(71 days)
Not Found
No
The document describes a standard ultrasound system with various imaging modes and post-processing capabilities, but there is no mention of AI, ML, or related technologies like deep neural networks (DNNs). The description focuses on traditional ultrasound functionalities.
No
The device is described as a "Diagnostic Ultrasound System" which acquires and displays ultrasound data to generate onscreen display of anatomic structures and fluid flow within the body. Its intended use is for various exams, none of which are therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states "The DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates." The word "Diagnostic" is used to describe the system.
No
The device description explicitly states it is an "ultrasonic diagnostic system" that employs "an array of probes," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this is a "software controlled, ultrasonic diagnostic system." It uses ultrasound waves to "acquire and display ultrasound data" and "generate onscreen display of anatomic structures and fluid flow within the body."
- Imaging Modality: The input imaging modality is "Diagnostic ultrasound imaging," which is an in-vivo (within the living body) imaging technique, not an in-vitro (outside the living body) diagnostic test.
- Anatomical Sites: The listed anatomical sites are all locations within the human body where ultrasound is used for imaging.
The device is a diagnostic imaging system that works by sending and receiving ultrasound waves to create images of internal structures. This is fundamentally different from an IVD, which analyzes samples taken from the body.
N/A
Intended Use / Indications for Use
The DC-70/DC-70T /DC-70 PRO/DC-70 EXP 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 and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.
Also stated as:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 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, Peripheral vessel, Urology.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, LLZ
Device Description
DC-70/DC-70T /DC-70 PRO/DC-70 EXP 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, Color-Mode, Power/Dirpower Mode, THI or the combined mode (i.e. 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.
Mentions image processing
Yes, "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."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, abdominal, pediatric, breast, thyroid, testes, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac, peripheral vessel, urology.
Indicated Patient Age Range
Adults, pregnant women, pediatric patients and neonates.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to evaluate acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety. The device was designed to conform with applicable medical safety standards and was tested under UD 2, AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO14971, ISO 10993-1, IEC 62366, and IEC 62304. Clinical studies were not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2015
Shenzhen Mindray Bio-Medical Electronics Co., LTD % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K150204 Trade/Device Name: DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, LLZ Dated: March 15, 2015 Received: March 19, 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
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,
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
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 below.
| 510(k) Number (if known) | K150204 |
|---|---|
| Device Name | DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System |
| Indications for Use (Describe) | The DC-70/DC-70T /DC-70 PRO/DC-70 EXP 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 and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
13 - 015 € L = 800 - 1 > 34
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| p |
| D |
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||||
| Clinical Application | ||||||||||
