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The D-Stat Radial Hemostatic Band is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

The D-Stat Radial Hemostatic Band consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride secured to a application device consisting of an adjustable retention strap, retainer, and attached pads. After hemostasis has been achieved, the lyophilized pad may be removed from the application device, covered with a provided adhesive bandage, and left in place for up to 24 hours.

The provided text is a 510(k) premarket notification for the D-Stat Dry Radial Hemostatic Band. It details the regulatory classification, device description, intended use, and a summary of non-clinical testing. However, it does not contain specific acceptance criteria or a study that proves the device meets such criteria in a quantitative or statistical manner typically expected for medical device performance studies (e.g., sensitivity, specificity, accuracy, or clinical endpoints for 510(k) devices that are usually compared to a predicate device's established performance).

The "study" mentioned here is a Summary of Non-Clinical Testing, which is a basic assessment of the device's functional integrity.

Here's the breakdown based on the information provided:

Acceptance Criteria and Device Performance

Note: The document states "No performance standards have been developed under section 514 for this device." This means there aren't pre-defined, standardized numerical benchmarks the device must meet for efficacy or safety. The 510(k) pathway relies on demonstrating substantial equivalence to a legally marketed predicate device.

Study Information

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified. The summary only mentions "Tests conducted included assessment of the ability to separate the lyophilized pad from the retainer and a biocompatibility assessment of new materials." This is qualitative testing, not a statistical sample size for clinical or diagnostic performance.
   • Data Provenance: Not specified, but generally, non-clinical tests would be performed in a laboratory setting by the manufacturer (Vascular Solutions, Inc.).

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

   • Not applicable. This device is for hemostasis, and the "tests" described are non-clinical, functional and biocompatibility assessments. "Ground truth" in the diagnostic or clinical sense (e.g., for image interpretation) is not established by experts for these types of tests.

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

   • Not applicable. No expert adjudication process is described for these non-clinical tests.

4. 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 not an AI/diagnostic device; therefore, no MRMC study, human readers, or AI assistance is relevant.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • For the non-clinical tests described, the "ground truth" would be established by standard engineering and chemical testing methodologies and specifications, not expert consensus, pathology, or outcomes data. For example, the separation force of the pad from the retainer would be compared against an internal engineering specification. Biocompatibility would be assessed against ISO standards (e.g., ISO 10993 series).

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable, as there is no training set mentioned or implied.

In summary, the provided document details a 510(k) submission for a medical device that controls bleeding. The "study" mentioned is a brief summary of non-clinical tests to assess functional aspects and biocompatibility, not a clinical trial or a diagnostic performance study. The device's clearance is based on substantial equivalence to predicate devices, focusing on indications for use and technological characteristics rather than meeting specific quantitative performance criteria through a detailed clinical study.

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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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