IS-1 HEMOSTASIS VALVE, MODEL 6799

K031398 · Guidant Corp. · DTL · May 20, 2003 · Cardiovascular

Device Facts

• Record ID: K031398
• Device Name: IS-1 HEMOSTASIS VALVE, MODEL 6799
• Applicant: Guidant Corp.
• Product Code: DTL · Cardiovascular
• Decision Date: May 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

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

Device Story

IS-1 Hemostasis Valve functions as a seal for IS-1 lead terminal pins. Device allows for flushing of lead lumen and facilitates introduction or withdrawal of interventional devices. Used in clinical settings by physicians during cardiovascular procedures. Provides a secure seal to prevent fluid loss or air entry during manipulation of leads and interventional tools.

Clinical Evidence

Bench testing only.

Technological Characteristics

Hemostasis valve designed for IS-1 lead terminal pins; includes wire guide; mechanical seal mechanism.

Indications for Use

Indicated for maintaining a seal around IS-1 lead terminal pins during lead lumen flushing or interventional device introduction/withdrawal.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2003

Guidant Corporation c/o Ms. Colleen McCarter Bloom 4100 Hamline Avenue North St. Paul, MN 55112-5798

Re: K031398

IS-1 Hemostasis Valve, Model 6799 Regulation Number: 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (two) Product Code: DTL Dated: May 2, 2003 Received: May 5, 2003

Dear Ms. McCarter Bloom:

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. Iisting 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. Colleen McCarter Bloom

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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## 2. INDICATIONS FOR USE STATEMENT

| 510(k) Number<br>(If known) | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | IS-1 Hemostasis Valve |
| Indications for<br>Use | The IS-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal<br>around the IS-1 lead terminal pin while flushing the lead lumen and/or during<br>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 Only

XQeartu

(Division Sign-Off)
Division of Cardiovascular Devices

**510(k) Number** K03134

Hemostasis IS-1 Valve Special 510K Guidant Corporation May 2003