| General | Specific (Track 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (specify) | Other (specify) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | Note 1,2,3, 4,6,7 | ||
| Abdominal | N | N | N | N | N | N | N | Note 1,2,3, 4,6,7 | ||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | Note 1,2, 4,6,7 | ||
| Small Organ (Specify**) | N | N | N | N | N | N | N | Note 1,2, 4,7,8 | ||
| Neonatal Cephalic | N | 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 1,2,4,6,7 | |
| Trans-rectal | N | N | N | N | N | N | N | Note 1,2,3,4,6,7 | ||
| Trans-vaginal | N | N | N | N | N | N | N | Note 1,2,3,4,6,7 | ||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| 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 1,2,4,7 | ||
| Intravascular | ||||||||||
| Cardiac | 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 | ||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | N | N | N | N | N | N | N | Note 1,2,4,6,7 | |
| Other (Specify***) | N | N | N | N | N | N | N | Note 1,2,4,6,7 | ||
| 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 + | ||||||||||
| *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 Device Evaluation(ODE) |
ายทาง 1 จรุป 104 รู้ที่ 104 รินด้ายว่า 2017 คน
:ພາອາຣຽ
4
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| ISSUSURICIE | コフ-Cつ | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| sevollo1 se vbod namud att 10 sizylems woft biult 10 gaigsmi bauosertlu 201501111 | ||||||||||
| സ്ഥാപിന്റെ Analistical | uoitsaaqO to apoM | |||||||||
| ານສະຫຼຸບ | ||||||||||
| (xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx | Specific (Track Krack I & | B | M | awa | വഹ | appado T | ||||
| Color | əpmişdir. Azərbaycan filmləri Filmin Mənbə Film Sənədlər Rəmaniya Rəsmin Film Sənədlər Rəsmin Film Sənədlər Film Sənədli Film Sənədlər Film Sənəd | |||||||||
| Doppler | Combined | |||||||||
| (({\iseds) | (yüzədə) vəqic | |||||||||
| phphphalmic | ophthalmic | |||||||||
| Atata | P | P | P | P | P | P | ote 1,224,6 | |||
| .7 | ||||||||||
| bbbonds | P | P | P | P | P | P | ote 1, 2, 4,6, | |||
| (*vfiisads) aviisiado-sun | ||||||||||
| intra-operative (Neuro | ||||||||||
| ാമ്പാട്ടാവുമുള | ||||||||||
| Pediatric | P | P | P | P | P | P | lote 1, 2, 4,6 | |||
| 7 | ||||||||||
| ***1109ds) urg.10 lleurs | ||||||||||
| sing the Charic | ||||||||||
| ສິນເຮືອນໄປໄປໄປໄປໄປປຸງໆ | Adult Cephalic | |||||||||
| & Other | Trans-rectal | |||||||||
| lanigav-suer | ||||||||||
| rans-urethu | ||||||||||
| aren-non) .uqose-sus r | ||||||||||
| Conventional | ||||||||||
| assembo-skeleta | P | P | P | P | P | P | lote 1, 2, 4,6, | |||
| 7 | ||||||||||
| ะเอ็อฟุร-oไทวรที่/ | ||||||||||
| laisifinding | ||||||||||
| arinoseveru | ||||||||||
| lubA osibus | ||||||||||
| ardiac Pediatric | ||||||||||
| Cardia | intravascular (Cardiac | |||||||||
| rans-esoph. (Cardiac | ||||||||||
| ാല്പ്മാലവന | ||||||||||
| Periphers | Participing and the sex of | P | P | P | P | P | P | lote 1, 2, 4,6, | ||
| 7 | ||||||||||
| vesssel | (***(Iiつきq() 19410 | |||||||||
| :(14ESEIx)ACH vd bernsis vlauoiverq=9 : noitroibui wau=M | ə xibnəqqə qəbun bəbbə=Ə | |||||||||
| 1 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - | ||||||||||
| on the say bas . Sistemore, the mores, and vessessed in | ||||||||||
| 2012-11-15 11:51 pm stressts theysels. testes | ||||||||||
| .vgolorU sebulɔni əsu 19db0* | ||||||||||
| ຂ້າມອອກ ການປະກວດຄວາມ ເດດ ຂອງ ອາເປນລາວ ອາໄປ .ງິດເມືອງຂອງປີ ວັນທຸລາວປີ : I ອາປ | ||||||||||
| Note 2: SamartISD | ||||||||||
| ote 3:4D(Real-time SD | ||||||||||
| Note 4: İSCape | ||||||||||
| ldır. İstinadlar Alban Alan Alan Alan Alan Alan Alan Alan Alan Alaban Alabaycan Alan Alan Alan Alan Alan Alat Alat Alat Alat Alat Alat Alat Alat Al | ||||||||||
| M 1010ଠ :9510k | ||||||||||
| əsinə aid bitki növü. İstinadlar Respubl | ||||||||||
| יינוני | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | ||||||||||
| (Track 1 Ophthalmic | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | ||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | P | P | P | P | P | Note 1, 2, 4,6,7 | ||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | P | P | P | Note 1, 2, 4,6,7 | ||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | P | P | P | P | P | Note 1, 2, 4,6,7 | ||||
