(62 days)
No
The summary describes a physical medical device (guidewire) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as a guide wire used for the introduction and placement of diagnostic or interventional devices, not for therapeutic treatment itself.
No
The device description indicates that guide wires are used for the introduction and placement of diagnostic or interventional devices, and facilitate the substitution of one diagnostic or interventional device for another. It does not perform a diagnostic function itself.
No
The device description and performance studies clearly indicate this is a physical guidewire, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for the "introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature." This describes a device used within the body for procedural guidance, not for testing samples outside the body.
- Device Description: The description details a physical wire with coatings and markers for visualization under fluoroscopy, consistent with a device used in interventional procedures.
- Performance Studies: The performance studies focus on physical properties like stiffness, torque, coating adhesion, and biocompatibility, which are relevant to a device used in the body. There are no mentions of analytical performance related to detecting substances or conditions in biological samples.
- Input Imaging Modality: The input imaging modality is fluoroscopy, which is used for real-time imaging during procedures within the body.
- Anatomical Site: The anatomical site is the "coronary and peripheral vasculature," which are locations within the body.
IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
Medtronic GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The Medtronic GTX 12 guidewires are available in nominal 180cm length and 300cm exchange length. They are available with PTFE, silicone or hydrophilic coatings. A portion of the distal length is opaque to allow for visualization under fluoroscopy and markers are etched on the proximal segment of the guide wire to aid in gauging guide wire position relative to the guiding catheter tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
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)
In-vitro bench testing was conducted according to the recommendations from relevant FDA guidance to demonstrate that the GTX 12 guidewire met the acceptance criteria and performed similarly to the predicate devices. The in-vitro tests that were conducted to evaluate the performance of the GX 12 guidewire include: Dimensional—Diameter, Dimensional—Diameter (GTX guidewires with a 0.009" tip joint only), Dimensional—Overall Length, Dimensional—Radiopaque Length, Tip Column Stiffness, Tortuous Torque Energy Transfer, Tip Integrity-Torsional, Tip Integrity-Strength, Radiopacity-Distal & Proximal, PTFE Coating Adhesion, Lubricity/ Durability, DOC Insertion and Extraction Force (180 cm only), DOC Crimp Wire Stiffness (180cm only).
Biocompatibility testing was performed on the predicate Medtronic GTX guidewires (K091582) to satisfy the requirements of ISO 10993-1 Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing. The following biocompatibility tests were performed: IS0 Cytotoxicity Study, IS0 Maximization Sensitization Study, IS0 Intracutaneous Study Extract (SC & SO), ISO/USP Systemic Toxicity Study (SC & SO), USP Material Mediated Pyrogen Study, ASTM Hemolysis Study, Compliment Activation (C3a & SC5b-9), In-vivo Thromboresistance Study, Plasma Recalcification.
Simulated Use Testing (Animal Study) was also performed using the GTX 12 guidewire.
No new safety or effectiveness issues were raised during the testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
| Submitter: | Medtronic Vascular
35-37A Cherry Hill Drive
Danvers, MA 01923 | APR 21 2016 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Colleen Mullins
Senior Regulatory Affairs Specialist
Phone: (978) 739-3267
Fax: (978) 739-7380 | |
| Alternate Contact | Fred Boucher
Director of Regulatory Affairs
Phone: (978) 739-3116
Fax: (978) 739-7380 | |
| Date Prepared: | April 19th, 2010 | |
| Trade Name: | Medtronic GTX Guidewires | |
| Common Name: | PTCA Guidewire | |
| Classification
Name: | Wire, Guide, Cardiovascular
21 CFR 1330, Product Code DQX | |
| Predicate Devices: | Medtronic GTX Guidewire (K091582) | |
| Device
Description: | The Medtronic GTX 12 guidewires are available in
nominal 180cm length and 300cm exchange length. They
are available with PTFE, silicone or hydrophilic coatings.
