The ACUSON P500 ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN(useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The system also provides the ability to measure and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system.

Note: This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular imaging."

Device Description

The ACUSON P500 Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Power(Amplitude) Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

AI/ML Overview

This document is a 510(k) summary for the ACUSON P500 Ultrasound System, seeking clearance for a modified device. It declares substantial equivalence to previously cleared predicate devices by the same company, the ACUSON P500 (K163396), ACUSON Juniper (K201130), and ACUSON Redwood (K210743).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present specific quantitative acceptance criteria or corresponding reported device performance values in a table. Instead, it relies on demonstrating substantial equivalence to predicate devices, asserting that the modified ACUSON P500 Ultrasound System (this submission) operates in the same manner and has similar technological characteristics as the previously cleared devices.

The "Determination of Substantial Equivalence" section (page 6-8) lists the features and characteristics of the submitted device and compares them to the predicate and reference devices. The core argument for acceptance is that the added features (transducers, applications, software features) and expanded clinical applications were already cleared on the reference devices.

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

The document explicitly states: "Since the ACUSON P500 Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence." (page 11, Section 8).

Therefore, there is no specific test set or associated sample size for a clinical study to prove the device meets acceptance criteria. The data provenance for performance relies on the previous clearances of the predicate and reference devices.

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

As no new clinical study was conducted for this submission, there were no experts specifically engaged to establish ground truth for a new test set for this clearance. The ground truth for the predicate and reference devices would have been established during their respective clearance processes.

4. Adjudication Method for the Test Set:

Since no new clinical study testing performance was performed for this 510(k), no adjudication method was specified or used for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

The document does not mention any MRMC comparative effectiveness study, nor does it discuss AI-assisted performance or its effect size on human readers. The ACUSON P500 is an ultrasound system with various imaging modes and measurement packages, not an AI-driven diagnostic assistance tool in the context of this submission.

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

The document does not report any standalone algorithm performance studies. The device is an ultrasound system intended for use by "appropriately trained healthcare professional in a clinical setting" (page 2, 5).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

As per the answer to point 2, no new clinical study was conducted for this submission. The basis for clearance is substantial equivalence to existing devices. Therefore, no new ground truth was established for this specific submission. The original ground truth for the clearances of the predicate and reference devices would have been established through methods appropriate for diagnostic ultrasound systems (e.g., expert interpretation of images, correlation with other diagnostic modalities or clinical outcomes). The Arterial Health Package (AHP) software, a feature of the device, references "normative tables that have been validated in peer-reviewed studies," which implies a form of ground truth based on established medical knowledge and research.

8. The Sample Size for the Training Set:

Since no new clinical study or algorithm development (in the context of this clearance) requiring a training set is discussed, no training set sample size is reported.

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

As no training set is discussed for this submission, the method for establishing its ground truth is not applicable or provided.

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 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.

Siemens Medical Solutions USA, Inc. % Sulgue Choi Regulatory Affairs 22010 S.E. 51st Street ISSAQUAH WA 98029

Re: K213487

Trade/Device Name: ACUSON P500 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ, OIJ Dated: January 18, 2022 Received: January 24, 2022

February 11, 2022

Dear Sulgue Choi:

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/cfpmp/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 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

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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,

Jessica Lamb Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213487

Device Name ACUSON P500 Ultrasound System

Indications for Use (Describe)

Operating Mode 2D-Mode 2D-Mode with Harmonics Imaging Color flow Doppler Color (Velocity) Power (Energy) Doppler Tissue Imaging Pulsed Wave Doppler Pulsed Wave Doppler Tissue Imaging High Pulsed Repetition Frequency Pulsed Wave Doppler Continuous Wave Doppler Steerable Continuous Wave Doppler for imaging transducers Auxiliary Continuous Wave Doppler for pencil transducers M-Mode M-Mode with Harmonics Imaging Anatomical M-Mode Combined Modes 2D-Mode with Color 2D-Mode with Power 2D/Doppler 2D/Doppler with Color 2D/Doppler with power 2D/M-mode 2D/M-mode with Color 2D/Anatomical M-mode

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K213487

510(k) Summary

Date:	February 8, 2022
1. Sponsor:	Siemens Medical Solutions USA, Inc.Ultrasound Division22010 South East 51st StreetIssaquah, Washington 98029
Contact Person:	Sulgue ChoiTel: (425) 281-9898
Secondary ContactPerson:	SeongMin HanTel: +82 10 4697 8360E-mail: seongmin.han@siemens-healthineers.com
2. Device Name:	ACUSON P500 Ultrasound System
Common Name:	Ultrasound System with Accessories
Classification:	Regulatory Class:Review Category:Classification Panel:	IITier IIRadiology
	Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
	Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
	Diagnostic Ultrasound Transducer		892.1570 90-ITX
	Diagnostic Intravascular Catheter		870.1200 90-OBJ
	Biopsy Needle Guide Kit		892.1560 90-OIJ
Manufacturing Site:	Siemens Healthineers, Ltd.2nd ~ 3rd Floor, 143, Sunhwan-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do, Republic of Korea

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3. Legally Marketed Predicate Devices

The ACUSON P500 Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the following company's own products.

