Who is the manufacturer of HYBRID Guidewire?

Balt USA, LLC filed the 510(k) submission for HYBRID Guidewire (K182337).

What is the FDA product code for HYBRID Guidewire?

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

What is the regulatory pathway for HYBRID Guidewire?

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

Who can help prepare an FDA 510(k) submission like HYBRID 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.

HYBRID Guidewire

Q: What are the predicate devices for HYBRID Guidewire?

Traxcess 14 Guidewire (K133725).

K182337 · Balt USA, LLC · MOF · Oct 4, 2018 · Cardiovascular

Device Facts

Record ID	K182337
Device Name	HYBRID Guidewire
Applicant	Balt USA, LLC
Product Code	MOF · Cardiovascular
Decision Date	Oct 4, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1330
Device Class	Class 2
Attributes	3rd-Party Reviewed

Indications for Use

The HYBRID Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries.

Device Story

HYBRID Guidewire is a steerable, coiled wire used to direct percutaneous microcatheters through tortuous intracranial and peripheral vasculature. Device consists of proximal stainless steel core and distal nitinol core, tapered at tip, encased in platinum/tungsten and stainless steel coil for radiopacity. Surface features hydrophilic coating on distal sections and PTFE on proximal section to enhance lubricity. Operated by physician in clinical setting; pushed and torqued to navigate anatomy. Output is physical guidance of catheter to target site, enabling diagnostic or therapeutic procedures. Benefits include improved navigation through complex vascular anatomy. Provided with torquer and introducer; sterile, single-use.

Clinical Evidence

No human clinical data. Evidence consists of bench testing (visual/dimensional inspection, simulated use in tortuous ICA model, coating integrity, tensile strength, corrosion resistance, torque strength/ability, fracture resistance, tip flexibility, particulate matter) and acute porcine animal model testing. All tests met acceptance criteria and demonstrated performance comparable to predicate devices. Biocompatibility testing (ISO 10993) confirmed non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-pyrogenic, and non-hemolytic status.

Technological Characteristics

Coiled guidewire; proximal stainless steel core, distal nitinol core; platinum/tungsten and stainless steel coil. Hydrophilic coating (distal) and PTFE (proximal). Dimensions: 120-310 cm length, 0.007-0.014" diameter. Sterilized via 100% Ethylene Oxide (ISO 11135). Manual operation; no software or energy source.

Indications for Use

Indicated for general intravascular use, including neuro and peripheral vasculature, to facilitate selective placement of diagnostic or therapeutic catheters. Not for use in coronary arteries.

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

Traxcess 14 Guidewire (K133725)

