← Product Code [OKL](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OKL) · DEN080009
# AIRPURGE (DEN080009)
_Anesthesia Safety Products, LLC · OKL · Mar 4, 2014 · General Hospital · DENG_
**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OKL/DEN080009
## Device Facts
- **Applicant:** Anesthesia Safety Products, LLC
- **Product Code:** [OKL](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OKL.md)
- **Decision Date:** Mar 4, 2014
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 880.5445
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic
## Indications for 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 Story
AirPurge System detects and automatically removes air from IV lines to prevent air embolism while minimizing infusion interruption. System comprises a sterile, single-use disposable fluid path unit and a reusable control unit. Ultrasonic sensors monitor the infusion line; upon air detection, the system diverts fluid flow to a waste collection bag, then restores flow to the patient once air is cleared. Used in OR and post-anesthesia care settings by trained clinicians. Output is automated fluid diversion; benefits include reduced risk of air infusion and fewer drug delivery interruptions compared to systems that stop infusion entirely. Not a replacement for human vigilance or proper IV setup.
## Clinical Evidence
Bench testing only. Studies verified air detection/removal response time (<60ms), minimum detectable air volume (25µL), flow rate range (1mL/hr to 600mL/min), and fluid loss per purge cycle. Additional testing included biocompatibility (ISO 10993), sterilization (ANSI/AAMI/ISO 11135), electrical safety/EMC, software verification/validation, and human factors validation.
## Technological Characteristics
System consists of a sterile, single-use disposable fluid path and a reusable control unit. Sensing via ultrasonic sensors. Flow control via automated diversion to waste. Sterilization via Ethylene Oxide (SAL 10^-6). Packaging: Tyvek/Poly pouch. Software classified as Major Level of Concern.
## Regulatory 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.
## 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.
*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.
## Submission Summary (Full Text)
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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
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.
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".
- 2. The device's minimum air volume identification sensitivity
| Minimum Detectable Air Volume |
|-------------------------------|
| 25 microliter |
- 3. 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 |
- 4. 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.
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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 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 | | | | | | |
#### System Nonelinical Studi Tablo 1
{4}------------------------------------------------
| | (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 | |
{5}------------------------------------------------
# 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.
{6}------------------------------------------------
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 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
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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 and
removal response time. | 60 milliseconds |
| The device's minimum air volume
identification sensitivity | 25 microliters |
{9}------------------------------------------------
| 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.
{10}------------------------------------------------
- (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
---
**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OKL/DEN080009](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OKL/DEN080009)
**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a De Novo](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).
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