(40 days)
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intrcperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial 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 typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.
The SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled diagnostic ultrasound system with an on-screen display for themical indices related to potential bio-effect mechanisms. Its function is to acquire primary of Secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Dopler Mode, a combination Continuous (CW) Doppler Mode, Color Dopen Mode, Ampling on a France, Nissalay of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display. The SC2000™Ultrasound System has been optimized for user ergonomics with adjustable keyboard height and rotation and independently adjustable Flat P available off-line workstation (SC2000WP).
Here's an analysis of the provided 510(k) summary regarding the Acuson SC2000™ Diagnostic Ultrasound System, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria and outcome metrics in the way a clinical trial for a new therapeutic device might. The "performance data" section in this type of submission generally refers to engineering verification and validation against internal specifications and relevant safety standards, rather than direct clinical performance in terms of diagnostic accuracy against a ground truth in a clinical setting.
Therefore, the answers below will reflect the information available in this type of regulatory document. Many of the requested details (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, effect size, and training set information) are explicitly not present in a standard 510(k) premarket notification for an ultrasound system, as this is a device modification submission focusing on safety and technological equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a modification to an existing device, the "acceptance criteria" are primarily based on established safety and performance standards for diagnostic ultrasound systems, and the "reported device performance" is the device's demonstrated compliance with these standards and verification of its specifications.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| UL 60601-1 (Safety Requirements for Medical Equipment) | Compliant |
| IEC 60601-2-37 (Diagnostic Ultrasound Safety Standards) | Compliant |
| CSA C22.2 No. 601-1 (Safety Requirements for Medical Equipment) | Compliant |
| AIUM/NEMA UD-3 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices) | Compliant |
| AIUM/NEMA UD-2 (Acoustic Output Measurement Standard for Diagnostic Ultrasound) | Compliant |
| IEC 60601-1 (Safety and EMC Requirements for Medical Equipment) | Compliant |
| IEC 60601-1-1 | Compliant |
| IEC 60601-1-2 | Compliant |
| IEC 1157 (Declaration of Acoustic Power) | Compliant |
| ISO 10993-1 (Biocompatibility) | Compliant |
| Meeting company's design control process and specifications | Verified and validated through extensive safety and performance testing |
| Substantial equivalence to predicate devices (K072365 and K102017) in intended use and technological characteristics | FDA determined substantially equivalent based on the submission |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical performance evaluation (e.g., patient data for diagnostic accuracy). The performance data cited refers to engineering and safety testing. Therefore, there is no information provided regarding sample size for a clinical test set or data provenance (e.g., country of origin, retrospective/prospective clinical data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/Not provided. As stated above, this submission focuses on technical safety and performance validation against standards, not a clinical study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable/Not provided. No clinical test set or adjudication method is mentioned in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No. The document does not mention any MRMC comparative effectiveness study, nor does it provide information on a human readers' improvement with or without AI assistance. This type of study is not common for 510(k) submissions of basic ultrasound system modifications.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. The SC2000™ is a diagnostic ultrasound system, an imaging device operated by a human. It is not an AI algorithm intended for standalone diagnostic performance. The document describes the system's ability to acquire and display ultrasound data, and its "calculation packages" provide information to the clinician for diagnosis, implying human interpretation is always in the loop.
7. The Type of Ground Truth Used
For the safety and performance testing described, the "ground truth" is defined by the technical specifications for the device and the objective criteria outlined in the various international and national safety and performance standards (e.g., acoustic output measurements, electrical safety limits, biocompatibility standards). This is engineering and regulatory compliance ground truth, not clinical ground truth (like pathology results or patient outcomes) for diagnostic accuracy.
8. The Sample Size for the Training Set
Not applicable/Not provided. This submission describes an ultrasound imaging system, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable/Not provided. As there is no mention of a machine learning model or training set, the establishment of ground truth for such a set is not relevant to this submission.
