(342 days)
Ultrasonic pulsed echo imaging, measurement, color Doppler, and color velocity imaging for Fetal, Abdominal, Pediatric, Small Organ, and Peripheral Vascular.
Apoqee 800 PLUS transmits ultrasound waves. receives the echoes, and generates images based on information contained in the echoes. The format in which the information is displayed depends on the imaging mode or modes that you select. The system is capable of real-time two-dimensional (2D) imaging, motion mode (M-mode) imaging, Doppler imaging, Power imaging, and color imaging. The system supports application and exam type presets, which means that the system is automatically optimized for the scanhead and application you have selected. Additionally, analysis protocols are made available so that you can store measurements in the patient's report. Physically the system consists of the monitor module, the control module, the main chassis, and transducers.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the SIUI Apogee 800 PLUS Ultrasound Imaging System, structured according to your request.
Please note: The provided document is a 510(k) Premarket Notification Summary from 1999. These types of documents are primarily concerned with demonstrating "substantial equivalence" to a predicate device, rather than providing detailed clinical study results and statistically derived acceptance criteria as might be expected for novel AI/ML-driven devices today. Therefore, much of the requested information (like specific sample sizes for test and training sets, expert qualifications, and adjudication methods for AI performance studies) is not present in this document. The "acceptance criteria" here are essentially the features and performance specifications of the device being compared directly to a predicate.
Acceptance Criteria and Device Performance for SIUI Apogee 800 PLUS Ultrasound Imaging System
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are effectively whether the new device's specifications and performance fall within a comparable range to the predicate device, demonstrating substantial equivalence. The document doesn't provide explicit statistical acceptance criteria for performance metrics in the way a clinical trial for a new diagnostic might. Instead, it presents a direct comparison of features and specifications.
| Feature/Criterion | Predicate Device (ATL Ultramark 9 / Interspec Apogee RX 400) | SIUI Apogee 800 PLUS (Reported Performance) | Acceptance (vs. Predicate) |
|---|---|---|---|
| Clinical Applications | |||
| Fetal | Yes | Yes | Met |
| Abdominal | Yes | Yes | Met |
| Pediatric | Yes | Yes | Met |
| Small Organ | Yes | Yes | Met |
| Peripheral Vascular | Yes | Yes | Met |
| Ophthalmic | Yes | No | Not Met (Different Scope) |
| Cardiac | Yes | No | Not Met (Different Scope) |
| Operation Modes | |||
| 2-D / B-mode | Yes | Yes | Met |
| M-mode | Yes | Yes | Met |
| PW Doppler (PWD) | Yes | Yes | Met |
| CW Doppler (CWD) | Yes | No | Not Met (Different Feature) |
| Color Flow (CFM/Color Doppler) | Yes | Yes | Met |
| HPRF | No | Yes | Exceeds Predicate |
| CPA | Yes | Yes | Met |
| Color M | Yes | Yes | Met |
| Display Formats | |||
| Full Screen 2D B-MODE | Yes | Yes | Met |
| Full Screen M-MODE | Yes | Yes | Met |
| Full Screen CFM | Yes | Yes | Met |
| Full Screen COLOR M-MODE | Yes | Yes | Met |
| Full Screen DOPPLER SPECTRUM | Yes | Yes | Met |
| Top/Bottom Split (various) | Yes | Yes | Met |
| Side by Side Split (various) | Yes | Yes | Met |
| General Formats (Freeze Frame, etc.) | Yes | Yes | Met |
| Other Specifications | |||
| Gray Scale | 256 (8 bits) | 256 (8 bits) | Met |
| Frame Rate (Max) | 156 FPS | 70 FPS | Not Met (Lower) |
| Beamformer | Digital | Analog | Not Met (Different Tech) |
| Signal post processing | Yes | Yes | Met |
| Image Modification | 8x, continuously variable | 24x, continuously variable | Exceeds Predicate |
| Preprogrammability | Yes | Yes | Met |
| Cineloop | Yes | Yes | Met |
| Imaging depth (max) | 25 cm | 24 cm | Met (Comparable) |
| Doppler measurable velocities (max) | 13.6 m/s (for CW) | 8 m/s (for PW) | Not Directly Comparable (Different Mode), but within acceptable range for PW. |
Study Details:
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document pre-dates modern AI/ML device evaluations. The "test set" in this context is the physical device and its performance against technical specifications and clinical uses, primarily through comparison to a predicate device. There is no mention of a separate "test set" of diagnostic images or patient data to evaluate algorithmic performance.
