(143 days)
Not Found
No
The description focuses on the mechanical function of a silicone valve and does not mention any computational or learning capabilities.
No
This device is an accessory to an intravascular catheter used for fluid administration and power injector procedures, and it incorporates features to prevent fluid displacement and reduce needlestick injuries. It does not directly treat a disease or condition.
No
The device is described as an accessory to an intravascular catheter for administering blood and fluids to patients and for power injector procedures. There is no mention of it being used to diagnose conditions or process diagnostic data.
No
The device description and performance studies clearly indicate a physical, hardware-based medical device (a connector with a silicone valve) and do not mention any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the CLAVE Neutron is for the administration of blood and fluids to patients via an intravascular catheter. This is a direct therapeutic or supportive function within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description focuses on the mechanical function of the connector and its valve to manage fluid flow and prevent displacement. It does not describe any testing or analysis of biological samples.
- Lack of IVD-related information: The provided information does not mention any aspects related to sample collection, analysis, reagents, or diagnostic results, which are all hallmarks of an IVD.
The CLAVE Neutron is a medical device used for patient care, specifically as an accessory for intravascular catheters, but it does not perform diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. The device may also be used with power injector procedures up to 10mL per second of contrast media and a maximum pressure of 350psi. The device incorporates a technology that will prevent fluid displacement resulting from the following: Connection of a luer; syringe plunger compression; patient vascular pressure changes, such as coughing or sneezing; and IV solution container run-dry. The CLAVE Neutron incorporates a pre-slit septum that does not reguire the use of needles and will therefore passively aid in the reduction of needlestick injuries.
Product codes (comma separated list FDA assigned to the subject device)
FPA, LHI
Device Description
The CLAVE Neutron is a normally closed, bidirectional connector that incorporates a unique silicone valve within the fluid path. The unique valve prevents fluid displacement, both positive and negative at all times, including when the device is accessed. There are four known causes of displacement associated with needleless connectors. They are:
- Connection or Disconnection of an Adaptable Luer Device. Fluid displacement occurs when a luer is inserted, or removed, from a connector by displacing a specific volume. This is also commonly known as positive or negative pressure when describing connectors.
- Syringe Plunger Rebound. This occurs when a flush has been done using a standard syringe. Once the syringe is emptied, the clinician has the ability to compress the syringe plunger in an effort to infuse all available solutions which, once released by the clinician's hand, will rebound and cause negative fluid displacement.
- Patient Vascular Pressure Changes. Routine events such as coughing, sneezing, crying and bearing down can cause a temporary increase in a patient's vascular pressure. This pressure can cause negative fluid displacement back through a standard needleless connector.
- IV Bag Run Dry. When an IV solution bag is allowed to empty, the normal gravity infusion pressure which is caused by the weight of the fluid hung at 36" head height diminishes to little or zero positive pressure. Normal patient vascular pressure may then overcome the fluid head height pressure and cause negative fluid displacement back through a standard needleless connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravascular, specifically vein or artery for catheter placement.
Indicated Patient Age Range
pediatrics and immunocompromised patients.
Intended User / Care Setting
Not Found
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)
The CLAVE Neutron was subjected to a variety of functional tests including Microbial Ingress testing and performance criteria. The testing demonstrates that there are no new issues of Safety and Efficacy that are raised with the introduction of the CLAVE Neutron.
Microbial Ingress testing demonstrates that the CLAVE Neutron in comparison to the CLAVE was equivalent in its ability to prevent bacterial ingress. Said testing shows that the device will prevent bacterial ingress, completely if used in accordance with the directions for use.
The CLAVE Neutron has been tested in accordance with its product specifications which accommodate known functional requirements for Critical Care, Neonatal Care and Pediatrics. All testing meets requirements as defined for the device, including power infusion up to 10ml per second of contrast media.
Testing demonstrates that the CLAVE Neutron is substantially equivalent and safe and effective for its intended use as demonstrated and supported in the performance testing according to the product specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Residual Volume: 0.14mL
- Gravity Fluid Flow: 100mL/minute
- Multiple Activations: 96 Intermittent, 3 extended time
- Positive Leak Pressure: 45psig
- Negative Leak Pressure: -8.5psig
- Luer Retention: ISO 594-1 (5.4)
- Component Assembly: >20lbf-in
- Power injectable: 10ml/sec of contrast media and
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
510(K) Summary
ICU MEDICAL INC.
