K Number

Device Name

PTFE Guidewire

Manufacturer

Lake Region Medical

Date Cleared

2024-12-06

(79 days)

Product Code

DQX PTF

Regulation Number

870.1330

Intended Use

To facilitate the placement of devices for diagnostic and interventional procedures. These guidewires are not intended for PTCA use.

Device Description

PTFE quidewire is designed to facilitate the placement of devices for diagnostic and interventional procedures. The guidewire is intended for single use. The guidewire is: .032" diameter and is 200cm in length. The guidewire is composed of three primary components: PTFE coating, a coil and a core. The core and coil are made of 304 stainless steel (ASTM A313). The coil is coated with low-friction polytetrafluoroethylene (PTFE). The coil provides the outer shell while the core is fit inside the inner diameter of the coil. The core provides the stiffness to the guidewire body and flexibility in the J-tip. The core and coil are secured together using a weld on both the distal and proximal of the guidewire. The guidewire is sterilized using ethylene oxide. The guidewire is loaded into a dispenser hoop and is provided with a J-straightener, which is used to aid the insertion of the delivery device. There are no accessories packaged with the guidewires.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K935170

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus solely on the physical and mechanical properties of a guidewire, with no mention of AI or ML.

Therapeutic

No
The device is a guidewire designed to facilitate the placement of other devices, not to provide therapy itself. Its intended use is diagnostic and interventional tool placement.

Diagnostic

No.
The device's "Intended Use / Indications for Use" states that it "facilitate[s] the placement of devices for diagnostic and interventional procedures," indicating it is an accessory for diagnostic procedures rather than a diagnostic device itself.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical guidewire made of stainless steel and PTFE, and the performance studies focus on physical characteristics and testing of this hardware. There is no mention of software as a component or function of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "To facilitate the placement of devices for diagnostic and interventional procedures." This describes a tool used during a medical procedure, not a device used to perform tests on samples taken from the body (which is the definition of an IVD).
Device Description: The description details a physical guidewire used to navigate within the body. It doesn't mention any components or functions related to analyzing biological samples.
Performance Studies: The performance studies focus on the physical properties and functionality of the guidewire (flexibility, torque strength, corrosion resistance, etc.) and its compatibility with other devices. There are no studies related to the accuracy or performance of diagnostic tests on biological samples.
Lack of IVD-specific information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims based on test results

Therefore, this device is a medical device used to aid in procedures, but it does not meet the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

To facilitate the placement of devices for diagnostic and interventional procedures. These guidewires are not intended for PTCA use.

Product codes

DQX

Device Description

PTFE quidewire is designed to facilitate the placement of devices for diagnostic and interventional procedures. The guidewire is intended for single use.

The guidewire is: .032" diameter and is 200cm in length. The guidewire is composed of three primary components: PTFE coating, a coil and a core. The core and coil are made of 304 stainless steel (ASTM A313). The coil is coated with low-friction polytetrafluoroethylene (PTFE). The coil provides the outer shell while the core is fit inside the inner diameter of the coil. The core provides the stiffness to the guidewire body and flexibility in the J-tip. The core and coil are secured together using a weld on both the distal and proximal of the guidewire.

The guidewire is sterilized using ethylene oxide. The guidewire is loaded into a dispenser hoop and is provided with a J-straightener, which is used to aid the insertion of the delivery device. There are no accessories packaged with the guidewires.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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

Non-clinical (bench) performance testing was performed in order to demonstrate that the PTFE Guidewire met applicable design and performance requirements and to support a determination of substantial equivalence to its predicate device. The following testing was conducted, according to established procedures, and samples were analysis according to predetermined acceptance criteria utilized by the predicate device. In addition, FDA guidance Coronary, Peripheral and Neurovascular Guidewires Performance Tests and Recommended Labeling (October 10, 2019) was utilized to support demonstrating substantial equivalence.

