The PreludeSYNC DISTAL™ Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial artery following catheterization procedures. It consists of a soft wristband and thumb saddle strap with secure hook and loop fasteners. The band delivers adjustable compression of the puncture site with an inflatable balloon, and a check valve for easy inflation and deflation with the accompanying 10mL syringe inflator. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement. PreludeSYNC DISTAL is available in a variety of graphic designs and a right or left-hand configuration.

AI/ML Overview

The provided text is a 510(k) Summary for the PreludeSYNC DISTAL™ Radial Compression Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria for clinical performance.

Therefore, the following information cannot be extracted directly from the provided text:

A table of acceptance criteria and reported device performance related to clinical efficacy.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance (this is an AI-specific question, and the device is a physical medical device, not an AI system).
If a standalone (algorithm only) performance study was done (again, not applicable to this type of device).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical performance.
The sample size for the training set.
How the ground truth for the training set was established.

What can be extracted and inferred from the text regarding acceptance criteria and performance study:

The document states that "Performance testing of the subject PreludeSYNC DISTAL Radial Compression Device was conducted based on the risk analysis and based on the requirements of the following international standard". It then lists several international standards for various types of testing, along with a list of "Performance Testing-Bench" tests and "Biocompatibility Testing."

The conclusion states: "The results of the testing demonstrated that the subject PreludeSYNC DISTAL met the predetermined acceptance criteria applicable to testing the safety and efficacy of the device." However, the specific quantitative acceptance criteria for each test and the detailed results are not provided in this summary.

In summary, this document is a regulatory filing for substantial equivalence, not a detailed report of a clinical performance study with explicit acceptance criteria for efficacy in patients. It describes bench testing and biocompatibility studies to demonstrate safety and equivalent performance to a predicate device based on its design and materials.

Here's a breakdown of what the document does provide, modified to fit the request where possible, but acknowledging limitations:

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

Test Category	Test Name	Acceptance Criteria (Implied/General)	Reported Device Performance
Performance Testing	Bubble Emission Packaging	Meet applicable standards (implied by ISO references)	Met predetermined acceptance criteria
	Visual Inspection - Packaging	Meet applicable standards	Met predetermined acceptance criteria
	Adapted Connector Torque	Meet ISO 80369-7: 2016 requirements	Met predetermined acceptance criteria
	Dimensions - Band Sizing Verification	Conform to specified dimensions	Met predetermined acceptance criteria
	Side Load and Leak Test	Withstand side load and prevent leaks (implied by device function)	Met predetermined acceptance criteria
	Indicator Mark Adherence	Marks adhere securely	Met predetermined acceptance criteria
	Hook and Laminate Integrity Test	Maintain integrity	Met predetermined acceptance criteria
	Balloon Burst Test	Withstand specified pressure before bursting	Met predetermined acceptance criteria
	Adapted Cap to Valve Attachment	Secure attachment	Met predetermined acceptance criteria
	Tensile Test Hook and Loop	Withstand specified tensile force	Met predetermined acceptance criteria
	Tensile Test Band to Backer Plate	Withstand specified tensile force	Met predetermined acceptance criteria
	Band Compliance	Function as intended	Met predetermined acceptance criteria
	Simulated Use	Perform safely and effectively in simulated use (implied)	Met predetermined acceptance criteria
Biocompatibility	Biocompatibility Assessment	Materials are biocompatible or identical to predicate materials	No further testing required (due to material equivalence)
Sterilization	Sterilization (Ethylene Oxide)	Meet ISO 11135:2014 requirements	Met predetermined acceptance criteria
Packaging Stability	Packaging Conditioning / Performance Testing	Meet ISO 2233:2000 and ASTM D4169:2016 requirements	Met predetermined acceptance criteria

Note: The specific quantitative acceptance criteria are not detailed in this summary; only a general statement that they were "met" is provided.

2. Sample sized used for the test set and the data provenance:

Test Set Sample Size: Not specified for any of the performance or biocompatibility tests.
Data Provenance: The tests are "Performance Testing-Bench" and "Biocompatibility Testing," implying lab-based, pre-clinical testing presumably conducted by the manufacturer, Merit Medical Systems, Inc. No country of origin for clinical data is mentioned as no clinical studies are referenced. The nature of these tests suggests they are prospective, following established protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not mentioned. The "ground truth" here refers to engineering specifications and international standards, not expert clinical interpretation.

4. Adjudication method for the test set:

Not applicable/Not mentioned. This typically relates to clinical studies or assessments requiring human interpretation.

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 physical medical compression device, not an AI system.

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

Not applicable. This device is a physical medical compression device, not an AI algorithm.

7. The type of ground truth used:

For Performance Testing-Bench: Engineering specifications, design requirements, and international standards (e.g., ISO 80369-7, ISO 11135, ISO 10993-1, ISO 10993-7, ISO 2233, ASTM D4169).
For Biocompatibility Testing: The "ground truth" was established based on the materials being identical to those of a legally marketed predicate device with the same intended use and contact, making further testing unnecessary.

