The Acuson AcuNav V Ultrasound Catheter is intended for intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

Device Description

The AcuNav V has been designed to meet the following product safety standards: UL 60601-1, Safety Requirements for Medical Equipment; IEC 60601-2-37 Diagnostic Ultrasound Safety Standards; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound; 93/42/EEC Medical Devices Directive; Safety and EMC Requirements for Medical Equipment - EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2; IEC 61157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility; ISO 14971 Risk Management; ISO 11607 Packaging for terminally sterilized medical devices. The AcuNav V catheter is to be used only on systems with which it has been tested and found compatible. Each of these system/transducer combinations shall be cleared through the 510(k) process and have a subsequent special report submitted.

AI/ML Overview

This 510(k) summary submission describes the Siemens AcuNav V Ultrasound Catheter, a modified device, and its substantial equivalence to the original AcuNav Ultrasound Imaging Catheter. The submission does not include a study to prove acceptance criteria in the traditional sense of clinical performance metrics. Instead, it focuses on demonstrating that the modified device continues to meet established safety and performance standards through verification and validation activities conducted as part of the company's design control process.

Here's an analysis of the provided information relative to your requested categories:

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

The submission does not provide quantitative "acceptance criteria" for clinical performance metrics (e.g., sensitivity, specificity, accuracy) or "reported device performance" in terms of those metrics. Instead, the acceptance criteria are related to compliance with product safety standards and design control processes. The reported "performance" is that the device has been verified and validated against these standards.

Acceptance Criteria (Standards Compliance)	Reported Device Performance
UL 60601-1, Safety Requirements for Medical Equipment	Designed to meet / Verified and validated
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards	Designed to meet / Verified and validated
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment	Designed to meet / Verified and validated
AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment	Designed to meet / Verified and validated
AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound	Designed to meet / Verified and validated
93/42/EEC Medical Devices Directive	Designed to meet / Verified and validated
EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2 (Safety & EMC)	Designed to meet / Verified and validated
IEC 61157 Declaration of Acoustic Power	Designed to meet / Verified and validated
ISO 10993-1 Biocompatibility	Designed to meet / Verified and validated
ISO 14971 Risk Management	Designed to meet / Verified and validated
ISO 11607 Packaging for terminally sterilized medical devices	Designed to meet / Verified and validated
Compatibility with specified ultrasound systems	Tested and found compatible (each system/transducer combo to be cleared via 510(k))
Intended Use: intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients	The device maintains this intended use.

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

This information is not provided in the submission. The submission states "The AcuNav modifications are verified and validated according to the company's design control process," but details on specific test sets, sample sizes, or data provenance (e.g., in-vitro, in-vivo, animal, human, retrospective/prospective) for these verification and validation activities are not included in this summary.

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 information is not provided. As no clinical performance study with a test set requiring expert ground truth is described, details about experts are absent.

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

This information is not provided, as no clinical performance study with a test set requiring expert adjudication is described.

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

An MRMC comparative effectiveness study was not done, and it is not applicable here. The device is a diagnostic ultrasound catheter, not an AI-powered diagnostic tool. The submission is for a modification to an existing device, focusing on safety and technical equivalence rather than comparative clinical effectiveness studies with or without AI assistance.

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

A standalone algorithm performance study was not done, and it is not applicable. The device is a physical ultrasound catheter, which always requires a human operator (human-in-the-loop).

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

The submission does not explicitly state the type of ground truth used for specific performance metrics of the catheter, as it primarily focuses on compliance with technical and safety standards. For electrical safety, acoustic output, biocompatibility, and risk management, the "ground truth" is adherence to the specified international and national standards, which would be verified through specific testing methodologies (e.g., electrical measurements, acoustic power measurements, biological assays, risk assessments). For imaging performance, if evaluated, it would likely involve phantom studies or in-vivo animal/human imaging compared to established imaging benchmarks or other validated imaging modalities, but these details are not provided.

8. The sample size for the training set

This information is not provided, and it is not applicable in the context of this device type and submission. The AcuNav V catheter is not an AI/machine learning device that requires a "training set" in the computational sense.

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

This information is not provided, and again, it is not applicable as the device does not employ machine learning or AI that would require a training set and associated ground truth establishment.

Summary of the Study and Acceptance Criteria in the Context of a 510(k) for Device Modification:

The provided 510(k) submission (K081808) is for a modified diagnostic ultrasound catheter (AcuNav V), establishing its substantial equivalence to a legally marketed predicate device (original AcuNav Ultrasound Imaging Catheter). For such submissions, especially for modifications to an existing device where the intended use remains the same, the "study" demonstrating adherence to "acceptance criteria" primarily revolves around technical verification and validation against recognized product safety and performance standards, rather than new clinical trials measuring diagnostic accuracy or effectiveness against a clinical ground truth.

