The PreludeSYNC™ Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It consists of a soft wristband with a secure hook and loop fastener and a clear curved backer plate that provides optimal visualization of the puncture site and ease of placement. The inflatable bulb delivers adjustable compression of the puncture site. A check valve and tubing allow for easy inflation and deflation with the accompanying 20ml syringe inflator. PreludeSYNC is available in a variety of graphic designs and in two band sizes: regular (24cm) and long (29cm).

AI/ML Overview

This document is a 510(k) Summary for the PreludeSYNC™ Radial Compression Device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for a novel AI or diagnostic system.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of regulatory submission and device. This document primarily outlines bench testing and biocompatibility testing conducted to ensure safety and function in comparison to a predicate, not to establish diagnostic accuracy or human performance improvement.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for each test and then report the exact performance. Instead, it lists the types of performance and biocompatibility tests conducted, implying that the device "meets the requirements" as part of the substantial equivalence determination.

Acceptance Criteria (Implied)	Reported Device Performance
Performance Testing - Bench
Dimensions conform to design	(Implied: Passed)
Tensile of Joints (strength)	(Implied: Passed)
Submerged Air Leak Test (integrity)	(Implied: Passed)
Inflation Bulb Burst Test (durability)	(Implied: Passed)
Hook-and-Loop Detachment Test (fastener strength)	(Implied: Passed)
Integrity Test (overall device integrity)	(Implied: Passed)
Band Absorbency (material properties)	(Implied: Passed)
Backer Plate Transparency (visualization)	(Implied: Passed)
Ink Adherence (labeling durability)	(Implied: Passed)
Simulated Use (functional relevance)	(Implied: Passed)
Biocompatibility Testing
Cytotoxicity (no cell harm)	(Implied: Passed)
Sensitization (no allergic reaction)	(Implied: Passed)
Irritation (no skin irritation)	(Implied: Passed)
Acute Systemic Toxicity (no toxic effects)	(Implied: Passed)

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

Sample Size: Not specified for individual tests. The testing methodology is outlined by referencing various ISO and ASTM standards (e.g., ISO 594-1, ISO 594-2, ISO 2233:2001, ISO 11607-1:2006, ASTM D4169-09, ASTM F1980-11, ISO 11135:2014, ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006). These standards would dictate the sample sizes for the specific tests, but the document itself does not report these numbers directly.
Data Provenance: Not applicable in the context of clinical data. This is bench and biocompatibility testing of a physical device.

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

Not applicable. Ground truth, in the sense of expert review for diagnostic accuracy, is not relevant for this type of device and testing. The "ground truth" for the performance tests would be the measurement against established engineering or material specifications, and for biocompatibility, the results of standardized biological assays.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described for these types of engineering and biocompatibility tests.

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

No. This is a physical medical device (radial compression device), not an AI or diagnostic imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or performed.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device, not an algorithm or software. "Standalone performance" in this context refers to the device's physical function and safety, without human-in-the-loop, which is addressed by the bench and biocompatibility testing.

7. Type of Ground Truth Used

The "ground truth" for these tests are:
- Engineering Specifications: For dimensions, tensile strength, leak tests, burst tests, etc.
- Material Science Standards: For absorbency, transparency, ink adherence.
- Biological Assay Results: For cytotoxicity, sensitization, irritation, and systemic toxicity, as defined by the ISO 10993 series of standards.
- Functional Objectives: For simulated use, ensuring the device performs its intended mechanical function.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

Not applicable. There is no training set.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 25, 2017

Merit Medical Systems, Inc. Ileana Davis Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095

Re: K162988

Trade/Device Name: PreludeSYNC Radial Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: December 22, 2016 Received: December 30, 2016

Dear Ms. Davis:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv.

