(60 days)
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO ARTIDA (Model SSH-880CV) is intended to be used for the following types of studies: cardiac, transesophageal, abdominal and peripheral vascular.
The APLIO ARTIDA, Model SSH-880CV is a mobile diagnostic ultrasound system. This is a Track 3 device that employs a wide array of probes including convex, pencil, flat linear array and sector array, with a frequency range of approximately 2.0 MHz to 7.5 MHz. This system supports basic measurements including distance, time, angle, and trace, as well as combinations of some basic measurements.
The provided 510(k) summary for the Toshiba Aplio Artida (SSH-880CV), V3.2, describes modifications to an already cleared diagnostic ultrasound system. It does not contain information about a study proving the device meets specific acceptance criteria in the typical sense of a clinical performance study with defined metrics.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Aplio Artida (SSH-880CV), V3.0) and confirming that "modifications to the cleared device which improves upon existing features including contour tracing and expansion of the sector display function for two existing transducers and use of a proprietary 4D render" do not change the indications for use or intended use.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as the submission relies on bench testing, software validation, risk management, and design controls to demonstrate safety and effectiveness for the modified features.
Here's a breakdown of the information that can be extracted or inferred, and what is explicitly not present:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table with specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for clinical performance, nor does it report device performance against such criteria. The "performance" demonstrated is that the modified features function as intended and do not compromise safety or effectiveness compared to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information on a "test set" in the context of clinical performance data is provided. The testing mentioned is "bench testing" and "software validation," which are likely internal engineering verification and validation activities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no external clinical test set and ground truth establishment by experts is described for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no external clinical test set and adjudication process is described for this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This submission is for modifications to a diagnostic ultrasound system (hardware/software features), not an AI algorithm intended to assist human readers in interpretation. There is no mention of AI or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm submission. The device is a diagnostic ultrasound system operated by a human user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of clinical performance. The "ground truth" for the modified features would be their proper functioning as verified through engineering tests and adherence to specifications.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning device that involves a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/machine learning device.
Summary of Device Acceptance and Study as Per Document:
- Acceptance Criteria (Implicit):
- The modified features (contour tracing, expanded sector display for two transducers, proprietary 4D render) function as intended.
- The modifications do not change the indications for use or the intended use of the device.
- The device continues to comply with relevant safety standards (e.g., IEC60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, NEMA UD3).
- The device is designed and manufactured under Quality System Regulations (21 CFR § 820 and ISO 13485 Standards).
- Study That Proves Device Meets Acceptance Criteria:
- The submission refers to "Risk Analysis and verification testing conducted through bench testing" to demonstrate that "requirements for the improved/added features have been met."
- "Software Documentation for a Moderate Level of Concern" and "software validation" were included to support the software modifications.
- Testing was conducted in accordance with applicable IEC standards for Medical Devices.
- The conclusion states: "Based upon bench testing and successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use."
In essence, this 510(k) submission for the Toshiba Aplio Artida V3.2 is for a modification to an existing device, and the "study" described is a series of engineering and software verification and validation activities rather than a clinical performance study with predefined acceptance metrics against patient data. The primary goal was to establish substantial equivalence and ensure the modifications did not introduce new safety or efficacy concerns.
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TOSHIBA
ding Innovation >>>
K140729
page 1 of 3
ТОВНІВА АМЕРІСА MEDICAL БУВТЕМВ, INC 2441 Michelle Drive, Tustin, CA 92780
Phone: (714) 730-5000
510(k) SUMMARY
- SUBMITTER'S NAME: 1. Toshiba America Medical Systems, Inc.
-
- ADDRESS: 2441 Michelle Drive Tustin, CA 92780-2068
-
- ESTABLISHMENT REGISTRATION: 2020563
CONTACT PERSON: 4. Paul Biggins Director, Regulatory Affairs (714) 669-7808
- Date Prepared: March 21, 2014
6. TRADE NAME(S):
Diagnostic Ultrasound System Aplio Artida (SSH-880CV), V3.2
COMMON NAME: 7.
