(244 days)
Not Found
No
The document describes standard ultrasound imaging modes and processing techniques (like Speckle Reduction) but does not mention AI, ML, or any related concepts. The performance studies focus on safety and equivalence to existing devices, not on the performance metrics typically associated with AI/ML algorithms.
No.
The device is described as a "diagnostic ultrasound system" and its intended use is for imaging and measurement to aid in "clinical diagnosis purposes." It does not provide therapy.
Yes
The 'Device Description' specifically states that the S2000 and S3000 Ultrasound Systems are "software controlled diagnostic ultrasound systems." Additionally, the 'Intended Use / Indications for Use' section mentions that the system provides "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."
No
The device description explicitly states it is a "multi-purpose mobile, software controlled diagnostic ultrasound systems" and describes its function as acquiring and displaying ultrasound echo data. This indicates the device includes hardware components for generating and receiving ultrasound waves, in addition to the software control and processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The S2000 and S3000 Ultrasound Systems are described as diagnostic ultrasound systems that acquire and display ultrasound echo data. This is an in vivo imaging modality, meaning it examines the body directly without taking specimens.
- Intended Use: The intended uses listed are all related to imaging and measuring anatomical structures within the body. While the information gathered can be used adjunctively for clinical diagnosis, the device itself is not performing a diagnostic test on a biological sample.
- No Mention of Specimen Analysis: The description of the device and its functions does not involve the analysis of any biological specimens.
Therefore, the S2000 and S3000 Ultrasound Systems, as described, fall under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult, Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, transesophageal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculoskeletal (superficial) and neonatal cardiac) and calculation packages that provide information 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 oction to reference normative tables that have been validated and published 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. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subcinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav 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.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX, OBJ
Device Description
The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, intraoperative neurological, small organ, trans-esophageal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial), neonatal cardiac, Intima Media (Carotid Arteries), intra-cardiac and intra-luminal (cardiac and great vessel).
Indicated Patient Age Range
Adult and pediatric patients.
Intended User / Care Setting
Not Found
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)
The S2000, S3000 and Aixplorer use 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.
K111674, K122825, K112255, K121329
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.
0
KB1164
page 1 of 7
S2000 and S3000 VTQ 510(k) Submission
DEC 2 4 2013
510(k) Summary Prepared April 17, 2013
- Siemens Medical Solutions, Inc., 1. Sponsor: Ultrasound Division 685 East Middlefield Road Mountain View, California 94043
| Contact Person: | Shelly Pearce |
|---|---|
| Telephone: (650) 694-5988 | |
| Fax: (650) 694-5580 |
-
- Device Name: Acuson S2000 and S3000 Diagnostic Ultrasound Systems
- Common Name: Diagnostic Ultrasound System
Classification:
Regulatory Class: ll 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 |
| Diagnostic Ultrasound Catheter | FR # 870.1200 | Product Code OBJ |
3. Legally Marketed Predicate Devices
The Acuson S2000 and S3000 Ultrasound Systems are substantially equivalent to the company's own S2000 and S3000 Ultrasound Systems and Supersonic Imagine Shearwave Elastography (K111674, K122825, K112255, K121329)
4. Device Description:
The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display. It is substantially equivalent to the S2000 (K111674) and S3000 system (K122825) which are legally marketed devices.
5. Intended Use
The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
1
| Siemens Medical Solutions, Inc. | S2000 and S3000 VTQ |
|---|---|
| Ultrasound Division | 510(k) Submission |
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 and published 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. 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 Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav 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 of adult and pediatric patients.
