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.

AI/ML Overview

Here's an analysis of the AirPurge System's acceptance criteria and the studies proving it meets them, based on the provided text:

Acceptance Criteria and Device Performance (Table 1 and 5)

Acceptance Criteria	Reported Device Performance	Study Type/Reference
The device's air identification and removal response time.	Less than 60 milliseconds	Non-clinical study (implied by "device's air identification and removal response time" in labeling controls).
The device's minimum air volume identification sensitivity.	25 microliters	"Limits of Air Detection" Non-clinical study (Characterization Test)
The minimum and maximum flow rates at which the device is capable of reliably detecting and removing air.	Minimum: 1 mL/hrMaximum: 600 mL/hr	"Flow Rate" Non-clinical study (Pass/Characterization)
Quantification of any fluid loss during device air removal operations as a function of flow rate.	600 mL/min: 10 mL300 mL/hr: 0.1 mL	"Fluid Loss" Non-clinical study (Characterization Test)

Study Information

The provided document describes non-clinical/bench studies to demonstrate the AirPurge System's performance and safety. It does not detail any clinical studies, MRMC studies, or standalone algorithm performance studies in the way typically associated with AI/software-as-a-medical-device (SaMD). The device itself appears to be a physical device with embedded software and sensors, not an AI diagnostic algorithm.

Here's the breakdown of the available information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each specific performance characteristic (e.g., how many air bubbles of 25 microliters were tested, or how many purge cycles were performed at each flow rate). The studies are referred to as "non-clinical/bench studies," suggesting laboratory-based testing rather than patient data.
- Data Provenance: The data is generated from non-clinical/bench testing conducted by Anesthesia Safety Products, LLC. There is no mention of country of origin of data or retrospective/prospective human data, as these were not clinical trials.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the described studies. The "ground truth" for the performance characteristics (e.g., actual air volume, actual flow rate, actual fluid loss, actual response time) would be established by the precise instrumentation and methodologies used in the bench testing, not by expert human interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of human image data or clinical cases to establish a consensus ground truth. The studies described are bench tests with objective, measurable parameters.
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:
- No MRMC comparative effectiveness study was done or described. This device is an automated physical system for air removal, not an AI diagnostic tool designed to assist human readers/clinicians in interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in the context of the device's function. The device (which includes embedded software) performs its air detection and removal function "standalone" as an automated system. The non-clinical performance tests ("Limits of Air Detection," "Fluid Loss," "Flow Rate," "Response Time") directly assess this standalone performance of the device system. However, this is not a standalone AI algorithm in the typical sense of a diagnostic or predictive model.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for the non-clinical performance studies was established through controlled laboratory measurements and characterization. For example:
  - Air volume: Precisely measured air injection.
  - Flow rate: Precisely controlled fluid flow rates.
  - Fluid loss/response time: Measured by instruments during testing.
- For other aspects like biocompatibility, sterilization, and electrical safety, the ground truth refers to conformance with established standards and the results of laboratory tests.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model in the typical sense that would require a "training set" of data. The software within the device is likely more rule-based or deterministic, rather than a learned model.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for an AI model.

Summary of Studies and Evidence:

The AirPurge System's regulatory approval is based on a comprehensive set of non-clinical/bench studies that verify its physical and software performance, safety controls, biocompatibility, sterility, electrical safety, and human factors. These studies, rather than clinical trials with human data, directly address the acceptance criteria related to its technical specifications (air detection, flow rates, fluid loss, response time) and hazard mitigation. The "ground truth" for these studies is derived from controlled laboratory conditions and measurements against predefined technical specifications and regulatory standards.

Summary

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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

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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 Lossper 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.

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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

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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 StudiesTest	Purpose	Acceptance Criteria	Results
(b)(4) Trade Secret Formula & Process			Pass
ComponentReliabilityAssessment	(b)(4) Trade Secret Formula & Process		Pass
Flow Rate			Pass
Fluid Loss	Characterize the fluid loss per airremoval cycle as a function of flowrate. Results included in labeling.	Characterization TestFlow Rate Fluid Volume Lossper Purge 600mL/min 10 mL 300mL/hr 0.1 mL
Limits of AirDetection	Characterize the minimum air volumedetection and removal capability ofthe device.	Characterization TestMinimum Detectable AirVolume 25 microliter
Safety Controls	(b)(4) Trade Secret Formula & Process		Pass

System Nonelinical Studi Tablo 1

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	(b)(4) Trade Secret Formula & Process
Fluid Ingress			Pass
Biocompatibility	Demonstrate that contaminationhazards caused by non-biocompatibledevice components are adequatelyaddressed.	See biocompatibilityreview summary	Pass
Sterilization	Demonstrate that contaminationhazards caused by non-sterile devicecomponents are adequatelyaddressed.	See sterilizationreview summary	Pass
Shelf Life	Support the labeled(b)(4) TS Formula shelf lifefor disposable units.(b)(4) Trade Secret Formula & Process	Demonstrate sterilebarrier packagingintegrity andfunctionalperformance.	Pass
(b)(4) Trade Secret Formula & Process			Pass
ElectromagneticCompatibilityand Electrical	Demonstrate that electrical hazardsare adequately addressed.	Demonstrateconformance torelevant aspects of	Pass
Safety		the followingstandards:
		(b)(4) Trade Secret Formula & Process
		Appropriateinformation isincluded in theAirPurge Systeminstructions for use..
Software	Demonstrate that the software isadequately verified and validated forits intended use.	See software reviewsummary	Pass
Human Factors	Demonstrate that the design of theAirPurge System has adequatelyaddressed potential use error hazardsthat may result in patient harm.	See human factorsreview summary	Pass
Test	Method	Results
(b)(4) Trade Secret Formula & Process		Pass
		Pass
		Pass
		Pass
		Pass
		Pass
		Pass
		Pass

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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.

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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

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	Pass
Sterile Barrier Packaging	The sterile components are packaged in aTyvek/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

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(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 andremoval response time.	60 milliseconds
The device's minimum air volumeidentification sensitivity	25 microliters

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The minimum and maximum flow ratesat which the device is capable ofreliably detecting and removing air.	Minimum: 1 mL/hrMaximum: 600 mL/min
Quantification of any fluid loss duringdevice air removal operations as afunction of flow rate.	Flow Rate	Fluid Volume Loss perPurge
	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 ArgumentSoftwareElectromagnetic CompatibilityHuman FactorsLabelingNon-clinical Performance Testing
Infusion delivery error	Hazard ArgumentSoftwareElectromagnetic CompatibilityHuman FactorsLabelingNon-clinical Performance Testing
Electric Shock	Hazard ArgumentElectrical SafetyElectromagnetic Compatibility
Adverse Tissue Reaction	Hazard ArgumentBiocompatibility
Infection	SterilizationShelf 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.

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(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

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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

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.