(62 days)
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.
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.
Here is an analysis of the provided 510(k) summary regarding the acceptance criteria and study information for the Medtronic GTX 12 Guidewire:
Please note: This 510(k) summary describes an in-vitro bench study and animal study for a medical device (guidewire), not an AI/ML powered medical device for which acceptance criteria typically refer to performance metrics like sensitivity, specificity, or AUC. Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets, training set sample size) are not applicable or extractable from this type of regulatory document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are qualitative, focusing on similarity to predicate devices and meeting established safety and performance benchmarks for guidewires, rather than specific quantitative performance metrics typical of AI/ML algorithms. The document emphasizes that the GTX 12 guidewire "met the acceptance criteria and performed similarly to the predicate devices." No specific numerical acceptance criteria (e.g., minimum diameter, maximum tortuous torque) are provided, nor are the exact numerical results for each test. Instead, the document states successful completion ("met the acceptance criteria").
| In-vitro Bench Testing Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional—Diameter | Similar to predicate devices (GTX 1 (K091582) and GTX 15) | Met acceptance criteria, performed similarly to predicates |
| Dimensional—Overall Length | Similar to predicate devices (GTX 1 (K091582) and GTX 15) | Met acceptance criteria, performed similarly to predicates |
| Dimensional—Radiopaque Length | Similar to predicate devices (GTX 1 (K091582) and Medtronic GTX 15) | Met acceptance criteria, performed similarly to predicates |
| Tip Column Stiffness | Acceptable performance for guidewire function | Met acceptance criteria |
| Tortuous Torque Energy Transfer | Acceptable performance for guidewire function | Met acceptance criteria |
| Tip Integrity-Torsional | Similar to predicate devices (GTX 1 (K091582) and GTX 15) | Met acceptance criteria, performed similarly to predicates |
| Tip Integrity-Strength | Similar to predicate devices (GTX 1 (K091582) and GTX 15) | Met acceptance criteria, performed similarly to predicates |
| Radiopacity-Distal & Proximal | Similar to predicate devices (GTX 1 (K091582) and GTX 15) | Met acceptance criteria, performed similarly to predicates |
| PTFE Coating Adhesion | Acceptable performance (similar to Medtronic Cougar XT (K032899)) | Met acceptance criteria, performed similarly to predicates |
| Lubricity/ Durability | Acceptable performance (similar to Medtronic Cougar XT (K032899)) | Met acceptance criteria, performed similarly to predicates |
| DOC Insertion and Extraction Force (180 cm only) | Acceptable performance (similar to Medtronic GT1 (K983927)) | Met acceptance criteria, performed similarly to predicates |
| DOC Crimp Wire Stiffness (180cm only) | Acceptable performance (similar to Medtronic GT1 (K983927)) | Met acceptance criteria, performed similarly to predicates |
| Biocompatibility | Meeting ISO 10993-1 and specific test standards | All specified tests performed, no new issues reported |
| Simulated Use Testing (Animal Study) | Acceptable performance | Performed, no new safety or effectiveness issues raised |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for each in-vitro test. The document mentions that "a bracketing sample strategy was chosen to support the test requirements" in some cases. For the animal study, the sample size is not specified.
- Data Provenance: The studies are in-vitro bench tests and an animal study. This type of data does not typically have "country of origin" in the same way human clinical data would. It is retrospective in the sense that the testing was performed on manufactured devices, not derived from observations of devices in clinical use over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an engineering and biocompatibility evaluation of a medical device, not a diagnostic AI/ML algorithm that relies on expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is an engineering and biocompatibility evaluation; no human interpretation or adjudication of results in the traditional sense is mentioned. The tests are designed to yield objective, measurable outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are specific to diagnostic AI/ML algorithms to assess human reader performance with and without AI assistance. This document pertains to a guidewire, which is a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm. The performance described is inherently "standalone" in that it refers to the physical device's characteristics in bench and animal testing.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on engineering specifications, established industry standards (e.g., ISO guidance, ASTM), and performance of legally marketed predicate devices. For example, for dimensional tests, the ground truth would be the specified dimensions of the device itself and comparison to predicate dimensions. For biocompatibility, the ground truth is defined by the toxicological and biological response criteria outlined in standards like ISO 10993-1. For functional tests like Tip Column Stiffness or Torque Energy Transfer, the ground truth is established by acceptable performance parameters typical for such devices, often benchmarked against predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is evaluated through engineering and biocompatibility testing, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved for this type of device evaluation.
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510(k) Summary
| Submitter: | Medtronic Vascular35-37A Cherry Hill DriveDanvers, MA 01923 | APR 21 2016 |
|---|---|---|
| Contact Person: | Colleen MullinsSenior Regulatory Affairs SpecialistPhone: (978) 739-3267Fax: (978) 739-7380 | |
| Alternate Contact | Fred BoucherDirector of Regulatory AffairsPhone: (978) 739-3116Fax: (978) 739-7380 | |
| Date Prepared: | April 19th, 2010 | |
| Trade Name: | Medtronic GTX Guidewires | |
| Common Name: | PTCA Guidewire | |
| ClassificationName: | Wire, Guide, Cardiovascular21 CFR 1330, Product Code DQX | |
| Predicate Devices: | Medtronic GTX Guidewire (K091582) | |
| DeviceDescription: | The Medtronic GTX 12 guidewires are available innominal 180cm length and 300cm exchange length. Theyare available with PTFE, silicone or hydrophilic coatings.A portion of the distal length is opaque to allow forvisualization under fluoroscopy and markers are etched onthe proximal segment of the guide wire to aid in gaugingguide wire position relative to the guiding catheter tip. | |
| Statement ofIntended Use: | Medtronic GTX Guidewires are steerable guide wires thatare used for the introduction and placement of diagnostic orinterventional devices in the coronary and peripheralvasculature and may be used to reach and cross a targetlesion. Medtronic guide wires are not intended for use inthe cerebral vasculature. Medtronic steerable exchangewires are used to facilitate the substitution of one diagnosticor interventional device for another. |
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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 TestingPerformed | Product Tested |
|---|---|
| Dimensional—Diameter | Medtronic GTX 1(K091582) and GTX 15 |
| Dimensional—Diameter (GTXguidewires with a 0.009" tipjoint only) | Medtronic GTX 15 |
| Dimensional—Overall Length | Medtronic GTX 1(K091582) and GTX 15 |
| Dimensional—RadiopaqueLength | Medtronic GTX 1(K091582) andMedtronic GTX 15 |
| Tip Column Stiffness | Medtronic GTX 12 |
| Tortuous Torque EnergyTransfer | 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 ExtractionForce (180 cm only) | Medtronic GT1(K983927) |
| DOC Crimp Wire Stiffness(180cm only) | Medtronic GT1(K983927) |
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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 ofClinical Data: | No clinical investigation has been performed for thisdevice. |
|---|---|
| Conclusion fromData: | Medtronic has demonstrated that the GTX 12 Guidewire issubstantially equivalent to the predicate devices based onits indications for use and fundamental scientifictechnology. Testing demonstrates that the GTX 12Guidewire device is safe, effective and performs as well orbetter then the predicate devices. |
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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
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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
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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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§ 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.