(28 days)
TE7 Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal,Intra-operative(abdominal, thoracic, and vascular) , Pediatric,small organ(breast, thyroid, testes), neonatal and adult cephalic,trans-esoph. (Cardiac), trans-raginal, musculo-skeletal(conventional, superficial), urology,Peripheral vessel, Adult and Pediatric cardiac exams.
TE7 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Power/Dirpower Mode, THI, LVO or the combined mode (i.e. Color-Mode , B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.
The provided text is a 510(k) summary for the Mindray TE7 Diagnostic Ultrasound System. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a traditional clinical study with defined performance metrics in the way a novel AI algorithm might.
Therefore, the information requested in your prompt regarding acceptance criteria, training/test sets, expert adjudication, and MRMC studies is not typically found or required in a 510(k) submission for an ultrasound system like the TE7, which is primarily demonstrating equivalence in terms of its technological characteristics and safety/effectiveness features to existing devices.
The document states:
- "Not applicable. The subject of this submission, TE7 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This directly addresses the study aspect.
- The comparison is based on "technological characteristics," "key safety and effectiveness features," "intended uses and basic operating modes," and compliance with "applicable medical safety standards."
However, I can extract information related to the device's performance through its comparison to predicate devices and compliance with standards, which implicitly serves as its "acceptance criteria" and "proof" for substantial equivalence.
Here's an interpretation based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, "acceptance criteria" are generally that the new device is as safe and effective as the predicate device. The "reported device performance" is demonstrated by showing identical or comparable features and adherence to safety standards.
| Acceptance Criteria Category (Derived from 510(k) process) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence | TE7 Diagnostic Ultrasound System has the same intended uses as the predicate device M7 (K131690), applicable for adults, pregnant women, pediatric patients, and neonates for various exams (fetal, abdominal, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal, urology, peripheral vessel, Adult and Pediatric cardiac exams). |
| Technological Characteristics Equivalence | TE7 has the same technological characteristics as the predicate devices. It is a software-controlled ultrasonic diagnostic system acquiring and displaying ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Power/Dirpower Mode, THI, LVO or combined modes (Color-Mode, B/M-Mode, B/PW-mode, B/PW/Color). It employs an array of probes (linear, convex) with a frequency range of approximately 3.0 MHz to 10.0 MHz. Specific probes are identical or similar to those on predicate devices M9 (K141010) and M7 (K131690). |
| Safety and Effectiveness Features Equivalence | TE7 has comparable key safety and effectiveness features as the predicate devices. This includes: - Same patient contact material as predicate M7 (K131690). - Acoustic power levels are below FDA limits, same as predicate M7 (K131690). - Designed in compliance with FDA recognized electrical and physical safety standards, same as predicate M7 (K131690). - Same imaging modes as predicate M7 (K131690): B, M, Color Doppler, PWD, CWD, Amplitude Doppler, Anatomical M Mode and combined mode. - Special functions (LVO, iNeedle) are identical to predicate M9 (K141010). - Same capacity for comments, body marks, and reporting as predicate M7 (K131690). - Conforms to applicable medical safety standards (UD 2, UD 3, AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO14971, ISO 10993-1, IEC 62366, IEC 62304). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the 510(k) summary. For ultrasound systems, performance is typically verified through technical bench testing and comparison to existing, cleared devices, not with clinical test sets or data provenance in the way an AI algorithm might require.
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 information is not applicable and not provided. Ground truth established by experts is a concept relevant to performance studies where a diagnosis or measurement needs validation, typically for novel algorithms or significant changes in diagnostic capabilities. This 510(k) submission does not describe such a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are used in clinical studies with human readers to establish a gold standard or resolve discrepancies, which is not part of this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no MRMC comparative effectiveness study mentioned. The document explicitly states: "Clinical Studies: Not applicable. The subject of this submission, TE7 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This type of study would be highly relevant for AI-assisted interpretation, which is not the primary focus of this ultrasound system's regulatory submission for substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The TE7 is a diagnostic ultrasound system, not an AI algorithm. Its performance is inherent in its imaging capabilities and modes, which are compared to predicate ultrasound devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of this 510(k) submission. The "ground truth" for demonstrating substantial equivalence lies in comparing its technical specifications and performance during non-clinical testing against established medical device standards and the technical attributes of predicate devices.