. FDA Pre-Conditioning: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
. Simulated Use: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
. Tip Flexibility: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
Torque Strength: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
. Particulate Residue: Tested in accordance with FDA guidance and USP 788. The predetermined acceptance criteria were met.
. ISO Fracture Resistance: Tested in accordance with FDA guidance and EN ISO 11070:2014 /A1:2018 Annex F. The predetermined acceptance criteria were met.
ISO Flex: Tested in accordance with FDA quidance and EN ISO 11070:2014/A1 2018. The predetermined acceptance criteria were met.
. Corrosion Resistance: Tested in accordance with FDA guidance and EN ISO 10555-1:2023. The predetermined acceptance criteria were met.
. Lubricity/Device Compatibility: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
Radiopacity: Tested in accordance with FDA guidance and EN ISO 11070:2014/A1:2018. The predetermined acceptance criteria were met.
Body Stiffness: Tested in accordance per internal requirement. The predetermined acceptance criteria were met.
. Kink Resistance: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
. Dimensional - Outer Diameter: Tested in accordance with FDA quidance. The predetermined acceptance criteria were met.
. Dimensional - Length: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
. Dimensional - J Tip Shape: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
. Coating Integrity: Tested in accordance with FDA quidance and EN ISO 11070:2014/A1:2018. The predetermined acceptance criteria were met.
Distal Tip Pull Test (Tensile Strength): Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
Visual Inspection: Tested in accordance with FDA quidance, internal requirements, and EN ISO 11070:2014/A1:2018. The predetermined acceptance criteria were met.
. Pouch Peel Strength: Tested in accordance with FDA guidance and ASTM F88/F88M-23. The predetermined acceptance criteria were met.
Dye Penetration: Tested in accordance with FDA guidance and ASTM F1929-23. The predetermined acceptance criteria were met.
. Bubble Leak: Tested in accordance with FDA quidance, ASTM F2096-11 (Reapproved 2019), and EN ISO 11607-1:2020/A1:2023. The predetermined acceptance criteria were met.
Device Shelf Life: Tested in accordance with FDA guidance and ASTM F1980-21. The predetermined acceptance criteria were met.
Packaging Integrity: Tested in accordance with FDA guidance, ASTM D4169023, and ISTA 3A ● (2018). The predetermined acceptance criteria were met.
Biocompatibility: Tested in accordance with ISO 10993-1 and all applicable parts of this standard series. The predetermined acceptance criteria were met.

Key Metrics

Not Found

Predicate Device(s)

K935170

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Lake Region Medical Clara Lee Sr. Regulatory Affairs Specialist 340 Lake Hazeltine Drive Chaska, Minnesota 55318

Re: K242824

Trade/Device Name: PTFE Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 18, 2024 Received: November 6, 2024

Dear Clara Lee:

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" (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 Rule"). 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-device-advicecomprehensive-regulatory-assistance/unique-device-identification-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).

Sincerely,

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

Indications for Use

Submission Number (if known)

K242824

Device Name

PTFE Guidewire

Indications for Use (Describe)

To facilitate the placement of devices for diagnostic and interventional procedures. These guidewires are not intended for PTCA use.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image is a logo for Lake Region Medical, an Integer company. The logo features a stylized heart shape in red and gray on the left, followed by the words "Lake Region" in black. Below "Lake Region" is the word "MEDICAL" in smaller, gray font, and below that is the text "An Integer company" in gray.

PTFE Guidewire - K242824 510(k) Summary

l. Submitter Owner/Operator: Lake Region Medical Address: 340 Lake Hazeltine Drive Chaska, MN 55318 Establishment Registration Number: 2126666 Primary Contact Person: Clara Lee, Sr. Regulatory Affairs Specialist Email: clara.lee@intege.net Phone: (952) 641 5423 Date Prepared: September 16, 2024 Subject Device ..

Device Name/Trade Name: Common Name: Classification Name: Regulatory Class: Product code:

PTFE Guidewire Catheter Guidewire Catheter Guidewire (21 CFR §870.130) Class II DQX

lll. Predicate Device

Device Name:
Manufacturer:
510(k) Number:
Regulatory Class:
Product Code:

Cardiovascular and Vascular Guidewire Lake Region Medical K935170 Class II (21 CFR §870.130) DQX

IV. Device Description

PTFE quidewire is designed to facilitate the placement of devices for diagnostic and interventional procedures. The guidewire is intended for single use.