Reference Devices

Traxcess 0.007" Mini Guidewire (K161803)
Transend 300 ES Guidewire (K022357)
Transend 300 Floppy Guidewire (K022357)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 4, 2018 Regulatory Technology Services LLC Mark Job Responsible Third Party Official 1394 25th Street NW Buffalo, Minnesota 55313 Re: K182337 Trade/Device Name: HYBRID Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: September 25, 2018 Received: September 26, 2018 Dear Mark Job: 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Xiaolin Zheng -S for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K182337 Device Name HYBRID Guidewire Indications for Use (Describe) The HYBRID Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic catheters. This device is not intended for use in the coronary arteries. | 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." {3}------------------------------------------------ ### HYBRID Guidewire 510(k) Summary This 510(k) Summary for HYBRID Guidewire is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014. #### SUBMITTER [807.92(a)(1)] Balt USA, LLC 29 Parker Irvine CA 92618 | Contact Person: | Nancy Xu Regulatory Affairs Manager | |-----------------|----------------------------------------| | Telephone: | 949-788-1443 | | E-mail: | nancy.xu@balt-usa.com | | Date prepared: | September 21, 2018 | #### DEVICE [807.92(a)(2)] | Name of Device: | HYBRID Guidewire | |---------------------------|-------------------------------------------------------------------| | Common or Usual Name: | Guidewire | | Classification Name: | Catheter Guide Wire | | Product Code: | MOF | | | DQX | | Regulatory Class: | Class II | | Submission Type: | Traditional 510(k) | | Regulation Number: | 21 C.F.R. 870.1330 | | Reviewing Product Branch: | Division of Neurological and Physical Medicine Devices (Office of | | | Device Evaluation, CDRH) | #### PREDICATE DEVICE [807.92(a)(3)] Traxcess 14 Guidewire (K133725) #### REFERENCE DEVICES Traxcess 0.007" Mini Guidewire (K161803) Transend 300 ES Guidewire and Transend 300 Floppy Guidewire (K022357) {4}------------------------------------------------ #### DEVICE DESCRIPTION [807.92(a)(4)] HYBRID Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It is used in association with catheters to enable insertion and easier navigation into the intracranial vascular branches for diagnostic or therapeutic use. Guidewires constitute an important element that conditions the success of the operation. They can be pushed and torqued to move forward through patient's tortuous anatomy. HYBRID Guidewire consists of a proximal coated stainless steel core wire and a distal coated nitinol core wire. The distal core wire is tapered at the distal tip and is contained within a 92/8 platinum/tungsten and stainless steel coil for maximum radiopacity. The distal tip comes in various tip designs; it can be straight or curved distal tip (forming a double angle). The coil section of the HYBRID Guidewire and the distal stainless steel section is coated with hydrophilic coating, while the proximal stainless steel section is coated with Polytetrafluoroethylene (PTFE). The purpose of the surface coatings is to provide lubricity when HYBRID Guidewire is passed through compatible microcatheters. A torquer and an introducer are also provided with the device. # INDICATIONS FOR USE [807.92(a)(5)] The HYBRID Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries. # COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6]] The technological characteristics of the HYBRID Guidewire is analogous to the technological characteristics of the Traxcess 14 Guidewire (K133725), Traxcess 0.007" Mini Guidewire (K161803), and Transend 300 ES Guidewire and Transend 300 Floppy Guidewire (K022357). Substantial equivalence is determined based on the following similarities: - similar intended use/indications for use ● - Same principles of operation ● - Same fundamental scientific technology ● - Incorporate similar basic guidewire design - Incorporate similar guidewire construction material . {5}------------------------------------------------ Table 1 comprises the comparison between HYBRID Guidewire (Subject Device) and Traxcess 14 Guidewire (Predicate Device, K133725), Traxcess .007" Mini Guidewire (Reference Device, K161803) and Transend 300 ES Guidewire and Transend 300 Floppy Guidewire (Reference Device, K022357). {6}------------------------------------------------ | Feature | Traxcess 14 Guidewire | Traxcess .007" Mini Guidewire | Transend 300 ES Guidewire Transend 300 Floppy Guidewire | HYBRID Guidewire | | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | [PREDICATE DEVICE K133725] | [REFERENCE DEVICE K161803] | [REFERENCE DEVICE K022357] | [SUBJECT