The Seal-Away CS™ Introducer Kit is a percutaneous catheter introducer kit with peelaway sheath that is indicated for the introduction of catheters into a vessel.

The Seal-Away™ Hemostasis Adapter is indicated for the introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.

Device Description

The Seal-Away CST™ introducer kit includes a Peel-Away Introducer, Obturator, Seal-Away™ detachable hemostasis valve, Guidewire, Syringe and Needle. The introducer kits are provided sterile, and are intended for single-use only.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "Seal-Away CST™ Introducer Kit." However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) summary focuses on establishing "substantial equivalence" to a predicate device (Peel away Sheath Introducer and Obturator from St. Jude Medical, Daig Division) rather than presenting a performance study with acceptance criteria.

The submission states: "All technological characteristics of the Seal-Away™ CS introducer kit are substantially equivalent to the predicate device including product design, packaging, sterilization, and labeling." This indicates that the regulatory pathway chosen was based on demonstrating similarity to an already approved device, not on conducting new performance studies against predefined acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence rather than a detailed performance study with acceptance criteria.

Summary

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K013029

8.0 510(k) Summary

Special 510(k): Device Modification

OCT - 9 2001	510(k) Summary
	(As required by 21 CFR 807.92)

Submitter Information A.

Submitter's Name:	St. Jude Medical, Daig Division
Address:	14901 DeVeau PlaceMinnetonka, Minnesota 55345-2126 U.S.A.
Telephone Number:	(952) 352-9769
Contact Person:	Jim M. Taufen
Date Submission Prepared:	07-Sep-2001

B. Device Information

Trade Name:	Seal-Away CST™ Introducer Kit
Common or Usual Name:	Percutaneous Catheter Introducer
Classification Name:	Percutaneous Catheter Introducer (per 21 CFR Part870.1340)
Device Classification:	Class II (per 21 CFR Part 870.1340)Panel - Cardiovascular
Predicate Device:	Peel away Sheath Introducer and ObturatorSt. Jude Medical, Daig Division
Device Description:	The Seal-Away CST™ introducer kit includes a Peel-Away Introducer, Obturator, Seal-Away™ detachablehemostasis valve, Guidewire, Syringe and Needle. Theintroducer kits are provided sterile, and are intended forsingle-use only.
Intended Use:	The Seal-Away CS Introducer kits are designed for theintroduction of catheters into a vessel.

Comparison of Required Technological Characteristics C.

All technological characteristics of the Seal-Away™ CS introducer kit are substantially equivalent to the predicate device including product design, packaging, sterilization, and labeling.

Support of the Substantial Equivalence D.

St. Jude Medical, Daig Division considers the Seal-Away CS introducer kit to be substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the light background of the emblem.

OCT - 92001

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jim M. Taufen St. Jude Medical Daig Division 14901 DeVeau Place Minnetonka, MN 55345

Re: K013029

Seal-Away CS™ Introducer Kit Regulation Number: 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 7, 2001 Received: September 10, 2001

Dear Mr. Taufen:

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, 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 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.

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

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Page 2 - Mr. Jim M. Taufen

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 premated noutineation one and 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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

KO13029 510(k) Number (if known): __

Device Name:

Seal-Away CS™ Introducer Kit

Indications for Use:

The Seal-Away CS™ Introducer Kit is a percutaneous catheter introducer kit with peelaway sheath that is indicated for the introduction of catheters into a vessel.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Re510(k) Number	K013024
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Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
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Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).