(63 days)
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.
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.
This 510(k) premarket notification describes the Zerusa Limited Guardian™ Hemostasis Valve, which is designed to maintain hemostasis during vascular procedures when interventional devices up to 8.0F are inserted. This submission specifically adds a Guidewire Torquer. The device is deemed substantially equivalent to the previously marketed Zerusa Limited Guardian Hemostasis Valve (K052381).
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantitative acceptance criteria for performance parameters. Instead, it makes a general statement about performance testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Performance | Demonstrated safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). It only mentions "a full battery of performance testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The device is a medical accessory, and ground truth in the context of clinical outcomes or diagnostic accuracy (which would typically involve expert review) is not discussed. Performance testing likely refers to engineering and functional tests rather than clinical evaluation with human subjects and expert-established ground truth.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method as it does not describe a study involving human interpretation or clinical endpoints that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or is not reported in this document. Such studies are typical for diagnostic imaging devices where human interpretation is a key component, which is not the primary function of this hemostasis valve.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a medical accessory and does not involve any algorithm or AI for standalone performance. Therefore, this type of study is not applicable and was not performed.
7. The Type of Ground Truth Used
The term "ground truth" as typically understood in studies involving diagnostic accuracy (e.g., pathology, outcomes data) is not applicable to the performance testing described for this device. The testing likely focused on physical and functional characteristics such as:
- Hemostasis effectiveness: Ability to seal around devices of specified diameters to minimize blood loss.
- Ease of use: Smooth introduction and withdrawal of interventional devices.
- Leakage: Absence of leakage during pressure injections.
- Durability and material compatibility: Ensuring the device withstands procedural stresses and is biocompatible.
- Sterility and packaging integrity.
The "ground truth" for these tests would be established by engineering specifications and industry standards.
8. The Sample Size for the Training Set
This question is not applicable as the device does not involve machine learning or AI, and hence, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
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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 .
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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.
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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.
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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
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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
§ 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.