- Data Provenance: The manufacturer is Shantou Institute of Ultrasonic Instruments, China. The device and its specifications are presented by the manufacturer for FDA review.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No explicit "ground truth" establishment by experts for a test set of data is described. The comparison is based on the declared technical specifications and intended uses, which are implicitly validated by general medical consensus and the established performance of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for a test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This document does not describe an MRMC study, nor does the device involve AI assistance for human readers. It is a standalone ultrasound imaging system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in concept, but not as an "algorithm." The "standalone performance" is the performance of the ultrasound system itself, as described by its technical specifications and capabilities, independent of a specific human operator’s interpretive skill. This is the core of what the comparison tables are trying to establish – that the system on its own can perform the stated functions. However, it's not an "algorithm-only" performance study in the modern sense of AI/ML evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in terms of a study. The "ground truth" for this submission is an implicit one: the established performance and safety of the predicate devices (ATL Ultramark 9 HDI system, K903603 and Interspec Inc Apogee RX 400, K924231) and the general understanding of what constitutes a safe and effective ultrasound imaging system for the stated intended uses. The clinical applications and modes of operation are standard for these devices and are understood to provide diagnostically useful information.
8. The sample size for the training set:
- Not Applicable. This is not a submission for an AI/ML device that requires a training set of data. The device is hardware-based.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set is relevant for this type of device submission.
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NOV - 1 1999
Image /page/0/Picture/1 description: The image shows the letters "SIUI" in a bold, sans-serif font. The letters are black and appear to be printed on a white background. The letters are evenly spaced and aligned horizontally. The image is clear and easy to read.
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS 汕头超声仪器研究所
Premarket Notification [510(k)] Summarv
August 10, 1999 (revised)
Trade Name: SIUI Apoqee 800 PLUS Ultrasound Imaging System SIUI 5-2 C40 Transducer SIUI 11-5L40 Transduced
Common Name: Ultrasound Imaging System
Classification: This product is substantially equivalent to one or more of the products FDA has classified or has proposed classification, as Class II devices, including
Ultrasonic pulsed Doppler imaging system 21 CFR 892.1550 Ultrasonic pulsed echo imaging system 21 CFR 892.1560 Diagnostic ultrasonic transducer 21 CFR 892.1570
Manufacturer's Name: Shantou Institute of Ultrasonic Instruments Address: #2, Jinsha Road, M., Shantou Sez, 515041, China
Corresponding Official: Mr. Jinzhong Yao Title: President
Telephone: (86) 754-8250150 Fax: (86) 754-8251499
Establishment Registration Number: 9615439
Predicate: Advanced Technology Laboratories, Ultramark 9 HDI system, K903603 and Interspec Inc Apogee RX 400, K924231
Device Description: Apoqee 800 PLUS transmits ultrasound waves. receives the echoes, and generates images based on information contained in the echoes.
The format in which the information is displayed depends on the imaging mode or modes that you select. The system is capable of
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real-time two-dimensional (2D) imaging, motion mode (M-mode) imaging, Doppler imaging, Power imaging, and color imaging.
The system supports application and exam type presets, which means that the system is automatically optimized for the scanhead and application you have selected. Additionally, analysis protocols are made available so that you can store measurements in the patient's report.
Physically the system consists of the monitor module, the control module, the main chassis, and transducers.
Intended Use: Ultrasonic pulsed echo imaging, measurement, color Doppler, and color velocity imaging for Fetal, Abdominal, Pediatric, Small Organ, and Peripheral Vascular.
Technological Characteristics:_ See the attached four Comparison Tables for the SIUI Apoqee 800 PLUS and the ATL Ultramark 9.
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SIUI Apogee 800PLUS Ultrasound Imaging System
| DeviceType | Ophthalmic | Fetal | Abdominal | Pediatric | SmallOrgan | Cardiac | PeripheralVascular |
|---|---|---|---|---|---|---|---|
| ATLUltramark 9 | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| SIUIApogee800PLUS | No | Yes | Yes | Yes | Yes | No | Yes |
·1 Indications for Use
2 OPERATION MODES
| Device Type | 2-D | B | M | PW | CW | ColorFlow | HPRF | CPA | ColorM |
|---|---|---|---|---|---|---|---|---|---|
| ATLUltramark 9 | Yes | Yes | Yes | Yes | Yes | Yes | No | Yes | |
| SIUIApogee800PLUS | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
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SIUI Apogee 800PLUS Ultrasound Imaging System
3 DISPLAY FORMATS
| DISPLAY FORMATS | SIUIApogee 800PLUS | ATLUltramark 9 | |
|---|---|---|---|
| Full Screen | 2 D B-MODE | Yes | Yes |
| M-MODE | Yes | Yes | |
| CFM | Yes | Yes | |
| COLOR M-MODE | Yes | Yes | |
| DOPPLER SPECTRUM | Yes | Yes | |
| Top/BottomSplit Screen | 2D/DOPPLER SPECTRUM | Yes | Yes |
| 2D/M | Yes | Yes | |
| CFM/DOPPLER SPECTRUM | Yes | Yes | |
| CFM/M | Yes | Yes | |
| CFM/COLOR M | Yes | Yes | |
| Side by SideSplit Screen | 2D/2D | Yes | Yes |
| 2D/CFM | Yes | Yes | |
| CFM/CFM | Yes | Yes | |
| CFM/CPA | Yes | No | |
| 2D/2D ZOOM | Yes | Yes | |
| CFM/COLOR ZOOM | Yes | Yes | |
| GeneralFormats | Freeze Frame | Yes | Yes |
| Apex Invert | Yes | Yes | |
| Left/Right Reverse | Yes | Yes | |
| Video Invert for Doppler Spectrum | Yes | Yes | |
| Video Invert for M-Mode | Yes | Yes |
- CFM - COLOR FLOW IMAGING or COLOR DOPPLER
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SIUI Apogee 800PLUS Ultrasound Imaging System
Other Specifications 4
.
