The Reprocessed ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

Device Description

The Reprocessed ViewFlex Xtra ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to visualize cardiac structures and blood flow within the heart. The Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The Reprocessed ViewFlex Xtra ICE Catheter shaft is a 9 French catheter with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64- element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for leftto-right and anterior-to-posterior deflection. The handle of the catheter has two deflection mechanisms that correspond with movement of the distal shaft in the four planes of movement. The Reprocessed ViewFlex Xtra Ice Catheter is compatible with ViewMate Z or ViewMate and Philips CX50 ultrasound consoles via the use of a compatible ViewFlex Catheter interface module.

AI/ML Overview

The provided text is a 510(k) summary for a reprocessed medical device, specifically a Reprocessed ViewFlex Xtra ICE Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against detailed acceptance criteria for a new AI or diagnostic device.

Therefore, many of the requested elements (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not applicable to this document as it describes a reprocessed catheter and not a new diagnostic algorithm or AI system.

However, I can extract the relevant information regarding performance testing that was conducted to demonstrate the reprocessed device's safety and effectiveness.

Here's a breakdown of what can be extracted, and where limitations exist based on the document:

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

The document describes the types of tests performed to demonstrate that the reprocessed device performs "as originally intended" and is "effectively identical" to the predicate. It does not provide specific quantitative acceptance criteria or detailed numerical performance results for these tests. The conclusion states the device is "at least as safe and effective as the predicate device," implying it met internal standards for each test.

Test Category	Reported Device Performance	Acceptance Criteria (Not explicitly stated in document)
Biocompatibility	Passed (implied by conclusion of safety and effectiveness)	(Not detailed, but typically involve ISO 10993 compliance)
Validation of Reprocessing	Passed (implied by conclusion of safety and effectiveness)	(Not detailed, but involves demonstrating proper cleaning, disinfection/sterilization, and restoration of function)
Sterilization Validation	Passed (implied by conclusion of safety and effectiveness)	(Not detailed, but involves demonstrating sterility assurance level)
Functional Performance Tests	"demonstrates that Reprocessed ViewFlex device perform as originally intended."	(Not detailed, would involve specific mechanical and operational parameters)
Acoustic Testing	Passed (implied by conclusion of safety and effectiveness)	(Not detailed, would involve ultrasound image quality and output parameters)
Electrical Safety Testing	Passed (implied by conclusion of safety and effectiveness)	(Not detailed, but typically involves IEC 60601 standards)
Electromagnetic Compatibility Testing	Passed (implied by conclusion of safety and effectiveness)	(Not detailed, but typically involves IEC 60601-1-2 standards)
Packaging Validation	Passed (implied by conclusion of safety and effectiveness)	(Not detailed, but involves maintaining sterility and product integrity)

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

Sample Size: Not specified. The document states "Each individual device is tested for appropriate function" during reprocessing, and that bench and laboratory testing was conducted. This implies testing on a statistically relevant sample of reprocessed devices, but the exact number isn't given.
Data Provenance: Not applicable in the context of this device and the types of tests described. These are laboratory/bench tests, not clinical data sets from patients.

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. This document describes engineering and laboratory testing for a reprocessed catheter, not a diagnostic algorithm that requires expert ground truth for interpretation.

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

Not applicable. Adjudication methods are used for interpreting clinical data, particularly in a reader study or when establishing ground truth from multiple experts. This is not relevant for bench testing of a catheter.

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 reprocessed catheter, not an AI or diagnostic imaging device. No MRMC study was mentioned or would be relevant for this type of submission.

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

Not applicable. There is no algorithm; this is a physical medical device.

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

Not applicable. The "ground truth" for these engineering tests would be established by validated test methods, adherence to specifications, and comparison to the original device's performance, as measured by calibrated equipment and documented procedures. For instance, the ground truth for electrical safety is adherence to established electrical safety standards.

8. The sample size for the training set:

Not applicable. This is a reprocessed physical device, not an AI model requiring a training set.

