The D-Stat Dry Silver and D-Stat Dry Clear Silver are applied topically as an adjunct to manual compression and are 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. D-Stat Dry Silver and D-Stat Dry Clear Silver contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.

The D-Stat Dry Wrap Silver hemostatic bandage and Thrombix Silver Hemostasis Patch are applied topically as an adjunct to manual compression and are indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes. D-Stat Dry Wrap Silver and Thrombix Silver contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.

Device Description

The D-Stat Dry Silver, D-Stat Dry Clear Silver, D-Stat Dry Wrap Silver and Thrombix Silver products are non-woven gauze pads lyophilized (frecze-dried) with procoagulant (thrombin, calcium chloride and sodium carboxymethylcellulose) and antimicrobial (ionic silver water) components. The D-Stat Drv/Wrap/ Thrombix pad creates a physical barrier to blood flow and facilitates hemostasis by the physiological coagulation-inducing properties of the lyophilized pad combined with compression. The lyophilized components (including thrombin) facilitate hemostasis through enzymatic cleavage and conversion of fibrinogen to fibrin. These products contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad and have not been clinically tested for their ability to reduce local infection, catheter-related bloodstream infections (CRBSI) and skin colonization of microorganisms commonly related to CRBSI .

In the presence of fluids (i.e., blood and wound fluids), ionic silver is released from the silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad. Ionic silver, an atom of silver that is missing one electron, provides the antimicrobial property by altering the protein structure and preventing bacterial cells from carrying out normal functions. The D-Stat Silver products demonstrated an antimicrobial effect in AATCC Test Method 100-2004 and Zone of Inhibition laboratory testing.

An adhesive foam or clear bandage accompanies some products in the family. All products are sterilized by electron-beam irradiation and are intended for single use only.

AI/ML Overview

The provided text is a 510(k) summary for the D-Stat Dry Silver product family. It describes the device, its intended use, and provides a summary of studies performed to demonstrate substantial equivalence to previously marketed predicate devices.

However, the document does not provide specific acceptance criteria or detailed study results in a format that allows for the creation of a table comparing acceptance criteria to reported device performance. It also lacks specific details on sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for establishing ground truth as requested in the prompt. While it mentions some studies, it does not present them as standalone performance studies or MRMC comparative effectiveness studies.

Based on the information available in the provided text, here is a breakdown addressing the prompt's requirements, with explicit notes where information is not present:

Acceptance Criteria and Device Performance Study

The document states that "The subject device met all established specifications in the design verification bench testing" and "Statistical evaluation of data from an acute topical laceration study in a porcine model showed the time-to-hemostasis for the D-Stat Dry Silver did not exceed the time-to-hemostasis for the D-Stat Dry (no silver)." This indicates that the primary performance criterion for hemostasis was non-inferiority to the predicate device. For antimicrobial properties, the criterion was a "greater than a 4 log reduction in microbial population" and "comparable zones" to silver-containing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria (Implicit from text)	Reported Device Performance
Hemostasis: Time-to-hemostasis	Non-inferior to predicate D-Stat Dry (no silver) in a porcine model.	"did not exceed the time-to-hemostasis for the D-Stat Dry (no silver)."
Antimicrobial Activity (AATCC Test Method 100-2004): Microbial population reduction	Greater than a 4 log reduction in microbial population.	"had greater than a 4 log reduction in microbial population under AATCC Test Method 100-2004" for all seven microorganism cultures.
Antimicrobial Activity (Zone of Inhibition testing): Zone size	Comparable zones to silver-containing predicate devices.	"demonstrated comparable zones between D-Stat Silver and the silver-containing predicate devices."
Thrombin Activity	Met established specifications	Met all established specifications in design verification bench testing
pH	Met established specifications	Met all established specifications in design verification bench testing
Moisture Content	Met established specifications	Met all established specifications in design verification bench testing
Wetting Time	Met established specifications	Met all established specifications in design verification bench testing
Product Conformability	Met established specifications	Met all established specifications in design verification bench testing
Silver Content	Met established specifications	Met all established specifications in design verification bench testing
Biocompatibility	Non-cytotoxic, not a significant sensitizer, negligible irritant (satisfying ISO 10993)	"demonstrated the device was non-cytotoxic, not a significant sensitizer and a negligible irritant, which confirms the D-Stat Silver products are biocompatible."

