(71 days)
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculoskeletal, cardiac, peripheral vascular, transvaginal and trans-rectal applications in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope, and others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG , VS Flow, Color M and DICOM).
The SIUI Apogee 2100/ Apogee 2300 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), others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG, VS Flow, Color M, DICOM). 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.
Here's a breakdown of the acceptance criteria and study information, based on the provided text, with a crucial caveat: The document describes a 510(k) submission for an ultrasound imaging system, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria through the types of studies you've listed (e.g., MRMC, standalone AI performance).
Therefore, many of your requested points about clinical studies, ground truth establishment, sample sizes for training/test sets, expert qualifications, and adjudication methods are not present in this type of regulatory document because they are not typically required for a 510(k) clearance of an ultrasound imaging system. The information provided heavily emphasizes hardware and software feature equivalence and safety standards.
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, accuracy, or reader agreement. Instead, the acceptance criteria for this 510(k) submission are implied through demonstrating substantial equivalence to predicate devices in terms of:
- Indications for Use: The new device's intended clinical applications must be substantially equivalent to or within the scope of the predicate devices.
- Technological Characteristics: The new device's core technology, operating modes, and transducers must be substantially equivalent.
- Safety and Effectiveness: Compliance with recognized medical device safety standards and acoustic output limits substituted for direct clinical evidence of safety and effectiveness for a new device.
Table of Acceptance Criteria and Reported Device Performance (as implied by the 510(k) process):
| Acceptance Criterion (Implied for 510(k) Clearance) | Reported Device Performance (Summary from Document) |
|---|---|
| 1. Indications for Use Equivalence | - Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculoskeletal, cardiac, peripheral vascular, transvaginal and trans-rectal applications. - Operating Modes: B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope), others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG, VS Flow, Color M, DICOM). - Comparison to Predicate: "All the Indications for Use of the Apogee 2100/ Apogee 2300 are included in the indications for use of predicate SIUI Apogee 1200." and "The Apogee 2100/ Apogee 2300 have three more imaging functions than the predicate SIUI Apogee 5500, namely VS Flow, Color M and DICOM." Additional new configurable transducers (L10LN, C6LN, U5LN) and 5 additional exams (Neonatal Cephalic, Trans-vaginal and Trans-rectal, Gynecology and Urology) are identical to Apogee 5500. |
| 2. Technological Characteristics Equivalence | - Apogee 2100/2300 vs. Apogee 1200: "mainly have cosmetic changes," "same in their working principle and internal modules," "use the same PC module, digital signal processing module, and ultrasound front-end module." Control panel and display adjusted for ergonomics. - Apogee 2100/2300 vs. Apogee 5500: "similar imaging modes," "similar diagnostic ultrasound applications," "similar technical parameters and hardware implementation principle" for transducers. |
| 3. Safety (Acoustic Output & General Safety Standards Compliance) | - Tested per FDA Guidance (Sept 2008) for Diagnostic Ultrasound Systems and Transducers. - Acoustic output measured and calculated per NEMA UD 2:2004. - Conforms to IEC 60601-1, ISO10993-5, ISO 10993-10, and IEC 60601-1-2. |
Study Information (Based on the 510(k) document):
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable/not provided. This document describes a 510(k) submission based on technical and performance equivalence and safety standards, not a clinical study with a specific test set of patient data with ground truth.
- Data Provenance: Not applicable/not provided for a clinical test set. The submission relies on engineering tests, compliance with standards, and comparison to existing cleared devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment by clinical experts is described for a test set of patient data.
-
Adjudication method for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
-
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. An MRMC study was not done, as this is an ultrasound imaging system regulatory submission, not an AI diagnostic algorithm for which such studies are commonly required. The device itself is the imaging system, not an AI feature providing interpretive assistance.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm. Its performance is inherent to its imaging capabilities, which are assessed against technical specifications and predicate device equivalence.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical ground truth. The "ground truth" in this context is adherence to engineering specifications, safety standards, and functional equivalence to predicate devices, verified through technical testing.
