(93 days)
DYB
DYB
No
The device description and performance studies focus on mechanical components and bench testing, with no mention of AI or ML.
No
The device is described as an access kit for placing guide wires into the vascular system, which is a procedural step rather than a direct therapeutic intervention.
No
The device is described as an access kit for percutaneous placement of guide wires, facilitating the introduction of larger diameter guide wires. Its intended use focuses on a procedural function (accessing the vascular system) rather than diagnosing conditions.
No
The device description clearly lists physical components such as introducers, dilators, needles, and guide wires, indicating it is a hardware-based medical device.
Based on the provided information, the Merit® MAK (Mini Access Kit) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the percutaneous placement of a guide wire into the vascular system. This is a procedure performed directly on a patient's body for access, not for testing a sample in vitro (outside the body).
- Device Description: The components are instruments used for accessing blood vessels (needles, introducers, dilators, guide wires). These are procedural tools, not reagents, analyzers, or other components typically associated with in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Merit® MAK is a medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DRE
Device Description
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing was conducted on the Merit® MAK in order to ensure device safety and effectiveness for its intended use. Bench testing was conducted according to international standards and guidance documents as well as in-house protocols. 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.
Key Metrics
Not Found
Predicate Device(s)
Micropuncture® Introducer Set, DYB
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
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
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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 (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 .
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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