System, Diagnostic Ultrasound
8. DEVICE CLASSIFICATION:
Class II
Ultrasonic Pulsed Doppler Imaging System – Product Code: 90-IYN [per 21 CFR 892.1550] Ultrasonic Pulsed Echo Imaging System – Product Code: 90-IYO [per 21 CFR 892.1560] Diagnostic Ultrasonic Transducer – Product Code: 90-ITX [per 21 CFR 892.1570]
9. PREDICATE DEVICE:
| Product | Marketed by | 510(k) Number | Clearance Date |
|---|---|---|---|
| Aplio Artida (SSH-880CV), V3.0 | Toshiba AmericaMedical Systems | K121577 | June 22, 2012 |
MAY 2 3 2014
Page 1 of 3
{1}------------------------------------------------
10. REASON FOR SUBMISSION:
Modification of a cleared device
11. DEVICE DESCRIPTION:
The APLIO ARTIDA, Model SSH-880CV is a mobile diagnostic ultrasound system. This is a Track 3 device that employs a wide array of probes including convex, pencil, flat linear array and sector array, with a frequency range of approximately 2.0 MHz to 7.5 MHz. This system supports basic measurements including distance, time, angle, and trace, as well as combinations of some basic measurements.
12. INDICATIONS FOR USE:
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO ARTIDA (Model SSH-880CV) is intended to be used for the following types of studies: cardiac, transesophageal, abdominal and peripheral vascular.
13. SUBSTANTIAL EQUIVALENCE:
This device is substantially equivalent to the Aplio Artida (SSH-880CV), V3.0, 510(k) cleared under K121577, marketed by Toshiba America Medical Systems. The Aplio Artida (SSH-880CV), V3.2, functions in a manner similar to and is intended for the same use as the predicate device. The subject device includes modifications to the cleared device which improves upon existing features including contour tracing and expansion of the sector display function for two existing transducers and use of a proprietary 4D render. A comparison table is included in this submission detailing the similarities and differences between the predicate device and the subject device.
14. SAFETY:
The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304 and NEMA UD3 Output Display standards.
15. TESTING
Risk Analysis and verification testing conducted through bench testing are included in this submission which demonstrates that the requirements for the improved/added features have been met.
Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
Additionally, testing of the modified system was conducted in accordance with the applicable standards published by the International Clectrotechnical Commission (IEC) for Medical Devices.
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K140729
page 3 of 3
16. CONCLUSION
The modifications incorporated into the Aplio Artida (SSH-880CV), V3.2 do not change the indications for use or the intended use of the device. Based upon bench testing and successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W(166-G609 Silver Spring, MD 20993-0002
May 23, 2014
Toshiba Medical Systems Corporation % Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780
Re: K140729
Trade/Device Name: Aplio Artida (SSH-880CV), V3.2 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 21, 2014 Received: March 24, 2014
Dear Mr. Biggins:
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. Iisting 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 Aplio Artida, V3.2, as described in your premarket notification:
Transducer Model Number
| PST-25SX | PST-30BT | PST-30SBT |
|---|---|---|
| PST-50BT | PST-65AT | PLT-704SB |
| PC-20M | PST-25BT | PVT-375BT |
| PLT-704AT | PET-508MA | PET-510MB |
| PET-512MC |
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
{4}------------------------------------------------
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.
