(129 days)
Not Found
No
The device description and intended use describe a mechanical access kit for placing guide wires, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an introducer kit intended for percutaneous placement of guide wires, which facilitates access to the vascular system for other procedures, rather than directly treating a disease or condition.
No
Explanation: The device is described as an access kit for placing guide wires into the vascular system, which is a procedural function, not a diagnostic one. It facilitates access for other procedures rather than providing information about a patient's condition.
No
The device description explicitly 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 "percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire into the vascular system." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The components listed (introducer/dilator pair, needle, guide wire) are all instruments used for accessing and navigating within the vascular system. They are not reagents, analyzers, or other components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory testing.
In summary, the Merit MAK® is a medical device used for a procedural purpose within the patient's body, not for performing diagnostic tests on samples outside the body.
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 (comma separated list FDA assigned to the subject device)
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) 4F or 5F Coaxial Introducer/Dilator Pair One (1) 21 gauge Introducer Needle One (1) 0.018" (0.46mm) Guide Wire Two new versions of guide wires will be offered: Stainless Steel Wire with Palladium Tip Nitinol Wire with Palladium 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
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, a battery of tests was performed according to protocols based on the requirements of industry standards and guidances and were shown to meet the acceptance criteria that were determined to demonstrate the safety and efficacy of the device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Merit Medical Systems, Inc. Section 5 Merit MAK with Palladium Tip Guide Wire 510(k) Summary Traditional Premarket Notification 510(k) 1091584 . ب . 2. 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Section 5 OCT 2 9 2009 510(k) Summary Submitter Name: Merit Medical Systems, Inc. 1600 West Merit Parkway Address: South Jordan, UT 84095 General Telephone Number: (801) 208-4789 Provisions Fax Number: (801) 253-6919 Contact Person: Susan Christensen May 28, 2009 Date of Preparation: Registration Number: 1721504 Trade Name: Merit MAK® (Mini Access Kit) Subject Common/Usual Name:Vessel Dilator/Introducer Sheath Device Classification Name: Vessel Dilator for Percutaneous Catheterization Trade Name: Merit® MAK (Mini Access Kit) Vessel Dilator for Percutaneous Classification Name: Predicate Catheterization Device Premarket Notification: K031691 Manufacturer: Merit Medical Systems, Inc. Class II 21 CFR § 870.1310, 74 DRE Classification Division of Cardiovascular Devices The Merit MAK (Mini Access Kit) is intended for percutaneous Intended Use placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire into the vascular system.
Y
1
, '
| | 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. |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | The Merit MAK® consists of the following components:
One (1) 4F or 5F Coaxial Introducer/Dilator Pair
One (1) 21 gauge Introducer Needle
One (1) 0.018" (0.46mm) Guide Wire
Two new versions of guide wires will be offered:
Stainless Steel Wire with Palladium Tip
Nitinol Wire with Palladium Tip |
| Technological
Characteristics | Technological characteristics of the subject Merit MAK® with
palladium tip guide wire are substantially equivalent to those of the
predicate, the currently marketed Merit MAK with platinum tip guide
wire [K031691]. |
| Safety &
Performance
Tests | No performance standards have been established under Section 514
of the Food, Drug and Cosmetic Act for these devices. However, a
battery of tests was performed according to protocols based on the
requirements of industry standards and guidances and were shown
to meet the acceptance criteria that were determined to demonstrate
the safety and efficacy of the device. |
| Summary of
Substantial
Equivalence | Based on the indications for use, design, safety, and performance
testing, the subject Merit MAK® with palladium tip guide wire meets
the requirements that are considered essential for its intended use
and is substantially equivalent to the predicate device, the currently
marketed Merit MAK with platinum tip guide wire manufactured by
Merit Medical Systems, Inc. |
い
・…
Confidential
:
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
・
.
.
・
:
:
·
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
・
.
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Merit Medical Systems, Inc. c/o Ms. Susan Christensen Regulatory Affairs Specialist II 1600 West Merit Parkway South Jordan, UT 84095
OCT 2 9 2009
Re: K091584
1
Trade/Device Name: Merit MAK® (Mini Access Kit) Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II (two) Product Code: DRE Dated: September 30, 2009 Received: October 1, 2009
Dear Ms. Christensen:
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. Drue, 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 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.
3
Page 2 - Ms. Susan Christensen
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 device-related adverse events) (21 CFR 803); good 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kc
Bram b. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4
Indications for Use Statement
510(k) Number (if known):
Device Name: Merit MAK® (Mini Access Kit) with Palladium Tip Guide Wire
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.
Prescription Use × (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)
K. L. Cox
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K091584