for the device, which includes the following:
(i) Description of the device indications for use, design, and technology, use environments, and users in sufficient detail to determine that the device complies with all special controls.
(ii) Demonstrate that controls are implemented to address device system hazards and their causes.
(iii) Include a justification supporting the acceptability criteria for each hazard control.
(iv) A traceability analysis demonstrating that all credible hazards have at least one corresponding control and that all controls have been verified and validated in the final device design.
(2) Appropriate software verification, validation, and hazard analysis must be performed.
(3) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of fluid path contacting components and the shelf life of these components.
(5) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC).
(6) Nonclinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Device system and component reliability testing must be conducted.
(ii) Fluid ingress protection testing must be conducted.
(iii) Testing of safety controls must be performed to demonstrate adequate mitigation of hazardous situations, including sensor failure, flow control failure, improper device position, device malfunction, infusion delivery error, and release of air to the patient.
(7) A human factors validation study must demonstrate that use hazards are adequately addressed.
(8) The labeling must include the following:
(i) The device's air identification and removal response time.
(ii) The device's minimum air volume identification sensitivity.
(iii) The minimum and maximum flow rates at which the device is capable of reliably detecting and removing air.
(iv) Quantification of any fluid loss during device air removal operations as a function of flow rate.