The Medline ReNewal Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheter is inteacardiac 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 AcuNav Diagnostic Ultrasound Catheters 8F 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

The provided text is a 510(k) summary for a reprocessed medical device, specifically an ultrasound catheter, and does not describe an AI/ML powered device. Therefore, information regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML powered device cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence of a reprocessed device to a legally marketed predicate device, primarily through non-clinical testing of functional performance, material characteristics, cleaning validation, biocompatibility, and sterilization validation. It does not contain details about a study evaluating an AI/ML algorithm's performance.

To answer your request, if this were an AI/ML powered device, the following information would typically be present in a separate study report or detailed within the 510(k) submission, and would not be found in a standard summary like the one provided:

Acceptance Criteria Table and Reported Performance: This would specify metrics like sensitivity, specificity, AUC, F1-score, accuracy, etc., and the target thresholds, along with the actual performance achieved by the AI model.
Sample Size and Data Provenance: Details on the number of cases/samples in the test set, and whether the data was retrospective or prospective, and its geographical origin.
Ground Truth Experts: The number and qualifications of experts who established the ground truth labels for the test set.
Adjudication Method: How discrepancies among experts were resolved (e.g., 2+1, 3+1, majority vote).
MRMC Comparative Effectiveness Study: If human readers were involved, details on a multi-reader, multi-case study to assess AI's impact on human performance, including effect sizes.
Standalone Performance: If the AI algorithm's performance was evaluated independently without human intervention.
Type of Ground Truth: The method used to establish the true diagnosis (e.g., expert consensus, biopsy, surgical findings, long-term outcomes).
Training Set Sample Size: The number of data points used to train the AI model.
Training Set Ground Truth: How the ground truth for the training data was established (often a multi-stage process, possibly involving automated methods, expert review, or existing clinical records).

In summary, the provided document relates to a reprocessed physical medical device and not an AI/ML enabled device. Therefore, it does not contain the information required to answer your specific questions about an AI/ML device's acceptance criteria and validation study.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.

September 10, 2024

Surgical Instrument Service and Savings Inc. (dba Medline Renewal) Stephanie Boyle Mays Senior Specialist, Regulatory Affairs Quality Assurance 1500 NE Hemlock Ave. Redmond, Oregon 97756

Re: K234064

Trade/Device Name: Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OWQ Dated: August 12, 2024 Received: August 12, 2024

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 Ouality 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.

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-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.

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director

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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 item numbers included in the scope of this submission are as follows:

OEM ModelNo.	Transducer	Curve	Size
10135910	GE Systems - 64 elementphased array	Four-way tip deflection:anterior/posterior; left/right	8 F x 90 cm
10135936	Siemens Systems - 64element phased array	Four-way tip deflection:anterior/posterior; left/right	8 F x 90 cm

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Indications for Use

510(k) Number (if known) K234064

Device Name

Medline ReNewal Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheter, 8F (for Siems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheter, 8F (for GE Systems) (10135910)

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subnart D)	Over-The-Counter Use (21 CFR 801 Subnart C)

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Image /page/5/Picture/1 description: The image contains the Medline and Renewal logos. The Medline logo is on the left side of the image and consists of a blue square with a white star inside. The Renewal logo is on the right side of the image and consists of the word "Renewal" in green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in smaller, black letters.

Traditional 510(k) Notification Medline ReNewal Reprocessed ACUSON AcuNav 8F Ultrasound Catheter

