(168 days)
No
The device description and performance testing focus solely on the physical properties and mechanical performance of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a guidewire intended to facilitate the introduction and placement of interventional devices; it does not directly treat or diagnose a disease.
No
Explanation: The device is a guidewire intended to facilitate the introduction and placement of other interventional devices within the heart. It does not perform any diagnostic function.
No
The device description clearly details a physical guidewire made of stainless steel with PTFE coating, intended for insertion into the heart. It undergoes bench testing for physical properties and animal studies, indicating it is a hardware device.
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 introduction and placement of interventional devices within the chambers of the heart." This describes a device used in vivo (within the body) for a procedural purpose.
- Device Description: The description details a physical guidewire designed to be inserted into the body.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the guidewire (e.g., lubricity, strength, flexibility, biocompatibility) and its performance in an animal model. These are typical tests for in vivo medical devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This guidewire is clearly designed for use in vivo during a medical procedure.
N/A
Intended Use / Indications for Use
Pre-Formed Extra Support guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used during transcatheter aortic valve procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Pre-Formed Guidewire Extra Support guidewire is designed to facilitate device placement during TAVR procedures and has a unique pre-shaped spiral distal tip to ensure placement within the heart. The guidewire is intended for single use.
The guidewire has a 0.035" diameter and is 275cm in length. The guidewire composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The proximal end of the core wire is coated with grev polytetrafluoroethylene (PTFE) coating. The coil component is fitted over the distal end of the core and is a stainless-steel coiled with green PTFE coating. The coil and core components are secured together using a weld on the distal and a glue joint at the proximal end of the coil, forming the guidewire. The pre-shaped distal end of the guidewire is available in three sizes (extra-small, small and large).
The Pre-Formed Extra Support guidewire is sterilized using ethylene oxide. There are no accessories packaged with the Pre-Formed Extra Support guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chambers of the heart
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)
The determination of substantial equivalence includes an assessment of non-clinical (bench) performance testing. This testing was performed in order to demonstrate that the Pre-Formed Extra Support guidewire met applicable design and performance requirements and to support a determination of substantial equivalence. The following testing was conducted according to established procedures and samples were analyzed according to predetermined acceptance criteria. FDA guidance Coronary, Peripheral and Neurovascular Guidewires Performance Tests and Recommended Labeling (October 10, 2019) was utilized.
- Thermal Conditional and Packaging Distribution - Tested in accordance with ASTM D4169 (Distribution simulation) and ISTA 2A (environmental conditioning). The predetermined acceptance criteria were met.
- Package Integrity evaluation, including:
- Visual Inspection - Tested in accordance with EN ISO 11070 & FDA Guidance. The predetermined acceptance criteria were met.
- Pouch Peel Tear - Tested in accordance with ASTM F88-15. The predetermined acceptance criteria were met.
- Seal Integrity – Tested in accordance with ASTM F1929-15. The predetermined acceptance criteria were met.
- Bubble Leak Testing - Tested in accordance with ASTM F2096-11(2019). The predetermined acceptance criteria were met.
- Dimensional Inspection, including:
- Length, Outer Diameter Tested in accordance with EN ISO 11070 & FDA Guidance. The predetermined acceptance criteria were met.
- Curve – Tested in accordance with internal procedures. The predetermined acceptance criteria were met.
- Lubricity Tested in accordance with FDA Guidance. The predetermined acceptance criteria were met.
- Guidewire Distal Joint Pull Test Tested in accordance with EN ISO 11070 & FDA Guidance. The predetermined acceptance criteria were met.
- 3 Point Bend Tested in accordance with internal procedures. The predetermined acceptance criteria were met.
- Coating Adhesion Tested in accordance with FDA Guidance. The predetermined acceptance criteria were met.
- Radiopacity - Tested in accordance with EN ISO 11070 & FDA Guidance. The predetermined acceptance criteria were met.
- ISO Corrosion Test Tested in accordance with EN ISO 11070 & FDA Guidance. The predetermined acceptance criteria were met.