8. The sample size for the training set
This is not applicable and not provided, as the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable and not provided, as the device is not an AI algorithm requiring a training set or ground truth establishment in that context.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
January 2, 2015
Re: K143472
Trade/Device Name: TE7 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 31, 2014 Received: December 5, 2014
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 mav 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.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.
Michael D.'Hara for
Janine Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
K143472
Device Name TE7
Indications for Use (Describe)
TE7 Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal,Intra-operative(abdominal, thoracic, and vascular) , Pediatric,small organ(breast, thyroid, testes), neonatal and adult cephalic,trans-esoph. (Cardiac), trans-raginal, musculo-skeletal(conventional, superficial), urology,Peripheral vessel, Adult and Pediatric cardiac exams.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{3}------------------------------------------------
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{4}------------------------------------------------
Diagnostic Ultrasound Indications For Use Format
System: TE7 Diagnostic Ultrasound System
Transducer: N/A
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Use:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other(specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | Note 1,2 | ||
| Abdominal | N | N | N | N | N | N | N | Note 1,2 | ||
| Intra-operative (Specify*) | N | N | N | N | N | N | N | Note 1,2 | ||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1,2 | ||
| Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1,2 | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2 | ||
| FetalImaging & | Adult Cephalic | N | N | N | N | N | N | N | Note 1,2 | |
| Other | Trans-rectal | N | N | N | N | N | N | N | Note 1,2 | |
| Trans-vaginal | N | N | N | N | N | N | N | Note 1,2 | ||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | Note 1,2 | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | N | Note 1,2 | ||
| Intravascular | ||||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1,2,3 | ||
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1,2 | ||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | N | N | N | N | N | N | N | Note 1 | ||
| Intra-cardiac | ||||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | N | N | Note 1,2 | |
| vessel | Other (Specify***) | N | N | N | N | N | N | N | Note 1,2 | |
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power | ||||||||||
| * Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note2: Biopsy Guidance | ||||||||||
| Note3: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudedeDoppler | Combined(specify) | Other(specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2 | |||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1,2 | |||
| FetalImaging & | Adult Cephalic | |||||||||
| Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | P | P | P | P | P | P | Note 1,2 | |||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | Note 1,2 | ||
| vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K141010); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note2: Biopsy Guidance | ||||||||||
| Note3: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other(specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | P | P | P | P | P | P | Note 1,2 | |||
| Abdominal | P | P | P | P | P | P | Note 1,2 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2 | |||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal | Adult Cephalic | |||||||||
| Imaging &Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | Note 1,2 | ||
| vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note2: Biopsy Guidance | ||||||||||
| Note3: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||||
| Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other(specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging &Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | P | P | Note 1 | ||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note2: Biopsy Guidance | ||||||||||
| Note3: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||||
| Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other(specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2 | |||
| Neonatal Cephalic | ||||||||||
| FetalImaging & | Adult Cephalic | |||||||||
| Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | Note 1,2 | |||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | Note 1,2 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | Note 1,2 | ||
| vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+ B、Power | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note2: Biopsy Guidance | ||||||||||
| Note3: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) |
Prescription USE (Per 21 CFR 801.109)
{5}------------------------------------------------
System: TE7 Diagnostic Ultrasound System
Transducer: C11-3s
{6}------------------------------------------------
System: TE7 Diagnostic Ultrasound System
Transducer: C5-2s Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
{7}------------------------------------------------
System: TE7 Diagnostic Ultrasound System
Transducer: P7-3Ts
{8}------------------------------------------------
| System: | TE7 Diagnostic Ultrasound System | |
|---|---|---|
| --------- | -- | ---------------------------------- |
Transducer: L12-4s
{9}------------------------------------------------
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other(specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2 | |||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2 | |||
| Neonatal Cephalic | ||||||||||
| FetalImaging & | Adult Cephalic | |||||||||
| Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | P | P | P | P | P | P | Note 1,2 | |||
