(69 days)
The COPILOT™ Bleedback Control Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic/interventional devices.
The COPILOT™ Bleedback Control Valve is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter < 0.096" during interventional procedures.
The COPILOT™ Bleedback Control Valve has a 0.096" (2.44 mm) inside diameter. This device has two seals that operate independently: the clamp seal and the bleedback control (BBC) seal. The clamp seal can be opened or closed by rotating the cap. Closing of the clamp seal allows for pressure injections up to 400 psi and also secures the diagnostic/interventional device in position within the vasculature. The BBC seal is a diaphragm seal that forms around diagnostic/ interventional devices as they move into and out of the vasculature. This seal provides minimal fluid loss without restricting device movement. The BBC seal is open when the cap is pressed down, and closed when the cap is released. An open BBC seal allows air and fluid to be purged and allows the advancement/ withdrawal of diagnostic/ interventional devices.
The provided document, K991102, is a 510(k) summary for the COPILOT™ Bleedback Control Valve. This document describes the device, its intended use, and its substantial equivalence to a predicate device. It also briefly mentions performance data.
However, the provided text does not contain acceptance criteria or detailed study information that would allow for a comprehensive answer to the requested questions. The "Performance data" section explicitly states: "The safety and effectiveness of the Guidant COPILOT™ Bleedback Control Valve have been demonstrated through data collected from nonclinical bench tests and analyses." This indicates that performance testing was done, but the details of these tests, including specific acceptance criteria and detailed results, are not included in this summary.
Therefore, I cannot provide the requested table or answer most of the questions based on the provided input.
Here's what I can extract and state based on the limited information:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: The document only generally states that "safety and effectiveness... have been demonstrated through data collected from nonclinical bench tests and analyses." No specific performance metrics or values are provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified.
- Data Provenance: "nonclinical bench tests and analyses" – Implies laboratory/bench testing, not patient data. Country of origin not specified. Retrospective/prospective is not applicable as it's non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. This device is a mechanical hemostatic valve. "Ground truth" in the context of expert judgment (like for image interpretation) is not relevant for this type of device's performance evaluation. The "bench tests and analyses" would likely rely on physical measurements and engineering standards rather than expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of data/images. This is a mechanical device evaluated via bench tests.
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 relevant for this type of medical device (a hemostatic valve). This type of study is used for diagnostic devices, particularly those involving human interpretation of imaging.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device, not an algorithm. Standalone performance for an algorithm is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For bench tests, "ground truth" would be established by validated measurement techniques, engineering specifications, and possibly comparison against industry standards or the predicate device's known performance. The document doesn't specify the exact metrics, but they would likely relate to seal integrity, pressure resistance, flow rates, and ease of device movement.
8. The sample size for the training set:
- Not Applicable. This is a mechanical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, this is a mechanical device and not an AI/ML algorithm.
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Attachment B - 510(k) Summary
| Submitter | Guidant Corporation, Vascular InterventionAdvanced Cardiovascular Systems, Inc.26531 Ynez Road, Temecula CA 92591Contact: Stacey SimonPhone: (909) 914-4527, Fax: (909) 914-6690 |
|---|---|
| Date | May 26, 1999 |
| Device name | Device Trade Name: COPILOT™ Bleedback Control ValveDevice Common Name: Hemostatic ValveDevice Classification Name: Adaptor, Stopcock, Manifold, Fitting,Cardiopulmonary BypassDevice Classification: Class II |
| Summary ofsubstantialequivalence | The design, materials, method of operation, and intended use featuresof the Guidant COPILOT™ Bleedback Control Valve are substantiallyequivalent with regard to these features in the predicate device, theACS .096" Rotating Hemostatic Valve (K854261). |
| Devicedescription | The COPILOT™ Bleedback Control Valve has a 0.096" (2.44 mm)inside diameter. This device has two seals that operate independently:the clamp seal and the bleedback control (BBC) seal. The clamp sealcan be opened or closed by rotating the cap. Closing of the clamp sealallows for pressure injections up to 400 psi and also secures thediagnostic/interventional device in position within the vasculature.The BBC seal is a diaphragm seal that forms around diagnostic/interventional devices as they move into and out of the vasculature.This seal provides minimal fluid loss without restricting devicemovement. The BBC seal is open when the cap is pressed down, andclosed when the cap is released. An open BBC seal allows air and fluidto be purged and allows the advancement/ withdrawal of diagnostic/interventional devices. |
| Intended use | The COPILOT™ Bleedback Control Valve is intended to maintainhemostasis during the introduction/withdrawal and use ofdiagnostic/interventional devices. |
| Indicationsstatement | The COPILOT™ Bleedback Control Valve is indicated for maintaininga seal around diagnostic/interventional devices with an outsidediameter < 0.096" during interventional procedures. |
| Technologicalcharacteristics | The Guidant COPILOT™ Bleedback Control Valve incorporatessimilar design, components, method operation, and intended use ofthe predicate device, the ACS .096" Rotating Hemostatic Valve(K854261), with exception of the BBC valve. The GuidantCOPILOT™ Bleedback Control Valve is provided with an innerdiameter of .096". |
| Performancedata | The safety and effectiveness of the Guidant COPILOT™ BleedbackControl Valve have been demonstrated through data collected fromnonclinical bench tests and analyses. |
.
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Appendix B - 510(k) Summary, Continued
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 9 1999
Ms. Stacey Simon Regulatory Affairs Coordinator Guidant Corporation 26531 Ynez Road Temecula, CA ਰੇਣ ਰੋਜ ਹੈ। ਹਵਾਲੇ ਹ
K991102 Re: COPILOT™ Bleedback Control Valve Trade Name: Regulatory Class: II Product Code: DTL Dated: March 31, 1999 Received: April 1, 1999
Dear Ms. Simon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices
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Page 2 - Ms. Stacey Simon
under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in_vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahar Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment A - Indications for Use Statement
| 510(k) number (if known): | The 510(k) number is K991102. |
|---|---|
| Device name | COPILOT™ Bleedback Control Valve |
| Indications for use | The COPILOT™ Bleedback Control Valve is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter < 0.096" during interventional procedures. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
i
OR
Over-The-Counter (Optional Format 1-1-96)
Cl.b.l.m. H. for TBC
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
(Division of Cardiovascular, Respiratory, and Neurological Devices
§ 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.