Search Results

The Catalyst II " System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Catalyst II System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using SF, 6F or 7F introducer sheaths.

The Catalyst™ III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Catalyst™ III System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

The Cardiva Catalyst systems are intended to promote hemostasis at arteriotomy sites as adjuncts to manual compression and retain the same indication for use as the Boomerang Catalyst System family of devices. The Cardiva Catalyst systems consist of a sterile disposable Cardiva Catalyst wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III System is specifically designed for use with heparinized patients. In conjunction with manual compression, the Cardiva Catalyst systems provide temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Cardiva Catalyst wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Cardiva Catalyst wire is deployed, which opens a flat, low-profile Catalyst Disc within the lumen of the femoral artery. During dwell, natural recoil of the smooth muscle of the vessel wall occurs at the arteriotomy site. A biocompatible coating on the Cardiva Catalyst III Wire aides the body's natural hemostatic process and promotes ease of removal. Specifically, the Cardiva Catalyst III System's biocompatible coating includes a minimal amount of Protamine Sulfate to further aid the body's natural hemostatic process in heparinized patients. Following the procedure, the Catalyst Disc is collapsed and the Cardiva Catalyst III wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Cardiva Catalyst III System.

The provided document is a 510(k) summary for the Cardiva Catalyst™ II and III systems, which are vascular clamps. It primarily discusses the device description, indications for use, and a comparison to predicate devices, stating that the subject device is identical to previously cleared devices with only an addition to contraindications.

This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or how ground truth was established for training sets.

Therefore, I cannot provide the requested table and information based on the input text. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies against acceptance criteria.

Ask a specific question about this device

The Cardiva Catalyst™ III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst™ III System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

The Cardiva Catalyst™ III System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst III system includes a design modification which involves the addition of Protamine Sulfate to the existing Boomerang Catalyst II System coating to further minimize ocze from the tissue tract and promote the hemostasis process in heparinized patients. The Cardiva Catalyst III System maintains the same indication for use as the Boomerang Catalyst System family of devices.

The Cardiva Catalyst III System consists of a sterile disposable Cardiva Catalyst III wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III System is specifically designed for use with heparinized patients. In conjunction with manual compression, the Cardiva Catalyst III System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Cardiva Catalyst III wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Cardiva Catalyst III wire is deployed, which opens the flat, low-profile Catalyst Disc within the lumen of the femoral artery. During dwell, natural recoil of the smooth muscle of the vessel wall occurs at the arteriotomy site. A biocompatible coating on the Cardiva Catalyst III Wire aides the body's natural hemostatic process and promotes ease of removal. Specifically, the Cardiva Catalyst III System's biocompatible coating includes a minimal amount of Protamine Sulfate to further aid the body's natural hemostatic process in heparinized patients. Following the procedure, the Catalyst Disc is collapsed and the Cardiva Catalyst III wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Cardiva Catalyst III System.

The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The text is a 510(k) summary for the Cardiva Catalyst™ III System, focusing on its substantial equivalence to a predicate device and its intended use. It describes the device, its function, and the fact that "All necessary bench testing was conducted on the Cardiva Catalyst III System to support a determination of substantial equivalence to the predicate device." However, it does not provide details about the specific acceptance criteria for this testing, the results of the testing with respect to those criteria, nor any clinical study details such as sample size, ground truth, or expert involvement.

Therefore, I cannot provide the requested table or answer the specific questions based on the given input.

Ask a specific question about this device

The Boomerang™ Catalyst/Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Catalyst/Catalyst II System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

The Boomerang™ Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang Catalyst II System includes design modifications to minimize ooze from the tissue tract and promote the hemostasis process. The Boomerang Catalyst II System maintains the same indication for use as the Boomerang Catalyst System family of devices, formerly referred to as the Boomerang PlusWire System.