| Fetal Imaging & Other | Adult Cephalic | |||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | Peripheral vessel | P | P | P | P | P | Note 1, 2, 4,6,7 | |||
| Other (Specify***) | ||||||||||
| N=new indication; P=previously cleared by FDA(K132341); 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 etc. | ||||||||||
| **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 Device Evaluation(ODE) | ||||||||||
| :1930psuc1 T | swollof se ypod usuny attitle woll biult to gaigsmi bunossatu sitsourgsid : 35U bebrand | |||||||||
| C-13 | ||||||||||
| Circal Application | noitsisqO to aboM | |||||||||
| on the provinsion of the first of the first of the fisse of the fisse of the fisse of the fisse of the fisse of the formation of the formation of the formation of the formati | ||||||||||
| There Consisted | pecific (Frack I & E | B | M | and one of the superior of the started on the starting the starting of the starting of the starting of the starting of the state of the state of the state of the state of the | Doppler | |||||
| Color | əpmişdir. A | |||||||||
| Doppler | Commined | |||||||||
| (firsds) | (virosds) 1941 | |||||||||
| imlethydo | omaning | |||||||||
| Petal | P | P | P | P | P | P | lote 1, 2, 4,6,7 | |||
| Abbondoppy | P | P | P | P | P | P | lote 1, 2, 4,6,7 | |||
| (**11iつつd8 +10lo0+ W9 >8 + 10lo2 >8+W9 >M+8--25bom beridmo3 > 2119mmo 15modi | ||||||||||
| əsinə aid bir növü. İstinadlar Şəhrin fəsiləsinə fəsiləsinə cinsinə aid bitk | ||||||||||
| 2017/01/2017 11:58:51, thryuoid, testes | ||||||||||
| orther use use includes Unologies | ||||||||||
| ນກາງຮອບ ຂະໜາດ ອະນຸ ການປະຊາທິນ ອປປີ . ງານ່າງຄວາມໄວ້ເທດການປະກວດນາງງາມ | ||||||||||
| lote 2: SmartID | ||||||||||
| Vote 3:40(Real-time 3D | ||||||||||
| Alote 4: İSCcape | ||||||||||
| Notes: TDI | ||||||||||
| Note6: Color M | ||||||||||
| in and in British Curities | ||||||||||
| ליין מערכת מקום מערכת המקום של המו | ||||||||||
| (ЯПО)поізвивала взічэа 10 годно ,НЯПО 10 езпечтизцоС |
: ພວາຣ໌ นทางเร็ง ทนทอรมป์ปี จันรอนริหานี ศุทรายการ ครอบความการ จาก งานทางการจัดเขาวา
17
| System: | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Transducer: | CW5s | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||
| Clinical Application | Specific (Track 1 & 3) | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Combined (specify) | ||
| General | ||||||||||
| (Track 1) | Ophthalmic | |||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify*) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (Specify**) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Fetal Imaging | ||||||||||
| & Other | 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) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral | ||||||||||
| vessel | Peripheral vessel | N | ||||||||
| 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+ E | ||||||||||
| *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. | ||||||||||
| 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 Device Evaluation (ODE) |
18
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
Date Prepared: December 23, 2014
- Device Name: DC-70/DC-70T /DC-70 PRO/DC-70 EXP 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)
-
21 CFR 892.2050 Picture Archiving and Communications System(LLZ)
19
3. Device Description:
DC-70/DC-70T /DC-70 PRO/DC-70 EXP 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, Color-Mode, Power/Dirpower Mode, THI or the combined mode (i.e. 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:
DC-70/DC-70T /DC-70 PRO/DC-70 EXP 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 and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams.
5. Comparison with Predicate Devices:
DC-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:
| Predicate Device | Manufacturer | Model | 510(k) Control
Number |
|------------------|--------------|-------|--------------------------|
| 1 | Mindray | DC-8 | K132341 |
| 2 | Mindray | DC-N2 | K132779 |
DC-70/DC-70T /DC-70 PRO/DC-70 EXP 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.