4455 Atherton Drive Salt Lake City, Utah (801) 264 - 1332, Phone (801) 264 - 1755, Fax Tracy S. Best, Sr. Regulatory Affairs Specialist Preparation Date: 06/23/2010
Summary of Safety and Effectiveness for the:
CLAVE® Neutron™ Trade Name: Needleless Connector, Closed Access Common Name: Classification Name: 21 CFR 880.5440, Class II Device, 80FPA & 80LHI, Accessory
Legally Marketed Predicate Devices for Substantial Equivalence:
*K970855 - CLAVE® Connector - ICU Medical Inc. * K021692 - CLC2000 Catheter Patency Device - ICU Medical, Inc. * K083723 - A6 Luer Access Device - B. Braun Medical, Inc.
Rationale for Substantial Equivalence:
The CLAVE Neutron is substantially equivalent to all three predicates by providing a normally closed, needleless connection and a route to deliver blood and fluids to a patient through a vascular access device. All three predicate devices and the proposed device are free of steel needle components and designed such that the use of a needle in the device would render them inoperable. This design feature passively aids in the prevention needles cannot be introduced into the system during use.
The anti-displacement feature of the CLAVE Neutron is substantially equivalent to both the CLC2000 and the A6 in that it prevents negative displacement.
The power injectable feature is substantially equivalent as the A6 Luer Access Device which allows the infusion of contrast media at 10mL per second at a maximum pressure of 300psi. The CLAVE Neutron allows infusion of contrast media of 10mL per second with a maximum pressure of 350psi.
Components of the CLAVE Neutron are made from materials that are substantially equivalent to the predicate devices. Comprehensive biocompatibility testing for the CLAVE Neutron is included in this Submission.
The CLAVE Neutron was sublected to a variety of functional tests including microbial ingress and performance criteria which prove it to be substantially equivalent to the predicate devices. Results of the testing demonstrate that there are no new issues of Safety and Efficacy that are raised with the introduction of the CLAVE Neutron.
Description of Submitted Device:
The CLAVE Neutron is a normally closed, bidirectional connector that incorporates a unique silicone valve within the fluid path. The unique valve prevents fluid displacement, both positive and negative at all times, including when the device is accessed. There are four known causes of displacement associated with needleless connectors. They are:
-
- Connection or Disconnection of an Adaptable Luer Device. Fluid displacement occurs when a luer is inserted, or removed, from a connector by displacing a specific volume. This is also commonly known as positive or negative pressure when describing connectors.
-
- Syringe Plunger Rebound. This occurs when a flush has been done using a standard syringe. Once the syringe is emptied, the clinician has the ability to compress the syringe plunger in an effort to infuse all available solutions which, once released by the clinician's hand, will rebound and cause negative fluid displacement.
-
- Patient Vascular Pressure Changes. Routine events such as coughing, sneezing, crying and bearing down can cause a temporary increase in a patient's vascular pressure. This pressure can cause negative fluid displacement back through a standard needleless connector.
1
-
- IV Bag Run Dry. When an IV solution bag is allowed to empty, the normal gravity infusion pressure which is caused by the weight of the fluid hung at 36" head height diminishes to little or zero positive pressure. Normal patient vascular pressure may then overcome the fluid head height pressure and cause negative fluid displacement back through a standard needleless connector.
Intended Uses of the CLAVE® Neutron™:
CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patlents. The device may also be used with power injector procedures up to 10mL per second of contrast media and a maximum pressure of 350psi. The device incorporates a technology that will prevent fluid displacement resulting from the following: Connection of a luer; syringe plunger compression; patlent vascular pressure changes, such as coughing or sneezing; and IV solution container run-dry. The CLAVE Neutron incorporates a pre-slit septum that does not require the use of needles and will therefore passively aid in the reduction of needlestick injuries.
Safety and Performance:
The CLAVE Neutron is intended for use on a patient's vascular access device including pediatrics and immunocompromised patients. As discussed in the Executive Summary, the CLAVE Neutron incorporates proprietary design features from the CLAVE Needleless Connector. Specifically the preslit septum and the internal cannula of the predicate CLAVE which are used to transfer fluid to the patient's catheter, are identical in design. These two components are the functional components which prohibit bacterial transfer. Microbial Ingress testing as provided in this submission demonstrates that the CLAVE Neutron in comparison to the CLAVE was equivalent in its ability to prevent bacterial ingress. Said testing shows that the device will prevent bacterial in gress. completely if used in accordance with the directions for use. The prevention of bacterial ingress is specifically important for pediatrics and immunocompromised patients that would otherwise be at risk of infection.