- Particulate Residue Test - Tested in accordance with FDA Guidance. The predetermined acceptance criteria were met.
- ISO Fracture Test Tested in accordance with EN ISO 11070. The predetermined acceptance criteria were met.
- ISO Flex Test Tested in accordance with EN ISO 11070. The predetermined acceptance criteria were met.
- Torque Fatigue Tested in accordance with FDA Guidance. The predetermined acceptance criteria were met.
- Kink Resistance - Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
- Biocompatibility Tested in accordance with ISO 10993-1 and all applicable parts of this standard series. The battery of tests included cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity, hemocompatibility, and thrombogenicity. The predetermined acceptance criteria were met.
The Pre-Formed Extra Support guidewire was evaluated in a porcine model in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non- Clinical Laboratory studies. The subject device Pre-Formed Extra Support guidewire shares the same intended use and fundamental scientific technology as the predicate and demonstrated all safety and performance objectives as the device performed equivalent to the predicate, Pre-Formed guidewire, and demonstrated all Customer Requirement Specifications as measured by post procedure feedback forms.
Conclusion: The Pre-Formed Extra Support guidewire met all design input requirements based on the intended use and supports the conclusion that the Pre-Formed Extra Support 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 Pre-Formed Guidewire (K151244).
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.
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
§ 870.1330 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.
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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2021
Lake Region Medical Deko Hussein Sr. Regulatory Specialist 340 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K211741
Trade/Device Name: Pre-Formed Extra Support Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: October 18, 2021 Received: October 21, 2021
Dear Deko Hussein:
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. 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 located 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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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.
for Jaime Raben Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K211741
Device Name Pre-Formed Extra Support Guidewire
Indications for Use (Describe)
Pre-Formed Extra Support guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used during transcatheter aortic valve procedures.
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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3
K211741 510(k) Summary
Submitter Address:
Establishment Registration Number: Primary Contact Person: Email: Phone: Prepared:
Subiect Device
Name of Device (Trade): Common or Usual Name: Classification: Regulatory Class: Product Code:
Predicate Device
Device Name: Manufacturer: 510(k) Number: Regulatory Class: Product Code:
Reference Device
- Device Name: Manufacturer: 510(k) Number: Regulatory Class: Product Code:
Lake Region Medical 340 Lake Hazeltine Drive Chaska, MN 55318 2126666 Deko Hussein, Sr. Regulatory Specialist deko.hussein@integer.net (952) 641-8302 June 4, 2021
Pre-Formed Extra Support Guidewire Catheter Guidewire Catheter Guidewire (21 CFR 870.1330) Class II DOX
Pre-Formed Guidewire Lake Region Medical K151244 (Cleared June 11, 2015) Class II per 21 CFR 870.1330 DQX
Lunderquist Extra Stiff William Cook Europe ApS K171513 Class II per 21 CFR 870.1330 DQX
Device Description
The Pre-Formed Guidewire Extra Support guidewire is designed to facilitate device placement during TAVR procedures and has a unique pre-shaped spiral distal tip to ensure placement within the heart. The guidewire is intended for single use.
The guidewire has a 0.035" diameter and is 275cm in length. The guidewire composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core
4
wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The proximal end of the core wire is coated with grev polytetrafluoroethylene (PTFE) coating. The coil component is fitted over the distal end of the core and is a stainless-steel coiled with green PTFE coating. The coil and core components are secured together using a weld on the distal and a glue joint at the proximal end of the coil, forming the guidewire. The pre-shaped distal end of the guidewire is available in three sizes (extra-small, small and large).
The Pre-Formed Extra Support guidewire is sterilized using ethylene oxide. There are no accessories packaged with the Pre-Formed Extra Support guidewire.
Indications for Use
Pre-Formed Extra Support guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used during transcatheter aortic valve procedures.
