D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015

• K Number: K083190
• Device Name: D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015
• Manufacturer: VASCULAR SOLUTIONS, INC.
• Date Cleared: 2008-11-12 ( 14 days)
• Product Code: QSX FRO
• Regulation Number: N/A

Intended Use

The D-Stat® Dry Wrap hemostatic bandage 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.

Device Description

The D-Stat® Dry Wrap Hemostatic Bandage consists of a lyophilized pad containing bovinederived thrombin as an aid to hemostasis (King Pharmaceuticals license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride. The sterile device is sold in a foil pouch and is ready to use. The end user removes the D-Stat Dry Wrap from the pouch and applies the device to the bleeding site. Included is a transparent sterile bandage attached to the primary packaging to apply over the hemostatic pad. The pad has a slit approximately half the length of the pad to allow for the wrapping of the pad around vascular access catheters, like PICC (peripherally inserted central catheter) lines. The D-State Dry Wrap is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical carrier to bleeding.

Predicate Devices

K072117, K073264

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the chemical and physical properties of the hemostatic bandage and does not mention any computational or algorithmic components. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".

Therapeutic

Yes.
The device is used to control superficial bleeding, which is a therapeutic action.

Diagnostic

No
The device is described as a hemostatic bandage used to control surface bleeding, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical bandage containing lyophilized components (thrombin, CMC, calcium chloride) and includes a transparent sterile bandage. It is a physical medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the D-Stat® Dry Wrap hemostatic bandage is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
• D-Stat® Dry Wrap Function: The D-Stat® Dry Wrap is a topical hemostatic bandage applied directly to a bleeding site on the body. It works by creating a physical barrier and providing components that aid in the formation of a blood clot in situ (at the site of bleeding).
• No Sample Analysis: The device does not involve taking a sample from the body and analyzing it outside the body to provide diagnostic information. Its function is purely therapeutic/hemostatic.

Therefore, the D-Stat® Dry Wrap falls under the category of a medical device used for wound care and hemostasis, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The D-Stat® Dry Wrap hemostatic bandage 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.

Product codes (comma separated list FDA assigned to the subject device)

QSX, FRO

Device Description

The D-Stat® Dry Wrap Hemostatic Bandage consists of a lyophilized pad containing bovinederived thrombin as an aid to hemostasis (King Pharmaceuticals license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride. The sterile device is sold in a foil pouch and is ready to use. The end user removes the D-Stat Dry Wrap from the pouch and applies the device to the bleeding site. Included is a transparent sterile bandage attached to the primary packaging to apply over the hemostatic pad. The pad has a slit approximately half the length of the pad to allow for the wrapping of the pad around vascular access catheters, like PICC (peripherally inserted central catheter) lines.

The D-State Dry Wrap is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical carrier to bleeding.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072117, K073264

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

0

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February 10, 2023

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

Re: K083190

Trade/Device Name: D-Stat® Dry Wrap Hemostatic Bandage 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 November 12, 2008. 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, [e-mail].

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

1

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vascular Solutions, Inc. % Ms. Lisa Gallatin, RAC Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369

NOV 12 2008

Re: K083190

Trade/Device Name: D-Stat® Dry Wrap Hemostatic Bandage Regulatory Class: Unclassified Product Code: FRO Dated: October 28, 2008 Received: October 29, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 -- Ms. Lisa Gallatin, RAC

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Mulkerson

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

Enclosure

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INDICATIONS FOR USE STATEMENT

KO 83190 510(k) Number (if known):

Device Name: D-Stat® Dry Wrap Hemostatic Bandage

Indications for Use: The D-Stat® Dry Wrap hemostatic bandage 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.

Mark A. Millam

(Division Sign-Off) (Division of General, Restorative, and Neurological Devices

510(k) Number K083190

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

of Page

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KO83190

Attachments

510(K) SUMMARY [As required by 21 CFR 807.92)]

1. Submitter's Name / Contact Person

Manufacturer

Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Tel: [phone] Fax: [phone]

2. General Information

Trade Name Common / Usual Name Classification Name Identification of Equivalent Devices

Contact Person Lisa Gallatin, RAC Sr. Regulatory Affairs Associate

Tel: [phone] (Direct) Fax: [phone] [e-mail]

D-Stat® Dry Wrap Hemostatic Bandage Topical Hemostat Dressing, Wound, Drug Thrombix™ Patch Thrombin Hemostasis Patch (K072117) D-Stat® Dry Clear Hemostatic Bandage (K073264)

3. Intended Use

The D-State Dry Wrap 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.

4. Device Description

The D-Stat® Dry Wrap Hemostatic Bandage consists of a lyophilized pad containing bovinederived thrombin as an aid to hemostasis (King Pharmaceuticals license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride. The sterile device is sold in a foil pouch and is ready to use. The end user removes the D-Stat Dry Wrap from the pouch and applies the device to the bleeding site. Included is a transparent sterile bandage attached to the primary packaging to apply over the hemostatic pad. The pad has a slit approximately half the length of the pad to allow for the wrapping of the pad around vascular access catheters, like PICC (peripherally inserted central catheter) lines.

The D-State Dry Wrap is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. The lyophilized components (thrombin, CMC, and calcium chloride) establish an environment in which a natural blood clot can build and form a physical carrier to bleeding.

5. Statement of Equivalence

The D-Stat® Dry Wrap is substantially equivalent to the Vascular Solutions, Inc. Thrombix™ Patch Thrombin Hemostasis Patch (K072117) and D-Stat® Dry Clear Hemostatic Bandage (K073264) products. The D-Stat® Dry Wrap only differs from this predicates in that it has a lengthwise slit cut in the lyophilized pad to allow placement of the pad around existing access lines.

Conclusion 6.

The D- State Dry Wrap is substantially equivalent to the currently marketed Thrombix™ Patch Thrombin Hemostasis Patch and D-Stat® Dry Clear Hemostatic Bandage products based on a comparison of the indications for use and technological characteristics of the device.

NOV 1 2 2008