(111 days)
No
The device description and performance studies focus on the physical properties and performance of a guidewire, with no mention of AI or ML.
No.
The device is a guidewire intended to facilitate catheter placement, not to treat a disease or condition itself.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the guidewires are "intended to facilitate catheter placement and exchange during diagnostic or interventional procedures." This indicates that the device is used in diagnostic procedures.
No
The device description clearly states it is a physical guidewire made of PTFE coated stainless steel, offered in different lengths and configurations. The performance studies also describe bench tests on physical properties and biocompatibility, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guidewires are used to "facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta." This describes a device used within the body to aid in a medical procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a physical guidewire made of stainless steel with a PTFE coating, designed to be inserted into the body. This is consistent with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Medtronic Archer 0.035 inch (0.89 mm) Super Stiff Guidewires are indicated to facilitate catheter placement and exchange during diagnostic or interventional procedures, where increased support, distal flexibility, and low surface friction of the guidewire is needed.
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.
Product codes
DQX
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aorta
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)
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
Tip Stiffness
Tip Integrity-Torsional
Tip Integrity-Strength
PTFE Coating Adhesion-Corewire and 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 Sensitization Study
ISO Intracutaneous Study
ISO/USP Systemic Toxicity Study
USP Material Mediated Pyrogen Study
ASTM Hemolysis Study
Compliment Activation (C3a & SC5b-9)
in Vivo Thromboresistance Study
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cook Lunderquist Wire Guide (K061670), Boston Scientific Corporation Back-Up Meier Steerable Guidewire (K020283)
Reference Device(s)
Not Found
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
| AUG 31 2010 | ||
|---|---|---|
| 5. | 510K SUMMARY | |
| Submitter: | Medtronic Vascular | |
| 3576 Unocal Place | ||
| Santa Rosa, CA 95403 | ||
| U.S.A. | ||
| Contact Person: | Colleen Mullins | |
| Sr. 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 Steerable | ||
| Guidewire (K020283) | ||
| Device Description: | 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 | ||
| Statement of | ||
| Intended Use: | The Medtronic Archer 0.035 inch (0.89 mm) Super Stiff | |
| Guidewires are indicated to facilitate catheter placement | ||
| and exchange during diagnostic or interventional |
Medtronic Vascular
Archer Super Stiff Guldewire
.
1
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 | Archer
Endovascular
Guidewire
(This 510k) | Cook
Lunderquist
Wire Guides
(K061670) | BSX Back-up
Meier
Guidewire
(K020283) |
|-------------------------|----------------------------------------------------|-------------------------------------------------|------------------------------------------------|
| Diameter | 0.035" | 0.035" | 0.035" |
| Length | 200 cm
260 cm | 260 cm
300 cm | 185-300 cm |
| Tip
Configuration | Single J or Double
J curve | Straight, Single J
or double J | Straight, Angled |
| Sterilization
Method | 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
2
Medtronic
| In vitro Bench Tests |
|---|
| Tip Stiffness |
| Tip Integrity-Torsional |
| Tip Integrity-Strength |
| PTFE Coating Adhesion-Corewire |
| and 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 Sensitization |
| Study |
| ISO Intracutaneous Study |
| ISO/USP Systemic Toxicity |
| Study |
| USP Material Mediated Pyrogen |
| Study |
| ASTM Hemolysis Study |
| Compliment Activation (C3a & |
| SC5b-9) |
| in Vivo Thromboresistance |
| Study |
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
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.
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.
4
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_