(28 days)
The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-vaginal, Trans-esoph. (non-cardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular.
This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the host single-board computer over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image. The Terason™ uSmart3300 ultrasound weighs approximately 14.6 pounds and has a 15.6" backlit screen. The system dimensions (10"(H) x 14.5"(W) x 2.5"(D)) are chosen to allow the system to be hand carried. A Lithium-Polymer battery (integrated into the unit) provides 2 hours of continuous ultrasound scanning. The system includes a medical-grade power supply (for battery charging). The ultrasound transducer connector is identical to that used in the Terason™ uSmart3300 predicate device. Optional accessories include a cart and printer.
The provided text describes the Terason uSmart3300 Ultrasound System and its associated transducers, focusing on demonstrating substantial equivalence to predicate devices for FDA 510(k) clearance. The study primarily involves comparing the device's technical characteristics and safety performance against established standards and predicates, rather than a clinical efficacy study with human readers or specific performance metrics like sensitivity/specificity for a diagnostic task.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by compliance with various medical device standards and demonstrating equivalence to predicate devices, particularly regarding safety and intended use. Performance is reported in terms of meeting these standards and having similar specifications to the predicates.
| Acceptance Criteria (Implicit) | Reported Device Performance and Compliance |
|---|---|
| Intended Use Equivalence: Device's intended uses are consistent with predicate devices. | The Terason uSmart3300's intended use ("general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body") is stated to be substantially equivalent to the predicate Terason uSmart3300 (K140773) and Sonosite Maxx (K071134). New indications for specific transducers (e.g., Ophthalmic for 15L4 and 12L5A) are compared to predicate devices with identical Ophthalmic indications (e.g., K071134 system and K082098 transducer). |
| Technological Characteristics Equivalence: Device's technical specifications are comparable to predicate devices. | System: The design and construction are identical to the predicate Terason uSmart3300 (K140773), using the same engine and custom beamformer chip for enhanced resolution. The ultrasound application software was modified to support new transducers and the new Ophthalmic indication. Transducer 9MC3: Similar indications for use as predicate 8MC3 (K112953). Different frequency range but identical shape. Same manufacturer, acoustic array, and patient contact materials. Acoustic characteristics met safety guidelines of IEC60601-2-37.Transducer 8TE3: Identical indications for use to predicate Philips(Oldelft) S7-3t (K132304, K070792). Similar frequency range and probe shape. Same original manufacturer (Oldelft), acoustic array, and patient contact materials. No differences reported compared to predicate.Transducer PDOF: Identical indications for use to predicate Aloka ProSound-C3 UST-T109 (K110482). Identical frequency range and probe shape. Same original manufacturer (Sound Technology), acoustic array, and patient contact materials.Transducer 15L4: Similar Ophthalmic indication for use, frequency settings, and shape to predicate Sonosite Edge L25x (K082098). Different manufacturer (Vermon). Similar acoustic array and patient contact materials. Acoustic output safety guidelines were met, ensuring safety and equal effectiveness.Transducer 12L5A: Similar Ophthalmic indication for use, frequency settings, and shape to predicate Sonosite Edge L25x (K082098). Different manufacturer (Apex). Similar acoustic array and patient contact materials. Acoustic characteristics met safety guidelines of IEC60601-2-37, ensuring safety and effectiveness.Previously filed transducers: 4V2, 5C2A, 8EC4A, 8L2, 8V3A, 12L5A (non-ophthalmic), 15L4 (non-ophthalmic), 16HL7 are identical to those cleared under K140773. |
| Acoustic Output Safety: Device adheres to acoustic output limits and standards. | Global Maximum Outputs (Worst Case Setting) reported for the system are: ISPTA.3: 652.9 mW/cm² (4V2A), TI Value: 5.64 (4V2A), MI: 1.78 (8EC4A), IPA.3@MI Max: 1029 W/cm² (15L4). These conform to NEMA UD 2-2004 and NEMA UD 3-2004. Acoustic testing was performed per IEC60601-2-37 standard for new transducers (9MC3, 8TE3, PDOF, 15L4 Ophthalmic, 12L5A Ophthalmic). |
| Electrical Safety and EMC: Device complies with relevant electrical safety and electromagnetic compatibility standards. | Compliance reports cited: IEC 60601-1, IEC60950-1, IEC 60601-2-37, IEC60601-1-2:2007. Specific Intertek and Oldelft reports are referenced for various transducers and system components. |
| Biocompatibility: Patient-contact materials are biocompatible. | Biocompatibility tests (ISO 10993 Part 5 and Part 10) were conducted for all transducers. Patient contact materials (e.g., Silicone ABS for 9MC3, Silicone for 8TE3, Epoxy Noryl for PDOF, Silicone ABS for 15L4 and 12L5A) are stated to be identical or similar to predicate devices and meet safety guidelines. |
| DICOM Compatibility: Device supports DICOM standards. | DICOM 3.0 Structured Reporting, Worklist - Image Viewer is supported, which is consistent with the predicate. |
| Quality Systems: Manufacturing processes adhere to recognized quality standards. | Stated that devices are manufactured using FDA GMPs and ISO-13485 quality systems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes a technical and performance comparison against predicate devices and mandated standards, not a clinical study involving a "test set" of patient data for evaluating a diagnostic algorithm's performance. The "tests" mentioned are for technical and safety compliance (e.g., acoustic output, electrical safety, biocompatibility).
