(350 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a guidewire, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The guidewire is intended for percutaneous entry of peripheral vessels and is explicitly stated as "not intended for use in the coronary or cerebral vasculature." Its purpose is to facilitate access and delivery during a medical procedure, not to treat a disease or condition itself.
No.
Explanation: The device, a guidewire, is intended for percutaneous entry of peripheral vessels using the Seldinger Technique, which is a procedural and interventional use, not a diagnostic one. There is no mention of it being used to collect or analyze data for diagnosis.
No
The device description clearly details physical components like shafts, coils, and a dispenser hoop, and the performance studies focus on material properties and mechanical performance, indicating 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 for "percutaneous entry of peripheral vessels using the Seldinger Technique." This describes a surgical or interventional procedure performed directly on a patient's body.
- Device Description: The device is a guidewire, a physical tool used to navigate within blood vessels.
- 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.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples. This device is clearly designed for direct use within a patient's circulatory system during a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vessels
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 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 (
§ 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
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
1
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
2
Indications for Use
Submission Number (if known)
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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3
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 |
4
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
(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 |
| Indications
for Use | The VSI 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. | 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. | Identical |
| Wire
Diameter | .018" | .018" - .021" | Substantially
Equivalent,
within current
legally marketed
brackets for this
type of device |
| Device
Length | 40cm - 130cm | 40cm - 80cm | Substantially
Equivalent,
within brackets of
predicate device |
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICE:
5
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 and
Shape | Straight, Angled | Straight | Substantially
Equivalent,
within brackets of
predicate device |
| Wire
Material | Stainless Steel, Nitinol | Stainless Steel, Nitinol | Identical |
| Coating
Material,
Length and
Location | None,
PTFE Coated | None | Substantially
Equivalent |
| Tip Material | Stainless Steel, Tungsten | Stainless Steel, Tungsten | Identical |
| Accessories | May be supplied in a Micro-
Introducer Access Kit | None | Substantially
Equivalent |
| Packaging
Configuration | 5 or 10 pack | 5 pack | Substantially
Equivalent |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Identical |
| Shelf Life | ≥2 years | 1 year | Substantially
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 (