(61 days)
Not Found
No
The device description and performance studies focus on mechanical properties and function, with no mention of AI or ML.
Yes
The device is indicated for assisting in the control of bleeding, which is a therapeutic action.
No
Explanation: The device is indicated for assisting in the control of bleeding, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that the D-Stat Handle consists of physical components (stainless steel handle and shaft), indicating it is a hardware device, not software-only.
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." This is a direct therapeutic or procedural intervention on a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "Stainless Steel handle and shaft" used with a clamp accessory. This describes a physical tool used in a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body or on the body surface) during a medical procedure.
N/A
Intended Use / Indications for Use
The D-Stat Handle is indicated for use with the D-Stat Clamp accessory to assist in the control of bleeding following cathetcrization or cannulation procedures.
Product codes
DXC
Device Description
Each D-Stat Handle consists of the following components:
- Stainless Steel handle and shaft with a configured press fit attachment for the D-. Stat Dry Clamp accessory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
To test the performance requirements of the D-Stat Handle, the non-clinical testing included; cnsuring that the device is reusable by being able to disconnect and reattach to 10 different clamp bases. It was weight tested, verifying that the device weighs less than 1.5 lbs. The D-Stat Clamp base was tested to confirm that it will stay attached to the D-Stat Handle after vertical shaking for 2 seconds. Comparable to current commercial hand held compression devices the D-Stat Handle was tested to ensure that it delivers even surface pressure.
No clinical evaluations of this product for this use have been conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a logo with a stylized graphic above the word "vascula". The graphic consists of a series of black squares arranged in a curved, vertical pattern, resembling a stylized wave or flow. The word "vascula" is written in a bold, sans-serif font, positioned directly below the graphic.
FEE 2 8 7007
510(k) Summary
510(k) Number: KO63871
Date Prepared
Submitter Information
Submitter's Name/ Address:
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369
Establishment Registration 2134812
Contact Person: Alyssa Malinski
Device Information
Trade Name: Vascular Solutions D-Stat Handle™ Common Name: Topical Hemostat/Vascular Clamp Classification Name: Vascular Clamp Product Code: DXC Regulation: 21 CFR 870.5150
Predicate Device(s)
D-Stat Clamp Accessory (K050146) FemoStop (K915280) EZ Hold (K973132)
Device Description
Each D-Stat Handle consists of the following components:
- Stainless Steel handle and shaft with a configured press fit attachment for the D-. Stat Dry Clamp accessory.
1
Intended Use/Indications for Use
The D-Stat Handle is indicated for use with the D-Stat Clamp accessory to assist in the control of bleeding following cathetcrization or cannulation procedures.
Summary of Non-Clinical Testing
To test the performance requirements of the D-Stat Handle, the non-clinical testing included; cnsuring that the device is reusable by being able to disconnect and reattach to 10 different clamp bases. It was weight tested, verifying that the device weighs less than 1.5 lbs. The D-Stat Clamp base was tested to confirm that it will stay attached to the D-Stat Handle after vertical shaking for 2 seconds. Comparable to current commercial hand held compression devices the D-Stat Handle was tested to ensure that it delivers even surface pressure.
Summary of Clinical Testing
No clinical evaluations of this product for this use have been conducted.
Statement of Equivalence
The D-Stat Handle and D-Stat Clamp accessory are substantially equivalent to the FemoStop and EZ Hold.
Conclusion
The D-Stat Handle is suitable for the intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. Encircling the caduceus is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA". The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2007
Vascular Solutions, Inc. Ms. Alyssa Malinski Regulatory Affairs Assistant 6464 Sycamore Court Minneapolis, MN 55369
Re: K063871
Trade/Device Name: D-Stat Handle, model number 8500-053 Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: DXC Dated: December 27, 2006 Received: December 29, 2006
Dear Ms. Malinski:
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. 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.
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
3
Page 2 - Ms. Malinski
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Uma R. bochner
Image /page/3/Picture/5 description: The image contains a signature. The signature is illegible, but it appears to be written in cursive. The signature is black and is on a white background. The signature is located on the left side of the image.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): _ K O6 3 8 7 |
Device Name: D-Stat Handle D-Stat Clamp accessory
Indications for Use:
The D-Stat Handle is indicated for use with the D-Stat Clamp accessory to assist in the control of bleeding following catheterization or cannulation procedures.
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 (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)
Suma R. Holmes
(D
Div Devices
51Anki mimmer K 06 58