K Number

Device Name

AIRPURGE

Manufacturer

ANESTHESIA SAFETY PRODUCTS, LLC

Date Cleared

2014-03-04

(1952 days)

Product Code

OKL

Regulation Number

880.5445

Intended Use

The AirPurge™ System is intended for detection and automatic removal of air in intravenous (I.V.) 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.

Device Description

The Airpurge System (AirPurge) is intended to detect and automatically remove air from an IV infusion line. Airpurge consists of two main components, the control unit and the disposable unit. The disposable unit (Figure-1a) contains the system fluid path and is a sterile, single-use component. This disposable unit is loaded onto the control unit (Figure-1b). The door of the control unit is then closed. Once the device is connected to the infusion line and primed, it uses an ultrasonic sensor to detect air in the infusion line. When air is detected, the device system closes the patient line and diverts the fluid flow to the waste collection bag. A second ultrasonic sensor detects when the air has been removed from the IV line and causes the controller to return the infusion flow back to the patient.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on ultrasonic sensors and control logic for air detection and removal, with no mention of AI or ML terms or concepts.

Therapeutic

Yes

This device is designed to prevent a harmful medical condition (air embolism) during intravenous administration, directly contributing to patient safety and health outcomes.

Diagnostic

The device is an automated air removal system for IV lines. While it uses sensors to detect air (a form of 'detection'), its primary function is to actively remove the air (intervention), not to provide a diagnosis of a patient's condition or to identify a disease or medical condition.

SaMD (Software as a Medical Device)

The device description explicitly states that the AirPurge System consists of two main components: a control unit and a disposable unit. These are physical hardware components, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the "detection and automatic removal of air in intravenous (I.V.) lines during administration of intravenous solutions, blood and blood products." This is a therapeutic and safety function related to the delivery of substances into the body, not the analysis of samples taken from the body.
Device Description: The device description focuses on the mechanical and electronic components that detect and remove air from the IV line. It does not mention any components or processes related to analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts with the fluid within the IV line, not with a sample taken from the patient for diagnostic purposes.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function falls outside of that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

OKL

Device Description

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

Operating Room and post anesthesia care areas.

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)

A series of non-clinical studies, summarized in Table 1, were conducted to verify that the AirPurge System performs as intended. These particular studies were chosen because of their relationship to demonstrating that the AirPurge System device hazards have been adequately addressed. The hazards are dependent on the context of use (e.g., indicated uses, use environments and users) and the device specific design.

Table 1 - AirPurge System Nonclinical Studies Test	Purpose	Acceptance Criteria	Results
(b)(4) Trade Secret Formula & Process			Pass
Component Reliability Assessment	(b)(4) Trade Secret Formula & Process		Pass
Flow Rate			Pass
Fluid Loss	Characterize the fluid loss per air removal cycle as a function of flow rate. Results included in labeling.	Characterization Test Flow Rate Fluid Volume Loss per Purge 600mL/min 10 mL 300mL/hr 0.1 mL
Limits of Air Detection	Characterize the minimum air volume detection and removal capability of the device.	Characterization Test Minimum Detectable Air Volume 25 microliter
Safety Controls	(b)(4) Trade Secret Formula & Process		Pass
Fluid Ingress			Pass
Biocompatibility	Demonstrate that contamination hazards caused by non-biocompatible device components are adequately addressed.	See biocompatibility review summary	Pass
Sterilization	Demonstrate that contamination hazards caused by non-sterile device components are adequately addressed.	See sterilization review summary	Pass
Shelf Life	Support the labeled(b)(4) TS Formula shelf life for disposable units. (b)(4) Trade Secret Formula & Process	Demonstrate sterile barrier packaging integrity and functional performance.	Pass
(b)(4) Trade Secret Formula & Process			Pass
Electromagnetic Compatibility and Electrical Safety	Demonstrate that electrical hazards are adequately addressed.	Demonstrate conformance to relevant aspects of the following standards: (b)(4) Trade Secret Formula & Process Appropriate information is included in the AirPurge System instructions for use..	Pass
Software	Demonstrate that the software is adequately verified and validated for its intended use.	See software review summary	Pass
Human Factors	Demonstrate that the design of the AirPurge System has adequately addressed potential use error hazards that may result in patient harm.	See human factors review summary	Pass

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Response Time: Less than 60 milliseconds
Minimum Detectable Air Volume: 25 microliter
Minimum Flow Rate: 1 mL/hr
Maximum Flow Rate: 600 mL/hr
Fluid Volume Loss per Purge:
- 600mL/min: 10 mL
- 300mL/hr: 0.1 mL

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

DE NOVO CLASSIFICATION REQUEST FOR AIRPURGE SYSTEM

REGULATORY INFORMATION

FDA identifies this generic type of device as:

INTRAVASCULAR ADMINISTRATION SET, AUTOMATED AIR REMOVAL SYSTEM

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.