- Test Set Sample Size: Not applicable in the context of a clinical test set for AI/algorithm performance. The "tests" refer to engineering and regulatory compliance assessments.
- Data Provenance: Not applicable. The "data" comes from engineering measurements and compliance testing, not patient studies.
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)
This is not applicable. The submission focuses on device equivalence and safety/performance standards, not on evaluating the diagnostic accuracy of the device against expert-established ground truth in a clinical setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as there is no clinical test set requiring expert adjudication.
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
This is not applicable. This document is for a medical ultrasound system (hardware and associated transducers), not an AI/algorithm-driven diagnostic aid. Therefore, no MRMC study or AI assistance evaluation would be conducted for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This submission is for an ultrasound imaging system, which is a diagnostic tool operated by a human, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of diagnostic accuracy. The "ground truth" here refers to the performance specifications and safety limits defined by recognized medical device standards (e.g., IEC, NEMA) and the established performance of predicate devices.
8. The sample size for the training set
This is not applicable. There is no mention of a training set as this is not an AI/machine learning device submission.
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this device.
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Image /page/0/Picture/1 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 a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2015
TERATECH CORPORATION C/O MARK JOB 1394 25TH STREET, NW BUFFALO MN 55313
Re: K150148
Trade/Device Name: Terason uSmart3300 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 22, 2015 Received: January 23, 2015
Dear Mr. Job:
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, listing 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.
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 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
{1}------------------------------------------------
Page 2-Mr. Job
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
You may obtain other general information on your responsibilities under the Act from 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.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K150148
Device Name
Terason uSmart3300 Ultrasound System
Indications for Use (Describe)
The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-vaginal, Trans-esoph. (non-cardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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{3}------------------------------------------------
510(k) Number (if known):
| Device Name: | Terason uSmart3300 Ultrasound System |
|---|---|
| -------------- | -------------------------------------- |
Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | Comb. | Other |
| (Track I Only) | (Tracks I & III) | Doppa | Modesb | |||||
| Ophthalmic | Ophthalmic | N | N | N | N | N | N | |
| Fetalh | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Abdominala: | P1 | p1 | P1 | P1 | p1 | P1 | ||
| Intra-operative (Spec.)d,e | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | Pediatric®: | P1 | P1 | P1 | P1 | P1 | P1 | |
| Imaqinq& Other | Small Organ (Thyroid, Breast,Testes, etc.)ª: | P1 | p1 | P1 | P1 | P1 | P1 | |
| Neonatal Cephalice: | P1 | P1 | P1 | p2 | P1 | P1 | P1 | |
| Adult Cephalica: | P1 | P1 | P1 | p2 | P1 | P1 | P1 | |
| Trans-rectal*: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Trans-vaginal9: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | N | N | N | N | N | N | ||
| Musculo-skel. (Convent.)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Musculo-skel. (Superfic)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | P1 | P1 | P1 | P1 | P1 | P1 | P1 | |
| Cardiac | Cardiac Pediatric | P1 | P1 | P1 | p2 | P1 | P1 | P1 |
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | |
| Other (Specify) | ||||||||
| Peripheral | Peripheral vesseld: | P1 | p1 | P1 | N | P1 | P1 | P1 |
| Vessel | Other (Specify) |
N= new indication: P= previously cleared by FDA; E= added under Appendix E
a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
° Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic and peripheral vessel.
f Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K140773
P2: uses previously cleared under K051334 Prescription Use _x AND/OR -Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)
Page 2 of 13
{4}------------------------------------------------
510(k) Number (if known): _________
Device Name: Terason uSmart3300 - 9MC3 Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | ColorDoppaa | Comb.Modesb | Otherc |
| Ophthalmic | Ophthalmic | |||||||
| Fetalh | N | N | N | N | N | N | ||
| Abdominald: | ||||||||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatricd: | N | N | N | N | N | N | |
| Small Organ (Thyroid, Breast,Testes, etc.)d: | N | N | N | N | N | N | ||
| Neonatal Cephalicd: | N | N | N | N | N | N | ||
| Adult Cephalicd: | N | N | N | N | N | N | ||
| 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 | N | N | N | N | N | N | |
| Cardiac Pediatric | N | N | N | N | N | N | ||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vesseld: | N | N | N | N | N | N | N |
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
° Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic and peripheral vessel.
