(65 days)
The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic.adult cephalic.trans-rectal, trans-vaginal, musculo-skeletal(supertional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric and peripheral vessel exams.
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, PW-mode, PW-mode, CW mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, TDI mode, Color M mode, Biopsy Guidance, Elastography, or the combined mode (i.e. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0MHz.
The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System. It describes the device's intended use and compares it to predicate devices to establish substantial equivalence. However, it explicitly states that clinical studies were not required or performed to demonstrate substantial equivalence for this device. Therefore, a study proving the device meets specific acceptance criteria based on clinical performance data is not detailed in this document.
The acceptance criteria mentioned are general safety and performance standards rather than specific clinical performance metrics. The document instead focuses on demonstrating that the new device is substantially equivalent to previously cleared devices through non-clinical testing.
Here's a breakdown of the requested information based on the provided text, with a clear indication when the information is not present or not applicable due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission asserting substantial equivalence based on non-clinical testing and comparison to predicates, the "acceptance criteria" are compliance with recognized standards and similarity to predicate devices. Specific performance metrics (e.g., sensitivity, specificity for a particular clinical task) are not provided as acceptance criteria for this type of submission.
| Acceptance Criteria (General Safety and Performance) | Reported Device Performance (Compliance Claimed) |
|---|---|
| Intended Use Equivalence to Predicate Device (DC-N3 K140030) | The device's intended uses (fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac adult, cardiac pediatric, and peripheral vessel exams) are stated to be the same as the predicate device (DC-N3 K140030), with the exception of "urology" which is an "other use" for the subject device. |
| Patient Contact Materials Biocompatibility | Tested under ISO 10993-1. |
| Acoustic Power Levels within FDA Limits | Acoustic power levels are below FDA limits, which are the same as the predicate device DC-N3 (K140030). |
| Electrical and Physical Safety Standards Compliance | Designed in compliance with FDA recognized electrical and physical safety standards, which are the same as the predicate device DC-N3 (K140030). |
| Imaging Modes Equivalence | Has the same imaging modes as the predicate devices. |
| Functions Equivalence | All functions are the same as the predicate devices. |
| Transducer Equivalence | Has the same transducers as the predicate devices. |
| Compliance with Specific Recognized Standards: | |
| - AAMI/ANSI ES60601-1 (Medical electrical equipment basic safety) | Compliance claimed. |
| - AAMI/ANSI/IEC 60601-1-2 (Electromagnetic compatibility) | Compliance claimed. |
| - IEC 60601-2-37 (Ultrasonic medical diagnostic equipment) | Compliance claimed. |
| - IEC 62304 (Medical device software life cycle processes) | Compliance claimed. |
| - IEC 62366 (Usability engineering) | Compliance claimed. |
| - IEC 60601-1-6 (Usability for basic safety and essential performance) | Compliance claimed. |
| - ISO 14971 (Risk management) | Compliance claimed. |
| - UD 2 (Acoustic Output Measurement Standard) | Compliance claimed. |
| - UD 3 (Real Time Display of Thermal and Mechanical Acoustic Output | Compliance claimed. |
| Indices) | |
| - ISO 10993-1 (Biological evaluation of medical devices) | Compliance claimed. |
2. Sample size used for the test set and the data provenance
- Not applicable for clinical performance data. The submission states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."
- For non-clinical tests (acoustic output, biocompatibility, electrical safety, etc.), the sample sizes are not specified in this summary. Data provenance would be from internal lab testing conducted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set with ground truth established by experts is mentioned in this 510(k) summary.
4. Adjudication method for the test set
- Not applicable. No clinical test set and thus no adjudication method is mentioned.
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
- No, an MRMC comparative effectiveness study was not done. The document explicitly states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." This device is a Diagnostic Ultrasound System, not an AI-assisted diagnostic tool that would typically undergo such studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a diagnostic ultrasound system; performance is inherently "human-in-the-loop" as it requires a trained operator to acquire and interpret images. There is no mention of a standalone algorithm's performance.
7. The type of ground truth used
- Not applicable for clinical performance. For non-clinical tests (e.g., electrical safety, acoustic output), ground truth is established by recognized standards and calibrated measurement equipment.
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" for an algorithm, as this is a diagnostic ultrasound imaging system, not an AI/ML-based diagnostic device in the context of this submission.
9. How the ground truth for the training set was established
- Not applicable. No training set for an algorithm is mentioned.
