HI-TORQUE Steelcore Bare Guide Wire

K200144 · Abbott Vascular · DQX · Apr 8, 2020 · Cardiovascular

Device Facts

• Record ID: K200144
• Device Name: HI-TORQUE Steelcore Bare Guide Wire
• Applicant: Abbott Vascular
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 8, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Hi-Torque Steelcore™ Bare Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not in the cerebral vasculature.

Device Story

Steerable guide wire; 300 cm length; 0.019" max diameter; 0.018" compatible. Used in catheterization labs or surgical suites by physicians to facilitate placement/exchange of diagnostic/therapeutic devices during intravascular procedures. Features silicone-based hydrophobic coatings (proximal/distal) and radiopaque distal tip. Manual operation; provides mechanical support and guidance for interventional devices.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility, sterilization, pyrogen validation, shelf life, and packaging testing, performed in accordance with FDA guidance for Coronary, Peripheral, and Neurovascular Guidewires.

Technological Characteristics

Steerable guide wire; 300 cm length; 0.019" max diameter; 0.018" compatible. Materials include silicone-based hydrophobic coatings. Radiopaque distal tip (5.0 cm). Sterilization via E-beam radiation. Single-use device.

Indications for Use

Indicated for patients undergoing intravascular procedures requiring placement and exchange of diagnostic or therapeutic devices. Not for use in cerebral vasculature.

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

• HT Steelcore 18 Guide Wire (K982876)

Reference Devices

• HT Command®18 Guide Wire (K172073)
• HT InfilTrac™ Guide Wire Family (K193126)
• HT Steelcore 18 LT Guidewire (K982876)

Submission Summary (Full Text)

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April 8, 2020

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Abbott Vascular Shilpa Satishchandra Project Manager, Regulatory Affairs 3200 Lakeside Drive Santa Clara, California 95054

#### Re: K200144

Trade/Device Name: HI-TORQUE Steelcore Bare Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: February 10, 2020 Received: February 11, 2020

#### Dear Shilpa Satishchandra:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 mediation-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-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K200144

Device Name HI-TORQUE Steelcore™ Bare Guide Wire

Indications for Use (Describe)

The Hi-Torque Steelcore™ Bare Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not in the cerebral vasculature.

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size:16px">✓</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------------------------------|
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| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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# SECTION 5 510(K) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

| 1. | Submitter's Name | Abbott Vascular<br>(with Business Trade Name as Abbott Medical) |
|-----|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Submitter's Address | 3200 Lakeside Dr., Santa Clara, CA 95054 |
| 3. | Telephone | 408-845-0775 |
| 4. | Fax | 408-845-3743 |
| 5. | Contact Person | Shilpa Satishchandra |
| 6. | Date Prepared | April 03, 2020 |
| 7. | Device Trade Name | HI-TORQUE Steelcore™ Bare Guide Wire |
| 8. | Device Common Name | Guide Wire |
| 9. | Device Classification<br>Name | Catheter Guide Wire (21 CFR 870.1330; Product Code -<br>DQX) |
| 10. | Predicate Device Name | HT Steelcore™ 18 Guide Wire (K982876, cleared on<br>August 14, 1998) |
| 11. | Reference Devices | HT Command®18 Guide Wire (K172073 cleared on<br>cleared on August 25, 2017)<br>HT InfilTrac™ Guide Wire Family (K193126, cleared<br>on December 11, 2019)<br>HT Steelcore 18 LT Guidewire (K982876) |

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## 12. Device Description

The HT Steelcore Bare Guide Wire is classified under the product code DOX, with the regulation number 21 CFR 870.1330, Catheter guide wire. The HT Steelcore Bare Guide Wire is a steerable wire offered in only one configuration and is designed to be used with devices compatible with 0.018" guide wires.

The HT Steelcore Bare Guide Wire is developed with 300 cm length and has a maximum diameter of 0.019". The distal tip has a radiopaque length of 5.0 cm. The HT Steelcore Bare Guide Wire will be available with the features as listed below:

- Proximal Coating Single Coat Silicone Based hydrophobic coating. ●
- Distal Coating Dual Coat Silicone Based Hydrophobic Coating. .

