(91 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the description focuses on standard ultrasound imaging modes and features.
No
The device is described as an "Ultrasound Imaging System" intended for "ultrasound evaluation," indicating its purpose is for diagnostic imaging, not therapeutic intervention.
Yes
The device is described as an "Ultrasound evaluation" system and explicitly mentions "Diagnostic Ultrasound Systems" in the performance studies section, indicating its diagnostic purpose.
No
The device description clearly states it is a "Digital Ultrasound Imaging System" and supports various hardware components like transducers and scanning modes, indicating it is a physical device with integrated software, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "ultrasound evaluation" of various anatomical sites and applications. This describes a diagnostic imaging system used on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details an "Ultrasound Imaging System" with various imaging modes and capabilities. This aligns with a medical imaging device, not an IVD.
- Input Imaging Modality: The input modality is "Ultrasound," which is a non-invasive imaging technique applied externally or internally to the body. IVDs typically use modalities like spectroscopy, chromatography, or immunoassay on biological samples.
- Anatomical Site: The listed anatomical sites are parts of the human body being imaged, not biological samples.
- Performance Studies: The performance studies mentioned relate to acoustic output and safety standards for ultrasound equipment, not the analytical performance of a test on a sample.
IVD devices are designed to perform tests on biological samples (like blood, urine, tissue) to diagnose diseases or conditions. This device is a diagnostic imaging system that uses ultrasound waves to create images of internal structures.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Testes, Breast), Neonatal Cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adult and Pediatric), Peripheral Vascular, Trans-rectal, Obstetrics/ Gynecology and Urology applications.
Product codes
IYN, IYO, ITX
Device Description
The SIUI Apogee 5500/ Apogee 5300 /Apogee 5800 is a Digital Ultrasound Imaging System capable of the following operating modes: B-Mode(B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined(B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope), and other(3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG).The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
Apogee 5500 vs. Apogee 5300:
The cosmetic structure designs are the same, except for the color of some structures.
- A Apogee 5500: the colors of speaker enclosure, keyboard cover board and elevation front and rear covers are dark gray, dark gray and white respectively.
- A Apogee 5300: the colors of speaker enclosure, keyboard cover board and elevation front and rear covers are all light gray.
Apogee 5800 vs. Apogee 5500:
The cosmetic and structure designs are basically the same. Main differences:
- A Apogee 5800: The cosmetic colors are pearl gray and white, and the dimensions are bigger. The overall shape is more plump and stable.
- A Apogee 5500: more delicate and concise.
Comparison between: Apogee 5500, Apogee 5300 and Apogee 5800
- Overall dimensions: Subject to market positioning, the overall dimensions of Apogee 5500 and Apogee 5300 are smaller than Apogee 5800.
- Chassis: Subject to market positioning, the dimensions and structures of the chassis for Apogee 5500, Apogee 5300 and Apogee 5800 are different.
- Internal module structure: The internal modules are the same, and the main difference is in the expansion space. The Apogee 5800 has bigger size, enabling the placement of some accessories such as cables. Both the left and right sides of Apogee 5800 have the additional glove compartments.
- Transducer socket position: Apogee 5500 and Apogee 5300: on the right of the main unit, Apogee 5800: at the middle front of the main unit
- Touch screen and monitor: the same. They all use a 10.4-inch touch screen and a 19-inch monitor.
- Call situations of some functional buttons on the control panels are modified.
- Functional Configuration: Subject to market positioning, the Apogee 5500/ Apogee 5300/ Apogee 5800 have different functional configurations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Testes, Breast), Neonatal Cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adult and Pediatric), Peripheral Vascular, Trans-rectal, Obstetrics/ Gynecology, Urology, Prostate, Kidney, Uterus, Ovary.
Indicated Patient Age Range
Adult, Pediatric, Neonatal.
Intended User / Care Setting
Qualified physician.