| | Feature / Characteristic | Submission
Device
S2000 | Submission
Device
S3000 | Acuson
S3000
K122825 | Acuson
S2000
K111674 | Supersonic
Imagine
K112255 /
K121329 |
|---------------------------------------------------|------------------------------------------|-------------------------------|-------------------------------|----------------------------|-----------------------------------------------|-----------------------------------------------|
| | Indications for Use: | | | | | |
| ■ | Fetal | √ | √ | √ | √ | |
| ■ | Abdominal | √ | √ | √ | √ | √ |
| ■ | Intraoperative abdominal and
vascular | √ | √ | √ | √ | |
| ■ | Intraoperative neurological | -- | -- | -- | -- | -- |
| ■ | Pediatric | √ | √ | √ | √ | √ |
| ■ | Small Organ | √ | √ | √ | √ | √ |
| ■ | Neonatal cephalic | √ | √ | √ | √ | |
| ■ | Adult Cephalic | √ | √ | √ | √ | |
| ■ | Cardiac | √ | √ | √ | √ | |
| ■ | Trans-esophageal | √ | √ | √ | √ | |
| ■ | Transrectal | √ | √ | √ | √ | √ |
| ■ | Transvaginal | √ | √ | √ | √ | √ |
| ■ | Peripheral vessel | √ | √ | √ | √ | √ |
| ■ | Laparoscopic | -- | -- | -- | -- | -- |
| ■ | Musculo-skeletal (conventional) | √ | √ | √ | √ | √ |
| ■ | Musculo-skeletal (superficial) | √ | √ | √ | √ | √ |
| | Center Frequencies Supported: | | | | | |
| ■ | 2.0 MHz | √ | √ | √ | √ | √ |
| ■ | 3.0 MHz | √ | √ | √ | √ | √ |
| ■ | 3.2 MHz | √ | √ | √ | √ | √ |
| Feature / Characteristic | Submission
Device
S2000 | Submission
Device
S3000 | Acuson
S3000
K122825 | Acuson
S2000
K111674 | Supersonic
Imagine
K112255/
K121329 | |
| • 3.3 MHz | √ | √ | √ | √ | √ | |
| • 4.2 MHz | √ | √ | √ | √ | √ | |
| • 4.4 MHz | √ | √ | √ | √ | √ | |
| • 4.8 MHz | √ | √ | √ | √ | √ | |
| • 5.0 MHz | √ | √ | √ | √ | √ | |
| • 5.2 MHz | √ | √ | √ | √ | √ | |
| • 6.0 MHz | √ | √ | √ | √ | √ | |
| • 6.5 MHz | √ | √ | √ | √ | √ | |
| • 6.9 MHz | √ | √ | √ | √ | √ | |
| • 9.5 MHz | √ | √ | √ | √ | √ | |
| • 10.0 MHz | √ | √ | √ | √ | √ | |
| Modes: | | | | | | |
| • B | √ | √ | √ | √ | √ | |
| • Parallel processing in B mode | √ | √ | √ | √ | √ | |
| • M | √ | √ | √ | √ | | |
| • PWD (Pulsed Wave Doppler) | √ | √ | √ | √ | √ | |
| • CWD (Continuous Wave Doppler) | √ | √ | √ | √ | √ | |
| • D (Color Doppler) | √ | √ | √ | √ | √ | |
| • Amplitude Doppler | √ | √ | √ | √ | √ | |
| • Combined (BMDC) | √ | √ | √ | √ | √ | |
| Features: | | | | | | |
| • Quad processing in color | √ | √ | √ | √ | | |
| • Native™ tissue harmonic imaging | √ | √ | √ | √ | | |
| • SieScape™ panoramic imaging | √ | √ | √ | √ | | |
| • Color SieScape™ panoramic
imaging | √ | √ | √ | √ | | |
| • 3-Scape™ real-time 3D imaging | √ | √ | √ | √ | | |
| • fourSight™ 4D transducer
technology | √ | √ | √ | √ | | |
| • TEQ™ ultrasound technology | √ | √ | √ | √ | | |
| • Extend imaging technology | √ | √ | √ | √ | | |
| • Cardiac Imaging
physiological signal display | √ | √ | √ | √ | | |
| • syngo ® Auto OB measurements | √ | √ | √ | √ | | |
| • Advanced SieClear™ spatial
compounding | √ | √ | √ | √ | | |
| • STIC (Fetal Heart Imaging) | √ | √ | √ | √ | | |
| • Amnioscopic rendering | √ | √ | √ | √ | | |
| • Cadence contrast agent imaging | √ | √ | √ | √ | | |
| • Clarify™ vascular enhancement
technology | √ | √ | √ | √ | | |
| • eSie™ Touch elasticity imaging | √ | √ | √ | √ | √ | |
| • syngo ® Auto Left heart | √ | √ | √ | √ | | |
| • syngo ® Velocity Vector Imaging | √ | √ | √ | √ | | |
| • Semi Auto-segmentation (eSie
Calc) | √ | √ | √ | √ | | |
| Feature / Characteristic | Submission
Device
S2000 | Submission
Device
S3000 | Acuson
S3000
K122825 | Acuson
S2000
K111674 | Supersonic
Imagine
K112255 /
K121329 | |
| Custom Tissue Imaging / Speed of
Sound | √ | √ | √ | √ | | |
| AHP | √ | √ | √ | √ | | |
| VTQ | √ | √ | | | √ | |
| 18L6HD Transducer | √ | √ | √ | √ | | |
| 6C1HD Transducer | √ | √ | √ | √ | | |
| 8C3HD Transducer | | √ | √ | | | |
| Monitor: FPD | √ | √ | √ | √ | √ | |
| Output Display Standard (Track 3) | √ | √ | √ | √ | | |
| Patient Contact Materials | Tested to ISO
10993-1 | Tested to ISO
10993-1 | Tested to ISO
10993-1 | Tested to ISO
10993-1 | Tested to ISO
10993-1 | |
| UL 60601-1 Certified | √ | √ | √ | √ | √ | |
6. Summary of Technological Characteristics - New Device Compared to Predicate
S2000/3000 510(k) Submission
Page 8 of 64
2
S2000 and S3000 VTQ 510(k) Submission
:
.
