(257 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a guidewire, with no mention of AI or ML.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device, a guidewire, is intended to direct a catheter for diagnostic or interventional procedures, which are actions taken to diagnose or perform a procedure, but the guidewire itself does not provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" states that the guidewires are intended to direct a catheter during "diagnostic or interventional procedures." This indicates that the device can be used in diagnostic procedures.
No
The device description clearly outlines a physical guidewire made of nickel-titanium alloy and polyurethane, packaged in a dispenser hoop and pouch. The performance studies focus on physical properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guidewires are used to "direct a catheter to a desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures." This describes a device used within the body to facilitate a medical procedure, not a device used to examine specimens outside the body to obtain diagnostic information.
- Device Description: The description details the physical components of a guidewire (core wire, jacket, dispenser, packaging) and its sterilization method. This aligns with a medical device used for navigation within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to obtaining diagnostic information from specimens in vitro.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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 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 (
§ 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.
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)
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 (