In summary, this 510(k) submission establishes substantial equivalence for a diagnostic ultrasound system primarily through a comparison to predicate devices and adherence to recognized non-clinical safety and performance standards. It does not involve clinical performance studies with specific acceptance criteria, test sets, expert ground truth, or AI algorithm validation.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2016
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Zhai Pei Engineer of Technical Regulation Department Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 CHINA
Re: K162845
Trade/Device Name: DC-40/DC-35/DC-45/DC-40 Pro 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: September 28, 2016 Received: October 11, 2016
Dear Zhai Pei:
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
{1}------------------------------------------------
forth in the quality systems (OS) 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 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
Robert Ochs, Ph.D. 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)
Device Name
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
Indications for Use (Describe)
The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic.adult cephalic.trans-rectal, trans-vaginal, musculo-skeletal(supertional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric and peripheral vessel exams.
Type of Use (Select one or both, as applicable)
V Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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{3}------------------------------------------------
| Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1) | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | Note 1, 2,3, 4,6 | |||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2,3, 4,6 | ||
| Intra-operative | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Small Organ | N | N | N | N | N | N | Note 1,2, 4,6,7 | |||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Fetal Imaging& Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,6, | |
| Trans-rectal | N | N | N | N | N | N | Note 1, 2, 4,6, | |||
| Trans-vaginal | N | N | N | N | N | N | Note 1, 2, 4,6, | |||
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | Note 1,2, 4,6,7 | |||
| Intravascular | ||||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,4,5,6, | ||
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,4,5,6, | ||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Other (Specify***) | ||||||||||
| 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 + PW +1 | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1 | 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, 4,6,7 | ||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Intra-operative | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Small Organ | ||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Fetal Imaging& Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | ||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |
| Other (Specify***) | ||||||||||
| 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 + PW +B | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular**Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | Note 1,2, 4,6,7 | |||
| Intra-operative | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2, 4,6,7 | |||
| Small Organ | N | N | N | N | N | N | Note 1,2, 4,6,7,8 | |||
| Neonatal Cephalic | N | N | N | N | N | N | Note 1,2, 4,6,7 | |||
| Fetal Imaging& Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph.(non- | ||||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | Note 1,2, 4,6,7 | |||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | Note 1,2, 4,6,7 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix EAdditional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW +Color+ B,Power + PW +B*Intraoperative includes abdominal, thoracic, and vascular**Small organ-breast, thyroid, testes.***Other use includes Urology.Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.Note 2: Smart3DNote 3:4D(Real-time 3D)Note 4: iScapeNote5: TDINote6: Color MNote7: Biopsy GuidanceNote8: Elastography(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined(specify) | Other (specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Intra-operative | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Small Organ | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Fetal Imaging& Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | |
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix EAdditional comments: Combined modes--B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +BIntraoperative includes abdominal, thoracic, and vascular* Small organ-breast, thyroid, testes.***Other use includes Urology.Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.Note 2: Smart3DNote 3:4D(Real-time 3D)Note 4: iScapeNote5: TDINote6: Color MNote7: Biopsy GuidanceNote8: Elastography(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDopple | AmplitudeDoppler | Combined | Other (specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | Note 1, 3, 4, 6 | |||
| Abdominal | N | N | N | N | N | N | Note 1, 3, 4, 6 | |||
| Intra-operative | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Fetal Imaging& Other | Small Organ | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | |||||||||
| Other (Specify***) | ||||||||||
| 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 + PW +B | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDopple | AmplitudeDoppler | Combined | Other (specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | Note 1,2, 4,7 | |||
| Small Organ | N | N | N | N | N | N | Note 1,2, 4,7,8 | |||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | Note 1,2, 4,7 | |||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | Note 1,2, 4,7 | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheralvessel | Peripheral vessel | N | N | N | N | N | N | Note 1,2, 4,7 | ||
| Other (Specify***) | ||||||||||
| 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 + PW +B | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | Combined | Other (specify) | |
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Abdominal | ||||||||||
| Intra-operative | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging& Other | Adult Cephalic | |||||||||
| Trans-rectal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Trans-vaginal | N | N | N | N | N | N | Note 1, 2, 4,6,7 | |||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Cardiac | Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | ||||||||||
