(210 days)
Not Found
No
The description focuses on ultrasonic sensors and automated mechanical responses, with no mention of AI or ML terms or concepts.
Yes
The device is intended for the detection and automatic removal of air in IV lines, which directly impacts the safety and efficacy of fluid and blood administration to a patient, thus providing a therapeutic benefit by preventing potential harm from air embolisms.
No
The device is designed to detect and remove air in IV lines to prevent air embolisms, which is a therapeutic rather than a diagnostic function. While it detects air, this detection is not for the purpose of informing a diagnosis of a patient's condition, but rather for directly intervening in the treatment process (by removing the air).
No
The device description clearly states it consists of two main components: a control unit (hardware) and a disposable cartridge (hardware). It also mentions ultrasonic sensors and a solenoid, which are hardware components. While there is software involved (mentioned in the performance studies), the device is not solely software.
Based on the provided information, the ClearLine IV™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the "detection and automatic removal of air in intravenous (IV) lines during administration of IV solutions, blood, and blood products." This is a function performed on the fluid being administered to the patient, not on a sample taken from the patient for diagnostic purposes.
- Device Description: The device works by detecting air bubbles within the IV line and diverting the fluid containing the air. This is a mechanical and ultrasonic process related to the delivery of fluids, not the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents or assays typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The ClearLine IV™'s function is related to the safe delivery of fluids, not the diagnosis or monitoring of a patient's condition through sample analysis.
N/A
Intended Use / Indications for Use
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.
Product codes
OKL
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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
critical care areas such as the operating room (OR), postanesthesia care unit (PACU), and intensive care unit (ICU).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Performance testing to verify functional requirements, including system start-up, cartridge priming, cartridge leak testing, air sensor response time, air detection to solenoid reaction time, detection and removal of air bubbles (≥ 25 µl) with various fluids (water, blood, lipids) and flow rates, system operation when tilted, and system operation with in-line filters, extension tubing, infusion, and syringe pumps. Also included system power/battery requirements and solenoid life expectancy testing.
- Software verification and validation testing of all software requirements: controller start-up self-test, software monitoring of system operation, and controller interface operations (including alarms).
- Electrical safety testing in conformance with IEC/EN 60601-1:2006 + A1:2013.
- Electromagnetic compatibility testing in conformance with IEC 60601-1-2:2007 and IEC 60601-1-2:2014.
- Sterilization validation for the sterile cartridge, including EtO sterilization cycle validation (ISO 11135), EtO residuals testing (ISO 10993-7:2008), and LAL testing (USP ).
- 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 categorized as externally communicating, prolonged contact, indirect blood contacting. Tests included:
- Cytotoxicity MEM elution test (ISO 10993-5:2009)
- Sensitization: guinea pig maximization (ISO 10993-10:2010)
- Intracutaneous reactivity in rabbits (ISO 10993-10:2010)
- Acute systemic toxicity in mice (ISO 10993-11:2006)
- Material-mediated pyrogenicity test in rabbits (ISO 10993-11:2006 and USP )
- Direct contact and indirect contact hemolysis testing (ISO 10993-4:2002 and ASTM F756-13)
- Complement activation testing (ISO 10993-4:2002)
- Chemical characterization and toxicological risk assessment (ISO 10993-18:2005)
- Package validation testing of cartridge pouches after 2X EtO sterilization: Seal strength test (ASTM F88/F88M-15) and bubble leak test (ASTM F2096-11).
- Cartridge integrity and functionality testing on samples subjected to sterilization, environmental, distribution, and aging conditions: Cartridge leak test and verification of bubble detection and removal at low and high flow rates.
- 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.
All testing met the pre-defined acceptance criteria and were considered to have passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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.
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) |
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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:
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.
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 Device
AirPurge™ System
(DEN080009) | Modified Device
ClearLine IV™ | Same or Discussion of
Differences |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The AirPurge™ is intended for
detection and automatic removal
of air in intravenous (IV) lines
during administration of
intravenous solutions, blood and
blood products. It is indicated for
use in the Operating Room and
post anesthesia care areas. The
AirPurge™ System is placed
distal to I.V. bags using gravity
feed or pressure, and may be
used with or without fluid
warmers. | 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), post-
anesthesia 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. | Clarification added that
device is used in critical
care areas, including the
ICU. Clarification added to
assure that the device is
placed between the patient
and IV source |
| System
Components | Control unit
Sterile, single-use disposable
cartridge
Waste outlet line
Waste collection bag | Control unit
Sterile, single-use disposable
cartridge
Waste outlet line
Waste collection bag | Same |
| | Cleared Device
AirPurge™ System
(DEN080009) | Modified Device
ClearLine IV™ | Same or Discussion of
Differences |
| Air detection
and removal
response time | Less than 60 msec | Less than 60 msec | Same |
| Minimal
detectable air
volume | 25 µL | 25 µL | Same |
| Flow rates for
reliable
detection and
air removal | 1 mL/min to 600 mL/min | 1 mL/min to 600 mL/min | Same |
| Fluid loss
during air
removal as a
function of flow
rate | 600 mL/min: ~10 mL
300 mL/hr: ~0.1 mL | 600 mL/min: ~10 mL
300 mL/hr: ~0.1 mL | Same |
| Software
controlled | Yes | Yes | Same |
| Indicators and
alarms | Discrete LEDs with limited
characters | Status displayed on LCD and
longer text messages provide
more descriptive information to
user | Redesigned I/O enables
more informative
messaging regarding device
status |
| Method of
detecting air | Ultrasonic sensors | Ultrasonic sensors | Same |
| Patient
contacting
materials
(cartridge) | Medical grade polymers:
PVC
SAN
ABSD | Medical grade polymers:
PVC
Polycarbonate
MBS | Biocompatibility of all fluid
path materials confirmed by
testing conducted in
conformance with
applicable ISO 10993
standards. |
| Cartridge
Sterilization | EtO | EtO | Same |
| Power | AC line and rechargeable battery
operation. Adapter rated at 15
watts. AC Source: 100-240V, 50-
60 Hz, 400 mA. 5 hours typical
battery life on fully charged
battery. | AC line and rechargeable battery
operation. Adapter rated at 15
watts. AC Source: 100-240V, 50-
60 Hz, 400 mA. 5 hours typical
battery life on fully charged
battery. | Same |
| Control Unit
Dimensions | 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 Unit
Weight (with
battery) | 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
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 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.