NEW REGULATION NUMBER: 21 CFR 880.5445

CLASSIFICATION: Class II

PRODUCT CODE: OKL

BACKGROUND

DEVICE NAME: AirPurge System

SUBMISSION NUMBER: K080644

DATE OF DE NOVO: October 29, 2008

CONTACT: Anesthesia Safety Products, LLC 155-M New Boston Street, Suite 127 Woburn, Massachusetts 01801

REQUESTER'S RECOMMENDED CLASSIFICATION: Class II

INDICATIONS FOR USE

LIMITATIONS Prescription use only

Limitations on device use are also achieved through the following statements included in the Instructions for Use Manual:

Warning: The safety and effectiveness of the AirPurge System has not been evaluated for use with active infusion devices. such as drug infusion pumps and hemodialysis systems.

Caution: The AirPurge™ System is not a replacement for human vigilance. I.V. lines should always be monitored for signs of entrapped air.

Caution: All Users must be trained; training is required for the safe and proper use of the AirPurge™ System.

Caution: The AirPurge™ System is not a replacement for the proper handling of I.V. setups.

Air Identification and Removal Specifications:

1. The device's air identification and removal response time.
  Image /page/1/Figure/7 description: The image shows a table with two rows. The first row contains the text "Response Time" in bold font. The second row contains the text "Less than 60 milliseconds".
1. The device's minimum air volume identification sensitivity

Minimum Detectable Air Volume
25 microliter

1. The minimum and maximum flow rates at which the device is capable of reliably detecting and removing air.

Flow Rate Specifications
Minimum Flow Rate	1 mL/hr
Maximum Flow Rate	600 mL/hr

1. Quantification of any fluid loss during device air removal operations as a function of flow rate.

| Flow Rate | Fluid Volume Loss
per Purge |
|-----------|--------------------------------|
| 600mL/min | 10 mL |
| 300mL/hr | 0.1 mL |

PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

DEVICE DESCRIPTION

The Airpurge System (AirPurge) is intended to detect and automatically remove air from an IV infusion line.

Image /page/2/Picture/2 description: The image shows a medical device with clear tubing and connections. The device is labeled with terms like 'PRIMARY,' 'FRONT,' and 'EXTENSION,' indicating its function in a medical setting. One image shows the device mounted on a machine, while the other shows it hanging on a wall.

Figure-1a, Disposable Unit

Figure-1b, Control Unit

Airpurge consists of two main components, the control unit and the disposable unit. The disposable unit (Figure-1a) contains the system fluid path and is a sterile, single-use component. This disposable unit is loaded onto the control unit (Figure-1b). The door of the control unit is then closed. Once the device is connected to the infusion line and primed, it uses an ultrasonic sensor to detect air in the infusion line. When air is detected, the device system closes the patient line and diverts the fluid flow to the waste collection bag. A second ultrasonic sensor detects when the air has been removed from the IV line and causes the controller to return the infusion flow back to the patient.

SUMMARY OF NONCLINICAL/BENCH STUDIES

| Table 1 - AirPurge System Nonclinical Studies

Test	Purpose	Results
(b)(4) Trade Secret Formula & Process		Pass
Component
Reliability
Assessment	(b)(4) Trade Secret Formula & Process	Pass
Flow Rate		Pass
Fluid Loss	Characterize the fluid loss per air
removal cycle as a function of flow
rate. Results included in labeling.	Characterization Test
Flow Rate Fluid Volume Loss
per Purge 600mL/min 10 mL 300mL/hr 0.1 mL
Limits of Air
Detection	Characterize the minimum air volume
detection and removal capability of
the device.	Characterization Test
Minimum Detectable Air
Volume 25 microliter
Safety Controls	(b)(4) Trade Secret Formula & Process	Pass

System Nonelinical Studi Tablo 1

	(b)(4) Trade Secret Formula & Process
Fluid Ingress			Pass
Biocompatibility	Demonstrate that contamination
hazards caused by non-biocompatible
device components are adequately
addressed.	See biocompatibility
review summary	Pass
Sterilization	Demonstrate that contamination
hazards caused by non-sterile device
components are adequately
addressed.	See sterilization
review summary	Pass
Shelf Life	Support the labeled(b)(4) TS Formula shelf life
for disposable units.
(b)(4) Trade Secret Formula & Process	Demonstrate sterile
barrier packaging
integrity and
functional
performance.	Pass
(b)(4) Trade Secret Formula & Process			Pass
Electromagnetic
Compatibility
and Electrical	Demonstrate that electrical hazards
are adequately addressed.	Demonstrate
conformance to
relevant aspects of	Pass
Safety		the following
standards:
		(b)(4) Trade Secret Formula & Process
		Appropriate
information is
included in the
AirPurge System
instructions for use..
Software	Demonstrate that the software is
adequately verified and validated for
its intended use.	See software review
summary	Pass
Human Factors	Demonstrate that the design of the
AirPurge System has adequately
addressed potential use error hazards
that may result in patient harm.	See human factors
review summary	Pass
Test	Method	Results
(b)(4) Trade Secret Formula & Process		Pass
		Pass
		Pass
		Pass
		Pass
		Pass
		Pass
		Pass

BIOCOMPATIBILITY/MATERIALS

The biocompatibility and hemocompatibility (Table 2) testing included those tests recommended by FDA memorandum G95-1 entitled "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing' for externally communicating devices, prolonged duration, blood path, indirect devices.

