(123 days)
Not Found
No
The summary describes a physical hemostatic device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The D-Stat Clamp Accessory directly assists in the control of bleeding and provides a hemostatic bandage, which are therapeutic actions.
No
This device is designed to control bleeding and assist in achieving hemostasis after medical procedures, not diagnose a condition.
No
The device description clearly states it consists of a lyophilized pad, compressible translucent pad, and plastic base, which are physical components, 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 to assist in the control of bleeding following catheterization or cannulation procedures and for the control of surface bleeding from vascular access sites. This is a therapeutic and hemostatic function performed directly on the patient's body.
- Device Description: The device consists of a pad containing thrombin and other substances designed to promote clotting. This is a topical hemostatic agent.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood and tissue, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. This device does not perform any of these functions. It is applied externally to control bleeding.
Therefore, the D-Stat Clamp Accessory is a hemostatic device used for controlling bleeding, not an in vitro diagnostic device.
N/A
Intended Use / 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."
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery, vascular access sites
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)
Tests conducted included assessment of the ability to separate the lyophilized pad from the Clamp Accessory Base and a biocompatibility assessment of new materials.
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
§ 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).
0
MAY 27 2005
Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "KOS0146". The characters are written in black ink on a white background.
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 Court | |
| Minneapolis, Minnesota 55369 | |
| Establishment Registration: | 2134812 |
| Contact: | Linda Busklein |
| Sr. Regulatory Affairs Associate | |
| (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 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. | |
| Intended 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. | |
| Summary of Non-Clinical Testing: | Tests conducted included assessment of the ability to separate |
| the lyophilized pad from the Clamp Accessory Base and a | |
| biocompatibility 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 the |
| currently marketed D-Stat Clamp Accessory and the D-Stat Dry | |
| Hemostatic Bandage based on a comparison of the indications | |
| for use and the technological characteristics of the device. |
1
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.
2
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
3
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
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Number K050146