1 Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy
9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
In Includes guidance of amniocentesis, infertility monitoring of follicle development.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k)_
Page 3 of 13
{5}------------------------------------------------
510(k) Number (if known):
Device Name: Terason uSmart3300 - 8TE3 Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | ColorDoppaa | Comb.Modesb | Otherc |
| Ophthalmic | Ophthalmic | |||||||
| Fetalh | ||||||||
| Abdominald: | ||||||||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatricd: | |||||||
| Small Organ (Thyroid, Breast,Testes, etc.)d: | ||||||||
| Neonatal Cephalicd: | ||||||||
| Adult Cephalicd: | ||||||||
| Trans-rectalf: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | N | N | N | N | N | N | N | |
| Musculo-skel. (Convent.)d: | ||||||||
| Musculo-skel. (Superfic)d: | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | |
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vesseld: | |||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Prescription Use ___x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_
Page 4 of 13
{6}------------------------------------------------
510(k) Number (if known):
Device Name: Terason uSmart3300 – PDOF Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | ColorDoppaa | Comb.Modesb | Otherc |
| Ophthalmic | ||||||||
| FetalImaging& Other | Fetalh | |||||||
| Abdominald: | ||||||||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatricd: | ||||||||
| 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 | N | ||||||
| Cardiac Pediatric | N | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vesseld: | |||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_
Page 5 of 13
{7}------------------------------------------------
510(k) Number (if known):
Device Name: Terason uSmart3300 - 15L4 Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | ColorDoppaa | Comb.Modesb | Otherc |
| Ophthalmic | Ophthalmic | N | N | N | N | N | N | |
| Fetalh | ||||||||
| Abdominald: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | Pediatricd: | P1 | P1 | P1 | P1 | P1 | P1 | |
| Imaging | Small Organ (Thyroid, Breast, | P1 | P1 | P1 | P1 | P1 | P1 | |
| & Other | Testes, etc.)d: | |||||||
| Neonatal Cephalicd: | ||||||||
| Adult Cephalicd: | ||||||||
| Trans-rectalf: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Musculo-skel. (Superfic)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vesseld: | P1 | P1 | P1 | P1 | P1 | P1 | |
| Vessel | Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K140773
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_
Page 6 of 13
{8}------------------------------------------------
510(k) Number (if known):
Device Name: Terason uSmart3300 – 12L5A Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | ColorDoppaa | Comb.Modesb | Otherc |
| Ophthalmic | Ophthalmic | N | N | N | N | N | N | |
| Fetalh | ||||||||
| Abdominald: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatricd: | P1 | P1 | P1 | P1 | P1 | P1 | |
| Small Organ (Thyroid, Breast,Testes, etc.)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Neonatal Cephalicd: | ||||||||
| Adult Cephalicd: | ||||||||
| Trans-rectalf: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Musculo-skel. (Superfic)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vesseld: | P1 | P1 | P1 | P1 | P1 | P1 | |
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K140773
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_
Page 7 of 13
{9}------------------------------------------------
510(k) Number (if known):
Device Name: Terason uSmart3300 - 4V2A Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | ColorDoppaa | Comb.Modesb | Otherc |
| Ophthalmic | Ophthalmic | |||||||
| Fetalh | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Abdominald: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatricd: | P1 | P1 | P1 | P1 | P1 | P1 | |
| Small Organ (Thyroid, Breast,Testes, etc.)d: | ||||||||
| Neonatal Cephalicd: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Adult Cephalicd: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| 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 | P1 | P1 | P1 | P1 | P1 | P1 | P1 |
| Cardiac Pediatric | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vesseld: | |||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K112953
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_
Page 8 of 13
{10}------------------------------------------------
510(k) Number (if known):
Device Name: Terason uSmart3300 - 5C2A Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | ColorDoppaa | Comb.Modesb | Otherc | |
| Ophthalmic | Ophthalmic | ||||||||
| Fetalh | P1 | P1 | P1 | P1 | P1 | P1 | |||
| Abdominald: | P1 | P1 | P1 | P1 | P1 | P1 | |||
| Intra-operative (Spec.)d,e | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| FetalImaging& Other | Pediatricd: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| 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 Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Other (Specify) | |||||||||
| PeripheralVessel | Peripheral vesseld: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K112953
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_
Page 9 of 13
{11}------------------------------------------------
510(k) Number (if known):
Device Name: Terason uSmart3300 – 8EC4A Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | ColorDoppaa | Comb.Modesb | Otherc |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetalh | P1 | P1 | P1 | P1 | P1 | P1 | |
| Abdominald: | ||||||||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatricd: | ||||||||
| Small Organ (Thyroid, Breast,Testes, etc.)d: | ||||||||
| Neonatal Cephalicd: | ||||||||
| Adult Cephalicd: | ||||||||
| Trans-rectalf: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Trans-vaginalg: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | ||||||||
| Musculo-skel. (Superfic)d: | ||||||||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vesseld: | |||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K112953
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_
Page 10 of 13
{12}------------------------------------------------
510(k) Number (if known):
Device Name: Terason uSmart3300 -8L2 Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | ColorDoppaa | Comb.Modesb | Otherc |
| Ophthalmic | Ophthalmic | |||||||
| Fetalh | ||||||||
| Abdominald: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatricd: | P1 | P1 | P1 | P1 | P1 | P1 | |
| 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: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Musculo-skel. (Superfic) d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vesseld: | P1 | P1 | P1 | P1 | P1 | P1 | |
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K140773
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_
Page 11 of 13
{13}------------------------------------------------
510(k) Number (if known):
Device Name: Terason uSmart3300 -8V3A Transducer
Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Otherc | ||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I Only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppaa | Comb.Modesb | |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetalh | P1 | P1 | P1 | P1 | P1 | P1 | |
| Abdominald: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-operative (Spec.)d,e | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatricd: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Small Organ (Thyroid, Breast,Testes, etc.)d: | ||||||||
| Neonatal Cephalicd: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Adult Cephalicd: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| 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 | P1 | P1 | P1 | P1 | P1 | P1 | P1 |
| Cardiac Pediatric | P1 | P1 | P1 | P1 | P1 | P1 | P1 | |
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vesseld: | |||||||
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K140773
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_
Page 12 of 13
{14}------------------------------------------------
510(k) Number (if known):
Device Name: Terason uSmart3300-16HL7 Transducer
Indications For Use: Diagnostic ultrasound imaging system 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 | ColorDoppa | Comb.Modes | Other |
| Ophthalmic | Ophthalmic | |||||||
| Fetalh | ||||||||
| Abdominald: | ||||||||
| Intra-operative (Spec.)d,e | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatricd: | |||||||
| Small Organ (Thyroid, Breast,Testes, etc.)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Neonatal Cephalicd: | ||||||||
| Adult Cephalicd: | ||||||||
| Trans-rectalf: | ||||||||
| Trans-vaginalg: | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Musculo-skel. (Superfic)d: | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Intra-luminal | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vesseld: | P1 | P1 | P1 | P1 | P1 | P1 | |
| Other (Specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
a Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.
b B+M; B+PWD; B+CD; B+DPD; B+PD.
