(195 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of AI or ML capabilities.
No
The device is an introducer guide wire used to facilitate the placement of introducer sheaths during diagnostic and interventional procedures, not for direct therapeutic treatment.
No
This device is a guide wire used to facilitate the placement of introducer sheaths during procedures, not to diagnose a condition.
No
The device description clearly states it is a physical guide wire made of stainless steel, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Prelude Small O.D. Introducer Guide Wire is a physical tool used within the body (in the peripheral vasculature) to facilitate the placement of other devices (introducer sheaths). It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for facilitating placement of introducer sheaths during diagnostic and interventional procedures, not for analyzing samples.
- Device Description: The description focuses on the physical construction and properties of the guide wire itself, not on any reagents or analytical components typical of IVDs.
This device is a medical device used in interventional procedures, but it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Prelude Small O.D. Introducer Guide Wire is intended to facilitate the placement of introducer sheaths during diagnostic and interventional procedures.
The Prelude Small O.D. Introducer Guide Wire is indicated for use in the peripheral vasculature only.
Product codes
DQX
Device Description
The Prelude® Small O.D. Introducer Guide Wire is composed of a stainless-steel core wire inside a stainless-steel coil. The guide wire is welded at the distal and proximal tips and has a polished weld finish. The stainless-steel construction provides radiopacity and visibility to the user under X-ray. The wires are available in outer diameters 0.018", 0.021" and 0.025", lengths from 45 cm to 80 cm, straight and double-ended J 3mm / straight tip shapes, Standard and Firm body wire stiffness profiles, with a flexible atraumatic tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
peripheral vasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No applicable mandatory performance standards or special controls exist for the subject device.
A battery of testing was conducted, on the Prelude Small O.D. Introducer Guide Wire, in accordance with test protocols based on requirements outlined in FDA Guidances and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence.
The following testing was successfully completed to demonstrate that the device meets the performance requirements for its intended use:
Non-Clinical Performance Testing: Dimensional Verification/Size Designation, Guide Wire J-Tip Straightening, Surface Finish, Fracture Test, Flexing Test, Guidewire Radiopacity, Guidewire Joints Tensile Strength, Guidewire Torque Strength, Corrosion Resistance, Tip Flexibility, Kink Resistance, Simulated Use Testing.
Biocompatibility Testing: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemocompatibility (Hemolysis, Thrombogenicity, Complement Activation).
The subject Prelude Small O.D. Introducer Guide Wire met the predetermined acceptance criteria and showed a performance comparable to the predicate device. This demonstrated that the Prelude Small O.D. Introducer Guide Wire subject device is substantially equivalent to the Predicate Uncoated Guidewire predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
December 10, 2024
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Merit Medical Systems, Inc. James Kenny Principal Regulatory Affairs Specialist Parkmore Business Park West Galway, Ireland
Re: K241521
Trade/Device Name: Prelude Small O.D. Introducer Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: Mav 29, 2024 Received: May 29, 2024
Dear James Kenny:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Samuel G. Raben -S
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241521
Device Name Prelude Small O.D. Introducer Guide Wire
Indications for Use (Describe)
The Prelude Small O.D. Introducer Guide Wire is intended to facilitate the placement of introducer sheaths during diagnostic and interventional procedures.
