The reprocessed ViewFlex™ Xtra ICE catheter is 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 accurately visualize cardiac structures, blood flow and other devices within the heart when connected to a compatible intracardiac ultrasound console via the compatible ViewFlex™ Catheter Interface Module. Examples of the types of other devices that can be visualized include, and are not limited to, intracardiac catheters, septal occluders, delivery wires, delivery sheaths, sizing balloons and transseptal needles. The use of these images is limited to visualization with no direct or indirect diagnostic use.
The Reprocessed ViewFlex™ Xtra ICE catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in each direction.

AI/ML Overview

The provided text describes the regulatory clearance for a reprocessed medical device, specifically the Reprocessed ViewFlex™ Xtra ICE Catheter (K190478). This document primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical performance and safety tests. It does not pertain to an AI/ML-driven device or a study involving human readers or efficacy in diagnosing conditions. Therefore, many of the requested categories in the prompt are not applicable.

Here's an analysis based on the information available:

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

The document details various tests performed to ensure the reprocessed device is substantially equivalent to the original predicate device. The "acceptance criteria" are implied to be that the reprocessed device performs "as originally intended" and meets the same functional and safety characteristics as the new, original (OEM) device.

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance
Cleaning Validation	Cleaning Validation	Demonstrated appropriate functional characteristics and validated cleaning procedures.
Sterilization Assurance	Sterilization Verification	Validated sterilization procedures.
Biocompatibility	Ethylene Oxide Residual Testing (ISO 10993-7)	Confirmed acceptable residual levels.
	Cytotoxicity	Met biocompatibility requirements per ISO 10993-1.
	Sensitization	Met biocompatibility requirements per ISO 10993-1.
	Irritation/Intracutaneous Reactivity	Met biocompatibility requirements per ISO 10993-1.
	Acute Systemic Toxicity	Met biocompatibility requirements per ISO 10993-1.
	Pyrogenicity	Met biocompatibility requirements per ISO 10993-1.
	Hemocompatibility	Met biocompatibility requirements per ISO 10993-1.
	Thrombogenicity	Met biocompatibility requirements per ISO 10993-1.
Packaging & Shelf-life	Packaging Validation (ASTM D4169, ASTM F88, ASTM F2096)	Validated packaging procedures.
	Shelf-life Validation (ASTM 1980-07)	Validated shelf-life.
Functional Performance	Electrical Leakage	Performed as originally intended.
(Bench Testing)	Torsional Strength	Performed as originally intended.
	Flexation Fatigue	Performed as originally intended.
	Fluid Integrity	Performed as originally intended.
	Joint Bond Strength	Performed as originally intended.
	Deflection Fatigue	Performed as originally intended.
	Stiffness	Performed as originally intended.
	Tip Buckling	Performed as originally intended.
	Transducer Sensitivity	Performed as originally intended.
	Ultrasound console compatibility	Compatible with listed consoles (ViewMate™ II, ViewMate™ Z, ViewMate™, Philips CX50a).
	Acoustic Output	Performed as originally intended.
	Thermistor Functionality	Performed as originally intended.
Manufacturing Process	Visual and validated functional testing of all products	Included in the manufacturing process to ensure product quality.
Device Tracking	Reprocessed device is marked and tracked	Ensures the device is rejected from further reprocessing after one cycle, indicating control over reprocessing limits.
Overall Conclusion	Substantial Equivalence to Predicate Device (K133853)	Performance testing demonstrated substantial equivalence to the predicate device and did not raise different questions in safety or effectiveness.

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

The document does not specify exact sample sizes for each particular test (e.g., number of catheters tested for electrical leakage). It refers to "representative samples of reprocessed devices" for functional testing. The data provenance is implied to be from internal lab testing conducted by Sterilmed, Inc. No information on country of origin or retrospective/prospective nature of the testing is provided beyond it being part of the 510(k) submission process for a reprocessed device.

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)

This is not applicable. The study described is a non-clinical, bench-top engineering and biocompatibility study comparing a reprocessed device to a new device, not a diagnostic study requiring expert interpretation of medical images or data. Therefore, there is no "ground truth" established by medical experts for a test set in the context of diagnostic accuracy.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies to resolve discrepancies in expert interpretation. This document describes physical, chemical, and functional engineering tests.

