(28 days)
Not Found
No
The document does not mention AI, ML, or related terms like deep learning or neural networks in the device description, intended use, or performance studies. The description focuses on standard ultrasound imaging modes and post-processing techniques.
No
The Intended Use / Indications for Use section clearly states that the device is "intended for diagnostic ultrasound imaging and fluid flow analysis" and for "clinical diagnosis purposes," which indicates a diagnostic rather than a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for diagnostic ultrasound imaging and fluid flow analysis." The "Device Description" also refers to it as a "diagnostic ultrasound system."
No
The device is described as a "multi-purpose mobile, software controlled, diagnostic ultrasound system" and mentions hardware components like a "Flat Panel Display" and evaluation for "thermal, electrical, electromagnetic and mechanical safety," indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, the ACUSON P500 ultrasound system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body. The ACUSON P500 is an ultrasound system that performs diagnostic imaging on the human body.
- The intended use and device description clearly state that the system is for diagnostic ultrasound imaging and fluid flow analysis within the body. It acquires echo data from within the patient and displays it on a screen.
- There is no mention of analyzing biological samples or performing tests on specimens.
Therefore, the ACUSON P500 is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACUSON P500 ultrasound system is intended for diagnostic ultrasound imaging and fluid flow analysis for the following applications: Fetal, Abdominal, Small Parts, OB/GYN, Pelvic, Cardiovascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures fetal, abdominal, small orqan, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) 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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The ACUSON P500 is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire harmonic 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, Tissue Doppler Image, Power (Amplitude) Doppler Mode and a combination of modes on a Flat Panel Display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Small Parts, OB/GYN, Pelvic, Cardiovascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, small orqan, transrectal, transvaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 P500 uses the same technology and principles as existing devices, clinical data is not required.
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.
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.
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a design that resembles an abstract bird or wing shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2015
Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K150050
Trade/Device Name: Acuson P500 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 5, 2015 Received: January 12, 2015
Dear Mr. Job:
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. 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 (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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
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 Industry and Consumer Education 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,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150050
Device Name Acuson P500 Ultrasound System
Indications for Use (Describe)
The ACUSON P500 ultrasound system is intended for diagnostic ultrasound imaging and fluid flow analysis for the following applications: Fetal, Abdominal, Small Parts, OB/GYN, Pelvic, Cardiovascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures fetal, abdominal, small organ, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Prepared December 15, 2014
| Sponsor: | Siemens Medical Solutions, Inc.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043 | | |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--|--|
| Manufacturing Facility | SIEMENS LTD SEOUL
2nd -30 floor, 143, Sunhwan-ro,
Jungwon-gu, Seongnam-si, Gyeonggi-do,
Republic of Korea | | |
| Contact Person: | Shelly Pearce
Telephone:
(650) 279-0134
(650) 694-5580
Fax: | | |
| Device Name: | ACUSON P500 Ultrasound System | | |
| Common Name: | Diagnostic Ultrasound System with Accessories | | |
| Classification:
a market of the comments of the comments of | | | |
Regulatory Class: = Review Category: Tier II Classification Panel: Radiology
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IYN |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IYO |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-ITX |
A. 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 our current product, the ACUSON X300 ultrasound system (K121699) and ACUSON S2000 ultrasound system (K140959).
B. Device Description:
The ACUSON P500 is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire harmonic 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, Tissue Doppler Image, Power (Amplitude) Doppler Mode and a combination of modes on a Flat Panel Display.
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C. Intended Use
The ACUSON P500 ultrasound imaging system is intended for the following applications: Fetal, Abdominal. Small Parts. OB/GYN. Pelvic. Cardiovascular. Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures fetal, abdominal, small orqan, transrectal, transvaginal, cardiovascular, peripheral vessel, musculoskeletal (conventional), and musculoskeletal (superficial) 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.