20
- Subject device DC-70/DC-70T /DC-70 PRO/DC-70 EXP has the same intended uses . as the predicated device DC-8(K132341)
| Subject Device | Predicate device |
|---|---|
| DC-70/DC-70T /DC-70 PRO/DC-70 EXP | DC-8(K132341) |
| The DC-70/DC-70T /DC-70 PRO/DC-70 EXP | The DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP |
| Diagnostic Ultrasound System is applicable | diagnostic ultrasound system is applicable for |
| for adults, pregnant women, pediatric patients | |
| and neonates. It is intended for use in fetal, | adults, pregnant women, pediatric patients and |
| neonates. It is intended for use in fetal, | |
| abdominal, pediatric, small organ(breast, | |
| thyroid, testes), neonatal and adult cephalic, | abdominal, pediatric, small organ (breast, |
| thyroid, testes), neonatal cephalic, adult | |
| trans-rectal, trans-vaginal, musculo-skeletal | |
| (conventional, superficial), adult and pediatric | cephalic, trans-rectal, trans-vaginal, |
| musculo-skeletal (conventional, superficial), | |
| cardiac, peripheral vessel and urology exams. | cardiac adult, cardiac pediatric, peripheral |
| vessel, urology exams. |
- All of the patient contact material of the DC-70/DC-70T /DC-70 PRO/DC-70 ● EXPare the same as that of the predicated device DC-8(K132341).
- The acoustic power levels of DC-70/DC-70T /DC-70 PRO/DC-70 EXP are below the limits of FDA, which is the same as the predicated device DC-8(K132341).
- DC-70/DC-70T /DC-70 PRO/DC-70 EXP is designed in compliance with the FDA recognized electrical and physical safety standard, which is the same as the predicated device DC-8(K132341).
- . DC-70/DC-70T /DC-70 PRO/DC-70 EXP has the same imaging modes as the predicated device DC-8(K132341): B, M, Color Doppler, PWD, CWD, Amplitude Doppler, Anatomical M Mode and combined mode).
- DC-70/DC-70T /DC-70 PRO/DC-70 EXP has some special functions. All of them are identical as the predicated device DC-8(K132341) and DC-N2(K132779).
- DC-70/DC-70T /DC-70 PRO/DC-70 EXP has the same capacity in term of making comments and body marks on the images, reporting patient exam results as the predicated device DC-8(K132341).
- . DC-70/DC-70T /DC-70 PRO/DC-70 EXP has similar probes as the predicated device DC-8(K132341):
21
| Subject device | Predicated device | NOTE |
|---|---|---|
| DC-70/DC-70T /DC-70 | ||
| PRO/DC-70 EXP | DC-8(K132341) | |
| C5-2E | C5-2E | Same |
| C7-3E | C7-3E | Same |
| C11-3E | C11-3E | Same |
| P4-2E | P4-2E | Same |
| P7-3E | P7-3E | Same |
| V11-3E | V11-3E | Same |
| V11-3BE | V11-3BE | Same |
| V11-3WE | V11-3WE | Same |
| L12-3E | L12-3E | Same |
| L14-6NE | L14-6NE | Same |
| L14-6WE | L14-6WE | Same |
| D6-2E | D6-2E | Same |
| DE10-3E | DE10-3E | Same |
| CW5s | CW5s/CW2s | Same |
- DC-70/DC-70T /DC-70 PRO/DC-70 EXP has the same measurement and calculation . functions as the predicated device DC-8(K132341).
6. Non-clinical Tests:
DC-70/DC-70T /DC-70 PRO/DC-70 EXP 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.
- 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
22
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 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, DC-70/DC-70T /DC-70 PRO/DC-70 EXP 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-70/DC-70T /DC-70 PRO/DC-70 EXP Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
B-5