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

Sample Size (Hemostasis Study): Not explicitly stated, only mentioned as "an acute topical laceration study in a porcine model."
Sample Size (Antimicrobial Testing): Not explicitly stated for the number of samples or replicates.
Data Provenance: The hemostasis study was conducted in a "porcine model," indicating an animal study. Other tests (bench, in vitro) are laboratory-based. No country of origin is specified for these studies, nor is it explicitly stated if they were retrospective or prospective, though the nature of these tests suggests they were prospective studies conducted for regulatory submission.

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

Not Applicable: The studies described (animal model, lab tests) do not involve human experts establishing ground truth in the way a diagnostic AI device would. The "ground truth" for these tests is based on objective laboratory measurements and observation in the animal model.

4. Adjudication method for the test set:

Not Applicable: Given the nature of the tests (animal model observation for hemostasis, quantitative lab tests for antimicrobial activity and physical properties), independent expert adjudication as defined for imaging or diagnostic studies is not relevant or described.

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: No MRMC comparative effectiveness study was conducted or described. This device is a topical hemostat, not a diagnostic AI device requiring human interpretation of data.

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

Partially Applicable (but not an algorithm): The device itself performs its function (hemostasis, antimicrobial action) as a standalone product. The "studies" were essentially standalone performance evaluations of the device's physical and biological properties. However, this is not an "algorithm-only" performance in the context of AI.

7. The type of ground truth used:

Hemostasis Study: The "ground truth" was the observed time-to-hemostasis in the porcine model.
Antimicrobial Testing: The "ground truth" was quantitative measurement of microbial population reduction and zone of inhibition size using standardized lab methods (AATCC Test Method 100-2004).
Biocompatibility: Based on objective ISO 10993 testing endpoints (cytotoxicity, sensitization, irritation).
Other Bench Tests: Based on objective measurements against established engineering and material specifications.

8. The sample size for the training set:

Not Applicable: This device is not an AI/ML algorithm that requires a "training set" in the computational sense. The product development process involves design and testing, but not machine learning training.

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

Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 10, 2023

Vascular Solutions, Inc. c/o Lisa Gallatin, RAC Principal Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K102212

Trade/Device Name: D-Stat Dry Silver, D-Stat Dry Clear Silver, D-Stat Dry Wrap Silver, Thrombix Silver Regulatory Class: Unclassified Product Code: QSX

Dear Lisa Gallatin:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 8, 2011. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSX.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie. Morabito@fda. hhs. gov.

Sincerely.

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted with flowing lines to represent its wings and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Vascular Solutions, Inc. % Ms. Lisa Gallatin, RAC Principal Regulatory Product Specialist 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K102212

Trade/Device Name: D-Stat Dry Clear Silver D-Stat Dry Silver D-Stat Dry Wrap Silver Thrombix Silver

APR - 8 2011

Regulatory Class: Unclassified Product Code: FRO Dated: March 24, 2011 Received: March 28, 2011

Dear Ms. Gallatin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Ms. Lisa Gallatin, RAC

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

A.J. B. D. h
for.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K102212

Device Name: D-Stat Dry Clear Silver

Indications for Use:

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. D-Stat Dry Clear Silver contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krone for Mxm

dic. storative Devices

510(k) Number K1022(2

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510(k) Number (if known): K102212

Device Name: D-Stat Dry Silver

Indications for Use:

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. D-Stat Dry Silver contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kimefer MKM

(Division Si urgical, Orthopedic, Restorative Devices

510(k) Number K102212

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510(k) Number (if known): K102212

Device Name: D-Stat Dry Wrap Silver

Indications for Use:

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. D-Stat Dry Wrap Silver contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kerefer MXM
(Division Sign-Off)