The "acceptance criteria" here are the comprehensive list of national and international safety, biocompatibility, and performance standards (e.g., UL 60601-1, IEC 60601-2-37, ISO 10993-1, AIUM/NEMA standards) that the device must meet. The "study that proves the device meets the acceptance criteria" is the "company's design control process," which includes the "verification and validation" activities confirming the modified device's compliance with all these product safety and performance specifications. This implicitly involves various engineering tests, material evaluations, and functional assessments without necessarily requiring a large-scale clinical study for this specific type of modification and submission. Compatibility with systems is also an acceptance criterion, met by testing and subsequent 510(k) clearance for each specific system/transducer combination.

Summary

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K081808
pg # 1 of 2

SEP 2 6 2008

SECTION 11

510(k) Summary Prepared June 24, 2008

Sponsor: Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, California 94043

Contact Person: Shelly Pearce Telephone: (650) 694-5988 Fax: (650) 694-5580

Submission Date: June 24, 2008

Modified Device Name: AcuNav V Ultrasound Catheter

Common Name: Diagnostic Ultrasound Catheter

Classification:

Regulatory Class: ============================================================================================================================================================================== Review Category: Tier 11 Classification Panel: Radiology Ultrasonic Imaging Catheter ; 21C FR # 892.1200; Product Code OBJ

A. Legally Marketed Predicate Devices

The modified AcuNav Diagnostic Ultrasound Catheter is substantially equivalent to the original AcuNav Ultrasound Imaging Catheter.

B. Device Description:

The AcuNav V has been designed to meet the following product safety standards:

UL 60601-1, Safety Requirements for Medical Equipment
I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
피 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
I AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
93/42/EEC Medical Devices Directive
I Safety and EMC Requirements for Medical Equipment
- o EN/IEC 60601-1
- EN/IEC 60601-1-1 o
- EN/IEC 60601-1-2 o
IEC 61157 Declaration of Acoustic Power
프 ISO 10993-1 Biocompatibility
ISO 14971 Risk Management
I ISO 11607 Packaging for terminally sterilized medical devices

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K0818e8
pg # 2 of 2

The AcuNav V catheter is to be used only on systems with which it has been tested and found compatible. Each of these system/transducer combinations shall be cleared through the 510(k) process and have a subsequent special report submitted.

C. Intended Use

D. Substantial Equivalence

The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.

E. Performance Data

The AcuNav modifications are verified and validated according to the company's design control process.

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Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 6 2008

Siemens Medical Solutions USA, Inc. c/o Ms. Shelly Pearce Regulatory Affairs P.O. 7393 1230 Shorebird Way Mountain View, CA 94039

Re: K081808

Trade Name: ACUSON AcuNav V 10F Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: September 5, 2008 Received: September 5, 2008

Dear Ms. Pearce:

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 such 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); good manufacturing practice requirements as set forth in the quality

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Page 2 - Ms. Shelly Pearce

systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact . CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

uma R.bacher

A 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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SECTION 6 Diagnostic Ultrasound Indications for Use Form

510(k) Number: KQ81803

Device Name: ACUSON AcuNav V 10F Ultrasound Catheter

Indications for Use: The AcuNav™ V Ultrasound Catheter 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.

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other:HarmonicImaging
Ophtalmic
Fetal
Abdominal
Intraoperative(Vascular)
Intraoperative(Neurological)
Pediatric
Small Organ(Specify)**
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P*
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intra-Luminal		P	P	P	P	P	P		P*
Peripheral Vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Intra-Cardiac)		P	P	P	P	P	P		P*

P=Previously cleared by the FDA.

ﻟﻠﺘﻌﻠﻴﻤﻴﺔ ﺍﻟﺘﺎﺭﻳﺦ ﺍﻟﺘﺎﺭﻳﺦ ﺍﻟﻤﺘﻮﺳﻴ AdditIonal Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NECESSARY)

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Donna R. Vachner

(Division Sian of Cardiovascular Devices

510(k) Number

Page 12 of 23
Page 1 of 2

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SECTION 7 Intended Use of the Device

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: AcuNav V Ultrasound Catheter, 10F

Indications For Use:

The Acuson AcuNav V Ultrasound Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

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)

Duma R. Sohner

(Division Sign-Off Division of Cardiovascular Devices

510(k) Number

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).