The Boomerang Catalyst II System consists of a sterile disposable Boomerang Catalyst II wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang Catalyst II System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Catalyst II wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Catalyst II wire is deployed, which opens the flat, lowprofile Boomerang Disc within the lumen of the femoral artery. The introducer sheath is then removed from the vessel over the Boomerang Catalyst II wire and the low-profile Boomerang Disc conforms to the contours of the vessel and secures it against the intima, sealing the arteriotomy. As gentle tension is applied to the Boomerang Catalyst II wire, the sleeve covering the tensioning coil is gently retracted until the distal tip appears at the skin surface to expose the coated tensioning coil to the tissue tract. The applied tension is maintained by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Catalyst II wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Boomerang Catalyst II System.

The provided text is a 510(k) summary for the Cardiva Medical Boomerang™ Catalyst II System. A 510(k) summary is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to establish new performance criteria through clinical studies directly.

Based on the provided document, the device (Boomerang™ Catalyst II System) is being considered substantially equivalent to a predicate device (Cardiva Medical Boomerang™ Catalyst System, K070485) rather than being subject to a de novo approval pathway requiring specific acceptance criteria beyond demonstrating equivalence.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, clinical study results, sample sizes for test/training sets, expert qualifications, or ground truth establishment in the way one might expect for a primary clinical trial or AI/software validation.

However, I can extract the information that is present and explain why certain sections are not applicable or missing based on the nature of a 510(k) submission for substantial equivalence.

Here's a breakdown based on your request, explaining what is available and what is not:

1. A table of acceptance criteria and the reported device performance

• Not Applicable/Not Provided Directly in this Document.
• A 510(k) submission for substantial equivalence typically does not define new, quantitative clinical acceptance criteria in the same way as a de novo or PMA submission. Instead, the device is evaluated against the performance and safety profile of the predicate device.
• The document states: "The Boomerang Catalyst II System is substantially equivalent to the predicate device with regard to function, intended use, physical characteristics and performance testing."
• "Various testing which included bench and biocompatibility was performed on the Boomerang Catalyst II System to insure the product and the product materials were adequately tested and evaluated to demonstrate the product meets or exceeds the performance requirements and is safe for the intended use of the device."
• This indicates that performance testing was done, but specific quantitative acceptance criteria and their corresponding results are not detailed in this summary. The "performance requirements" would implicitly be those demonstrated by the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Provided Directly.
• The document mentions "various testing which included bench and biocompatibility," but it does not describe clinical test sets, patient sample sizes, or data provenance (e.g., country of origin, retrospective/prospective). This often means the substantial equivalence was based primarily on engineering design, material equivalence, and non-clinical testing rather than new clinical trials with patient cohorts.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable/Not Provided.
• Since no clinical test set or ground truth establishment is described in this summary, information about experts and their qualifications is not present. This type of detail would be relevant for studies evaluating diagnostic accuracy or a new clinical endpoint, which is not the focus of this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable/Not Provided.
• Similar to point 3, without a described clinical test set requiring ground truth establishment, there is no mention of adjudication methods.

5. 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

• Not Applicable/Not Provided.
• This type of study is relevant for AI or diagnostic imaging devices. The Boomerang Catalyst II System is a physical medical device (vascular clamp) intended to promote hemostasis. It does not involve AI, image reading, or human interpretative tasks.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable/Not Provided.
• As noted in point 5, this is a physical device, not an algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not Applicable/Not Provided.
• For a substantial equivalence claim based on bench and biocompatibility testing for a physical device, the "ground truth" refers to established engineering standards, material properties, and biological safety profiles, rather than clinical outcomes or expert consensus for diagnostic interpretation. These are implicitly compared to the predicate.

8. The sample size for the training set

• Not Applicable/Not Provided.
• The concept of a "training set" is relevant for machine learning algorithms. This is a physical medical device, not an AI/ML product.

9. How the ground truth for the training set was established

• Not Applicable/Not Provided.
• As noted in point 8, this is not an AI/ML product.

Summary of what the document focuses on regarding device performance and substantial equivalence:

• Device Description: The Boomerang™ Catalyst II System is described as a sterile, disposable wire and clip system that promotes hemostasis through temporary site-specific compression at a femoral access site.
• Intended Use/Indications for Use: To promote hemostasis at arteriotomy sites as an adjunct to manual compression, for 5F, 6F, or 7F introducer sheaths in femoral artery catheterization.
• Substantial Equivalence Claim: The Boomerang Catalyst II System is claimed to be substantially equivalent to the predicate device (Boomerang™ Catalyst System, K070485) "with regard to function, intended use, physical characteristics and performance testing."
• Performance Testing Mentioned: "Various testing which included bench and biocompatibility was performed... to insure the product and the product materials were adequately tested and evaluated to demonstrate the product meets or exceeds the performance requirements and is safe for the intended use of the device."

