(30 days)
Not Found
No
The description focuses on mechanical components and their function in maintaining hemostasis, with no mention of AI or ML technologies.
Yes
The device is described as "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" and "intended to maintain hemostasis during the use of diagnostic/interventional devices." Maintaining hemostasis and facilitating interventional procedures within the human vascular system are therapeutic actions.
No
The device is described as a hemostasis valve and a conduit for interventional devices, intended to maintain hemostasis and secure devices, not to diagnose conditions itself.
No
The device description clearly details physical components like seals, a cap, a nut, a stainless steel tube, and a polycarbonate hub, 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 human vascular system. This is a function performed in vivo (within the living body).
- Device Description: The description details a mechanical valve designed to be inserted into the vascular system and interact with other devices and the patient's blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a tool used during a procedure within the body, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Guardian® II NC Hemostasis Valve is intended to maintain hemostasis during the introduction, withdrawal and use of diagnostic/interventional devices during vascular procedures. The Guardian® II NC 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 NC HV.
The Torque Device is intended to manipulate the steering of the guidewire within the vascular regions.
Product codes
74 DTL, DTL
Device Description
The Zerusa Guardian® II NC 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 high-pressure seal. Depressing the cap opens the low-pressure seal, releasing the cap closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the highpressure 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 NC Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the Guardian® II NC Hemostasis Valve. It consists of an austenitic stainless steel tube connected to a hub constructed of polycarbonate.
Also included with the Guardian® II NC 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 regions
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 NC 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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:
MAY 2 2010
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 011-353-91-863060 Phone: Date Prepared: April 22, 2010
MAY 2 ] 2010
2. DEVICE:
| Tradename: | Guardian® II NC 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:
The only change being requested in this Special 510(k) Premarket Notification is to modify the manner in which the device's low pressure seal is activated. The low pressure seal on Zerusa's currently marketed Guardian® II Hemostasis Valve is clicked "open" and clicked "closed" in two separate actions by the user (i.e., push / push mechanism). The proposed Guardian® II NC Hemostasis Valve incorporates a low pressure seal which is held open by depressing the cap. The seal will automatically close once the user releases the cap (i.e., spring loaded action).
The predicate device used to determine substantial equivalence for this device was the Zerusa Limited's currently marketed Guardian® II Hemostasis Valve (#K092711).
DEVICE DESCRIPTION: 4.
The Zerusa Guardian® II NC 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.
1
The device has two seals: the low-pressure seal (or wiper seal) and the high-pressure seal. Depressing the cap opens the low-pressure seal, releasing the cap closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the highpressure 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 NC Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the Guardian® II NC Hemostasis Valve. It consists of an austenitic stainless steel tube connected to a hub constructed of polycarbonate.
Also included with the Guardian® II NC HV is a simple Guidewire Torquer which is used to manipulate the steering of a guidewire within the vascular regions.
INTENDED USE: ડ.
The Guardian® II NC 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 NC 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 NC 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.
2
Image /page/2/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "K101113". Below that, the text reads "pg 3 of 3". The handwriting appears to be somewhat messy and the text is slightly slanted.
8. PERFORMANCE DATA:
The Guardian® II NC 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/0 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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAY 2 ] 2010
Zerusa Limited c/o Mr. Stephen M. Page Regulatory Consultant 219-220 Business Innovation Centre, NUIG Galway, Ireland
Re: K101113
Guardian® II NC Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold or Fitting Regulatory Class: Class II Product Code: DTL Dated: April 22, 2010 Received: April 21, 2010
Dear Mr. Page:
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 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. Stephen M. Page
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.
ff 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
R., Viihnen
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KI01113
Indications for Use
510(k) Number (if known): K101113
Device Name: Guardian® II NC Hemostasis Valve
Indications for Use: The Guardian® II NC 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 NC 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)
printer R. balmes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_ ¥ 10 113 ---
Page 1 of 1
(Posted November 13, 2003)