(77 days)
No
The 510(k) summary describes a physical guide wire and its performance testing, with no mention of AI or ML capabilities.
No.
The device's intended use is to "facilitate the placement and exchange of diagnostic and therapeutic devices," meaning it aids in the use of other devices, rather than directly providing therapy itself.
No
The device is a guide wire intended to facilitate the placement and exchange of other diagnostic and therapeutic devices, but it is not itself performing a diagnostic function.
No
The device description clearly outlines a physical guide wire made of steel with coatings, intended for intravascular procedures. It is classified under a regulation for catheter guide wires, which are hardware devices. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures." This describes a device used within the body to aid in medical procedures, not a device used to test samples outside the body to diagnose conditions.
- Device Description: The description details a physical guide wire used in catheterization procedures. This aligns with an interventional medical device, not an IVD.
- Regulation Number: The regulation number 21 CFR 870.1330, Catheter guide wire, specifically classifies this type of device as a cardiovascular device, not an IVD.
- Performance Studies: The performance studies listed (Biocompatibility, Sterilization, Pyrogen Validation, Shelf life and Packaging, Non-clinical bench testing) are typical for medical devices used in the body, not for IVDs which would focus on analytical and clinical performance related to testing samples.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This guide wire does not perform such a function.
N/A
Intended Use / Indications for 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.
Product codes
DQX
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. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not in the cerebral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Single-use device for procedure performed in a catheterization laboratory or surgical suite
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)
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 .
- . 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known)
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)
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| --------------------------------------------------------------------------------------------------- |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
| --------------------------------------------------------------------------- |
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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
(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
Name | Catheter Guide Wire (21 CFR 870.1330; Product Code -
DQX) |
| 10. | Predicate Device Name | HT Steelcore™ 18 Guide Wire (K982876, cleared on
August 14, 1998) |
| 11. | Reference Devices | HT Command®18 Guide Wire (K172073 cleared on
cleared on August 25, 2017)
HT InfilTrac™ Guide Wire Family (K193126, cleared
on December 11, 2019)
HT Steelcore 18 LT Guidewire (K982876) |
4
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
HT Steelcore Bare
Guide Wire | Predicate Device
HT Steelcore 18 Guide Wire
(K982876) |
|-----------------------|---------------------------------------------------|-------------------------------------------------------------|
| Device Classification | Class II
74DQX
CFR § 870.1330 | Class II
74DQX
CFR § 870.1330 |
| Classification Name | Catheter Guide Wire | Catheter Guide Wire |
5
| Attribute | Subject Device
HT Steelcore Bare
Guide Wire | Predicate Device
HT Steelcore 18 Guide Wire
(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
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. | All Hi-Torque Guide Wires are intended to
facilitate the placement and exchange of
diagnostic and therapeutic devices during
intravascular procedures. |
| Sterilization | E-beam radiation | EtO
and E-Beam |
| Shelf Life | 2 years | 2 years |
| Conditions of use | Single-use device for procedure performed
in a catheterization laboratory or surgical
suite | Single-use device for procedure performed
in a catheterization laboratory or surgical
suite |
| Preparation for Use | Flush hoop dispenser and shape guide wire
tip as necessary | Flush hoop dispenser and shape guide wire
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 .
6
- . 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.