(37 days)
Not Found
No
The document describes a mechanical hemostasis valve and a torque device, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
The device is described as maintaining hemostasis and aiding in steering guidewires, which are functional roles during a procedure rather than directly treating a disease or condition.
No
The device description clearly states its purpose is to "maintain hemostasis during the use of diagnostic or interventional devices" and to "be used as conduits when interventional devices... are inserted," not to perform any diagnostic function itself. The "torque device is provided as an aid in steering the guidewire." These functions are supportive to diagnostic or interventional procedures, but not diagnostic in nature.
No
The device description clearly details physical components (hemostasis valves, guidewire introducer, torque device) and their mechanical functions, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to maintain hemostasis during the use of diagnostic or interventional devices within the vascular system. This is a function related to the procedure itself, not to analyzing a sample from the body to provide diagnostic information.
- Device Description: The device is described as a conduit with seals for inserting interventional devices and allowing pressure injections. This is a mechanical function within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on the results of a test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is procedural and supportive, not diagnostic in the IVD sense.
N/A
Intended Use / Indications for Use
Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67 mm) during diagnostic/ interventional procedures.
The torque device is provided as an aid in steering the guidewire within the vascular anatomy.
Product codes (comma separated list FDA assigned to the subject device)
DTL
Device Description
The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the lowpressure seal and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/ interventional device in position within the vasculature and allows for pressure injections up to 600 psi (40 ATM).
A guidewire introducer and guidewire torque device may be included with the Guardian II NC hemostasis valves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular anatomy
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)
Bench test results support the pressure injection upper limit modification. The bench test results did not raise new safety or performance questions and confirmed that the Guardian II devices are substantially equivalent to the predicate devices.
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
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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K122301 pg 1 of 2
SEP 7 2012
2 510(k) Summary
Date Prepared: July 30, 2012
Submitter's Name / Contact Person
Manufacturer
Vascular Solutions Zerusa Limited 208 Business Innovation Centre NUI Galway, Newcastle Road Galway, IRELAND Tel: 011-353-91-861611 Establishment Registration # 3005395947
Contact Person Jennifer Ruether Sr. Regulatory Product Specialist Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 Tel: 763-656-4300; Fax: 763-656-4250 Establishment Registration # 2134812
General Information
| Trade Name | Guardian® II and Guardian® II NC |
|---|---|
| Common / Usual Name | Hemostasis Valves |
| Classification Name | 870.4290; DTL; Cardiopulmonary bypass adaptor, stopcock, |
| manifold, or fitting; Class II | |
| Predicate Devices | K101113 – Guardian II NC (Vascular Solutions Zerusa Limited) |
| K092711 – Guardian II (Vascular Solutions Zerusa Limited) |
Device Description
The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the lowpressure seal and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/ interventional device in position within the vasculature and allows for pressure injections up to 600 psi (40 ATM).
A guidewire introducer and guidewire torque device may be included with the Guardian II NC hemostasis valves.
1
Intended Use/Indications for Use
Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67 mm) during diagnostic/ interventional procedures.
The torque device is provided as an aid in steering the guidewire within the vascular anatomy.
Technological/Performance Characteristics
The Guardian II devices consist of the same materials and design as the predicate devices. Labeling changes have been implemented. The pressure injection upper limit has been changed from 150 psi to 600 psi; bench testing confirmed the devices are capable of performing as intended at the increased pressure injection limit.
Substantial Equivalence and Summary of Studies
The Guardian II devices are substantially equivalent to the currently marketed predicate devices, based on comparisons of the device classifications, technological characteristics, and the indications for use. Bench test results support the pressure injection upper limit modification. The bench test results did not raise new safety or performance questions and confirmed that the Guardian II devices are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three lines representing the feathers. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 7 2012
Vascular Solutions Zerusa Limited c/o Ms. Jennifer Ruether Sr. Regulatory Product Specialist Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369
Re: K122301
Trade/Device Name: Guardian® II and Guardian® II NC Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold or Fitting Regulatory Class: Class II Product Code: DTL Dated: July 30, 2012 Received: August 1, 2012
Dear Ms. Ruether:
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.
3
Page 2 - Ms. Jennifer Ruether
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/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
$\mu l$
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K122301 510(k) Number (if known):
Device Name: Guardian® II and Guardian® II NC Hemostasis Valve
Indications for Use:
Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8F (0.105" or 2.67 mm) during diagnostic/ interventional procedures.
The torque device is provided as an aid in steering the guidewire within the vascular anatomy.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
vascular Device
510(k) Number K12230
Page 1 of 1 (Posted November 13, 2003)