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102212

K 102212: D-Stat Silver Traditional 510(k) Premarket Notification Response to Deficiencies - Page 237 of 238

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510(k) Number (if known): K102212

Device Name: Thrombix Silver

Indications for Use:

Applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and perculaneous catheters or tubes. Thrombix Silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane for MXM

(Division Sinn. Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102212

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8 2011

3. 510(k) Summary

[As required by 21 CFR 807.92]

510(k) Number: K102212

Date prepared: March 24, 2011

Submitter Information / Contact Person

Manufacturer

Vascular Solutions, Inc. (VSI) 6464 Sycamore Court Minneapolis, MN 55369 USA Tel: 763.656.4300; Fax: 763.656.4250 Establishment registration: 2134812

Contact Person Lisa Gallatin, RAC Principal Regulatory Product Specialist Email: Igallatin@vascularsolutions.com Tel: 763.656.4399; Fax: 763.656.4253

General Information

Trade Name: D-Stat Dry Silver, D-Stat Dry Clear Silver, D-Stat Dry Wrap Silver, Thrombix Silver Common / Usual Name: Topical Hemostat Classification Name: Dressing, Wound, Drug Identification of Equivalent Devices: K061219 D-Stat Dry (Vascular Solutions, Inc.) K073264 D-Stat Dry Clear (Vascular Solutions, Inc.) K083190 D-Stat Dry Wrap (Vascular Solutions, Inc.) K072117 Thrombix (Vascular Solutions, Inc.) K041268 Silver Alginate Foam Dressing (ADRI) K 090254 Silver Hydrofiber® Dressing Reinforced with Nylon (ConvaTec, Inc.)

Intended Use

Device Description

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K102212 A. 2/2

Vascular Solutions, Inc.

Traditional 510(k) Premarket Notification D-Stat Silver: Dry, Clear, Wrap and Thrombix

lyophilized components (including thrombin) facilitate hemostasis through enzymatic cleavage and conversion of fibrinogen to fibrin. These products contain silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad and have not been clinically tested for their ability to reduce local infection, catheter-related bloodstream infections (CRBSI) and skin colonization of microorganisms commonly related to CRBSI .

An adhesive foam or clear bandage accompanies some products in the family. All products are sterilized by electron-beam irradiation and are intended for single use only.

Summary of Studies

The bench, in vivo and in vitro testing and results that specifically support the substantial equivalence determination of the subject device to the predicates are tests for thrombin activity, pH, moisture content, wetting time, product conformability, silver content, biocompatibility, hemostatic effectiveness, and antimicrobial activity (AATCC Test Method 100-2004 and Zone of Inhibition). The subject device met all established specifications in the design verification bench testing. Biocompatibility tests satisfying ISO 10993 demonstrated the device was non-cytotoxic, not a significant sensitizer and a negligible irritant, which confirms the D-Stat Silver products are biocompatible. Statistical evaluation of data from an acute topical laceration study in a porcine model showed the time-to-hemostasis for the D-Stat Dry Silver did not exceed the time-to-hemostasis for the D-Stat Dry (no silver). Antimicrobial testing demonstrated that after 24 hours of contact with representative D-Stat Silver test samples, all seven microorganism cultures, including some antibiotic resistant cultures, had greater than a 4 log reduction in microbial population under AATCC Test Method 100-2004 and zone of inhibition testing demonstrated comparable zones between D-Stat Silver and the silver-containing predicate devices.

Statement of Equivalence

The D-Stat Silver products are similar in indications for use and design to currently marketed topical hemostats and wound dressings. Technological differences between the subject and predicate devices were sufficiently addressed through bench, in vivo and in vitro testing and no new safety or performance issues were raised during biomaterial or design verification testing. As such, the D-Stat Dry Silver products (D-Stat Dry Silver, D-Stat Dry Clear Silver, D-Stat Dry Wrap Silver and Thrombix Silver) can be considered substantially equivalent to the predicate devices.

Regulation Number and Section

N/A