## 13. Indication for Use

Hi-Torque Steelcore Bare Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.

### 14. Technological Characteristics and Substantial Equivalence

The HT Steelcore Bare Guide Wire has the same Indications for Use and has similar technological characteristic to the predicate device - HT Steelcore 18 Guide Wire. They use the same functional specifications, operating principle, materials and design (with minor modifications). They have the same, shelf life and packaging components-materials and meet the same Sterility Assurance Levels(SAL) of 10°.

Table 14-1 illustrates comparison between the subject device - HT Steelcore Bare Guide Wire and its predicate. This comparison was performed to support a substantial equivalence determination. The substantial equivalence comparison included the device's indications for use, design, technological characteristics, materials, operating principle, sterilization, shelf life and packaging. The conclusion of the comparison analysis is that the subject device - HT Steelcore Bare Guide Wire is substantially equivalent to the currently marketed predicate device - HT Steelcore 18 Guide Wire.

| Table 14-1 Comparison between HT Steelcore Bare guidewire and HT Steelcore 18 |
|-------------------------------------------------------------------------------|
| guidewire |

| Attribute | Subject Device<br>HT Steelcore Bare<br>Guide Wire | Predicate Device<br>HT Steelcore 18 Guide Wire<br>(K982876) |
|-----------------------|---------------------------------------------------|-------------------------------------------------------------|
| Device Classification | Class II<br>74DQX<br>CFR § 870.1330 | Class II<br>74DQX<br>CFR § 870.1330 |
| Classification Name | Catheter Guide Wire | Catheter Guide Wire |

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| Attribute | Subject Device<br>HT Steelcore Bare<br>Guide Wire | Predicate Device<br>HT Steelcore 18 Guide Wire<br>(K982876) |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Overall Design | Core to Tip 0.018" Wire | Core to Tip 0.018" Wire |
| Tip Design | Flattened Tip | Flattened Tip |
| Tip Shape | Straight (shapeable) | Straight (shapeable) |
| Distal Coating | Silicone Based Hydrophobic Coating | Silicone Based Hydrophobic Coating |
| Proximal Coating | Silicone Based Hydrophobic Coating | PTFE |
| Diameter | 0.0190" max. (0.48mm) | 0.0190" max. (0.48mm) |
| Length | 300cm | 130, 190, 300cm |
| Radiopaque Tip | Yes | Yes |
| Indications for Use | The HI-TORQUE STEELCORE™ BARE<br>Guide Wire is intended to facilitate the<br>placement and exchange of diagnostic and<br>therapeutic devices during<br>intravascular procedures. It is not intended<br>for use in the cerebral vasculature. | All Hi-Torque Guide Wires are intended to<br>facilitate the placement and exchange of<br>diagnostic and therapeutic devices during<br>intravascular procedures. |
| Sterilization | E-beam radiation | EtO<br>and E-Beam |
| Shelf Life | 2 years | 2 years |
| Conditions of use | Single-use device for procedure performed<br>in a catheterization laboratory or surgical<br>suite | Single-use device for procedure performed<br>in a catheterization laboratory or surgical<br>suite |
| Preparation for Use | Flush hoop dispenser and shape guide wire<br>tip as necessary | Flush hoop dispenser and shape guide wire<br>tip as necessary |

### 15. Performance Data

Performance testing was conducted in accordance with the FDA guidance: Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling: 2019, and pertinent standards as recommended by the FDA guidance document as applicable. Testing conducted included:

- . Biocompatibility
- Sterilization
- Pyrogen Validation .

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- . Shelf life and Packaging
- . Non-clinical bench testing

The performance testing passed with results meeting acceptance criteria, and demonstrated that the HT SteelCore Bare Guide Wire is as safe and as effective, compared to the predicate device, in performing its intended use.

## 16. Conclusions

Test results from the performance testing conducted demonstrates that the HT Steelcore Bare Guide Wire met all acceptance criteria requirements. Therefore, Abbott Vascular considers the subject device - HI-TORQUE Steelcore Bare Guide Wire to be as safe and effective as the currently marketed predicate device - HT Steelcore 18 Guide Wire for its intended use.