(105 days)
Not Found.
No
The description focuses on hardware and software modifications to process harmonic echoes based on established physics principles (Rayleigh's theory). There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML algorithms.
No.
The device description indicates that it is a modification to an existing ultrasound system (SSA-380A) to improve its ability to detect and process harmonic echoes for imaging purposes, rather than to provide therapy.
Yes
Explanation: The device is an ultrasound system (SSA-380A) designed to detect and process echoes for imaging, which is a key function of diagnostic medical devices. The mention of its functionality to "detect and process those harmonic echoes" further supports its role in acquiring information about the body, which is then used for diagnosis.
No
The device description explicitly states the modification includes "the addition of several new/modified circuit boards," indicating the inclusion of hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for an existing ultrasound system (SSA-380A). Ultrasound systems are used for imaging the body, not for examining specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description focuses on modifying the ultrasound system's ability to transmit and receive different frequencies to detect harmonic echoes. This is a technical modification to an imaging device.
- Scientific Concept: The scientific concept relates to the behavior of bubbles in an ultrasonic field, which is relevant to ultrasound imaging, particularly with contrast agents.
- Input Imaging Modality: The input modality is explicitly stated as "Ultrasonic." IVDs typically involve analyzing biological samples (blood, urine, tissue, etc.).
- Anatomical Site: The listed anatomical sites are all parts of the human body that are imaged using ultrasound.
- No mention of analyzing biological samples: There is no indication that this device interacts with or analyzes any biological specimens.
The modification described is an enhancement to an existing ultrasound imaging system to improve its ability to detect certain types of echoes, likely for better visualization or characterization of tissues or contrast agents. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SSA-380A is ready for use with Contrast Agents for their approved uses.
Product codes
90-IYN, 90 ITX
Device Description
Functionality: This modification will allow the existing SSA-380A system to transmit at one frequency and receive the returning echo at a different frequency.
Scientific Concept: Rayleigh's theory predicts that a bubble in an ultrasonic field will radiate harmonic echoes that are multiples of the incident beam. This theory also stipulates that the second resonated frequency echoed could possibly be higher that the echoed fundamental frequency. This modification equips the SSA-380A to detect and process those harmonic echoes.
Description of Modification: The modification includes the addition of several new/modified circuit boards and modifications to the software to allow two existing transducers to operate in this manner.
Significant Safety Concerns: None. The FDA is currently evaluating the use of contrast agents for their Safety and Effectiveness. This modification does not change the amount of acoustic output required in conventional ultrasonography. The modification is to provide and existing device with the capability of receiving echoes at a frequency different than the transmitted frequency.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Ultrasonic Pulsed Doppler Imaging System
Anatomical Site
Fetal, Abdominal, Intraoperative (Abdominal), Pediatric, Small Organ (Breast, Testicle, Thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vascular, Laparoscopic, Musculo-skeletal Superficial, Musculo-skeletal Conventional
Indicated Patient Age Range
Fetal, Pediatric, Neonatal Cephalic, Adult Cephalic
Intended User / Care Setting
Not Found.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
K964309, K961459, K963315, K933473, K943303
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
JUL 31 1000
510(k) Summary of Safety and Effectiveness: 21 CFR 807.92
KQ81397
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|---|---|
| Address: | P.O. Box 2068,2441 Michelle Drive Tustin, CA 92781-2068 |
| Contact: | Paul Biggins, Regulatory Affairs Specialist |
| Telephone No .: | (714) 730-5000 |
Device Proprietary Name: PowerVision 7000 Ultrasound Imaging System Common Name:
Classification:
Regulatory Class: П Tier II Review Category: Ultrasonic Pulsed Doppler Imaging System Accessory [Fed.Reg.No .: 892.1550.Pro.Code:90-IYN]
Identification of Predicate Devices:
Toshiba America Medical Systems believes that the SSA-380A PowerVision 7000 is substantially equivalent to:
-
- HP Sonos 2500 510(k) K964309 found to be SE on April 22, 1997
-
- ATL Level 10 HDI 510k) K961459 found to SE on March 26,1997
-
- Diasonics/Vingmed System 5 510(k) K963315 found to be SE on March 17, 1997
Device Description:
Functionality: This modification will allow the existing SSA-380A system to transmit at one frequency and receive the returning echo at a different frequency.
Scientific Concept: Rayleigh's theory predicts that a bubble in an ultrasonic field will radiate harmonic echoes that are multiples of the incident beam. This theory also stipulates that the second resonated frequency echoed could possibly be higher that the echoed fundamental frequency. This modification equips the SSA-380A to detect and process those harmonic echoes.