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

This is not applicable. The device is an intracardiac ultrasound catheter for visualization, not an AI-driven diagnostic tool that assists human readers. No MRMC study was performed.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" in this context is the performance and safety specifications of the original (OEM) predicate device (ViewFlex™ Xtra ICE Catheter, K133853). The reprocessed device is tested to ensure it meets these established technical specifications and performance characteristics, demonstrating "substantial equivalence" rather than diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

This is not applicable. There is no AI/ML algorithm that requires a training set. The study involves reprocessed physical devices.

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

This is not applicable. There is no AI/ML algorithm or training set.

Summary

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November 14, 2019

Sterilmed, Inc. Jan Flegeau Associate Director, Regulatory Affairs 5010 Cheshire Pkwy N. Suite 2 Plymouth, Minnesota 55446

Re: K190478

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: October 9, 2019 Received: October 10, 2019

Dear Jan Flegeau:

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/cfpmn/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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole Gillette Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices 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	ReprocessedViewFlex™ Xtra ICECatheter	90 cm	9F

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Indications for Use

510(k) Number (if known) K190478

Device Name Reprocessed ViewFlex™ Xtra ICE catheter

Indications for Use (Describe)

The reprocessed ViewFlex™ Xtra ICE catheter is 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Date Prepared:	November 14, 2019
Submitter andManufacturer:	Sterilmed, Inc.5010 Cheshire Parkway N, Suite 2Plymouth, MN 55446www.sterilmed.com
ManufacturingFacility Address:	11400 73rd AvenueNorth Maple GroveMN 55369
OfficialCorrespondent:	Jan FlégeauAssociate Director, Regulatory AffairsSterilmed, Inc.Tel: 786-575-5903Email: jflegeau@its.jnj.com
Trade Name:	Reprocessed ViewFlex™ Xtra ICE catheter
Regulation Name:	Diagnostic Intravascular Catheter
Device Classification:	Class II
Product Code	OWQ
Predicate Device:	ViewFlex™ Xtra ICE Catheter (K133853)
Device Description:	The Reprocessed ViewFlex™ Xtra ICE catheter is a temporaryintracardiac ultrasound catheter intended for use in patients toaccurately visualize cardiac structures, blood flow and otherdevices within the heart when connected to a compatibleintracardiac ultrasound console via the compatible ViewFlex™Catheter Interface Module. Examples of the types of otherdevices that can be visualized include, and are not limited to,intracardiac catheters, septal occluders, delivery wires,delivery sheaths, sizing balloons and transseptal needles. Theuse of these images is limited to visualization with no direct orindirect diagnostic use.The Reprocessed ViewFlex™ Xtra ICE catheter has a useablelength of 90 cm, with a 9 French (F) shaft with an ultrasoundtransducer. A10F introducer is recommended for use with thiscatheter for insertion into the femoral or jugular veins. Thecatheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of atleast 120 degrees in each direction.

