(140 days)
Not Found
No
The description focuses on mechanical components and their function in achieving hemostasis. There is no mention of AI, ML, or any computational analysis of data for decision-making or operation.
Yes
The device is intended to "promote hemostasis at arteriotomy sites as an adjunct to manual compression," which is a therapeutic function addressing a medical condition (bleeding at an arteriotomy site).
No
The device is a vascular closure system intended to promote hemostasis at arteriotomy sites after catheterization procedures; it does not collect or analyze data to diagnose a condition.
No
The device description explicitly details physical components: a sterile, disposable catheter and a sterile, disposable tensioning device. It describes their physical characteristics and how they are used to achieve hemostasis. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "promote hemostasis at arteriotomy sites as an adjunct to manual compression" during femoral artery catheterization procedures. This is a therapeutic/procedural use, not a diagnostic one.
- Device Description: The device is a physical system (catheter and tensioner) used to apply pressure and promote clotting at a wound site. It does not analyze biological samples (blood, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Cardiva Medical VasoStasis Vascular Closure System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The VasoStasis Vascular Closure System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
The VasoStasis Vascular Closure System consists of the following components: (1) a sterile. disposable catheter (VasoStasis™ VCS Catheter), and (2) a sterile, disposable tensioning device (VasoStasis™ VCS Tensioner). The VasoStasis Vascular Closure System, in conjunction with manual compression, provides hemostasis at femoral access sites after femoral arterial catheterization while allowing continued perfusion of the lower extremities.
The VasoStasis VCS Catheter is a single lumen, low profile catheter with an elastomeric membrane at the distal tip. The membrane is covered by a tip guide, which protects the membrane as the cledeployed catheter is inserted into the artery through a previously placed introducer sheath. A small loon handle is at the proximal end of the device and moves axially to deploy or de-deploy a Nitinol coil within the membrane. Once the catheter is introduced into the vessel, the membrane is positioned distal to the introducer sheath and deployed by pushing the loop handle forward. In its fully deployed state, the membrane nominally achieves 13 F in diameter. The Cardiva VasoStasis VCS Tensioner clips on the VasoStasis VCS Catheter shaft on the surface of the skin at the entrance to the arteriotomy and holds the catheter secure while the membrane is deployed in the vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery
Indicated Patient Age Range
Not Found
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)
Bench performance testing of the VasoStasis Vascular Closure System demonstrated that the System meets or exceeds the performance requirements for the intended clinical use of the device. The results demonstrated that the VasoStasis Vascular Closure System satisfies all of its performance requirements, which are designed to ensure that the System is safe and effective for its intended use.
Biocompatibility testing of all device components and materials was conducted pursuant to FDA's Guidance Document (#G95-1), Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995), which specifically outlines the types of biocompatibility tests that are required based on the nature of the device and the extent and duration of its contact with blood or tissues. Additional tests have also been conducted according to ISO 10993-4, "Biological Evaluation of Medical Devices, Part 4, Selection of Tests for Interaction with Blood." Based on the test results the VasoStasis Vascular Closure System has been demonstrated to be biocompatible.
The performance and safety of the VasoStasis Vascular Closure System were evaluated in vivo in several animal studies. Acute animal studies: supported the safe and effectre ing femoral artery catheterization procedures. The chronic nimal study was ochadeted to Nature the device, place it in tension and achieve hemostasis. Three anteral access muroducer sheath aspied of three weeks after which tissue harvests were obtained to allimals were then survived for a person or a virus of healing responses after treatment. Several animal studies were also conducted to evaluate certain performance characteristics of the VCS, including positioning techniques and membrane pull-through force. The animal studies v Co, monamig positioning wonnee and safety of the VasoStasis Vascular Closure System.
Four Cardiva Medical and BioInterventional (former Company) sponsored clinical studies were conducted with the VasoStasis VCS and prior versions of the technology comprising an evaluation of a total of 441 patients (one enrolled but not treated). The German clinical evaluation was a post-market study evaluating a total of 144 patients. The US II, US I, and Canadian Clinical multies comprised an evaluation of a total of 278 consecutive phase patients. The data obtained from the prospective Canadian Clinical Study was retrospectively analyzed using the same outcome definitions as the US I Studies. The clinical results obtained from the US II, US I and Canadian clinical evaluations demonstrate the safety and effectiveness of the VasoStasis Vascular Closure System as an adjunct to manual compression for providing hemostasis at arteriotomy sites in Cloud of demonstic femoral artery catheterization procedures. This was demonstrated by the observed device success rates (>70%) and low major complication rates (70%), low major complication rates (
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
OCT 2 2 2004
510(k) SUMMARY Cardiva Medical, Inc. VasoStasis™ Vascular Closure System 510(k) Notification K041486
GENERAL INFORMATION
| Manufacturer: | Cardiva Medical, Inc. |
|---|---|
| 2585 Leghorn Street | |
| Mountain View, CA 94043 | |
| Phone: (650) 964-8900 | |
| Facsimile: (650) 964-8911 | |
| Establishment Registration Number: 3004182619 |
Augustine Lien Contact Person: Founder, Chairman and CEO
Date Prepared: October 15, 2004
DEVICE INFORMATION
| Trade name: | VasoStasis™ Vascular Closure System |
|---|---|
| Classification Names: | Vascular Clamp (21 C.F.R. § 870.4450); |
| Catheter, Intravascular, Diagnostic (21 C.F.R. § 870.1200); | |
| Surgical Vessel Dilator (21 C.F.R. § 870.4475); | |
| Blood Access Device and Accessories (21 C.F.R. § 870.5540) |
Class II Classification:
PREDICATE DEVICES
- Radi Medical Systems AB, FemoStop™ System 1.
