The Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only not treatment delivery, during cardiac interventional percutaneous procedures.

Device Description

The Medline ReNewal Reprocessed Siemens AcuNav Diagnostic Ultrasound Catheters 10F are licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheters are to be used only on systems with which they have been tested and found compatible.

AI/ML Overview

This document is a 510(k) premarket notification for a reprocessed medical device, specifically an ultrasound catheter, not a new device involving AI or complex software. As such, the information requested in your prompt regarding acceptance criteria and studies that prove a device meets acceptance criteria specifically for AI/Software performance is not present in this document.

The 510(k) submission for the Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F focuses on demonstrating substantial equivalence to a predicate device (the original, single-use Siemens AcuNav Diagnostic Ultrasound Catheter). This is achieved through non-clinical testing to show that the reprocessed device performs as safely and effectively as the original.

Therefore, many of the specific points you've asked for, such as sample size for a test set for AI performance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and ground truth for training data, are not applicable to this type of device and submission.

However, I can extract information related to the non-clinical testing performed to establish substantial equivalence for this reprocessed device, which serves as its "proof" of meeting performance criteria.

Here's an interpretation based on the provided document:

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

The document doesn't present a formal table of quantitative acceptance criteria with numerical performance data. Instead, it lists the types of non-clinical tests performed to demonstrate that the reprocessed device's functional characteristics are substantially equivalent to the predicate device. The implied acceptance criterion for each test is that the reprocessed device performs comparably to the original to ensure safety and effectiveness.

Test Category	Implied Acceptance Criterion	Reported Device Performance
Functional Performance	Equivalent to predicate; safe and effective in intended use.	"evaluated and found to be substantially equivalent"
Simulated Use	Function similar to original in a simulated environment.	Performed, result is substantial equivalence.
Artificial Soiling	Cleaning processes effective after simulated contamination.	Performed, result is substantial equivalence.
Visual Inspection	No detrimental changes or defects after reprocessing.	Performed, result is substantial equivalence.
Mechanical Characteristics	Maintains physical integrity and functionality.	Performed, result is substantial equivalence.
Ultrasound Transducer Testing	Acoustic performance equivalent to original.	Performed, result is substantial equivalence.
Dimensional Analysis	Dimensions remain within specified tolerances.	Performed, result is substantial equivalence.
Device Functionality	Performs all intended functions.	Performed, result is substantial equivalence.
Electrical Safety	Meets dielectric and current leakage standards.	Performed; "dielectric and current leakage"
Cleaning Validation	Effective removal of contaminants.	Performed
Biocompatibility	No adverse biological reactions.	Performed
Sterilization Validation	Achieves required sterility assurance level (SAL).	Performed ("bioburden testing; ethylene oxide and ethylene chlorohydrin residuals testing; and bacteriostasis/fungistasis")
Packaging and Shelf Life Validation	Maintains integrity and sterility over shelf life.	Performed
Product Stability	Remains stable over time.	Performed

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

Sample Size for Test Set: The document does not specify the exact number of units/samples used for each type of non-clinical test. This level of detail is typically found in the full testing reports submitted to the FDA, not in the public 510(k) summary.
Data Provenance: The tests were conducted by Medline ReNewal. While not explicitly stated, such tests are generally conducted at their facilities or certified labs. The country of origin of the data would be the USA (Oregon, specifically, as per the address). The data is prospective in the sense that Medline ReNewal specifically conducted these tests to support this 510(k) submission for their reprocessed device.

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

Not applicable. This relates to AI/software performance evaluation where human experts establish ground truth for image interpretation or diagnosis. For a reprocessed physical device, "ground truth" is established by adherence to engineering specifications, performance standards, and established test methodologies (e.g., AAMI standards for sterilization, ISO standards for biocompatibility). The "experts" involved would be engineers, microbiologists, and other technical personnel who design and execute these tests, and interpret the results against pre-defined success criteria.

4. Adjudication method for the test set:

Not applicable. This refers to consensus-building among medical experts for labeling data, which is not relevant for the physical performance testing of a reprocessed medical device. Test results are compared against objective criteria and engineering 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:

Not applicable. This type of study is relevant for AI-powered diagnostic devices. This submission is for a reprocessed ultrasound catheter.

