(23 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ (Thyroid, Breast and Testicles), Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.
The 7300 is a compact ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissuc Enhancement Imaging (TEI). The 7300 is equipped with an LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7300 can drive phased (PA), convex (CA) and linear array (1.A) probes. The 7300 is equipped with a CD-RW disk drive that can be used for image storage. Data can also be stored directly to a Personal Computer via a LAN port. Optional accessory devices available for the 7300 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an isolation transformer.
This document is a 510(k) Summary for the 7300 Ultrasound Imaging System. It describes the device's characteristics and intended uses, and asserts its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic capabilities. Instead, it demonstrates acceptance primarily through substantial equivalence to predicate devices. The "reported device performance" is implicitly that the 7300 Ultrasound Imaging System meets the same safety and effectiveness standards as the predicate devices for its stated intended uses and technological characteristics.
The table provided in the document focuses on technological characteristics and intended uses to demonstrate equivalence to the predicate "Megas (K982444 & 994369)".
Characteristic 7300 (This submission) Megas (K982444 & 994369) Electrical Safety IEC60601-1 IEC60601-1 Ultrasound Safety Track 3 (Acoustic Output Display) Track 3 (Acoustic Output Display) Indication for Use • Cardiac YES YES • Transesophageal YES YES • Peripheral Vascular YES YES • Neonatal Cephalic YES YES • Adult Cephalic YES YES • Small organ YES YES • Musculoskeletal (conventional & superficial) YES NO (This is a new indication for the 7300 compared to Megas) • Abdominal YES YES • OB/Fetal YES YES • Transvaginal YES YES • Transrectal YES YES • Pediatric YES YES Probe Technology • Annular Array NO YES • Phased Array YES YES • Linear array YES YES • Convex Array YES YES Modes of operation 2D, M-Mode, PW, CW, CFM, Amplitude Doppler, TEI 2D, M-Mode, PW, CW, CFM, Amplitude Doppler, TEI Imaging Frequencies 2.0,2.5, 3.5, 5.0, 7.5, 10 MHz 2.0,2.5, 3.5, 5.0, 7.5, 10 MHz CFM/Doppler Frequencies 2.0, 2.5, 3.3, 5.0 MHz 2.0, 2.5, 3.3, 5.0 MHz Tissue Velocity Mapping feature YES NO (This is a new feature for the 7300) Biopsy Guidance YES YES • Biopsy Intended Uses General Purpose, Transrectal, Transvaginal General Purpose, Transrectal, Transvaginal • Biopsy Line Depth marker 1 cm 1 cm Needle Guide Angle ABS421: 20° 30°, ABS523: 45°, ABS123: 3.8° ABS421: 20° 30°, ABS523: 45°, ABS123: 3.8° Display Type SVGA SVGA Digital Archival Capabilities YES YES DICOM Classes YES (Media Storage, Storage SCU) YES VCR / Page Printer YES YES M&A Capabilities Cardiac, Vascular, OB and general purpose measurements Cardiac, Vascular, OB and general purpose measurements Weight 10 kg 25 kg Dimensions portable: 35.5 (w) x 14 (h) x 49 (d) cm; use: 35.5 (w) x 41 (h) x 49 (d) cm portable: 46 (w) x 23.5 (h) x 55 (d) cm; use: 46 (w) x 23.5 (h) x 68 (d) cm The acceptance criterion is that the 7300 Ultrasound Imaging System is substantially equivalent to the predicate devices (Esaote, S.p.A. 7250 Ultrasound Imaging System K982444, K004360, K994369, and Technos Ultrasound Imaging System K014168, and Philips Medical Systems M2540 Ultrasound System K014199) in terms of intended use, technological characteristics, and safety/effectiveness. The table above serves to demonstrate this equivalence by comparing features.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The 510(k) summary does not describe a specific clinical test set, sample size, or data provenance for proving the device's performance in a diagnostic capacity. The clearance hinges on substantial equivalence, which primarily involves comparing the device's technical specifications and intended uses to those of legally marketed predicate devices. The FDA letter mentions a requirement for a "postclearance special report" to be submitted prior to shipping the first device, which should contain "complete information, including acoustic output measurements based on production line devices." This suggests that performance testing related to acoustic output would be done post-clearance on production units, not as part of a pre-market test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable as the document does not describe a clinical study involving a test set and ground truth established by experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable for the same reason as point 3.
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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:
This information is not applicable. The 7300 Ultrasound Imaging System is a diagnostic imaging device, not an AI-assisted interpretation tool. The document does not describe any MRMC study or AI components.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is an ultrasound imaging system, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable as the document does not describe a clinical test set requiring a ground truth. The basis for clearance is technical comparison and safety standards adherence.
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The sample size for the training set:
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
This information is not applicable as the device is not an AI/ML algorithm that requires a training set and ground truth.
Summary of Study that Proves Device Meets Acceptance Criteria:
The "study" proving the device meets acceptance criteria is primarily a comparative analysis of technical characteristics and intended uses against legally marketed predicate devices. The acceptance criteria are essentially that the 7300 Ultrasound Imaging System is substantially equivalent to the predicate devices in terms of safety and effectiveness, based on adherence to recognized safety standards (IEC60601-1, Track 3 Acoustic Output Display) and comparable technological features and clinical indications. The document asserts that the differences in technological characteristics (e.g., Musculoskeletal indication, Tissue Enhancement Imaging, absence of Annular Array, and changes in physical dimensions) do not raise new questions of safety or effectiveness. The FDA's issuance of the 510(k) clearance letter (K040596) signifies their agreement with this assessment of substantial equivalence.
§ 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.