(21 days)
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.
The SIUI Apogee 3800 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
This document is a 510(k) summary for the SIUI Apogee 3800 Digital Color Doppler Ultrasound Imaging System. It describes the device, its intended use, and its substantial equivalence to a predicate device (Apogee 3500, K102023).
The summary does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor does it provide details about reported device performance metrics.
The document primarily focuses on:
- Identification of the device and manufacturer.
- Identification of the predicate device.
- Description of the device's operating modes and capabilities.
- Stated intended uses and clinical applications (abdominal, pediatric, small organs, musculo-skeletal, cardiac, and peripheral vascular, in B, M, PWD, Color Doppler, and 3D modes).
- Safety considerations and compliance with relevant medical device safety standards (NEMA UD 2, UD 3, IEC 60601-1, ISO10993-5, ISO 10993-10).
- FDA's substantial equivalence determination letter.
- Detailed Indications for Use forms for the system and each associated transducer (C3L60C, L8L38C, C5L40C, P3F14C), specifying which clinical applications are "new indications" (denoted by "N") for various modes of operation.
Therefore, I cannot populate the requested table or answer most of the specific questions about the study design, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.
The closest information provided is the "Safety Considerations" section, which states: "The Apogee 3800 Digital Color Doppler Ultrasound Imaging System has been tested per the FDA Guidance document Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued in September 2008. The device conforms to applicable medical device safety standards. It has been designed to meet the following standards: NEMA UD 2, UD 3, IEC 60601-1, ISO10993-5 and ISO 10993-10." This indicates that the device underwent testing for safety and compliance with general performance standards for ultrasound systems, but it does not detail any specific performance acceptance criteria or the results of such testing related to diagnostic accuracy or effectiveness.
In summary, the provided text does not contain the requested information regarding acceptance criteria, device performance metrics, or details of a study assessing such performance.
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510(k) Summary
APR 1 5 2011
This summary of 510(k) safety and effectiveness information is provided in accordance
with the requirements of SMDA 1990 and 21 CFR 807.92(c).
The assigned 510(k) number is:
- 510(k) Owner:
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI)
77 Jinsha Road, Shantou, Guangdong 515041, China
Tel: 86-754-88250150 Fax: 86-754-88251499
Contact Person:
Flower Cai
Shantou Institute of Ultrasonic Instruments Co., Ltd.
77 Jinsha Road, Shantou, Guangdong 515041, China
Date Prepared: March 22, 2011
2. Device/Trade Name:
Apogee 3800 Digital Color Doppler Ultrasound Imaging System
Classification Name:
Regulatory Class: II
Ultrasonic Pulsed Doppler Imaging System IYN (per 21 CFR 892.1550) IYO (per 21 CFR 892.1560) Ultrasonic Pulsed Echo Imaging System ITX (per 21 CFR 892.1570) Diagnostic Uitrasound Transducer
510(k) Summary
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3. Legally Marketed (Unmodified) Device Predicate Device:
The subject device is modified based on and substantially equivalent to the device currently having FDA 510(k) clearance SIUI Apogee 3500 Digital Color Doppler Ultrasound Imaging System, K102023 with respect to intended use, principles of operation and technological characteristics.
4. Device Description:
The SIUI Apogee 3800 is a Digital Ultrasound Imaging System capable of the following operating modes: 2D (B mode), M, Doppler (PWD mode), Color (CFM mode) and 3D. The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array and 3D transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
5. Intended Use:
The device is intended for ultrasonic pulsed echo imaging and measurement for abdominal, pediatric, small organs, musculo-skeletal, cardiac and peripheral vascular applications.
6. Safety Considerations:
The Apogee 3800 Digital Color Doppler Ultrasound Imaging System has been tested per the FDA Guidance document Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issued in September 2008.
The device conforms to applicable medical device safety standards. It has been designed to meet the following standards: NEMA UD 2, UD 3, IEC 60601-1, ISO10993-5 and ISO 10993-10.
7. Conclusion:
The conclusions drawn from testing of the Apogee 3800 Digital Color Doppler Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate device.