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The reprocessed ViewFlex™ Xtra ICE catheter is compatiblewith the ultrasound consoles listed in the table below. See tablebelow for specifics on each ultrasound console.
Compatible UltrasoundConsole*	ViewMate™ II	ViewMate™ Zor ViewMate™	PhilipsCX50a
Compatible ViewFlex™Catheter Interface Module	100038191	H701374100043720	H701375H700296
Maximum Viewing Depth*All consoles are not available in all countries.	18 cm	18 cm	18 cm
Model Number	RD087031
Indications For Use:	The Reprocessed ViewFlex™ Xtra ICE catheter is indicated foruse in adult and adolescent pediatric patients to visualizecardiac structures, blood flow and other devices within theheart.
TechnologicalCharacteristics:	The Reprocessed ViewFlex™ Xtra ICE catheter has the sametechnological and performance characteristics as the predicatedevice (K133853). The catheter is connected to a compatibleultrasound console via the appropriate Catheter InterfaceModule (CIM). Clinically, these devices are most often insertedinto a vein and advanced into the heart. A small incision ismade in the skin, usually in the groin or neck area, then a needleand introducer sheath are used to puncture the vein. Thecatheter is inserted and manipulated through the sheath into thevein until appropriately positioned. The ultrasound transduceron the tip of the catheter is then used to visualize cardiacstructures, blood flow and other devices within the heart.
Functional and SafetyTesting:	Representative samples of reprocessed devices were tested todemonstrate appropriate functional characteristics. Processvalidation testing was performed to validate the cleaning andsterilization procedures as well as device packaging. Inaddition, the manufacturing process includes visual andvalidated functional testing of all products produced. Thereprocessed ViewFlex™ Xtra ICE catheter is marked andtracked through the reprocessing cycle. After the device hasbeen reprocessed one (1) time, it is rejected from furtherreprocessing.
Summary ofNon-Clinical TestsConducted:	Specific non-clinical tests performed included: cleaningvalidation, sterilization verification, ethylene oxide residualtesting (ISO 10993-7), packaging validation (ASTM D4169,ASTM F88, ASTM F2096), and shelf-life validation (ASTM1980-07). In addition, validation of functional performance(bench testing) was performed through simulated use, visualinspection, and fatigue testing.

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	Testing performed:• Electrical Leakage• Torsional Strength• Flexation Fatigue• Fluid Integrity• Joint Bond Strength• Deflection Fatigue• Stiffness• Tip Buckling• Transducer Sensitivity• Ultrasound console compatibility• Acoustic Output• Thermistor FunctionalityPerformance testing shows the reprocessed ViewFlex™ Xtra ICE catheter to perform as originally intended.In addition, the device was tested for biocompatibility per ISO 10993-1 for external communicating device, short duration contact with circulating blood (<24 hours).Biocompatibility testing included:• Cytotoxicity• Sensitization• Irritation/Intracutaneous Reactivity• Acute Systemic Toxicity• Pyrogenicity• Hemocompatibility• Thrombogenicity
Conclusion:	Sterilmed conducted performance testing (described above) for the Reprocessed ViewFlex™ Xtra ICE catheter against the OEM predicate device, ViewFlex™ Xtra ICE catheter (K133853). Results demonstrated substantial equivalence to the predicate devices and does not raise different questions in safety or effectiveness.Sterilmed therefore concludes that the Reprocessed ViewFlex™ Xtra ICE catheter is substantially equivalent to the predicate device, ViewFlex™ Xtra ICE catheter.

Testing performed:• Electrical Leakage• Torsional Strength• Flexation Fatigue• Fluid Integrity• Joint Bond Strength• Deflection Fatigue• Stiffness• Tip Buckling• Transducer Sensitivity• Ultrasound console compatibility• Acoustic Output• Thermistor FunctionalityPerformance testing shows the reprocessed ViewFlex™ Xtra ICE catheter to perform as originally intended.In addition, the device was tested for biocompatibility per ISO 10993-1 for external communicating device, short duration contact with circulating blood (<24 hours).Biocompatibility testing included:• Cytotoxicity• Sensitization• Irritation/Intracutaneous Reactivity• Acute Systemic Toxicity• Pyrogenicity• Hemocompatibility• Thrombogenicity

Conclusion:

Sterilmed conducted performance testing (described above) for the Reprocessed ViewFlex™ Xtra ICE catheter against the OEM predicate device, ViewFlex™ Xtra ICE catheter (K133853). Results demonstrated substantial equivalence to the predicate devices and does not raise different questions in safety or effectiveness.Sterilmed therefore concludes that the Reprocessed ViewFlex™ Xtra ICE catheter is substantially equivalent to the predicate device, ViewFlex™ Xtra ICE catheter.

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The following device is included in the 510(K) submission:

Device Name	OEM ModelNumber	Sterilmed CatalogNumber	System Compatibility
ReprocessedViewFlex™ XtraICE Catheter	D087031	RD087031	ViewMate™ II
ReprocessedViewFlex™ XtraICE Catheter	D087031	RD087031	ViewMate™ Z
ReprocessedViewFlex™ XtraICE Catheter	D087031	RD087031	ViewMate™
ReprocessedViewFlex™ XtraICE Catheter	D087031	RD087031	Philips CX50

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).