(11 days)
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe training or test sets typically associated with AI/ML development.
No.
The intended use explicitly states "diagnostic ultrasound imaging or fluid flow analysis," not therapeutic application.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic ultrasound imaging or fluid flow analysis of the human body".
No
The device description explicitly states it is an "Ultrasound System" and introduces "two new versions of the TERATECH Model 2000 Imaging System," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device that interacts directly with the patient's body to produce images or analyze physiological processes.
- Device Description: It's an "Ultrasound System," which is a type of medical imaging equipment used externally or internally on a patient.
- Input Imaging Modality: "Diagnostic ultrasound" is a non-invasive imaging technique applied to the patient.
- Anatomical Site: The listed anatomical sites are all locations within the human body where ultrasound is applied.
IVD devices, on the other hand, are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The description of this device clearly indicates it's used on the body, not with specimens from the body.
N/A
Intended Use / Indications for Use
The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler introduces two new versions of the TERATECH Model 2000 Imaging System.
TERATECH 2000: Transmit: Receive Beam forming Channels 128:64, CW Doppler No, ECG Trigger No, Tissue Doppler No, LV Dyssynchrony Assessment No
TERASON™ t3000: Transmit: Receive Beam forming Channels 128:64, CW Doppler Yes, ECG Trigger Yes, Tissue Doppler No, LV Dyssynchrony Assessment No
TERASON™ Echo: Transmit: Receive Beam forming Channels 128:128, CW Doppler Yes, ECG Trigger Yes, Tissue Doppler Yes, LV Dyssynchrony Assessment Yes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Thyroid, Breast, Testes, etc.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic), Intra-luminal, Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Includes uses in military field settings in addition to hospital/clinic settings.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K992505, K012191, K010883, K010003, K030199, K040840, K043278
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
510(k) Summary TERATECH Corporation TERASON™ Ultrasound System with Continuous Wave (CW) Doppler
-
- SPONSOR
TERATECH Corporation 77-79 Terrace Hall Rd. Burlington, MA 01803
| Contact Person: | Charles F. Hottinger, Ph.D., RAC,
Regulatory Affairs Consultant | | | |
|--------------------|--------------------------------------------------------------------|--|--|--|
| Telephone: | 206-780-7945 | | | |
| Date Prepared: | May 11, 2005 | | | |
| DEVICE NAME | | | | |
| Proprietary Name: | TERASON™ Ultrasound System with Continuous
Wave (CW) Doppler | | | |
| Common/Usual Name: | Diagnostic Ultrasound System | | | |
- Classification Name: Diagnostic Ultrasound Transducer (21 CFR 892.1570, 90-ITX) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX)
-
- PREDICATE DEVICES
Toshiba Powervision 6000 (K991710)
-
- INTENDED USE
The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this
- INTENDED USE
1
submission.
5. DEVICE DESCRIPTION
The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler introduces two new versions of the TERATECH Model 2000 Imaging System.
| TERATECH | TERASON ™ | TERASON ™ | |
|---|---|---|---|
| 2000 | t3000 | Echo | |
| Transmit: Receive | |||
| Beam forming Channels | 128:64 | 128:64 | 128:128 |
| CW Doppler | No | Yes | Yes |
| ECG Trigger | No | Yes | Yes |
| Tissue Doppler | No | No | Yes |
| LV Dyssynchrony | |||
| Assessment | No | No | Yes |
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The TERASON™ Ultrasound System is substantially equivalentto the Toshiba Powervision 6000, which is currently in commercial distribution in the United States. Since it is identical in modes of operation, and intended for the same clinical applications, as described in this submission.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
JUN 3 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TERATECH Corporation % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K051334
K031334
Trade Name: TERASON Ultrasound System with Continuous Wave Doppler Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 19, 2005 Received: May 23, 2005
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Soctor o re(i) proxing 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 merslate collinered pror to May 20, 1978, its classified in accordance with the provisions of the Amendinents, or to devices and Cosmetic Act (Act). You may, therefore, market the device, subject to Federal Food, Drug, and Oosmetic Fee et. The general controls provisions of the Act include the general controls provisions of the Frica - Fift going of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for I mis deternmination of subbanial vith Continuous Wave Doppler, as described in your premarket notification:
Transducer Model Number
4C2 4V2
3
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), ( If your device is classified (see above) into entrols. Existing major regulations affecting your device. FDA it may be subject to such additional controls: "Listing negation of 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 800 to 100 can be found in the Code of I cuctar Rogalations, Friderice in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substitive with other requirements of the Act
that FDA has made a determination that your device also anaios. You must that FDA has made a delefinination and your arres by other Federal agencies. You must or any Federal statutes and regulations administered by Septiration and listing (21)
comply with all the Act's requirements, including, but not limited on viraments as set comply with all the Act s requirements, mortalians practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); god if caplicable, the electronic CFR Part 807); labeling (21 CFA 1 at 601); good manaxt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicab forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
This determination of substantial equivalence is granted on the prior to shipping of This determination of substantial cquivalence special report. This seport should contain complete the first device, you submit a postclearance spocal reportan ine devices, requested
information, including acoustic output measurements based on production for Masufaqurers information, including accusur output measurements 30, 1997 "Information for Manufacturers" in Appendix G, (enclosed) of the Celler's beptems and Translucers." If the special Seeking Marketing Clearance of Diagnosite United Oritus output greater than approved report is incomplete of contails macceptable values (orgi, accuration of possible 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 The special report should reference are marked 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 I his letter will anow you to begin marketing your device of your device to a legally marketed nothication. The FDA midnig of substantial equivalier of 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 If you desire specific advice ion your act (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Compunation at (210FR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-204 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