In conclusion, this 510(k) summary for the Cardiva Medical Boomerang™ Catalyst II System indicates that the device met acceptance criteria by demonstrating substantial equivalence to an existing predicate device (K070485) through bench and biocompatibility testing. The document does not provide details on specific quantitative performance criteria, clinical study designs, sample sizes, or expert involvement, as these types of detailed studies are generally not required for a 510(k) submission based on substantial equivalence of a physical device with a known mechanism of action.

Ask a specific question about this device

The Boomerang™ Wire/PlusWire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire/PlusWire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

The Boomerang™ Plus Wire System is an extension of the Boomerang Wire System family of devices. The Boomerang Plus Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Plus Wire System includes design modifications to enhance ease of device removal and to minimize ooze from the tissue tract. The Boomerang Plus Wire System maintains the same indication for use as the Boomerang Wire System family of devices.

The Boomerang Plus Wire System consists of a sterile disposable Boomerang Plus Wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang PlusWire System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Plus Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Plus Wire is deployed, which opens the flat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Plus Wire and the low-profile Boomerang Disc conforms to the contours of the vessel and secures it against the intima, sealing the arteriotomy. As gentle tension is applied to the Boomerang Plus Wire, the sleeve covering the tensioning coil is gently retracted until the distal tip appears at the skin surface to expose the coated tensioning coil to the tissue tract. The applied tension is maintained by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Plus Wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Boomerang Plus Wire System.

The provided text describes the Cardiva Medical Boomerang™ Plus Wire System. However, it does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes, expert qualifications, or ground truth establishment methods as typically required for medical device clearance based on AI/ML.

Here's an analysis of what is present and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated. The document focuses on demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: No specific quantitative performance metrics (e.g., success rates, complication rates, time to hemostasis) are provided in a table. The document states that "various testing which included bench, biocompatibility, animal and clinical testing was performed... to insure the product and the product materials were adequately tested and evaluated to demonstrate the product meets or exceeds the performance requirements and is safe and effective for its intended use." However, the results of this testing are not detailed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not provided. While "clinical testing" is mentioned, no details about the size or characteristics of the patient cohort are given.
• Data Provenance: Not provided. There's no information about the country of origin, whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable/Not provided. This device is a mechanical hemostasis system, not an AI/ML diagnostic tool requiring expert ground truth establishment for image or data interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. As above, this is not an AI/ML diagnostic device.

5. 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. This is not an AI/ML device, and therefore, no MRMC study or AI assistance comparison would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not explicitly stated for the "clinical testing." For a device like this, ground truth would likely be based on clinical outcomes relevant to hemostasis (e.g., successful closure, absence of bleeding, time to hemostasis, complication rates) assessed by treating physicians and follow-up. The document does not elaborate on how these outcomes were measured or whether they were adjudicated against a specific "ground truth" standard.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that uses a "training set."

9. How the ground truth for the training set was established:

• Not applicable.

Summary of Device and Approval Process based on the text:

• Device Name: Cardiva Medical Boomerang™ Plus Wire System
• Intended Use: To promote hemostasis at arteriotomy sites as an adjunct to manual compression in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F, or 7F introducer sheaths.
• Predicate Device: Cardiva Medical Boomerang™ Wire System (K051817)
• Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "The Boomerang PlusWire System is substantially equivalent to the predicate device with regard to function, intended use, physical characteristics and performance testing."
• Testing Mentioned: Bench, biocompatibility, animal, and clinical testing were performed to ensure safety and effectiveness and that the product meets performance requirements. However, detailed results or specific acceptance criteria from these tests are not included in this summary.