S2000/3000 510(k) Submission
Page 9 of 64 .
.
3
S2000 and S3000 VTQ 510(k) Submission
| Shear Wave Elasticity Imaging Software | VTQ | Supersonic
Imagine
Aixplorer | Comments |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparable Exam Types | Abdomen,
Breast,
Thyroid | Abdomen,
Breast,
Thyroid | |
| Transducer for same Exam Types | 6C1 HD,
4C1, 4V1,
9L4 | SC6-1
SL15-4 | |
| Operating Mode | Single Frame | Low Frame
Rate Real
Time | Note 1 |
| Cool Down period before live imaging
resumes | Yes (variable.
~1-3 sec) | No | Note 1 |
| Push Pulse sequence | Dual Push
Beams: one
on each side
of
measurement
ROI | Low (variable
with FOV
size)
Reference
Figure 13 in
Supersonic
White Paper | Note 1 |
| Multiple Push Pulse Focal Zones | No (Single
focal position
tracks with
ROI location
in depth) | "Mach Cone" | In both cases, radiation force uniformity is
maintained with depth by optimizing push beam
focus at region of interest. "Mach Cone" is the
Supersonic term for compound transmit focusing
"Supersonic Imagine has implemented a two
dimensional image display representing shear
wave speed or Young's modulus. The region of
interest size is adjustable within limits. A potential
advantage is the ability to visualize variability of
the elasticity parameter over a wider area of
interest, however this is visual reference without
quantification of variance. Outside the USA, the
ability to get a mean value is provided for the
larger area or with reduced measurement ROI |
| Two Dimensional Display with Elasticity
Region of Interest | No | Yes | size, a localized value. This feature is not cleared
in the USA. VTQ provides a mean shear wave |
| | | | speed over a predefined region of interest that is
not adjustable. For the 4C1, 6C1 HD and 4V1
abdomen transducers, the ROI size is 10mm x
5mm. For the 9L4 transducer, the ROI size is 5 x
5 mm. Multiple measurements can be made over
larger areas and statistics for Mean, Median.
Standard Deviation and IQR (Interquartile range)
are provided for analyzing multiple
measurements. There is no evidence to suggest
one method is more accurate than the other,
therefore we believe they are equivalent in clinical
use." |
| Localized Quantitative Shear Wave
Velocity measurement | Yes | Yes -
Predicate not
cleared in the
U.S.A. | |
| Localized Quantitative Young's Modulus
measurement | No | Yes -
Predicate not
cleared in the
U.S.A. | Supersonic Imagine has implemented the shear
wave velocity scale in the color bar which
indicates relative shear wave speed in the image
and has been cleared in the U.S. Young's
modulus is not cleared. Siemens VTQ is
equivalent to Supersonic except Siemens is
requesting clearance for point measurements in
addition to displaying shear wave velocity on the
color bar. When Young's modulus is displayed
(kPa), assumptions are made regarding tissue
density and viscosity that may not be correct in a
wide range of biological tissues and is therefore
an indirect measurement. Shear wave velocity is
a direct measurement. |
| Localized Shear Wave Velocity
measurement area | 6C1 HD,
4C1, 4V1:
10mm
(height) by 6
mm (width)
9L4: 5mm
(height) by 6
mm (width) | Yes -
Predicate not
cleared in the
U.S.A. | With VTQ, shear wave velocity estimates must
pass a confidence interval check (≥0.8) to display
a value, otherwise an "x.xx" result is displayed. |
| Shear Wave Propagation "Movie" (clip) | No | Yes | The Supersonic shear wave propagation movie
provides information specific to their
implementation of shear wave imaging, as noted
in Note 1. |
| Shear Wave Velocity Measurement Range | 0.5-5.5 m/sec
(6C1 HD,
4C1, 4V1)
0.5-8.4 m/sec
(9L4) | SC6-1: 0-10
m/sec
(default 0-3.2
m/sec)
SL15-4: 0-10
m/sec | Siemens has chosen a lower velocity cutoff of 0.5
m/s to avoid potential erroneous shear wave
velocity estimates. In in-vivo studies, shear wave
velocities below 0.5 m/s have not been
encountered so there is no impact on clinical
efficacy. For abdomen (liver) applications, in
several in-vivo studies the maximum recorded
values did not exceed 4.4 m/sec. |
| Color Coded Shear Wave Velocity Display | No | Yes | |
| Adjustable Maximum and Minimum
Velocity Scale | No | Yes | |
| In Color Code, Red is 'stiff' and blue is
'soft' | N/A | Yes | |
| Color map is transparent over B mode
display | N/A | Yes | |
| Other system features: | | | |
| B Mode Imaging | Yes | Yes | |
| Pulse Wave Doppler Imaging | Yes | Yes | |
| Color Flow Doppler Imaging | Yes | Yes | |
| Spatial Compound Imaging | Yes | Yes | |
| Speckle Reduction Image Processing | Yes | Yes | |
| Tissue Harmonic Imaging | Yes | Yes | |
S2000/3000 510(k) Submission
Page 10 of 64
4
S2000 and S3000 VTQ 510(k) Submission
.
