(230 days)
The VSI Micro-Introducer Sct is used for percutaneous introduction of up to an 0.038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
The VS1 micro-introducer sets consist of a sheath and a dilator and are available in lengths of 10 cm to 30 cm. The sheath is available with either a 4 F or 5 F outer diameter (O.D.), and the dilator is available with regular flexibility or in a 'stiffen' version.
The sheath and dilator consist of a high-density polyethylene shaft and hub; the sheath shaft has a tapered distal tip that provides a smooth transition to the distal tip of the dilator. A rotating luer lock on the distal end of the dilator hub can be locked on to the sheath hub. The stiffen dilator shafts contains a stainless steel hypotube.
The provided text describes a 510(k) submission for the VSI Micro-Introducer Set. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance criteria through clinical trials. Therefore, much of the requested information (performance metrics, sample sizes for test/training sets, expert involvement, MRMC studies, ground truth details) is not typically part of a 510(k) summary for a device like a micro-introducer set.
However, I can extract the acceptance criteria and the types of studies performed as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Ink Adhesion | Qualified |
| Dimensional Verification | Qualified |
| Visual Inspection | Qualified |
| Radiopacity | Qualified |
| Guidewire Compatibility | Qualified |
| Insertion Force | Qualified |
| Corrosion Resistance | Qualified |
| Kink | Qualified |
| Liquid Leak | Qualified |
| Aspiration | Qualified |
| Tensile Strength | Qualified |
Biocompatibility Testing (per ISO 10993-1):
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Cytotoxicity | Performed |
| Sensitization | Performed |
| Acute systemic toxicity | Performed |
| Hemocompatibility | Performed |
| Irritation/intracutaneous reactivity | Performed |
Additional Notes on Performance:
- The document states: "Results of design verification testing did not raise new safety or performance questions." This implies all tests met their predetermined acceptance criteria, which are not explicitly detailed (e.g., specific force values, leak rates, etc.) in this summary.
- The overall "performance" is establishing substantial equivalence to the predicate devices (Greatbatch Medical Coaxial Micro-Introducer Set - Standard, K990705, and Coaxial Micro-Introducer Set – Stiffen, K071574) based on functionality, technological characteristics, and Indications for Use.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary. For these types of engineering and biocompatibility tests, sample sizes are typically determined by standards and risk assessments but are not reported in this summary.
- Data Provenance: The tests are "design verification testing" performed by the manufacturer, Vascular Solutions, Inc., likely at their facilities (Minneapolis, MN, USA) or through contracted labs. This is internal company data, not clinical data from a specific country or population. The studies are prospective in the sense of being conducted as part of the device development and regulatory submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for engineering and biocompatibility tests are defined by the test methods, specifications, and regulatory standards (e.g., ISO 10993-1). There are no "experts" in the sense of clinicians or radiologists establishing ground truth for these types of tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human interpretation is involved. These are objective engineering and laboratory tests where the outcome is typically pass/fail against a predetermined specification.
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
- Not applicable. This device is a micro-introducer set, a physical medical instrument, not an AI-powered diagnostic or assistive tool. MRMC studies and AI-related performance metrics are irrelevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical medical instrument. There is no algorithm or standalone performance in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for these tests are the established specifications, test methods, and regulatory standards (e.g., ASTM standards for mechanical properties, ISO 10993-1 for biocompatibility). For example, a "kink" test would have an objective definition of what constitutes a "kink" and how much force is applied. "Guidewire compatibility" would involve ensuring a guidewire of a specified size can pass through without obstruction.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI-driven device or a diagnostic device relying on machine learning.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as point 8.
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K101604
pg. 1 of 2
2 510(k) Summary
Date Prepared: August 16, 2010
JAN 2 4 2011
Submitter's Name / Contact Person
Manufacturer
Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person Jennifer Ruether Sr. Regulatory Affairs Associate Tel: 763-656-4300; Fax: 763-656-4253
General Information
VSI Micro-Introducer Set
Trade Name Common / Usual Name Classification Name Predicate Devices
Catheter introducer 870.1340; DYB; Catheter introducer; Class II K 990705 Coaxial Micro-Introducer Set - Standard (Greatbatch Medical) K071574 Coaxial Micro-Introducer Set – Stiffen (Greatbatch Medical)
Device Description
The VS1 micro-introducer sets consist of a sheath and a dilator and are available in lengths of 10 cm to 30 cm. The sheath is available with either a 4 F or 5 F outer diameter (O.D.), and the dilator is available with regular flexibility or in a 'stiffen' version.
The sheath and dilator consist of a high-density polyethylene shaft and hub; the sheath shaft has a tapered distal tip that provides a smooth transition to the distal tip of the dilator. A rotating luer lock on the distal end of the dilator hub can be locked on to the sheath hub. The stiffen dilator shafts contains a stainless steel hypotube.
Intended Use / Indications
The VSI Micro-Introducer Set is used for percutaneous introduction of up to an 0.038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
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Technological Characteristics
The VSI Micro-Introducer Sets are similar in design components, dimensions, and materials to the predicate devices. The subject and predicate devices consist of a sheath and a dilator, are available in the same O.D.s, and utilize similar materials of construction. The VSI Micro-Introducer is available in a longer length than the predicate devices. Like the predicate devices, the VSI Micro-Introducer Sets have radiopaque components and are compatible with guidewires and catheters with a maximum O.D. of 0.038". Both the VSI Micro-Introducer Sets and Greatbatch Coaxial Micro-Introducer Sets are sterilized in an ethylene oxide process, and have similar sterile barrier packaging materials.
Substantial Equivalence and Summary of Studies
The VSI Micro-Introducer Set is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and Indications for Use. The device design has been qualified through the following tests:
- . Ink Adhesion
- . Dimensional Verification
- . Visual Inspection
- Radiopacity ●
- Guidewire Compatibility and . Insertion Force
- Corrosion Resistance .
- Kink .
- Liquid Leak .
- Aspiration ●
- Tensile Strength .
Biocompatibility testing per ISO 10993-1 was performed, consisting of the following tests:
- Cytotoxicity .
- Sensitization .
- Acute systemic toxicity ●
- Hemocompatibility ●
- Irritation/intracutaneous reactivity .
- Results of design verification testing did not raise new safety or performance questions.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The eagle is black, and the text is also black.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Vascular Solutions, Inc. c/o Ms. Jennifer Ruether Sr. Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
JAN 2 4 2011
Re: K101604
Trade/Device Name: VSI Micro-Introducer Set Regulation Number: 21 CFR 870.1340 Regulatory Class: II Product Code: DYB Dated: December 22, 2010 Received: December 23, 2010
Dear Ms. Ructher:
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 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
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Page 2 – Ms. Jennifer Ruether
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/ucm 1 1 5809.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.
Sincerely vours.
Dina R. Weiner
S 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): K101604
Device Name: VSI Micro-Introducer Set
Indications for Use:
The VSI Micro-Introducer Sct is used for percutaneous introduction of up to an 0.038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
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)
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Page 1 of 1 (Posted November 13, 2003)
buna R.V. hune
ivision Sign-Off) ision of Cardiovascular Devices
C10/1/ Number
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).