(48 days)
Not Found
No
The summary describes a physical guidewire and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a guidewire used for percutaneous entry into peripheral vessels, which is a diagnostic/interventional access tool rather than a device that directly treats a medical condition.
No
The VSI Guidewire is indicated for percutaneous entry of peripheral vessels, which is a procedural function, not a diagnostic one. There is no mention of it being used to detect or diagnose any medical conditions.
No
The device description clearly outlines physical components like a guidewire with a shaft and tip, made of materials like stainless steel or nitinol, and potentially PTFE coated. This indicates a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "percutaneous entry of peripheral vessels using the Seldinger Technique." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a physical guidewire used for navigating blood vessels. This is a surgical/interventional tool, not a reagent, instrument, or system used for examining specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The VSI Guidewire is a medical device used in a clinical procedure, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
The VSI Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is not indicated for use in the coronary or cerebral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
' The VSI Guidewire is available in a diameter of 0.018" and lengths ranging from 40-130 cm. The device is available with a stainless steel or nitinol shaft with a stainless steel or tungsten tip. Some models are PTFE coated to increase lubricity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vessels. Not indicated for use in the coronary or cerebral 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)
Because the subject and predicate devices are identical in design, materials, construction, and Indications for Use, no performance testing was conducted or is warranted in support of the determination of substantial equivalence. Further processing conducted by VSI leads to no new questions of safety or effectiveness.
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.
Not Found
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
K112631 page 1 of 2
OCT 2 7 2011 VSI Guidewire
VSI Guidewire
. .
Vascular Solutions, Inc. Traditional 510(k) Premarket Notification
2 510(k) Summary
Date Prepared: September 8, 2011
Manufacturer's Information / Contact Person
| Manufacturer | Contact |
|---|---|
| Vascular Solutions, Inc. | Melinda Swanson |
| 6464 Sycamore Court | Sr. Director, Regulatory Affairs and Clinica l |
| Minneapolis, MN 55369 USA | Research |
| Establishment Registration # 2134812 | Tel: 763.656.4256(direct) |
| Fax: 763.656.4253 | |
| Email: mswanson@vasc.com |
General Information
1
| Trade Name | VSI Guidewire |
|---|---|
| Common / Usual Name | Guidewire |
| Classification Name | 870.1330; DQX; Wire, Guide, Catheter; Class II: 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. | |
| Predicate Device(s) | VascuPuncture™ PICC Guidewire (K012861 and K043398, |
| Neometrics, Inc.) |
Device Description
' The VSI Guidewire is available in a diameter of 0.018" and lengths ranging from 40-130 cm. The device is available with a stainless steel or nitinol shaft with a stainless steel or tungsten tip. Some models are PTFE coated to increase lubricity.
Intended Use / Indications
The VSI Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is not indicated for use in the coronary or cerebral vasculature.
しな
1
K112651 Page 2 of 2
VSI Guidewire
Technological Characteristics
The subject and predicate devices are identical in design, materials, and construction. There are no differences in technological characteristics.
Substantial Equivalence and Summary of Studies
Because the subject and predicate devices are identical in design, materials, construction, and Indications for Use, no performance testing was conducted or is warranted in support of the determination of substantial equivalence. Further processing conducted by VSI leads to no new questions of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Vascular Solutions, Inc. c/o Melinda Swanson 6464 Sycamore Court Minneapolis, MN 55369
OCT 2 7 2011
Re: K112631
Trade/Device Name: VSI Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: September 8, 2011 Received: September 9, 2011
Dear Ms. Swanson:
ਂ
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 or any Federal statutes and regulations administered by other Federal agencies. You must
3
Page 2 - Ms. Melinda Swanson
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 (OS) 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/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/ReportalProblem/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.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
K112631 page 1 of 1
Vascular Solutions, Inc. Traditional 510(k) Premarket Notification VSI Guidewire
Indications for Use
510(k) Number (if known): K112631
Device Name: VSI Guidewire
Indications for Use:
The VSI Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is not indicated for use in the coronary or cerebral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) ivision of Cardiovascular Devices
510(k) Number K112631
Confidential VSI Guidewire Traditional 510(k)