Description of Modification: The modification includes the addition of several new/modified circuit boards and modifications to the software to allow two existing transducers to operate in this manner.
Significant Safety Concerns: None. The FDA is currently evaluating the use of contrast agents for their Safety and Effectiveness. This modification does not change the amount of acoustic output required in conventional ultrasonography. The modification is to provide and existing device with the capability of receiving echoes at a frequency different than the transmitted frequency.
Statement of Intended Use:
Intended use remains unchanged from the SSA-380A.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
JUL 31
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Paul Bigggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. P.O. Box 2068 2441 Michelle Drive Tustin, CA 92781-2068
Re: K981397 Trade Name: Harmonic Imaging and Flash Echo Imaging Function for the SSA-380A Diagnostic Ultrasound System (PowerVision 7000) Regulatory Class: II/21 CFR 892.1550/21 CFR 892.1570 90 IYN/90 ITX Product Code: Dated: July 1, 1998 Received: July 2, 1998
Dear Mr. Biggins:
We have reviewed your Section 510(k) 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 SSA-380A Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
PSK - 25AT PVT - 357AT
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Paul Biggins
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers (Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
3
Diagnostic Ultrasound Indications For Use Form
System X Transducer____________________________________________________________________________________________________________________________________________________________________ Model SSA-380A 510(k) Number(s) _K933743, K943303, K964865, K970047
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Tissue
Harmonics | Harmonics
w/Contrast | FEI |
|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|-------------------------|-----|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | p | p | p | p | p | p | p | p | * | n | | |
| Abdominal | p | p | p | p | p | p | p | p | * | n | | |
| Intraoperative (Abdominal) | e | e | e | e | e | e | e | e | * | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | p | p | p | p | p | p | p | p | * | n | | |
| Small Organ | p | p | p | p | p | p | p | p | * | | | |
| -Breast | | | | | | | | | | | | |
| -Testicle | | | | | | | | | | | | |
| -Thyroid | | | | | | | | | | | | |
| Neonatal Cephalic | p | p | p | p | p | p | p | p | * | | | |
| Adult Cephalic | p | p | p | p | p | p | p | p | * | | | |
| Cardiac | p | p | p | p | p | p | p | p | * | n | n | n |
| Transesophageal | p | p | p | p | p | p | p | p | * | | | |
| Transrectal | p | p | p | p | p | p | p | p | * | | | |
| Transvaginal | p | p | p | p | p | p | p | p | * | | | |
| Transurethral | p | p | p | p | p | p | p | p | * | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | p | p | p | p | p | p | p | p | * | n | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Superficial | p | p | p | p | p | p | p | p | * | | | |
| Musculo-skeletal Conventional | p | p | p | p | p | p | p | p | * | | | |
| Other (specify) | | | | | | | | | | | | |
| | | | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combinations B/M, BDF/MDF, B/PWD, BDF/PWD, B-TDJ,M-TDI
The SSA-380A is ready for use with Contrast Agents for their approved uses.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER PAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Wilkan you
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
Radiological Devices
510(k) Number K981397
4
Diagnostic Ultrasound Indications For Use Form
System _____ Transducer 区 Model PSK-25AT 510(k) Number(s) K933743
| | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Tissue
Harmonics | Harmonics
w/Contrast | FEI |
|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|-------------------------|-----|
| Clinical Application | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | | |
| -Breast | | | | | | | | | | | | |
| -Testicle | | | | | | | | | | | | |
| -Thyroid | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | p | p | p | p | p | p | p | p | * | n | n | n |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combinations BM, BDF/MDF, B/PWD, BDF/PWD, B-TDI,M-TDI
The PSK-25AT is ready for use with Contrast Agents for their approved uses.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGE Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
W.Carlyn
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi
510(k) Number K981397
5
Diagnostic Ultrasound Indications For Use Form
System Transducer_X Model PVK-357AT 510(k) Number(s) K943303
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Tissue
Harmonics | Harmonics
w/Contrast | FEI |
|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|-------------------------|-----|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | p | p | p | p | p | p | p | * | n | | |
| Abdominal | | p | p | p | p | p | p | p | * | n | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | p | p | p | p | p | p | p | * | n | | |
| Small Organ | | p | p | p | p | p | p | p | * | | | |
| -Breast | | | | | | | | | | | | |
| -Testicle | | | | | | | | | | | | |
| -Thyroid | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | p | p | p | p | p | p | p | * | n | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |
N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)
Additional Comments: Combinations B/M, BDF/MDF, B/PWD, BDF/PWD, B-TDI,M-TDI
The PVK-357AT is ready for use with Contrast Agents for their approved uses.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON OTHER PAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
and Radiological Dev
510(k) Number
Division of Reproductive, Abdominal, ENT,