S2000/3000 510(k) Submission
Page 11 of 64
5
S2000 and S3000 VTQ 510(k) Submission
Note 1:
There are differences in push pulse sequencing and shear wave detection between the predicate device (Supersonc Aixplorer) and Siemens VTQ. Siemens uses focused push beams on each side of the measurement ROI and a fixed number of closely spaced focused detection beams resulting in higher signal to noise ratio in shear wave imaging than the predicate device. A reduced push beam mechanical index is used on the Aixplorer as compared to the constant value of 1.7 with VTQ, which allows pseudo-real time operation on the Aixplorer of approximately 1 frame per second. The user is required to compound the image at the region of interest over several seconds with the Aixplorer to allow the image to "build up" over several frames to improve signal to noise ratio. VTQ is a single frame image acquisition that allows higher signal to noise ratio without image compounding and generates a more consistent shear wave velocity estimation based on our experience in in-vivo studies.
7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.
The devices have 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 .
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards l
- 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 .
- I IEC 1157 Declaration of Acoustic Power
- . ISO 10993-1 Biocompatibility
Cleared patient contact materials, electrical and mechanical safety are unchanged.
8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.
The S2000, S3000 and Aixplorer use the same technology and principles as existing devices, clinical data is not required.
9. 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 Regulation and ISO 13485:2003 quality system standards. The product is
S2000/3000 510(k) Submission
6
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 devices are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
S2000/3000 510(k) Submission
Page 13 of 64
7
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-0002
December 24, 2013
Siemens Medical Solutions USA, Inc. c/o Ms. Shelly Pearce Regulatory Affairs 1230 Shorebird Way MOUNTAIN VIEW CA 94043
Re: K131164
Trade/Device Name: Acuson S2000 and S3000 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, OBJ Dated: November 19, 2013 Received: November 22, 2013
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. 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Acuson S2000 Diagnostic Ultrasound Systems, as described in your premarket notification:
Transducer Model Number
CW2 9L4 Linear Array 6C2 Curved Array 4VI Phased Array 7CF2 Curved Array 8V3 Phased Array EV8C4 V7M TEE
CWS 14L5 Multi-D Array 4C1 Curved Array 10V4 Phased Array 9EVF4 Curved Array 4V Ic Phased Array 8C3HD Curved Array ACUNAV 8F
EC9-4 Curved Array 4PI Phased Array 6CIHD Curved Array 14L5 SP Linear Array V5Ms Multiplane TEE ୧୮3 18L6 HD Linear Array ACUNAV 10F
8
Page 2-Ms. Pearce
..............................................................................................................................................................................
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 (2 1 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/Medica|Devices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Samung Hi. Mesgo
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
9
1.3 Indications for Use
K131164 A. 510(k) Number (if known):
Device Name: S2000 and S3000 Diagnostic Ultrasound Systems
Indications for Use:
The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult, Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, transesophageal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculoskeletal (superficial) and neonatal cardiac) and calculation packages that provide information 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 oction to reference normative tables that have been validated and published 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. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subcinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".
The Acuson Acunav 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.
Prescription Use × (Part 21CFR 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)
currence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Semung M. Mase
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR)
510(k).
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S2000/3000 510(k) Submission
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