| (Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | Note 1,2 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | P | Note 1,2 | ||
| vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、PW+Color+B、Power | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note2: Biopsy Guidance | ||||||||||
| Note3: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||||
| Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other(specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | b | Note 1,2 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2 | |||
| Neonatal Cephalic | P | P | P | P | P | b | Note 1,2 | |||
| FetalImaging & | Adult Cephalic | |||||||||
| Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | Note 1,2 | |||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | Note 1,2 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | P | b | Note 1,2 | ||
| vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes-B+M、PW+B、Color + B、PW+Color+B、Power | ||||||||||
| * Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note2: Biopsy Guidance | ||||||||||
| Note3: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||||
| Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other(specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2 | |||
| Neonatal Cephalic | ||||||||||
| FetalImaging &Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | Note 1,2 | |||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | Note 1,2 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | P | P | P | P | P | P | Note 1,2 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note2: Biopsy Guidance | ||||||||||
| Note3: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other(specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | b | Note 1,2 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | b | b | b | Note 1,2 | ||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | b | Note 1,2 | ||
| FetalImaging & | Adult Cephalic | P | P | P | P | P | b | b | Note 1,2 | |
| Other | Trans-rectal | |||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,3 | ||
| Cardiac Pediatric | P | P | P | P | b | b | P | Note 1,2 | ||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| vessel | Other (Specify***) | |||||||||
| N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes-B+M、PW+B、Color + B、PW +Color+B、Power | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note2: Biopsy Guidance | ||||||||||
| Note3: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||||
| Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other(specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| FetalImaging &Other | Fetal | P | P | P | P | P | P | Note 1,2 | ||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Other | Trans-rectal | P | P | P | P | P | P | Note 1,2 | ||
| Trans-vaginal | P | P | P | P | P | P | Note 1,2 | |||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | |||||||||
| Other (Specify***) | P | P | P | P | P | P | Note 1,2 | |||
| N=new indication; P=previously cleared by FDA(K141010); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW +Color+B、Power | ||||||||||
| * Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note2: Biopsy Guidance | ||||||||||
| Note3: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1Only) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudedeDoppler | Combined(specify) | Other(specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | P | Note 1,2 | |||
| Intra-operative (Specify*) | P | P | P | P | P | P | Note 1,2 | |||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | P | Note 1,2 | |||
| Small Organ (Specify**) | P | P | P | P | P | P | Note 1,2 | |||
| Neonatal Cephalic | P | P | P | P | P | P | Note 1,2 | |||
| FetalImaging &Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | Note 1,2 | |||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | Note 1,2 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | P | P | P | P | P | P | Note 1,2 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K131690); E=added under Appendix E | ||||||||||
| Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power | ||||||||||
| * Intraoperative includes abdominal, thoracic, and vascular etc. | ||||||||||
| ** Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note2: Biopsy Guidance | ||||||||||
| Note3: Contrast imaging (Contrast agent for LVO) | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of Device Evaluation(ODE) | ||||||||||
| Prescription USE (Per 21 CFR 801.109) |
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
System: TE7 Diagnostic Ultrasound System
Transducer: L7-3s
{10}------------------------------------------------
System: TE7 Diagnostic Ultrasound System
Transducer: L14-6s
{11}------------------------------------------------
System: TE7 Diagnostic Ultrasound System
Transducer: L14-6Ns
{12}------------------------------------------------
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
System: TE7 Diagnostic Ultrasound System
Transducer: P4-2s
{13}------------------------------------------------
System: TE7 Diagnostic Ultrasound System
Transducer: V11-3Ws
{14}------------------------------------------------
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
System: TE7 Diagnostic Ultrasound System
Transducer: 7LT4s
{15}------------------------------------------------
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92(c).
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
1. Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +86 755 8188 5640 Fax: +86 755 2658 2680
Contact Person:
Yang Zhaohui Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
October 29, 2014 Date Prepared:
2. Device Name: TE7 Diagnostic Ultrasound System
Classification
Regulatory Class: II
Review Category: Tier II
21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
3. Device Description:
{16}------------------------------------------------
TE7 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Power/Dirpower Mode, THI, LVO or the combined mode (i.e. Color-Mode , B/M-Mode, B/PW-mode, B/PW/Color).
