(99 days)
The D-Stat Radial Topical Hemostat is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
D-Stat Radial topical hemostat (D-Stat Radial) is a hemostatic band consisting of an application device containing a lyophilized pad consisting of thrombin, sodium carboxylmethylcellulose and calcium chloride in a nonwoven gauze, and an adjustable retention strap and attached foam pads. Hemostasis is achieved by the physiological coagulation-inducing properties of the lyophilized pad combined with the compression delivered by the application device.
The D-Stat Radial has been sterilized with irradiation.
The provided text is a 510(k) Pre-market Notification for the D-Stat Radial Topical Hemostat. It focuses on demonstrating substantial equivalence to a predicate device, not on validating the device's absolute efficacy via a clinical study with detailed acceptance criteria and outcome measurements. Therefore, much of the requested information cannot be extracted directly from this document.
However, I can provide what is present regarding the device's technical validation and comparison to a predicate.
The primary change in the device is to the retention strap material. The demonstration of substantial equivalence relies on:
- Performance Testing: "Securement Force"
- Biocompatibility Testing: "Cytotoxicity", "Sensitization", "Irritation"
Here's an analysis of what can be inferred or explicitly stated from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific acceptance criteria for "Securement Force" are not detailed in this document. | Device samples passed the securement force test. |
| Compliance with ISO 10993-1 for biological evaluation. | Device samples passed biocompatibility tests (Cytotoxicity, Sensitization, Irritation). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document only states "Device samples" were used for performance and biocompatibility tests. No specific sample sizes are mentioned.
- Data Provenance: Not specified, but generally, 510(k) testing is performed by the manufacturer or a contract research organization. The manufacturing facility is listed in Minneapolis, MN, USA.
- Retrospective/Prospective: Not applicable in this context as these are laboratory and bench tests, not clinical studies on patient cohorts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The validation methods described (Securement Force, Biocompatibility) are objective laboratory tests against established standards (e.g., ISO 10993-1), not subjective assessments requiring expert consensus for "ground truth".
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As mentioned above, the tests are objective, not requiring adjudication.
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. This is not an AI/software device. The document describes a physical medical device (a hemostatic band).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground truth for the performance and biocompatibility tests are the established specifications and ISO standards. For example, for biocompatibility, the ground truth is compliance with the limits set by ISO 10993-1. For securement force, the ground truth would be a predetermined force range or threshold.
8. The sample size for the training set
- Not Applicable. This is not a machine learning/AI device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for this device.
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February 10, 2023
Vascular Solutions LLC Melissa Sommerfeld Principal Regulatory Product Specialist 6401 Sycamore Court North Maple Grove, Minnesota 55369
Re: K200720
Trade/Device Name: D-Stat Radial Topical Hemostat Regulatory Class: Unclassified Product Code: QSX
Dear Melissa Sommerfeld:
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 June 26, 2020. 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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June 26, 2020
Vascular Solutions LLC Melissa Sommerfeld Principal Regulatory Product Specialist 6401 Sycamore Ct N Maple Grove, Minnesota 55369
Re: K200720
Trade/Device Name: D-Stat Radial Topical Hemostat Regulatory Class: Unclassified Product Code: FRO Dated: Mav 28, 2020 Received: May 29, 2020
Dear Melissa Sommerfeld:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Anjana Jain -S
Anjana Jain, Ph.D. Acting 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
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name:
D-Stat Radial Topical Hemostat
Indications for Use (Describe)
The D-Stat Radial Topical Hemostat is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared: June 26, 2020
510(k) Number: K200720
Submitter's Name / Contact Person
Manufacturer Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Melissa Sommerfeld Principal Regulatory Product Specialist Tel: 763-656-4300
General Information
| Trade Name | D-Stat Radial Topical Hemostat |
|---|---|
| Common / Usual Name | D-Stat Radial |
| Classification Name | Unclassified |
| Regulatory Class: | Unclassified |
| Product Code: | FRO |
| Predicate Device | K050133, D-Stat Radial Hemostatic Band (Vascular Solutions, Inc.) |
| Reference Device | K092612, D-Stat Radial Rad-Band (Vascular Solutions, Inc.) |
Device Description
D-Stat Radial topical hemostat (D-Stat Radial) is a hemostatic band consisting of an application device containing a lyophilized pad consisting of thrombin, sodium carboxylmethylcellulose and calcium chloride in a nonwoven gauze, and an adjustable retention strap and attached foam pads. Hemostasis is achieved by the physiological coagulation-inducing properties of the lyophilized pad combined with the compression delivered by the application device.
The D-Stat Radial has been sterilized with irradiation.
Indications for Use
The D-Stat Radial topical hemostat is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Technological Characteristics Comparison
The key technological difference between the D-Stat Radial and the predicate device is a change to the retention strap material.
Substantial Equivalence and Summarv of Studies
The technological difference between the subject and predicate device has been evaluated through performance and biocompatibility tests to provide evidence of substantial equivalence for D-Stat Radial.
The device performance was verified through the following test:
- Securement Force .
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K200720 Page 2 of 2
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The D-Stat Radial is considered a surface device that contacts the skin for a limited duration (under 24 hours). The battery of tests included the following:
- Cytotoxicity ●
- Sensitization
- . Irritation
Conclusions
The D-Stat Radial Hemostatic Band is substantially equivalent in both the indications for use and technological characteristics to the predicate device and do not raise new questions of safety or effectiveness.
N/A