(158 days)
The D-Stat Dry 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 4-6 Fr. introducer sheaths.
The D-Stat Dry Hemostatic Bandage consists of the following components:
- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose (CMC) and calcium chloride
- Adhesive bandage
The D-Stat Dry Hemostatic Bandage achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by the bandage. 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.
The provided text describes the D-Stat Dry Hemostatic Bandage and its FDA 510(k) clearance, but it does not provide detailed acceptance criteria or a study that proves the device meets specific performance criteria in the format requested.
Here's a breakdown of why and what information is available:
Key Takeaways from the Document:
- Device: D-Stat Dry Hemostatic Bandage
- Intended Use: Applied topically as an adjunct to manual compression for control of surface bleeding from vascular access sites and percutaneous catheters/tubes, and reducing time-to-hemostasis in patients undergoing diagnostic endovascular procedures using 4-6 Fr. introducer sheaths.
- Regulatory Clearance: 510(k) substantial equivalence to predicate devices (D-Stat Dry Hemostatic Bandage K030836 and Syvek excel Vascular Access Hemostasis System K053300).
- Testing:
- No non-clinical testing was conducted.
- A "prospective, randomized, non-significant risk clinical investigation" was conducted. This study provided "clinical evidence that use of the D-Stat Dry Hemostatic Bandage in the intended study population was safe and reduced the time-to-hemostasis following diagnostic catheterization procedures."
- Absence of Specific Performance Data: The document explicitly states "No performance standards have been developed under section 514 for this device" and does not present a table of acceptance criteria or reported device performance metrics (e.g., specific time-to-hemostasis in seconds, success rates). The clinical study is mentioned but no results are detailed.
Therefore, I cannot populate the requested table or answer questions 2-9 with the provided text. The document focuses on regulatory clearance via substantial equivalence rather than detailing performance studies against specific acceptance criteria.
Hypothetical Example of what the document would need to contain to answer your questions (this is NOT in the provided text):
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance (D-Stat Dry) |
|---|---|---|
| Time-to-Hemostasis (TTH) | Mean TTH < [e.g., 5.0 minutes] | Mean TTH = [e.g., 3.2 minutes] (p<0.01 vs. control) |
| Success Rate (within 10 min) | ≥ 90% of patients achieve hemostasis within 10 minutes | 95% |
| Re-bleeding Rate (within 24h) | < 2% | 1.5% |
| Adverse Event Rate (specific to device) | < 1% (e.g., skin irritation, hematoma > 5cm) | 0.8% |
2. Sample sized used for the test set and the data provenance
* Test Set Sample Size: [e.g., 200 patients (100 control, 100 device)]
* Data Provenance: Prospective, multi-center study conducted in the USA and Canada.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* Not applicable for this type of device where objective measurements (time, re-bleeding) are typically used rather than subjective expert consensus on images/data. For a device like this, the "ground truth" is typically the directly measured clinical outcome.
4. Adjudication method for the test set
* Not applicable as the outcomes (e.g., time to hemostasis, re-bleeding) are objectively measured during the procedure and follow-up. An independent Clinical Events Committee (CEC) might adjudicate serious adverse events, but not the primary efficacy endpoint.
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 direct application, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
* Clinical outcomes directly measured: Time-to-hemostasis, presence/absence of re-bleeding, adverse event rates.
8. The sample size for the training set
* Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
* Not applicable.
In summary, the provided document serves as an FDA clearance letter based on substantial equivalence and briefly mentions a clinical study, but it lacks the detailed performance data and study specifics needed to fully answer your request.
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February 10, 2023
Vascular Solutions, Inc. c/o Julie Tapper Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K061219
Trade/Device Name: D-Stat Dry Hemostatic Bandage Regulatory Class: Unclassified Product Code: QSX, DXC
Dear Julie Tapper:
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 October 6, 2006. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus, which is a symbol featuring a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 6 2006
Vascular Solutions, Inc. c/o Ms. Julie Tapper Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369
Re: K061219
Trade Name: D-Stat Dry Hemostatic Bandage accessory Regulation Number: 21 CFR 870.4450 and unclassified Regulation Name: Vascular Clamp, Topical Hemostat Regulatory Class: Class II Product Code: DXC. FRO Dated: September 28, 2006 Received: October 3, 2006
Dear Ms. Tapper:
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 Foond, Or vo 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, l'isting 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, EDA over publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Julie Tapper
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 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 Office of Compliance at (240) 276-0120. Also, please note (24 creation over), pro-"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain 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) 633-2011 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bfimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement-D-Stat Dry™ Hemostatic Bandage
510(k) Number:
Device Name:
Vascular Solutions D-Stat Dry™ Hemostatic Bandage
Indications for Use:
The D-Stat Dry 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 4-6 Fr. introducer sheaths.
Prescription Use x AND/OR -(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Bhumma
sion Sign-Off) scular Devices Division of Cardlova 510(k) Number_
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K061219
Page 1 of 2
D-Stat Dry Hemostatic Bandage 510(k) Summary
| Common/Usual Name: | Topical Hemostat | |
|---|---|---|
| Product Trade Name: | D-Stat Dry™ Hemostatic Bandage | |
| Classification Name: | Unclassified | |
| Product Code: | DXC | OCT - 6 2000 |
| Manufacturer: | Vascular Solutions, Inc.6464 Sycamore CourtMinneapolis, Minnesota 55369USA | |
| Establishment Registration: | 2134812 | |
| Contact: | Linda BuskleinRegulatory Affairs Manager(763) 656-4217 phone(763) 656-4250 fax |
Performance Standards:
No performance standards have been developed under section 514 for this device. Device Description:
The D-Stat Dry Hemostatic Bandage consists of the following components:
- Lyophilized pad consisting of thrombin, sodium carboxymethylcellulose (CMC) and calcium chloride
- · Adhesive bandage
The D-Stat Dry Hemostatic Bandage achieves its principal intended action (hemostasis) by creating a physical barrier to blood flow with compression supplied by the bandage. 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.
Intended Use:
The D-Stat Dry 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 4-6 Fr. introducer sheaths.
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Summary of Non-Clinical Testing:
No non-clinical testing was conducted.
Summary of Clinical Testing:
A prospective, randomized, non-significant risk clinical investigation was conducted and provided r clinical evidence that use of the D-Stat Dry Hemostatic Bandage in the intended study population was safe and reduced the time-to-hemostasis following diagnostic catheterization procedures.
Predicate Devices:
D-Stat Dry™ Dry Hemostatic - K030836
Syvek excel Vascular Access Hemostasis System - K053300
Conclusions:
The D-Stat Dry™ Hemostatic Bandage is substantially equivalent to the D-Stat Dry™ Hemostatic Bandage, based on comparisons between the intended use, construction materials, and device dimensions.
N/A