(111 days)
The Medtronic Archer 0.035 inch (0.89 mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.
The Medtronic Archer Super Stiff Guidewire is a PTFE coated stainless steel guidewire. The Archer Super Stiff Guidewire is offered in 200cm and 260cm lengths and incorporates a flexible tip section and inner 8cm radiopaque spring for enhanced visibility. The Archer Super Stiff guidewire is offered in single and double curve tip configurations. The Archer Super Stiff guidewire is sterile, non-pyrogenic, disposable and for single use only.
The Medtronic Archer Super Stiff Guidewire (K101339) is a medical device for facilitating catheter placement and exchange. The acceptance criteria and the study proving it meets these criteria are described below:
1. Acceptance Criteria and Reported Device Performance
The document summarizes non-clinical data, implying that the device's performance was compared to established standards and predicate devices (Cook Lunderquist Wire Guide (K061670) and Boston Scientific Corporation Back-Up Meier Steerable Guidewire (K020283)). The acceptance criteria are implicitly met if the device demonstrates "substantial equivalence" to these predicates through various bench tests and biocompatibility testing. No specific numerical acceptance criteria (e.g., minimum tensile strength value) are provided in the summary; instead, the overall conclusion states that the test results "verify that the Archer Super Stiff Guidewire is substantially equivalent to the predicate devices and is adequate for its intended use."
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance (Implicitly Meets Criteria) |
|---|---|---|
| Dimensions | OD-Tip Joint | Met specifications for "Medtronic Archer Super Stiff Guidewire" |
| OD-Proximal Joint | Met specifications for "Medtronic Archer Super Stiff Guidewire" | |
| OD-Distal Spring | Met specifications for "Medtronic Archer Super Stiff Guidewire" | |
| OD-Corewire | Met specifications for "Medtronic Archer Super Stiff Guidewire" | |
| Overall Length | Met specifications for "Medtronic Archer Super Stiff Guidewire" | |
| Tip Width | Met specifications for "Medtronic Archer Super Stiff Guidewire" | |
| Out of Plane | Met specifications for "Medtronic Archer Super Stiff Guidewire" | |
| Radiopaque Length | Met specifications for "Medtronic Archer Super Stiff Guidewire" | |
| Mechanical Properties | Tip Stiffness | Met specifications for "Medtronic Archer Super Stiff Guidewire" |
| Tip Integrity-Torsional | Met specifications for "Medtronic Archer Super Stiff Guidewire" | |
| Tip Integrity-Strength | Met specifications for "Medtronic Archer Super Stiff Guidewire" | |
| PTFE Coating Adhesion-Corewire and springs | Met specifications for "Medtronic Archer Super Stiff Guidewire" | |
| 3 Point Bend Stiffness-Proximal | Met specifications for "Medtronic Archer Super Stiff Guidewire" | |
| Biocompatibility | ISO Cytotoxicity Study | Met ISO 10993-1 requirements |
| ISO Maximization Sensitization Study | Met ISO 10993-1 requirements | |
| ISO Intracutaneous Study | Met ISO 10993-1 requirements | |
| ISO/USP Systemic Toxicity Study | Met ISO 10993-1 requirements | |
| USP Material Mediated Pyrogen Study | Met ISO 10993-1 requirements (non-pyrogenic) | |
| ASTM Hemolysis Study | Met ASTM standards for hemolysis | |
| Compliment Activation (C3a & SC5b-9) | Met biocompatibility standards | |
| In Vivo Thromboresistance Study | Demonstrated thromboresistance | |
| Longevity/Stability | Shelf life testing (product and packaging) | Met shelf life requirements |
| In-Vivo Performance | In-vivo pre-clinical (Animal Study) | Demonstrated satisfactory performance |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided 510(k) summary does not specify the exact sample sizes for each non-clinical bench test or the animal study. It generally states that "Non-clinical verification and validation...consists of the following in vitro bench tests" and "in-vivo pre-clinical (Animal Study) testing was performed."
The data provenance is not explicitly stated in terms of country of origin. The studies are described as "in vitro bench tests" and "in-vivo pre-clinical (Animal Study) testing," implying that they were conducted in a controlled environment, likely by the manufacturer (Medtronic Vascular) or a contracted lab. These are prospective studies designed to evaluate the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The device is a guidewire, and its performance evaluation in this 510(k) relies on objective physical and chemical testing (bench tests, biocompatibility tests), and an animal study. There is no mention of human expert assessment or review of images/cases to establish ground truth as would be the case for an AI-powered diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, often in diagnostic imaging or clinical trials. The studies described are objective bench tests and animal studies where measurements and observations are made against predefined criteria, not requiring an adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The device is a guidewire, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was performed to assess human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a physical medical instrument (guidewire), not an algorithm or software. Therefore, no standalone algorithm performance study was conducted.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of the guidewire was primarily based on:
- Engineering Specifications and Industry Standards: For the dimensions and mechanical properties, the "ground truth" would be the engineered specifications of the device and adherence to relevant industry standards for guidewire performance.
- Biocompatibility Standards: Ground truth for biocompatibility was established by recognized international standards (e.g., ISO 10993-1 and ASTM standards).
- Predicate Device Performance: Implicitly, the performance of the legally marketed predicate devices (Cook Lunderquist Wire Guide and Boston Scientific Corporation Back-Up Meier Steerable Guidewire) also served as a "ground truth" or benchmark for demonstrating substantial equivalence. The new device was shown to have "similar materials of construction" and "the same technological characteristics" as the predicates.
- Pre-clinical Animal Study Observations: For the in-vivo evaluation, the ground truth would be observations and measurements of the device's behavior and effects within a living system, assessed against expected physiological responses and safety parameters.
