(57 days)
The Viamo SSA-640 v1.2 Ultrasound System is indicated for the visualization of structures, characteristics, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, and musculo-skeletal (both conventional and superficial).
The Viamo is a mobile system. It is a Track 3 device that employs a wide range of probes that include flat linear array, convex array and sector array with a frequency range of approximately 2.5 MHz to 7.5 MHz.
The provided text is a 510(k) summary for the Toshiba Viamo SSA-640A Version 1.2 Diagnostic Ultrasound System. This document focuses on the substantial equivalence of the new device to previously cleared predicate devices and outlines its technical specifications and intended uses. It does not contain information related to acceptance criteria, specific device performance metrics (such as sensitivity, specificity, or accuracy), or details of a clinical study designed to test the device's performance against such criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these types of clinical performance evaluations are typically not included or required in a 510(k) for a diagnostic ultrasound system that is being cleared based on substantial equivalence to existing devices.
The document primarily covers:
- Device Description: A mobile ultrasound system with various probes and frequency ranges.
- Intended Use: Visualization of structures, characteristics, and dynamic processes within the human body for diagnosis in applications such as fetal, abdominal, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, and musculo-skeletal.
- Predicate Device Identification: Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V4.0 510(k) ● K091295.
- Transducer Information: A list of transducers (PST-25ST, PVT-375ST, PLT-704ST, PLT-805AT, PVT-382BT) and the specific clinical applications for which each is indicated, along with the available modes of operation.
The absence of performance study details is characteristic of 510(k) submissions for devices like diagnostic ultrasound systems, where substantial equivalence is often demonstrated through technological similarity and adherence to recognized standards, rather than direct clinical performance comparison against acceptance criteria in a study.
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510(k) Summary
| Submitter's Name: | Toshiba America Medical Systems, Inc. | DEC - 4 2009 |
|---|---|---|
| Address: | PO Box 2068, 2441 Michelle Drive Tustin, CA 92781-2068 | |
| Contact: | Paul Biggins, Director Regulatory Affairs | |
| Telephone No .: | (714) 730-5000 |
| Device Proprietary Name: | VIAMO MODEL SSA-640A Version 1.2 |
|---|---|
| Common Name: | Diagnostic Ultrasound System |
Classification:
- Regulatory Class: II .
- . Review Category: Tier II
- . Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [Fed. Reg.No.: 892.1550]
- . Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO [Fed. Reg.No .: 892.1560]
- . Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [Fed. Reg. No.: 892.1570]
Identification of Predicate Devices:
Toshiba America Medical Systems believes that this device is substantially equivalent to:
- Toshiba Ultrasound Diagnostic System Aplio XG MODEL SSA-790A V4.0 510(k) ● K091295
Device Description:
The Viamo is a mobile system. It is a Track 3 device that employs a wide range of probes that include flat linear array, convex array and sector array with a frequency range of approximately 2.5 MHz to 7.5 MHz.
Intended Use:
The Viamo SSA-640 v1.2 Ultrasound System is indicated for the visualization of structures, characteristics, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, peripheral vascular, and musculo-skeletal (both conventional and superficial).
Declaration of Conformity:
This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-1 (applicable portion), IEC 60601-1-2 (applicable portion), IEC 60601-1-4 (applicable portion), IEC60601-2-37 (applicable portions), IEC 62304 (applicable portion) and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
DEC - 4 2009
Re: K093171
Trade/Device Name: VLAMO SSA-640 v1.2 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 19, 2009 Received: November 20, 2009
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 VIAMO SSA-640 v1.2 Ultrasound System, as described in your premarket notification:
Transducer Model Number
| PST-25ST |
|---|
| PVT-375ST |
| PLT-704ST |
| PLT-805AT |
| PVT-382BT |
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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 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); 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.htm 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 Shahram Vaezy at (301) 796-6242.
Sincerely yours,
Vorun M. Khan
m Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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510(k) Premarket Notification Viam0 v1.2 SSA-640 Ultrasound System
510(k) Number (if known): K093171
Device Name: Viamo SSA-640 v1.2 Ultrasound System
Indications for Use:
The Viamo SSA-640 v1.2 Ultrasound System is indicated for the visualization of structures, characteristics, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, peripheral vascular and musculo-skeletal (both conventional and superficial).
