COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331

K991102 · Guidant Corp. · DTL · Jun 9, 1999 · Cardiovascular

Device Facts

• Record ID: K991102
• Device Name: COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
• Applicant: Guidant Corp.
• Product Code: DTL · Cardiovascular
• Decision Date: Jun 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The COPILOT™ Bleedback Control Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic/interventional devices.

Device Story

COPILOT™ Bleedback Control Valve is a hemostatic valve used during interventional procedures to maintain hemostasis while allowing introduction/withdrawal of diagnostic or interventional devices. Device features 0.096" inner diameter and two independent seals: a clamp seal and a bleedback control (BBC) seal. Clamp seal, operated by rotating cap, secures devices and supports pressure injections up to 400 psi. BBC seal, a diaphragm seal, minimizes fluid loss during device movement; seal is open when cap is pressed, closed when released. Device allows air/fluid purging and device manipulation without restricting movement. Used by clinicians in interventional settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Hemostatic valve with 0.096" (2.44 mm) inner diameter. Features dual-seal design: clamp seal for pressure injections up to 400 psi and diaphragm-based bleedback control (BBC) seal. Mechanical operation via rotating cap and manual pressure. Non-powered device.

Indications for Use

Indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter < 0.096" during interventional procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ACS .096" Rotating Hemostatic Valve (K854261)

Submission Summary (Full Text)

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K991102

## Attachment B - 510(k) Summary

| Submitter | Guidant Corporation, Vascular Intervention<br>Advanced Cardiovascular Systems, Inc.<br>26531 Ynez Road, Temecula CA 92591<br>Contact: Stacey Simon<br>Phone: [phone], Fax: [phone] |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | May 26, 1999 |
| Device name | Device Trade Name: COPILOT™ Bleedback Control Valve<br>Device Common Name: Hemostatic Valve<br>Device Classification Name: Adaptor, Stopcock, Manifold, Fitting,<br>Cardiopulmonary Bypass<br>Device Classification: Class II |
| Summary of<br>substantial<br>equivalence | The design, materials, method of operation, and intended use features<br>of the Guidant COPILOT™ Bleedback Control Valve are substantially<br>equivalent with regard to these features in the predicate device, the<br>ACS .096" Rotating Hemostatic Valve (K854261). |
| Device<br>description | The COPILOT™ Bleedback Control Valve has a 0.096" (2.44 mm)<br>inside diameter. This device has two seals that operate independently:<br>the clamp seal and the bleedback control (BBC) seal. The clamp seal<br>can be opened or closed by rotating the cap. Closing of the clamp seal<br>allows for pressure injections up to 400 psi and also secures the<br>diagnostic/interventional device in position within the vasculature.<br>The BBC seal is a diaphragm seal that forms around diagnostic/<br>interventional devices as they move into and out of the vasculature.<br>This seal provides minimal fluid loss without restricting device<br>movement. The BBC seal is open when the cap is pressed down, and<br>closed when the cap is released. An open BBC seal allows air and fluid<br>to be purged and allows the advancement/ withdrawal of diagnostic/<br>interventional devices. |
| Intended use | The COPILOT™ Bleedback Control Valve is intended to maintain<br>hemostasis during the introduction/withdrawal and use of<br>diagnostic/interventional devices. |
| Indications<br>statement | The COPILOT™ Bleedback Control Valve is indicated for maintaining<br>a seal around diagnostic/interventional devices with an outside<br>diameter < 0.096" during interventional procedures. |
| Technological<br>characteristics | The Guidant COPILOT™ Bleedback Control Valve incorporates<br>similar design, components, method operation, and intended use of<br>the predicate device, the ACS .096" Rotating Hemostatic Valve<br>(K854261), with exception of the BBC valve. The Guidant<br>COPILOT™ Bleedback Control Valve is provided with an inner<br>diameter of .096". |
| Performance<br>data | The safety and effectiveness of the Guidant COPILOT™ Bleedback<br>Control Valve have been demonstrated through data collected from<br>nonclinical 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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. |

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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