(16 days)
The device is intended for use by a qualified physician for ultrasound evaluation of adult abdomen, adult cardiology, pediatric abdomen, pediatric cardiology, fetal cardiology, gynecology, obstetrics (first trimester, second and third trimester), kidney, prostate, thyroid, breast, and other small parts, and peripheral vascular (peripheral artery and peripheral vein), and carotid scanning.
The DC-6 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound mages in B-Mode, M-Mode, Color mode, PW mode, Power/DirPower mode 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 and convex linear array with a frequency range of approximately 2.5 MHz to 12 MHz.
The provided text is a 510(k) summary for the DC-6 Diagnostic Ultrasound System. This document does not describe acceptance criteria for specific performance metrics of the device or a study designed to prove the device meets such criteria in terms of diagnostic accuracy or effectiveness.
Instead, the document focuses on:
- Substantial Equivalence: It asserts that the DC-6 Diagnostic Ultrasound System is "substantially equivalent" to several legally marketed predicate devices. This is the primary regulatory pathway for this type of device, meaning it doesn't need to prove entirely new safety and effectiveness but rather equivalence to existing cleared devices.
- Safety Considerations: It states that the device has been tested as a "Track 3 Device" per FDA guidance, acoustic output has been measured and calculated per NEMA UD standards, and the device conforms to applicable medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1). These are safety criteria and standards for the device itself, not performance metrics related to diagnostic accuracy.
- Intended Use and Modes of Operation: The attached forms (pages 5-9) specify the clinical applications and modes of operation (B, M, PWD, Color Doppler, etc.) for which the system and its transducers are intended. This defines the scope of its use, but not specific performance targets (e.g., sensitivity, specificity for a particular condition).
Therefore, based on the provided text, I cannot extract the requested information about acceptance criteria for device performance (e.g., diagnostic accuracy) and a study proving the device meets those criteria because such details are not present.
The document implies that the device's safety and effectiveness are established through adherence to standards and comparison to predicate devices, rather than a specific clinical performance study with predefined acceptance criteria for diagnostic output.
{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:
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
October 16, 2006 Date Prepared:
- Device Name: DC-6 Diagnostic Ultrasound System
Classification
Regulatory Class: Il
Review Category: Tier II
21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-FYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)
3. Marketed Device:
DC-6 Diagnostic Ultrasound System is substantially equivalent to the following devices: Toshiba NEMIO SSA-550A (K#010631) and FAMIO SSA-530A (K#051500), Aloka SSD-5000 (K#012080), Philips iU22 (K#042540), Siemens SONOLINE G60 S (K#052894) and Sequoia 512 (K#052410), Mindray DP-9900 (#K061189).
0042
{1}------------------------------------------------
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4. Device Description:
The DC-6 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound mages in B-Mode, M-Mode, Color mode, PW mode, Power/DirPower mode 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 and convex linear array with a frequency range of approximately 2.5 MHz to 12 MHz.
5. Intended Use:
The device is intended for use by a qualified physician for ultrasound evaluation of adult abdomen, adult cardiology, pediatric abdomen, pediatric cardiology, fetal cardiology, gynecology, obstetrics (first trimester, second and third trimester), kidney, prostate, thyroid, breast, and other small parts, and peripheral vascular (peripheral artery and peripheral vein), and carotid scanning.
6. Safety Considerations:
The DC-6 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 IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37 and ISO 10993-1.
Conclusion:
The conclusions drawn from testing of the DC-6 Diagnostic Ultrasound System demonstrate that the device is as safe and effective as the legally marketed predicate devices.
0043
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, all facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2006
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Robert Mosenkis President Citech 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298
Re: K063500
Trade Name: DC-6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 17, 2006 Received: November 20, 2006
Dear Mr. Mosenkis:
This letter corrects our substantially equivalent letter of December 6, 2006.
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.