4
Page 3 – Mr. Job
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Rat C. Pelly
ﮨﮯ
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
5
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
| System: | TERASON™ Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | (see comments) | |||||||
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppa | Comb. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetalh | P1,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | |
| Abdominali: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 | |
| Intra-operative (Spec.)j,k | P4 | P4 | P4 | P4 | P4 | P4 | ||
| Intra-operative (Neuro) | P5 | P5 | P5 | P5 | P5 | P5 | ||
| Laparoscopic | P6 | P6 | P6 | P6 | P6 | P6 | ||
| Pediatricd: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 | |
| Small Organ (Thyroid, Breast, Testes, etc.)c,d: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Neonatal Cephalice: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 | |
| Adult Cephalice: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 | |
| Trans-rectalf: | P2,4 | P3,4 | P3,4 | P3,4 | P3,4 | P3,4 | ||
| Trans-vaginalg: | P2,4 | P3,4 | P3,4 | P3,4 | P3,4 | P3,4 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Musculo-skel. (Superfic)e: | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | P1 | P2 | P2 | N | P2 | P2 | P2 |
| Cardiac Pediatric | P1 | P2 | P2 | N | P2 | P2 | P2 | |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vesseld: | P1,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | |
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
" Molades Oblor Boppicil (OD), B+DPD, B+PD.
° Harmonic Imaging (HI)
4 Includes ultrasound guidance for placement of needles, catheters.
- Abdominal organs and peripheral vessel.
I Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
Includes guidance of amniocentesis, infertility monitoring of follicle development. 1
System uses previously cleared under K992505 with 3 MHz Mindel L3 (Linear).
2 System uses previously cleared under K0121919
3 System uses previously cleared under K0121919
3 System uses previously cleared under K012191
3 System uses previously cleared under K010883.
System uses previously cleared under K040840.
System uses previously cleared under K040040.
Includes uses in military field settings in addition to hospital/clinic settings.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)
Ruta Phillips
(Division Sign-Off and Ra 510k) Nur
6
| System: | TERASON TM Ultrasound System |
|---|---|
| --------- | ------------------------------ |
Transducer: 4C2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppa | Comb. | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetald | P1,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Abdominald: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 | |
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatricd: | P1,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | |
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.)d: | ||||||||
| Neonatal Cephalicd: | ||||||||
| Adult Cephalicd: | ||||||||
| Trans-rectalf: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | ||||||||
| Musculo-skel. (Superfic)d: | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | N1 | N2 | N2 | N | N2 | N2 | N2 |
| Cardiac Pediatric | N1 | N2 | N2 | N | N2 | N2 | N2 | |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vesseld: | |||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
' Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
0 B+M; B+PWD; B+CD; B+DPD; B+PD.
° Harmonic Imaging (HI)
4 Includes ultrasound guidance for placement of needles, catheters.
Abdominal organs and peripheral vessel.
Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
" Includes guidance of amniocentesis, infertility monitoring of follicle development.
System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).
3 System uses previously cleared under K992505
2 System uses previously cleared under K012191.
System uses previously cleared under K012103183.
- System uses previously cleared under K030191.
System uses previously cleared under K040840.
· System uses previously cleared under K043278.
Includes uses in military field settings in addition to hospital/clinic settings. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)
Rach Phillips
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
7
TERASON ™ Ultrasound System System:
Transducer: 4V2
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppa | Comb | |||||||
| Modesb | Otherc | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetalh | P1,4 | P2,4 | P2,4 | P2,4 | P2,4 | P2,4 | ||
| Abdominald: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 | |
| Intra-operative (Spec.)a,e | N4 | N4 | N4 | N4 | N4 | N4 | ||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatricc: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 |
| Small Organ (Thyroid, | ||||||||
| Breast, Testes, etc.)d: | ||||||||
| Neonatal Cephalicc: | P1 | P2 | P2 | N | P2 | P2 | P2 | |
| Adult Cephalicc: | P1 | P2 | P2 | N | P2 | P2 | P2 | |
| Trans-rectalf: | ||||||||
| Trans-vaginalf: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | ||||||||
| Musculo-skel. (Superfic)d: | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | P1 | P2 | P2 | N | P2 | P2 | P2 |
| Cardiac Pediatric | P1 | P2 | P2 | N | P2 | P2 | P2 | |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vesseld: | |||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
B+M; B+PWD; B+CD; B+DPD; B+PD.
°Harmonic Imaging (HI)
4 Includes ultrasound guidance for placement of needles, catheters.
Abdominal organs and peripheral vessel.
Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
4 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
" Includes guidance of amniocentesis, infertility monitoring of follicle development.
System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).
3 System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).
2 System uses previously cleared under K012191.
3 System uses previously cleared under K010883.
"System uses previously cleared under K010003.
- System uses previously cleared under K030191.
System uses previously cleared under K0408441.
-
System uses previously cleared under K040844.
-
System uses previously cleared under K040830.
-
System uses previously cleared under K043278.
Includes uses in military field settings in addition to hospital/clinic settings.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)
Rata Phillips
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number