º Harmonic Imaging (HI)
d Includes ultrasound guidance for placement of needles, catheters.
e Abdominal, thoracic 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.
b Includes guidance of amniocentesis, infertility monitoring of follicle development.
Additional Comments: P1: uses previously cleared under K110020
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_
Page 13 of 13
{15}------------------------------------------------
510(k) Summary
Teratech Corporation
Terason™ uSmart3300 Ultrasound System
1. Sponsor:
Teratech Corporation 77-79 Terrace Hall Ave. Burlington, MA 01803
Contact Person: Ben Chiampa, Quality Assurance and Regulatory Affairs Telephone: 781-270-4143
Date Prepared: January 20, 2015
2. Device Name
Terason™ uSmart3300 Ultrasound System Proprietary Name: Common / Usual Name: Diagnostic Ultrasound System Classification Name: Diagnostic Ultrasound Transducer
Ultrasonic Pulsed Doppler Imaging System (21 CFR 892.1550, 90-IYN) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX)
3. Predicate Devices
Terason uSmart3300 Ultrasound System (K140773, K071134), Terason t3000 8MC3 transducer (K112953), Philips iE33 S7-3t TE transducer (K132304, K070792), Aloka ProSound-C3 UST-T109 PDOF transducer (K110482) and Sonosite Edge L25x transducer (K082098).
4. Device Description
This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. These
{16}------------------------------------------------
data are then transferred to the host single-board computer over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image.
The Terason™ uSmart3300 ultrasound weighs approximately 14.6 pounds and has a 15.6" backlit screen. The system dimensions (10"(H) x 14.5"(W) x 2.5"(D)) are chosen to allow the system to be hand carried. A Lithium-Polymer battery (integrated into the unit) provides 2 hours of continuous ultrasound scanning. The system includes a medical-grade power supply (for battery charging). The ultrasound transducer connector is identical to that used in the Terason™ uSmart3300 predicate device. Optional accessories include a cart and printer.
5. Intended Use
The Teratech Corporation Terason™ uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (noncardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular.
6. Technology Characteristics
The design and construction of the Terason™ uSmart3300 ultrasound system is identical to the Terason™ uSmart3300 predicate system. This system utilizes a single-board computer running Windows 7 to execute the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. For the uSmart3300, the engine is housed in a compartment that is attached to the base of the chassis.
The similarities and differences between the Terason™ uSmart3300 (current filing) and the predicate Terason uSmart3300 Ultrasound System (K140773) include the following:
- . The engines are the identical with no modifications. As in the predicate device, the custom beamformer chip provides the processing of the return ultrasound echoes to support wide bandwidth signals and provide enhanced resolution across the entire image field.
{17}------------------------------------------------
-
The ultrasound application software has been modified to support 3 new transducers (9MC3, 8TE3, PDOF) and the new Ophthalmic indication for use (with the 15L4 and 12L5A transducers). The predicate devices that provide identical Ophthalmic indications for use are: K071134 (system) and K082098 (transducer).
Transducers: The Terason uSmart3300 will support 3 new transducers and the new Ophthalmic indication for use (IFU). (The Terason uSmart3300 has been previously cleared with eight transducers in K140773). The new transducers and associated predicate devices include: -
. 9MC3: Predicate device 8MC3 cleared in 510k submission K112953
-
. 8TE3: Predicate device Philips(Oldelft) S7-3t previously cleared in 510k submissions K132304 and K070792
-
PDOF: Predicate device Aloka ProSound-C3 UST-T109 previously clear in 510k submission K110482
-
. 15L4: Ophthalmic IFU predicate device Sonosite Edge L25x previously cleared in 510k submission K082098
-
12L5A: Ophthalmic IFU predicate device Sonosite Edge L25x previously cleared in 510k submission K082098.
The following provides additional details of the 5 transducers presented in this submission.
- . 9MC3: Identical indications for use to the predicate transducer 8MC3. Different frequency range but the shape of the transducer is identical when compared to the predicate. Same manufacturer, same acoustic array and patient contact materials as the predicate 8MC3 transducer.
- 8TE3: Identical indications for use to the predicate trans-esophageal (TE) . probe Philips(Oldelft) S7-3t. Similar frequency range and probe shape when compared to the predicate. Same original manufacturer (Oldelft), same acoustic array and patient contact materials as the predicate Philips S7-3t TE probe.
- PDOF: Identical indications for use to the predicate PDOF Aloka ProSound-C3 UST-T109 transducer. Identical frequency range and probe shape when compared to the predicate. Same original manufacturer (Sound Technology), same acoustic array and patient contact materials as the predicate Aloka UST-T109 transducer.
- . 15L4: Similar Ophthalmic indication for use, frequency settings, and shape of transducer head as the predicate Sonosite Edge L25x transducer. Different manufacturer (Vermon). Similar acoustic array and patient contact materials.
- 12L5A: Similar Ophthalmic indication for use, frequency settings, and shape . of transducer head as the predicate Sonosite Edge L25x transducer. Different manufacturer (Apex). Similar acoustic array and patient contact materials.
