BNLE Access Guidewire

K221390 · Biomerics Nle · DQX · Apr 28, 2023 · Cardiovascular

Device Facts

• Record ID: K221390
• Device Name: BNLE Access Guidewire
• Applicant: Biomerics Nle
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

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.

Device Story

BNLE Access Guidewire facilitates percutaneous entry of peripheral vessels via Seldinger Technique; used by clinicians in peripheral vascular procedures. Device consists of solid core shaft (Nitinol or Stainless Steel) with ground tapered distal section; micro-coil (Stainless Steel or Tungsten) wound over distal section; distal end welded; proximal end adhesive-bonded. Available in 40-80 cm lengths and 0.018"–0.021" diameters. Device provides mechanical guidance for catheter placement; radiopaque tip aids visualization under fluoroscopy. Supplied in protective polymer dispenser hoop; available sterile in Tyvek pouch or bulk non-sterile for procedure trays.

Clinical Evidence

Bench testing only. Testing included simulated use, corrosion, kink resistance, tip flexibility, radiopacity, tensile strength, dimensional analysis, reverse bend/flex, fracture resistance, and torqueability. Biocompatibility testing performed per ISO 10993-1 for limited (<24 hour) blood-contacting devices, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, thrombogenicity (canine), and chemical characterization.

Technological Characteristics

Materials: Nitinol or Stainless Steel shafts; Stainless Steel or Tungsten coils. Dimensions: 40-80 cm length, 0.018"-0.021" diameter. Principle: Mechanical guidewire for vessel access. Sterilization: Ethylene Oxide. No software or electronic components.

Indications for Use

Indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. Contraindicated for use in coronary or cerebral vasculature.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• VSI Guidewire (K112631)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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:

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.

#### 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<br>(Predicate Device) | BNLE Access Guidewire<br>(Subject Device) | Discussion |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Class | II | II | Identical |
| Product Code | DQX | DQX | Identical |
| Regulation<br>(FDA) | 21 CFR 870.1330 | 21 CFR 870.1330 | Identical |
| Indications<br>for Use | The VSI Guidewire is<br>indicated for percutaneous<br>entry of peripheral vessels<br>using the Seldinger<br>Technique. This device is not<br>indicated for use in the<br>coronary or cerebral<br>vasculature. | The BNLE Access<br>Guidewire is intended for<br>percutaneous entry of<br>peripheral vessels using the<br>Seldinger Technique. This<br>device is not indicated for<br>use in the coronary or<br>cerebral vasculature. | Identical |
| Wire<br>Diameter | .018" | .018" - .021" | Substantially<br>Equivalent,<br>within current<br>legally marketed<br>brackets for this<br>type of device |
| Device<br>Length | 40cm - 130cm | 40cm - 80cm | Substantially<br>Equivalent,<br>within brackets of<br>predicate 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<br>(Predicate Device) | BNLE Access Guidewire<br>(Subject Device) | Discussion |
|------------------------------------------------|------------------------------------------------------|-------------------------------------------|------------------------------------------------------------------------|
| Tip Type and<br>Shape | Straight, Angled | Straight | Substantially<br>Equivalent,<br>within brackets of<br>predicate device |
| Wire<br>Material | Stainless Steel, Nitinol | Stainless Steel, Nitinol | Identical |
| Coating<br>Material,<br>Length and<br>Location | None,<br>PTFE Coated | None | Substantially<br>Equivalent |
| Tip Material | Stainless Steel, Tungsten | Stainless Steel, Tungsten | Identical |
| Accessories | May be supplied in a Micro-<br>Introducer Access Kit | None | Substantially<br>Equivalent |
| Packaging<br>Configuration | 5 or 10 pack | 5 pack | Substantially<br>Equivalent |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Identical |
| Shelf Life | ≥2 years | 1 year | Substantially<br>Equivalent |

# 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).