This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 10.0 MHz.
4. Intended Use:
TE7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal,Intra-operative(abdominal, thoracic, and vascular) .Pediatric.small organ(breast, thyroid, testes), neonatal and adult cephalic,trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), urology, Peripheral vessel, Adult and Pediatric cardiac exams.
5. Comparison with Predicate Devices:
TE7 Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| Predicate Device | Manufacturer | Model | 510(k) Number | Control |
|---|---|---|---|---|
| 1 | Mindray | M9 | K141010 | |
| 2 | Mindray | M7 | K131690 |
TE7 has the same technological characteristics, is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices. All systems transmit ultrasonic energy into patients and perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.
- . Subject device TE7has the same intended uses as the predicated device M7(K131690)
{17}------------------------------------------------
| Subject Device | Predicate device |
|---|---|
| TE7 | M7(K131690) |
| TE7 Diagnostic Ultrasound System isapplicable for adults, pregnant women,pediatric patients and neonates. It is intendedfor use in fetal, abdominal, Intra-operative(abdominal, thoracic, and vascular),Pediatric,small organ(breast, thyroid, testes),neonatal and adult cephalic,trans-esoph.(Cardiac), trans-rectal, trans-vaginal,musculo-skeletal(conventional, superficial),urology, Peripheral vessel, Adult and Pediatriccardiac exams. | The M7/M7T Diagnostic Ultrasound System isapplicable for adults, pregnant women, pediatricpatients and neonates. It is intended for use ingynecology, obstetric, abdominal, pediatric,small parts (breast, testes, thyroid), neonatalcephalic, trans-cranial, cardiac, trans-vaginal,trans-rectal, peripheral vascular, urology,orthopedic, and muscular-skeletal (conventionaland superficial), Intra-operative andTrans-esophageal (cardiac) exams. |
- All of the patient contact material of the TE7are the same as that of the predicated device M7(K131690).
- The acoustic power levels of TE7 are below the limits of FDA, which is the same as the predicated device M7(K131690).
- TE7 is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device M7(K131690).
- TE7 has the same imaging modes as the predicated device M7(K131690): B, M, Color Doppler, PWD, CWD, Amplitude Doppler, Anatomical M Mode and combined mode).
- . TE7 has some special functions: LVO, and iNeedle All of them are identical as the predicated device M9(K141010).
- TE7 has the same capacity in term of making comments and body marks on the images, reporting patient exam results as the predicated device M7(K131690).
- TE7 has similar probes as the predicated device M9(K141010) and M7(K131609):
| Subject device TE7 | Predicated deviceM9(K141010) | Predicated deviceM7(K131690) | NOTE |
|---|---|---|---|
| C5-2s | / | C5-2s | Same |
| L12-4s | / | L12-4s | Same |
{18}------------------------------------------------
| L7-3s | / | L7-3s | Same |
|---|---|---|---|
| P4-2s | SP5-1s | P4-2s | Same |
| P7-3Ts | / | P7-3Ts | Same |
| L14-6s | / | L14-6s | Same |
| L14-6Ns | / | L14-6Ns | Same |
| V11-3Ws | V11-3WE | / | Same |
| C11-3s | C11-3s | / | Same |
| 7LT4s | / | 7LT4s | Same |
- TE7 has the same measurement and calculation functions as the predicated device M9(K141010).
6. Non-clinical Tests:
TE7 Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been designed to conform with applicable medical safety standards. This device has been tested and evaluated under the following standards:
- UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
- UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- . AAMI / ANSI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
- . IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- . ISO14971 Medical devices - Application of risk management to medical devices
- . ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- . IEC 62366 Medical devices - Application of usability engineering to medical
{19}------------------------------------------------
devices
- IEC 62304 Medical device software Software life cycle processes
These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.
7. Clinical Studies
Not applicable. The subject of this submission, TE7 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.
Conclusion:
Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards. Therefore, the TE7 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
§ 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.