ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX

K994334 · Daig Corp. · DYB · May 15, 2000 · Cardiovascular

Device Facts

• Record ID: K994334
• Device Name: ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX
• Applicant: Daig Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: May 15, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Ultra-Flex Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.

Device Story

Ultra-Flex Hemostasis Introducer provides vascular access for interventional procedures; facilitates insertion of pacing leads, angiographic catheters, closed end catheters, balloon catheters, and electrodes into vessels. Device minimizes blood loss during catheter/electrode introduction. Used in clinical settings by physicians; functions as a temporary access site closure mechanism. No complex electronics or software involved.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparison to the predicate device.

Technological Characteristics

Vascular introducer; mechanical design for catheter/electrode insertion and blood loss minimization. Characteristics including design, packaging, sterilization, and labeling are equivalent to the predicate device.

Indications for Use

Indicated for patients requiring vascular access for the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes where blood loss minimization is required.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Fast-Cath™ Hemostasis Introducer (K910861)

Submission Summary (Full Text)

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# 510(k) Summary (As required by 21 CFR 807.92)

#### Submitter Information A.

| Submitter's Name: | Daig Corporation, a St. Jude Medical Company |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 14901 DeVeau Place<br>Minnetonka, Minnesota 55345-2126 U.S.A. |
| Telephone Number: | [phone] |
| Contact Person: | Todd J. Kornmann |
| Date Submission Prepared: | December 22, 1999 |
| B. | Device Information |
| Common or Usual Name: | Ultra-Flex Hemostasis Introducer |
| Classification Name: | Introducer |
| Predicate Device: | Fast-Cath™ Hemostasis Introducer (K910861) |
| Device Description: | The Daig Ultra-Flex Hemostasis Introducer is an<br>Introducer designed to provide easy access to the<br>vascular system while providing convenient<br>temporary closure of a standard indwelling<br>introducer access site during introduction of pacing<br>leads, angiographic catheters, closed end catheters,<br>balloon catheters and electrodes into a vessel. |
| Intended Use: | The Ultra-Flex Hemostasis Introducer is designed<br>for the introduction of angiographic catheters,<br>closed end catheters, balloon catheters and<br>electrodes into a vessel where minimizing blood<br>loss is essential. (same as predicate device) |

#### C. Comparison of Required Technological Characteristics

All technological characteristics of the Ultra-Flex Hemostasis Introducer are substantially equivalent to the predicate device (K910861) including product design, packaging, sterilization, and labeling.

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# 8.0 510(k) Summary

### Support of the Substantial Equivalence D.

Daig Corporation considers the Ultra-Flex Hemostasis Introducer to be substantially equivalent to the following predicate device: the Fast-Cath™ Hemostasis Introducer which received marketing clearance on May 7, 1991 (K910861).

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2000

Mr. Todd Kornmann DAIG Corporation 14901 Deveau Pl. Minnetonka, MN 55345-2126

Re : K994334/S0002 Trade Name: Ultra-Flex Hemostasis Introducer Regulatory Class: II (two) : Product Code: DYB Dated: April 10, 2000 Received: April 11, 2000

Dear Mr. Kornmann:

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 control provisions of the Act. The general control 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 Eederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Todd Kornmann

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial in foal oce of your device to a legally marketed predicate device equivales or your device and thus, permits 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 reguracton (Er ces), please contact the Office of Compliance at Graghobere devices), prouse y, for questions on the promotion and [phone] hauter, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). ffrobrancing by Formation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its be obseree number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of

510(k) Number (if known):

Device Name:

Ultra-Flex Hemostasis Introducer

Indications for Use:

The Ultra-Flex Hemostasis Introducers are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.

Bim E. Otum

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)