Who is the manufacturer of BNLE Hydrophilic Jacketed Peripheral Guidewire?

Biomerics Nle filed the 510(k) submission for BNLE Hydrophilic Jacketed Peripheral Guidewire (K232662).

What is the FDA product code for BNLE Hydrophilic Jacketed Peripheral Guidewire?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for BNLE Hydrophilic Jacketed Peripheral Guidewire?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BNLE Hydrophilic Jacketed Peripheral Guidewire?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BNLE Hydrophilic Jacketed Peripheral Guidewire

Q: What are the predicate devices for BNLE Hydrophilic Jacketed Peripheral Guidewire?

Terumo Radifocus Glidewire (K152740).

K232662 · Biomerics Nle · DQX · May 14, 2024 · Cardiovascular

Device Facts

Record ID	K232662
Device Name	BNLE Hydrophilic Jacketed Peripheral Guidewire
Applicant	Biomerics Nle
Product Code	DQX · Cardiovascular
Decision Date	May 14, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1330
Device Class	Class 2

Intended Use

The BNLE Hydrophilic Jacketed Peripheral Guidewires are intended to direct a catheter to a desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

Device Story

Hydrophilic-coated guidewire; nickel-titanium alloy core; tungsten-infused polyurethane jacket. Used to direct catheters to specific peripheral vascular locations during diagnostic/interventional procedures. Operated by physicians in clinical settings. Device provides mechanical support and navigation through vasculature; hydrophilic coating reduces friction. Benefits include improved trackability and navigation. EO sterilized; supplied in dispenser hoop and Tyvek pouch.

Clinical Evidence

Bench testing only. Performance testing included visual inspection, dimensional analysis, device compatibility, tensile strength, torqueability, torque strength, kink resistance, flex resistance, fracture resistance, tip flexibility, radiopacity, particulate evaluation, coating integrity, and lubricity/durability. Biocompatibility testing per ISO 10993-1 included cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, complement activation, thrombogenicity (canine), and chemical characterization. All acceptance criteria met.

Technological Characteristics

Core: Nickel-titanium alloy. Jacket: Tungsten-infused polyurethane. Coating: Diphenylmethane diisocyanate and Polyvinylpyrrolidone. Dimensions: 150-260 cm length, 0.018-0.035 inch diameter. Sterilization: Ethylene Oxide. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring catheter guidance to anatomical locations within the peripheral vasculature during diagnostic or interventional procedures. Not for neurovascular or coronary use.

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

Terumo Radifocus Glidewire (K152740)