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.lda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part the regulation entitled, "missimating reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/McdicalDevices/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 rou may 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,
Smh
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Aplio Artida™ (SSH-880CV), V3.2
Indications for Use (Describe)
The DIAGNOSTIC ULTRASOUND SYSTEM APLIO ARTIDA (Model SSH-880CV) is intended to be used for the following types of studies: cardiac, transesophageal, abdominal and peripheral vascular.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Sm.h.7)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{6}------------------------------------------------
System: ______________________________________________________________________________________________________________________________________________________________________ Transducer: __
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | THI | DynamicFlow | Power | TDI | CHI2D | 4D(Realtime3D) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | P | P | P | P | P | P | P | P | P | P |
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | P | P | P | P | P | P | P | P | ||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | P | P | ||||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | P | P | ||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | P | P | P | P |
| Cardiac Pediatric | P | P | P | P | P | P | P | P | P | P | P | P |
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | P | ||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | P | P | |||
| Other (Specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510k of the transducer: K121577
•Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
{7}------------------------------------------------
510(k) Premarket Notification Aplio Artida ™(v3.2) SSH-880CV Ultrasound System
Aplio Artida (SSH-880CV), V3,2 System: Transducer _ PST-25SX
Intended Use: Diagnostic ultrasound imaging or Nuid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | THI | DynamicFlow | Power | TDI | CHI2D | 4D(Realtime3D) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | ||||||||||||
| Musculo-skeletal(Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | P | P | P | |||||||||
| Cardiac Pediatric | P | P | P | |||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cicared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121577
•Combined mode includes BM: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
{8}------------------------------------------------
Aplio Artida (SSH-880CV), V3.2V System: _ Transducer ._ PST-30BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical ApplicationSpecific(Tracks 3) | Mode of Operation | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | THI | DynamicFlow | Power | TDI | CHI2D | 4D(Realtime3D) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||||
| Fetal | |||||||||||||
| Abdominal | P | P | P | P | P | P | P | P | P | P | |||
| Intra-operative (Specify) | |||||||||||||
| Intra-operative (Neuro) | |||||||||||||
| Laparoscopic | |||||||||||||
| Pediatric | |||||||||||||
| Small Organ (Specify) (1) | |||||||||||||
| Neonatal Cephalic | |||||||||||||
| Adult Cephalic | |||||||||||||
| Trans-rectal | |||||||||||||
| Trans-vaginal | |||||||||||||
| Trans-urethral | |||||||||||||
| Trans-esoph. (non-Card.) | |||||||||||||
| Musculo-skeletal(Conventional) | |||||||||||||
| Musculo-skeletal (Superficial) | |||||||||||||
| Intravascular | |||||||||||||
| Other (Specify) | |||||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | P | P | P | ||
| Cardiac Pediatric | P | P | P | P | P | P | P | P | P | P | P | ||
| Intravascular (Cardiac) | |||||||||||||
| Trans-esoph. (Cardiac) | |||||||||||||
| Intra-cardiac | |||||||||||||
| Other (Specify) | |||||||||||||
| Peripheral vessel | |||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121577
•Combined mode includes BM: B/PWD; BDF/PWD: BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
{9}------------------------------------------------
510(k) Premarket Notification Aplio Artida ™(v3.2) SSH-880CV Ultrasound System
Aplio Artida (SSH-880CV), V3.2 System: ______________________________________________________________________________________________________________________________________________________________________ PST-30SBT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | THI | DynamicFlow | Power | TDI | CHI2D | 4D(Realtime3D) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | P | |||
| Cardiac Pediatric | P | P | P | P | P | P | P | P | P | |||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA: E = added under this appendix Previous 510(k) of the transducer. K121577
•Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
·
{10}------------------------------------------------
510(k) Premarket Notification Aplio Artida ™(v3.2) SSH-880CV Ultrasound System
Aplio Artida (SSH-880CV), V3.2 System: PST-50BT Transducer:_
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify)* | THI | DynamicFlow | Power | TDI | CHI2D | 4D(Realtime3D) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | ||||
| Cardiac Pediatric | P | P | P | P | P | P | P | P | ||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication: P = previously cleared by FDA; E = added under this appendix
Previous $10(k) of the transducer: K l 21577
�Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
·
{11}------------------------------------------------