{0}------------------------------------------------
510(k) Summary Prepared October18, 2011
| Sponsor: | Siemens Medical Solutions, Inc.,Ultrasound Division1230 Shorebird WayMountain View, California 94043 | |
|---|---|---|
| Contact Person: | Robert F. LawrenceTelephone:Fax: | (650) 694-5984(650) 694-5580 |
| Submission Date: | October 18, 2011 | |
| Device Name: | Acuson SC2000™ Diagnostic Ultrasound System | |
| Common Name: | Diagnostic Ultrasound System |
Classification:
Regulatory Class: ll Tier II Review Category: Classification Panel: Radiology
| Ultrasonic Pulsed Doppler Imaging System | FR # 892.1550 | Product Code 90-IY |
|---|---|---|
| Ultrasonic Pulsed Echo Imaging System | FR # 892.1560 | Product Code 90-IY |
| Diagnostic Ultrasound Transducer | FR # 892.1570 | Product Code 90-IT |
A. Legally Marketed Predicate Devices
/ . Bogany
The Acuson SC2000™ Ultrasound System in this 510k is a modification to SC2000™ The Acuson SC2000 - Oltrasound System in this of K072365 and K102017.
Diagnostic Ultrasound System previously cleared in K072365 and K102017.
B. Device Description:
The SC2000™ Diagnostic Ultrasound System is a multi-purpose mobile, software controlled The SC2000™ Diagnostic Unrasund System be porporal and mechanical indices
diagnostic ultrasound system with an on-screen display for themical indices diagnostic ultrasound system with an on-scieer alspire primary of secondary
related to potential bio-effect mechanisms. Its function is to acquire primary of Secondary related to potential bio-enect mechanisms. It in B-Mode, Pulsed (PW) Dopler Mode,
harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Dopler Mode, a combinati harmonic ultrasound echo data and ulished on inistration of online of Oppler Mode, a combination
Continuous (CW) Doppler Mode, Color Dopen Mode, Ampling on a France, Nissalay Continuous (CVV) Dopper Mode, Oolor Doppler Model, Mipmont on a Flat Panel Display.
of modes, 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.
of mouse, of the SC2000"
The SC2000™Ultrasound System has been optimized for user ergonomics with adjustable The SC2000™ Diffasound System nas been oplimized for assessmently adjustable Flat Panel Display. There is an
keyboard height and rotation and independently adjustable Flat P available off-line workstation (SC2000WP)
{1}------------------------------------------------
C. Intended Use
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Petal Gallanc, Pedianie, Transespondged, Aland Musculo-skeletal Superficial applications. The system recorogiou, massure 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 typical examinations performed using the SC2000 Ultrasound System are:
Cardiac Imaging Applications and Analysis
The system transmits ultrasound energy into adult, pediatric, neonatal, and fetal cardiac patients creating The System tantonial List acor Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac and continuous were , and surrounding anatomical structures to evaluate the presence of vathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of r re system aloo bupports can belysiology as well as visualization of other devices in the heart of adult and pediatric patients.
The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), The system cranillis alsocure energy ... (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Ooks Doppor (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the Doppier (Orro) to other magos and arteries in the arms and legs; and surrounding analomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Vascular Measurements and Calculation Packages that provide information that may be The System not Vabodian medical data obtained by a physician for clinical diagnosis purposes.
Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), The System Canadinia and abouter (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Oopler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal Dopping (OTTB) to outdir incatomical structures to evaluate the presence or absence of pathology. The system may be used to aquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
Intraoperative imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during neurological intraoperative procedures.
Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler The System transmile andescribed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) (OD), Outlin images and blood flow velocity of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
{2}------------------------------------------------
D. Substantial Equivalence
The submission device is a modification is a modification to SC2000™ Diagnostic Ultrasound System previously cleared in K072365 and K102017 with regard to both intended use and technological characteristics.
E. Performance Data
The SC2000™is designed, verified, and validated according to the company's design control process and has been subjected to extensive safety and performance testing before release. Final testing of the SC2000 included various safety and performance testing designed to ensure the device meets all of its specifications. Safety tests have been performed to ensure the device complies with applicable industry and safety standards including:
The Acuson SC2000™ has been designed to meet the following product safety standards:
- UL 60601-1. Safety Requirements for Medical Equipment l
- . IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment .
- AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical ■ Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUMINEMA UD-2. Acoustic Output Measurement Standard for Diagnostic Ultrasound .
- Safety and EMC Requirements for Medical Equipment .
- = IEC 60601-1
- · IEC 60601-1-1
- IEC 60601-1-2 .
- l IEC 1157 Declaration of Acoustic Power
- l ISO 10993-1 Biocompatibility
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol consisting of four curved lines that resemble human profiles facing to the right.
Food and Orug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Medical Solutions USA. Inc. - Ultrasound Group % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K113179
Trade/Device Name: SC2000TM Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, and ITX Dated: November 29, 2011 Received: November 30, 2011
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the SC2000™ Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
9L4 VSM TEE 4V1c 8V3c AUX CW2 4Zlc (Apollo) AcuNav 8F and 10F Ultrasound Catheter ACUSON AcuNav™ V 10F Ultrasound Catheter SoundStar 10F Ultrasound Catheter
DEC - 7 2011
{4}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Jeffrey Ballyns at (301) 796-6105.
Sincerely Yours.
Mukal D. O'Hare fin
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
{5}------------------------------------------------
1.3 Indications for Use
510(k) Number (if known):
Device Name:
SC2000 ™ Diagnostic Ultrasound System
Indications for Use:
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intracperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial 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 typical examinations performed using the SC2000 Ultrasound System are:
Cardiac Imaging Applications and Analysis
The system transmits ultrasound eneroy into adult, pediatic, neonatal, and fetal cardiac creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Dopter (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound Images.
The system also supports catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.
The system transmits ultrasound energy from either a transthoracic or transesophageal approach in adult and pediatric patients; and from a transthoracic approach in neonatal and fetal cardiac patients creating 2D (B), 3D, M-Mode (M), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave (PW) Doppler, and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
The system has Cardiac Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Vascular Imaging Applications and Analysis
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of the carotid arteries or juggler veins in the neck; superficial and deep veins and arteries in the arms and legs; and surrounding anatomical structures to evaluate the presence or absence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic capture of ultrasound images.
The system has Vascular Measurements and Calculation Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Superficial Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), Pulsed Wave Doppler (PWD), and Continuous Wave Doppler (CWD) to obtain images and blood flow velocity of conventional or superficial musculoskeletal structures and surrounding anatomical structures to evaluate the presence of pathology. The system may be used to acquire patient electrocardiogram for synchronizing the diastolic and systolic capture of ultrasound images.
Page 13 of 1653
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Intraoperative Imaging Applications
The system transmits ultrasound energy into various parts of the body of adult patients creating 2D (B), Color Doppler (CD), Color Power Doppler (CPD), and Pulsed Wave Doppler (PWD) to obtain images and blood flow velocity that provide guidance during neurological intraoperative procedures.
Transcranial Imaging Applications
The system transmits ultrasound energy into the cranium of adult patients creating 2D (B), Color Doppler r no System framerike okled Wave Doppier (PWD), and Continuous Wave Doppler (CWD) (OD), Odlor Fower Dopper (Or D), of the brain and surrounding anatomical structures to evaluate the presence or absence of pathology.
The system provides Measurement Packages that provide information that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONȚINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD)
Muhal D.O.R.