Related Devices

K193653 — Hydrophilic Coating Guide Wire · Suzhou Hengrui Disheng Medical Co., Ltd. · Aug 26, 2020
K954642 — HYDRO-SELECT GUIDEWIRE · Microvena Corp. · Dec 17, 1996
K170915 — TXM Hydrophilic Guidewire · Texasmedical Technologies, Inc. · Nov 21, 2017
K033742 — BOSTON SCIENTIFIC V-18 CONTROL WIRE · Boston Scientific Corp · Jan 12, 2004
K981667 — HYDROPHILIC COATED GUIDEWIRE · Lake Region Mfg., Inc. · Jun 5, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ May 14, 2024 Image /page/0/Picture/1 description: The image shows the name Brandie Moore, followed by the title Regulatory Affairs Specialist II. The text is in a simple, sans-serif font. The text is aligned to the left. Canyon Labs 16217 S Bringhurst Dr., Suite 600 Bluffdale, Utah 84065 Re: K232662 Trade/Device Name: BNLE Hydrophilic Jacketed Peripheral Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: April 30, 2024 Received: April 30, 2024 Dear Brandie Moore: 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. 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 (https://www.fda.gov/medical-devices/ device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-andcontinuing-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-regulatory-assistance/contact-usdivision-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. 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 {2}------------------------------------------------ Enclosure {3}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. Submission Number (if known) K232662 Device Name BNLE Hydrophilic Jacketed Peripheral Guidewire Indications for Use (Describe) The BNLE Hydrophilic Jacketed Peripheral Guidewires are intended to direct a catheter to a desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/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 company name in bold, blue letters. Below the name is the address: 10351 Xylon Avenue N., Suite 160, Brooklyn Park, MN 55445. ### 510(k) SUMMARY ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ### Submitter: Brandie Moore Regulatory Affairs Specialist II 16217 S Bringhurst Dr., Suite 600 Bluffdale, UT 84065 Phone: (801) 243-0534 Email: Brandie.Moore@canyonlabs.com ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ #### Manufacturer: Biomerics NLE 10351 Xylon Avenue N., Suite 160 Brooklyn Park, MN 55445 #### DATE PREPARED: 31 August 2023 ### NAME OF MEDICAL DEVICE: | Proprietary Name: | BNLE Hydrophilic Peripheral Jacketed 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: | Terumo Radifocus Glidewire | |----------------------|----------------------------| | Common/Usual Name: | Guidewire | | Classification Name: | Wire, Guide, Catheter | | 510(k) Number: | K152740 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Biomerics. The logo consists of a blue abstract design on the left, followed by the word "BIOMERICS" in a bold, dark blue font. Below the word "BIOMERICS" is a horizontal line, followed by the letters "XNLE" in a smaller, lighter blue font. ## DEVICE DESCRIPTION: The BNLE Hydrophilic Jacketed Peripheral Guidewire is available in 150 cm - 260 cm lengths and in 0.018" - 0.035" diameter ranges. The hydrophilic coated guidewire consists of a nickel-titanium alloy core wire and tungsten infused polyurethane jacket in configurations of wire stiffness and tip shape. The finished guidewire is placed in a dispenser hoop and Tyvek pouch. Five (5) Tyvek pouches are placed into a shelf box with an IFU, and 26 shelf cartons are placed into a shipper box. Labels are placed on the Tyvek pouch and shelf box. The finished product is EO sterilized. ## INTENDED USE/INDICATION FOR USE: Intended Use: The BNLE Hydrophilic Jacketed Peripheral Guidewires are intended to direct a catheter to a desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Indications for Use: The BNLE Hydrophilic Jacketed Peripheral Guidewires are intended to direct a catheter to a desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions. | Feature | Terumo Radifocus Glidewire K152740 (Predicate Device) | BNLE Hydrophilic Jacketed Peripheral Guidewire (Subject Device) | Discussion | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Class | II | II | Identical | | Product Code | DQX | DQX | Identical | | Regulation (FDA) | 21 CFR 870.1330 | 21 CFR 870.1330 | Identical | | Indications for Use | The Glidewire is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions. | The BNLE Hydrophilic Jacketed Peripheral Guidewires are intended to direct a catheter to a desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions. | Identical | | Wire Diameter | 0.035" | 0.018" - 0.035" | Substantially Equivalent, within current legally marketed brackets for this type of device. | | Length of Wire | 260, 300, 350, 400, and 450cm | 150, 180, 260cm | Substantially Equivalent, within current legally | | Feature | Terumo Radifocus Glidewire K152740 (Predicate Device) | BNLE Hydrophilic Jacketed Peripheral Guidewire (Subject Device) | Discussion | | | | | marketed brackets for this type of device. | | Distal Tip shape | Straight, Angled | Straight, Angled, and J-Tip | Substantially Equivalent, within brackets of predicate device | | Wire Type | Standard or Stiff | Standard or Stiff | Identical | | Lengths of the Flexible Tip | 3 and 5cm | 3 cm | Substantially Equivalent, within brackets of predicate device | | Jacket Material | Tungsten and Polyurethane | Tungsten and Polyurethane | Identical | | Wire Coating | Hydro gel: Hydrophilic polymer (half-ester methyl vinyl ether-maleic anhydride copolymer) Under coat: Polyvinyl chloride | Hydrophilic polymer: Diphenylmethane diisocyanate and Polyvinylpyrrolidone | Though the materials are different performance testing demonstrates that we meet our design requirements and performance is substantially equivalent to the predicate, Terumo Radifocus Glidewire | | Core Wire | Nickel-titanium alloy | Nickel-titanium alloy | Identical | | Guidewire Inserter | Polyethylene | High Density Polyethylene (HDPE) | Substantially Equivalent, both are biocompatible for their intended use per ISO 10993 | | Packaging | • Individual package • Unit box • Shipping carton | • Individual package • Unit box • Shipping carton | Identical | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical | | Shelf Life | 2 years | 1 year | Performance testing demonstrates that we meet our design requirements and | | Feature | Terumo Radifocus Glidewire K152740 (Predicate Device) | BNLE Hydrophilic Jacketed Peripheral Guidewire (Subject Device) | Discussion | | | | | perform substantially equivalent to the predicate, Terumo Radifocus Glidewire | #### TECHNOLOGICAL COMPARISON TO PREDICATE DEVICE: {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Biomerics NLS. The logo consists of a blue abstract design on the left, followed by the word "BIOMERICS" in bold, dark blue letters. Below "BIOMERICS" is "NLS" in a lighter blue color with a line extending from the left side of the N to the right side of the S. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for Biomerics NLE. The logo consists of a blue molecular-like graphic on the left, followed by the word "BIOMERICS" in bold, dark blue letters. Below "BIOMERICS" is "NLE" in a smaller font, underlined by two blue lines. #### PERFORMANCE TESTING The BNLE Hydrophilic Peripheral Jacketed Guidewire was thoroughly tested and verifies that it performs as designed and is suitable for its intended use. Performance Testing included the following: - Visual Inspection ● - Dimensional ● - Device Compatibility ● - Tensile - Torqueability ● - Torque Strength - . Kink Resistance - Flex Resistance - Fracture Resistance - Tip Flexibility - Radiopacity - Particulate Evaluation / Coating Integrity ● - Lubricity and Durability ● Biocompatibility 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 - Complement Activation Assay - Thrombogenicity in Canine - · Chemical Characterization BNLE Hydrophilic Peripheral Jacketed Guidewire met all predetermined acceptance criteria and raised no new concerns regarding safety or efficacy. BNLE Hydrophilic Peripheral Jacketed Guidewire {8}------------------------------------------------ Image /page/8/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 a bold, dark blue font. Below the word "BIOMERICS" is the text "XNLE" in a lighter blue font with a line above it. # CONCLUSION: The BNLE Hydrophilic Peripheral Jacketed Guidewire has been demonstrated to be substantially equivalent in design, materials, sterilization, principles of operation, performance, and indications for use to the predicate, Terumo Radifocus Glidewire (K152740).