Search Results
Found 4 results
510(k) Data Aggregation
(20 days)
V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications.
ACUSON Antares Ultrasound System: The Acuson Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal. Great Vessel, and Peripheral Vascular 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.
ACUSON CV70 Cardiovascular System: The CV70 ultrasound imaging system is intended for the following applications: Abdominal. Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Gephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular 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.
ACUSON Cypress Ultrasound System: The Cypress platform is intended for use in the following applications: General Imaging and Cardiology for Fetal. Abdominal. Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intraluminal and Intra-cardiac applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes
ACUSON S1000/S2000 Ultrasound System: The S2000™ ultrasound imaging systems are intended for the following applications: Fetal. Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal(conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician 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."
ACUSON SC2000 Ultrasound System: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.
ACUSON Sequoia Ultrasound System: The Siemens ACUSON Sequoia ultrasound imaging system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
ACUSON X300 Ultrasound System: The Siemens ACUSON X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides measurement of anatomical structures and 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 reqarding 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 V5Ms Transesophageal Transducer consists of a gastroscope control housing where nosepiece articulation and transducer rotation are controlled. A flexible transesophageal guide tube with a nosepiece containing the acoustic array extends from one end of the control housing and the system cable/connector extends from the other end. The acoustic array has 64 elements and rotates 180 degrees to provide imaging planes from transverse view to inverse transverse view. Rotation is powered by a motor in the control housing and is controlled by the operator using a switch button on the control housing for clockwise and counterclockwise rotation. Nosepiece articulation is achieved by manipulating a vertebrae section adjacent to the nosepiece through a series of control wires attached to knobs on the control housing. The nosepiece can be articulated in both the anterior/posterior and left/right directions.
Here's a breakdown of the requested information, based on the provided document:
Acceptance Criteria and Study Details for V5Ms Transesophageal Transducer
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) submission document does not explicitly state quantitative acceptance criteria or specific device performance metrics in the way one might expect for a new or significantly modified device. Instead, the submission relies heavily on substantial equivalence to a previously cleared predicate device (Siemens V5Ms Transesophageal Transducer, K052021). The key "performance data" presented is that "Performance data is not required for this modification as there is no change to software or hardware." This implies that the device is expected to perform identically to its predicate because the changes are limited to patient contact materials.
Therefore, the acceptance criteria are implicitly met by demonstrating that the modifications do not negatively impact the established performance of the predicate device.
Implicit Acceptance Criteria and Reported Performance (Based on Substantial Equivalence):
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | The modified device is safe and effective for its intended uses, as demonstrated by its substantial equivalence to the predicate device (Siemens V5Ms Transesophageal Transducer, K052021). No changes to software or hardware, thus performance is maintained. |
| Biocompatibility | Meets ISO10993-1 standards for cytotoxicity, sensitization, and irritation. |
| Intended Use (across various ultrasound systems) | The device is intended for the same cardiology applications and clinical applications (e.g., Transesophageal, Cardiac, various Doppler modes, 3D imaging, Harmonic Imaging) as the predicate when used with compatible ACUSON systems. The intended uses are identical to the predicate device. |
| Technological Characteristics | The device possesses the same fundamental technological characteristics (e.g., phased array transducer, 64 elements, 180-degree rotation, nosepiece articulation) as the predicate, with modifications only to patient contact materials. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable (N/A). The document explicitly states, "Performance data is not required for this modification as there is no change to software or hardware." Therefore, there was no clinical performance test set used. The evaluation centered on non-clinical tests for biocompatibility and asserting substantial equivalence.
- Data Provenance: N/A for clinical performance data. For biocompatibility testing, the data would typically originate from a laboratory (likely in the USA or a facility that adheres to international standards like ISO). The origin is not specified beyond "Nonclinical tests contained in this submission include biocompatibility testing per ISO10993-1 (cytotoxicity, sensitization, irritation)."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- N/A. As no clinical performance test set was conducted, there was no need for experts to establish ground truth. The primary "experts" involved in the submission would be Siemens' own regulatory and engineering teams, and subsequently, FDA reviewers.
4. Adjudication Method for the Test Set
- N/A. Since no clinical performance test set was conducted, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. No MRMC study was conducted. The submission is a 510(k) for substantial equivalence based on minor modifications (patient contact materials) to an existing device, not a new clinical effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. The device is a diagnostic ultrasound transducer, not an AI algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.
7. The Type of Ground Truth Used
- N/A for clinical effectiveness. For biocompatibility, the "ground truth" is defined by the ISO10993-1 standard for cytotoxicity, sensitization, and irritation. This involves standardized biological tests.
8. The Sample Size for the Training Set
- N/A. This device is a hardware component (transducer) and does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
- N/A. As there is no training set for this device, this question is not applicable.
Ask a specific question about this device
(20 days)
The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial), intraoperative, and urology exams.