In Bouza (2003), the CLAVE was found in a randomized clinical trial to independently reduce catheter hub and tip bacterial colonization. The patient population for the study was immunocompromised, intensive care patients at the Department of Cardiovascular Surgery, Hospital General University of Madrid, Madrid, Madrid, Spain. The identical CLAVE pre-slit septum component used in the study, is still used in the CLAVE today and also in the proposed CLAVE Neutron. This study demonstrates that the specific CLAVE split-septum design may safely be used In immunocompromised patient populations.
In Maragakis' (2006), the CLAVE was clinically studied in pediatric and immunocompromised patient populations. In this study, pediatric ICU and pediatric oncology service patients at the John's Hopkins Hospital in Baltimore Maryland were observed for Cather Related Bloodstream Infection Rates. The identical CLAVE pre-slit septum component used in this study, is still used in the CAVE today and also in the proposed CLAVE Neutron. This study demonstrates that the CLAVE split-septum design may safely be wed in pediatric and immunocompromised patient populations.
The CLAVE Neutron has been tested in accordance with its product specifications which accommodate known functional requirements for Critical Care, Neonatal Care and Pediatrics.
The CLAVE Neutron is individually packaged and pre-sterilized in a peel type pouch. The device can be included as part of a kit or set - as the physician may prescribe. ICU Medical performs analysis and design verification testing based on predetermined criteria, which is documented in the Performance Specification contained in this submission. All testing meets themements on the la as defined for the device, including power infusion up to 1000 per second of contrast media. The design of the device allows it to accept a male luer as defined by ISO 594-1 and ISO 594-2 which is considered to be an industry standard.
ICU Medical has also performed testing that is recommended by the guidance document "Intravascular Administration Sets Premarket Notifications [510(k)/i and we have included that successful testing as part of this submission.
2
| Specification: | CLAVE® | CLC2000® | Braun A6 | CLAVE® Neutron™ |
|---|---|---|---|---|
| 510(k) Approval | K970855 | K021692 | K083723 | This submission |
| Functional use | Needleless connector | Needleless Connector | ||
| with anti-reflux | Needleless connector | |||
| with anti-fluid | ||||
| displacement and | ||||
| power injectable | Needleless connector | |||
| with anti-fluid | ||||
| displacement and | ||||
| power injectable | ||||
| Patient Populations* | Adults, Pediatrics and | |||
| Immunocompromised | ||||
| patients | Adults | Adults | Adults, Pediatrics and | |
| Immunocompromised | ||||
| patients | ||||
| Residual Volume | 0.06mL | 0.07mL | 0.30mL | 0.14mL |
| Gravity Fluid Flow | 100mL/min | 200mL/min | Unavailable for test | 100mL/minute |
| Syringe Disconnect: | ||||
| Fluid Displacement | Negative Displacement | Positive Displacement | Positive Displacement | Integral valve prevents |
| displacement, both | ||||
| positive and negative® | ||||
| Syringe Plunger | ||||
| Compression: Fluid | ||||
| Displacement | N/A | N/A | N/A | Integral valve prevents |
| displacement, both | ||||
| positive and negative | ||||
| Patient Pressure: Fluid | ||||
| Displacement | N/A | N/A | N/A | Integral valve prevents |
| displacement, both | ||||
| positive and negative | ||||
| Bag Run-Dry: | ||||
| Fluid Displacement | N/A | N/A | N/A | Integral valve prevents |
| displacement, both | ||||
| positive and negative | ||||
| Multiple Activations | 96 intermittent | |||
| 3 extended time | 96 intermittent | |||
| 3 extended time | Unavailable for test | 96 Intermittent | ||
| 3 extended time | ||||
| Positive Leak Pressure | 60psig | 60psig | Unavailable for test | 45psig ** |
| Negative Leak Pressure | -8.5psig | -8.5psig | Unavailable for test | -8.5psig |
| Luer Retention | ISO 594-1 (5.4) | ISO 594-1 (5.4) | Unavailable for test | ISO 594-1 (5.4) |
| Component Assembly | >51bf-in | >15lbf-in | Unavailable for test | >20lbf-in |
| Chemical Compatibility | Lipids, Alcohol | Lipids, Alcohol | Unavailable for test | Lipids, Alcohol |
| Power injectable | N/A | N/A | 10ml/sec of contrast | |
| media and |