-
The sample size for the training set:
- Not applicable. There is no mention of an algorithm being trained on a dataset.
-
How the ground truth for the training set was established:
- Not applicable. No training set is mentioned.
In summary: The provided document is a 510(k) premarket notification for an ultrasound imaging system. The "study" referenced is largely a technical and engineering comparison study to predicate devices and a compliance assessment against recognized safety and performance standards. It does not involve a clinical study with patients, expert readers, or AI performance metrics as would be seen for a diagnostic AI device submission.
{0}------------------------------------------------
Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) % Ms. Flower Cai Liaison Manager 77 Jinsha Road Shantou, Guangdong 515041 CHINA
December 7, 2017
Re: K173000
Trade/Device Name: Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 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: September 28, 2017 Received: October 2, 2017
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
{1}------------------------------------------------
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
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) K173000
Device Name
Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
Indications for Use (Describe)
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculoskeletal, cardiac, peripheral vascular, transvaginal and trans-rectal applications in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope, and others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG , VS Flow, Color M and 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}------------------------------------------------
3.1 System Indications for Use Form
System: Apogee 2100/ Apogee 2300
| 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 | N | N | N | |||
| Abdominal | N | N | N | N | N | |||
| 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 | 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 | 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, 4-D Imaging, Elastography, XBeam, Panoscope, Trapezoidal /Extended Sector Imaging, Anatomical M-mode, ECG, VS Flow, Color M,DICOM 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 C3LN
| 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 | N | N | N | |||
| Abdominal | N | N | N | 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 | N | 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 of operation include: CPA, 3-D Imaging, XBeam, Panoscope, Trapezoidal / Extended Sector Imaging, Anatomical M-mode, ECG,VS Flow, Color M,DICOM
Additional Comments: Other uses include: Gynecology, Urology, Prostate, Kidney, Uterus, Ovary
{5}------------------------------------------------
3.3 Transducer Indications for Use Form
Transducer: Linear Array L8LN
| 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 | 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) | N | N | N | N | N | |||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| PeripheralVessel | 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, Elastography, XBeam, Panoscope, Trapezoidal / Extended Sector Imaging, Anatomical M-mode, ECG,VS Flow, Color M,DICOM Additional Comments: Small organs include: Thyroid, Testes, Breast
{6}------------------------------------------------
3.4 Transducer Indications for Use Form
Transducer: Convex Array C5LN
| 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 | N | N | N | |||
| Abdominal | N | N | N | N | N | |||
| FetalImaging& Other | 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 | 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: CPA, 4-D Imaging, XBeam, Panoscope, Trapezoidal /Extended Sector Imaging, Anatomical M-mode, ECG,DICOM
Additional Comments: Other uses include: Gynecology, Urology, Prostate, Kidney, Uterus, Ovary
{7}------------------------------------------------
3.5 Transducer Indications for Use Form
Transducer: Phased Array P3FN
| 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 | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| 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 | Cardiac Adult | N | N | N | N | N | N | |
| Cardiac Pediatric | N | N | 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
- Other modes of operation include: CPA, Trapezoidal /Extended Sector Imaging Anatomical M-mode, TDI, ECG,VS Flow, Color M,DICOM
{8}------------------------------------------------
3.6 Transducer Indications for Use Form
Transducer: Endocavity V6LN
| 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 | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| 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 | 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, XBeam, Panoscope, Trapezoidal /Extended Sector
Imaging, Anatomical M-mode, ECG,VS Flow, Color M,DICOM
Additional Comments: Other uses include: Gynecology, Urology, Uterus, Ovary
{9}------------------------------------------------
3.7 Transducer Indications for Use Form
Transducer: Endocavity Biplane ECBN