The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, Color mode, Color M mode, CW mode, CW mode, Power/DirPower mode, TDI mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz. This modification will provide users with 3 additional transducers, some additional optional features called STIC, Stress Echo, iPage, and etc. These modifications all lead to overall quality and image enhancement.
The DC-7 Diagnostic Ultrasound System is a general purpose ultrasound system with various transducers and modes of operation. The provided text is a 510(k) summary for this device, seeking substantial equivalence to predicate devices, and outlines its intended use, non-clinical tests, and technological characteristics. The document does not contain specific acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/CADe device.
Instead, the document details the Indications for Use (IFU) for the DC-7 Diagnostic Ultrasound System and its various transducers across different clinical applications and modes of operation. The "acceptance criteria" here are implicitly that the new system and its transducers can perform these functions ("P" for previously cleared, "N" for new indications) safely and effectively, demonstrating substantial equivalence to the listed predicate devices.
Here's a breakdown based on your request, interpreting "acceptance criteria" as the claimed capabilities and "study" as the information provided for regulatory clearance:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) clearance for a general-purpose ultrasound system and not a specific AI/CADe algorithm with performance metrics like sensitivity/specificity, the "acceptance criteria" are the claimed modes of operation and clinical applications for each transducer. The "reported device performance" is that the system and transducers are capable of these indicated uses, demonstrating substantial equivalence to predicate devices.
The tables for each transducer (e.g., 3C5A, C5-2, V10-4, L12-4, P7-3, etc.) list the following "acceptance criteria" (indicated by 'P' for previously cleared or 'N' for new) and their reported performance (the presence of 'P' or 'N' in the table signifies the device meets these criteria for the given transducer):
| Clinical Application | B Mode | M Mode | PWD | CWD | Color Doppler | Amplitude Doppler | Combined Mode | Other Features |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,6,7 |
| Abdominal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,5,6,7 |
| Intraoperative (includes abdominal, thoracic, vascular) | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Pediatric | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,5,6,7 |
| Small Organ (breast, testes, thyroid) | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Neonatal Cephalic | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,5,6,7 |
| Adult Cephalic | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,5,6,7 |
| Trans-rectal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,6,7 |
| Trans-vaginal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,6,7 |
| Musculoskeletal Conventional | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Musculoskeletal Superficial | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Cardiac Adult | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,5,6,7 |
| Cardiac Pediatric | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,5,6,7 |
| Peripheral Vascular | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Other (Urology) | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
Notes:
- Tissue Harmonic Imaging: The feature does not use contrast agents.
- Smart3D: (Likely a 3D imaging feature)
- 4D (Real-time 3D): (Real-time 3D imaging)
- iScape: (Likely an extended field of view imaging feature)
- TDI (Tissue Doppler Imaging): (Cardiac function assessment)
- Color M: (Color M-mode)
- Biopsy Guidance: (Assistance for biopsy procedures)
P = Previously cleared by FDA; N = New indication (for this specific K-number, it implies new to this device or transducer combination)
Entries are filled based on the collective information from all transducer tables where "P" or "N" is indicated for at least one transducer. Some specific cells might be blank for certain transducers, meaning that mode/application is not indicated for that specific transducer.
The "study" proving these criteria are met is the "Non-clinical Tests" and the demonstration of "Technological Characteristics" being substantially equivalent to predicate devices.
2. Sample Size Used for the Test Set and the Data Provenance
- The 510(k) summary does not describe a specific "test set" in terms of patient data for a clinical study comparing performance metrics.
- Instead, the submission relies on non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal/electrical/mechanical safety) and comparison of technological characteristics to predicate devices to establish substantial equivalence.
- Data provenance: Not applicable in the context of a clinical test set from patient data. The provenance for the non-clinical tests would be internal laboratory testing by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. This is a clearance for a general diagnostic ultrasound system based on technological equivalence and safety standards, not an AI/CADe device requiring expert-established ground truth for a clinical performance study.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical test set requiring expert adjudication is described in the provided summary.
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
- Not applicable. This is not an AI/CADe device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an AI/CADe device.
7. The Type of Ground Truth Used
- Not applicable. The clearance is based on adherence to medical safety standards (IEC, ISO), acoustic output, biocompatibility, and demonstrated technological equivalence to legally marketed predicate devices, rather than comparison to a clinical ground truth like pathology or outcomes data for a specific diagnostic task.
8. The Sample Size for the Training Set
- Not applicable. This is a hardware/software system, not an AI/CADe algorithm requiring a training set from patient data in the context of medical imaging.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this is not an AI/CADe algorithm with a training set.
