(17 days)
Not Found
No
The device description focuses on the chemical and physical properties of the hemostatic bandage and its components (thrombin, CMC, calcium chloride). There is no mention of AI, ML, image processing, or any computational analysis of data for diagnosis, treatment, or prediction. The mechanism of action is described as a chemical and physical process to aid blood clotting.
No
Explanation: The device is a hemostatic bandage used to control surface bleeding and reduce time-to-hemostasis, which is a supportive function rather than a treatment for a disease or condition. Its primary function is to aid in the body's natural clotting process.
No
The device is described as a hemostatic bandage used for controlling surface bleeding and reducing time-to-hemostasis. Its function is therapeutic (to stop bleeding), not diagnostic (to identify or characterize a medical condition).
No
The device description clearly outlines a physical bandage containing lyophilized components (thrombin, CMC, calcium chloride) and a transparent sterile bandage. This is a hardware-based medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes, and reducing time-to-hemostasis. This is a topical application to a bleeding site on the body.
- Device Description: The device is a hemostatic bandage applied directly to the bleeding source. It contains components that interact with blood at the site of bleeding to promote clotting.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are performed outside the body.
This device is a topical hemostatic agent used to control bleeding on the surface of the body, not a test performed on a sample taken from the body.
N/A
Intended Use / Indications for Use
The D-Stat Dry Clear 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 a 4-6 Fr. introducer sheath.
Product codes (comma separated list FDA assigned to the subject device)
QSX, FRO
Device Description
The D-Stat® Dry Clear Hemostatic Bandage consists of a lyophilized pad containing bovinederived thrombin as an aid to hemostasis (King Pharmaceutical license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride. Included is a transparent sterile bandage attached to the primary packaging to apply over the hemostatic pad. The only difference between the D-Stat® Dry Clear Hemostatic Bandage and the predicate is the replacement of the opaque sterile bandage included with the device with a transparent sterile bandage.
The D-Stat® Dry Clear 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 barrier to bleeding. The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access sites and percutaneous catheters or tubes
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)
No human clinical testing was required for this device.
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.
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services 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 James Chapman Regulatory Affairs Associate 907 South Lakewood Avenue Baltimore, Maryland 21224
Re: K073264
Trade/Device Name: D-Stat® Dry Clear, Hemostatic Bandage Regulatory Class: Unclassified Product Code: QSX
Dear James Chapman:
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 December 7, 2007. 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
1
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 stylized eagle with three stripes forming its body and wing. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vascular Solutions, Inc. % Mr. James Chapman Regulatory Affairs Associate 907 South Lakewood Avenue Baltimore, Maryland 21224
DEC 7 2007
Re: K073264
Trade/Device Name: D-State® Dry Clear Hemostatic Bandage Regulatory Class: Unclassified Product Code: FRO Dated: November 19, 2007 Received: November 20, 2007
Dear Mr. Chapman:
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.
2
Page 2 - Mr. James Chapman
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 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 (240) 276-0115. 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 Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number: K073264
Device Name: D-Stat
®
Dry Clear Hemostatic Bandage
Indications for Use:
The D-Stat Dry Clear 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 a 4-6 Fr. introducer sheath.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
(Division Sign-Off) (Division bigand Neurological Devices
103264
510(k) Number:
4
Special 510(k) Summary (As required by 21 CFR 807.92(c))
K073264 Special 510(k) Number: Page 1 of 2
Date Prepared: November 19, 2007
Submitter Information
| Submitter's Name: | Vascular Solutions, Inc. |
|---|---|
| Address: | 6464 Sycamore Court |
| Minneapolis, MN 55369 |
Establishment Registration: 2134812
| Contact Person: | James Chapman |
|---|---|
| Regulatory Affairs Associate | |
| Phone: | (763) 656-4300 ext. 380 |
| Fax: | (763) 656-4253 |
Device Information
| Trade Name: | D-Stat® Dry Clear, Hemostatic Bandage |
|---|---|
| Common Name: | Topical hemostat |
| Classification Name: | Unclassified |
| Product Code: | FRO |
| Regulation: | Not Applicable |
Predicate Device
The predicate device is the currently marketed D-Stat® Dry Topical Hemostat (K030836).
Device Description
The D-Stat® Dry Clear Hemostatic Bandage consists of a lyophilized pad containing bovinederived thrombin as an aid to hemostasis (King Pharmaceutical license number 0977), sodium carboxymethylcellulose (CMC), and calcium chloride. Included is a transparent sterile bandage attached to the primary packaging to apply over the hemostatic pad. The only difference between the D-Stat® Dry Clear Hemostatic Bandage and the predicate is the replacement of the opaque sterile bandage included with the device with a transparent sterile bandage.
The D-Stat® Dry Clear 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 barrier to bleeding.
OEC 7 2007
5
Vascular Solutions, Inc. D-Stat® Dry Clear Hemostatic Bandage Special 510(k) Pre-market Notification Page 2 of 2
The thrombin facilitates hemostasis by enhancing the surface-activated clotting cascade through enzymatic cleavage and conversion of fibrinogen to fibrin. This fundamental scientific technology is exactly the same as the predicate D-Stat Dry hemostatic bandage,
Intended Use/Indications for Use
The D-Stat Dry Clear has the same indications for use and is intended to be used in the same manner as the predicate D-Stat Dry. The D-Stat Dry Clear 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 a 4-6 Fr. introducer sheath.
Summary of Design Control Activities
The risk analysis method used to assess the impact of the modification to the device was a Failure Modes and Effects Criticality Analysis. Based on the risk assessment, no design verification tests were required for inclusion of the sterile clear compression bandage to the D-Stat Dry Clear device.
A declaration of conformity with design controls is included in Section 7.
Summary of Clinical Testing
No human clinical testing was required for this device.
Statement of Equivalence
The D-Stat® Dry Clear Hemostatic Bandage and the currently marketed D-Stat® Dry Hemostatic Bandage have the following commonalities:
- · Both have the same indicated use,
- · Both use the same operating principle
- · Both incorporate the same basic device design.
- · Incorporate the same materials.
- · Have the same shelf life, and
- · Are packaged and sterilized using the same materials and processes
Conclusion
In summary, the D-Stat® Dry Clear Hemostatic Bandage is substantially equivalent to the currently marketed D-Stat® Dry Hemostatic Bandage based on a comparison of the indications for use and the technological characteristics of the device.