The results of this testing demonstrated the disposable components of the AirPurge System is biocompatible when used as intended.

Table 2 - Biocompatibility Tests

STERILITY

Sterilization specifications (Table 3) were evaluated in a similar manner as IV administration sets.

Table 3 - Sterilization Data

Sterilization Information	Methods / Results
Sterilization Method	Ethylene Oxide
Sterilant Residuals	(b)(4) Trade Secret Formula & Process
Sterilization Validation Method	ANSI/AAMI/ISO 11135
Sterility assurance level (SAL):	10-6
Pyrogenicity Evaluation	(b)(4) Trade Secret Formula & Process

	Pass
Sterile Barrier Packaging	The sterile components are packaged in a
Tyvek/Poly pouch.

SOFTWARE

Software for the device consisted of proprietary software. The device software was reviewed and the provided documentation (Table 4) was found adequate and consistent with a 'MAJOR' Level of Concern , as defined in FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005.

FDA's review of the documentation determined that the documentation is complete and deemed acceptable.

Level of Concern: Major
Software description:	Acceptable
Device Hazard Analysis:	Yes
Software Requirements Specifications:	Yes
Architecture Design Chart:	Yes
Design Specifications:	Yes
Traceability Analysis/Matrix:	Yes
Development:	Yes
Verification & Validation Testing:	Yes
Revision level history:	Yes
Unresolved anomalies:	Yes

Table 4 - Software Documentation
----------------------------------	--

HUMAN FACTORS

A human factors study was conducted (b)(4) Trade Secret Formula & Process

A final human factors study report was reviewed for the following information:

(b)(4) Trade Secret Formula & Process

Based on the results of the study, Anesthesia Safety Products will require that all users Bases of the proper use of the AirPurge Systembly Trades Will Indessere Formula & Foo

A user task analysis identified the following tasks necessary for use of the device seret Formula &

(b)(4) Trade Secret Formula & Process

Specific use errors observed included:

(b)(4) Trade Secret Formula & Process

LABELING

(b)(4) Trade Secret Formula & Pro

In addition to meeting the general labeling controls for prescription devices under 21 CFR 801.109, the following specific labeling controls, as identified in Table 5, are included and necessary to reasonably ensure safety and effectiveness of the AirPurge System:

Table 5 - Labeling Controls

Labeling Control	AirPurge System Data
The device's air identification and
removal response time.	60 milliseconds
The device's minimum air volume
identification sensitivity	25 microliters

| The minimum and maximum flow rates
at which the device is capable of
reliably detecting and removing air. | Minimum: 1 mL/hr
Maximum: 600 mL/min | |
|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------|
| Quantification of any fluid loss during
device air removal operations as a
function of flow rate. | Flow Rate | Fluid Volume Loss per
Purge |
| | 600mL/min | 10 mL |
| | 300mL/hr | 0.1 mL |

RISKS TO HEALTH

Table 6 identifies the risks to health that may be associated with use of an intravascular administration set automated air removal system and the measures necessary to mitigate these risks.

Risk	Mitigation
Embolus	Hazard Argument
Software
Electromagnetic Compatibility
Human Factors
Labeling
Non-clinical Performance Testing
Infusion delivery error	Hazard Argument
Software
Electromagnetic Compatibility
Human Factors
Labeling
Non-clinical Performance Testing
Electric Shock	Hazard Argument
Electrical Safety
Electromagnetic Compatibility
Adverse Tissue Reaction	Hazard Argument
Biocompatibility
Infection	Sterilization
Shelf Life

Table 6 - Risks to Health and Mitigation Measures

SPECIAL CONTROLS:

In combination with the general controls of the FD&C Act, the AirPurge System is subject to the following special controls:

(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) Non-clinical 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.

In addition, this is a prescription device and must comply with 21 CFR 801.109.

IT/RISK DETERMINATION

The primary review criteria used to evaluate the device are the device's capability to detect and remove air from an infusion line. The characteristics evaluated are

Air detection and removal response time ●
Minimum air volume identification sensitivity
Minimum and Maximum flow rates at which the device is capable of reliably detecting ● and removing air

Quantification of fluid loss during air removal operations as a function of flow rate ) Trade Secret Formula & Proce

Many devices that include air detection mechanisms stop the drug delivery when the air is detected. The expected benefit of the Airpurge device is the prevention of air infusion coupled with the minimization of drug delivery interruptions.

In conclusion, given the available information above, the data support that for detection and automatic removal of air in intravenous (I.V.) lines during administration of intravenous solutions, blood and blood products, the probable benefits outweigh the probable risks for the AirPurge System. The device provides benefits and the risks can be mitigated by

CONCLUSION

The de novo for the AirPurge System is granted and the device is classified under the following:

Product Code: OKL Device Type: Intravascular Administration Set, Automated Air Removal System Class: II Regulation: 21 CFR 880.5445