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

Not applicable. This refers to the performance of a software algorithm.

7. The type of ground truth used:

For this reprocessed device, "ground truth" is based on engineering specifications, established performance standards (e.g., mechanical strength, electrical safety, acoustic performance), and validated manufacturing processes (e.g., cleaning efficacy, sterilization efficacy). The original predicate device's performance also serves as a benchmark for comparison.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set."

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 10, 2025

Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) Stephanie Boyle Mays Senior Regulatory Affaiirs Specialst, QA/RA 1500 NE Hemlock Ave. Redmond, Oregon 97756

Re: K243101

Trade/Device Name: Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWQ Dated: February 12, 2025 Received: February 12, 2025

Dear Stephanie Boyle Mays:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director 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 devices are included in the scope of this 510(k) premarket notification:

OEM Model No.	Transducer	Curve	Size(cm)
Siemens ACUSON AcuNav Ultrasound Catheter 10F
08255790	Siemens Systems, 64 elementphased array	Four-way tip deflection,anterior/posterior, left/right	10F x 90
10043342	GE Systems, 64 element phasedarray	Four-way tip deflection,anterior/posterior, left/right	10F x 90

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Indications for Use

Submission Number (if known)

K243101

Device Name

Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F (for Siemens Systems) (08255790);

Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F (for GE Systems) (10043342)

Indications for Use (Describe)

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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Image /page/5/Picture/1 description: The image shows the Medline Renewal logo. The word "Renewal" is written in a combination of green and blue colors, with the "Re" in green and the "newal" in blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in blue. To the left of the word "Renewal" is the Medline logo, which consists of a blue square with a white star-like symbol and the word "MEDLINE" in white.

Traditional 510(k) Notification

Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Čatheter 10F

510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.

Submitter/Owner	Surgical Instrument Service and Savings Inc. (dba MedlineReNewal) 1500 NE Hemlock Ave., Redmond, OR 97756
Contact/Prepared by	Stephanie Boyle MaysSenior Specialist, Regulatory Affairs Quality AssuranceP: 541-516-4205 • F: 541-923-3375 • smays@medline.com
Date Prepared	September 27, 2024
Device Nameand	Proprietary/TradeName:	Medline ReNewal Reprocessed Siemens ACUSONAcuNav Ultrasound Catheter 10F (for SiemensSystems) (08255790); Medline ReNewal ReprocessedSiemens ACUSON AcuNav Ultrasound Catheter 10F(for GE Systems) (10043342)
Classification	Common or UsualName	Ultrasound catheter, reprocessed
	RegulatoryName/Reference	Reprocessed intravascular, ultrasound catheter,21 CFR § 870.1200
	Regulatory Class	2
	Product Code	OWQ
	Panel	Cardiovascular
	Predicateselection rationale	The predicate models in K170263 include the subjectdevice models of this submission. The predicate devicesand subject devices are the same except the subjectdevices have been reprocessed.
	510(k) Number	K170263
PredicateDevice	Proprietary orTrade Name	AcuNav Diagnostic Ultrasound Catheter 8F, 10F
	Common or UsualName	Ultrasound catheter
	RegulatoryName/Reference	Catheter, ultrasound, intravascular21 CFR § 870.1200
	Regulatory Class	2
	Product Code	OBJ
	Panel	Cardiovascular
	510(k) applicant	Siemens Medical Solutions, 685 E. Middlefield Rd.,Mountain View, CA 94043
DeviceDescription	The Medline ReNewal Reprocessed Siemens AcuNav Diagnostic UltrasoundCatheters 10F are licensed for single use only. The catheter is optimized forintracardiac scanning. With the catheter, the physician can maneuver the
	imaging plane located inside the catheter tip to see the region of interest. Thephysician can steer the catheter to optimize tissue visualization.The catheters are to be used only on systems with which they have beentested and found compatible.
TechnologicalCharacteristics	The technological characteristics, materials, and the fundamental scientifictechnology of the subject device is equivalent to the predicate device. Thesubject device is a reprocessed version of the predicate device. Each deviceis marked, tracked, and taken out of service once the maximum number ofcycles has been reached. K170263 AcuNav Diagnostic Ultrasound Catheterwas used as the primary predicate to support intended use, technological
Non-clinicalTestingSummary	characteristics, and functional performance specifications.The functional characteristics of the subject device have been evaluated andfound to be substantially equivalent to the predicate device based on thefollowing tests:Functional performance: simulated use and artificial soiling; visual inspection; mechanical characteristics; ultrasound transducer testing; dimensional analysis; and device functionality Electrical Safety dielectric and current leakage Cleaning Validation Biocompatibility Sterilization Validation bioburden testing; ethylene oxide and ethylene chlorohydrin residuals testing; and bacteriostasis/fungistasis Packaging and shelf life validation Product stability
Summary Table: Predicate and Medline ReNewal Reprocessed Siemens ACUSON AcuNavDiagnostic Ultrasound Catheter comparison chart.
	Predicate	Proposed	Comparison
DeviceCharacteristics	Siemens Medical SolutionsAcuNav DiagnosticUltrasound Catheter	Medline ReNewalReprocessed SiemensACUSON AcuNavDiagnostic UltrasoundCatheter 10F	As Stated
510(k)	K170263	K243101	N/A
Model Numbers	10135936 and 10135910, 8F08255790 and 10043342, 10F	08255790 and 10043342, 10F	As stated
Common Name	Ultrasound catheter	Ultrasound catheterReprocessed	As stated
Regulation No.	21 CFR § 870.1200	21 CFR § 870.1200	Same