{18}------------------------------------------------
7. Table of Similarities and Differences Compared to the Predicate Devices
New Transducers: 9MC3, 8TE3, PDOF
New Indication for Use (IFU): Ophthamology for 15L4 and 12L5A transducers Previously Cleared Transducers (K140773): 8EC4A, 16HL7, and 15L4, 12L5A, 5C2A, 4V2A, 8V3A, and 8L2
Terason uSmart3300 Ultrasound System
| Subject Device Model | Comparable Predicate Device | Comparable Predicate Device | |
|---|---|---|---|
| Terason uSmart3300 | Terason uSmart3300K140773 | Sonosite MaxxK071134 | |
| (This Submission) | |||
| Intended Use | Diagnostic Ultrasoundimaging or fluid flow analysisof the human body | Diagnostic Ultrasoundimaging or fluid flow analysisof the human body | Diagnostic Ultrasoundimaging or fluid flow analysisof the human body |
| Indication for Use | Ophthalmic, Fetal,Abdominal, Intra-operative(Spec. and Neuro.), Pediatrics,Small Organ (Thyroid, Breast,Testes); Neonatal and AdultCephalic, Trans-rectal, Trans-vaginal, Trans-esophageal(non-Cardiac and Cardiac),Musculo-skeletal(Conventional andSuperficial); Cardiac (Adult &Pediatric), Peripheral Vascular | Fetal, Abdominal, Intra-operative (Spec. and Neuro.),Pediatrics, Small Organ(Thyroid, Breast, Testes),Neonatal and Adult Cephalic,Trans-rectal, Trans-vaginal,Musculo-skel. (Conventionaland Superficial), Cardiac(Adult and Pediatric),Peripheral Vascular | 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, Musculo-skel.(Convent.), Musculo-skel.(Superficial), Cardiac Adult,Cardiac Pediatric,Trans-esophageal (Cardiac),Peripheral vessel |
| Transducer Types | Linear ArrayCurved ArrayPhased ArrayEndocavity - curved arrayHockey Stick - LinearPDOFTrans-esophageal | Linear ArrayCurved ArrayPhased ArrayEndocavity - curved array | Linear ArrayCurved ArrayPhased ArrayEndocavity - curved arrayHockey Stick - LinearTransesophageal |
| Acoustic Output and FDALimits | Display Features for HighOutputs | Display Features for HighOutputs | Display Features for HighOutputs |
| Global MaximumOutputs/Worst Case Setting | ISPTA.3: 652.9 mW/cm² (4V2A)TI Type: TIB (4V2A)TI Value: 5.64 (4V2A) | ISPTA.3: 652.9 mW/cm² (4V2A)TI Type: TIB (4V2A)TI Value: 5.64 (4V2A) | N/A |
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| MI: 1.78 (8EC4A)IPA.3@MI Max: 1029 W/cm²(15L4) | MI: 1.78 (8EC4A)IPA.3@MI Max: 1029 W/cm²(15L4) | MI: 1.78 (8EC4A)IPA.3@MI Max: 1029 W/cm²(15L4) | |||
|---|---|---|---|---|---|
| Modes of Operation | B-Mode Grayscale ImagingTissue Harmonic ImagingM-Mode (motion)Anatomical M-ModeColor M-ModeColor Power DopplerVelocity Color DopplerDuplex/Triplex – DopplerimagingPulsed Wave (PW) DopplerTeraVision II Postprocessing | B-Mode Grayscale ImagingTissue Harmonic ImagingM-Mode (motion)Anatomical M-ModeColor M-ModeColor Power DopplerVelocity Color DopplerDuplex/Triplex – DopplerimagingPulsed Wave (PW) DopplerTeraVision II Postprocessing | B-Mode Grayscale ImagingTissue Harmonic ImagingM-Mode (motion)Anatomical M-ModeColor M-ModeColor Power DopplerVelocity Color DopplerDuplex/Triplex – DopplerimagingPulsed Wave (PW) Doppler | ||
| PW Doppler | Available for all transducersTriplex ModeB-Mode and PW DopplerHigh PRF | Available for all transducersTriplex ModeB-Mode and PW DopplerHigh PRF | Available for all transducersTriplex ModeB-Mode and PW DopplerHigh PRF | ||
| Transducer Frequency | 2.0—15.0 MHz | 2.0—15.0 MHz | 2.0 – 15.0 MHz (est.) | ||
| #Transmit Channels | 128 Channels | 128 Channels | 128 Channels | ||
| # Receive Channels | 128 Channels | 128 Channels | 128 Channels | ||
| Acoustic OutputMeasurement Standard | NEMA UD 2-2004NEMA UD 3-2004 | NEMA UD 2-2004NEMA UD 3-2004 | NEMA UD 2-2004NEMA UD 3-2004 | ||
| DICOM | DICOM 3.0 StructuredReporting, Worklist - ImageViewer | DICOM 3.0 StructuredReporting, Worklist - ImageViewer | DICOM supported | ||
| Product Safety Certification | IEC60601-1IEC60601-1-2IEC60601-1-6IEC60601-2-37 | IEC60601-1IEC60601-1-2IEC60601-1-6IEC60601-2-37 | IEC60601-1IEC60601-1-2IEC60601-1-4IEC60601-2-37 | ||
| EMC | IEC60601-1-2CISPR11 Class B | IEC60601-1-2CISPR11 Class B | IEC60601-1-2CISPR11 Class B | ||
| SystemCharacteristics | board computer over aFireWire (aka IEEE 1394) | uSmart3300:Integrated single-boardcomputerWeighs 14.6 lbs (6.62 Kg)15.6" backlit touch screen.System dimensions (15.58"(H) x 15.29"(W) x 3.5"(D)).A Lithium-Polymer battery(integrated into the tablet)provides 2 hours ofcontinuous ultrasoundscanningMedical-grade power supplyData transferred to the single-board computer over a | board computer over aFireWire (aka IEEE 1394) | uSmart3300:Integrated single-boardcomputerWeighs 14.6 lbs (6.62 Kg)15.6" backlit touch screen.System dimensions (15.58"(H) x 15.29"(W) x 3.5"(D)).A Lithium-Polymer battery(integrated into the tablet)provides 2 hours ofcontinuous ultrasoundscanningMedical-grade power supplyData transferred to the single-board computer over a | Sonosite Maxx:Information available on thecorporate web site:http://www.sonosite.com. |
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Three transducers have been added to the Terason uSmart3300 in this submission: 9MC3, 8TE3 and PDOF. A new indication for use (IFU) that is included in this submission is for Ophthalmic use with the 15L4 transducer.
