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The D-Stat Dry is applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths.

The D-Stat Dry Hemostatic Bandage consists of the following components:

• Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose (CMC) and calcium chloride
• Adhesive bandage
  The D-Stat Dry Hemostatic Bandage achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by the bandage. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.

The provided text describes the D-Stat Dry Hemostatic Bandage and its FDA 510(k) clearance, but it does not provide detailed acceptance criteria or a study that proves the device meets specific performance criteria in the format requested.

Here's a breakdown of why and what information is available:

Key Takeaways from the Document:

• Device: D-Stat Dry Hemostatic Bandage
• Intended Use: Applied topically as an adjunct to manual compression for control of surface bleeding from vascular access sites and percutaneous catheters/tubes, and reducing time-to-hemostasis in patients undergoing diagnostic endovascular procedures using 4-6 Fr. introducer sheaths.
• Regulatory Clearance: 510(k) substantial equivalence to predicate devices (D-Stat Dry Hemostatic Bandage K030836 and Syvek excel Vascular Access Hemostasis System K053300).
• Testing:
  • No non-clinical testing was conducted.
  • A "prospective, randomized, non-significant risk clinical investigation" was conducted. This study provided "clinical evidence that use of the D-Stat Dry Hemostatic Bandage in the intended study population was safe and reduced the time-to-hemostasis following diagnostic catheterization procedures."
• Absence of Specific Performance Data: The document explicitly states "No performance standards have been developed under section 514 for this device" and does not present a table of acceptance criteria or reported device performance metrics (e.g., specific time-to-hemostasis in seconds, success rates). The clinical study is mentioned but no results are detailed.

Therefore, I cannot populate the requested table or answer questions 2-9 with the provided text. The document focuses on regulatory clearance via substantial equivalence rather than detailing performance studies against specific acceptance criteria.

Hypothetical Example of what the document would need to contain to answer your questions (this is NOT in the provided text):

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

2. Sample sized used for the test set and the data provenance
* Test Set Sample Size: [e.g., 200 patients (100 control, 100 device)]
* Data Provenance: Prospective, multi-center study conducted in the USA and Canada.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* Not applicable for this type of device where objective measurements (time, re-bleeding) are typically used rather than subjective expert consensus on images/data. For a device like this, the "ground truth" is typically the directly measured clinical outcome.

4. Adjudication method for the test set
* Not applicable as the outcomes (e.g., time to hemostasis, re-bleeding) are objectively measured during the procedure and follow-up. An independent Clinical Events Committee (CEC) might adjudicate serious adverse events, but not the primary efficacy endpoint.

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. This is a medical device for direct application, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used
* Clinical outcomes directly measured: Time-to-hemostasis, presence/absence of re-bleeding, adverse event rates.

8. The sample size for the training set
* Not applicable. This is a physical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established
* Not applicable.

In summary, the provided document serves as an FDA clearance letter based on substantial equivalence and briefly mentions a clinical study, but it lacks the detailed performance data and study specifics needed to fully answer your request.

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is intended for use under the direction of a healthcare professional for the local management and control of bleeding from vascular access sites and percutaneous catheters and tubes.

The D-Stat Dry Family Products consists of the following components:

• Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and calcium chloride .
• Adhesive bandage .
  These Products achieve their principal intended action (hemostasis) by creating a physical barrier to blood flow with compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment, in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.

This document is a 510(k) summary for the Vascular Solutions D-Stat Dry Product Family (D-Stat Dry Hemostatic Bandage, D-Stat Radial Hemostatic Band, and D-Stat 2 Dry Hemostatic Bandage). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials for a novel device.

Therefore, the information requested about acceptance criteria and detailed study data (like sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone performance) is not typically provided or required in this context for a device of this classification (Unclassified, Product Code FRO/QSX). The original 510(k) submission (K040118) for these devices, dated January 16, 2004, stated "No additional non-clinical testing of this product for this use was conducted" and "No clinical evaluations of this product for this use have been conducted."

The "Conclusions" section in the summary (page 2/2) only refers to "12-month testing results are acceptable, within product specification and substantiate an extension in product shelf life to 12 months." This indicates stability testing rather than performance testing against specific acceptance criteria for a new device's efficacy or safety.

Based on the provided document, the following is observed:

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

Since no non-clinical or clinical performance testing for the device's intended use was submitted for this 510(k), there are no specific performance acceptance criteria or reported device performance metrics in the document beyond the shelf-life testing conclusion.

2. Sample sized used for the test set and the data provenance:

Not applicable. No performance testing involving a "test set" for the device's intended use (hemostasis) was conducted or reported in this 510(k). The shelf-life testing would have its own sample sizes, but these are not disclosed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No performance testing requiring ground truth establishment by experts for the device's intended use was conducted or reported.

4. Adjudication method for the test set:

Not applicable. No performance testing was conducted.