8. The sample size for the training set
This section is not applicable. The device is a physical medical guidewire, not a machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the ground truth for the training set was established
This section is not applicable, as there is no "training set" for this type of device.
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| AUG 31 2010 | ||
|---|---|---|
| 5. | 510K SUMMARY | |
| Submitter: | Medtronic Vascular3576 Unocal PlaceSanta Rosa, CA 95403U.S.A. | |
| Contact Person: | Colleen MullinsSr. Regulatory Affairs Specialist(978) 739-3267 | |
| Date Prepared: | May 6th, 2010 | |
| Trade Name: | Archer Super Stiff Guidewires | |
| Common Name: | Guidewire | |
| Classification Name: | Wire, Guide, Cardiovascular | |
| Class: | 21 CFR 1330, Product Code DQX | |
| Product Code: | DQX | |
| Predicate Device(s): | Cook Lunderquist Wire Guide (K061670)Boston Scientific Corporation Back-Up Meier SteerableGuidewire (K020283) | |
| Device Description: | The Medtronic Archer Super Stiff Guidewire is a PTFEcoated stainless steel guidewire. The Archer Super StiffGuidewire is offered in 200cm and 260cm lengths andincorporates a flexible tip section and inner 8cm radiopaquespring for enhanced visibility. The Archer Super Stiffguidewire is offered in single and double curve tipconfigurations. The Archer Super Stiff guidewire is sterile,non-pyrogenic, disposable and for single use only | |
| Statement ofIntended Use: | The Medtronic Archer 0.035 inch (0.89 mm) Super StiffGuidewires are indicated to facilitate catheter placementand exchange during diagnostic or interventional |
Medtronic Vascular
Archer Super Stiff Guldewire
.
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Image /page/1/Picture/0 description: The image shows the Medtronic logo. The logo consists of a stylized image on the left and the word "Medtronic" on the right. The stylized image appears to be a symbol or emblem, while the word "Medtronic" is written in a bold, sans-serif font.
procedures, where increased support, distal flexibility, and low surface friction of the guidewire is needed
Summary of Technological Characteristics:
All configurations of the Archer Super Stiff Guidewire have the same distal spring construction with an inner radiopaque spring and an outer spring. The springs are attached to the corewire. The Archer Super Stiff Guidewires have a nominal 0.035'' OD and are available in 200 cm and 260 cm lengths with either a single or double curve tip configuration. The entire device is PTFE coated.
The Archer Super Stiff Guidewire has similar materials of construction to the predicate devices. It also has the same technological characteristics as the predicate devices as shown in the table below.
| Characteristic | ArcherEndovascularGuidewire(This 510k) | CookLunderquistWire Guides(K061670) | BSX Back-upMeierGuidewire(K020283) |
|---|---|---|---|
| Diameter | 0.035" | 0.035" | 0.035" |
| Length | 200 cm260 cm | 260 cm300 cm | 185-300 cm |
| TipConfiguration | Single J or DoubleJ curve | Straight, Single Jor double J | Straight, Angled |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
Summary of Non-Clinical data:
Non-clinical verification and validation of the Archer Super Stiff Guidewire consists of the following in vitro bench tests that were performed on the Archer Super Stiff Guidewire.
| In vitro Bench Tests |
|---|
| ---------------------- |
| Dimensions-OD-Tip Joint |
|---|
| Dimensions-OD-Proximal Joint |
| Dimensions-OD-Distal Spring |
| Dimensions-OD-Corewire |
| Dimensions-Overall Length |
| Dimensions-Tip Width |
| Dimensions-Out of Plane |
| Dimensions-Radiopaque Length |
Medtronic Vascular Archer Super Stiff Guidewire
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Medtronic
| In vitro Bench Tests |
|---|
| Tip Stiffness |
| Tip Integrity-Torsional |
| Tip Integrity-Strength |
| PTFE Coating Adhesion-Corewireand springs |
| 3 Point Bend Stiffness-Proximal |
Biocompatibility testing was also performed per the requirements of ISO 10993-1 on the Archer Super Stiff Guidewire as listed below:
| Biocompatibility Tests |
|---|
| ISO Cytotoxicity Study |
| ISO Maximization SensitizationStudy |
| ISO Intracutaneous Study |
| ISO/USP Systemic ToxicityStudy |
| USP Material Mediated PyrogenStudy |
| ASTM Hemolysis Study |
| Compliment Activation (C3a &SC5b-9) |
| in Vivo ThromboresistanceStudy |
In addition shelf life testing (product and packaging) and in-vivo pre-clinical (Animal Study) testing was performed on the Archer Super Stiff guidewire.
The Non-Clinical test results verify that the Archer Super Stiff Guidewire is substantially equivalent to the predicate devices and is adequate for its intended use
Conclusion from Data:
The Archer Super Stiff Guidewire is substantially equivalent in intended use, materials, technological characteristics and performance of the predicates wires, the Cook Lunderquist Wire Guide (K061670) and Boston Scientific Corporation Back-Up Meier Steerable Guidewire (K020283).
Medtronic Vascular Archer Super Stiff Guidewire
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Vascular c/o Ms. Colleen Mullins Senior Regulatory Affairs Specialist 37 A Cherry Hill Drive Danver, MA 01923
AUG 3 1 2010
Re: K101339
Trade/Device Name: Medtronic Archer Super Stiff Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II (two) Product Code: DQX Dated: July 20, 2010 Received: July 21, 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.
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.
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Page 2 - Ms. Colleen Mullins
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
W. Wood.
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 (if known): K 101339
Device Name: Medtronic Archer Super Stiff Guidewires
Indications for Use:
The Medtronic Archer 0.035 inch (0.89 mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.
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) | |
|---|---|
| K101339 | |
| (Division Sign-Off) | |
| Division of Cardiovascular Devices |
510(k) Number_
§ 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.