SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229

K984062 · Diag Corp. · DYB · Mar 24, 1999 · Cardiovascular

Device Facts

• Record ID: K984062
• Device Name: SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229
• Applicant: Diag Corp.
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Daig Seal-Away™ Hemostasis Adapter is designed to minimize the blood loss during the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel.

Device Story

Seal-Away™ Hemostasis Adapter is an introducer accessory; provides temporary closure of standard indwelling introducer access sites. Used during percutaneous procedures to facilitate insertion of catheters and electrodes into vascular system. Minimizes blood loss during device introduction. Operated by clinicians in clinical settings. Device functions as a mechanical seal; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical hemostasis adapter; used as an introducer accessory. No energy source, software, or complex materials specified. Sterilization and packaging are equivalent to the predicate device.

Indications for Use

Indicated for use in patients requiring the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

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

• Removable Hemostasis Adapter with Sideport (K894343)

Submission Summary (Full Text)

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3/24/99

984062

# 8.0 510(k) Summary

# 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: | November 13, 1998 |

**B. Device Information**

| Common or Usual Name: | Seal-Away™ Hemostasis Adapter |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Introducer |
| Predicate Device: | Removable Hemostasis Adapter with Sideport (K894343) |
| Device Description: | The Daig Seal-Away™ Hemostasis Adapter is an Introducer Accessory designed to provide easy access to the vascular system while providing convenient temporary closure of a standard indwelling introducer access site during introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel. |
| Intended Use: | The Daig Seal-Away™ Hemostasis Adapter is designed to minimize the blood loss during the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel. (same as predicate device) |

### Comparison of Required Technological Characteristics C.

Seal-Away™ Hemostasis Adapter, 510(k) Submission Daig Corporation, November 1998

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8.0 510(k) Summary

All technological characteristics of the Seal-Away™ Hemostasis Adapter are substantially equivalent to the predicate device (K894343) 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 Seal-Away™ Hemostasis Adapter to be substantially
equivalent to the following predicate device: the Removable Hemostasis Adapter with Sideport used with the Percutaneous Catheter Introducer which received marketing clearance on September 26, 1989 (K894343).

:

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 1999

Mr. Todd Kornmann Senior Regulatory Affairs Specialist DAIG Corporation 14901 DeVeau Place Minnetonka, MN 55345-2126

K984062 Re: Seal-Away™ Hemostasis Adapter Trade Name: Requlatory Class: II Product Code: DYB Dated: February 18, 1999 Received: February 19, 1999

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 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 J 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 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 Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Todd Kornmann

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.

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 requlation (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 qeneral 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. Callaha Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page -1 of

K984062 510(k) Number (if known):

Device Name: Seal- Away™ Hemostasis Adapter

Indications for Use:

The Seal-Away™ Hemostasis Adapters 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.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Christopher M. Fattic

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number Over-The-Counter Use OR (Optional Format 1-2-96)

1 Prescription Use (Per 21 CFR 801.109)