The Merit® MAK (Mini Access Kit) utilizes a small diameter coaxial introducer/dilator pair and guide wire for placement of larger diameter guide wires into the vasculature system when a small needle stick is preferred.

The Merit® MAK consists of the following components:

One (1) 4 French or 5 French Coaxial Introducer/Dilator Pair .
One (1) 21 gauge Introducer Needle ●
One (1) 0.018" (0.46mm) Guide Wire . Three versions of guide wires will be offered:
- Stainless Steel Wire and Tip .
- Stainless Steel Wire with Platinum Tip .
- Nitinol Wire with Platinum Tip .

AI/ML Overview

The document provided is a 510(k) Premarket Notification for a medical device (Merit MAK - Mini Access Kit). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for a device that uses AI or for which clinical studies with human readers are conducted in the same way as AI software.

Therefore, many of the requested categories (e.g., AI performance, sample size for test set with data provenance, number of experts, adjudication method, MRMC study, training set details) are not applicable to this type of device and submission.

However, I can extract the information relevant to the acceptance criteria and the study performed to demonstrate safety and effectiveness for a traditional medical device like this one.

Here's the breakdown of the available information:

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

The document states: "Bench testing was conducted on the Merit® MAK in order to ensure device safety and effectiveness for its intended use." and "Performance data demonstrates that the Merit® MAK is substantially equivalent to the predicate device and/or met the acceptance criteria as defined in design verification and validation protocols."

However, specific acceptance criteria values and the detailed reported performance results are not provided in this summary document. The summary only concludes that the device "met all acceptance criteria of the testing performed."

Therefore, a table with specific criteria and results cannot be generated from the given text.

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

This information is not applicable as the studies mentioned are "bench testing" on the device itself, not clinical studies involving patient data or test sets in the context of AI.

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)

This information is not applicable as the studies are "bench testing," not clinical studies that require expert-established ground truths for interpreting images or data.

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

This information is not applicable for the same reasons as above.

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

No such study was done or is applicable for this type of device (a vessel dilator/introducer sheath). This is a physical medical device, not an AI-powered diagnostic tool.

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

This information is not applicable as this is a physical medical device, not an algorithm.

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

For the "bench testing" mentioned, the "ground truth" would be established by engineering specifications, international standards, and in-house protocols for performance (e.g., tensile strength, flow rates, dimensions, material compatibility). These are objective measurements rather than interpretations requiring expert consensus or pathology. The document states: "Bench testing was conducted according to international standards and guidance documents as well as in-house protocols."

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the word "MERITMEDICAL" in a bold, sans-serif font. The "MERIT" portion of the word is solid black, while the "MEDICAL" portion is outlined in black with a white fill. There is a small dot after the word "MEDICAL".

SEP - 3 2003

K031691/

Merit Medical Systems, Inc 1600 WEST MERIT PARKWAY South Jordan, Utah 84095 PHONE 801-253-1600 AX 801-253-1688 www.merit.com

Merit Medical Systems, Inc. Merit MAK (Mini Access Kit) ABBREVIATED PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL 510(k) Summary (per 21 CFR 807.92)

Premarket Notification [510(k)] Summary of Safety and 11.0 Effectiveness

Submitter Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, Utah 84095-2416 USA Establishment Registration Number 1721504 Contact Person(s) Primary Contact: Jerrie Hendrickson Regulatory Affairs Specialist Merit Medical Systems, Inc. Telephone Number: (801) 208-4119 Fax Number: (801) 253-1684 e-mail: jhendri@merit.com Alternate Contact: John W. Nicholson Senior Regulatory Affairs Specialist Merit Medical Systems, Inc. Telephone Number: (801) 208-4405 (801) 253-1684 Fax Number: e-mail: inicholson(@merit.com Date Prepared May 30, 2003

057

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Merit Medical Systems, Inc. Merit MAK (Mini Access Kit) ABBREVIATED PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL 510(k) Summary (per 21 CFR 807.92)