9MC3 Transducer
| Key Features | Subject Device ModelTerason 9MC3 Transducer | Comparable PredicateDeviceTerason 8MC3 Transducer | Same or Different |
|---|---|---|---|
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K112953 | n/a |
| Indications for Use | The transducer is intendedto be used with aconventional ultrasoundsystem (TerasonuSmart3300) to image fetal,pediatric, small organs,cephalic (neonatal andadult), cardiac andperipheral vessels. | The transducer is intendedto be used with aconventional ultrasoundsystem (Terason t3000) toimage fetal, pediatric, smallorgans, cephalic (neonataland adult), cardiac andperipheral vessels. | Same. The proposedtransducer and the predicatetransducer have the identicalclaim of imaging similarregions in the human body. |
| Acoustic Array Technology: | Piezoelectric elements | Piezoelectric elements | Same.Regarding Safety: Same.Effectiveness: Both arrays |
| Acoustic Array Style: | Micro Curved Array | Micro Curved Array | allow focused transmissionand reception of ultrasoundenergy to enhance imagequality within the region ofinterest. |
| Acoustic ArrayCharacteristics: | Different: Element count,center frequency, elementsize and elevation focus.Acoustic characteristics havemet safety guidelines ofIEC60601-2-37. Safety andeffectiveness unchanged frompredicate. | ||
| Element count... | 80 | 128 | |
| Center frequency... | 6.5 | 5.0 | |
| Element size (pitch xelevation)... | 0.321mm X 6.0mm | 0.25mm X 8.0mm | |
| Elevation focus... | 30mm | 40mm | |
| Acoustic Array | The transducer imagingperformance has beenevaluated in an acoustictank. | The transducer performancehas been evaluated in theprevious 510(k) filing(K112953). | Same: The 9MC3 uses a sameacoustic array materials asthe predicate device andtherefore has same acousticcharacteristics. To ensureproper safety guidelines aremet, acoustic testing wasperformed per the IEC60601-2-37 standard. |
| Patient Contact Material | Silicone ABS | Silicone ABS | Same: The contact material isidentical. |
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The 9MC3 uses a same acoustic array materials as the predicate (8MC3) device and therefore has same acoustic characteristics. To ensure proper safety guidelines are met, acoustic testing was performed per the IEC60601-2-37 standard.
The 9MC3 consists of same patient contact material as the predicate device. To ensure proper safety guidelines are met, biocompatibility tests were run on the patient contact materials.
Transducer 8TE3
| Key Features | Subject Device ModelTerason(Oldelft) 8TE3Transducer | Comparable PredicateDevicePhilips(Oldelft) S7-3t | Same or Different |
|---|---|---|---|
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K132304 (EPIQ)K070792 (iE33) | n/a |
| Indications for Use | The transducer is intended tobe used with a conventionalultrasound system (TerasonuSmart3300) for trans-esophageal (non-cardiac andcardiac) imaging. | The transducer is intended tobe used with a conventionalultrasound system (PhilipsEPIQ) for trans-esophageal(non-cardiac and cardiac)imaging. | Same. The proposedtransducer and thepredicate transducer havethe identical claim ofimaging similar regions inthe human body. |
| Acoustic Array Technology | Piezoelectric elements | Piezoelectric elements | Same |
| Transducer Style | TE (Trans-esophageal) | TE (Trans-esophageal) | Same. |
| Acoustic ArrayCharacteristics:Element count...Center frequency...Element size (pitch xelevation)...Elevation focus... | 645.0 MHz0.16mm X 9.6mm50mm | 645.0 MHz0.16mm X 9.6mm50mm | Same. |
| Acoustic Output and DeviceSettings | The transducer performancehas been evaluated in anacoustic tank | The transducer performancehas been evaluated in theprevious 510(k) filing(K132304, K070792). | Same. |
| Patient Contact Material | Silicone | Silicone | Same. The 8TE3 and thepredicate S7-3t transducersare both manufactured byOldelft and consist ofidentical patient contactmaterials. |
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There are no differences between this device and the predicate device used in this comparison. The transducer has been added to the uSmart3300 Ultrasound system.
Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 8TE3 transducer is substantially equivalent to the predicate TE transducer with respect to safety and effectiveness.