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. This is a medical device for hemostasis, not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This is a medical device for hemostasis, not an algorithm.

7. The type of ground truth used:

Not applicable. No performance testing was reported.

8. The sample size for the training set:

Not applicable. No performance testing was reported.

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

Not applicable. No performance testing was reported.

Summary of what is stated in the document regarding "acceptance criteria" and "study":

The only "study" mentioned with an outcome, and thus an implied "acceptance criterion" (being "acceptable" and "within product specification"), is related to shelf-life.

• Acceptance Criteria for Shelf-Life: The device's stability over 12 months was "within product specification."
• Reported Device Performance: The "12-month testing results are acceptable."
• Study Type: Stability testing to extend product shelf life. No details on this study (e.g., sample size, methods, specific parameters measured) are provided in the summary.
• Rationale for 510(k): The submission relies on substantial equivalence to predicate devices (the D-Stat Dry Product Family itself, implying previous versions or closely related devices) rather than new performance data for its intended use.

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The Vascular Solutions D-Stat-Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band is intended for use under the direction of a healthcare professional for the local management and control of bleeding from vascular access sites and percutaneous catheters and tubes.

The D-Stat Dry hemostatic bandage consists of the following components:

• Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and calcium chloride
• Adhesive bandage
  The D-Stat Radial hemostatic band consists of the following components:
• Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose and calcium chloride in a non-woven gauze
• Application device consisting of an adjustable retention strap, collar and attached gauze pad
  The D-Stat Dry hemostatic bandage and D-Stat Radial hemostatic band achieves their principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by either the adhesive bandage or the retention band. The Iyophilized components (thrombin, CMC, and calcium chloride) establish an environment, in which a natural blood clot can build and form a physical barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.

Here's an analysis of the provided text regarding the D-Stat Dry™ Hemostatic Bandage and D-Stat Radial™ Hemostatic Band, focusing on the acceptance criteria and study information:

Based on the provided FDA 510(k) summary (K030836), no specific acceptance criteria or details of a study proving the device meets acceptance criteria are documented in the traditional sense you might expect for an AI algorithm or a device with measurable performance metrics.

This document is a 510(k) premarket notification for a medical device that relies on substantial equivalence to predicate devices, rather than a de novo submission with extensive clinical trials establishing novel performance criteria. The device is a "hemostatic bandage/band," which operates based on physical properties and established biological mechanisms (thrombin) to assist with local hemostasis.

Let's break down the information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Not Explicitly Stated for this 510(k) Submission	Not Explicitly Stated for this 510(k) Submission
   Implicitly, the device must achieve local hemostasis as intended, and be safe and effective when compared to predicate devices.	Non-clinical testing confirmed suitability for intended use, and the device is deemed substantially equivalent to predicates that perform this function.

   Explanation: The 510(k) summary does not define quantitative acceptance criteria (e.g., "hemostasis achieved in X% of cases within Y minutes"). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The performance is "reported" as being suitable for its intended use based on non-clinical tests and the comparison to an existing product with a similar mechanism of action.

2. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not applicable/Not provided. The document states, "No clinical evaluations of this product for this use have been conducted."
   • Data Provenance: Not applicable, as there were no clinical evaluations. "Non-Clinical Testing" was performed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • Not applicable. There was no clinical test set that required expert-established ground truth.

4. Adjudication Method for the Test Set:

   • Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Was an MRMC study done? No.
   • Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as this device is a physical hemostatic product and not an AI-assisted diagnostic or therapeutic device involving human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Was standalone performance done? Not applicable in the context of an "algorithm only." This device is a physical product directly applied by a healthcare professional ("under the direction of a healthcare professional"). Its "standalone" performance would refer to its physical and biological function (clotting ability, mechanical properties) rather than an algorithm's output. The "Summary of Non-Clinical Testing" addresses this.

7. Type of Ground Truth Used:

   • For the non-clinical testing: The "ground truth" was established by "assessments of the physical properties of the lyophilized pad" and "the ability of the lyophilized components to achieve its intended use (clot blood) and biocompatibility assessments." This implies laboratory measurements, material science testing, and in vitro/in vivo biocompatibility studies using established scientific methods and standards. It relies on objective measurements of physical and biological characteristics.

8. Sample Size for the Training Set:

   • Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that sense.

9. How the Ground Truth for the Training Set Was Established:

   • Not applicable (see point 8).

In summary:

This FDA 510(k) document (K030836) pertains to a physical medical device (hemostatic bandage/band) that achieved market clearance through the "substantial equivalence" pathway. This pathway does not typically require the same type of detailed performance criteria and clinical study reporting as a novel device or an AI/software as a medical device (SaMD). The device's "performance" was demonstrated through non-clinical testing of its physical and biological properties and by showing it is similar enough to predicate devices that are already cleared for the same intended use. Clinical trials were explicitly stated as not having been conducted for this submission.

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