{3}------------------------------------------------
Page 2 - Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
3C1
This determination of substantial equivalence applies to the following transducers intended for I mis determination of backs of our as described in your premarket notification:
Transducer Model Number
6CV1
7L4
૩૮૨
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 it may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA oun or louits in ther announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advisou mail i Driv issum that your device complies with other requirements of the Act that I Dri has made a dollations 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 CITY art 607), adoning (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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 This letter will anow you to orgin manunting of your device to a legally marketed nonication. The I Driving of casting 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 IT you desire specific at 12-12-12-12-120. Also, please note the regulation entitled, Contact the Office of Confightalso as (2 + notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response 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
{4}------------------------------------------------
Page 3 - Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
If you have any questions regarding the content of this letter, please contact Ralph Shuping at (240) 276-3666.
Sincerely yours,
David h. hyman
f
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{5}------------------------------------------------
3500
× System
Transducer
Model:
DC-6
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 | N | ||||
| Abdominal | N | N | N | N | N | N | N | ||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | N | N | N | N | N | N | N | ||||
| Small organ(specify) | N | N | N | N | N | N | |||||
| Neonatal Cephalic | N | N | N | N | N | N | |||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | N | N | N | N | ||||
| Transesophageal | |||||||||||
| Transrectal | N | N | N | N | N | N | |||||
| Transvaginal | N | N | N | N | N | N | |||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | |||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N | |||||
| Musculo-skeletal Superficial | N | N | N | N | N | N | |||||
| Other (specify) | |||||||||||
| N=new indication; P=previously cleared by FDA; E=added under Appendix E |
A dditional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B,
Power + PW +B.
*Other: Tissue Harmonic Imaging. The feature does not use contrast agents.
**Small organ-breast, thyroid, testes, etc.
(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)
(Division Sign-Off)
0047
Division of Reproductive, Abdor and Radiological Devices 510(k) Number
{6}------------------------------------------------
| System | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|---|---|---|
| Model: | 3CS |
× Transducer
510(k) Number(s)
| 4 |
|---|
| 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 | N | ||||
| Abdominal | N | N | N | N | N | N | N | ||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small organ(specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
Additional comments: Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B,
Power + PW +B.
*Other: Tissue Harmonic Imaging. The feature does not use contrast agents.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number _
Concurrence of CDRH, Office of Device Evaluation(ODE)
David h. Slayton
(Division Sign-Off)
Division of Reproductive, Abdominal, Prescription USE (Per 21 CFR 801.109) and Radiological Devices
{7}------------------------------------------------
System
Transducer ×
3CI Model:
510(k) Number(s)
D6 5500
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | N | |||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | N | |||
| Small organ(specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | N | N | N | N | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| 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.
*Other: Tissue Harmonic Imaging. The feature does not use contrast agents.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
David le. Leggans. 0043
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number
Prescription USE (Per 21 CFR 801.109)
{8}------------------------------------------------
| System | |
|---|---|
| Transducer | X |
| Model: | 6CV1 |
| 510(k) Number(s) | K063500 |
| 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) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | N | N | N | N. | N | N | |||||
| Transvaginal | N | N | N | N | N | N | |||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
Additional comments: Combined modes: B+M, PW+B, Color +B, Power + B, PW +Color+ B,
Power + PW +B.
(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)
(Division Sign-Off) 4
Division of Reproductive, Abdominal,.
and Radiological Devices
510(k) Number K063500
0050
{9}------------------------------------------------
System Model:
Transducer
7L4
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 | |||||
| Neonatal Cephalic | N | N | N | N | N | N | |||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | |||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | N | N | N | N | N | N | |||||
| Musculo-skeletal Superficial | N | N | N | N | N | 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+ B,
Power + PW +B.
** Small organ-breast, thyroid, testes, etc.
(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)
0051
(Division Sign-Off)
Division of Reproductive, Abdominal,..
and Radiological Devices
510(k) Number K063500
§ 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.