The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential.

Device Description

The Engage device consists of an introducer sheath with hemostasis valve and sideport for 3-way stopcock, hub, dilator, and guidewire. At the end of the sheath is a snap fit hub that is equipped with a hemostasis valve and sideport containing tubing ending with a 3way stopcock valve. The 3-way stopcock is provided for air aspiration, fluid infusion, blood sampling and pressure monitoring. The dilator lumen is designed to provide close fit to appropriately sized guidewires by incorporating a tapered distal tip.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the St. Jude Medical Ultimum/Engage/Engage TR Hemostasis Introducer (K091137):

Executive Summary:

The provided 510(k) summary for the Engage Introducer does not contain information about specific performance acceptance criteria or a study designed to prove the device meets such criteria. Instead, the submission states that "This submission is for indication clarification; there have been no device changes and subsequently, no additional device testing was required." The basis for clearance is substantial equivalence to previously cleared predicate devices.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as such a study was explicitly stated as not required for this particular submission.

Detailed Breakdown of Information (as available from the provided text):

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Reported Device Performance
Not applicable Not applicable

Explanation: The document explicitly states, "This submission is for indication clarification; there have been no device changes and subsequently, no additional device testing was required." This means there were no new performance acceptance criteria established for this specific submission nor any new performance data generated to meet them. The device is being cleared based on its substantial equivalence to previously cleared devices which would have met their own performance criteria at the time of their clearance.
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable (no new testing was performed for this submission).
- Data Provenance: Not applicable (no new testing was performed for this submission).
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable (no new testing was performed for this submission, thus no ground truth established by experts for a test set).
Adjudication Method for the Test Set:
- Not applicable (no new testing was performed for this submission).
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was one done? No.
- Effect size improvement: Not applicable.
Explanation: MRMC studies are typically for evaluating diagnostic or imaging devices where human readers interpret data, often with or without AI assistance. This device is a medical introducer (a physical tool) and does not involve such diagnostic interpretation.
Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:
- Was one done? No.
Explanation: This concept is relevant for AI algorithms or software devices. The Engage Introducer is a physical medical device.
Type of Ground Truth Used:
- Not applicable (no new testing was performed for this submission).
Sample Size for the Training Set:
- Not applicable (no new testing or AI model training performed for this submission).
How the Ground Truth for the Training Set Was Established:
- Not applicable (no new testing or AI model training performed for this submission).

Acceptance Criteria	Reported Device Performance
Not applicable	Not applicable

Summary of the K091137 Submission:

The K091137 submission for the St. Jude Medical Ultimum/Engage/Engage TR Hemostasis Introducer is a 510(k) Pre-market Notification primarily focused on indication clarification and establishing substantial equivalence to existing predicate devices.

Rationale for Clearance: The submission asserts that the Engage Introducer is substantially equivalent to two predicate devices:
1. St. Jude Medical's Ultimum Hemostasis Introducer (K001346, cleared 2000)
2. Terumo's GlideSheath (K082644, cleared 2008)
Key Argument for Substantial Equivalence:
- No device changes: The submission explicitly states, "there have been no device changes."
- Same intended use, principles of operation, and technological characteristics as the cleared Ultimum Hemostasis Introducer.
- Similar sub-indications for use and principles of operations as the Terumo GlideSheath.
- The "differences between this device and its predicate device do not raise new questions of safety or efficacy."
Purpose of Submission: To provide "further clarity to the physicians regarding the indications for use of Ultimum in procedures requiring vessel access, including but not limited to femoral, radial, and brachial approach."

In essence, this submission is an administrative update to the labeling of an existing device (or a renamed existing device) to broaden or clarify its listed indications for use, without making any physical changes to the device itself, and therefore, without requiring new performance testing.

Summary

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510(K) SUMMARY

K09113)

APR ११२ २००९

5.1. APPLICANT INFORMATION

Submitted by:

St. Jude Medical 6500 Wedgwood Rd. N. Maple Grove, MN 55311

Contact Person:	Linh Pham
Telephone:	763-383-2586
Fax:	763-383-2559
Date Prepared:	10 April, 2009

5.2. DEVICE INFORMATION

Classification Name:	Introducer, Catheter
Common Name:	Hemostasis Introducer
Trade Name:	Ultimum/Engage/Engage TR
Classification:	Class II per 21 CFR 870.1340
Product Code:	DBY

Ultimum and Engage are the same devices (intended use, function and specifications, and device materials). SJM reserves the right to modify the trade name of the Ultimum/Engage device in the future; as a result, the name, Engage Introducer (Engage), will be referred to for the remainder of this submission.

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5.3. DEVICE DESCRIPTION

To further assist physicians on the application of the Ultimum/Engage device, SJM is providing physicians with more clarity in the device's indications for use.

5.4. INTENDED USE

5.5. TEST SUMMARY

This submission is for indication clarification; there have been no device changes and subsequently, no additional device testing was required.

5.6. PREDICATE DEVICE

The predicate devices are provided below:

Product Name	510k #
Ultimum HemostasisIntroducer (St. JudeMedical)	K001346 (cleared 05/24/2000)
GlideSheath (TerumoCorporation)	K082644 (cleared 09/18/2008)

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5.7. SUBSTANTIAL EQUIVALENCE

The Engage Introducer covered by this submission is substantially equivalent to the previously cleared St. Jude Medical's Ultimum Hemostasis Introducer-K001346-05/24/2000 and Terumo's GlideSheath-K082644-09/18/2008. Differences between devices do not raise any issues of safety or effectiveness.

5.8. CONCLUSION

The Engage Introducer in this submission has the same intended use, principles of operation, and technological characteristics as the Ultimum Hemostasis Introducer (K001346), and it has similar sub-indications for use and principles of operations as the Terumo GlideSheath (K082644). The Engage is submitted to provide further clarification to the physicians regarding the indications for use of Ultimum in procedures requiring vessel access, including but not limited to femoral, radial, and brachial approach.

As a result, the differences between this device and its predicate device do not raise new questions of safety or efficacy. Therefore, the Engage Introducer is substantially equivalent to the predicate devices.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a stylized representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2009

St. Jude Medical c/o Mark Job, Reviewer Regulatory Technology Services 1394 25th Street NW Buffalo, MN 55313

Re: K091137

Trade/Device Name: Ultimum/Engage/Engage TR Hemostasis Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 17, 2009 Received: April 20, 2009

Dear Mr. Job:

This letter corrects our substantially equivalent letter of April 22, 2009.

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 (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 additional controls. Existing major regulations affecting your

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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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

A Bram D. Zuckerman, M.D. Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ultimum/Engage Introducer Premarket Notification 510(k)
4. INDICATIONS FOR USE STATEMENT
Device Name:	Ultimum/Engage/Engage TR
Indications for Use:
The introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential.
Prescription Use(Part 21 CFR 801 Subpart D)	X AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K69137
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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).