The Prelude Small O.D. Introducer Guide Wire is indicated for use in the peripheral vasculature only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
| 510(k) Summary | ||
|---|---|---|
| General | ||
| Provisions | Submitter Name: | |
| Address: | ||
| Telephone Number: | ||
| Fax Number: | ||
| Contact Person: | ||
| Registration Number: | ||
| Correspondent Name: | ||
| Address: | Merit Medical Systems, Inc. | |
| 1600 West Merit Parkway | ||
| South Jordan, UT 84095 | ||
| (+353) 91 703798 | ||
| (+353) 91 680104 | ||
| James Kenny | ||
| 1721504 | ||
| Merit Medical Ireland Ltd. | ||
| Parkmore Business Park | ||
| Parkmore, Galway, Ireland | ||
| Telephone Number: | ||
| Fax Number: | ||
| Contact Person: | ||
| Date of Preparation: | ||
| Registration Number: | (+353) 91 703798 | |
| (+353) 91 680104 | ||
| James Kenny | ||
| May 29, 2024 | ||
| 9616662 | ||
| Subject | ||
| Device | Premarket Notification: | |
| Trade Name: | ||
| Common/Usual Name: | K241521 | |
| Prelude® Small O.D. Introducer | ||
| Guide Wire | ||
| Class: | ||
| Product code: | ||
| Classification Name: | ||
| Regulation Number: | ||
| Regulation Medical Specialty Cardiovascular | Guide Wire | |
| II | ||
| DQX | ||
| Wire, Guide, Catheter | ||
| 21 CFR 870.1330 | ||
| Predicate | ||
| Device | Trade Name: | |
| Class: | ||
| Product code: | ||
| Classification Name: | ||
| Regulation Number: | ||
| Regulation Medical Specialty Cardiovascular | ||
| Premarket Notification: | ||
| Manufacturer: | Predicate® Uncoated Guidewire | |
| II | ||
| DQX | ||
| Wire, Guide, Catheter | ||
| 21 CFR 870.1330 | ||
| K770977 | ||
| Integer® Holdings Corporation | ||
| Device | ||
| Description | The Prelude® Small O.D. Introducer Guide Wire is composed of a | |
| stainless-steel core wire inside a stainless-steel coil. The guide | ||
| wire is welded at the distal and proximal tips and has a polished | ||
| weld finish. The stainless-steel construction provides radiopacity | ||
| and visibility to the user under X-ray. The wires are available in | ||
| outer diameters 0.018", 0.021" and 0.025", lengths from 45 cm to | ||
| 80 cm, straight and double-ended J 3mm / straight tip shapes, | ||
| Standard and Firm body wire stiffness profiles, with a flexible | ||
| atraumatic tip. | ||
| Intended Use/ | ||
| Indications for | ||
| Use | The Prelude Small O.D. Introducer Guide Wire is intended to | |
| facilitate the placement of introducer sheaths during diagnostic and | ||
| interventional procedures. | ||
| The Prelude Small O.D. Introducer Guide Wire is indicated for use | ||
| in the peripheral vasculature only. | ||
| Comparison | ||
| to Predicate | The subject Prelude Small O.D. Introducer Guide Wire has a similar | |
| design and materials of construction. There is no difference in | ||
| intended use or differences in technological characteristics between | ||
| the subject device and predicate device: | ||
| Both the subject device and predicate device are composed of | ||
| stainless-steel core wire with a grind profile ending in a flexible | ||
| distal tip. Both have a stainless-steel coil attached at the proximal | ||
| end and distal end to the core wire. The wires have equivalent wire | ||
| lengths, wire outer diameters, and wire tip configurations. Neither | ||
| has a safety wire or coating. | ||
| The fundamental technology and operating principles of the subject | ||
| device and the predicate device are the same. Both are used to | ||
| facilitate the placement of devices during peripheral diagnostic and | ||
| interventional procedures. | ||
| Safety & | ||
| Performance | ||
| Tests | No applicable mandatory performance standards or special controls | |
| exist for the subject device. | ||
| A battery of testing was conducted, on the Prelude Small O.D. | ||
| Introducer Guide Wire, in accordance with test protocols based on | ||
| requirements outlined in FDA Guidances and industry standards | ||
| and these were shown to meet the acceptance criteria that were | ||
| determined to demonstrate substantial equivalence. | ||
| The following testing was successfully completed to demonstrate | ||
| that the device meets the performance requirements for its | ||
| intended use |
5
510(k) Summary
6
510(k) Summary
Non-Clinical Performance Testing
- Dimensional Verification/Size Designation ●
- Guide Wire J-Tip Straightening ●
- Surface Finish ●
- Fracture Test ●
- Flexing Test
- Guidewire Radiopacity
- Guidewire Joints Tensile Strength
- Guidewire Torque Strength
- Corrosion Resistance
- Tip Flexibility
- Kink Resistance
- Simulated Use Testing
Biocompatibility Testing
- Cytotoxicity ●
- Sensitization
- Irritation ●
Corporation.
- Acute Systemic Toxicity .
- Pyrogenicity ●
- Genotoxicity ●
- Hemocompatibility ●
- o Hemolysis
- o Thrombogenicity
- o Complement Activation
The subject Prelude Small O.D. Introducer Guide Wire met the predeterminded acceptance criteria and showed a performance comparable to the predicate device. This demonstrated that the Prelude Small O.D. Introducer Guide Wire subject device is substantially equivalent to the Predicate Uncoated Guidewire predicate device. The subject Prelude Small O.D. Introducer Guide Wire is Summary of substantially equivalent in intended use, function, materials, Substantial method of operation, and performance to the Predicate Uncoated Equivalence Guidewire (K770977) manufactured by Integer Holdings