| 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 | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| 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 | 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
- Other modes of operation include: CPA, 3-D Imaging, XBeam, Panoscope, Trapezoidal / Extended Sector
Imaging, Anatomical M-mode, ECG,VS Flow, Color M,DICOM
Additional Comments: Other uses include: Gynecology, Uterus, Ovary
{10}------------------------------------------------
3.8 Transducer Indications for Use Form
Transducer: Linear Array L10LN
| 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 | ||||||||
| Fetal | Pediatric | 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(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 | Peripheral vessel | 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, VS Flow, Color M,DICOM
Small organs include: Thyroid, Testes, Breast
{11}------------------------------------------------
3.9 Transducer Indications for Use Form
Transducer: Endocavity Linear U5LN
| 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 | N | N | N | N | N | |||
| 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) | ||||||||
| PeripheralVessel | 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, XBeam, Panoscope, Trapezoidal /Extended Sector Imaging, Anatomical M-mode, ECG,VS Flow, Color M,DICOM
Additional Comments: Other uses include: Urology,
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3.10 Transducer Indications for Use Form
Transducer: Convex Array C6LN
| 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 | N | N | N | |||
| Abdominal | N | N | N | N | N | |||
| FetalImaging& Other | Intra-operative (Specify) | |||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| 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) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | N | 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
- Other modes of operation include: CPA, 3-D Imaging, XBeam, Panoscope, Trapezoidal /Extended Sector Imaging, Anatomical M-mode, ECG,VS Flow, Color M,DICOM
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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: K173000
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: September 25, 2017
2. Device/Trade Name:
Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 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. Device Description:
The SIUI Apogee 2100/ Apogee 2300 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), others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG, VS Flow, Color M, DICOM).
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 2100 vs. Apogee 2300:
The Apogee 2100 and Apogee 2300 are the same in their working principle and internal modules.
Here are their main differences:
- The colors of rear panels are different.
- The structures of probe connectors are different, and the cosmetic designs of the supporting probe matching boxes are different. However, the working principle and the implementation principle of the probes are the same.
Figures of Apogee 2100 rear panel and supporting probe cosmetic design
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Image /page/15/Figure/1 description: The image shows the back of a portable ultrasound machine and two diagrams of an ultrasound probe. The back of the machine has two probe ports labeled "PROBE B" and "PROBE A", along with various ventilation grills. The diagrams show the side and top views of the ultrasound probe, with the top view showing the label "SIUI C3LN 3.5MHz".
Figures of Apogee 2300 rear panel and supporting probe cosmetic design
- Subject to different market positioning, the Apogee 2100 / Apogee 2300 have different functional configurations. See the table below for details:
| Functional Configuration | Apogee 2100 | Apogee 2300 |
|---|---|---|
| B | √ | √ |
| 2B | √ | √ |
| 4B | √ | √ |
| B/M | √ | √ |
| M | √ | √ |
| PW | √ | √ |
| B+CFM | √ | √ |
| B+CPA | √ | √ |
| B+PW | √ | √ |
| Triplex(B+CFM+PW,B+CPA+PW) | √ | √ |
| Trapezoidal /ExtendedSector Imaging | √ | √ |
| XBeam | √ | √ |
| Panoscope | √ | √ |
| Anatomical M-mode | √ | √ |
| CW | √ | O |
| 3D | √ | √ |
| 4D | √ | √ |
| TDI | O | O |
| Elastography | O | O |
| MFI | √ | √ |
| ECG | O | O |
| Color M | O | O |
| VS Flow | √ | √ |
| B Flow | √ | √ |
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| Functional Configuration | Apogee 2100 | Apogee 2300 |
|---|---|---|
| HPRF | √ | √ |
| DICOM | √ | √ |
Notes: √ for standard configuration, and ○ for optional purchase.
4. Indications For Use:
Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculoskeletal, cardiac, peripheral vascular, trans-vaginal and trans-rectal applications in B-Mode (B, 2B, 4B), M-Mode, CFM, CPA, PWD, CWD, Combined (B, M, CFM, CPA, PWD, CWD, XBeam, Panoscope, and others (3D, 4D, Trapezoidal /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG , VS Flow, Color M and DICOM). Comparison to Predicate Devices:
The Apogee 2100/ Apogee 2300 have three more imaging functions than the predicate SIUI Apogee 5500, namely VS Flow, Color M and DICOM.
