(15 days)
The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal -OB/GYN, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transvaginal, transrectal, peripheral vascular, and musculoskeletal (conventional and superficial) exams.
The DC-3/DC-3T is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power-Mode, Dirpower-Mode or the combined mode (i.c. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 12 MHz.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a 510(k) summary for a diagnostic ultrasound system (Mindray DC-3/DC-3T).
The document focuses on:
- Device Description: General purpose, mobile, software-controlled ultrasonic diagnostic system with various imaging modes (B-Mode, M-Mode, PW-Mode, Color-Mode, Power-Mode, Dirpower-Mode, combined modes).
- Intended Use: Specifies applicable patient populations (adults, pregnant women, pediatric, neonates) and exam types (fetal-OB/GYN, abdominal, pediatric, small parts, neonatal cephalic, transvaginal, transrectal, peripheral vascular, musculoskeletal).
- Safety Considerations: Compliance with FDA guidance for Track 3 devices, acoustic output measurement standards (NEMA UD 2, NEMA UD 3), and medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1).
- Substantial Equivalence: A statement that the device is as safe and effective as legally marketed predicate devices (Mindray M5, Mindray DC-6).
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence and lists the transducers included.
- Indications for Use Forms: Detail the specific clinical applications and modes of operation for the main system and each transducer (3C5A, 6CV1, 7L4A, 7L6, 10L4).
Missing Information:
The document does not provide the following information that would be necessary to answer the prompt:
- A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, resolution) or acceptance thresholds are listed.
- Sample size used for the test set and data provenance: No performance study data is presented, so no information on test set size or its origin.
- Number of experts used to establish the ground truth for the test set and qualifications: No ground truth establishment is described for a performance study.
- Adjudication method for the test set: Not applicable as no performance study is detailed.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study information: No such study is mentioned.
- Standalone (algorithm only) performance study information: Not applicable as this is a complete ultrasound system, not an AI algorithm with standalone performance.
- Type of ground truth used: Not applicable as no performance study is detailed.
- Sample size for the training set: Not applicable as no data training is described for an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory submission focused on demonstrating substantial equivalence to existing devices through safety and intended use considerations, rather than reporting on a specific performance study with acceptance criteria.
{0}------------------------------------------------
510(K) SUMMARY Exhibit B
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: 1081320
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 2658 2888 Fax: +86 755 2658 2680
Contact Person:
Li Dongling 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: April 18, 2008
- Device Name: DC-3/DC-3T Diagnostic Ultrasound System
Classification
Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-1YN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
3. Marketed Device:
DC-3/DC-3T Diagnostic Ultrasound System is substantially equivalent to the following devices: Mindray M5 (K#080640), Mindray DC-6 (K#072164).
4. Device Description:
The DC-3/DC-3T is a general purpose, mobile, software controlled, ultrasonic
. : `
{1}------------------------------------------------
diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power-Mode, Dirpower-Mode or the combined mode (i.c. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 12 MHz.
5. Intended Use:
The DC-3/DC-3T diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal -OB/GYN, abdominal, pediatric, small parts (breast, thyroid, testicle, etc), neonatal cephalic, transvaginal, transrectal, peripheral vascular, and musculoskeletal (conventional and superficial) exams.
6. Safety Considerations:
The DC-3/DC-3T Diagnostic Ultrasound System has been tested as Track 3 Device per the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued September 1997. The acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 and NEMA UD 3 Output Display Standard. The device conforms to applicable medical device safety standards, such as IFC 60601-1, IEC 60601-1-2, IEC 60601-2-37 and ISO 10993-1.
Conclusion:
The conclusions drawn from testing of the DC-3/DC-3T Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.
..............................................................................................................................................................................
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a row. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the top half of the logo.
JUL 3 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Robert Mosenkis President Citech 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K081320
Trade/Device Name: DC-3 and DC-3T Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 9, 2008 Received: May 12, 2008
Dear Mr. Mosenkis:
This letter corrects our substantially equivalent letter of May 27, 2008.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the DC-3 and DC-3T, as described in your premarket notification: -
Transducer Model Number
3C5A 6CV 1 7L4A, 7L6, 10L4
{3}------------------------------------------------
Page 2 - Mr. Mosenkis
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Lauren Hefner at ' (240) 276-3666.
Sincerely yours,
lori In Whang
Jancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
×
Diagnostic Ultrasound Indications for Use Form
System Model:
Transducer DC-3, DC-3T
510(k) Number(s)
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | Note 1, 2, 3 | |||
| Abdominal | N | N | N | N | N | N | Note 1, 2, 3 | |||
| Intraoperative (specify)* | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 2, 3 | |||
| Small organ(specify)** | N | N | N | N | N | N | Note 2, 3 | |||
| Neonatal Cephalic | N | N | N | N | N | N | Note 2, 3 | |||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | N | N | N | N | N | N | Note 2, 3 | |||
| Transvaginal | N | N | N | N | N | N | Note 2, 3 | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N | Note 2, 3 | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | Note 2, 3 | |||
| Musculo-skeletal Superficial | N | N | N | N | N | N | Note 2, 3 | |||
| Other (specify) *** | N | N | N | N | N | N | Note 2, 3 | |||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E | ||||||||||
| Additional comments: Combined modes: B+M. PW+B. Color + B. PW +Color+B. PW +Color+B. Power + PW+B. |
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology/Prostate.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
tonui m. Whang
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
0071
{5}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
System Transducer ×
Model: 510(k) Number(s) 3C5A
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) | |
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | Note 1, 2, 3 | |||
| Abdominal | N | N | N | N | N | N | Note 1, 2, 3 | |||
| Intraoperative (specify)* | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | Note 1, 2, 3 | |||
| Small organ(specify)** | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (Urology) | ||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E |
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes, etc.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 1: Tissue Harmonic Imaging. The fea
Note 2: Smart3D
Note 3: iScape
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
Toni M. Whay
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
0072
{6}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
| System | |
|---|---|
| Model: | 6CV I |
| Transducer | X |
510(k) Number(s)
__ и на исковое заявление
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | Note 2, 3 | |||
| Abdominal | ||||||||||
| Intraoperative (specify)* | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small organ(specify)** | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | N | N | N | N | N | N | Note 2, 3 | |||
| Transvaginal | N | N | N | N | N | N | Note 2, 3 | |||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) *** | N | N | N | N | N | N | Note 2, 3 | |||
| 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 etc.
**Small organ-breast, thyroid, testes, etc.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
Asque M. Whag
of Reproductive, Abdominal ar Radiologica vices 510(k) Numb
0073
{7}------------------------------------------------
Mindray Co. Ltd.- DC-3/DC-3T Diagnostic Ultrasound System
Diagnostic Ultrasound Indications for Use Form
| System | Transducer | X |
|---|---|---|
| Model: | 7L4A, 7L6, 10L4 | |
| 510(k) Number(s) |
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other (specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify)* | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small organ(specify) ** | N | N | N | N | N | N | N | Note 2, 3 | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | Note 2, 3 | ||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | Note 2, 3 | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | Note 2, 3 | ||
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | Note 2, 3 | ||
| 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 etc. |
** Small organ-breast, thyroid, testes, etc.
Note I: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Smart3D
Note 3: iScape
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription USE (Per 21 CFR 801.109)
Torquato Weiz
ie Ahdor Divisio Radio 510(k) Nu
0074
§ 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.