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)
The conclusions drawn from testing of the Apogee 5500/ Apogee 5300 /Apogee 5800 Digital Color Doppler Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and professional, reflecting the department's role in public health and welfare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2016
Shantou Institute of Ultrasonic Instruments Co., Ltd (SIUI) % Ms. Flower Cai Liaison Manager 77 Jinsha Road Shantou, Guangdong 515041 CHINA
Re: K160853
Trade/Device Name: Apogee 5500 Digital Color Doppler Ultrasound Imaging System Apogee 5300 Digital Color Doppler Ultrasound Imaging System Apogee 5800 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, ITX Dated: March 29, 2016 Received: April 4, 2016
Dear Ms. Cai:
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 Ocks
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) K160853
Device Name
Apogee 5500 Digital Color Doppler Ultrasound Imaging System Apogee 5300 Digital Color Doppler Ultrasound Imaging System Apogee 5800 Digital Color Doppler Ultrasound Imaging System
Indications for Use (Describe)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Testes, Breast), Neonatal Cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adult and Pediatric), Peripheral Vascular, Trans-rectal, Obstetrics/ Gynecology and Urology applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subnart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
3.1 System Indications for Use Form
System: Apogee 5500/ Apogee 5300/ Apogee 5800
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | |||
| Abdominal | N | N | N | N | N | |||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | N | ||
| Small Organ (Specify) | N | N | N | N | N | |||
| Neonatal Cephalic | N | N | N | N | N | N | ||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | |||
| Trans-vaginal | N | N | N | N | N | |||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | N | N | N | N | N | |||
| Musculo-skeletal | ||||||||
| (Superficial) | N | N | N | N | N | |||
| Intravascular | ||||||||
| Other (Specify) | N | N | N | N | N | |||
| Cardiac Adult | N | N | N | N | N | N | ||
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | N | N | N | N | N | ||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Other modes of operation include: CPA, 3-D Imaging, 4-D Imaging, Elastography, XBeam, Panoscope, Trapezoidal /Extended Sector Imaging, Anatomical M-mode, ECG
Additional Comments: Other uses include: Gynecology, Prostate, Urology, Kidney, Uterus, Ovary Small organs include: Thyroid, Testes, Breast
4
3.2 Transducer Indications for Use Form
Transducer: Convex Array C3LC
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | |||
| Abdominal | N | N | N | N | N | |||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | Pediatric | |||||||
| Imaging | Small Organ (Specify) | |||||||
| & Other | 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 | N | |||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Other modes of operation include: CPA, 3-D Imaging, Elastography, XBeam, Panoscope, Trapezoidal / Extended Sector Imaging, Anatomical M-mode, ECG
Additional Comments: Other uses include: Gynecology, Urology, Prostate, Kidney, Uterus, Ovary
5
3.3 Transducer Indications for Use Form
Transducer: Linear Array L8LC
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | Pediatric | N | N | N | N | N | ||
| Imaging | Small Organ (Specify) | N | N | N | N | N | ||
| & Other | Neonatal Cephalic | |||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | N | N | N | N | N | |||
| (Conventional) | ||||||||
| Musculo-skeletal | N | N | N | N | N | |||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | N | N | N | N | N | |||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | N | N | N | N | N | ||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix * Other modes of operation include: CPA, 3-D Imaging, Elastography, XBeam, Panoscope, Trapezoidal / Extended Sector Imaging, Anatomical M-mode, ECG Additional Comments: Small organs include: Thyroid, Testes, Breast
6
3.4 Transducer Indications for Use Form
Transducer: Convex Array C5LF
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | |||
| Abdominal | N | N | N | N | N | |||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & 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 | N | N | N | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Other modes include: CPA, 3-D Imaging, 4-D Imaging, Elastography, XBeam, Panoscope, Trapezoidal /Extended Sector Imaging, Anatomical M-mode, ECG
Additional Comments: Other uses include: Gynecology, Urology, Prostate, Kidney, Uterus, Ovary
7
3.5 Transducer Indications for Use Form
Transducer: Phased Array P3FC
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | N | N | N | N | N | N | ||
| 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 | N | N | ||
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Other modes of operation include: CPA, Elastography, XBeam, Trapezoidal /Extended Sector Imaging Anatomical M-mode, TDI, ECG
8
3.6 Transducer Indications for Use Form
Transducer: Endocavity V6LC
