(17 days)
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.
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. This fundamental scientific technology is exactly the same as the predicate D-Stat Dry hemostatic bandage.
The provided document is a 510(k) Pre-market Notification for the D-Stat® Dry Clear Hemostatic Bandage. It is a submission to the FDA seeking to demonstrate substantial equivalence to a predicate device. This type of document is generally for regulatory approval and does not contain specific acceptance criteria, device performance data, or detailed study results in the manner that would be expected for a comprehensive clinical study report.
Based on the content of the provided document, here's what can be extracted:
The document explicitly states: "No human clinical testing was required for this device." This means that a clinical study with a test set, ground truth, experts, or statistical analysis of device performance against acceptance criteria, as typically understood in a medical device efficacy study, was not performed for this submission.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device by highlighting commonalities.
Therefore, the requested information elements (1-9) cannot be fully populated as they pertain to a type of performance study that was not conducted for this 510(k) submission.
Here's an attempt to address the questions based on the available information, noting where information is explicitly absent:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document explicitly states "No human clinical testing was required for this device." Therefore, there were no specific acceptance criteria for a new clinical performance study, nor reported device performance from such a study. The submission relies on equivalence to a predicate device already on the market.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No human clinical testing was required, so there was no test set or associated data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No human clinical testing was required; therefore, no ground truth was established by experts for a test set.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
Not applicable. No human clinical testing was required; therefore, no adjudication method for a test set was employed.
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. The device is a hemostatic bandage, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a hemostatic bandage, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No human clinical testing was required to establish ground truth for a new device performance claim. The "ground truth" for the submission is the established safety and efficacy of the predicate device.
8. The Sample Size for the Training Set
Not applicable. The device is not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. The device is not an algorithm that requires a training set.
Summary of the 510(k) Submission's Approach:
The K073264 submission for the D-Stat® Dry Clear Hemostatic Bandage is a Special 510(k). As stated in the document, "No human clinical testing was required for this device." The basis for clearance is demonstrating substantial equivalence to an already legally marketed predicate device, the D-Stat® Dry Topical Hemostat (K030836).
The key argument for equivalence is:
- The only difference between the D-Stat® Dry Clear and the predicate is the replacement of an opaque sterile bandage with a transparent sterile bandage.
- All other core components and principles are the same: same lyophilized pad containing bovine-derived thrombin, CMC, and calcium chloride; same mechanism of action; same intended use/indications for use; same operating principle; same basic device design; same materials (for the active components); same shelf life; and same packaging and sterilization processes.
- A risk analysis (Failure Modes and Effects Criticality Analysis) was performed, and based on this assessment, "no design verification tests were required for inclusion of the sterile clear compression bandage to the D-Stat Dry Clear device."
Therefore, this submission relies on engineering and design control assessments to demonstrate that the minor change (transparent bandage) does not alter the fundamental safety or effectiveness established by the predicate device, obviating the need for new clinical trials.
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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
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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 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.
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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
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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:
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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
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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.
N/A