(61 days)
The Medtronic Steerant Super Stiff Guidewire is intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta. The guidewire is not indicated for coronary or neuro vasculature.
Steerant™ Super Stiff Guidewire (herein after referred to as Steerant) is a 0.035" diameter PTFE coated stainless steel guidewire. The Steerant guidewire is offered in 200 cm and 260 cm lengths and incorporates a flexible tip section and inner 8 cm radiopaque tungsten coil for enhanced visibility. The Steerant guidewire is offered in single and double curve tip configurations. The Steerant guidewire is sterile, non-pyrogenic, disposable and for single use only.
The provided text is a 510(k) premarket notification for a medical device (Steerant Super Stiff Guidewire). It focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets individual acceptance criteria for an AI/software component through a study.
Therefore, the information required to answer your prompt, specifically concerning acceptance criteria, study design for AI performance, sample sizes for training and test sets, expert involvement, and ground truth establishment, is not present in the provided document.
The document details the device's physical characteristics, indications for use, and a comparison to predicate and reference devices. It mentions "Non-Clinical Performance Data" and states that "All the predetermined acceptance criteria were met and results passed to support a determination of substantial equivalence." However, it does not elaborate on what those criteria were for the performance of the device (e.g., accuracy, sensitivity, specificity for an AI algorithm), nor does it describe a study involving humans and AI assistance or algorithm-only performance.
The "Non-Clinical Performance Data" section lists various engineering and regulatory tests such as:
- Design Verification Testing
- Design Validation Testing
- Sterilization Validation per requirements of ISO 11135
- Biocompatibility Testing per the requirements of ISO 10993-1
- Packaging Design Verification Testing per requirements of ISO 11607
- Shelf Life Testing
These are standard tests for a physical medical device and do not involve AI or software performance evaluation in the manner described in your prompt.
In summary, this document does not contain the information needed to answer your request about acceptance criteria and study data for an AI-powered medical device.
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October 24, 2023
Medtronic Vascular Amy Sanders Principal Regulatory Affairs Specialist 3850 Brickway Blvd. Santa Rosa, California 95403
Re: K232570
Trade/Device Name: Steerant Super Stiff Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: August 24, 2023 Received: August 24, 2023
Dear Amy Sanders:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatoryassistance/contact-us-division-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, Lydia S. Glaw -S
Digitally signed by Lydia S. Glaw -S Date: 2023.10.24 15:35:57 -04'00'
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
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Indications for Use
510(k) Number (if known) K232570
Device Name Steerant Super Stiff Guidewire
Indications for Use (Describe)
The Medtronic Steerant Super Stiff Guidewire is intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the guidewire is not indicated for coronary or neuro vasculature.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| Submitter: | Medtronic Vascular, Inc.3850 Brickway BlvdSanta Rosa, CA 95403(707) 591-2091(707) 566-1432 |
|---|---|
| Contact Person: | Amy SandersSr. Regulatory Affairs Specialist3850 Brickway BlvdSanta Rosa, CA 95403Amy.Sanders@medtronic.com |
| Date Prepared: | August 25, 2023 |
| Device Trade Name: | Steerant™ Super Stiff Guidewire |
| Device Classification: | Class II |
| Classification Name: | Guidewire |
| Regulation Number: | 21 CFR 870.1330 |
| Classification Product Code: | DQX |
| Classification Panel: | Cardiovascular |
| Predicate Device: | Archer Super Stiff Guidewire (K101339) |
| Reference Device: | Cook Lunderquist Extra Stiff Wire Guide(K220137) |
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Device Description:
Steerant™ Super Stiff Guidewire (herein after referred to as Steerant) is a 0.035" diameter PTFE coated stainless steel guidewire. The Steerant guidewire is offered in 200 cm and 260 cm lengths and incorporates a flexible tip section and inner 8 cm radiopaque tungsten coil for enhanced visibility. The Steerant guidewire is offered in single and double curve tip configurations. The Steerant guidewire is sterile, non-pyrogenic, disposable and for single use only.