(Division Sign-Off)
510K k: 113199
Page 14 of 39
Page 14 of 1653
(Division Sign-Of Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
{7}------------------------------------------------
1.3 Indications for Use Forms
Diagnostic Ultrasound Indications for Use Form
510(k) Number (if known):
Device Name: SC2000 Diagnostic Ultrasound System
Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | Color ·VelocityImaging | Combined(Specify) | Other:HarmonicImaging | Other:3D | Other:Real Time3D |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||||
| Fetal | P | P | P | P | P | P | P* | P | P | |||
| Abdominal | ||||||||||||
| IntraoperativeAbdominal | ||||||||||||
| IntraoperativeNeurological | P | P | P | P | P | P | P* | P | ||||
| Pediatric | P | P | P | P | P | P | P* | P | P | P | ||
| Small Organ(specify) | ||||||||||||
| NeonatalCephalic | ||||||||||||
| Adult Cephalic | P | P | P | P | P | P | P* | P | ||||
| Cardiac | P | P | P | P | P | P | P* | P | P | P | ||
| Trans-esophageal | P | P | P | P | P | P* | P | |||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intra-Luminal | N | N | N | N | N | N | N* | N | ||||
| Peripheral Vessel | P | P | P | P | P | P | P | P* | P | |||
| Laparoscopic | ||||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | P | P* | P | ||||
| Musculo-skeletalSuperficial | P | P | P | P | P | P | P* | P | ||||
| Other (NeonatalCardiac) | P | P | P | P | P | P | P* | P | ||||
| Other (Intra-Cardiac) | N | N | N | N | N | N | N* | N |
N=new indication. P = Previously Cleared in 510(k) K072365, K102017
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF N Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)
Page 15 of 39
{8}------------------------------------------------
510(k) Number (if known):
Device Name:
914
Indications for Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other:HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | P | P | P | P | P | P | P* | P | ||
| Pediatric | ||||||||||
| Small Organ(specify) | ||||||||||
| NeonatalCephalicAdult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intra-Luminal | ||||||||||
| Peripheral Vessel | P | P | P | P | P | P | P* | P | ||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | P | P | P | P | P | P | P* | P | ||
| Musculo-skeletalSuperficial | P | P | P | P | P | P | P* | P | ||
| Other (specify) |
N=new indication. P = Previously Cleared in 510(k) K072365, K102017
Additional Comments:
*Combinations include: B+M, B+PWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE 1000
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)
Michael Dóhm
SC2000 510(k) Submission
Page 16 of 39
{9}------------------------------------------------
510(k) Number (if known):
Device Name:
V5M TEE
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other:HarmonicImaging | Other:3D |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| IntraoperativeAbdominal | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | P | P | P* | P | ||||
| Small Organ(specify) | |||||||||||
| NeonatalCephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P* | P | ||||
| Trans-esophageal | P | P | P | P | P | P* | P | ||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intra-Luminal | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N=new indication. P = Previously Cleared in 510(k) K072365, K102017
Additional Comments:
- Combinations include: B+M, B+PWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color D Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, __ B+CWD+Power Doppler, B+Clarify VE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)
Murhul DÖKhm
SC2000 510(k) Submission
Page 17 of 39
.
{10}------------------------------------------------
510(k) Number (if known):
Device Name: 4V I c
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other:HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P * | P | ||
| Abdominal | ||||||||||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P * | P | ||
| Small Organ(specify) | ||||||||||
| NeonatalCephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | P * | P | ||
| Cardiac | P | P | P | P | P | P | P * | P | ||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intra-Luminal | ||||||||||
| Peripheral Vessel | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (NeonatalCardiac) | P | P | P | P | P | P | P * | P |
N=new indication. Previously Cleared in 510(k) K072365, K102017
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color, Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE ............................................................................................................................................
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (O1VD) Prescription Use (Per 21 CFR 801.109)
Michael D. Ahn
SC2000 510(k) Submission
Image /page/10/Picture/14 description: The image shows a sequence of handwritten digits and letters. The sequence starts with the letter 'K', followed by the number '113179'. The handwriting style appears casual and slightly uneven, with varying stroke thicknesses.