All the Indications for Use of the Apogee 2100/ Apogee 2300 are included in the indications for use of predicate SIUI Apogee 1200.
5. Legally Marketed Predicate Device:
The Apogee 2100/ Apogee 2300 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:
| PredicateDevice | Manufacturer | Model | 510(k) ControlNumber |
|---|---|---|---|
| 1 | SIUI | Apogee 1200 Digital Color DopplerUltrasound Imaging System | K113613 |
| 2 | SIUI | Apogee 5500 Digital Color DopplerUltrasound Imaging System | K160853 |
Compared to the predicate devices SIUI Apogee 1200 (K113613):
The Apogee 2100/ Apogee 2300 mainly have cosmetic changes based on SIUI Apogee
1200 (K113613), with additional new features and new configurable transducers.
-
- In cosmetic design, the Apogee 2300 is close to the Apogee 1200, except for changes
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in some structure of the upper part of the machine and some adjustment on the control panel. In the overall structure, the control panels of the Apogee 2300 and Apogee 2100 are modified based on the Apogee 1200. Some functions achieved by toggle switches are changed to other knobs or menu operations through software control changes, but the overall control interface and protocol is not changed substantially. The display structure is modified that allows the display rotated up and down 35 degrees, which enhances the user experience and makes full use of structural space, making the system lighter and more compact.
Subject to cosmetic changes, the PCBAs in the system are adjusted in their size and layout, while the overall circuit principle is not changed. The Apogee 2100 /Apogee2300 and Apogee 1200 use the same PC module, digital signal processing module, and ultrasound front-end module.
With the changes in system cosmetic design, the cosmetic design of the connectors between probes and main unit is modified. To differentiate marketing needs, the cosmetic design of connector and match box is modified.
- In new features, the Apogee 2100/ Apogee2300 have additional 4D, Trapezoidal 2) /Extended Sector Imaging, Elastography, Anatomical M-mode, TDI, MFI, ECG,VS Flow and Color M, which are also available in Apogee 5500 (K160853), but the same in ultrasound diagnostic functions, imaging modes, measurement and calculation function, file storage management and compatible peripheral devices.
- In probe configuration, due to cosmetic changes in connector and match box in the 3) Apogee 2100 / Apogee 2300, the probe models are changed, and some additional transducers L10LN, C6LN, U5LN are configured (identical to Apogee 5500 (K160853)), and the range of application includes 5 additional exams Neonatal Cephalic, Trans-vaginal and Trans-rectal, Gynecology and Urology (identical to Apogee 5500 (K160853)).
- The Apogee 2100/ Apogee 2300 are similar in technological characteristics to the SIUI 4) Apogee 1200(K113613) .
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Compared to the predicate devices Apogee 5500 (K160853):
For the technical specifications and transducers on the SIUI Apogee 2100/ Apogee 2300, the claim of substantial equivalence to devices currently having FDA 510(k) clearance is Apogee 5500 (K160853).
The Apogee 2100/ Apogee 2300 are similar in technological characteristics to the Apogee 5500.
- The Apogee 2100/ Apogee 2300 and the Apogee 5500 have similar imaging modes. 1)
- The Apogee 2100/ Apogee 2300 and the Apogee 5500 have similar diagnostic 2) ultrasound applications
-
- The transducers of Apogee 2100/ Apogee 2300 and the Apogee 5500 have similar technical parameters and hardware implementation principle.
-
- The Apogee 2100/ Apogee 2300 have similar diagnostic ultrasound applications as Apogee 5500.
6. Safety Considerations:
The Apogee 2100/ Apogee 2300 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, ISO 10993-10, and IEC 60601-1-2.
7. Conclusion:
The conclusions drawn from testing of the Apogee 2100/ Apogee 2300 Digital Color Doppler Ultrasound Imaging System demonstrates that the device is as safe and effective as the legally marketed predicate devices.
§ 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.