The Hemostasis Valve is a valve consisting of a clear polycarbonate body, silicone valve, polyacetal actuation lever, and polycarbonate and EPDM o-ring rotating male Luer lock connector and female Luer lock.

AI/ML Overview

This document, a 510(k) Premarket Notification for a Hemostasis Valve, does not contain the level of detail regarding acceptance criteria and study design that would be found in a clinical trial report or a more extensive study. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive evaluation against specific performance metrics for a novel technology like an AI-powered device.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Fluid-tight seal around interventional and diagnostic devices during use.	The device is approved for marketing, implying it met standards for safety and effectiveness related to maintaining a fluid-tight seal.
Specific quantitative thresholds (e.g., leakage rate, pressure resistance) are not provided in this summary.	No specific quantitative performance data (e.g., specific leakage rates, pressure tolerances) are reported as they would be in a detailed test report.
Biocompatibility	Component materials "were found safe for their intended use" and support the device's safety.

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

Not explicitly stated. The document refers to "performance data provided" but does not detail the sample size or the nature of the tests conducted (e.g., in-vitro, ex-vivo, in-vivo studies). Data provenance is also not mentioned.

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)

Not applicable/Not stated. This type of information is relevant for studies involving qualitative assessments, such as image interpretation by medical professionals, which is not the case for this mechanical device.

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

Not applicable/Not stated. Adjudication methods are typically used when there's subjective interpretation or disagreement among experts, which doesn't seem to be relevant for the mechanical performance testing of a valve.

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

Not applicable. This device is a mechanical hemostasis valve, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.

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

Not applicable. This device is a mechanical hemostasis valve, not an algorithm or AI system.

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

Implied engineering and performance standards. For a mechanical device like a hemostasis valve, the "ground truth" would likely be established through engineering specifications, validated test methods (e.g., leakage tests, pressure tests, material compatibility tests), and comparison to the predicate device's established performance. The document states that the technological characteristics are "similar in design and technology" to the predicate.

8. The sample size for the training set

Not applicable. This information pertains to machine learning models, not the development of a mechanical device.

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

Not applicable. This information pertains to machine learning models, not the development of a mechanical device.

Summary based on the provided text:

The provided document describes a 510(k) premarket notification for a Hemostasis Valve. The acceptance criteria are implicitly that the device is safe and effective for its intended use, specifically to "maintain a fluid-tight seal around interventional and diagnostic devices during use," and that its component materials are biocompatible. The study proving this involves "performance data provided" and biocompatibility statements, along with a comparison of its design and technology to a legally marketed predicate device (Merit Passage® Hemostasis Valve, K925419).

The document is a regulatory submission for a traditional medical device, not an AI/ML-powered device. Therefore, many of the questions related to AI-specific study design (e.g., training sets, expert ground truth, MRMC studies) are not applicable to this context and are not addressed in the provided text. The "study" here refers to the testing and comparison performed by the manufacturer to demonstrate substantial equivalence, rather than a clinical trial with human subjects or a formal AI performance evaluation.

Summary

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

SECTION 5: 510(k) SUMMARY

NOV 2 0 2007

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

CONTACT:	Shirley Hyink
DATE PREPARED:	September 7, 2007
TRADE OR PROPRIETARY NAME:	Hemostasis Valve
CLASSIFICATION NAME:	Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting21CFR 870.4290
PREDICATE DEVICE:	Merit Passage® Hemostasis Valve (K925419)

DEVICE DESCRIPTION: The Hemostasis Valve is a valve consisting of a clear polycarbonate body, silicone valve, polyacetal actuation lever, and polycarbonate and EPDM o-ring rotating male Luer lock connector and female Luer lock.

Image /page/0/Picture/5 description: The image shows a detailed technical drawing of a mechanical device, possibly a type of valve or actuator. The device features a cylindrical body with various attachments and levers. The drawing style suggests it is a blueprint or schematic, emphasizing the mechanical components and their arrangement.

INTENDED USE: The Hemostasis Valve is intended to maintain a fluid-tight seal around interventional and diagnostic devices during use.

TECHNOLOGICAL CHARACTERISTICS: The Hemostasis Valve and the predicate device Passage are similar in design and technology. All of the component materials found in the Hemostasis Valve have been used in legally marketed Merit devices and were found safe for their intended use.

The prior use of component materials of the Hemostasis Valve in legally marketed devices, a similar indication for use, the performance data provided, and the biocompatibility statement support the safety and effectiveness of this hemostasis valve for the indicated use.

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

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird, with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2007

Merit Medical Systems, Inc. c/o Ms. Shirley Hyink Manager, Regulatory Affairs 1600 West Merit Parkway South Jordan, UT 84095

Re: K072556 Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II Product Code: DTL Dated: September 7, 2007 Received: September 10, 2007

Dear Ms. Hyink:

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, 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 (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. Shirley Hyink

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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. lochner

\Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

SECTION 4: INDICATIONS FOR USE

KOZ2556 510(k) Number (if known):

Device Name: Hemostasis Valve

Indications for Use:

The Hemostasis Valve is indicated to maintain a fluid-tight seal around interventional and diagnostic devices during use.

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. Jaimes

(Division Sign-Off) (Division of Cardiovascular Devices

310(k) Number K072556

Premarket Notification

Hemostasis Valve

Merit Medical Systems, Inc.

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.