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 modified Engage TR Introducer is essentially a modification of the previously cleared Engage/Engage TR/Ultimum introducer (K091137). The modified Engage TR Introducer is intended to provide easy access to the vascular system, while providing convenient temporary closure of the access port during catheter exchanges. The Engage TR Introducer range in effective length is from 7cm to 25cm. The Engage TR Introducer sheaths included in the scope of this submission range in sizes from 4-6F ACT (Active Clotting Time). In addition, the Engage TR Introducer has HPC coating on the sheath and it is compatible with 0.025" guidewires. The Engage device consists of two primary components: the Hemostasis sheath assembly and the dilator. The Hemostasis sheath assembly is the vessel access device and the dilator fits inside the sheath providing support. The dilator lumen is designed to provide a close fit to appropriately sized guidewire. At the proximal end of the Hemostasis sheath is a snap-lock hub which is equipped with a Hemostasis valve and side port with approximately 8 cm of tubing attached and ending with a 3-way stopcock. Some of the Engage devices are packaged with FDA cleared devices such as guidewires and needles.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the Engage TR Introducer. This submission primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study of acceptance criteria and performance as might be expected for a novel device or significant modification requiring clinical trials.

Therefore, many of the requested points, particularly those related to a clinical study (sample size, data provenance, experts, adjudication, MRMC study, standalone performance, training set details), are not applicable or not provided in this document. The submission explicitly states that "no additional animal or clinical data was deemed necessary" due to the scope of modifications.

Here's the breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments
Functional	Passed verification specification criteria	Based on predetermined design performance criteria. Specific functional criteria (e.g., flow rate, hemostasis, ease of insertion, durability) are not detailed in this summary.
Packaging	Passed verification specification criteria	Specific criteria not detailed.
Sterilization	Passed verification specification criteria	Specific criteria not detailed.
Biocompatibility	Passed verification specification criteria	Specific criteria not detailed.
Shelf Life	Passed verification specification criteria	Specific criteria not detailed.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document refers to "predetermined design performance criteria" and "verification specification criteria," implying product testing, but does not provide details on sample sizes for these tests.
Data Provenance: Not specified. These would be laboratory/engineering test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. No clinical study was performed requiring expert ground truth establishment for a test set. Design performance criteria would likely be established by engineers and product development teams.

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

Not Applicable. No clinical study was performed requiring adjudication of a test set.

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 (introducer sheath), not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted.

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 consensus, pathology, outcomes data, etc):

Not Applicable / Engineering Specifications. For the functional, packaging, sterilization, biocompatibility, and shelf-life tests, the "ground truth" would be established engineering and quality control specifications and industry standards for medical devices.

8. The sample size for the training set:

Not Applicable. No machine learning or AI training set was used. This is a physical medical device.

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

Not Applicable. No machine learning or AI training set was used.

Summary of the Study:

The "study" described in the 510(k) summary is a series of engineering and quality assurance tests ("functional, packaging, sterilization, biocompatibility, and shelf life tests"). These tests were performed to demonstrate that the modified Engage TR Introducer meets "predetermined design performance criteria" and "verification specification criteria," thus confirming its substantial equivalence to previously cleared predicate devices. The modifications were considered minor enough that no new animal or clinical data was required by the FDA for this submission. The core of the submission relies on the "substantially equivalent" principle, where the device's technical characteristics and intended use are compared to existing, legally marketed devices.

Summary

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K093130

NOV - 4 2009

Section 4. 510(k) Summary

Applicant Information 4.1

Submitted by: St. Jude Medical 6500 Wedgwood Road Maple Grove, MN 55311

Contact Person:	Linh Pham
Telephone:	763-383-2586
Fax:	763-383-2559
Date Prepared:	1 October, 2009

Device Information 4.2

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

4.3 Device Description

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Engage TR Introducer has HPC coating on the sheath and it is compatible with 0.025" guidewires.

The Engage device consists of two primary components: the Hemostasis sheath assembly and the dilator. The Hemostasis sheath assembly is the vessel access device and the dilator fits inside the sheath providing support. The dilator lumen is designed to provide a close fit to appropriately sized guidewire. At the proximal end of the Hemostasis sheath is a snap-lock hub which is equipped with a Hemostasis valve and side port with approximately 8 cm of tubing attached and ending with a 3-way stopcock. Some of the Engage devices are packaged with FDA cleared devices such as guidewires and needles.

4.4 Intended Use

There is no change to the intended use of the modified Engage TR Inroducer as it is identical to the predicate Engage/Engage TR Introducer, K091137-April 22, 2009.

Predicate Device Comparison/Technological Characteristics 4.5

The modified Engage TR Introducer included in this Special 510(k) submission shares the same intended use as the predicate Engage/Engage TR Introducer (K091137, April, 22, 2009), which is indicated for 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. The modified Engage TR Introducer, covered by this submission, is substantially equivalent to the St. Jude Medical Engage/Engage TR Introducer (K091137. April, 22, 2009), Ultimum Hemostasis Introducer (K001346. May 24. 2000), Strada Carotid Guiding Sheath, (K070166, April 06, 2007), and Fast Cath Hemostasis Introducer (K914090, October 28, 1991).

St. Jude Medical Engage TR Introducer Special 510k

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The modifications to the Engage TR Introducer do not affect the intended use of the system and there is no alteration in the fundamental scientific technology of the device. The Engage TR Introducer covered by this Special 510(k) submission is similar in function and technological characteristics, mechanism of action and intended use as the market cleared predicated devices, Engage TR Introducer, Ultimum Hemostasis Introducer, Strada Carotid Guiding Sheath (K070166, April 06, 2007), and Fast-Cath Introducer (K091137, K001346, K070166 & K914090).

Test Summary 4.6

The Engage TR Introducer product family is required to pass predetermined design performance criteria. The summary of Engage TR test performance data is provided in this 510k submission. Based on passing verification specification criteria for functional, packaging, sterilization, biocompatibility, and shelf life tests, the Engage TR Introducer performs substantially equivalent to predicate devices. Given the scope of the modifications incorporated to create the proposed Engage TR Introducer, no additional animal or clinical data was deemed necessary.

4.7 Substantial Equivalence

The Engage TR Introducer covered by this submission is substantially equivalent to the previously cleared Engage TR Introducer (K091137, April, 22, 2009), Ultimum Hemostasis Introducer (K001346, May 24, 2000), Strada Carotid Guiding Sheath (K070166, April 06, 2007), and Fast Cath Hemostasis Introducer (K914090, October 28, 1991), given equivalent intended use, principles of operation and similar technological characteristics.

4.8 Conclusion

In conclusion, the modified Engage/Engage TR Introducer is substantially equivalent to the market cleared Engage/Engage TR Introducer, Ultimum Hemostasis Introducers, and Fast Cath Hemostasis Introducer (K091137, K001346, K070166 & K914090 respectively).

4-3

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol on the right, which is a common emblem associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

St. Jude Medical c/o Ms. Lynh Pham 6500 Wedgewood Road Maple Grove, MN 55311

NOV - 4 2009

Re: K093130

Engage™ TR Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 2, 2009 Received: October 5, 2009

Dear Ms. Pham:

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 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 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.

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Page 2 -- Ms. Linh Pham

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

una R. v.dines

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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Section 3. Indication For Use

K09313D 510(k) Number:

Device Name: Engage™ TR Introducer

Indication for Use:

Prescription Use . X (Part 21 CFR 801 Subpart D)

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)

MAMIE R. VASSAR

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko 931 3 C

St. Jude Medical Engage TR Introducer Special 510k 3-1

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).