In summary: The provided 510(k) summary for the Mindray DC-7 Diagnostic Ultrasound System is for a general-purpose diagnostic imaging device, not an AI or CADe product. Therefore, the "acceptance criteria" and "study" described align with the requirements for establishing substantial equivalence for such a device, focusing on safety, performance, and technological similarity to already cleared predicate devices, rather than detailed performance metrics from clinical trials or AI algorithm validation.
Ask a specific question about this device
(82 days)
The S2000™ ultrasound imaging systems are intended for the following applications: Fetal, Abdominal. Intraoperative. Pediatric. Small Parts. Transcranial. OB/GYN. Cardiac, Pelvic, Neonatal/Adult Cephalic, Vasculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The system also provides the ability to measure anatomical structures (fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician 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 S2000™ has been designed to meet the following product safety standards:
- l UL 60601-1, Safety Requirements for Medical Equipment
- l IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- t CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- li AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- I AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- t 93/42/EEC Medical Devices Directive
- Safety and EMC Requirements for Medical Equipment 트
- . EN/IEC 60601-1
- . EN/IEC 60601-1-1
- I EN/IEC 60601-1-2
- IEC 1157 Declaration of Acoustic Power 트
- ISO 10993-1 Biocompatibility l
This 510(k) submission (K093812) for the Siemens Acuson S2000 Ultrasound System describes the device's technical specifications and intended uses, and asserts substantial equivalence to a predicate device. However, it does not contain information regarding a specific clinical study with acceptance criteria and device performance metrics, as would be expected for a novel AI-powered diagnostic device.
The document primarily focuses on:
- Device Description: Listing safety standards the system meets (e.g., UL 60601-1, IEC 60601-2-37).
- Intended Use: Broad applications for ultrasound imaging across various anatomical regions and patient populations.
- Transducer Information: Detailed tables indicating the modes of operation (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging) and additional features (e.g., tissue harmonic imaging, spatial compounding) cleared for each specific transducer.
- Predicate Device: Stating the Acuson S2000 is substantially equivalent to the Acuson Antares Ultrasound System.
The "Arterial Health Package (AHP) software," which provides "capability to measure Intima Media Thickness and the option to reference normative tables," mentions that these tables "have been validated and published in peer-reviewed studies." However, it does not provide details of an internal study conducted by Siemens to prove that their device's AHP functionality meets specific acceptance criteria based on these peer-reviewed studies.
Therefore, I cannot populate the requested tables and information as a study proving device performance against acceptance criteria is not present in the provided text. The document is a regulatory submission for device clearance based on substantial equivalence, rather than a detailed report of a performance study.
Ask a specific question about this device
(95 days)
The Biosense Webster SOUNDSTAR™ 3D Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the CARTO® XP EP Navigation System Version 9 or greater, the SOUNDSTAR" 3D Ultrasound Catheter provides location information.
The Biosense Webster SOUNDSTAR" 3D Ultrasound Catheter is a 90 cm 10F IntraCardiac Echo (ICE) Catheter with an acoustic array identical to the ACUSON AcuNav 10F Diagnostic Ultrasound Catheter. The catheter has a location sensor (providing location information to the CARTO® EP XP Navigation System Version 9 - 510(k) submitted separately) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip.
The SOUNDSTAR™ 3D Ultrasound Catheter has a bifurcated 'tail' originating from its handle (see Figure 1). One leg terminates in the SOUNDSTAR tab connector, which connects via a Swiftlink™ cable to an ultrasound system (ACUSON) Sequoia " Ultrasound System of the and 510(k) K052331 respectively). The other leg terminates in the CARTO Hypertronic connector, which connects via a Patient Interface Unit (PIU) extension cable to the CARTO® XP EP Navigation System Version 9 (510(k) submitted bundled with the SOUNDSTAR 31) Ultrasound Catheter submission).
The Sequoia and Cypress Ultrasound Systems were designed to acquire two dimensional (2D) ultrasound (U/S) images and display them. The SOUNDSTAR" 3D Ultrasound Catheter connects to either of these ultrasound systems via the appropriate SwiftLink connector cable. The U/S images are Vector" images for wide angle viewing of the heart anatomy. These systems are used to image the anatomy of the heart and also visualize blood flow through Doppler imaging. They are also used to visualize other catheters and devices in the heart.
The imaging software in the Sequoia and Cypress U/S systems that currently drives AcuNav Catheters will be the same software that drives the SOUNDSTAR" 3D Ultrasound Catheter.
The acoustic array used in the SOUNDSTAR™ 3D Ultrasound Catheter is identical to the acoustic array currently used in the AcuNav Catheter.
The CARTO® XP EP Navigation System Version 9 is designed to acquire. analyze, and display electro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical potential maps, impedance maps and chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real-time on the display screen.
The SOUNDSTAR™ 3D Ultrasound Catheter is compatible with the CARTO® XP EP Navigation System Version 9, (Version 8 cleared under 510(k) K042999).