Indications for Use:
The Medtronic Steerant Super Stiff Guidewire is intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta. The guidewire is not indicated for coronary or neuro vasculature.
Device Modifications:
The purpose of this submission is to introduce the Steerant guidewire that includes modifications from the cleared Archer guidewire (K101339).
Comparison of Technical Characteristics:
The subject device. Steerant Guidewire predicate device Archer Guidewire (K101339), and reference device Lunderquist (K220137) all have a similar design and materials of construction.
There is no change of intended use or fundamental scientific technology between the proposed, predicate, and reference devices. The proximal core wire is designed to provide support to aid the interventional device placement. The distal section is designed to be flexible, atraumatic, and radiopaque. The coating is designed to reduce friction between the guidewire and lumen of the catheter.
| Description | Predicate Device(K101339) | Reference Device(K220137) | Subject Device |
|---|---|---|---|
| Manufacturer | Medtronic | Cook Medical | Medtronic |
| Name | Archer Super StiffGuidewire | Lunderquist Extra-StiffWire Guide | Steerant Super StiffGuidewire |
| Diameter | 0.035" | 0.035" | 0.035" |
| Length | 200 cm or 260 cm | 260 cm or 300 cm | 200 cm or 260 cm |
| Tip Configurations | Single or Double curve | Single or Double curve | Single or Double curve |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
Table 6-1: Predicate, Reference, and Subject Device Comparison
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| Description | Predicate Device(K101339) | Reference Device(K220137) | Subject Device |
|---|---|---|---|
| Indications for Use | The Medtronic Archer0.035 in (0.89 mm) super stiffguidewire is intendedto facilitate catheterplacement and exchangeduring diagnostic orinterventional procedures inthe aorta, where increasedsupport, distal flexibility,and low surface friction ofthe guide wire is needed. | The Lunderquist Extra StiffWire Guides are intended tofacilitate catheterizationand/or placement of devicesduring vascular diagnosticprocedures and vascularinterventional procedures.The Lunderquist Extra StiffWire Guides are intended foruse in the major vessels, theaorta and vena cava,including their accessvessels and adjacent vessels. | The Medtronic SteerantSuper Stiff Guidewire isintended to be used tofacilitate catheter placementand exchange duringdiagnostic or interventionalprocedures in the aorta. Theguidewire is not indicated forcoronary or neuro vasculature. |
| Outer Coil Coating | PTFE (with PFOA) | PTFE | PTFE (Zero-PFOA) |
| Core Wire | Stainless Steel | Stainless Steel | Stainless Steel |
| Outer Coil | Stainless Steel | Stainless Steel | Stainless Steel |
| Inner Coil | Gold Plated Tungsten | Gold | Tungsten |
| Tip Joint | Plasma Weld | Weld | Plasma Weld |
| Proximal Joint | Laser Weld | Weld | Epoxy Bond |
Table 6-1: Predicate, Reference, and Subject Device Comparison
Substantial Equivalence to K101339:
The assessment of non-clinical performance data demonstrates that the Steerant guidewire is substantially equivalent to the Archer guidewire.
Non-Clinical Performance Data:
The following tests were performed on the subject device to demonstrate that the device meets performance requirements for its intended use. All the predetermined acceptance criteria were met and results passed to support a determination of substantial equivalence. Steerant met all of the Archer performance requirements that were carried over.
- Design Verification Testing ●
- Design Validation Testing ●
- Sterilization Validation per requirements of ISO 11135 ●
- Biocompatibility Testing per the requirements of ISO 10993-1 ●
- Packaging Design Verification Testing per requirements of ISO 11607 ●
- Shelf Life Testing
Conclusion:
The Steerant guidewire is substantially equivalent in intended use, function, materials, method of operation, and performance to the previously cleared Archer guidewire (K101339). Steerant has the same fundamental technological characteristics, principles of operation, and applications as the predicate and reference devices.
§ 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.