(105 days)
No
The document describes a standard ultrasound system with various imaging modes and measurement packages, but there is no mention of AI or ML capabilities in the intended use, device description, or other sections. The performance studies section also indicates that clinical studies were not required because the device uses the same technology as existing devices, which is less common for devices incorporating novel AI/ML algorithms.
No
The device description and intended use clearly state that it is a "diagnostic ultrasound system" and "intended to provide images" and "measure and calculation packages...for clinical diagnosis purposes." It does not mention any therapeutic capabilities.
Yes
The "Intended Use / Indications for Use" section states that the system provides "information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes." Additionally, the "Device Description" explicitly calls it a "diagnostic ultrasound system."
No
The device description explicitly states it is a "multi-purpose mobile, software controlled, diagnostic ultrasound system" and describes its function in transmitting and receiving ultrasound echo data, which are hardware functions. While it is software-controlled, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ACUSON P500 is an ultrasound imaging system. It works by transmitting and receiving ultrasound waves to create images of structures inside the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states that the system provides images or signals from inside the body for various anatomical applications. While it provides measurements and calculations that can be used adjunctively with other medical data, this is based on the ultrasound imaging data, not on the analysis of biological samples.
Therefore, the ACUSON P500 falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
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, 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."
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, OBJ, OIJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained healthcare professional in a clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Since the ACUSON P500 Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ACUSON P500 (K163396)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
ACUSON Juniper (K201130), ACUSON Redwood (K210743)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known) K213487
Device Name ACUSON P500 Ultrasound System
Indications for Use (Describe)
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."
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
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
| Date: | February 8, 2022 | ||
|---|---|---|---|
| 1. Sponsor: | Siemens Medical Solutions USA, Inc. | ||
| Ultrasound Division | |||
| 22010 South East 51st Street | |||
| Issaquah, Washington 98029 | |||
| Contact Person: | Sulgue Choi | ||
| Tel: (425) 281-9898 | |||
| Secondary Contact | |||
| Person: | SeongMin Han | ||
| Tel: +82 10 4697 8360 | |||
| E-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: | II | ||
| Tier II | |||
| Radiology | |||
| 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 |
5
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
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.
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.
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."
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
6
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.
7
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 P500
This Submission | ACUSON P500
K# 163396
Predicate device | ACUSON
Juniper
K# 201130
Reference device | ACUSON
Redwood
K# 210743
Reference device |
|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| | Indications for Use: | | | | |
| ■ | Fetal | √ | √ | | |
| ■ | Abdominal | √ | √ | | |
| ■ | Pediatric | √ | √ | | |
| ■ | Small Organ | √ | √ | | |
| ■ | Cardiac | √ | √ | | |
| ■ | Transrectal | √ | √ | | |
| ■ | Transvaginal | √ | √ | | |
| ■ | Vascular
(Peripheral vessel
Arterials, Peripheral
vessel Venous,
Cerebrovascular,
Transcranial
Doppler) | √ | √
(Peripheral vessel
Arterials, Peripheral
vessel Venous,
Cerebrovascular) | √
(Transcranial
Doppler) | |
| ■ | Musculo-skeletal
(conventional) | √ | √ | | |
| ■ | Musculo-skeletal
(superficial) | √ | √ | | |
| ■ | Neonatal cephalic | √ | √ | | |
| Feature /
Characteristic | ACUSON P500
This Submission | ACUSON P500
K# 163396
Predicate device | ACUSON
Juniper
K# 201130
Reference device | ACUSON
Redwood
K# 210743
Reference 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) | | |
| Frequencies
Supported: | √
(1.0MHZ18MHz) | √18MHz) | √
(1.0MHZ
(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 P500
This Submission | ACUSON P500
K# 163396
Predicate device | ACUSON
Juniper
K# 201130
Reference device | ACUSON
Redwood
K# 210743
Reference device |
| ■ | THI (Tissue
Harmonic Imaging) | √ | √ | | |
| ■ | M-THI | √ | √ | | |
| ■ | Panoramic 2D
Imaging (SieScape) | √ | √ | | |
| ■ | Dual-Beam
Processing | √ | √ | | |
| ■ | Quad-Beam
Processing | √ | √ | | |
| ■ | Clip Capture | √ | √ | | |
| ■ | Spectral DTI | √ | √ | | |
| ■ | Stress Echo | √ | √ | | |
| ■ | 2D(color) DTI | √ | √ | | |
| ■ | DIMAQ (PIMS
Workplace) | √ | √ | | |
| ■ | Vascular
Enhancement
(Clarify VE) | √ | √ | | |
| ■ | eSielmage | √ | √ | | |
| ■ | Advance SieClear | √ | √ | | |
| ■ | Multiple Frequency
Imaging(MultiHertz) | √ | √ | | |
| ■ | Digital Architecture | √ | √ | | |
| ■ | DICOM SR Vascular | √ | √ | | |
| ■ | DICOM SR OB/GYN | √ | √ | | |
| ■ | DICOM SR Cardiac | √ | √ | | |
| Feature /
Characteristic | ACUSON P500
This Submission | ACUSON P500
K# 163396
Predicate device | ACUSON
Juniper
K# 201130
Reference device | ACUSON
Redwood
K# 210743
Reference device | |
| Dynamic TCE | √ | √ | | | |
| Syngo AHP | √ | √ | | | |
| eSieMeasure | √ | √ | | | |
| eSieScan | √ | √ | | | |
| Enhanced Needle
Visualization | √ | √ | | | |
| Probe Saver | √ | √ | | | |
| Intracardiac
Echocardiography
(ICE) Imaging | √ | √ | | | |
| CARTOSOUND
Communication | √ | √ | | | |
| Velocity Vector
Image (VVI) | √ | | √ | | |
| Anatomical M-mode
(AMM) | √ | | √ | | |
| eSieLink | √ | | | √ | |
| Hibernation(Quick
boot) | √ | | | | |
| Wireless | √ | √ | | | |
| Monitor: 15.4"WXGA(FPD) | √ | √ | | | |
| Output Display Standard
(Track 3) | √ | √ | | | |
| Patient Contact Materials | Tested to ISO
10993-1 | Tested to ISO
10993-1 | | | |
| UL 60601-1 Certified | √ | √ | | | |
| Feature /
Characteristic | ACUSON P500
This Submission | ACUSON P500
K# 163396
Predicate device | ACUSON
Juniper
K# 201130
Reference device | ACUSON
Redwood
K# 210743
Reference device | |
| Indications for Use | √ | √ | | | |
8
Siemens Medical Solutions USA, Inc.
Ultrasound System
510(k) Submission
9
Siemens Medical Solutions USA, Inc.
Ultrasound Division
ACUSON P500 Ultrasound System
510(k) Submission
10
Siemens Medical Solutions USA, Inc.
Ultrasound Division
ACUSON P500 Ultrasound System
510(k) Submission
11
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.
12
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.