Predicate device:	ACUSON P500 (K163396)
Reference device(s):	ACUSON Juniper (K201130)
	ACUSON Redwood (K210743)

4. Device Description

5. Intended Use/Indications for Use

The ACUSON P500 ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN(useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Intra Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Operating Mode 2D-Mode

2D-Mode with Harmonics Imaging Color flow Doppler Color (Velocity) Power (Energy) Doppler Tissue Imaging Pulsed Wave Doppler Pulsed Wave Doppler Tissue Imaging High Pulsed Repetition Frequency Pulsed Wave Doppler Continuous Wave Doppler Steerable Continuous Wave Doppler for imaging transducers

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Ultrasound Division

Auxiliary Continuous Wave Doppler for pencil transducers M-Mode M-Mode with Harmonics Imaging Anatomical M-Mode Combined Modes 2D-Mode with Color 2D-Mode with Power 2D/Doppler 2D/Doppler with Color 2D/Doppler with power 2D/M-mode 2D/M-mode with Color 2D/Anatomical M-mode

6. Summary of Technological Characteristics and Determination of Substantial Equivalence

The modified ACUSON P500 Ultrasound System is substantially equivalent to the company's own previously cleared predicate ACUSON P500 (K163396), the ACUSON Juniper (K201130) and the ACUSON Redwood (K210743) with regard to both intended use and technological characteristics. Both the modified ultrasound system under this review and the predicate ultrasound systems function in the same manner as all diagnostic ultrasound systems and transducers.

The submission device differs from the predicated devices as following:

. The modified ACUSON P500 Ultrasound System includes the addition of the 11M3. 18H5, 5VT transducers which were already cleared on the ACUSON Juniper (K201130).
The modified ACUSON P500 Ultrasound System includes the addition of the Transesophageal . and Lung applications which were already cleared on the ACUSON Juniper (K201130).
. The modified ACUSON P500 Ultrasound System includes the addition of VVI(Velocity Vector Image) and AMM(Anatomical M-Mode) software features which were already cleared on the ACUSON Juniper (K201130).
. The modified ACUSON P500 Ultrasound System includes the expansion of TCD(Transcranial Doppler), Lung, FAST(Focused assessment with Sonography in Trauma) clinical applications for P4-2, which were already cleared on the ACUSON Juniper (K201130).
. The modified ACUSON P500 Ultrasound System includes the expansion of Lung, FAST(Focused assessment with Sonography in Trauma) clinical applications for CH5-2, which were already cleared on the ACUSON Juniper (K201130).
. The modified ACUSON P500 Ultrasound System includes the expansion of Lung clinical application for VF10-5, which was already cleared on the ACUSON Juniper (K201130).
. The modified ACUSON P500 Ultrasound System includes the expansion of Lung clinical application for L10-5v, which was already cleared on the ACUSON Juniper (K201130).
. The modified ACUSON P500 Ultrasound System includes the update wording of the Clinical application from 'Neonatal' to 'Neonatal Cephalic' which was already cleared on the ACUSON P500 (K163396).
The modified ACUSON P500 Ultrasound System includes the addition of eSieLink software . feature which was already cleared on the ACUSON Redwood (K210743).
The modified ACUSON P500 Ultrasound System includes the addition of Hibernation(Quick boot) feature.

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All other hardware and software features of the ACUSON P500 Ultrasound device remain unchanged. The foundation of the ACUSON P500 (this submission) is the ACUSON P500(K163396) with features and transducers integrated with the ACUSON P500(K163396) hardware and the ACUSON P500 (this submission) reuse software developed for P500(K163396) mainly as well as 11M3, 18H5, 5VT transducer and VVI(Velocity Vector Image) feature from Juniper (K201130), eSieLink feature from Redwood (K210743).