| ATL Ultramark 9 | SIUI Apogee 800PLUS | |
|---|---|---|
| Gray Scale | 256 (8bits) | 256 (8 bits) |
| Frame Rate (Max) | 156 FPS | 70 FPS |
| Beamformer | Digital | Analog |
| Signal post processing | Yes | Yes |
| Image Modification | 8x, continuously variable | 24x, continuously variable |
| Preprogrammability | Yes | Yes |
| Cineloop | Yes | Yes |
| Imaging depth (max) | 25 (cm) | 24 (cm) |
| Doppler measurablevelocities (max) | 13.6 m/s (for CW) | 8 m/s (for PW) |
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a bird or eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 1999
Shantou Institute of Ultrasonic Instruments c/o Robert Morton President ORS 1106 Chiltern Drive Walnut Creek, CA 94596
Re: K984203 SIUI Apogee 800PLUS Ultrasound Imaging System Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN Dated: Auqust 9, 1999 Received: August 17, 1999
Dear Mr. Morton:
We have reviewed your Section 510(k) 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 SIUI Apogee 800PLUS Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
Convex Array 5-2C40 Linear Array 11-5140
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Robert Morton
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" .
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
CAPT. Daniel C. Schultz, M.D.
CAPT. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Re: K984203
SIUI Apogee 800PLUS Ultrasound Imaging System
Indications for Use Form
Diagnostic Ultrasound System Indications for Use Form Device Name: SIUI Apogee 800 PLUS
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | ||||||||||
| Fetal | N | N | N | |||||||
| Abdominal | N | N | N | |||||||
| Intraoperative (specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | N | N | N | N | N | |||||
| Small Organ (specify) | N | N | N | N | N | |||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethrat | ||||||||||
| Intravascular | ||||||||||
| Perpheral Vascular | N | N | N | N | N | |||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalsuperficial | ||||||||||
| Other (specify) |
N=new indication
Additional Comments: Small organ includes: thyroid, parathyroid, submaxillary gland, testes and breast
Combined Modes: Fetal: B+M
| Abdominal: B+M |
|---|
| Pediatric: B + M, B + PWD, B + Color, B + Color + M, B + Color + PWD |
| Small Organ: B + M, B+PWD, B + Color, B +Color +M, B+ Color + PWD |
| Peripheral Vascular: B+M, B+ PWD, B+ color, B + Color + M, B + Color + PWD |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED |
Concurrence of CDRH, office of Device Evaluation (OBE)
4
510(k) Number
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyic
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Re: K984203
SIUI Apogee 800PLUS Ultrasound Imaging System
1. Scanhead Indications for Use Form Device Name: Convex Array 5-2 C 40
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | ||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | ||||||||
| Abdominal | N | N | N | ||||||||
| Intraoperative (specify) | |||||||||||
| IntraoperativeNeurological | |||||||||||
| Pediatric | N | N | N | ||||||||
| Small Organ (specify) | N | N | N | ||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethrat | |||||||||||
| Intravascular | |||||||||||
| Perpheral Vascular | N | N | N | ||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletalsuperficial | |||||||||||
| Other (specify) |
N=new indication
Additional Comments: Small organ includes: thyroid_parathyroid_submaxillary cland. Jestes and breast.
Combined Modes: Fetal: B+M. Abdominal: B+M.
Pediatric: B + M. Small Organ: B + M.
Peripheral Vascular: B+M.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF WEEDED
Concurrence of CDRH, office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Signature
2
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyic
510(k) Number K984203
{9}------------------------------------------------
Re: K984203
SIUI Apogee 800PLUS Ultrasound Imaging System
2. Scanhead Indications for Use Form Device Name: Linear Array 11-5 L 40
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | N | N | N | N | N | |||||
| Small Organ (specify) | N | N | N | N | N | |||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethrat | ||||||||||
| Intravascular | ||||||||||
| Perpheral Vascular | N | N | N | N | N | |||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalsuperficial | ||||||||||
| Other (specify) |
N=new indication
Additional Comments: Small organ includes: thyroid, parathyroid, submaxillary gland, testes and breast
Combined Modes: Pediatric: B + M. B + PWD. B + Color + M. B + Color + M. B + Color + PWD
Small Organ: B + M B+PWD. B + Color. B +Color +M. B + Color + PWD
Peripheral Vascular: B+M. B+ PWQ, B+ color, B+ Color + M. B + Color + PWD
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)
(ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices Ka 510(k) Number
3
§ 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.