Comparison of Technological Characteristics with the Predicate Devices
The Pre-Formed Extra Support has the same indication for use/intended use and principles of operation as the legally marketed Pre-Formed guidewire (K151244). In addition, the functional characteristics of the Pre-Formed Extra Support are substantially equivalent to the Pre-Formed guidewire, with similar materials, dimensions, and method of construction. The design modifications to the new device include differences in material used on the coating for the core, the proximal joint and the partial coil design on the distal end. Performance and safety testing have shown that these modifications have not raised any new questions of safety or efficacy and the device continues to meet its intended use.
Summarv of Testing
The determination of substantial equivalence includes an assessment of non-clinical (bench) performance testing. This testing was performed in order to demonstrate that the Pre-Formed Extra Support guidewire met applicable design and performance requirements and to support a determination of substantial equivalence. The following testing was conducted according to established procedures and samples were analyzed according to predetermined acceptance criteria. FDA guidance Coronary, Peripheral and Neurovascular Guidewires Performance Tests and Recommended Labeling (October 10, 2019) was utilized.
- . Thermal Conditional and Packaging Distribution - Tested in accordance with ASTM D4169 (Distribution simulation) and ISTA 2A (environmental conditioning). The predetermined acceptance criteria were met.
- Package Integrity evaluation, including:
- . Visual Inspection - Tested in accordance with EN ISO 11070 & FDA Guidance. The predetermined acceptance criteria were met.
- . Pouch Peel Tear - Tested in accordance with ASTM F88-15. The predetermined acceptance criteria were met.
5
- . Seal Integrity – Tested in accordance with ASTM F1929-15. The predetermined acceptance criteria were met.
- . Bubble Leak Testing - Tested in accordance with ASTM F2096-11(2019). The predetermined acceptance criteria were met.
- Dimensional Inspection, including:
- Length, Outer Diameter Tested in accordance with EN ISO 11070 & ● FDA Guidance. The predetermined acceptance criteria were met.
- . Curve – Tested in accordance with internal procedures. The predetermined acceptance criteria were met.
- Lubricity Tested in accordance with FDA Guidance. The predetermined acceptance o criteria were met.
- Guidewire Distal Joint Pull Test Tested in accordance with EN ISO 11070 & FDA ● Guidance. The predetermined acceptance criteria were met.
- 3 Point Bend Tested in accordance with internal procedures. The predetermined . acceptance criteria were met.
- Coating Adhesion Tested in accordance with FDA Guidance. The predetermined . acceptance criteria were met.
- . Radiopacity - Tested in accordance with EN ISO 11070 & FDA Guidance. The predetermined acceptance criteria were met.
- ISO Corrosion Test Tested in accordance with EN ISO 11070 & FDA . Guidance. The predetermined acceptance criteria were met.
- . Particulate Residue Test - Tested in accordance with FDA Guidance. The predetermined acceptance criteria were met.
- ISO Fracture Test Tested in accordance with EN ISO 11070. The predetermined o acceptance criteria were met.
- ISO Flex Test Tested in accordance with EN ISO 11070. The predetermined . acceptance criteria were met.
- Torque Fatigue Tested in accordance with FDA Guidance. The predetermined . acceptance criteria were met.
- . Kink Resistance - Tested in accordance with FDA guidance. The predetermined acceptance criteria were met.
- Biocompatibility Tested in accordance with ISO 10993-1 and all applicable parts of this . standard series. The battery of tests included cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity, hemocompatibility, and thrombogenicity. The predetermined acceptance criteria were met.
Performance Data (Animal)
The Pre-Formed Extra Support guidewire was evaluated in a porcine model in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non- Clinical Laboratory studies. The subject device Pre-Formed Extra Support guidewire shares the same intended use and fundamental scientific technology as the predicate and demonstrated all safety and performance objectives as the device performed equivalent to the predicate, Pre-Formed guidewire, and
6
demonstrated all Customer Requirement Specifications as measured by post procedure feedback forms.
Conclusion: The Pre-Formed Extra Support guidewire met all design input requirements based on the intended use and supports the conclusion that the Pre-Formed Extra Support 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 Pre-Formed Guidewire (K151244).