- Instromedix, Inc., COMPRESSAR® Universal System 2.
-
- CardioThoracic Systems, Inc., CTS FloCoil™ Shunt
- Bio-Vascular, Inc., Flo-Rester® Internal Vessel Occluder 4.
INTENDED USE/INDICATIONS FOR USE
The Cardiva Medical VasoStasis Vascular Closure System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The VasoStasis Vascular Closure System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.
1
K041456 3306.
Cardiva Medical, Inc.
VasoStasis™ Vascular Closure System 510(k) Notification
DEVICE DESCRIPTION
The VasoStasis Vascular Closure System consists of the following components: (1) a sterile. disposable catheter (VasoStasis™ VCS Catheter), and (2) a sterile, disposable tensioning device (VasoStasis™ VCS Tensioner). The VasoStasis Vascular Closure System, in conjunction with manual compression, provides hemostasis at femoral access sites after femoral arterial catheterization while allowing continued perfusion of the lower extremities.
The VasoStasis VCS Catheter is a single lumen, low profile catheter with an elastomeric membrane at the distal tip. The membrane is covered by a tip guide, which protects the membrane as the cledeployed catheter is inserted into the artery through a previously placed introducer sheath. A small loon handle is at the proximal end of the device and moves axially to deploy or de-deploy a Nitinol coil within the membrane. Once the catheter is introduced into the vessel, the membrane is positioned distal to the introducer sheath and deployed by pushing the loop handle forward. In its fully deployed state, the membrane nominally achieves 13 F in diameter. The Cardiva VasoStasis VCS Tensioner clips on the VasoStasis VCS Catheter shaft on the surface of the skin at the entrance to the arteriotomy and holds the catheter secure while the membrane is deployed in the vessel.
METHOD OF USE
The VasoStasis VCS Catheter is inserted through a previously placed catheter introducer sheath in its de-deployed state. Once positioned, the VasoStasis VCS Catheter membrane is deployed in the inner lumen of the femoral artery and is physically seated against the arterial wall at the arteriotomy site by the user. The VasoStasis VCS Tensioner is applied to the VasoStasis VCS Catheter on the surface of the skin at the entrance to the arteriotomy to control movement of the membrane and to provide a slight upward tension on the system to ensure that the membrane remains seated against the arteriotomy and hemostasis is maintained. This membrane provides temporary occlusion of the arteriotomy while the natural mechanisms of hemostasis are enacted. Closure of the arteriotomy occurs when the smooth muscle wall of the artery and the fascial tract contract, and the blood remaining in the tract coagulates. The VasoStasis VCS does not have any mechanism to alter or manipulate the natural response of the body, and no part of the device remains in the patient after it is removed.
DATA DEMONSTRATING SUBSTANTIAL EQUIVALENCE
Bench performance testing of the VasoStasis Vascular Closure System demonstrated that the System meets or exceeds the performance requirements for the intended clinical use of the device. The results demonstrated that the VasoStasis Vascular Closure System satisfies all of its performance requirements, which are designed to ensure that the System is safe and effective for its intended use.
Biocompatibility testing of all device components and materials was conducted pursuant to FDA's Guidance Document (#G95-1), Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing (1995), which specifically outlines the types of biocompatibility tests that are required based on the nature of the device and the extent and duration of its contact with blood or tissues. Additional tests have also been conducted according to ISO 10993-4, "Biological Evaluation of Medical Devices, Part 4, Selection of Tests for Interaction with Blood." Based on the test results the VasoStasis Vascular Closure System has been demonstrated to be biocompatible.
2
VasoStasis™ Vascular Closure System 510(k) Notification
The performance and safety of the VasoStasis Vascular Closure System were evaluated in vivo in The performance and salery of the Passimal studies have been conducted: acute animal studies, a several animal study, as well as device performance verification studies. The acute animal study chionic allinial sudy, as wer as device person to control bleeding and promote evaluations support the sale and effectre ig femoral artery catheterization procedures. The chronic nemostasis at the arteriormy site tonewing thirty to place the device in the femoral artery through an annial study was ochadeted to Nature the device, place it in tension and achieve hemostasis. Three anteral access muroducer sheath aspied of three weeks after which tissue harvests were obtained to allimals were then survived for a person or a virus of healing responses after treatment. Several animal studies were also conducted to evaluate certain performance characteristics of the VCS, including positioning techniques and membrane pull-through force. The animal studies v Co, monamig positioning wonnee and safety of the VasoStasis Vascular Closure System.
Four Cardiva Medical and BioInterventional (former Company) sponsored clinical studies were r our Cardival with the VasoStasis VCS and prior versions of the technology comprising an evaluation of a total of 441 patients (one enrolled but not treated). The four separate clinical studies evaluated the a tour of 11 f ectiveness of the system. Initial clinical evaluations, sponsored by BioInterventional were conducted in Germany and in Canada. These studies were followed by two Non-Significant were conductions in Cormairy and in Callauates, one sponsored by BioInterventional (US I) and one sponsored by Cardiva Medical (US II).
Summaries of the clinical evaluations were provided and the results support the safe and effective use of the current VasoStasis VCS for its intended use. The German clinical evaluation was a postor the carrent & abouting a total of 144 patients. The US II, US I, and Canadian Clinical multies comprised an evaluation of a total of 278 consecutive phase patients. The data obtained from the prospective Canadian Clinical Study was retrospectively analyzed using the same outcome definitions as the US I Studies. The clinical results obtained from the US II, US I and Canadian clinical evaluations demonstrate the safety and effectiveness of the VasoStasis Vascular Closure System as an adjunct to manual compression for providing hemostasis at arteriotomy sites in Cloud of demonstic femoral artery catheterization procedures. This was demonstrated by the observed device success rates (>70%) and low major complication rates (