LV-1 HEMOSTASIS VALVE, MODEL #6789

K021282 · Guidant Corp. · DTL · May 2, 2002 · Cardiovascular

Device Facts

• Record ID: K021282
• Device Name: LV-1 HEMOSTASIS VALVE, MODEL #6789
• Applicant: Guidant Corp.
• Product Code: DTL · Cardiovascular
• Decision Date: May 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The LV-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal around the LV-1 lead terminal pin while flushing the lead lumen and/or during introduction/withdrawal of interventional devices.

Device Story

The LV-1 Hemostasis Valve is a delivery system accessory used during the implantation of a Guidant left ventricular (LV-1) lead via the coronary sinus. The device attaches to the lead terminal pin to maintain a seal. It features a side arm port for flushing the lumen and a diaphragm-based bleedback control seal. This seal allows the introduction of a guide wire (up to 0.070" diameter) while restricting fluid loss and maintaining a seal during wire movement. A plastic funnel accessory (wire guide) is included to facilitate guide wire insertion. The device is used by clinicians in a procedural setting to manage fluid loss and facilitate lead/wire manipulation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a mechanical hemostasis valve featuring a diaphragm seal for bleedback control. It includes a side arm port for flushing and a plastic funnel accessory for guide wire introduction. The internal diameter is 0.070" (1.8 mm). It is a non-powered, single-use accessory.

Indications for Use

Indicated for maintaining a seal around the LV-1 lead terminal pin during flushing of the lead lumen and the introduction or withdrawal of interventional devices.

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

• GUIDANT COPILOT™ Bleedback Control Valve (K991102)

Submission Summary (Full Text)

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## MAY 0 2 2002

# Appendix A - 510(k) Summary

Submitter

GUIDANT CORPORATION Cardiac Rhythm Management 4100 Hamline Avenue St. Paul, MN 55112

Contact: Michael Husby, Sr. Regulatory Affairs Associate Tel: [phone], Fax: [phone]

Date

November 30, 2001

Device name

Device Trade Name: Device Common Name: Device Classification Name: LV-1 HEMOSTATIC VALVE Hemostatic Valve Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Class II

Device Classification:

Summary of substantial equivalence

The design, materials, method of operation, and intended use features of the GUIDANT LV-1™ Bleedback Control Valve are substantially equivalent to those of the predicate device, the GUIDANT COPILOT™ Bleedback Control Valve (K991102).

Device description

The LV-1 HEMOSTASIS VALVE, Model 6789 is a delivery system accessory for use in the implant of a GUIDANT left ventricular (LV-1) lead through the coronary sinus. The tip of the valve attaches to the LV-1 lead terminal pin and maintains a seal. A side arm port allows the lumen seal to be flushed and a bleedback control seal allows the introduction of an appropriately sized guide wire through an inside diameter of 0.070" (1.8 mm) while providing a seal.

The bleedback control seal is a diaphragm seal that forms around a guide wire as it moves into and out of the lead lumen, catheter, and vasculature. This seal restricts fluid loss without significantly inhibiting wire movement. The bleedback control seal is easily penetrated by the wire guide, a small plastic funnel accessory that facilitates the introduction of a guide wire.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of three abstract shapes that resemble a human figure with outstretched arms, symbolizing care and protection. The overall design is simple, clean, and conveys a sense of government authority and public service.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2002

Ms. Karen S. Alsop Pr. Regulatory Affairs Associate Guidant Corporation 4100 Hamline Avenue N St. Paul. MN 55112

#### Re: (K021282

Trade Name: LV-1 Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold fitting Regulatory Class: Class II (two) Product Code: DTL

#### Re: K021283

Trade Name: Guidant Balloon Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO

#### Re: K021284

Trade Name: EASYTRAK® Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY

#### Re: K021285

Trade Name: HI-TORQUE® Guide Wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: April 17, 2002 Received: April 18, 2002

Dear Ms. Alsop:

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 enclosures) 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

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### Page 2 - Ms. Karen S. Alsop

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 11 Jour do not additional controls. Existing major regulations affecting your device can be found in the . burger to been a Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA I 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 r 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 11 Jul desire spotial or 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International roop classimer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Desh Tuller

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular' and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Appendix C - Indications for Use Statement

Applicant: GUIDANT CORPORATION

510(k) Number (if known): KO Q L 2

Device Name: LV-1 HEMOSTASIS VALVE

### Indications for Use:

The LV-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal around the LV-1 lead terminal pin while flushing the lead lumen and/or during introduction/withdrawal of interventional devices.

(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)

OR

Over-The-Counter

Division of Cardiovascular & Respiratory Devices
510(k) Number K021282

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