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | |||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | |||
| Trans-vaginal | N | N | N | N | N | |||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | N | N | N | N | N | |||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Other modes of operation include: CPA, 3-D Imaging, Elastography, XBeam, Panoscope, Trapezoidal /Extended Sector Imaging, Anatomical M-mode, ECG
Additional Comments: Other uses include: Gynecology, Urology, Prostate, Kidney, Uterus, Ovary
9
3.7 Transducer Indications for Use Form
Transducer: Endocavity Biplane ECBP
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | |||
| Trans-vaginal | N | N | N | N | N | |||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | N | N | N | N | N | |||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Other modes of operation include: CPA, 3-D Imaging, Elastography, XBeam, Panoscope, Trapezoidal / Extended Sector Imaging, Anatomical M-mode, ECG
Additional Comments: Other uses include: Urology, Prostate, Kidney, Uterus, Ovary
10
3.8 Transducer Indications for Use Form
Transducer: Linear Array L10LC
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatric | N | N | N | N | |||
| Small Organ (Specify) | N | 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 | N | |||
| Musculo-skeletal | ||||||||
| (Superficial) | N | N | N | N | N | |||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | 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: CPA, 3-D Imaging, Elastography, XBeam, Panoscope, Trapezoidal
/Extended Sector Imaging, Anatomical M-mode, ECG
Small organs include: Thyroid, Testes, Breast
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3.9 Transducer Indications for Use Form
Transducer: Endocavity Linear U5LC
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | N | N | N | N | N | |||
| Trans-vaginal | N | N | N | N | N | |||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | N | N | N | N | N | |||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Other modes of operation include: CPA, 3-D Imaging, Elastography, XBeam, Panoscope, Trapezoidal /Extended Sector Imaging, Anatomical M-mode, ECG
Additional Comments: Other uses include: Gynecology, Urology, Prostate, Kidney, Uterus, Ovary
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3.10 Transducer Indications for Use Form
Transducer: Convex Array C6LC
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | N | N | N | N | N | |||
| Abdominal | N | N | N | N | N | |||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Pediatric | |||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | N | N | N | N | N | |||
| 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 | N | |||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | N | N | N | N | N | ||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Other modes of operation include: CPA, 3-D Imaging, Elastography, XBeam, Panoscope, Trapezoidal
/Extended Sector Imaging, Anatomical M-mode, ECG
Additional Comments: Other uses include: Gynecology, Urology, Prostate, Kidney, Uterus, Ovary
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510(k) Summary
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: K160853
1. 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 24, 2016
2. Device/Trade Name:
Apogee 5500 Digital Color Doppler Ultrasound Imaging System Apogee 5300 Digital Color Doppler Ultrasound Imaging System Apogee 5800 Digital Color Doppler Ultrasound Imaging System
Classification Name:
Regulatory Class: II
| Ultrasonic Pulsed Doppler Imaging System | 90-IYN (per 21 CFR 892.1550) |
|---|---|
| Ultrasonic Pulsed Echo Imaging System | 90-IYO (per 21 CFR 892.1560) |
| Diagnostic Ultrasound Transducer | 90-ITX (per 21 CFR 892.1570) |
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3. Intended Use
The Apogee 5500/ Apogee 5300 /Apogee 5800 Digital Color Doppler Ultrasound Imaging System is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Testes, Breast), Neonatal Cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adult and Pediatric), Peripheral Vascular, Trans-vaginal, Trans-rectal, Obstetrics/ Gynecology and Urology applications.
4. Device Description
The SIUI Apogee 5500/ Apogee 5300 /Apogee 5800 is a Digital Ultrasound Imaging System capable of the following operating modes: B-Mode(B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined(B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope), and other(3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG).The system is designed for use in linear, convex, phased array and 3D scanning modes and supports linear, convex, phased array, 3D and endocavity (trans-vaginal and trans-rectal) transducers. The system has cine review, image zoom, measurements and calculations, image storage and review, printing and recording capabilities.
Apogee 5500 vs. Apogee 5300:
The cosmetic structure designs are the same, except for the color of some structures.
- A Apogee 5500: the colors of speaker enclosure, keyboard cover board and elevation front and rear covers are dark gray, dark gray and white respectively.
- A Apogee 5300: the colors of speaker enclosure, keyboard cover board and elevation front and rear covers are all light gray.
