(83 days)
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 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").
The provided text describes a 510(k) summary for the Zerusa Limited Guardian Hemostasis Valve with Guidewire Introducer. It states that the device was subjected to a "full battery of performance testing" and that the "results of the performance testing demonstrated the safety and effectiveness of the device."
However, the document does not provide specific details on:
- Acceptance Criteria: What specific thresholds or metrics were defined for acceptable performance.
- Reported Device Performance: The actual quantitative results from the performance tests.
- Study Design Details: Information regarding sample sizes, data provenance, ground truth establishment, expert involvement, or specific types of studies (MRMC or standalone).
Therefore, based only on the provided text, I cannot answer the questions comprehensively. The document focuses on demonstrating substantial equivalence to predicate devices and receiving FDA clearance, rather than detailing the specifics of the performance study itself.
Here's what can be inferred and what is missing:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the document. It only broadly states that testing "demonstrated the safety and effectiveness of the device," implying that the device met internal Zerusa Limited criteria.
- Reported Device Performance: Not specified in the document. No quantitative results from any performance testing are included.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of detail (expert involvement for ground truth) is typically associated with studies involving subjective interpretation, like imaging. For a hemostasis valve, testing would likely involve objective, measurable parameters (e.g., leak rate, burst pressure, force to advance/withdraw devices). Therefore, the concept of "experts establishing ground truth" in this context might not apply or is not described. No information is provided about experts.
4. Adjudication method for the test set:
- Not applicable/not specified, as the type of ground truth and existence of expert involvement is not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study is not mentioned. This type of study is relevant for AI systems in image interpretation. The device described is a physical medical device (hemostasis valve), not an AI-powered diagnostic tool. Therefore, this question is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, indirectly. The "full battery of performance testing" would be considered standalone testing of the device itself (not an algorithm) without a human-in-the-loop, as it's a physical device. However, no details of these tests are provided.
7. The type of ground truth used:
- For physical device testing like a hemostasis valve, the "ground truth" would likely be defined by engineering specifications and validated test methods. For example, a leakage test would have a "ground truth" of zero leakage or a maximum allowable leakage rate. A force measurement for device insertion/withdrawal would have a "ground truth" of acceptable force ranges. The document does not explicitly state these, but this is the implied type of "ground truth" for such a device.
8. The sample size for the training set:
- Not applicable/not specified. A "training set" typically refers to data used to train a machine learning algorithm. This is a physical device, not an AI system.
9. How the ground truth for the training set was established:
- Not applicable/not specified. See point 8.
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1052381 PE 1082
NOV 2 1 2005
510(K) SUMMARY
SUBMITTER: 1.
Zerusa Limited 219-220 Business Innovation Centre, NUIG Galway, Ireland Telephone: 011-353-91-861611 Establishment Registration Number: Pending
Official contact: Ms. Oonagh Sweeney, Quality Systems Manager Phone: 011-353-91-863062 Date Prepared: August 24, 2005
2. DEVICE:
Guardian Hemostasis Valve with Guidewire Introducer Tradename: 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 predicate devices used to determine substantial equivalence for the Zerusa Limited Guardian Hemostasis Valve were the CoPilot Bleedback Control Valve marketed by Guidant (#K991102) and the EasyPass Y-connector Hemostatic Valve marketed by Millimed A/S (#K042060).
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.
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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").
5. INTENDED 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.
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.
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 with Guidewire Introducer 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zerusa Limited c/o Ms. Oonagh Sweeney Quality Systems Manager 219-220 Business Innovation Centre, NUIG
Galway, Ireland
Re: K052381
Guardian Hemostasis Valve with Guidewire Introducer Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (Two) Product Code: DTL Dated: August 24, 2005 Received: August 30, 2005
NOV 2 1 2005
Dear Ms. Sweeney:
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 - Ms. Oonagh Sweeney
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dmna R. Vichner
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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Page 1 of 1
510(k) Number (if known): #K052381
Device Name: Guardian Hemostasis Valve with Guidewire Introducer
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.
(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)
Duma R. Klines
(Di
Divi... Vascular Dens
510(N) Namb
§ 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.