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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the Seal-Away™ Hemostasis Adapter, focusing on its substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews in the context of typical AI/software device studies.

The document primarily states:

Substantial Equivalence: The Seal-Away™ Hemostasis Adapter is considered substantially equivalent to the Removable Hemostasis Adapter with Sideport (K894343).
Technological Characteristics: All technological characteristics (product design, packaging, sterilization, labeling) are substantially equivalent to the predicate device.
Intended Use: Designed to minimize blood loss during the introduction of various catheters and electrodes into a vessel.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device assessment (AI/Software) than the 510(k) submission for a physical medical device.

Here's a breakdown of what can be inferred from the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criterion is "substantial equivalence" to the predicate device.
Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, blood loss volume, etc.) are reported in this document. The "performance" is implicitly deemed equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable / Not Provided: This document describes a physical medical device (hemostasis adapter) and its substantial equivalence. There is no "test set" of data in the context of an AI/software algorithm. The clearance is based on comparison to an existing device, not on a clinical performance study using a data set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not Applicable / Not Provided: Ground truth establishment by experts for a test set is relevant for AI/software devices. This document does not describe such a process. The "ground truth" for this device's clearance is its functional similarity to a previously cleared predicate device.

4. Adjudication Method for the Test Set:

Not Applicable / Not Provided: Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations for AI/software ground truth. This is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No, Not Applicable: MRMC studies compare human performance with and without AI assistance. This document describes a physical medical device; no such study was conducted or is applicable.

6. If a Standalone (algorithm only without human-in-the-loop performance) study was done:

No, Not Applicable: Standalone performance studies are for AI algorithms. This is a physical device submission.

7. The Type of Ground Truth Used:

Predicate Device Equivalence: The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate device (K894343). The new device is simply shown to be sufficiently similar in design and intended use to warrant equivalence without new, extensive clinical trials.

8. The Sample Size for the Training Set:

Not Applicable / Not Provided: "Training set" refers to data used to train an AI algorithm. This concept does not apply to the Seal-Away™ Hemostasis Adapter.

9. How the Ground Truth for the Training Set was Established:

Not Applicable / Not Provided: As there is no training set for an AI algorithm, the establishment of ground truth for it is irrelevant in this context.

In summary: The provided 510(k) summary is for a physical medical device and relies on the concept of "substantial equivalence" to a predicate device. It does not involve AI/software performance studies, and therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, and expert reviews is not present in the document.

Summary

{0}------------------------------------------------

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 PlaceMinnetonka, Minnesota 55345-2126 U.S.A.
Telephone Number:	(612) 933-4700
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

{1}------------------------------------------------

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.

{2}------------------------------------------------

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).

..............................................................................................................................................................................

{3}------------------------------------------------

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

{4}------------------------------------------------

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 (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 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 (800) 638-2041 or (301) 443-6597 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

{5}------------------------------------------------

Page -1 of

K984062 510(k) Number (if known):

Device Name: Seal- Away™ Hemostasis Adapter

Indications for Use:

(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)

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).