D. Substantial Equivalence
The ACUSON P500 is substantially equivalent to the ACUSON X300, cleared via K121699, and ACUSON S2000. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
| | Feature / Characteristic | Predicate Device
ACUSON X300
(K121699) | Predicate Device
ACUSON S2000
(K140959) | Submission Device
ACUSON P500 |
|--------------------------------------------------------------------------------------------|----------------------------------------------|-----------------------------------------------|-----------------------------------------------|----------------------------------|
| | Indications for Use: | | | |
| ■ | Fetal | √ | √ | √ |
| ■ | Abdominal | √ | √ | √ |
| ■ | Small Organ | √ | √ | √ |
| ■ | Cardiac | √ | √ | √ |
| ■ | Transrectal | √ | √ | √ |
| ■ | Transvaginal | √ | √ | √ |
| ■ | Peripheral vessel | √ | √ | √ |
| ■ | Musculo-skeletal (conventional) | √ | √ | √ |
| ■ | Musculo-skeletal (superficial) | √ | √ | √ |
| ■ | Emergency Medicine | √ | √ | √ |
| | Center Frequencies Supported: | | | |
| ■ | 2.0 MHz | √ | √ | √ |
| ■ | 2.5 MHz | √ | √ | √ |
| ■ | 3.0 MHz | √ | √ | √ |
| ■ | 3.5 MHz | √ | √ | √ |
| ■ | 4.0 MHz | √ | √ | √ |
| ■ | 5.0 MHz | √ | √ | √ |
| ■ | 5.5 MHz | √ | √ | √ |
| ■ | 6.0 MHz | √ | √ | √ |
| ■ | 6.5 MHz | √ | √ | √ |
| ■ | 7.5 MHz | √ | √ | √ |
| ■ | 8.0 MHz | √ | √ | √ |
| ■ | 9.0 MHz | √ | √ | √ |
| ■ | 10.0 MHz | √ | √ | √ |
| Feature / Characteristic | Predicate Device
ACUSON X300
(K121699) | Predicate Device
ACUSON S2000
(K140959) | Submission Device
ACUSON P500 | |
| 11.0 MHz | √ | √ | √ | |
| Modes: | | | | |
| B | √ | √ | √ | |
| M | √ | √ | √ | |
| PWD (Pulsed Wave Doppler) | √ | √ | √ | |
| SCW (Steerable CW) | √ | √ | √ | |
| D (Color Doppler) | √ | √ | √ | |
| Power Doppler
(Amplitude Doppler) | √ | √ | √ | |
| Combined (BM, BC, BCM, BCD) | √ | √ | √ | |
| THI (Tissue Harmonic Imaging) | √ | √ | √ | |
| M-THI | √ | √ | √ | |
| Features: | | | | |
| 3D Imaging (3-Scape) | √ | √ | -- | |
| 3D Measurements | √ | √ | -- | |
| 4D Basic Imaging (fourSight 4D) | √ | √ | -- | |
| Panoramic 2D Imaging (SieScape) | √ | √ | -- | |
| Cardiac Imaging
physiological signal display
multiplane TEE
fourSight TEE Imaging | √ | √ | -- | |
| Dual-Beam Processing | √ | √ | √ | |
| Quad-Beam Processing | √ | √ | √ | |
| SynAps | √ | √ | -- | |
| Clip Capture | √ | √ | √ | |
| Tissue Grayscale Optimization (TGO) | √ | √ | -- | |
| Spectral DTI | √ | √ | -- | |
| Axius OB Automated Calipers | √ | √ | -- | |
| Steerable CW | √ | √ | √ | |
| Stress Echo | √ | √ | -- | |
| 2D(color) DTI | √ | √ | -- | |
| Image Arena reporting S/W | √ | √ | -- | |
| DIMAQ (PIMS Workplace) | √ | √ | √ | |
| Vascular Enhancement (Clarify VE) | √ | √ | -- | |
| eSielmage | -- | √ | √ | |
| Advance SieClear | -- | √ | √ | |
| Multiple Frequency Imaging(MultiHertz) | √ | √ | √ | |
| Digital Architecture | √ | √ | √ | |
| Fully integrated DICOM | √ | √ | √ | |
| Dynamic TCE | √ | √ | √ | |
| AHP | √ | √ | -- | |
| Monitor: 15.4"WXGA (FPD) | √ (17" FPD) | √ (19" FPD) | √ | |
| Wireless | √ | √ | √ | |
| Feature / Characteristic | Predicate Device
ACUSON X300
(K121699) | Predicate Device
ACUSON S2000
(K140959) | Submission Device
ACUSON P500 | |
| # Channels | 128 | 192 | 64 | |
| Output Display Standard
(Track 3) | √ | √ | √ | |
| Patient Contact Materials | Tested to ISO 10993-1 | Tested to ISO 10993-1 | Tested to ISO 10993-1 | |
| UL60601-1 Certified | √ | √ | √ | |
The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
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E. 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, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:
- UL 60601-1, Safety Requirements for Medical Equipment 国
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards 보
- CSA C22.2 No. 601-1. Safety Requirements for Medical Equipment l
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical 전 Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 피 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive 별
- 트 Safety and EMC Requirements for Medical Equipment
- EN/IEC 60601-1 L
- I EN/IEC 60601-1-1
- 트 EN/IEC 60601-1-2
- 트 EN/IEC 60601-1-6
- . EN/IEC 62304
- EN/IEC 62366 家
- I EN/IEC 60601-2-18
- 트 EN/IEC 60601-2-25
- ISO 10993-1 Biocompatibility 피
Cleared patient contact materials, electrical and mechanical safety are unchanged.
F. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
Since the P500 uses the same technology and principles as existing devices, clinical data is not required.
G. Summary
Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Requlation and ISO 13485:2003 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the P500 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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The ACUSON P500 is verified and validated according to the company's design control process.