Apogee 5800 vs. Apogee 5500:
The cosmetic and structure designs are basically the same. Main differences:
- A Apogee 5800: The cosmetic colors are pearl gray and white, and the dimensions are bigger. The overall shape is more plump and stable.
- A Apogee 5500: more delicate and concise.
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Image /page/15/Figure/1 description: The image shows two different models of ultrasound imaging systems, the Apogee 5500 and the Apogee 5300 Digital Color Doppler Ultrasound Imaging System. The image also shows a close up of the side of one of the machines, with the brand name SIUI visible. The image has annotations pointing out that the two machines have different colors.
Apogee 5800 Digital Color Doppler Ultrasound Imaging System
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Comparison between: Apogee 5500, Apogee 5300 and Apogee 5800
- Overall dimensions: Subject to market positioning, the overall dimensions of Apogee 5500 and Apogee 5300 are smaller than Apogee 5800.
- Chassis: Subject to market positioning, the dimensions and structures of the chassis for Apogee 5500, Apogee 5300 and Apogee 5800 are different.
- Internal module structure: The internal modules are the same, and the main difference is in the expansion space. The Apogee 5800 has bigger size, enabling the placement of some accessories such as cables. Both the left and right sides of Apogee 5800 have the additional glove compartments.
- Transducer socket position: Apogee 5500 and Apogee 5300: on the right of the main unit, Apogee 5800: at the middle front of the main unit
- Touch screen and monitor: the same. They all use a 10.4-inch touch screen and a 19-inch monitor.
- Call situations of some functional buttons on the control panels are modified.
- Functional Configuration: Subject to market positioning, the Apogee 5500/ Apogee 5300/ Apogee 5800 have different functional configurations. See the details in the table below.
| Functional
| Configuration | Apogee 5500 | Apogee 5300 | Apogee 5800 |
|---|---|---|---|
| B | √ | √ | √ |
| 2B | √ | √ | √ |
| 4B | √ | √ | √ |
| B/M | √ | √ | √ |
| M | √ | √ | √ |
| PW | √ | √ | √ |
| B+CFM | √ | √ | √ |
| B+CPA | √ | √ | √ |
| B+PW | √ | √ | √ |
| Triplex | |||
| (B+CFM+PW, | |||
| B+CPA+PW) | √ | √ | √ |
| Trapezoidal | |||
| /Extended Sector | |||
| Imaging | √ | √ | √ |
| XBeam | √ | √ | √ |
| Panoscope | √ | √ | √ |
| Anatomical | |||
| M-mode | √ | √ | √ |
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| CW | √ | √ | √ |
|---|---|---|---|
| 3D | √ | O | √ |
| 4D | √ | √ | √ |
| TDI | √ | O | √ |
| Elastography | O | O | O |
| MFI | √ | √ | √ |
| ECG | O | O | √ |
Notes: √ for standard configuration, and ○ for optional purchase.
5. Legally Marketed Predicate Devices and Substantial Equivalence
The Apogee 5500/ Apogee 5300 /Apogee 5800 Digital Color Doppler Ultrasound Imaging Systems are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to these predicate devices:
| Predicate
Device | Manufacturer | Model | 510(k)
Number |
|---------------------|--------------|----------------------------------------------------------------|------------------|
| 1 | SIUI | Apogee 3800 Digital Color Doppler
Ultrasound Imaging System | K110841 |
| 2 | SIEMENS | Acuson X700
Diagnostic Ultrasound System | K141846 |
5.1 Comparison of Indications for Use (IFU)
A IFU Statement
The subject device Apogee 5500/ Apogee 5300 /Apogee 5800 Digital Color Doppler Ultrasound Imaging System is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Testes, Breast), Neonatal Cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adult Pediatric), Peripheral Vascular, Trans-vaginal, Trans-rectal, and Obstetrics/ Gynecology and Urology applications.
The predicate device Apogee 3800 Digital Color Doppler Ultrasound Imaging System (K110841) is intended for 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 predicate device SIEMENS Acuson X700 and X600 ultrasound imaging system
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(K141846) "is intended for the following applications: Cardiac (Adult, Pediatric), Transesophageal (Cardiac), Intracardiac. Cerebrovascular, Peripheral Vessel, Abdominal, Renal, Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography: Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging.