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than providing a detailed technical report of all performance testing results and acceptance criteria. For detailed performance data, one would usually refer to the full 510(k) submission or associated clinical trial reports, which are not provided here. The questions posed are highly relevant to AI/ML device submissions, which this is not.

Ask a specific question about this device

The Cardiva Medical Boomerang™ Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5, 6 or 7 Fr introducer sheaths.

The Boomerang™ Wire System consists of a sterile disposable Boomerang Wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang Wire System provides hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Wire is deployed, which open the flat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Wire and the low-profile Boomerang Disc is positioned against the inside of the arteriotomy. Gentle upward tension is applied to the Boomerang Wire, which conforms the Boomerang Disc to the contours of the vessel and secures it against the intima, sealing the arteriotomy. The tension is then held in place by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Wire is completely removed for the artery. No part of the device is left behind nor is there any material introduced to alter the body's own natural clotting process. Final closure of the vessel occurs with manual compression to close the remaining needle puncture site left by removing the Boomerang Wire.

The provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. It states that "various testing which included bench, biocompatibility, and animal testing was performed on the Boomerang Wire System to ensure the product and the product materials were adequately test and evaluated to demonstrate the product meets or exceeds the performance requirements and is safe and effective for its intended use. In addition, post market clinical data have been included to further support that the product meets or exceeds the performance requirements and is safe and effective for its intended use." However, it does not provide the specifics of these tests or the "post market clinical data."

Therefore, I cannot populate the table or answer the specific questions provided in the request based on the given information.

Missing Information:

• Specific Acceptance Criteria: The document does not list any quantitative or qualitative acceptance criteria (e.g., success rates, complication rates, time to hemostasis, etc.).
• Reported Device Performance: Without acceptance criteria, the document does not report specific performance metrics that can be directly compared against criteria.
• Study Design Details: There are no details about the design of any clinical studies, including:
  • Sample size for test set
  • Data provenance
  • Number of experts, their qualifications, or adjudication methods for ground truth
  • MRMC study details or effect size
  • Standalone performance
  • Type of ground truth used
  • Sample size for training set (if applicable for an AI device, which this is not)
  • How ground truth for training set was established (if applicable)

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than detailing the results of performance studies against specific acceptance criteria.

Ask a specific question about this device

The Cardiva Medical Boomerang™ Wire is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.

The Boomerang™ Wire consists of a sterile disposable Boomerang Wire and a sterile disposable Boomerang Clip (refer to the detailed Figures 1,2,3 in Section VIII). In conjunction with manual compression, the Boomerang Wire provides hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Wire is deployed, which opens the ffat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Wire and the low-profile Boomerang Disc is positioned against the inside of the arteriotomy. Gentle upward tension is applied to the Boomerang Wire, which conforms the Boomerang Disc to the contours of the vessel and secures it against the intima, sealing the arteriotomy. The tension is then held in place by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Wire is completely removed from the artery. No part of the device is left behind nor is there any material introduced to alter the body's own natural clotting process. Final closure of the vessel occurs with manual compression to close the remaining needle puncture site left by removing the Boomerang Wire.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request. The document describes the Boomerang™ Wire device, its intended use, predicate devices, and the fact that performance testing (bench, biocompatibility, animal, and post-market clinical data) was performed to demonstrate substantial equivalence. However, it does not specify the acceptance criteria for these tests, the reported device performance against those criteria, or details regarding sample sizes, data provenance, expert involvement, adjudication methods, or specific study designs (like MRMC or standalone studies).

Therefore, I cannot create the table or provide specific answers to questions 1 through 9.

Ask a specific question about this device

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.

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.

Acceptance Criteria and Study for Cardiva Medical VasoStasis™ Vascular Closure System

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Cardiva Medical VasoStasis™ Vascular Closure System does not explicitly state pre-defined acceptance criteria in terms of specific numerical thresholds for success rates or complication rates against which the observed performance was directly measured. Instead, it refers to "performance requirements" that the system met or exceeded, and then presents the clinical study results as evidence of safety and effectiveness, implying these results are within acceptable ranges.

However, based on the narrative, the implicit acceptance criteria can be inferred from the positive statements made about the study outcomes.

Ask a specific question about this device