510(k) 234064 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 Medline ReNewal)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	December 21, 2023
Device NameandClassification	Proprietary/TradeName:	Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter(for Siemens Systems) (10135936); Medline ReNewal Reprocessed SiemensACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)
Device NameandClassification	Common or UsualName	Ultrasound catheter, reprocessed
Device NameandClassification	RegulatoryName/Reference	Reprocessed intravascular, ultrasound catheter,21 CFR § 870.1200
Device NameandClassification	Regulatory Class	2
Device NameandClassification	Product Code	OWQ
Device NameandClassification	Panel	Cardiovascular
Device NameandClassification	Predicateselection rationale	The predicate models in K170263 include the subjectdevice models of this submission. The predicatedevices and subject devices are the same except thesubject devices have been reprocessed.
Device NameandClassification	510(k) Number	K170263
PredicateDevice	Proprietary orTrade Name	AcuNav Diagnostic Ultrasound Catheter 8F, 10F
PredicateDevice	Common or UsualName	Ultrasound catheter
PredicateDevice	RegulatoryName/Reference	Catheter, ultrasound, intravascular21 CFR § 870.1200
PredicateDevice	Regulatory Class	2
PredicateDevice	Product Code	OBJ
PredicateDevice	Panel	Cardiovascular
DeviceDescription	510(k) applicant	Siemens Medical Solutions, 685 E. Middlefield Rd.,Mountain View, CA 94043
DeviceDescription	The Medline ReNewal Reprocessed AcuNav Diagnostic UltrasoundCatheters 8F are licensed for single use only. The catheter is optimized forintracardiac scanning. With the catheter, the physician can maneuver theimaging 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 beentested and found compatible.
TechnologicalCharacteristics	The technological characteristics, materials, and the fundamental scientifictechnology of the subject device is equivalent to the predicate device. Theproposed device is a reprocessed version of the predicate device. Eachdevice is marked, tracked, and taken out of service once the maximumnumber of cycles has been reached. K170263 AcuNav DiagnosticUltrasound Catheter was used as the primary predicate to support intendeduse, technological characteristics, and functional performancespecifications.
Non-clinicalTestingSummary	The functional characteristics of the subject device have been evaluatedand found to be substantially equivalent to the predicate device based onthe following tests:Functional performance:●simulated use and artificial soiling;●visual inspection;●mechanical characteristics●ultrasound transducer testing●dimensional analysis●device functionality:●Electrical Safety●dielectric and current leakage●Cleaning Validation●Biocompatibility●Sterilization Validation●bioburden testing; and●ethylene oxide and ethylene chlorohydrin residuals testing●bacteriostasis/fungistasis●Packaging and shelf life validation●Product stability
	Summary Table: Predicate and Medline ReNewal Reprocessed AcuNav DiagnosticUltrasound Catheter comparison chart.
	Predicate	Proposed	Comparison
View	Siemens Medical SolutionsAcuNav DiagnosticUltrasound Catheter	Medline ReNewalReprocessed SiemensACUSON AcuNavDiagnostic UltrasoundCatheter 8F	As Stated
510(k)	K170263	234064	N/A
Model Numbers	10135936 and 10135910, 8F08255790 and 10043372, 10F	10135936 and 10135910 8F	As stated
Common Name	Ultrasound catheter	Ultrasound catheterReprocessed	As stated
' Regulation No.	21 CFR § 870.1200	21 CFR § 870.1200	Same
RegulatoryClass	2	2	Same

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Image /page/6/Picture/1 description: The image shows the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left, with the word "MEDLINE" in white letters on a blue square. To the right of the Medline logo is the word "Renewal" in large green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in smaller blue letters.

Traditional 510(k) Notification

Medline ReNewal Reprocessed ACUSON AcuNav 8F Ultrasound Catheter

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Image /page/7/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is on the left side of the image and is a blue square with a white star and the word "MEDLINE" in white letters. 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 smaller letters.

K234064

Traditional 510(k) Notification Medline ReNewal Reprocessed ACUSON AcuNav 8F Ultrasound Catheter

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 8F 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 proposed devices in this application have the sameindications for use and technological characteristics. Based on this and thenon-clinical testing data presented in this 510(k) submission, the MedlineReNewal Reprocessed AcuNav Ultrasound Catheter 8F models 10135936and 10135910 are substantially equivalent to the predicate device.
a	Neither K170263 nor the current submission included the consoles or any other systemcomponents as part of their respective submissions. Only devices 10135936 and 10135910 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).