M.A. Hillemann

for 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

510(k) Number (if known) K162988

Device Name

PreludeSYNC Radial Compression Device

Indications for Use (Describe)

The PreludeSYNC is a compression device used to assist in gaining hemostasis of arterial percutaneous access sites.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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5.0 510(k) Summary

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date Prepared:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4187(801) 316-4065Ileana Davis, Regulatory Affairs Specialist26 October 20161721504
Subject Device	Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel:	PreludeSYNC™ Radial Compression DeviceRadial Compression DeviceVascular ClampIIDXC870.4450Cardiovascular
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Vasc™ Band HemostatVascular ClampK142359Lepu Medical Technology (Beijing) Co., Ltd.This predicate has not been subject to a design-related recall in the US.
DeviceDescription	The PreludeSYNC™ Radial Compression Device is a sterile, single usedisposable device used to assist in gaining and maintaining hemostasisof the radial and ulnar artery following catheterization procedures. Itconsists of a soft wristband with a secure hook and loop fastener and aclear curved backer plate that provides optimal visualization of thepuncture site and ease of placement. The inflatable bulb deliversadjustable compression of the puncture site. A check valve and tubingallow for easy inflation and deflation with the accompanying 20mlsyringe inflator.PreludeSYNC is available in a variety of graphic designs and in twoband sizes: regular (24cm) and long (29cm).
Indications forUse	The PreludeSYNC is a compression device used to assist in gaininghemostasis of arterial percutaneous access sites.The Indications for Use statement for the PreludeSYNC is not identicalto the predicate device; however, the differences do not alter theintended therapeutic use of the device nor do they affect the safety andeffectiveness of the device relative to the predicate. Both the subject
Comparison toPredicateDevice	and predicate devices have the same intended use of providingcompression to assist hemostasis of percutaneous access sites.
	The technological characteristics of the subject PreludeSYNC™ RadialCompression device are substantially equivalent to those of thepredicate Vasc™ Band Hemostat.At a high level, the subject and predicate devices are based on thefollowing same technological elements:
	Clinical use Labeling Basic design Principle of operation Performance Band sizes
	The following technological difference exists between the subject andpredicate devices: Materials
	No performance standards have been established under Section 514 ofthe Food, Drug and Cosmetic Art for these devices. Performance

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rug and Cosmetic Act for testing of the subject PreludeSYNC™ Radial Compression Device was conducted based on the risk analysis and based on the requirements of the following international standards:

ISO 594-1 Conical fittings with 6% (Luer) taper for syringes. ● needles and certain other medical equipment – Part 1: General requirements
. ISO 594-2 - Conical fittings with 6% (Luer) taper for syringes. needles and certain other medical equipment – Part 2: Lock fittings
ISO 2233:2001 Packaging Complete, filled transport packages . and unit loads - Conditioning for testing

Performance Data

. ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems
. ASTM D4169-09 - Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F1980-11 Standard Guide for Accelerated Aging of Sterile . Barrier Systems for Medical Devices
. ISO 11135:2014 – Sterilization of health-care products – Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
. ISO 10993-1:2009 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-7:2008 – Biological evaluation of medical devices – Part 7: Ethylene oxide residuals

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ISO 10993-10:2010 Biological evaluation of medical devices ● Part 10: Tests for irritation and skin sensitization
. ISO 10993-11:2006 – Biological evaluation of medical devices – Part 11: Tests for systemic toxicity

The following performance data were provided in support of the substantial equivalence determination:

Performance Testing - Bench

Dimensions ●
Tensile of Joints ●
Submerged Air Leak Test ●
Inflation Bulb Burst Test ●
Hook-and- Loop Detachment Test
Integrity Test ●
Band Absorbency
Backer Plate Transparency ●
Ink Adherence ●
Simulated Use

Biocompatibility testing

The biocompatibility evaluation for the PreludeSYNC™ Radial Compression Device was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following:

Cytotoxicity ●
Sensitization ●
Irritation
Acute Systemic Toxicity ●

Based on the indications for use, design, safety and performance testing, the subject PreludeSYNC™ Radial Compression Device Summary of meets the requirements that are considered essential for its intended Substantial use and is substantially equivalent to the predicate device, the Vasc™ Equivalence Band Hemostat, K142359.

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).