The Acuson Acunav and Soundstar Ultrasound Catheter are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients. "
A Application
The Apogee 5500/ Apogee 5300 /Apogee 5800 and the predicate Apogee 3800 (K110841) have the same applications except for 5 additional applications in the subject device: Neonatal Cephalic, Trans-vaginal, Trans-rectal, Gynecology and Urology. All the applications of the subject device Apogee 5500/ Apogee 5300 /Apogee 5800 are included in the applications of predicate Acuson X700 (K141846).
A Display Mode
The Apogee 5500/ Apogee 5300 /Apogee 5800 and the predicate Apogee 3800 (K110841) have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same basic operating modes. All systems
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transmit ultrasonic energy into patients, perform post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body.
Based on the same principle, the front-end transmit circuit controls are similar. After various post-processing for the acquired information data, the subject device Apogee 5500/ Apogee 5300 /Apogee 5800 has new imaging modes (XBeam, Panoscope, 4D, Trapezoidal / Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI), as well as the addition of ECG application circuit and function. The new imaging modes, which are similar to the predicate Acuson X700 (K141846), were tested and proved no impact on device safety and effectiveness.
A Measurement and reporting
The Apogee 5500/ Apogee 5300 /Apogee 5800 and the predicate Apogee 3800 (K110841) have the same measurement functions, measurement packages and reporting functions.
5.2 Comparison with the predicate device SIUI Apogee 3800 (K110841)
The Apogee 5500, Apogee 5300 and Apogee 5800 mainly have cosmetic changes based on SIUI Apogee 3800 (K110841), with additional new features and new configurable transducers.
-
- In cosmetic design, the Apogee 5800 is close to the Apogee 3800, except for changes in some structure of the upper part of the machine and some adjustment on the control panel. Both Apogee 5500 and Apogee 5300 have slimmer cosmetic design to adapt to clinical application in smaller space, and the probe sockets are changed from the middle front to the right of the main unit, the locations of I/O panel, keyboard are changed accordingly, but the corresponding interfaces and circuit principle are not changed.
- In new features, the Apogee 5500/ Apogee 5300/ Apogee 5800 have additional CWD, 2) 3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI and ECG (identical to Acuson X700 K141846).
- In probe configuration, the Apogee 5500/ Apogee 5300/ Apogee 5800 have additional 3) V6LC, ECBP, L10LC, C6LC, U5LC transducers (identical to Acuson X700 K141846),
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and the range of application includes 5 additional exams Neonatal Cephalic, Trans-vaginal and Trans-rectal. Gynecology and Urology (identical to Acuson X700 K141846).
The SIUI Apogee 5500/ Apogee 5300/ Apogee 5800 are similar in technological characteristics to the SIUI Apogee 3800.
5.3 Comparison with the predicate device SIEMENS Acuson X700 (K141846)
For the technical specifications and transducers on the SIUI Apogee 5500/ Apogee 5300/ Apogee 5800, the claim of substantial equivalence to devices currently having FDA 510(k) clearance is Siemens Acuson X700 (K141846).
The SIUI Apogee 5500/ Apogee 5300/ Apogee 5800 is similar in technological characteristics to the Siemens Acuson X700.
- A The SIUI Apogee 5500/ Apogee 5300/ Apogee 5800 and the Siemens Acuson X700 have similar imaging modes.
- A The SIUI Apogee 5500/ Apogee 5300/ Apogee 5800 and the Siemens Acuson X700 have similar diagnostic ultrasound applications
- A The transducers of SIUI Apogee 5500/ Apogee 5300/ Apogee 5800 and the Siemens Acuson X700 have similar technical parameters and hardware implementation principle.
- A The SIUI Apogee 5500/ Apogee 5300/ Apogee 5800 have similar diagnostic ultrasound applications as Siemens Acuson X700.
6. Safety Considerations
The Apogee 5500/ Apogee 5300 /Apogee 5800 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 acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004. The device conforms to applicable medical device safety standards, such as IEC 60601-1, ISO10993-5 and ISO 10993-10.
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7. Conclusion
The conclusions drawn from testing of the Apogee 5500/ Apogee 5300 /Apogee 5800 Digital Color Doppler Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate devices.