510(k) Summary
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Ms. Flower Cai Assistant to Director Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) 77 Jinsha Road Shantou, Guangdong, 515041 CHINA
APR 1 5 2011
Re: K110841
Trade/Device Name: Apogee 3800 Digital Color Doppler Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: March 23, 2011 Received: March 25, 2011
Dear Ms. Cai:
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 Apogee 3800 Digital Color Doppler Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
Convex Array C3L60C Linear Array L8L38C Convex Array C5L40C Phased Array P3F14C
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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 895. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
If you have any questions regarding the content of this letter, please contact Shahram' Vaezy at (301) 796-6242.
Sincerely Yours.
Marcy Pastel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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Indications for Use
510(k) Number (if known):
Device Name:
Apogee 3800 Digital Color Doppler Ultrasound Imaging System with
Convex Array Transducer C3L60C
Linear Array Transducer L8L38C
Convex Array Transducer C5L40C
Phased Array Transducer P3F14C
Indications for Use:
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac,
peripheral vascular applications in B, M, PWD, Color Doppler and 3D imaging modes.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Stahl
(Division Sign Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K116841
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5.1 System Indications for Use Form
System: Apogee 3800
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | |||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | N | N | N | N | ||||
| Small Organ (Specify) | N | N | N | N | ||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | ||||
| Musculo-skeletal(Superficial) | N | N | N | N | ||||
| Intravascular | ||||||||
| Other (Specify) | N | N | N | N | N | |||
| Cardiac | Cardiac Adult | N | N | N | N | |||
| Cardiac Pediatric | N | N | N | N | ||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | |||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Other modes of operation include: 3-D Imaging;
Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary Small organs include: Thyroid, Testes, Breast
Prescription Use (Per 21 CFR 801.109) (CFR 801.109
Mary S. Patel
(Division Sign-Off)
Division of Radiological Device Office of In Vitro Diagnostic Device Evaluation and Safety
K110841
510K
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5.2 Transducer Indications for Use Form Transducer: Convex Array C3L60C
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| FetalImaging& Other | Fetal | N | N | N | N | |||
| Abdominal | N | N | N | N | ||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | N | N | N | N | ||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N= new indication: P = previously cleared by FDA; E = added under this appendix Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary
Prescription Use (Per 21 CFR 801.109)
Mary S Patel
Division Sign-Off Division of Radiological Davice Office of In Vitro Diagnostic Devi Evaluation and Safety
510K. K110841
Indications For Use
14
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SIUI Apogee 3800 Digital Color Doppler Ultrasound Imaging System
Diagnostic Ultrasound Indications for Use Form
5.3 Transducer Indications for Use Form Transducer: Linear Array L8L38C
| Clinical Application | Mode of Operation! | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | N | N | N | N | |||
| Small Organ (Specify) | N | N | N | N | ||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | ||||
| Musculo-skeletal(Superficial) | N | N | N | N | ||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | N | N | |||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix Additional Comments: Small organs include: Thyroid, Testes, Breast
Prescription Use (Per 21 CFR 801.109)
Mary S. Patel
on Sian-Division of Radiological Devices Office of In Vitro Diagnostic Device Ev tion and Safety
510K 110841
Indications For Use
:
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5.4 Transducer Indications for Use Form Transducer: Convex Array C5L40C
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | ||||||
| Abdominal | N | N | ||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | |||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | N | N | ||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix * Other modes include: 3-D Imaging:
Additional Comments: Other uses include: Prostate, Kidney, Uterus, Ovary
Prescription Use (Per 21 CFR 801.109)
Mary S Postel
(Division Sign-On)
Division of Radiology fice of in 510k
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5.5 Transducer Indications for Use Form Transducer: Phased Array P3F14C
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 Only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(Specify) | Other*(Specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| FetalImaging& Other | Pediatric | |||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal(Conventional) | ||||||||
| Musculo-skeletal(Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | N | N | N | N | ||||
| Cardiac | Cardiac Pediatric | N | N | N | N | |||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
Prescription Use (Per 21 CFR 801.109)
Mary Pastel
(Division Sign-Of Division of Radiological De Office of In Vitro Diagnostic Device Evalue
510K. 1810841
Indications For Use
Page 6 of 6
§ 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.