A portion of the distal length is opaque to allow for
visualization under fluoroscopy and markers are etched on
the proximal segment of the guide wire to aid in gauging
guide wire position relative to the guiding catheter tip. | |
| Statement of
Intended Use: | Medtronic GTX Guidewires are steerable guide wires that
are used for the introduction and placement of diagnostic or
interventional devices in the coronary and peripheral
vasculature and may be used to reach and cross a target
lesion. Medtronic guide wires are not intended for use in
the cerebral vasculature. Medtronic steerable exchange
wires are used to facilitate the substitution of one diagnostic
or interventional device for another. | |
1
Summary of Technological Characteristics: The Medtronic Vascular GTX 12 Guidewire consists of a corewire covered with spring coils and terminated in a hemispherical tip, which impart various characteristics to the distal tip of the wire, such as tip stiffness. Wire coatings provide sufficient lubricity to reach and cross target lesions. Markers on the proximal portion of the corewire aid in gauging guide wire position relative to the guiding catheter tip. The technological characteristics of the Medtronic GTX-12 guidewire are identical to that of the Medtronic GTX guidewires (K091523).
Summary of Nonclinical Data:
In-vitro bench testing was conducted according to the recommendations from relevant FDA guidance to demonstrate that the GTX 12 guidewire met the acceptance criteria and performed similarly to the predicate devices. As noted below, in some cases a bracketing sample strategy was chosen to support the test requirements. The in-vitro tests that were conducted to evaluate the performance of the GX 12 guidewire include:
| In-vitro Bench Testing
| Performed | Product Tested |
|---|---|
| Dimensional—Diameter | Medtronic GTX 1 |
| (K091582) and GTX 15 | |
| Dimensional—Diameter (GTX | |
| guidewires with a 0.009" tip | |
| joint only) | Medtronic GTX 15 |
| Dimensional—Overall Length | Medtronic GTX 1 |
| (K091582) and GTX 15 | |
| Dimensional—Radiopaque | |
| Length | Medtronic GTX 1 |
| (K091582) and | |
| Medtronic GTX 15 | |
| Tip Column Stiffness | Medtronic GTX 12 |
| Tortuous Torque Energy | |
| Transfer | Medtronic GTX 12 |
| Tip Integrity-Torsional | Medtronic GTX 1 |
| (K091582) and GTX 15 | |
| Tip Integrity-Strength | Medtronic GTX 1 |
| (K091582) and GTX 15 | |
| Radiopacity-Distal & Proximal | Medtronic GTX 1 |
| (K091582) and GTX 15 | |
| PTFE Coating Adhesion | Medtronic Cougar XT |
| (K032899) | |
| Lubricity/ Durability | Medtronic Cougar XT |
| (K032899) | |
| DOC Insertion and Extraction | |
| Force (180 cm only) | Medtronic GT1 |
| (K983927) | |
| DOC Crimp Wire Stiffness | |
| (180cm only) | Medtronic GT1 |
| (K983927) |
2
Due to shared materials of construction, biocompatibility testing was performed on the predicate Medtronic GTX guidewires (K091582) to satisfy the requirements of ISO 10993-1 Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing. The following biocompatibility tests were performed:
- IS0 Cytotoxicity Study .
- IS0 Maximization Sensitization Study .
- IS0 Intracutaneous Study Extract (SC & SO) �
- ISO/USP Systemic Toxicity Study (SC & SO) �
- USP Material Mediated Pyrogen Study .
- ASTM Hemolysis Study .
- Compliment Activation (C3a & SC5b-9) .
- In-vivo Thromboresistance Study .
- Plasma Recalcification �
Simulated Use Testing (Animal Study) was also performed using the GTX 12 guidewire.
No new safety or effectiveness issues were raised during the testing.
| Summary of
Clinical Data: | No clinical investigation has been performed for this
device. |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion from
Data: | Medtronic has demonstrated that the GTX 12 Guidewire is
substantially equivalent to the predicate devices based on
its indications for use and fundamental scientific
technology. Testing demonstrates that the GTX 12
Guidewire device is safe, effective and performs as well or
better then the predicate devices. |
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 2 1 2010
Medtronic Inc. c/o Ms. Colleen Mullins Senior Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, MA 01923
Re: K100470
Trade/Device Name: Medtronic Vascular GTX 12 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 23, 2010 Received: March 25, 2010
Dear Ms. Mullins:
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. 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
4
Page 2 - Ms. Colleen Mullins
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
ina R. hohner
Image /page/4/Picture/8 description: The image contains a handwritten symbol on the left and the words "Bra" and "Di" on the right. The symbol appears to be a combination of curved and angular lines, possibly representing a stylized signature or mark. The text is in a simple, sans-serif font and is vertically aligned.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number_K100470
Device Name: Medtronic GTX-12 Guidewires
Indications for Use:
Medtronic GTX guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
NANCY R. VICKNER
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K100470
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