(196 days)
No
The document describes standard ultrasound imaging modes and features, and explicitly states that mentions of AI, DNN, or ML were "Not Found".
No
This device is an ultrasound imaging system used for diagnostic purposes, such as evaluating anatomical structures, and is not described as performing any therapeutic (treating or curing) function.
Yes
The Intended Use/Indications for Use section explicitly states that "The system is intended to be used by a trained qualified physician in a hospital or clinical setting for ultrasound evaluation of fetal, abdominal, pediatric, small organ... cardiac... etc. applications." Evaluation is a key component of diagnosis.
No
The device description explicitly states it is a "Digital Color Ultrasound Imaging System" and mentions supporting various transducers (linear, convex, phased array, endocavity), which are hardware components. While it mentions "Ultrasound Software," the overall system is clearly a hardware-based ultrasound machine with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this is a "Digital Color Ultrasound Imaging System." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use: The intended use describes the various anatomical sites and applications for ultrasound evaluation, all of which are performed directly on the patient's body.
Therefore, the SIUI Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Ultrasound Imaging System is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The system is intended to be used by a trained qualified physician in a hospital or clinical setting 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 in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, CWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D/4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).
Product codes
IYN, IYO, ITX
Device Description
The SIUI Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Ultrasound Imaging System capable of the following operating modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, DPA, PWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D/4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).
The system is designed for use in linear, convex, phased array scanning modes and supports linear, convex, phased array 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.
This system is a Track 3 device and the software used in Apogee 6500 / Apogee 6300/Apogee 6200 Digital Color Ultrasound Imaging System is Ultrasound Software by SIUI and is based on the predicate device. The Level of Concern for the Ultrasound Software is Moderate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
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 and urology.
Indicated Patient Age Range
Adult, pediatric, neonatal, fetal
Intended User / Care Setting
trained qualified physician in a hospital or clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed. Clinical testing was not necessary. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) % Flower Cai Liaison Manager 77 Jinsha Road Shantou. Guangdong 515041 CHINA
Re: K210318
Trade/Device Name: Apogee 6500, Apogee 6300, Apogee 6200 Digital Color Doppler Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 8, 2021 Received: July 12, 2021
August 18, 2021
Dear Flower 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210318
Device Name
Apogee 6500 Digital Color Doppler Ultrasound Imaging System Apogee 6300 Digital Color Doppler Ultrasound Imaging System Apogee 6200 Digital Color Doppler Ultrasound Imaging System
Indications for Use (Describe)
The system is intended to be used by a trained qualified physician in a hospital or clinical setting 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 in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, CWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D/4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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: _ K210318
5.1 Submitter
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: July 29, 2021
5.2 Device
Name of Device:
Apogee 6500 Digital Color Doppler Ultrasound Imaging System Apogee 6300 Digital Color Doppler Ultrasound Imaging System Apogee 6200 Digital Color Doppler Ultrasound Imaging System 510(k) submitter: SIUI
Classification Name:
| 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 ultrasonic transducer | 90-ITX (per 21 CFR 892.1570) |
TAB 2 Section 5
4
Regulatory Class: II
Product Code: IYN, IYO, ITX
5.3 Predicate Device
Name of Predicate Device:
Apogee 5500 Digital Color Doppler Ultrasound Imaging System (K160853)
510(k) holder: SIUI
Regulatory Class: II
Product Code: IYN, IYO, ITX
Classification Name:
| 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 ultrasonic transducer | 90-ITX | (per 21 CFR 892.1570) |
5.4 Device Description
5.4.1 Description
The SIUI Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Ultrasound Imaging System capable of the following operating modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, DPA, PWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D/4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).
The system is designed for use in linear, convex, phased array scanning modes and supports linear, convex, phased array 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.
This system is a Track 3 device and the software used in Apogee 6500 / Apogee 6300/Apogee 6200 Digital Color Ultrasound Imaging System is Ultrasound Software
5
by SIUI and is based on the predicate device. The Level of Concern for the Ultrasound Software is Moderate.
5.4.2 Comparisons of Apogee 6500/Apogee 6300/Apogee 6200 devices
The Apogee 6500/ Apogee 6300/ Apogee 6200 use the same safe critical components, with the same circuit modules and working principles. The mechanical structure is designed for the market requirements of the devices according to the requirements of international general safety standard (IEC 60601-1). The hardware design is exactly the same for Apogee 6500/ Apogee 6300/ Apogee 6200. Subject to market positioning, the Apogee 6500/ Apogee 6300/Apogee 6200 have different software functional configurations. See the table below.
| Product Model | Apogee 6500 | Apogee 6300 | Apogee 6200 |
|---|---|---|---|
| Photo | |||
| Functional | |||
| configuration | XBeam | ||
| ✓ | XBeam | ||
| ◯ | XBeam | ||
| ✓ | |||
| Panoscope | |||
| ✓ | Panoscope | ||
| ✓ | Panoscope | ||
| ◯ |
Note: "y" means "standard configuration", "o" means "option configuration".
5.5 Indications for Use
The system is intended to be used by a trained/qualified physician in a hospital or clinical setting 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 in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, DPA, PWD, CWD, Combined (B, M, CFM, CPA, DPA, PWD, CWD, XBeam, Panoscope), and others (3D/4D, Trapezoidal /Extended Sector
TAB 2 Section 5
6
Imaging, Elastography, Anatomical M-mode, TDI, THI, MFI, ECG, VS Flow, Color M, DICOM).