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

	Feature /Characteristic	ACUSON P500This Submission	ACUSON P500K# 163396Predicate device	ACUSONJuniperK# 201130Reference device	ACUSONRedwoodK# 210743Reference device
	Indications for Use:
■	Fetal	√	√
■	Abdominal	√	√
■	Pediatric	√	√
■	Small Organ	√	√
■	Cardiac	√	√
■	Transrectal	√	√
■	Transvaginal	√	√
■	Vascular(Peripheral vesselArterials, Peripheralvessel Venous,Cerebrovascular,TranscranialDoppler)	√	√(Peripheral vesselArterials, Peripheralvessel Venous,Cerebrovascular)	√(TranscranialDoppler)
■	Musculo-skeletal(conventional)	√	√
■	Musculo-skeletal(superficial)	√	√
■	Neonatal cephalic	√	√
Feature /Characteristic	ACUSON P500This Submission	ACUSON P500K# 163396Predicate device	ACUSONJuniperK# 201130Reference device	ACUSONRedwoodK# 210743Reference device
Emergency Medicine(Emergency Medicine, Focused Assessment with Sonography for Trauma)	√	√(Emergency Medicine)	√(FAST clinical application in Abdominal)
Intracardiac	√	√
Trans-esophageal	√		√
Lung	√		√(Lung clinical application in Abdominal)
FrequenciesSupported:	√(1.0MHZ~18MHz)	√(1.0MHZ~18MHz)	√(2.0MHz~17MHz)
Modes:
B	√	√
M	√	√
PWD (Pulsed Wave Doppler)	√	√
CWD (Continuous Wave Doppler)	√	√
PW DTI (Doppler Tissue Image)	√	√
Color Doppler	√	√
Power Doppler	√	√
Combined (BMDC)	√	√
Features:
	Feature /Characteristic	ACUSON P500This Submission	ACUSON P500K# 163396Predicate device	ACUSONJuniperK# 201130Reference device	ACUSONRedwoodK# 210743Reference device
■	THI (TissueHarmonic Imaging)	√	√
■	M-THI	√	√
■	Panoramic 2DImaging (SieScape)	√	√
■	Dual-BeamProcessing	√	√
■	Quad-BeamProcessing	√	√
■	Clip Capture	√	√
■	Spectral DTI	√	√
■	Stress Echo	√	√
■	2D(color) DTI	√	√
■	DIMAQ (PIMSWorkplace)	√	√
■	VascularEnhancement(Clarify VE)	√	√
■	eSielmage	√	√
■	Advance SieClear	√	√
■	Multiple FrequencyImaging(MultiHertz)	√	√
■	Digital Architecture	√	√
■	DICOM SR Vascular	√	√
■	DICOM SR OB/GYN	√	√
■	DICOM SR Cardiac	√	√
Feature /Characteristic	ACUSON P500This Submission	ACUSON P500K# 163396Predicate device	ACUSONJuniperK# 201130Reference device	ACUSONRedwoodK# 210743Reference device
Dynamic TCE	√	√
Syngo AHP	√	√
eSieMeasure	√	√
eSieScan	√	√
Enhanced NeedleVisualization	√	√
Probe Saver	√	√
IntracardiacEchocardiography(ICE) Imaging	√	√
CARTOSOUNDCommunication	√	√
Velocity VectorImage (VVI)	√		√
Anatomical M-mode(AMM)	√		√
eSieLink	√			√
Hibernation(Quickboot)	√
Wireless	√	√
Monitor: 15.4"WXGA(FPD)	√	√
Output Display Standard(Track 3)	√	√
Patient Contact Materials	Tested to ISO10993-1	Tested to ISO10993-1
UL 60601-1 Certified	√	√
Feature /Characteristic	ACUSON P500This Submission	ACUSON P500K# 163396Predicate device	ACUSONJuniperK# 201130Reference device	ACUSONRedwoodK# 210743Reference device
Indications for Use	√	√

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Siemens Medical Solutions USA, Inc.

Ultrasound System

510(k) Submission

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Siemens Medical Solutions USA, Inc.

Ultrasound Division

ACUSON P500 Ultrasound System

510(k) Submission

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Siemens Medical Solutions USA, Inc.

Ultrasound Division

ACUSON P500 Ultrasound System

510(k) Submission

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7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety and have been found to conform to applicable medical device safety standards. The systems comply with the following voluntary standards:

IEC 62359: Edition 2.1 2017-09, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields / Combines IEC 62359 (2010-10) and AMD 1 (2017-09)
Safety and EMC Requirements for Medical Equipment
- AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 o (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
- o IEC 60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance / This document and its separate amendments continue to be valid together with the consolidated version
- IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment Part 1-2: General O requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- o IEC 60601-2-18: Edition 3.0 2009-08, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment Part 2-37: Particular o requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
ISO 10993-1 Fifth edition 2018-08-01, Biological evaluation of medical devices Part 1: ■ Evaluation and testing within a risk management process / Corrected and reprinted in 2018-10

8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.

Since the ACUSON P500 Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence.

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9. Summary

The ACUSON P500 Ultrasound System is verified and validated according to the company's design control process.

Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms to 21 CFR 820 Quality System Regulation and ISO 13485:2016 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound system has accumulated a long history of safe and effective performance. Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON P500 system is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.