Prescription Use Only (Per 21 CRF801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Larry Miller
(Division Sig (Division Sign of Reproductive, Abdominal, and Radiological Devic 510(k) Number
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510(k) Premarket Notification Viamo (v1.2) SSA-640A Ultrasound System
System: Viamo v1.2 SSA-640A
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 | CHI2D | 4D | Other[Note] |
| Ophthalmic | ||||||||||||
| Fetal | N | N | N | N | 2 | N | N | |||||
| Abdominal | N | N | N | N | 2 | N | N | |||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | N | N | N | N | 2 | N | N | |||||
| Small Organ (Note 1) | N | N | N | N | 2 | N | N | |||||
| Neonatal Cephalic | N | N | N | N | 2 | N | N | |||||
| Adult Cephalic | N | N | N | N | 2 | N | N | |||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | 2 | N | N | |||||
| Musculo-skeletal (Superficial) | N | N | N | N | 2 | N | N | |||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | N | N | N | N | 2 | N | N | |||||
| Cardiac Pediatric | N | N | N | N | 2 | N | N | |||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | N | N | N | N | 2 | N | N | |||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer:
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Prescription Use Only (Per 21 CRF801.109)
Arras M. Mz
(Division Sign-Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.
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510(k) Premarket Notification Viamo (v1.2) SSA-640A Ultrasound System
System: Viamo v1.2 SSA-640A Transducer:_ PST-25ST
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical ApplicationSpecific(Tracks 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify)* | THI | DynamicFlow | Power | CHI2D | 4D | Other(Note) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | N | N | N | N | 2 | N | N | |||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | N | N | N | N | 2 | N | N | |||||
| Small Organ (Note 1) | ||||||||||||
| Neonatal Cephalic | N | N | N | N | 2 | N | N | |||||
| Adult Cephalic | N | N | N | N | 2 | N | N | |||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | ||||||||||||
| Musculo-skeletal (Superficial) | ||||||||||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | N | N | N | N | 2 | N | N | |||||
| Cardiac Pediatric | N | N | N | N | 2 | N | N | |||||
| 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
Note 1 Small organ includes thyroid, breast and testicle.
Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Prescription Use Only (Per 21 CRF801.109)
Arzain Wh
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number K013171
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Viamo v1.2 SSA-640A System: _ Transducer:_ PVT-375ST
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical ApplicationSpecific(Tracks 3) | Mode of Operation | Other[Note] | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | Combined(Specify) | THI | DynamicFlow | Power | CHI2D | 3D | ||
| Ophthalmic | ||||||||||||
| Fetal | N | N | N | N | 2 | N | N | |||||
| Abdominal | N | N | N | N | 2 | N | N | |||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | N | N | N | N | 2 | N | N | |||||
| 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 | ||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note I Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
· Prescription Use Only (Per 21 CRF801.109)
Norma M. White
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
{7}------------------------------------------------
System: _ Viamo v4.0 SSA-640A Transducer:___ PLT-704ST
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 | CHI2D | 3D | Other[Note] |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | N | N | N | N | N | 2 | N | N | ||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | 2 | N | N | ||||
| Musculo-skeletal (Superficial) | N | N | N | N | N | 2 | N | N | ||||
| Intravascular | ||||||||||||
| Other (Specify) | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Intravascular (Cardiac) | ||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||
| Intra-cardiac | ||||||||||||
| Other (Specify) | ||||||||||||
| Peripheral vessel | N | N | N | N | N | 2 | N | N | ||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Prescription Use Only (Per 21 CRF801.109)
;
.
. .
Aorge M. Witz
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number __
B-4
{8}------------------------------------------------
510(k) Premarket Notification Viamo (v1.2) SSA-640A Ultrasound System
System: Viamo v1.2 SSA-640A Transducer: PLT-805AT
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 | CHI2D | 3D | Other[Note] | |
| Ophthalmic | ||||||||||||
| Fetal | ||||||||||||
| Abdominal | ||||||||||||
| Intra-operative (Abdominal) | ||||||||||||
| Intra-operative (Neuro) | ||||||||||||
| Laparoscopic | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (Specify) (1) | P | P | P | P | 2 | P | P | |||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Trans-rectal | ||||||||||||
| Trans-vaginal | ||||||||||||
| Trans-urethral | ||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | 2 | P | P | |||||
| Musculo-skeletal (Superficial) | 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 | 2 | P | P | |||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Prescription Use Only (Per 21 CRF801.109)
Aorry In We
(Division Sigh-Off) Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number
{9}------------------------------------------------
510(k) Premarket Notification Viamo (v1.2) SSA-640A Ultrasound System
System: Viamo v1.2 SSA-640A Transducer: PVT-382BT
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 | CHI2D | 3D | Other[Note] |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||||||
| Fetal | P | P | P | P | 2 | P | P | ||||||
| Abdominal | P | P | P | P | 2 | P | P | ||||||
| Intra-operative (Abdominal) | |||||||||||||
| Intra-operative (Neuro) | |||||||||||||
| Laparoscopic | |||||||||||||
| Pediatric | P | P | P | P | 2 | P | P | ||||||
| Small Organ (Specify) (1) | P | ||||||||||||
| 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 | |||||||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Previous 510(k) of the transducer: K091295
Note 1 Small organ includes thyroid, breast and testicle. Note 2 Combined mode includes BrM; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Prescription Use Only (Per 21 CRF801.109)
Lois Mertz
(Division Sign-6 ff Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
B-6
§ 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.