The IN-LINE Hemostasis Valve is recommended for minimizing back bleeding when a catheter, guide wire or similar device is placed in the vascular system as well as maintaining a fluid-tight seal around interventional devices, catheters, and guide wires.

Device Description

A hemostasis valve is a device which is used to control the amount of blood loss or fluid flow while permitting vasculature access. An "in-line" hemostasis valve is a device used to control fluid which is geometrically configured in a single straight path. The inner lumen does not have additional or intersecting fluid paths.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Merit IN-LINE Hemostasis Valve:

1. A table of acceptance criteria and the reported device performance

Based on the provided 510(k) summary, the acceptance criteria and reported device performance are summarized as follows:

Acceptance Criteria	Reported Device Performance
Provide a leak-proof seal around angioplasty catheters and guide wires.	"Products have been tested to substantiate Merit's claim that the hemostasis provides a leak-proof seal around angioplasty catheters and guide wires."
Control amount of blood loss/fluid flow.	The device is intended to "control the amount of blood loss or fluid flow while permitting vasculature access."
Minimize back bleeding.	The device is "recommended for minimizing back bleeding when a catheter, guide wire or similar device is placed in the vascular system."
Maintain a fluid-tight seal around interventional devices, catheters, and guide wires.	The device is "recommended for...maintaining a fluid-tight seal around interventional devices, catheters, and guide wires."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only states that "Products have been tested."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not specify the number of experts used or their qualifications for establishing ground truth. The evaluation likely involved mechanical testing rather than expert-driven assessment of imaging or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication method. Given the nature of a hemostasis valve, the assessment would likely be based on objective measurements (e.g., fluid leakage, pressure drop) rather than subjective expert 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

This is not applicable to the Merit IN-LINE Hemostasis Valve. This device is a mechanical medical device (hemostasis valve), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance would not be conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical hemostasis valve, not an algorithm. Its performance is inherent to its design and material properties, rather than an algorithm running independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device's performance would primarily be based on objective physical measurements and engineering standards, specifically related to:

Leakage/Seal integrity: Quantifying any fluid leakage under specified pressures when a catheter/guidewire is inserted.
Flow control: Measuring the ability to control blood/fluid flow.
Back bleeding prevention: Demonstrating the ability to prevent or minimize back bleeding.

This would be assessed through bench testing and compliance with relevant industry standards for medical devices of this type. It would not typically involve expert consensus, pathology, or outcomes data in the traditional sense for determining basic functional performance.

8. The sample size for the training set

This is not applicable. As a mechanical medical device, there is no "training set" in the context of machine learning or AI. Performance is evaluated through physical testing.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated above (not an AI/ML device).

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol followed by the word "MERIT" in bold, black letters. The word "MEDICAL" is written to the right of "MERIT" in an outlined font.

MAR 1 5 2000

510(k) SUMMARY This summary was prepared on March 19, 1999

Submitter's name:	Chester McCoy, RAMerit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, Utah 84095P(801) 253-1600 ext. 404F(801) 253-1684	MERIT MEDICALSYSTEMS, INC.1600 WESTMERIT PARKWAYSOUTH JORDAN,
Contact Person:	Same as above
Name of device:	IN-LINE Hemostasis Valve (Passage
Common name:	Hemostasis Valve
Classification name:	Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting(74DTL)
Predicate device:	Merit Y-adaptor with hemostasis valve

PRODUCT DESCRIPTION

A hemostasis valve is a device which is used to control the amount of blood loss or fluid 801-253-1600 flow while permitting vasculature access. An "in-line" hemostasis valve is a device used to control fluid which is geometrically configured in a single straight path. The inner lumen does not have additional or intersecting fluid paths. FAX 801-253-1651

UTAH 84095

INTENDED USE

The Merit IN-LINE Hemostasis Valve is recommended for minimizing back bleeding when a catheter, guide wire or similar device is placed in the vascular system as well as maintaining a fluid-tight seal around interventional devices, catheters, and guide wires.

SUBSTANTIAL EQUIVALENCE STATEMENT

The IN-LINE Hemostasis Valve is manufactured from plastics that have a history of safe blood contact use. Products have been tested to substantiate Merit's claim that the hemostasis provides a leak-proof seal around angioplasty catheters and guide wires. The IN-LINE Hemostasis Valve's intended use is similar to the predicate device's intended use.

Therefore, Merit Medical Systems, Inc. believes this product is substantially equivalent to the predicate device and that its introduction into interstate commerce will not raise new questions of safety or efficacy.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes extending to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2000

Mr. Chester McCoy Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095

Re: K990975 Merit IN-LINE™ Hemostasis Valve Requlatory Class: II (two) Product Code: DYB Dated: December 15, 1999 Received: December 16, 1999

Dear Mr. McCoy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 reqistration, listing 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 - Mr. Chester McCoy

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Chistopher Alan for.

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use Statement

510(k) Number (if Known)	K990975
Device Name	INspector™ Hemostasis Valve
Indications for Use	The IN-LINE Hemostasis Valve is recommended for minimizing back bleeding when a catheter, guide wire or similar device is placed in the vascular system as well as maintaining a fluid-tight seal around interventional devices, catheters, and guide wires.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE) Respiratory, ivision of Clivision of Clevision of Street Neurole Division Newrology

And Newrology Numb × Over-The-Counter Use DR

Prescription Use

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).