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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "D-Stat Handle." This document focuses on the regulatory submission process and non-clinical testing, rather than a clinical study with detailed acceptance criteria and performance metrics typically found in clinical trial reports.

Here's an analysis based on the provided text, addressing your points:

Acceptance Criteria and Study for D-Stat Handle (No Clinical Study Performed)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Non-Clinical Testing)
Device is reusable (disconnect and reattach to 10 different clamp bases).	The non-clinical testing ensured the device is reusable by being able to disconnect and reattach to 10 different clamp bases.
Device weighs less than 1.5 lbs.	It was weight tested, verifying that the device weighs less than 1.5 lbs.
D-Stat Clamp base remains attached to D-Stat Handle after vertical shaking for 2 seconds.	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.
Device delivers even surface pressure (comparable to current commercial hand-held compression devices).	The D-Stat Handle was tested to ensure that it delivers even surface pressure.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Specific sample sizes for each non-clinical test are not explicitly provided in terms of the number of devices tested beyond "10 different clamp bases" for reusability. For the other tests (weight, shaking, even surface pressure), the sample size is implied to be at least one device, but a precise number is not given.
Data Provenance: The data is from non-clinical testing conducted by the submitter (Vascular Solutions, Inc.). The country of origin is not explicitly stated but can be inferred as the United States given the submitter's address and the FDA submission. This is retrospective in the sense that the tests were completed before the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device's evaluation was based on non-clinical engineering and performance testing against predefined specifications, not on expert-adjudicated clinical outcomes or "ground truth" derived from expert consensus.

4. Adjudication Method for the Test Set

Not applicable. No clinical adjudication was performed, as this was a non-clinical device performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical evaluations of this product for this use have been conducted." Therefore, no MRMC study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a mechanical handle for a clamp, not an AI algorithm. Its performance is inherent to its physical design and operation, and it is intended for human-in-the-loop use.

7. Type of Ground Truth Used

Engineering/Performance Specifications: The "ground truth" for this device's non-clinical testing was based on predetermined engineering and performance specifications (e.g., weighing less than 1.5 lbs, staying attached after shaking, delivering even pressure).

8. Sample Size for the Training Set

Not applicable. This is a hardware medical device, not an AI/ML algorithm. There is no training set in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for this type of device.

Summary of Clinical Testing Statement:
The document clearly states: "No clinical evaluations of this product for this use have been conducted." The entire submission relies on non-clinical testing and substantial equivalence to predicate devices (D-Stat Clamp Accessory, FemoStop, EZ Hold) to demonstrate safety and effectiveness.

Summary

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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.

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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.

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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

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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

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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

Regulation Number and Section

§ 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).