The BNLE Access Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. This device is not intended for use in the coronary or cerebral vasculature.

Device Description

The BNLE Access Guidewires are available in 40 cm to 80 cm lengths and in the 0.018" – 0.021" diameter range. The BNLE Access Guidewires are available with Nitinol or Stainless Steel (SS) shafts and in configurations with SS coils or radiopaque Tungsten coils.

The BNLE Access Guidewires consist of a solid core shaft with a ground tapered section at the distal end of the guidewire. A micro-coil is wound with a lumen that is then placed over the tapered distal section. The distal end is secured to the shaft via a weld and the proximal end is bonded to the shaft using adhesive. The micro-coil will provide tip radiopacity in designated models. The finished guidewire is placed in a protective polymer dispenser hoop for either sterile packaging in a labeled Tyvek pouch or shipped in bulk non-sterile condition to use with in a procedure tray by a customer.

AI/ML Overview

The provided text is a 510(k) summary for the BNLE Access Guidewire, a medical device classified as a catheter guide wire (Product Code: DQX, Regulation Number: 21 CFR 870.1330). This document focuses on demonstrating substantial equivalence to a predicate device, the VSI Guidewire (K112631), rather than outlining a study to prove acceptance criteria for a new AI/ML-driven device.

Therefore, the following information, typically requested for AI/ML device studies, is not available in the provided text:

Acceptance Criteria and Reported Device Performance Table: The document explicitly states "BNLE Access Guidewire raised no new concerns regarding safety or efficacy" and aims to prove "substantially equivalent" rather than meeting specific performance metrics against a predefined acceptance criterion.
Sample size used for the test set and data provenance: No information on a test set (clinical or otherwise for performance evaluation) is provided. The testing described is primarily mechanical and material-based.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there is no mention of a test set requiring expert ground truth.
Adjudication method for the test set: Not applicable.
Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is a conventional medical device, not an AI-assisted one.
Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

However, the document does list the performance testing conducted to support the substantial equivalence claim for the BNLE Access Guidewire:

Performance Testing Items:

Simulated Use/Device Compatibility
Corrosion
Kink Resistance
Tip Flexibility
Radiopacity
Tensile
Dimensional
Visual Inspection
Reverse Bend / Flex
Fracture Resistance
Torqueability
Torque Strength
Shelf Life

Biocompatibility Testing (per ISO 10993-1 for an external communicating device, limited (<24 hour) blood contacting device):

Cytotoxicity L929 MEM Elution
Maximum Sensitization
Irritation Intracutaneous Reactivity
Systemic Toxicity
Material Mediated Pyrogen
Hemolysis Extract and Direct Contact
ASTM Partial Thromboplastin
Complement Activation Assay
Thrombogenicity in Canine
Chemical Characterization

The study described here is a premarket notification (510(k)) which aims to demonstrate that the new device (BNLE Access Guidewire) is substantially equivalent to a legally marketed predicate device (VSI Guidewire K112631) in terms of design, materials, sterilization, principles of operation, performance, and indications for use. The performance testing outlined above was conducted to support this claim of substantial equivalence and ensure the new device performs as designed and is suitable for its intended use, posing no new concerns regarding safety or efficacy compared to the predicate.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

April 28, 2023

Biomerics NLE % Jonathan Holmes Senior Manager, Regulatory Affairs MedVenture Health 299S Main St., Suite 2300 Salt Lake City, Utah 84111

Re: K221390

Trade/Device Name: BNLE Access Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: April 14, 2023 Received: April 14, 2023

Dear Jonathan Holmes:

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.

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

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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,

Kenneth J. Cavanaugh -S

Kenneth J. Cavanaugh Jr., Ph.D. Deputy Director OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K221390

Device Name

BNLE Access Guidewire

Indications for Use (Describe)

The BNLE Access Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. This device is not intended for use in the coronary or cerebral vasculature.

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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Image /page/3/Picture/0 description: The image shows the logo for Biomerics NLE, along with their address. The logo features a blue molecular-like graphic on the left, followed by the text "BIOMERICS" in a bold, dark blue font. Below the company name is "NLE" in a stylized font. The address "10351 Xylon Avenue N., Suite 100" is printed below the logo.

