Reprocessed 3D Diagnostic Ultrasound Catheters are indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO® XP EP Navigation System Version 9 or greater.

Device Description

3D Diagnostic Ultrasound Catheters are specially designed catheters that provide two-dimensional imaging using an ultrasound transducer and three-dimensional location information using a location sensor. The ultrasound transducer and location sensor are at the distal tip of the catheter and can be positioned for ultrasound imaging and 3D mapping by a steering mechanism that rotates the catheter tip and variable deflection. 3D Diagnostic Ultrasound Catheters incorporate a handpiece, a flexible shaft and a distal tip section containing an ultrasound transducer and a location sensor. The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter 3-D location sensor provides location information to the CARTO® XP EP Navigation System (mapping system). The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter is 10 French with a 90 cm insertion length.

AI/ML Overview

The provided text describes a 510(k) summary for "Reprocessed 3D Diagnostic Ultrasound Catheters." This submission is for a reprocessed medical device, not a new AI-powered diagnostic system. Therefore, most of the requested information regarding AI performance metrics, ground truth, expert consensus, and training/test sets is not applicable to this document.

The document focuses on demonstrating that the reprocessed devices perform as originally intended and are substantially equivalent to the predicate device.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	Bench and laboratory testing demonstrated performance (safety and effectiveness).
Biocompatibility	Biocompatibility testing was conducted.
Reprocessing Validation	Validation of reprocessing was conducted.
Sterilization Validation	Sterilization Validation was conducted.
Function Test(s)	Function test(s) were conducted.
Packaging Validation	Packaging Validation was conducted.
Substantial Equivalence	Ascent Healthcare Solutions concluded that the modified devices are safe, effective, and substantially equivalent to the predicate devices.

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

Not Applicable. This submission is for reprocessed physical devices, and the "test set" refers to the physical units tested in bench and laboratory settings, not a data set for an algorithm. The document does not specify the number of reprocessed units tested for each criterion.

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

Not Applicable. Ground truth in the context of expert review for diagnostic accuracy is not relevant here. The "ground truth" for a reprocessed device is whether it meets its original performance specifications after reprocessing.

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human readers on image interpretation. This is not a human-in-the-loop diagnostic study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is not an MRMC study. It is a submission for a reprocessed physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This device is a physical diagnostic ultrasound catheter, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used:

The "ground truth" for this type of submission is the original performance specifications and functional requirements of the predicate device. The studies conducted (bench, lab, biocompatibility, sterilization, function, packaging validation) aim to prove that the reprocessed device meets these identical standards.

8. The Sample Size for the Training Set:

Not Applicable. There is no "training set" in the context of an AI algorithm for this submission.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. There is no "training set" or explicit "ground truth" establishment in the AI sense for this submission.

Summary

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K092425

SECTION 5: 510(k) SUMMARY

Submitter:	Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044
Contact:	Amanda BabcockRegulatory Affairs Specialist(480) 763-5300 (o)(863) 904-2312 (f)ababcock@ascenths.com	OCT 21 2009
Date of preparation:	August 5, 2009
Name of device:	Trade/Proprietary Name: Reprocessed 3D DiagnosticUltrasound CathetersClassification Name: Catheter, Angiography, Reprocessed
Predicate DeviceK070242	510(k) TitleSOUNDSTAR™ 3D UltrasoundCatheter, Model M-5723-05	ManufacturerBiosense Webster, Inc.
Device description:	3D Diagnostic Ultrasound Catheters are specially designedcatheters that provide two-dimensional imaging using anultrasound transducer and three-dimensional locationinformation using a location sensor. The ultrasound transducerand location sensor are at the distal tip of the catheter and canbe positioned for ultrasound imaging and 3D mapping by asteering mechanism that rotates the catheter tip and variabledeflection. 3D Diagnostic Ultrasound Catheters incorporate ahandpiece, a flexible shaft and a distal tip section containing anultrasound transducer and a location sensor. The SOUNDSTAR™3D Diagnostic Ultrasound Catheter 3-D location sensor provideslocation information to the CARTO® XP EP Navigation System(mapping system). The SOUNDSTAR™ 3D Diagnostic UltrasoundCatheter is 10 French with a 90 cm insertion length.
Indications for Use:	Reprocessed 3D Diagnostic Ultrasound Catheters are indicatedfor intracardiac and intraluminal visualization of cardiac andgreat vessel anatomy and physiology as well as visualization ofother devices in the heart. The 3D Diagnostic UltrasoundCatheter provides location information when used with theCARTO® XP EP Navigation System Version 9 or greater.
Technologicalcharacteristics:	The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter is a90cm 10F IntraCardiac diagnostic ultrasound catheter with anacoustic array identical to the ACUSON AcuNav 10F DiagnosticUltrasound Catheter. The catheter has a location sensor(providing location information to the CARTO®	EP XP

Ascent Healthcare Solutions
Reprocessed 3D Diagnostic Ultrasound Catheters
Reprocessed 3D Diagnostic Ultrasound Catheters
Traditional 510(k)

Page 18 OF2

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Navigation System) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip. It also has a pre-amplifier circuit board inside the handle that amplifies the signals from the location sensor. The location sensor consists of a set of three micro-machined coils that act as pick up coils when placed in an external electromagnetic field created by external field generator coils. The sensor coils are positioned orthogonal to each other inside the sensor assembly. The coils pick up signals from the field in response to their position and orientation with respect to a frame of reference. The signals are processed by a system to calculate the position and orientation of the tip of the catheter. The associated circuitry for the sensor consists of pre-amplifier circuits for each coil.

Performance data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed 3D Diagnostic Ultrasound Catheters. This included the following tests:

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

Performance testing demonstrates that Reprocessed 3D Diagnostic Ultrasound Catheters perform as originally intended.

Conclusion:

Ascent Healthcare Solutions concludes that the modified devices (Reprocessed 3D Diagnostic Ultrasound Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein.

Ascent Healthcare Solutions Reprocessed 3D Diagnostic Ultrasound Catheters Traditional 510(k)

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling the perimeter, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. In the center of the seal is a stylized depiction of a bird-like symbol, which is the department's official logo. The logo is a modern representation of a human figure embracing a bird, symbolizing care and protection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ascent Healthcare Solutions c/o Ms. Amanda Babcock Regulatory Affairs Specialist 10232 South 51st Street Phoenix, AZ 85044

OCT 21 2009

Re: K092425

Trade/Device Name: Reprocessed 3D Ultrasound Catheter (See Enclosed Model) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (two) Product Code: NLI Dated: August 5, 2009 Received: August 7, 2009

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.

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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Page 2 - Ms. Amanda Babcock

Please bé 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 (reporting of medical device-related adverse events) (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 go to http://www.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Duna R. Richter

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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Page 3 – Ms. Amanda Babcock

Original model found to be SE SE SE SE SOUNDSTAR™ 3D Ultrasound Catheter, Model M-5723-05

. . .

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SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K092425

Device Name: Reprocessed 3D Diagnostic Ultrasound Catheters

Indications For Use:

Prescription Use × (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)

W.M.P.

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K092425

CONFIDENTIAL

Ascent Healthcare Solutions Reprocessed 3D Diagnostic Uitrasound Catheters Traditional 510(k)

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).