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

Not applicable. As above, no training set for an AI model is involved.

Summary of the Study:

The study described is a series of bench and laboratory tests designed to confirm that the Reprocessed ViewFlex Xtra ICE Catheter is safe and effective and performs "as originally intended," thereby demonstrating substantial equivalence to the predicate device.

The tests included:

Biocompatibility
Validation of Reprocessing
Sterilization Validation
Functional Performance Tests
Acoustic Testing
Electrical Safety Testing
Electromagnetic Compatibility Testing
Packaging Validation

The specific detailed results or quantitative acceptance criteria for each test are not provided in this summary document, only the general statement that the testing "demonstrates that Reprocessed ViewFlex device perform as originally intended" and that the device is "at least as safe and effective as the predicate device." The study essentially aims to prove that the reprocessing process does not negatively impact the device's original validated performance and safety characteristics.

Summary

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May 8, 2019

Stryker Sustainability Solutions Ramona Kulik Staff Specialist Regulatory Affairs 1810 West Drake Drive Tempe. Arizona 85283

Re: K182238

Trade/Device Name: Reprocessed ViewFlex Xtra ICE Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWQ Dated: April 3, 2019 Received: April 4, 2019

Dear Ramona Kulik:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bram Zuckerman, M.D. Director Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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The following device model is included in the scope of this 510(k) submission:

Model Number	Description	Useable Length	French Size
D087031	Reprocessed ViewFlex Xtra ICECatheter	90 cm	9F

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Indications for Use

510(k) Number (if known) K182238

Device Name

Reprocessed ViewFlex™ Xtra ICE Catheter

Indications for Use (Describe)

The Reprocessed ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

Type of Use (Select one or both, as applicable)

XJ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5: 510(k) SUMMARY

Submitter:

Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283

Contact:

Ramona Kulik Staff Regulatory Affairs Specialist 480-763-2952 (o) 480-763-2965 (f) ramona.kulik@stryker.com

August 17, 2018 Date of Preparation:

Name of Device:

Trade/Proprietary Name:	Reprocessed ViewFlex™ Xtra ICE Catheter
Common Name:	Diagnostic Intravascular Catheter
Classification Information:	Class: IIRegulation Number: 21 CFR 870.1200Product Code: OWO

Predicate Devices:

Model	510(k)	510(k) Title	Original
Number	Number		Manufacturer
D087031	K133853	VIEWFLEX XTRA ICE CATHETER	IrvineBiomedicalInc. A St. JudeMedicalCompany

Device Description:

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The model number included in the scope of this submission is as follows:

ModelNumber	Description	Useable Length	French Size
D087031	Reprocessed ViewFlex Xtra ICECatheter	90 cm	9F

Intended Use:

The Reprocessed ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

Summary of Technological Characteristics:

The design, materials, and intended use of Reprocessed ViewFlex Xtra ICE Catheter are equivalent to the predicate device. The mechanism of the reprocessed device is identical to the predicate device 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 ViewFlex Xtra ICE Catheter includes removal of adherent visible soil and decontamination. Each individual device 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 (safety and effectiveness) of Reprocessed ViewFlex Xtra ICE Catheter. This included the following tests:

Biocompatibility .
Validation of Reprocessing
Sterilization Validation
. Functional Performance Tests
Acoustic Testing
. Electrical Safety Testing
Electromagnetic Compatibility Testing
Packaging Validation .

The functional performance testing demonstrates that Reprocessed ViewFlex device perform as originally intended.

The Reprocessed ViewFlex Xtra ICE Catheter is reprocessed no more than one (1) time. Each reprocessed device is tracked with a serial number label which is affixed to the cable. Once the device reaches the maximum number of reprocessing cycles, it is rejected and taken out of service. Reprocessing is conducted only by Stryker Sustainability Solutions. Stryker Sustainability Solutions restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

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Conclusion:

Stryker Sustainability Solutions concludes that the Reprocessed ViewFlex Xtra ICE Catheter is at least as safe and effective as the predicate device as described herein.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).