Brooklyn Park, MN 55445 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) SUMMARY

Submitter:

Jonathan Holmes Senior Manager, Regulatory Affairs MedVenture Health 299S. Main Street, Suite 2300 Salt Lake City, UT 84111

Manufacturer Contact:

Jason Albers VP of Engineering and Operations, MN Biomerics NLE 10351 Xylon Avenue N., Suite 100 Brooklyn Park, MN 55445

DATE PREPARED: May 12, 2022

NAME OF MEDICAL DEVICE:

Proprietary Name:	BNLE Access Guidewire
Common/Usual Name:	Guidewire
Classification Name:	Wire, Guide, Catheter

DEVICE CLASSIFICATION:

Classification Panel:	Cardiovascular
Regulatory Class:	Class II
Product Code:	DQX
Regulation Number:	21 CFR 870.1330

PREDICATE DEVICE:

Proprietary Name:	VSI Guidewire
Common/Usual Name:	Guidewire
Classification Name:	Wire, Guide, Catheter
510(k) Number:	K112631

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Image /page/4/Picture/0 description: The image shows the logo for Biomerics NLE. The logo consists of a blue molecular-like graphic on the left, followed by the word "BIOMERICS" in a bold, dark blue font. Below the word "BIOMERICS" is a blue line, followed by the letters "NLE" in a smaller, blue font.

DEVICE DESCRIPTION:

INTENDED USE/INDICATION FOR USE:

Intended Use: The BNLE Access Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. This device is not indicated for use in the coronary or cerebral vasculature.

Indications for Use: The BNLE Access Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. This device is not indicated for use in the coronary or cerebral vasculature.

Feature	VSI Guidewire K112631(Predicate Device)	BNLE Access Guidewire(Subject Device)	Discussion
Class	II	II	Identical
Product Code	DQX	DQX	Identical
Regulation(FDA)	21 CFR 870.1330	21 CFR 870.1330	Identical
Indicationsfor Use	The VSI Guidewire isindicated for percutaneousentry of peripheral vesselsusing the SeldingerTechnique. This device is notindicated for use in thecoronary or cerebralvasculature.	The BNLE AccessGuidewire is intended forpercutaneous entry ofperipheral vessels using theSeldinger Technique. Thisdevice is not indicated foruse in the coronary orcerebral vasculature.	Identical
WireDiameter	.018"	.018" - .021"	SubstantiallyEquivalent,within currentlegally marketedbrackets for thistype of device
DeviceLength	40cm - 130cm	40cm - 80cm	SubstantiallyEquivalent,within brackets ofpredicate device

TECHNOLOGICAL COMPARISON TO PREDICATE DEVICE:

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Image /page/5/Picture/0 description: The image shows the logo for Biomerics NLE. The logo consists of a blue molecular-like graphic on the left, followed by the word "BIOMERICS" in bold, blue letters. Below "BIOMERICS" is "NLE" in blue, with a line extending from either side of the letters.

Feature	VSI Guidewire K112631(Predicate Device)	BNLE Access Guidewire(Subject Device)	Discussion
Tip Type andShape	Straight, Angled	Straight	SubstantiallyEquivalent,within brackets ofpredicate device
WireMaterial	Stainless Steel, Nitinol	Stainless Steel, Nitinol	Identical
CoatingMaterial,Length andLocation	None,PTFE Coated	None	SubstantiallyEquivalent
Tip Material	Stainless Steel, Tungsten	Stainless Steel, Tungsten	Identical
Accessories	May be supplied in a Micro-Introducer Access Kit	None	SubstantiallyEquivalent
PackagingConfiguration	5 or 10 pack	5 pack	SubstantiallyEquivalent
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Identical
Shelf Life	≥2 years	1 year	SubstantiallyEquivalent

PERFORMANCE TESTING

The BNLE Access Guidewire was thoroughly tested and verifies that it performs as designed and is suitable for its intended use.

Performance Testing included the following:

· Simulated Use/Device Compatibility
Corrosion
Kink Resistance
· Tip Flexibility
· Radiopacity
Tensile
· Dimensional
Visual Inspection
Reverse Bend / Flex
Fracture Resistance
· Torqueability
Torque Strength
Shelf Life

Biocompatibility per ISO 10993-1 for an external communicating device, limited (<24 hour) blood contacting device.

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Image /page/6/Picture/0 description: The image shows the logo for Biomerics. The logo consists of a blue abstract shape on the left, followed by the word "BIOMERICS" in blue, and then the letters "NLE" in blue with a line underneath. The abstract shape is made up of several interconnected circles.

Cytotoxicity L929 MEM Elution
Maximum Sensitization
· Irritation Intracutaneous Reactivity
· Systemic Toxicity
· Material Mediated Pyrogen
Hemolysis Extract and Direct Contact
ASTM Partial Thromboplastin
· Complement Activation Assay
Thrombogenicity in Canine
Chemical Characterization

BNLE Access Guidewire raised no new concerns regarding safety or efficacy.

CONCLUSION:

The BNLE Access Guidewire has been demonstrated to be substantially equivalent in design, materials, sterilization, principles of operation, performance, and indications for use to the predicate, VSI Guidewire (K112631).

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.