The Reprocessed Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Device Description

The Reprocessed Steerable Introducer Set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is filtered with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise less than or equal to 90 degrees. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

AI/ML Overview

The provided text describes a 510(k) submission for a Reprocessed Steerable Introducer. This document is a premarket notification to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in the same way a novel device might.

Therefore, many of the requested elements (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth for a novel AI/diagnostic device) are not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a reprocessed device seeking 510(k) clearance, the "acceptance criteria" are primarily that the reprocessed device performs, as originally intended, equivalently to the predicate device, and that the reprocessing method is validated and does not compromise safety or efficacy. The reported "performance" focuses on demonstrating this equivalence through various tests.

Acceptance Criteria (Implicit for Reprocessed Device)	Reported Device Performance
Material/Design Equivalence to Predicate	The design, materials, and intended use are identical to predicate devices. The mechanism is identical, utilizing the same standard mechanical design, materials, and sizes. No changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation.
Biocompatibility (Device remains biocompatible after reprocessing)	Biocompatibility testing was conducted.
Validation of Reprocessing (Reprocessing renders device safe and functional)	Validation of reprocessing was conducted. Each individual Introducer is tested for appropriate function of its components prior to packaging and labeling.
Sterilization Validation (Device remains sterile after reprocessing)	Sterilization Validation was conducted.
Functional Equivalence (Device performs as originally intended)	Function test(s) were conducted. Performance testing demonstrates that Reprocessed Steerable Introducer performs as originally intended.
Packaging Integrity (Packaging protects sterility and device integrity)	Packaging Validation was conducted.

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

Sample Size: Not explicitly stated. The document refers to "Bench and laboratory testing" and that "Each individual Introducer is tested for appropriate function." This implies a sample size determined by the validation protocols for reprocessing, biocompatibility, sterilization, and function, but specific numbers are not provided in this summary.
Data Provenance: Not applicable in the context of a clinical study. The data provenance here would relate to the in-house testing conducted by Stryker Sustainability Solutions during their reprocessing validation.

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

Not Applicable: This is a reprocessed medical device, not a diagnostic or AI device that requires expert-established ground truth on clinical images or data. The "ground truth" here is the original design specifications and performance of the predicate device, against which the reprocessed device's performance is compared through engineering and lab testing.

4. Adjudication Method for the Test Set

Not Applicable: There is no "adjudication method" in the sense of expert consensus on clinical cases. Performance is objectively measured against specifications through validated test methods.

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 not an AI/diagnostic device.

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

Not Applicable: This is not an AI/diagnostic device.

7. The Type of Ground Truth Used

Engineering Specifications and Predicate Device Performance: The "ground truth" for this reprocessed device is the original design specifications, material properties, and demonstrated performance characteristics of the predicate (original, new) devices. The testing aims to confirm that the reprocessed device meets these established performance benchmarks.

8. The Sample Size for the Training Set

Not Applicable: This is not an AI/diagnostic device that uses a "training set."

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

Not Applicable: This is not an AI/diagnostic device that uses a "training set."

Summary

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SECTION 5: 510(k) SUMMARY

JAN 2 4 2013

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Submitter:

Stryker Sustainability Solutions 1810 W Drake Dr Tempe, Arizona 85283

Contact:

Amanda Babcock Regulatory Affairs Lead (480) 763-5300 (o) (863) 904-2312 (f) amanda.babcock@stryker.com

Date of preparation: 24 October 2012

Name of device:

Trade/Proprietary Name: Reprocessed Steerable Introducer Classification Name: Catheter introducer

Predicate Device	510(k) Title	Manufacturer
K081645	AGILIS NxT Steerable Introducer (ModelG408324)	St. Jude Medical
K061363	AGILIS NxT Steerable Introducer	St. Jude Medical

Device Description:

Indications for Use:

The Reprocessed Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Technological Characteristics:

The design, materials, and intended use of Reprocessed Steerable Introducer are identical to the predicate devices. The mechanism of Reprocessed Steerable Introducer is identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of Steerable Introducer includes removal of adherent visible soil and decontamination. Each

Stryker Sustainability Solutions Reprocessed Steerable Introducer Traditional 510(k)

Page 13

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individual Introducer is tested for appropriate function of its components prior to packaging and labeling operations

Performance data:

Bench and laboratory testing was conducted to demonstrate performance of Reprocessed Steerable Introducer. This included the following tests:

� Biocompatibility
Validation of reprocessing ●
Sterilization Validation ●
Function test(s) �
Packaging Validation .

Performance testing demonstrates that Reprocessed Steerable Introducer perform as originally intended.

Conclusion:

Stryker Sustainability Solutions concludes that the modified devices (Reprocessed Steerable Introducer) are substantially equivalent to the predicate devices as described herein.

K12333

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

JAN 2 4 2013

Stryker Sustainability Solutions, Inc. c/o Amanda Babcock Regulatory Affairs Lead 1810 W Drake Dr Tempe, Arizona 85283

Re: K123334

Trade Name: Reprocessed Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: October 24, 2012 Received: October 26, 2012

Dear Ms. Babcock:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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 Of ICFR 807); as this (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 11 you active spec.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,

Matthew G. Hillebrenner

for

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 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known): )く1233334

Device Name: Reprocessed Steerable Introducer

Indications For Use: The Reprocessed Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.g. Willh

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K123334

Stryker Sustainability Solutions Reprocessed Steerable Introducer Traditional 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).