(123 days)
The D-Stat Clamp Accessory is indicated for use with the Compressar Universal System (Advanced Vascular Dynamics) and the Femoral Artery Vascular Clamp (Pressure Products) compression devices or as a stand alone device to assist in the control of bleeding following catheterization or cannulation procedures. Following achieving hemostasis the D-Stat Dry Bandage may be detached from the D-Stat Clamp Accessory and left in place for up to 24 hours and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
The D-Stat Clamp Accessory consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride secured to a compressible translucent pad and plastic base. The device is designed for attachment to several commercially available femoral access compression devices or as a standalone device. After hemostasis has been achieved, the lyophilized pad may be removed from the Clamp Accessory base, covered with a provided adhesive bandage, and left in place for up to 24 hours.
The provided text is a 510(k) Summary for the D-Stat Clamp Accessory. It describes the device, its intended use, and states that it is substantially equivalent to previously marketed devices. However, it explicitly states under "Summary of Non-Clinical Testing" that only "Tests conducted included assessment of the ability to separate the lyophilized pad from the Clamp Accessory Base and a biocompatibility assessment of new materials." There are no clinical performance testing or studies described in this document to establish specific acceptance criteria for efficacy or safety (beyond biocompatibility) of the D-Stat Clamp Accessory itself.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader studies, as this information is not present in the provided text. The document focuses on regulatory equivalence based on technological characteristics and indication of use in comparison to predicate devices, rather than detailed performance studies for this specific device.
The "Summary of Non-Clinical Testing" listed is very specific and limited to mechanical separation and biocompatibility, not clinical effectiveness.
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MAY 27 2005
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510(K) SUMMARY
| Common/Usual Name: | Topical Hemostat/Vascular Clamp Accessory |
|---|---|
| Product Trade Name: | D-Stat Clamp Accessory |
| Classification Name: | Vascular Clamp, 21CFR 870.4450, product code DXC |
| Manufacturer: | Vascular Solutions, Inc.6464 Sycamore CourtMinneapolis, Minnesota 55369 |
| Establishment Registration: | 2134812 |
| Contact: | Linda BuskleinSr. Regulatory Affairs Associate(763) 656-4217 phone(763) 656-4250 fax |
| Performance Standards: | No performance standards have been developed under section514 for this device. |
| Device Description: | The D-Stat Clamp Accessory consists of a lyophilized padcontaining thrombin, sodium carboxymethylcellulose, andcalcium chloride secured to a compressible translucent pad andplastic base. The device is designed for attachment to severalcommercially available femoral access compression devices or asa standalone device. After hemostasis has been achieved, thelyophilized pad may be removed from the Clamp Accessorybase, covered with a provided adhesive bandage, and left in placefor up to 24 hours. |
| Intended Use: | The D-Stat Clamp Accessory is indicated for use with theCompressar Universal System (Advanced Vascular Dynamics)and the Femoral Artery Vascular Clamp (Pressure Products)compression devices or as a stand alone device to assist in thecontrol of bleeding following catheterization or cannulationprocedures. Following achieving hemostasis the D-Stat DryBandage may be detached from the D-Stat Clamp Accessory andleft in place for up to 24 hours and is indicated for the control ofsurface bleeding from vascular access sites and percutaneouscatheters or tubes. |
| Summary of Non-Clinical Testing: | Tests conducted included assessment of the ability to separatethe lyophilized pad from the Clamp Accessory Base and abiocompatibility assessment of new materials. |
| Predicate Devices: | Vascular Solutions D-Stat Clamp Accessory (K040730)Vascular Solutions D-Stat Dry Hemostatic Bandage (K030836) |
| Conclusions: | The D-Stat Clamp Accessory is substantially equivalent to thecurrently marketed D-Stat Clamp Accessory and the D-Stat DryHemostatic Bandage based on a comparison of the indicationsfor use and the technological characteristics of the device. |
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, superimposed over a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 2005
Vascular Solutions, Inc. c/o Ms. Linda Busklein Sr. Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
Re: K050146 D-Stat Clamp™ Accessory Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (Two) Product Code: DXC Dated: April 13, 2005 Received: April 14, 2005
Dear Ms. Busklein:
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) i 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. Iisting 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.
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Page 2 - Ms. Linda Busklein
Please be advised that FDA's issuance of a substantial equivalence determination does not muan 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 sct 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 the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.huml.
Sincerely yours,
Dunker R Kirchner
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
| 510(k) Number: | K050146 |
|---|---|
| Device Name: | Vascular Solutions D-Stat Clamp Accessory |
Indications for Use:
The D-Stat Clamp Accessory is indicated for use with the Compressar Universal System (Advanced Vascular Dynamics) and the Femoral Artery Vascular Clamp (Pressure Products) compression devices or as a stand alone device to assist in the control of bleeding following catheterization or cannulation procedures. Following achieving hemostasis the D-Stat Dry Bandage may be detached from the D-Stat Clamp Accessory and left in place for up to 24 hours and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes."
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)
Duna R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Number K050146
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).