DEVICE] | | | Product Code | MOF, DQX | MOF, DQX | DQX | Same as Traxcess .007" Mini Guidewire and Traxcess 14 Guidewire | | | Regulatory Class | Class II | Class II | Class II | Same as Predicate Device | | | Regulation Number | 21 CFR 870.1330 | 21 CFR 870.1330 | 21 CFR 870.1330 | Same as Predicate Device | | | Regulation Name | Catheter Guide Wire | Catheter Guide Wire | Catheter Guide Wire | Same as Predicate Device | | | Generic Name | Guidewire | Guidewire | Guidewire | Same as Predicate Device | | | Indications for Use Statement | The Traxcess 14 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. | Traxcess .007" Mini Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries. | The Transend 300 ES Guidewire and Transend 300 Floppy Guidewire are intended for general intravascular use, including the neuro and peripheral vasculature. The guidewires can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. These devices are not intended for use in coronary arteries. A torque device (pin vise) is included to facilitate directional manipulation of the guidewires. | The HYBRID Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in the coronary arteries. | | | Performance | | | | | | | Function | The steerable guidewire is used to facilitate the selective placement of diagnostic or therapeutic catheters. | The steerable guidewire is used to facilitate the selective placement of diagnostic or therapeutic catheters. | The guidewire can be torqued to facilitate the selective placement of diagnostic or therapeutic catheters. | Same as Traxcess .007" Mini Guidewire and Traxcess 14 Guidewire | | | Anatomical Location | General intravascular use, including the neuro and peripheral vasculature. | General intravascular use, including the neuro and peripheral vasculature. | General intravascular use, including the neuro and peripheral vasculature. | Same as Predicate Device | | | Design | | | | | | | Overall Length | 200 cm | 210 cm | 300 cm | 120 cm* – 310cm (*The 120 cm length device model is only indicated to be used in the peripheral vasculature.) | | | Proximal Diameter | .014" | .014" | Not Listed | .012" – .014" | | | Distal Diameter | .012" | .007" | 0.014" minimum | .007" – .014" | | | Core wire configuration | 60 cm Nitinol welded to Stainless Steel | 60 cm Nitinol welded to Stainless Steel | Not Listed | 40 cm – 60 cm Nitinol soldered to Stainless Steel | | | Coil Length | 40 cm | 6 cm | Not Listed | 8 cm or 31 cm | | | Coil Configuration | 3 cm Platinum Nickel alloy and 37 cm Stainless Steel | 6 cm Platinum Nickel alloy | Not Listed | 3 cm of Platinum Tungsten and 27 cm stainless steel Or 8 cm of Platinum Tungsten | | | | | | | | | | Coil Length (Radiopaque) | 3 cm | 6 cm | Not Listed | 3 cm or 8 cm | | | Stainless Steel Coil Length | 40 cm | N/A | Not Listed | 27 cm Stainless steel coil length not applicable to models with 8cm Pt/W configuration | | | Distal Shaft Length (Shapeable Length) | 1.4 cm | 1.4 cm | Not Listed | 1.8 cm -2.0 cm | | | Distal tip thickness (core wire) | 0.037 mm | 0.037 mm | Not Listed | 0.040 mm | | | Docking Wire Compatibility | Yes | No | Not Listed | No | | | | Material | | | | | | Proximal Core Wire | Stainless Steel | Stainless steel | Not Listed | Same as Traxcess .007" Mini Guidewire and Traxcess 14 Guidewire | | | Distal Core Wire | Nickel titanium (Nitinol) alloy | Nickel titanium (Nitinol) alloy | Not Listed | Same as Traxcess .007" Mini Guidewire and Traxcess 14 Guidewire | | | Coil | Platinum nickel alloy and Stainless Steel | Platinum nickel alloy | Not Listed | Platinum/Tungsten and Stainless Steel | | | Coating Material | | | | | | | Coil | Hydrophilic Coating [SLIP-COAT by Argon Medical] | Hydrophilic Coating [SLIP-COAT by Argon Medical] | Not Listed | Same as Traxcess .007" Mini Guidewire and Traxcess 14 Guidewire | | | Distal Stainless Steel | Hydrophilic Coating [SLIP-COAT by Argon Medical] | Hydrophilic Coating [SLIP-COAT by Argon Medical] | Not Listed | Same as Traxcess .007" Mini Guidewire and Traxcess 14 Guidewire | | | Proximal Stainless Steel | Hydrophilic Coating | No PTFE | Not Listed | PTFE | | | Hydrophilic Coating Length | Hydrophilic coating = 1450 mm | Hydrophilic coating = 1580 mm | Not Listed | Hydrophilic coating = 9 cm -59 cm PTFE = 160 cm or 250 cm | | | | Other Attributes | | | | | | Method of supply | Sterile and single use | Sterile and single use | Not Listed | Same as Traxcess .007" Mini Guidewire and Traxcess 14 Guidewire | | | Sterilization method | Ethylene oxide gas | Ethylene oxide gas | Not Listed | Same as Traxcess .007" Mini Guidewire and Traxcess 14 Guidewire | | | Accessories | Shaping mandrel, Torque device, and Insertion Tool | Shaping mandrel, Torque device, and Insertion Tool | Torque Device (pin vise) | Torquer Introducer | | | Package configuration | Placed into a Dispenser hoop, Tyvek pouch, and Carton box | Placed into a Dispenser hoop, Tyvek pouch, and Carton box | Not Listed | Same as Traxcess .007" Mini Guidewire and Traxcess 14 Guidewire | | # Table 1: Predicate Devices and Reference Devices vs. Subject Device Comparison Table {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ # PERFORMANCE DATA [807.92(b)] Performance Bench Testing and Animal Testing: Results of the performance bench testing and animal testing (Table 2) indicate that HYBRID Guidewire (Subject Device) meets established performance requirements and is substantially equivalent for its intended use. | Performance Bench Testing | | | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Tests | Test Method Summary | Results | | Visual and Dimensional Inspection | Test samples were visually inspected for damage under 2.5X magnification. The external surface of the effective length of the guidewire shall be free from process and surface defects that could cause trauma to vessels during use. Inspect dimensions for overall length, radiopaque length, outer diameter (distal and proximal), and distal shape per product specification. | All test samples passed testing. | | Catheter Compatibility & Simulated Use | Verify the in vitro performance of neurovascular guidewires under simulated use conditions using a worst case tortuous ICA vessel model. | All test samples passed testing. | | Coating Integrity and Adherence | Test samples were dyed and gone through simulated use testing. Inspect the coating quality of the dyed guidewire under a microscope. | All test samples passed testing. | | Tensile Strength | The minimum force to break the guidewire was tested per ISO 11070. Tensile strength of the subject device was compared to the predicate device. | All test samples passed testing. Tensile strength was comparable to predicate devices. | | Corrosion Resistance | The test article is immersed in sodium chloride solution before being placed in | All test samples passed testing. | | | boiling distilled or deionized water. Subsequently, the test article is examined visually for evidence of corrosion. | | | Torque Strength | Torque strength was determined by number of turns-to-failures. Torque strength of the subject device was compared to the predicate device. | All test samples passed testing. The torque strength of the subject device is equivalent to the predicate device. | | Torqueability | Rotational input to output ratio (torqueability value) is compared to the predicate device. | All test samples passed testing. The torqueability value of the subject device is equivalent to the predicate device. | | Fracture Resistance and Flexing Test | Testing was conducted to determine the guidewire's resistance to damage by flexing and resistance to fracture per ISO 11070. | All test samples passed testing. | | Tip Flexibility | Flexibility testing was conducted to determine the force required to deflect the distal tip of the guidewire when deflected to 45° and 90°. Tip flexibility of the subject device was compared to the predicate device. | All test samples passed testing. The tip flexibility of the subject device is equivalent to the predicate device. | | Particulate Matter Characterization | Particulate matter in injections of the device were quantified after simulated use. Particulate matter characterization of the subject device was compared to the predicate device. | All test samples passed testing. Particulate matter characterization was comparable to predicate device. | | Design Verification and Packaging Validation | This test is to evaluate the device design and packaging design and to demonstrate that the device will meet the product specification requirements at t=1 year time- point after exposing to 1x EtO sterilization. | All test samples passed testing. | #### Table 2: Performance Bench Testing and Animal Testing Summary {12}------------------------------------------------ {13}------------------------------------------------ | Packaging Integrity Test | | | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Visual Inspection | Visually inspect packaging for any signs of damage. All seals shall be free of incomplete seals, voids, channels, wrinkles, foreign material in the seal and/or over heated sections. Labels shall be legible and intact, with no damage or delamination. | All test samples met the acceptance criteria.…

HYBRID Guidewire

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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HYBRID Guidewire

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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