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 Introducer is essentially a modification of the previously cleared Engage/Engage TR/Ultimum introducer (K091137). The modified Engage 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 Introducer sheaths range in effective length from a nominal 12cm to a nominal 25cm. The Engage Introducer sheaths included in the scope of this submission range in sizes from 4-9F ACT (Active Clotting Time). Guidewire compatibility ranges from 0.035" to 0.038".

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 the St. Jude Medical Engage Introducer, focusing on establishing substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving a device meets specific performance metrics in the way a clinical trial or a machine learning algorithm validation study would.

This submission is for a medical device (an introducer catheter) that has undergone design modifications and asserts that these modifications do not alter its intended use or fundamental scientific technology. The review process for such a device primarily focuses on demonstrating that the modified device performs as safely and effectively as its predicate devices, rather than establishing new performance benchmarks with an AI component or complex diagnostic accuracy studies.

Therefore, many of the requested elements (like MRMC studies, standalone AI performance, ground truth for training sets, etc.) are not applicable to this type of device submission.

Here's a breakdown of the information that is available in the provided text, adapted to the request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission indicates that the device is "required to pass predetermined design performance criteria," but it does not list specific quantitative acceptance criteria or their corresponding reported performance values. Instead, it broadly states that the device passed various categories of tests:

Acceptance Criteria Category	Reported Device Performance
Functional	Passed verification criteria
Packaging	Passed verification criteria
Sterilization	Passed verification criteria
Biocompatibility	Passed verification criteria
Shelf Life	Passed verification criteria

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

The document states, "Based on passing verification criteria for functional, packaging, sterilization, biocompatibility, and shelf life tests, the Engage Introducer performs substantially equivalent to predicate devices. Given the scope of the modifications incorporated to create the proposed Engage Introducer, no additional animal or clinical data was deemed necessary."

This indicates that:

Sample Size for Test Set: Not applicable in the context of clinical or large-scale performance testing for this submission. The "test set" would refer to the specific units of the device subjected to the functional, packaging, sterilization, biocompatibility, and shelf life tests. The exact number of units tested for each category is not provided.
Data Provenance: The tests are likely performed by the manufacturer (St. Jude Medical) as part of their design verification process, not from external clinical data. The data is internal to the company and would be considered prospective for these internal tests.

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

This is not applicable as the evaluation herein is not based on expert-adjudicated ground truth like in a diagnostic study. The "ground truth" for the engineering tests would be the established specifications and standards for the device's physical and functional properties.

4. Adjudication method for the test set

This is not applicable as there is no human adjudication of diagnostic outcomes or image interpretation. The "adjudication" for the engineering tests would be by technical personnel verifying compliance with specifications.

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

An MRMC study is not applicable to this device. This is a physical medical device (an introducer catheter), not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

This is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used

For the functional, packaging, sterilization, biocompatibility, and shelf life tests, the "ground truth" is defined by predetermined design performance criteria and established industry standards for such medical devices, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable as there is no mention of an algorithm or AI system requiring a training set.

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

This is not applicable as there is no training set for an algorithm.

Summary

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K092575

Section 7. 510(k) Summary

7.1 Applicant Information

OCT - 8 2009

Submitted by:	St. Jude Medical6500 Wedgwood RoadMaple Grove, MN 5531
Contact Person:	Linh Pham
Telephone:	763-383-2586
Fax:	763-383-2559
Date Prepared:	14 August, 2009

Device Information 7.2

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

7.3 Device Description

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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.

7.4 Intended Use

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

7.5 Predicate Device Comparison/Technological Characteristics

The modified Engage Introducer included in this Special 510(k) submission shares the same intended use as the predicate Engage/Engage TR Introducer (K091137. Avril. 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, 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), and Fast Cath Hemostasis Introducer (K914090, October 28, 1991).

The modifications to the Engage device do not affect the intended use of the system and there is no alteration in the fundamental scientific technology of the device. The Engage 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/Engage TR Introducer and Ultimum Hemostasis Introducer, and Fast-Cath Introducer (K091137, K001346, & K914090).

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7.6 Test Summary

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

7.7 Substantial Equivalence

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

7.8 Conclusion

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

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

St. Jude Medical c/o Mr. Mark Job 1394 25th St. NW Buffalo, MN 55313

OCT - 8 2009

Re: K092575

Engage™ Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 19, 2009 Received: September 23, 2009

11:12

Dear Mr. Job:

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. 1

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Page 2 - Mr. Mark Job

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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

una R. vri Mner

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 6. Indication For Use

510(k) Number: K092575 Device Name: Engage™ 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)

sima R. Lames

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K092575

St. Jude Medical Engage Introducer 510(k)

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).