System: ______________________________________________________________________________________________________________________________________________________________________
Intended Use: Diagnostic ultrasound imaging or Nuid flow analysis of the human body as follows:
| Clinical ApplicationSpecific(Tracks 3) | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler. | Combined(Specify) | THI | DynamicFlow | Power | TDI | CHI2D | 4D(Realtime3D) | |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | ||||
| Cardiac Pediatric | P | P | P | P | P | P | P | P | ||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer. K 121577
*Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
{12}------------------------------------------------
510(k) Premarket Notification Aplio Artida ™(v3.2) SSH-880CV Ultrasound System
Aplio Artida (SSH-880CV), V3.2 System: Transducer: PLT-704SBT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | THI | DynamicFlow | Power | TDI | CHI2D | 4D(Realtime3D) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | P | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal (Superficial) | P | P | P | P | P | P | P | P | P | |||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | P | P | |||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer. K 121577
•Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
{13}------------------------------------------------
510(k) Premarket Notification Aplio Artida ™(v3.2) SSH-880CV Ultrasound System
Aplio Artida (SSH-880CV), V3,2 System: Transducer: PC-20M
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 3) | हि | M | PWD CWD | ColorDoppler | Combined(Specify) | THI | DynamicFlow | Power | TDI | CHI2D | 4 D(Realtime3D) | |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethra! | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | ||||||||||||
| Musculo-skeletal(Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | P | |||||||||||
| Cardiac Pediatric | P | |||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | P | |||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121577
*Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
.
{14}------------------------------------------------
Aplio Artida (SSH-880CV), V3.2 System: PST-25BT Transducer:_
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify)* | THI | DynamicFlow | Power | TDI | CII2D | 4D(Realtime3D) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | P | P | ||
| Cardiac Pediatric | P | P | P | P | P | P | P | P | P | P | ||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121577
•Combined mode includes B/M: B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
:
{15}------------------------------------------------
System: _ Aplio Artida (SSH-880CV), V3.2 Transducer. PVT-375BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | THI | DynamicFlow | Power | TDI | CHI2D | 4D(Realtime3D) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | P | P | P | P | P | P | P | P | ||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | P | ||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121577
•Combined mode includes BM: B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
{16}------------------------------------------------
Aplio Artida (SSH-880CV), V3.2 System: _ Transducer._ PLT-704AT
Intended Use: Diagnostic ultrasound imaging or thuid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | THI | DynamicFlow | Power | TDI | CHI2D | 4D(Realtime3D) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | P | P | |||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer. K 121577
•Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF/PWD; 2D/CWD; BDF/CWD
{17}------------------------------------------------
510(k) Premarket Notification Aplio Artida ™(v3.2) SSH-880CV Ultrasound System
Aplio Artida (SSH-880CV), V3.2 System: . Transducer:_ PET-508MA
Intended Use: Diagnostic ultrasound imaging or Nuid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | THI | DynamicFlow | Power | TDI | CHI2D | 4D(Realtime3D) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | ||||||||||||
| Musculo-skeletal(Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | P | ||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121577
•Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
{18}------------------------------------------------
510(k) Premarket Notification Aplio Artida TM(v3.2) SSH-880CV Ultrasound System
Aplio Artida (SSH-880CV), V3,2 System: PET-SIOMB Transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical ApplicationSpecific(Tracks 3) | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | Combined(Specify) | THI | DynamicFlow | Power | TDI | CHI2D | 4D(Realtime3D) | |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | P | ||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K121577
*Combined mode includes BM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
{19}------------------------------------------------
Aplio Artida (SSH-880CV), V3.2 System: PET-512MC Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specific(Tracks 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) * | THI | DynamicFlow | Power | TDI | CHI2D | 4D(Realtime3D) |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Specify) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | P | ||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | ||||||||||||
| Other (Specify) |
N = new indication: P = previously cleared by FDA: E = added under this appendix
Previous 510(k) of the transducer:K121577
•Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
§ 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.