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K243101

Image /page/6/Picture/1 description: The image shows the Medline Renewal Full Circle Reprocessing logo. The Medline logo is on the left side of the image and is a blue square with a white cross inside. The Renewal logo is on the right side of the image and is green and blue. Underneath the Renewal logo is the text "Full Circle Reprocessing".

Traditional 510(k) Notification

Medline ReNewal Reprocessed ACUSON AcuNav 10F Ultrasound Catheter

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Image /page/7/Picture/1 description: The image contains the Medline Renewal logo. The Medline logo is on the left side of the image and consists of a blue square with a white cross inside. The word "MEDLINE" is written in white letters inside the blue square. To the right of the Medline logo is the word "Renewal" in green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in blue letters.

Traditional 510(k) Notification Medline ReNewal Reprocessed ACUSON AcuNav 10F Ultrasound Catheter

RegulatoryClass	2	2	Same
Product Code	OBJ	OWQ	As stated
Indications forUse	The catheter is intended forintra-cardiac and intra-luminalvisualization of cardiac andgreat vessel anatomy andphysiology as well asvisualization of other devicesin the heart of adult andpediatric patients. The catheteris intended for imagingguidance only, not treatmentdelivery, during cardiacinterventional percutaneousprocedures.	The Medline ReNewalReprocessed SiemensACUSON AcuNav DiagnosticUltrasound Catheter isintended for intra-cardiac andintra-luminal visualization ofcardiac and great vesselanatomy and physiology aswell as visualization of otherdevices in the heart of adultpatients. The catheter isintended for imaging guidanceonly, not treatment delivery,during cardiac interventionalpercutaneous procedures.	Same
TechnologicalCharacteristicsa	To operate, the device isconnected to a compatibleconsole (ACUSON, Vivid I,Vivid q) via a compatiblemodule interface.	To operate, the device isconnected to a compatibleconsole (ACUSON, Vivid I,Vivid q) via a compatiblemodule interface.	Same
Reprocessing	Each catheter is reprocessed no more than one time. Medline ReNewal doesnot reprocess the catheters of other reprocessors.
Conclusion	The predicate and subject devices in this application have the same indicationsfor use and technological characteristics. Based on this and the non-clinicaltesting data presented in this 510(k) submission, the Medline ReNewalReprocessed AcuNav Ultrasound Catheter 10F models 08255790 and10043342 are substantially equivalent to the predicate device.
aNeither K170263 nor the current submission included the consoles or any other systemcomponents as part of their respective submissions. Only devices 08255790 and 10043342 areincluded in the project scope.

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).