(257 days)
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.
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.
The provided text is a 510(k) summary for a medical device (BNLE Hydrophilic Jacketed Peripheral Guidewire). It does not describe a study involving an AI/Machine Learning device or a diagnostic device that would have acceptance criteria related to accuracy metrics like sensitivity, specificity, or AUC, nor does it involve expert readers establishing ground truth.
Instead, this document details the substantial equivalence of a physical medical device (a guidewire) to a predicate device. The "performance testing" described is for the physical and biological characteristics of the guidewire itself, not for an algorithm's performance.
Therefore, most of the requested information (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone algorithm performance, AI-related ground truth types) is not applicable to this document.
However, I can extract the acceptance criteria and performance as described for this physical device.
Acceptance Criteria and Device Performance (for a physical medical device - Guidewire)
Since this document pertains to a physical medical device (a guidewire) and not an AI/diagnostic algorithm, the "acceptance criteria" discussed are related to the device's physical and biocompatibility characteristics. The document doesn't provide specific numerical acceptance criteria or performance metrics for each test, but it states the overarching conclusion that the device "met all predetermined acceptance criteria."
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Physical Performance Tests | Met all predetermined acceptance criteria |
| Visual Inspection | Pass |
| Dimensional | Pass |
| Device Compatibility | Pass |
| Tensile | Pass |
| Torqueability | Pass |
| Torque Strength | Pass |
| Kink Resistance | Pass |
| Flex Resistance | Pass |
| Fracture Resistance | Pass |
| Tip Flexibility | Pass |
| Radiopacity | Pass |
| Particulate Evaluation / Coating Integrity | Pass |
| Lubricity and Durability | Pass |
| Biocompatibility Tests (per ISO 10993-1 for external communicating device, limited (<24 hour) blood contacting device) | Met all predetermined acceptance criteria |
| Cytotoxicity (L929 MEM Elution) | Pass |
| Maximum Sensitization | Pass |
| Irritation (Intracutaneous Reactivity) | Pass |
| Systemic Toxicity | Pass |
| Material Mediated Pyrogen | Pass |
| Hemolysis (Extract and Direct Contact) | Pass |
| Complement Activation Assay | Pass |
| Thrombogenicity (in Canine) | Pass |
| Chemical Characterization | Pass |
| Overall Conclusion | No new concerns regarding safety or efficacy. |
Explanation for "Pass": The document states: "BNLE Hydrophilic Peripheral Jacketed Guidewire met all predetermined acceptance criteria and raised no new concerns regarding safety or efficacy." This implies that for each listed test, the device's performance fell within the acceptable range defined by the manufacturer for demonstrating substantial equivalence. Specific numerical ranges or results for each test are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- This information is not applicable as this is a physical device, not an AI/diagnostic algorithm using a "test set" of patient data.
- The tests are performed on samples of the manufactured guidewire itself. The sample size for each specific physical or biocompatibility test is not detailed in this 510(k) summary.
- Data provenance for a physical device refers to the conditions under which the tests were conducted (e.g., lab conditions, animal models for biocompatibility). These specifics are not detailed in this public summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for a physical medical device. "Ground truth" in this context would be established by validated test methods and standards (e.g., ISO, ASTM standards), not by human experts interpreting images or data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is for resolving discrepancies in expert interpretations of data, which is not relevant to the testing of a physical guidewire.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a framework for evaluating diagnostic AI algorithms involving human readers, which is not the subject of this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to the evaluation of an AI algorithm's performance on its own, which is not relevant to a physical guidewire.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For physical devices, "ground truth" is typically established by:
- Standardized Test Methods: Adherence to recognized industry standards (e.g., ISO, ASTM) and internal design specifications.
- Physical Measurements: Direct measurements of device dimensions, strength, flexibility, etc., against predefined specifications.
- Chemical Analysis: Verification of material composition.
- Biological Response in vitro/in vivo: Assessment of biocompatibility based on established biological assays (e.g., cytotoxicity, sensitization, hemolysis) and animal studies (e.g., thrombogenicity in canine).
8. The sample size for the training set:
- Not applicable. This refers to the data used to train machine learning models, which is not relevant to this physical device.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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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"
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(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
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Enclosure
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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.
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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 |
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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 RadifocusGlidewire K152740(Predicate Device) | BNLE HydrophilicJacketed PeripheralGuidewire(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 Glidewire is designedto direct a catheter to thedesired anatomicallocation in the peripheralvasculature duringdiagnostic orinterventional procedures.This device is not intendedfor neurovascular orcoronary interventions. | The BNLE HydrophilicJacketed PeripheralGuidewires are intended todirect a catheter to a desiredanatomical location in theperipheral vasculature duringdiagnostic or interventionalprocedures. This device is notintended for neurovascular orcoronary interventions. | Identical |
| WireDiameter | 0.035" | 0.018" - 0.035" | SubstantiallyEquivalent, withincurrent legallymarketed bracketsfor this type ofdevice. |
| Length ofWire | 260, 300, 350, 400, and450cm | 150, 180, 260cm | SubstantiallyEquivalent, withincurrent legally |
| Feature | Terumo RadifocusGlidewire K152740(Predicate Device) | BNLE HydrophilicJacketed PeripheralGuidewire(Subject Device) | Discussion |
| marketed bracketsfor this type ofdevice. | |||
| Distal Tipshape | Straight, Angled | Straight, Angled, and J-Tip | SubstantiallyEquivalent, withinbrackets ofpredicate device |
| Wire Type | Standard or Stiff | Standard or Stiff | Identical |
| Lengths ofthe FlexibleTip | 3 and 5cm | 3 cm | SubstantiallyEquivalent, withinbrackets ofpredicate device |
| JacketMaterial | Tungsten andPolyurethane | Tungsten and Polyurethane | Identical |
| Wire Coating | Hydro gel: Hydrophilicpolymer (half-ester methylvinyl ether-maleicanhydride copolymer)Under coat: Polyvinylchloride | Hydrophilic polymer:Diphenylmethane diisocyanateand Polyvinylpyrrolidone | Though thematerials aredifferentperformancetestingdemonstrates thatwe meet ourdesignrequirements andperformance issubstantiallyequivalent to thepredicate, TerumoRadifocusGlidewire |
| Core Wire | Nickel-titanium alloy | Nickel-titanium alloy | Identical |
| GuidewireInserter | Polyethylene | High Density Polyethylene(HDPE) | SubstantiallyEquivalent, bothare biocompatiblefor their intendeduse per ISO 10993 |
| Packaging | • Individual package• Unit box• Shipping carton | • Individual package• Unit box• Shipping carton | Identical |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Identical |
| Shelf Life | 2 years | 1 year | Performancetestingdemonstrates thatwe meet ourdesignrequirements and |
| Feature | Terumo RadifocusGlidewire K152740(Predicate Device) | BNLE HydrophilicJacketed PeripheralGuidewire(Subject Device) | Discussion |
| performsubstantiallyequivalent to thepredicate, TerumoRadifocusGlidewire |
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICE:
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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.
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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
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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).
§ 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.