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

Device Description

The Ultraflex™ EV (9-12F) Hemostasis Introducers are introducers designed to provide easy access to the vascular system while providing convenient temporary closure of a standard indwelling introducer access site. The introducers include a sheath, hub, hemostasis valve, sideport for 3-way stopcock, and dilator. The introducers are provided sterile, and are intended for single-use only.

AI/ML Overview

This 510(k) summary (K012922) pertains to the St. Jude Medical, Daig Division's Ultraflex™ EV Hemostasis Introducer. The device is a "Catheter Introducer" and its intended use is for "the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential."

Critically, this submission is a claim of substantial equivalence to a predicate device (Ultraflex™ Hemostasis Introducer) and does not contain specific acceptance criteria for performance, nor does it detail a study proving the device meets such criteria. Instead, it relies on the assertion that its "technological characteristics... are substantially equivalent to the predicate device including product design, sterilization, and labeling."

Therefore, I cannot provide the requested information in the format given, as the underlying document does not contain a study with performance metrics, sample sizes, expert ground truth establishment, or comparative effectiveness.

However, I can extract the relevant information regarding the basis of the substantial equivalence claim:

1. A table of acceptance criteria and the reported device performance:

This document does not contain any specific acceptance criteria or reported device performance metrics from a study. It asserts substantial equivalence to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No test set or associated data provenance is mentioned as this is a substantial equivalence claim based on technological characteristics rather than a new performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable, as no test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a medical device (catheter introducer), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable, as no ground truth for a performance study is mentioned.

8. The sample size for the training set:

Not applicable, as a training set for a performance study is not described.

9. How the ground truth for the training set was established:

Not applicable, as a training set for a performance study is not described.

Summary of the document's argument:

The 510(k) submission states that the Ultraflex™ EV Hemostasis Introducer is substantially equivalent to the predicate device, Ultraflex™ Hemostasis Introducers, based on shared "product design, sterilization, and labeling." This implies that the new device is considered safe and effective because its fundamental characteristics match an already legally marketed device with a known safety and effectiveness profile. The FDA's letter concurs with this substantial equivalence.

Summary

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012922

SEP 2 5 2001

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

A. Submitter Information

Submitter's Name:	St. Jude Medical, Daig Division
Address:	14901 DeVeau PlaceMinnetonka, Minnesota 55345-2126 U.S.A.
Telephone Number:	952-933-4465
Contact Person:	Kirk Honour
Date Submission Prepared:	August 24, 2001
Device Information
Common or Usual Name:	Ultraflex™ EV Hemostasis Introducer
Classification Name:	Catheter Introducer
Predicate Device:	Ultaflex™ Hemostasis IntroducerSt. Jude Medical, Daig Division
Device Description:	The Ultraflex™ EV (9-12F) Hemostasis Introducers areintroducers designed to provide easy access to thevascular system while providing convenient temporaryclosure of a standard indwelling introducer access site.The introducers include a sheath, hub, hemostasis valve,sideport for 3-way stopcock, and dilator. Theintroducers are provided sterile, and are intended forsingle-use only.
Intended Use:	The Ultraflex™ EV Hemostasis Introducers are designedfor the introduction of angiographic catheters, closed endcatheters, balloon catheters and electrodes into a vesselwhere minimizing blood loss is essential.

C. Comparison of Required Technological Characteristics

All technological characteristics of the Ultraflex™ EV Hemostasis Introducers are substantially equivalent to the predicate device including product design, sterilization, and labeling.

D. Support of the Substantial Equivalence

St. Jude Medical, Daig Division considers the Ultraflex™ EV Hemostasis Introducers to be substantially equivalent to the predicate device, Ultraflex™ Hemostasis Introducers.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2001

Mr. Kirk Honour Regulatory Affairs St. Jude Medical Daig Division 14901 Deveau Place Minnetonka, MN 55345

Re: K012922

Trade Name: Ultraflex™ EV Hemostasis Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer. Regulatory Class: II Product Code: DYB Dated: August 31, 2001 Received: August 31, 2001

Dear Mr. Honour:

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 all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Kirk Honour

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 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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510(k) Number (if known):

Ultraflex™ EV Hemostasis Introducer Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Ultraflex™ EV Hemostasis Introducer is designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing 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)

Division of Cardiovascular & Respiratory Devices

510(k) Number	12012922
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Prescription Use(Per 21 CFR 801.109)	✓	OR	Over-The-Counter Use
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(Optional Format 1-2-96)

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).