Name of Medical Device

Classification Name:

Common/Usual Name: Trade/Proprietary Name:

Merit® MAK (Mini Access Kit)

Vessel Dilator for Percutaneous Catheterization (21 CFR 870.1310) Vessel Dilator/Introducer Sheath Merit® MAK (Mini Access Kit)

Device Classification

Panel: Device Class: Product Code: Regulation Number: Cardiovascular Class II 74 DRE 21 CFR 870.1310

Predicate Device Identification

Device Brand Name Classification Name Device Class Classification Panel Number Product Code Clearance Status Manufacturer Registration Number

Micropuncture® Introducer Set Catheter Introducer (21 CFR 870.1340) Class II 870 Cardiovascular Devices DYB Preamendment Device Cook Incorporated 1820334

Device Description

The Merit® MAK consists of the following components:

One (1) 4 French or 5 French Coaxial Introducer/Dilator Pair .
One (1) 21 gauge Introducer Needle ●
One (1) 0.018" (0.46mm) Guide Wire . Three versions of guide wires will be offered:
- Stainless Steel Wire and Tip .
- Stainless Steel Wire with Platinum Tip .
- Nitinol Wire with Platinum Tip .

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Merit Medical Systems, Inc. Merit MAK (Mini Access Kit) ABBREVIATED PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL 510(k) Summary (per 21 CFR 807.92)

Intended Use

The Merit® MAK (Mini Access Kit) is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire into the vascular system.

Summary of Characteristics in Relation to Predicate Device

Does the new device have the same indication statement as the predicate device? Yes.

Does the new device have the same technological characteristics, e.g., design, materials, etc. as the predicate device?

Yes. The Merit® MAK employs a similar method of operation and design as compared to the predicate device. Both devices consist of a coaxial introducer/dilator pair, introducer needle and guide wires in similar configurations.

Are the descriptive characteristics precise enough to ensure equivalence to the predicate device?

No. Bench testing was conducted on the Merit® MAK in order to ensure device safety and effectiveness for its intended use.

Are performance data available to assess effects of the new device as compared to the predicate device?

Yes. Bench testing was conducted according to international standards and guidance documents as well as in-house protocols.

Does performance data demonstrate equivalence?

Yes. Performance data demonstrates that the Merit® MAK is substantially equivalent to the predicate device and/or met the acceptance criteria as defined in design verification and validation protocols. The risks associated with use of the Merit® MAK were found acceptable when evaluated by FMEA.

Conclusion: "Substantial Equivalence" Determination

The Merit® MAK met all acceptance criteria of the testing performed and, based on CDRH's substantial equivalence decision tree, is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three horizontal lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus.

Public Health Service

SEP - 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Merit Medical Systems, Inc. c/o Jerrie Hendrickson Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095-2416

K031691 Re:

Merit MAK (Mini Access Kit) Regulation Number: 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization. Regulatory Class: Class II Product Code: DRE Dated: August 27, 2003 Received: August 28, 2003

Dear Ms. Hendrickson:

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.

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

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Page 2 - Ms. Jerrie Hendrickson

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 (301) 594-4646. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Sincerely, yours,

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

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Merit Medical Systems, Inc. Merit®MAK (Mini Access Kit) ABBREVIATED PREMARKET NOTIFICATION [510(k)] CONFIDENTIAL

INDICATION(S) FOR USE STATEMENT *

The Merit® MAK (Mini Access Kit) is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire into the vascular system.

Signature of 510(k) Submitter:

Printed Name of Submitter:

Jessie Henderson

Jerrie Hendrickson Regulatory Affairs Specialist Merit Medical Systems, Inc.

Date:

May 30, 2003

*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number

Division Sign-Off

Office of Device Evaluation

ice of Device Evaluation (ODE)
KORHAKI

(Division Sign-Off)
Division of Cardiovascular Devices

10(k) Number K03769/

Prescription Use

Over-The-Counter Use OR

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).