8. The sample size for the training set:

Not applicable/Not mentioned. This refers to algorithm training, not relevant to this physical device.

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

Not applicable/Not mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 17, 2018

Merit Medical Systems, Inc Susan Christensen Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095

Re: K180723

Trade/Device Name: PreludeSYNC DISTAL™ Radial Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: March 15, 2018 Received: March 19, 2018

Dear Ms. Christensen:

We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); good

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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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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5.0 510(k) Summary

GeneralProvisions	Submitter Name:	Merit Medical Systems, Inc.
	Address:	1600 West Merit ParkwaySouth Jordan, UT 84095
	Telephone Number:	(801) 208-4789
	Fax Number:	(801) 253-6919
	Contact Person:	Susan Christensen
	Date Prepared:	March 15, 2018
	Registration Number:	1721504
Subject Device	Trade Name:	PreludeSYNC DISTAL™ Radial CompressionDevice
	Common/Usual Name:	Radial Compression Device
	Classification Name:	Vascular Clamp
	Regulatory Class:	II
	Product Code:	DXC
	21 CFR §:	870.4450
	Review Panel:	Cardiovascular
PredicateDevice	Trade Name:	PreludeSYNC™ Radial Compression Device
	Classification Name:	Radial Compression Device
	Premarket Notification:	K162988
	Manufacturer:	Merit Medical Systems, Inc.
		The predicate has been the subject of a design-related recall, referenceZ-1766-2017
ReferenceDevice	No reference devices were used in this submission.
DeviceDescription	The PreludeSYNC DISTAL™ Radial Compression Device is a sterile,single use disposable device used to assist in gaining and maintaininghemostasis of the radial artery following catheterization procedures.It consists of a soft wristband and thumb saddle strap with secure hookand loop fasteners. The band delivers adjustable compression of thepuncture site with an inflatable balloon, and a check valve for easyinflation and deflation with the accompanying 10mL syringe inflator. Aclear curved backer plate provides optimal visualization of the puncturesite and ease of placement.PreludeSYNC DISTAL is available in a variety of graphic designs and aright or left-hand configuration.
Indications forUse	The PreludeSYNC DISTAL™ is a compression device used to assist ingaining hemostasis of arterial percutaneous access sites.

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The design and technological characteristics of the subject PreludeSYNC DISTAL Radial Compression Device are substantially equivalent to those of the predicate PreludeSYNC. The subject device has the same materials and use as the predicate device. The main difference between the subject and the predicate device is the design of the PreludeSYNC DISTAL is slightly different (including addition of a thumb saddle strap and modified syringe inflator components) with different dimensions of the backer plate, straps, and balloon. The comparison between the subject and the predicate devices is based on the following:

Comparison to Predicate Device

Performance

Data

Same Clinical use
Same Intended use ●
Same Indications for use ●
Same Materials ●
Similar design
Same Sterilization methods ●
Same Labeling and packaging .
Same Fundamental technology/principle of operation .

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject PreludeSYNC DISTAL Radial Compression Device was conducted based on the risk analysis and based on the requirements of the following international standard:

. ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
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 10993-7:2008, Biological evaluation of medical devices -● Part 7: Ethylene oxide sterilization residuals
. ISO 2233:2000, Packaging - complete, filled transport packages and unit loads - conditioning for testing
ASTM D4169:2016, Standard practice for performance testing ● of shipping containers and systems

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The following tests were performed to demonstrate there were no unacceptable risks associated with the changes made to the device:

Performance Testing-Bench

Bubble Emission Packaging .
Visual Inspection - Packaging
Adapted Connector Torque ●
Dimensions - Band Sizing Verification
Side Load and Leak Test
Indicator Mark Adherence ●
Hook and Laminate Integrity Test
Balloon Burst Test .
Adapted Cap to Valve Attachment ●
Tensile Test Hook and Loop ●
Tensile Test Band to Backer Plate .
. Band Compliance
- Simulated Use .

Biocompatibility Testing

	All materials of the subject device (excluding the colorant in theplunger) are used in the legally marketed predicate PreludeSYNC withthe same intended use, patient contact, processing and sterilizationmethods. Therefore, no further biocompatibility testing is required forthese materials. The plunger in the inflation syringe is categorized ashaving no direct or indirect contact with the human body. Based on thecontact categorization of the plunger component, biocompatibilitytesting is not required.
	The PreludeSYNC DISTAL is categorized as a Surface Device withBreached or Compromised Surface Contact for a Limited (< 24 hours)Duration
	The results of the testing demonstrated that the subject PreludeSYNCDISTAL met the predetermined acceptance criteria applicable to testingthe safety and efficacy of the device.
Summary ofSubstantialEquivalence	Based on the indications for use, design, safety and performancetesting, the subject PreludeSYNC DISTAL Radial Compression Deviceraises no new questions of safety or effectiveness compared to thepredicate device and is substantially equivalent to the predicate device,the PreludeSYNC K162988 manufactured by Merit Medical Systems,Inc.

Safety & Performance Data

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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).