(28 days)
Not Found
No
The description focuses on mechanical components and their function in maintaining hemostasis and facilitating device insertion. There is no mention of any computational or data-driven processes indicative of AI/ML.
No.
The device is intended to maintain hemostasis and provide a seal during diagnostic/interventional procedures, acting as a conduit for other devices. It does not directly treat a disease or condition.
No
The device is described as a hemostasis valve and its components, intended to maintain hemostasis and facilitate the passage and manipulation of diagnostic/interventional devices, not to diagnose a condition itself.
No
The device description clearly outlines physical components like seals, a cap, a nut, a guidewire introducer (tube and hub), and a guidewire torquer, indicating it is a hardware 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 and provide a seal around diagnostic/interventional devices during procedures within the vascular system. This is a function performed in vivo (within the living body) to facilitate a medical procedure.
- Device Description: The description details a valve system designed to be inserted into the human vascular system to manage blood flow and pressure during the insertion of other devices. This is a physical device used directly on the patient.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, in order to provide information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures. This device does not perform any analysis of biological specimens.
The Guardian™ II HV is a device used during diagnostic/interventional procedures, but it is not performing the diagnostic test itself. It's a tool to facilitate the safe and effective use of other devices that might be used for diagnosis or intervention.
N/A
Intended Use / Indications for Use
The Guardian™ II Hemostasis Valve is intended to maintain hemostasis during the introduction, withdrawal and use of diagnostic/interventional devices during vascular procedures.
The Guardian™ II HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
The guidewire introducer is included to facilitate the guidewire's passage through the Guardian™ II HV.
The Torque Device is intended to manipulate the steering of the guidewire within the vascular regions.
Product codes (comma separated list FDA assigned to the subject device)
74 DTL
Device Description
The Zerusa Guardian™ II Hemostasis Valve is designed to be used as a conduit when interventional devices with diameters up to 8.0F (2.67mm or 0.105") are inserted into the human vascular system.
The device has two seals: the low-pressure seal (or wiper seal) and the highpressure seal. Depressing the cap engages the Quikloc " to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. 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 also allows for pressure injections up to 150 psi (10 ATM).
Included with the Guardian™ II Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the Guardian IIM II Hemostasis Valve. It consists of an austenitic stainless steel tube connected to a hub constructed of polycarbonate.
Also included with the Guardian™ II HV is a simple Guidewire Torquer which is used to manipulate the steering of a guidewire within the vascular regions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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)
The Guardian™ II Hemostasis Valve was subjected to a full battery of performance testing. The results of the performance testing demonstrated the safety and effectiveness of the device.
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.
0
1092711
510(K) SUMMARY
1. SUBMITTER:
Zerusa Limited 219-220 Business Innovation Centre, NUIG Galway, Ireland 011-353-91-861611 Telephone: Establishment Registration Number: 3005395947
Official contact: Mr. Liam Mulloy, CEO Phone: 011-353-91-863060 Date Prepared: August 31, 2009
OCT - 1 2009
DEVICE: 2.
| Tradename: | Guardian TM II Hemostasis Valve |
|---|---|
| Classification Name: | Cardiopulmonary Bypass Adaptor, Stopcock, Manifold or Fitting |
| Classification: | Class II |
| Common Name: | Hemostatic Valve |
| Product Code: | 74 DTL |
| Regulation Number: | 870.4290 |
3. PREDICATE DEVICE:
This current 510(k) Premarket Notification is being submitted for the following changes:
- . Reduce overall Hemostasis Valve product length
- Reduce length of the Guidewire Introducer provided for use with the HV ●
- Incorporate a dead stop on the lower body .
- . Add a Parylene N.coating to the O-ring
- Change printed graphics color from Sericol white to Sericol black .
- Remove 8% Blue Polycarbonate Master Batch 23034 Granulate tint from . the Rotolock and Luer on the HV
The predicate device used to determine substantial equivalence for this device was the Zerusa Limited's currently marketed Guardian™ Hemostasis Valve (#K052381 and #K073620).
1
DEVICE DESCRIPTION: 4.
The Zerusa Guardian™ II Hemostasis Valve is designed to be used as a conduit when interventional devices with diameters up to 8.0F (2.67mm or 0.105") are inserted into the human vascular system.
The device has two seals: the low-pressure seal (or wiper seal) and the highpressure seal. Depressing the cap engages the Quikloc " to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. 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 also allows for pressure injections up to 150 psi (10 ATM).
Included with the Guardian™ II Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the Guardian IIM II Hemostasis Valve. It consists of an austenitic stainless steel tube connected to a hub constructed of polycarbonate.
Also included with the Guardian™ II HV is a simple Guidewire Torquer which is used to manipulate the steering of a guidewire within the vascular regions.
5. INTENDED USE:
The Guardian™ II Hemostasis Valve is intended to maintain hemostasis during the introduction, withdrawal and use of diagnostic/interventional devices during vascular procedures.
INDICATIONS FOR USE: 6.
The Guardian™ II HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
The guidewire introducer is included to facilitate the guidewire's passage through the Guardian™ II HV.
The Torque Device is intended to manipulate the steering of the guidewire within the vascular regions.
2
COMPARISON OF CHARACTERISTICS: 7.
Comparisons of the proposed and predicate devices show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed predicate devices.
PERFORMANCE DATA: 8.
The Guardian™ II Hemostasis Valve was subjected to a full battery of performance testing. The results of the performance testing demonstrated the safety and effectiveness of the device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or body. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Zerusa Limited c/o Mr. Liam Mulloy 219-220 Business Innovation Centre, NUIG Galway, Ireland
OCT - 1 2009
Re: K092711
Guardian™ II Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTL Dated: August 31, 2009 Received: September 3, 2009
Dear Mr. Mulloy:
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 - Mr. Liam Mulloy
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Radiological Health
Duna R. Kilmer
Image /page/4/Picture/7 description: The image contains what appears to be a signature. The signature is composed of a series of curved and angular lines, forming a unique and stylized design. The lines are dark and bold, contrasting with the white background.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and
Enclosure
5
Indications for Use
510(k) Number (if known): K092711
Device Name: Guardian™ II Hemostasis Valve
Indications for Use: The Guardian™ II HV is intended to maintain hemostasis during the use of diagnostic/interventional device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures.
The guidewire introducer is included to facilitate the guidewire's passage through the Guardian™ II HV.
The Torque Device is included to manipulate the steering of the guidewire within the vascular regions.
Prescription Use XXX (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)
smma R. V. h
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_Ko9271)
Page 1 of 1
(Posted November 13, 2003)