| Other (Specify***) | ||||||||||
| 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 + PW +B | ||||||||||
| *Intraoperative includes abdominal, thoracic, and vascular | ||||||||||
| **Small organ-breast, thyroid, testes. | ||||||||||
| ***Other use includes Urology. | ||||||||||
| Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents. | ||||||||||
| Note 2: Smart3D | ||||||||||
| Note 3:4D(Real-time 3D) | ||||||||||
| Note 4: iScape | ||||||||||
| Note5: TDI | ||||||||||
| Note6: Color M | ||||||||||
| Note7: Biopsy Guidance | ||||||||||
| Note8: Elastography | ||||||||||
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) | ||||||||||
| Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) |
System:
Transducer:
N/A
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Note7: Biopsy Guidance Note8: Elastography
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3C5A Transducer:
{5}------------------------------------------------
Transducer: 7L4A
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Transducer: L7-3
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
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Transducer: D7-2E
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Transducer: L14-6NE
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Transducer: V11-3
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| System: | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System |
|---|---|
| Transducer: | P4-2 |
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General(Track 1 | Specific (Track 1 & 3) | B | M | PWD | CWD | ColorDopple | AmplitudeDoppler | Combined | Other (specify) |
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | N | N | N | N | N | N | N | Note 1, 2,4,6,7 | |
| Intra-operative | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| Neonatal Cephalic | |||||||||
| Fetal Imaging& Other | Adult Cephalic | N | N | N | N | N | N | N | Note 1, 2,4,6,7 |
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non- | |||||||||
| Musculo-skeletal(Conventional) | |||||||||
| Musculo-skeletal(Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7 | |
| Cardiac Pediatric | N | N | N | N | N | N | N | Note 1, 2,4,5,6,7 | |
| Cardiac | Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheralvessel | Peripheral vessel | ||||||||
| Other (Specify***) |
{11}------------------------------------------------
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 5604 Fax: +86 755 2658 2680
Contact Person:
Zhai Pei Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
September 28, 2016 Date Prepared:
2. Device Name: DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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:
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, PW-mode, PW-mode, CW mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, TDI mode,
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Color M mode, Biopsy Guidance, Elastography, or the combined mode (i.e. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0MHz.
4. Intended Use:
The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric and peripheral vessel exams.
5. Comparison with Predicate Devices:
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| PredicateDevice | Manufacturer | Model | 510(k) Number |
|---|---|---|---|
| 1 | Mindray | DC-N3 | K140030 |
| 2 | Mindray | DC-60 | K152545 |
| 3 | Mindray | Resona 7 | K162267 |
The modified DC-40/DC-35/DC-40S/DC-40 Pro Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then 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. The subject device also has the same intended uses and basic operating modes as the predicate devices.
Subject device DC-40/DC-35/DC-45/DC-40S/DC-40 Pro has the same intended uses as the predicated device DC-N3 (K140030).
| Items | Subject DeviceDC-40/DC-35/DC-45/DC-40S/DC-40Pro | Predicate deviceDC-N3 (K140030) |
|---|---|---|
| IntendedUse | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound Systemis applicable for adults, pregnant women, pediatric patients andneonates. | The DC-N3 diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. |
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| It is intended for use infetal,abdominal,pediatric,small organ(breast, thyroid, testes),neonatal cephalic,adult cephalic,trans-rectal,trans-vaginal,musculo-skeletal(conventional),musculo-skeletal(superficial),cardiac adult,cardiac pediatricand peripheral vessel exams. | It is intended for use infetal,abdominal,pediatric,small organ (breast, thyroid, testes),neonatal cephalic,adult cephalic,trans-rectal,trans-vaginal,musculo-skeletal(conventional),musculo-skeletal(superficial),cardiac adult,cardiac pediatric,peripheral vessel and urologyexams. |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
-
. The patient contact materials of the transducers are tested under ISO 10993-1.
. The acoustic power levels of the DC-40/DC-35/DC-45/DC-40S/DC-40 Pro are below the limits of FDA, which are the same as the predicated device DC-N3 (K140030). -
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device DC-N3 (K140030).
-
The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro has the same imaging modes as the predicated devices.
-
All of the functions of DC-40/DC-35/DC-45/DC-40S/DC-40 Pro are the same as the predicated devices.
-
I The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro has same tranducers with the predicated devices.
6. Non-clinical Tests:
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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.
Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:
{14}------------------------------------------------
- AAMI/ANSI ES60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- AAMI/ANSI/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
- IEC 62304: Medical device software - Software life cycle processes
- IEC:62366:Medical devices - application of usability engineering to medical devices
- . IEC 60601-1-6: medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.
- . ISO14971: Medical devices - Application of risk management to medical devices
- 1 UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
- UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- . ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
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, DC-40/DC-35/DC-45/DC-40S/DC-40 Pro 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 DC-40/DC-35/DC-40S/DC-40 Pro 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.