Comparison of Technological Characteristics with the Predicate Device 5.6
The Apogee 6500/Apogee 6300/Apogee 6200 Digital Color Doppler Ultrasound Imaging Systems are multi-purpose diagnostic ultrasound systems with accessories and proprietary software, and are substantially equivalent to the predicate device.
| Type | Manufacturer | Device | 510 (K) Number |
|---|---|---|---|
| Predicate device | SIUI | Apogee 5500 Digital Color | |
| Doppler Ultrasound | |||
| Imaging System | K160853 |
For the intended use and technical specifications on the SIUI Apogee 6500/Apogee 6300/Apogee 6200, the claim of substantial equivalence to devices currently having FDA 510(k) clearance is SIUI Apogee 5500 Digital Color Doppler Ultrasound Imaging System (K160853).
For the transducers on the SIUI Apogee 6500/Apogee 6300/Apogee 6200, the claim of substantial equivalence to devices currently having FDA 510(k) clearance are SIUI Apogee 5500 Digital Color Doppler Ultrasound Imaging System (K160853).
Intended Use Comparison:
Compared with the predicate device Apogee 5500 (K160853), the Subject Devices have the same intended use.
Technical Characteristics Comparison:
The basic and key technical features of the subject Device are the same as the predicate device Apogee 5500 (K160853), including Operation Principle, Operation Controls, System Setup, Operation Modes, Measurement, Calculation and Report item Cine and File Management.
Acoustic power levels Comparison:
The Acoustic power levels of subject devices meet the limits of FDA same as the predicate device Apogee 5500 (K160853)
Materials of probes Comparison:
The materials of probes with subject device are same as the predicate device of Apogee 5500 (K160853).
Probes Comparison:
Apogee 6500/Apogee 6300/Apogee 6200 has similar probes as the predicated device
TAB 2 Section 5
7
of Apogee 5500. The proposed Apogee 6500/Apogee 6300/Apogee 6200 adds two new transducers P5FC and V6LF to the system. Applications for these probes are within the indications for use of the predicate system Apogee 5500 (K160853). The application range and probe type of the P5FC probe is the same as that of the P3FC probe for the predicate device Apogee 5500 (K160853). The application range of the V6LF probe is the same as that of the V6LC probe for the predicate device Apogee 5500 (K160853).
Any differences between the predicate and the new device have no impact on safety or efficacy of the new device and do not raise any new potential or increased safety risks, and the new device is equivalent in performance to existing legally marketed devices.
5.7 Non-clinical Testing Summary
The Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Doppler Ultrasound Imaging System comply with and/or were tested in accordance with the following FDA guidance and International Standards:
- . IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC60601-1-2:2014 Medical electrical equipment requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
- . 60601-2-37:2007+A1:2015 | Medical | electrical | equipment | - | Part IEC 2-37:Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
- . IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- . ISO 14971:2019 Medical devices - Application of risk management to medical devices
- ISO 10993-1:2018 Biological evaluation of medical devices Part1: Evaluation ● and testing within a risk management process
- . ISO 10993-5:2009 Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10:Tests for .
8
irritation and skin sensitization
- IEC 62304:2006+A1:2015 Medical device software - Software life cycle processes
- IEC 60601-1-6:2010+A1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366-1:2015/COR1:2016 Medical devices – Part 1: Application of usability engineering to medical devices
- ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
- . ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- . Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
The subject device and the predicate device are comparable in terms of technical features, general functions, applications and intended uses. The test results showed compliance with the above standards. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate.
5.8 Clinical Testing
Clinical testing is not necessary for the Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Doppler Ultrasound Imaging System in order to demonstrate substantial equivalence to the predicate device.
5.9 Conclusion
The subject device Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Doppler Ultrasound Imaging System and the predicate device SIUI Apogee 5500 Digital Color Doppler Ultrasound Imaging System are comparable in terms of technical features, general functions, applications and indications for use.
Therefore, SIUI Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Doppler Ultrasound Imaging System is substantially equivalent with respect to safety and effectiveness of the predicate device currently cleared for market.
9
Appendix
| Acronym | Full Name |
|---|---|
| CFM | Color Flow Map |
| CPA | Color Power Angio |
| DPA | Directional Power Angio |
| PWD | Pulsed Wave Doppler |
| CWD | Continuous Wave Doppler |
| THI | Tissue Harmonic Imaging |
| TDI | Tissue Doppler Imaging |
| MFI | Macro fidelity Imaging |
| VS Flow | Vector Space Flow |
1. Acronyms and full names of imaging modes
2. Equivalent Names of Subject Device
| Equivalent
Names of
Subject
Device | Apogee 6500 Digital Color Doppler Ultrasound Imaging System
Apogee 6300 Digital Color Doppler Ultrasound Imaging System
Apogee 6200 Digital Color Doppler Ultrasound Imaging System |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Apogee 6500/ Apogee 6300/ Apogee 6200 Digital Color Ultrasound
Imaging System |
| | Apogee 6500/ Apogee 6300/ Apogee 6200 |
| | Apogee 6500 series |