Page 18 of 39
{11}------------------------------------------------
510(k) Number (if known):
Device Name:
8V3c
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other:HarmonicImaging | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P | P * | P | |||
| Abdominal | |||||||||||
| IntraoperativeAbdominal | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | P | P | P | P * | P | |||
| Small Organ(specify) | |||||||||||
| NeonatalCephalicAdult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P * | P | |||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intra-Luminal | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (NeonatalCardiac) | P | P | P | P | P | P | P | P * | P |
N=new indication. Previously Cleared in 510(k) K102017
Additional Comments:
- Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)
escription
SC2000 510(k) Submission
Page 19 of 39
{12}------------------------------------------------
510(k) Number (if known):
Device Name:
AUX CW2
Intended Use:
Ultrasound imaging or fluid flow analysis of the human body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other:HarmonicImaging |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| IntraoperativeAbdominal | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | P | |||||||||
| Small Organ(specify) | ||||||||||
| NeonatalCephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | P | |||||||||
| Trans-esophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intra-Luminal | ||||||||||
| Peripheral Vessel | P | |||||||||
| Laparoscopic | - | |||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N=new indication. Previously Cleared in 510(k) K072365, K102017
Additional Comments:
(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)
hul D Othn
SC2000 510(k) Submission
Page 20 of 39
{13}------------------------------------------------
510(k) Number (if known):
Device Name:
4Z1c (Apollo)
Intended Use:
Ultrasound imaging or fluid flow analysis of the buman body as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other:HarmonicImaging | Other:RealTime3D |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | P | P | P | P | P | P* | P | P | |||
| Abdominal | |||||||||||
| IntraoperativeAbdominal | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | P | P | P | P | P | P* | P | P | |||
| Small Organ(specify) ** | |||||||||||
| NeonatalCephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P* | P | P | |||
| Trans-esophageal | - | ||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intra-Luminal | |||||||||||
| Peripheral Vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (specify) |
N=new indication. P = Previously Cleared in 510(k) K072365, K102017
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
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ul D SAmm
KII317C
Page 21 of 39
{14}------------------------------------------------
510(k) Number (if known):
Device Name:
AcuNav 8F and 10F Uitrasound Catheter
Intended Use:
Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other:HarmonicImaging | Other:RealTime3D | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| IntraoperativeAbdominal | ||||||||||||
| IntraoperativeNeurological | ||||||||||||
| Pediatric | P | P | P | P | P | P | P* | |||||
| Small Organ(specify) ** | ||||||||||||
| NeonatalCephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | P | P | P | P | P | P | P* | |||||
| Trans-esophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intra-Luminal | P | P | P | P | P | P | P* | |||||
| Peripheral Vessel | ||||||||||||
| Laparoscopic | ||||||||||||
| Musculo-skeletalConventional | ||||||||||||
| Musculo-skeletalSuperficial | ||||||||||||
| Other (Intra-Cardiac) | P | P | P | P | P | P | P* |
N=new indication. P = Previously Cleared in 510(k) K071234, K093812
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)
Presc
{15}------------------------------------------------
510(k) Number (if known):
Device Name:
ACUSON AcuNav™ V 10F Ultrasound Catheter
Intended Use:
Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients as follows:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other:HarmonicImaging | Other:RealTime3D |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| IntraoperativeAbdominal | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | N | N | N | N | N | N | N | N* | N | ||
| Small Organ(specify) ** | |||||||||||
| NeonatalCephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | P* | N | ||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intra-Luminal | P | P | P | P | P | P | P | P * | N | ||
| Peripheral Vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (Intra-Cardiac) | P | P | P | P | P | P | P | P* | N |
N=new indication. P = Previously Cleared in S10(k) K081808
Additional Comments:
- Combinations include: B+M, B+PWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler, B+Clarify VE
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD) Prescription Use (Per 21 CFR 801.109)
Prescrip
muchal ODA
SC2000 510(k) Submission
Page 23 of 39
{16}------------------------------------------------
510(k) Number (if known):
Device Name:
SoundStar 10F Ultrasound Catheter
Intended Use:
Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart:
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other:HarmonicImaging | Other:RealTime3D |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| IntraoperativeAbdominal | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ(specify) ** | |||||||||||
| NeonatalCephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P* | ||||
| Trans-esophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intra-Luminal | P | P | P | P | P | P | P* | ||||
| Peripheral Vessel | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalSuperficial | |||||||||||
| Other (Intra- | P | P | P | P | P | P | P* |
N=new indication. P = Previously Cleared in 510(k) K070242
Additional Comments:
*Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler
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Prescript
§ 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.