PDOF Transducer
| Key Features | Subject Device Model | Comparable Predicate Device | Same or Different |
|---|---|---|---|
| Terason uSmart3300 PDOFTransducer | Aloka(Terason) ProSound C3 UST-T109 PDOF Transducer | ||
| DeviceClassification | ITX | ITX | Same |
| 510(k) Number | KXXXXX | K110482 | n/a |
| Indications forUse | The transducer is intended tobe used with a conventionalultrasound system (TerasonuSmart3300) for Cardiaccontinuous-wave Doppler(CWD) (adult and pediatric). | The transducer is intended to beused with a conventionalultrasound system (Aloka/TerasonProSound C3) for Cardiaccontinuous-wave Doppler (CWD)(adult and pediatric). | Same. The proposed transducerand the predicate transducer havethe identical claim of imagingsimilar regions in the human body. |
| Acoustic ArrayTechnology: | Piezoelectric elements | Piezoelectric elements | Same.Regarding Safety: Both arrays allowfocused transmission and receptionof ultrasound energy to enhanceimage quality within the region ofinterest. |
| Acoustic ArrayStyle: | Pencil Transducer | Pencil Transducer | |
| Acoustic ArrayCharacteristics:Element count... | 2 | 2 | Same. |
| Centerfrequency | 2.0MHz | 2.0MHz | |
| Element size(diameter)... | 13.8mm | 13.8mm | |
| Elevation focus... | 55mm | 55mm |
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| Acoustic Array | The transducer CWDperformance has beenevaluated in an acoustic tank. | The transducer CWD performancehas been evaluated in theprevious 510(k) filing (). | Same. As the predicate device andtherefore has same acousticcharacteristics. To ensure propersafety guidelines are met, acoustictesting was performed per theIEC60601-2-37 standard. |
|---|---|---|---|
| Patient ContactMaterial | Epoxy Noryl | Epoxy Noryl | Same. The PDOF transducerconsists of identical patient contactmaterials as the predicate device. |
There are no differences between this device and the predicate device used in this comparison. The transducer has been added to the uSmart3300 Ultrasound system.
Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason PDOF transducer is substantially equivalent to the predicate PDOF transducer with respect to safety and effectiveness.
15L4 Transducer
| Key Features | Subject Device ModelTerason 15L4 Transducer | Comparable PredicateDeviceSonosite Edge L25x/13-6Transducer | Same or Different |
|---|---|---|---|
| 510(k) Number | K1XXXXXX | K082098 | n/a |
| Classification | ITX | ITX | Same |
| Indications for Use | The transducer is intendedto be used with aconventional ultrasoundsystem (TerasonuSmart3300) to imageophthalmic, abdomen, smallparts, musculo-skel,peripheral vascular regions.Ophthalmic is the new IFU. | The transducer is intendedto be used with aconventional ultrasoundsystem (Sonosite Edge) toimage ophthalmic,abdomen, pediatric, smallparts, musculo-skel andperipheral vascular regions. | Different: The proposedtransducer and the predicatetransducer have the claim ofimaging similar regions in thehuman body. Ophthalmic isthe new Indication for Use. |
| Acoustic Array Technology: | Piezoelectric elements | Piezoelectric elements | Same: Identical material. |
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| Acoustic Array Style: | Linear Array | Linear Array | Effectiveness: Both arrays allow focused transmission and reception of ultrasound energy to enhance image quality within the region of interest. |
|---|---|---|---|
| Acoustic Array Characteristics: Element count... Center frequency... Element size (pitch x elevation)... Elevation focus... | 128 elements 7.5 MHz 0.3mm X 4.0mm 20mm | 128 elements 9.5 MHz (est) 0.195mm X 3.0mm (est) 18mm (est) | Same: element count. Acoustic characteristics have met safety guidelines of IEC60601-2-37. |
| Acoustic Output and Device Settings | The transducer performance has been evaluated in an acoustic tank. | The transducer performance has been evaluated in the 510(k) filing (K082098). | Different; acoustic output safety guidelines. Safety is not compromised. Effectiveness equal. |
| Patient Contact Material | Silicone ABS | Silicone ABS | Same. The 15L4 transducer consists of same patient contact materials as the predicate device. The safety of each device with respect to biocompatibility is equivalent. |
The 15L4 uses a same acoustic array than the predicate device and therefore has same acoustic characteristics. To ensure proper safety guidelines for ophthalmic use are met, acoustic testing was performed per the IEC60601-2-37 standard.
The 15L4 transducer consists of same patient contact materials as the predicate device.
Based on the test results, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 15L4 transducer is substantially equivalent to the Sonosite L25x transducer (K082098) with respect to safety and effectiveness. Based on test results, the 15L4 transducer can be safely used for ophthalmological use.
