(63 days)
Not Found
No
The device description and intended use focus on mechanical components for maintaining hemostasis and manipulating guidewires, with no mention of AI or ML capabilities.
No.
The device is intended to maintain hemostasis and facilitate the introduction and manipulation of other diagnostic/interventional devices, rather than directly treating a condition itself.
No
The device, a hemostasis valve, is intended to maintain hemostasis during the introduction, withdrawal and use of diagnostic/interventional devices. It is a conduit and accessory for other diagnostic/interventional devices, not a diagnostic device itself.
No
The device description clearly details physical components like seals, a cap, a nut, a guidewire introducer, and a guidewire torquer, 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 clearly states that the device is for maintaining hemostasis during the introduction, withdrawal, and use of diagnostic/interventional devices during vascular procedures. This is a procedural device used in vivo (within the body) during a medical procedure.
- Device Description: The description details the mechanical function of the valve and its components for controlling blood flow and facilitating the passage of other devices. This aligns with a surgical or interventional device, not a device used to test samples in vitro (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 laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on managing blood flow and facilitating procedures within the vascular system.
N/A
Intended Use / Indications for Use
The Guardian Hemostasis Valve is intended to maintain hemostasis during the introduction, withdrawal and use of diagnostic/interventional devices during vascular procedures.
The Guardian 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 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™ Hemostasis Valve is designed to be used as a conduit for which interventional devices with diameters up to 8.0F are inserted into the human vascular system.
The device has two seals: the low-pressure seal and the high-pressure seal. Depressing the cap engages the Quikloc TM 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 secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections. The two independently operated seals allow for minimal blood loss during vascular procedures. When the low pressure seal is open, it allows the device to be flushed. During the procedure, the low pressure seal is opened in order to allow the advancement/withdrawal of diagnostic/interventional devices.
Included with the Guardian™ Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the hemostasis valve. The Guidewire Introducer has an effective length of 125mm (4.9") and an inside diameter of 0.6mm (or 0.023").
A Guidewire Torquer, intended to manipulate the steering of the guidewire within the vascular regions, is also included.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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™ 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
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. Ger Brett, CEO Phone: 011-353-91-863061 Date Prepared: December 21, 2007
2. DEVICE:
Tradename: Guardian™ 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 addition of a Guidewire Torquer. The predicate device used to determine substantial equivalence for this device was the Zerusa Limited's currently marketed Guardian Hemostasis Valve (#K052381).
DEVICE DESCRIPTION: 4.
The Zerusa Guardian™ Hemostasis Valve is designed to be used as a conduit for which interventional devices with diameters up to 8.0F are inserted into the human vascular system.
The device has two seals: the low-pressure seal and the high-pressure seal. Depressing the cap engages the Quikloc TM to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise.
22 27 .
1
Closure of the high-pressure seal secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections. The two independently operated seals allow for minimal blood loss during vascular procedures. When the low pressure seal is open, it allows the device to be flushed. During the procedure, the low pressure seal is opened in order to allow the advancement/withdrawal of diagnostic/interventional devices.
Included with the Guardian™ Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the hemostasis valve. The Guidewire Introducer has an effective length of 125mm (4.9") and an inside diameter of 0.6mm (or 0.023").
A Guidewire Torquer, intended to manipulate the steering of the guidewire within the vascular regions, is also included.
5. INTENDED USE:
The Guardian 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 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 HV.
The Torque Device is intended to manipulate the steering of the guidewire within the vascular regions.
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.
8. PERFORMANCE DATA:
The Guardian™ 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.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a bird or abstract human figure, positioned to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.
FEB 2 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zerusa Limited c/o Mr. Gerard Brett CEO and Official Correspondent 219-220 Business Innovation Centre, NUIG Galway, Ireland
Re: K073620
Guardian™ Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (two) Product Code: DTL Dated: December 21, 2007 Received: December 26, 2007
Dear Mr. Brett:
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 such 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 – Mr. Gerard Brett
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.
Sincerely yours,
B/rimmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K073620
Device Name: Guardian™ Hemostasis Valve
Indications for Use: The Guardian 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 HV.
The Torque device is included to manipulate the steering of the guidewire within the vascular regions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Posted July 1, 1998)
(Optional Format 3-10-98)
B.Bummo
510iki Nu