The SOUNDSTAR™ 3D Ultrasound Catheter, when connected to the CARTO® XP EP Navigation System Version 9, and the Sequoia or the Cypress Ultrasound Systems, will provide real-time integration of ultrasound images with CARTO electromagnetic acquired maps.
The SoundStar 3D Ultrasound Catheter underwent extensive non-clinical studies to establish its substantial equivalence to predicate devices, namely the ACUSON AcuNav 10F Diagnostic Ultrasound Catheter and the Biosense Webster NAVISTAR Diagnostic catheter.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text states that the device "passed all intended criteria in accordance with appropriate acceptance criteria and standards" for extensive bench and electrical testing. However, specific quantitative acceptance criteria and detailed performance metrics are not explicitly provided in the given document. The information outlines the general areas of performance that were evaluated.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench and Electrical Testing | The catheter passed all intended criteria in accordance with appropriate acceptance criteria and standards. (This implies meeting established electrical safety, mechanical integrity, and functional performance benchmarks, though specific values are not detailed). |
| Safety and Effectiveness | Non-clinical studies demonstrate that the SOUNDSTAR™ 3D Ultrasound Catheter is safe and effective for: |
- Intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology.
- Visualization of other devices in the heart.
- Acquisition of location information for CARTO mapping. |
| Equivalence to Predicate Devices| The studies establish equivalence of the SOUNDSTAR™ 3D Ultrasound Catheter to the predicate devices, the NAVISTAR Diagnostic catheter and the AcuNav 10F Ultrasound Catheter. This implies that its performance in the key areas listed above is comparable to or better than the legally marketed predicate devices. |
| Simulated Use Conditions | The SOUNDSTAR™ 3D Ultrasound Catheter was also tested under simulated use conditions in animals. (This implies successful operation and performance in a physiological environment that mimics human use, though specific outcomes are not detailed). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "extensive bench and electrical testing" and "simulated use conditions in animals" but does not quantify the number of units tested or the number of animals used.
- Data Provenance: The studies were non-clinical, implying they were conducted in a controlled environment (bench testing) and an animal model. The country of origin for the data is not specified, but the applicant and manufacturer are based in the USA. The studies are prospective in nature, as they are conducted for the purpose of demonstrating device performance prior to market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. As this is a traditional 510(k) for a hardware device focused on substantial equivalence to existing technology, it's unlikely a formal expert-driven ground truth establishment process (as seen in AI/imaging diagnostic devices) was explicitly documented in this summary. The "ground truth" for electrical and bench testing would rely on established engineering specifications and measurement standards, and for animal studies, it would be based on physiological observations and established medical assessment methods.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the device (hardware/catheter), an adjudication method for test results as typically described for diagnostic algorithms (e.g., 2+1, 3+1 for discrepancies) is not directly applicable. Performance would likely be assessed against predetermined pass/fail criteria on a per-test basis.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not explicitly mentioned or implied. This type of study is more common for diagnostic imaging algorithms where human reader performance is a key metric. The focus here is on the device's physical and functional equivalence to predicate devices, and its ability to provide clear visualization and location information.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The device itself is a "Diagnostic Ultrasound Catheter" and an "Electrophysiologic Mapping/Ultrasound Catheter." It provides real-time ultrasound images and location information for human interpretation and use within a larger system (CARTO XP EP Navigation System). Therefore, its performance is inherently linked to human-in-the-loop operation, as it generates data for human clinicians to act upon. While individual components (like the acoustic array) underwent standalone testing, the complete device is designed for human interaction. The summary focuses on the device's ability to "acquire real-time ultrasound images" and "provide location information," which are standalone functions of the algorithm/hardware working.
7. The Type of Ground Truth Used:
- Bench and Electrical Testing: Ground truth would be based on engineering specifications, established measurement standards, and physical principles. For example, electrical impedance measurements would be compared against a known standard or internal specification.
- Animal Studies: Ground truth would be established through physiological observations, direct visualization during the procedure, and potentially post-mortem examination or correlation with other established diagnostic methods.
- Equivalence to Predicate Devices: The primary "ground truth" for equivalence is the performance and characteristics of the legally marketed predicate devices, against which the SoundStar 3D Ultrasound Catheter was compared.
8. The Sample Size for the Training Set:
This question is not applicable in the context of this traditional 510(k) for a physical medical device. "Training set" typically refers to data used to train an artificial intelligence or machine learning algorithm. This submission describes a hardware device with an acoustic array (identical to a predicate device) and a location sensor. There's no indication of AI or machine learning being used in a way that would require a "training set" in the conventional sense. The "imaging software" in the ultrasound systems that drives the catheter is the same as that used for the predicate, suggesting no new algorithm development requiring a training set for this specific device.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reasons as point 8. No training set for an algorithm is mentioned in the filing.
Ask a specific question about this device
Page 1 of 1