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12L5A Transducer
| Key Features | Subject Device ModelTerason 12L5A Transducer | Comparable Predicate DeviceSonosite Edge L25x/13-6Transducer | Same or Different |
|---|---|---|---|
| DeviceClassification | ITX | ITX | Same |
| 510(k) Number | KXXXXX | K082098 | n/a |
| Indications forUse | The transducer is intended to beused with a conventionalultrasound system (TerasonuSmart3200T) to imageophthalmic, fetal, abdominal,pediatric, small organ, cephalic,musculo-skel, cardiac andperipheral vessel.Ophthalmic is the new IFU. | The transducer is intended tobe used with a conventionalultrasound system (SonositeEdge) to image ophthalmic,abdomen, pediatric, small parts,musculo-skel and peripheralvascular regions. | Same. The proposed transducerand the predicate transducerhave the identical claim ofimaging similar regions in thehuman body. |
| Acoustic ArrayTechnology: | Piezoelectric elements | Piezoelectric elements | Same.Regarding Safety: Both arraysallow focused transmission andreception of ultrasound energyto enhance image quality withinthe region of interest. |
| Acoustic ArrayStyle: | Linear Array | Linear Array | Same in elevation Safety andeffectiveness unchanged frompredicate |
| Acoustic ArrayCharacteristics:Element count... | 128 | 128 | |
| Centerfrequency... | 7.5MHz | 9.5MHz (est) | |
| Element size(pitch xelevation)... | 0.3mm X 4.0mm | 0.195mm X 3.0mm (est) | |
| Elevation focus... | 19mm | 18mm (est) | |
| Acoustic Array | The transducer imagingperformance has been evaluated inan acoustic tank. | The transducer performancehas been evaluated in theprevious 510(k) filing(K082098). | Same. As the predicate deviceand therefore has same acousticcharacteristics. To ensure propersafety guidelines are met,acoustic testing was performedper the IEC60601-2-37 standard. |
| Patient ContactMaterial | Silicone ABS | Silicone ABS | Same. The 12L5A transducerconsists of same patient contactmaterials as the predicatedevice. |
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The 12L5A uses a same acoustic array than the predicate device and therefore has same acoustic characteristics. To ensure proper safety guidelines for ophthalmic use are met, acoustic testing was performed per the IEC60601-2-37 standard.
The 12L5A transducer consists of same patient contact materials as the predicate device.
Based on the test results, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 12L5A transducer is substantially equivalent to the Sonosite L25x transducer (K082098) with respect to safety and effectiveness. Based on test results, the 12L5A transducer can be safely used for ophthalmological use.
Previously filed transducers:
The following transducers are identical to those previously cleared under FDA 510(k) K140773, May 30, 2014 for the Terason uSmart3300:
- . 4V2
- 5C2A
- . 8EC4A
- . 8L2
- . 8V3A
- 12L5A (not including Ophthalmic use)
- . 15L4 (not include Ophthalmic use)
- . 16HL7.
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3. Accessories / Kits:
There are no new accessories associated with the new transducers or ophthalmic indications for use.
| uSmart3300Transducer | Starter Contents | FDA 510k Clearance # | Replacement Kit | FDA 510k ClearanceNumbers |
|---|---|---|---|---|
| 5C2A | Protek kit #7138 | K973958 | Protek 16 Ga biopsy kit#4216Protek 18 Ga biopsy kits#4218Protek 22 Ga biopsy kits#4222Biopsy kits includeneedle guide, probecover, and gel | K140773K973958 |
| 15L4 | Civco 612-085 (inplane)needle guide Starter KitCivco 683-002(transverse) needleguide starter kit | K882383/A | Civco 610-579 | K140773K882383/A |
Accessories previously cleared under FDA 510(k) K140773 include:
4) Conclusion
The intended uses and features are consistent with the traditional clinical practices and FDA guidance of Diagnostic ultrasound systems and transducers. The uSmart3300 and predicate devices both conform to applicable electric safety medical device standards with compliance verified through independent evaluation. The uSmart3300 and predicate devices both meet FDA requirements for track 3 devices, indications for use, biocompatibility, and are manufactured using FDA GMPs and ISO-13485 quality systems. Teratech Corporation believes that the uSmart3300 ultrasound system is substantially equivalent with regards to safety and effectiveness to the predicate devices as noted above.
B1. Non Clinical Tests
The Terason™ uSmart3300 system has been tested for compliance to the following standards (with the corresponding report referenced for each standard).
- IEC 60601-1 Medical Electrical Equipment Part 1: General . Requirements for Basic Safety.
- Intertek Test Record Number 101288219BOX-004.
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- IEC60950-1 Information Technology Equipment Safety Part 1: . General Requirements
- o IEC60950-1 IEI Integration Corp. Test Report Number, 1308046001.
- IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: . Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
- IEC60601-2-37 Transducer Model 8TE3 |Intertek Report O 101501543BOX-006]
- IEC60601-2-37 Transducer Model 12L5A Ophthalmic [Intertek O Report 100404853BOX-006]
- IEC60601-2-37 Transducer Model 15L4 Ophthalmic [Intertek O Report 100404853BOX-007]
- IEC60601-2-37 Transducer Model 9MC3 [Intertek Report O #100404854BOX-001b]
- o IEC60601-2-37 Transducer Model PDOF IIntertek Report #100404858BOX-002].
IEC 60601-2-37 reports associated with previously cleared transducers can be found in FDA 510(k) K140773.
- IEC60601-1-2:2007 / EN60601-1-2:2007 Electromagnetic . Compatibility, Harmonic Current Emissions
- o IEC60601-1-2:2007 8TE3 Transducer [Oldelft Technical Report 2011-002]
- IEC60601-1-2:2007 EMC Emissions Evaluation of Terason uSmart3300 Cart with 3 port MUX [Intertek Report #101753715BOX-001]
IEC 60601-1-2:2007 reports associated with previously the cleared Terason uSmart3300 ultrasound system can be found in FDA 510(k) K140773.
- . NEMA UD 3 Acoustic Output Display Terason uSmart3300 Ultrasound System User Guide, Volume 2 (16-3312).
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- Biocompatibility Tests, ISO 10993 Part 5 and Part 10 .
- Biocompatibility reports for all transducers.
§ 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.