V. Indications for Use

To facilitate the placement of diagnostic and interventional procedures. These quidewires are not intended for PTCA use.

Image /page/5/Picture/0 description: The image shows the logo for Lake Region Medical, an Integer company. The logo features a geometric shape in red and gray, followed by the words "Lake Region" in a bold, sans-serif font. Below "Lake Region" is the word "MEDICAL" in a smaller font, and below that is the text "An Integer company".

VI. Comparison with the Predicate Device

The PTFE Guidewire is substantially equivalent to the predicate device. The PTFE Guidewire has the same indications for use/intended use including the disease, condition, and patient population, and principles of operation as the legally marketed Cardiovascular and Vascular Guidewire (K935170). Both the predicate device and the subject device are general use guidewires that are intended to facilitate the placement of devices for diagnostic and interventional procedures as specified in Indications for Use. The functional characteristics of the PTFE Guidewire are identical to the predicate device with regards to material, dimensions, and method of constructions.

VII. Summary of Testing Data

. FDA Pre-Conditioning: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
. Simulated Use: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
. Tip Flexibility: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
Torque Strength: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
. Particulate Residue: Tested in accordance with FDA guidance and USP 788. The predetermined acceptance criteria were met.
. ISO Fracture Resistance: Tested in accordance with FDA guidance and EN ISO 11070:2014 /A1:2018 Annex F. The predetermined acceptance criteria were met.
ISO Flex: Tested in accordance with FDA quidance and EN ISO 11070:2014/A1 2018. The predetermined acceptance criteria were met.
. Corrosion Resistance: Tested in accordance with FDA guidance and EN ISO 10555-1:2023. The predetermined acceptance criteria were met.
. Lubricity/Device Compatibility: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
Radiopacity: Tested in accordance with FDA guidance and EN ISO 11070:2014/A1:2018. The predetermined acceptance criteria were met.
Body Stiffness: Tested in accordance per internal requirement. The predetermined acceptance criteria were met.
. Kink Resistance: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
. Dimensional - Outer Diameter: Tested in accordance with FDA quidance. The predetermined acceptance criteria were met.
. Dimensional - Length: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
. Dimensional - J Tip Shape: Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.

Image /page/6/Picture/0 description: The image shows the logo for Lake Region Medical, which is an Integer company. The logo consists of a geometric shape in red and gray, followed by the words "Lake Region" in black. Below that, the word "MEDICAL" is written in a smaller font size.

. Coating Integrity: Tested in accordance with FDA quidance and EN ISO 11070:2014/A1:2018. The predetermined acceptance criteria were met.
Distal Tip Pull Test (Tensile Strength): Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
Visual Inspection: Tested in accordance with FDA quidance, internal requirements, and EN ISO 11070:2014/A1:2018. The predetermined acceptance criteria were met.
. Pouch Peel Strength: Tested in accordance with FDA guidance and ASTM F88/F88M-23. The predetermined acceptance criteria were met.
Dye Penetration: Tested in accordance with FDA guidance and ASTM F1929-23. The predetermined acceptance criteria were met.
. Bubble Leak: Tested in accordance with FDA quidance, ASTM F2096-11 (Reapproved 2019), and EN ISO 11607-1:2020/A1:2023. The predetermined acceptance criteria were met.
Device Shelf Life: Tested in accordance with FDA guidance and ASTM F1980-21. The predetermined acceptance criteria were met.
Packaging Integrity: Tested in accordance with FDA guidance, ASTM D4169023, and ISTA 3A ● (2018). The predetermined acceptance criteria were met.
Biocompatibility: Tested in accordance with ISO 10993-1 and all applicable parts of this standard series. The predetermined acceptance criteria were met.

VIII. Conclusion

The PTFE Guidewire, described in this submission, met all design input requirements based on the intended use and supports the conclusion that the PTFE Guidewire does not raise new questions of safety and effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device, the Cardiovascular & Vascular Guidewire (K935170).