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510(k) Data Aggregation
(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.
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(112 days)
The CardioOptics Augmentative Cardiac Optical Imaging System is intended to image and onical structures within the chambers of the heart and great vessels. The system is to be used in conjunction with fluoroscopic imaging.
The system is also indicated for accessing the coronary sinus for pacemaker lead implantation. The system includes visualization means to image anatomical structures to augment navigation into the coronary sinus.
The CardioOptics Augmentative Cardiac Optical Imaging System is composed of a single-use catheter, accessories, and an Image Acquisition System. The system incorporates infrared light (IR) technology to provide visualization through flowing blood. This submission modifies the indications for use originally cleared in 510(k) No. K050808 to include visualization of the cardiac chambers and great vessels.
I'm sorry, but based on the provided text, I cannot find the information needed to describe the acceptance criteria, the study that proves the device meets those criteria, or any of the detailed aspects like sample sizes, ground truth establishment, or MRMC studies.
The document is a 510(k) summary for the CardioOptics Augmentative Cardiac Optical Imaging System, primarily focused on its regulatory clearance. It identifies the device, its indications for use, and confirms that it was found substantially equivalent to predicate devices. However, it does not include performance data, detailed study designs, or acceptance criteria usually found in a clinical study report.
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(35 days)
The Sequoia ultrasound imaging system is intended for use in 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), Transesophageal, Transvaginal, Peripheral Vessels, and Musculosceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance 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.
Ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis), Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Neonatal Cardiac, Intra-luminal, Intra-Cardiac.
The Siemens Acuson Sequoia is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.
The provided document is a 510(k) Pre-market Notification for the Siemens ACUSON Sequoia Ultrasound System. It details intended uses and lists various transducers with their cleared applications. However, it does not contain information about specific acceptance criteria or a study proving device performance against those criteria.
The document states in Section E, "Performance Data": "The Sequoia modifications are verified and validated according to the company's design control process." This is a general statement and does not provide details of a study to demonstrate acceptance criteria. The clearance in this 510(k) is based on substantial equivalence to a predicate device (Siemens Acuson Sequoia ultrasound system (K052410)), not on new performance data demonstrating meeting specific acceptance criteria for a novel functionality.
Therefore, many of the requested items cannot be answered from the provided text.
Here's a summary of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Not provided in the document. The submission is based on substantial equivalence to a predicate device, not on meeting new quantitative performance criteria described in this document.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not mentioned. No specific test set or data provenance for proving performance against acceptance criteria is described. The document indicates that prior applications for existing transducers were "previously cleared by the FDA under premarket notifications" (e.g., #K052410, #K051139, etc.), implying their performance was established in those earlier submissions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable/Not mentioned.
4. Adjudication Method for the Test Set
Not applicable/Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable/Not mentioned. The submission is for an ultrasound system and transducers, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable/Not mentioned.
7. Type of Ground Truth Used
Not applicable/Not mentioned. The document relies on "previously cleared" indications for use from predicate devices.
8. Sample Size for the Training Set
Not applicable/Not mentioned.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not mentioned.
Additional Information from the Document:
- Acceptance Criteria (General): The device (and its modifications) are verified and validated according to the company's design control process. This implies internal acceptance criteria for design validation, but the specifics are not disclosed in this summary.
- Proof of Meeting Acceptance Criteria: The submission relies on "substantial equivalence" to a predicate device (Siemens Acuson Sequoia ultrasound system (K052410)) for its intended uses and technological characteristics. The performance of individual transducers for specific clinical applications (e.g., Fetal, Abdominal, Cardiac) is indicated by "P=previously cleared by the FDA under premarket notifications" or "N=New Indication" for specific modes (B, M, PWD, CWD, Color Doppler, Power Doppler, Harmonic Imaging). This means the performance for these indications was established in earlier 510(k) submissions, not in this current one.
In essence, this 510(k) is a "Special 510(k)" submission, which is typically used for modifications to a manufacturer's own legally marketed device. The focus is on demonstrating that the changes do not affect the safety and effectiveness of the device as cleared in the predicate, rather than generating new performance data against specific, public-facing acceptance criteria for a novel technology.
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(76 days)
Diagnostic imaging or fluid flow analysis of the human body as follows:
General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intra-luminal and Intra-cardiac applications, and intended uses as defined in the FDA guidance 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.
The Cypress system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number(s):
K042055 (August 16, 2004) cleared as Cypress™ Ultrasound System .
K021497 (July 9, 2002) cleared as Cypress™ Ultrasound System .
K010950 (June 27, 2001) cleared as Cypress™ Ultrasound System .
K991872 (June 16, 1999) cleared as Lynx Ultrasound System .
K982800 (September 22, 1998) cleared as Ecton Lynx Ultrasound System .
The Cypress Ultrasound System has been designed to conform to the following product safety standards:
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment ●
AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for . Diagnostic Ultrasound
AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
93/42/EEC Medical Device Directive .
Safety and EMC Requirements for Medical Equipment ●
EN 60601-1 .
EN 60601-1-1, Safety Requirements for Medical Equipment .
EN 60601-1-2 .
EN 60601-1-2-37 ●
ISO 10993 Biocompatibility .
The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable)
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, results of any study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC comparative effectiveness studies, standalone performance, ground truth types, or training set details. This document is a 510(k) summary for an ultrasound system, primarily focusing on its regulatory classification, predicate devices, device description, and intended uses, along with various transducer-specific indications. It states that the device is "substantially equivalent" to previously cleared predicate devices but does not provide details of any new study conducted to demonstrate this.
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(20 days)
The Sequoia platform is intended for use in the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), 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 guidance 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.
The Sequoia system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification number: K051139 (May 13, 2005) cleared as ACUSON Sequoia™ Diagnostic Ultrasound . System. The Sequoia Diagnostic Ultrasound System has been designed to conform to the following product safety standards: UL 2601-1, Safety Requirements for Medical Equipment . CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment . AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic . Ultrasound AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment 93/42/EEC Medical Device Directive . Safety and EMC Requirements for Medical Equipment . . EN 60601-1 · EN 60601-1-1 EN 60601-1-2 . ISO 10993 Biocompatibility . The system's acoustic output is in accordance with ALARA principle (as low as . reasonably achievable)
The provided document is a 510(k) Pre-Market Notification for the ACUSON Sequoia™ Ultrasound System. It primarily outlines the substantial equivalence to a previously cleared device (K051139) and lists the intended uses for various transducers. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document details the intended uses for a wide range of transducers and clinical applications, stating that these uses were "P=previously cleared by the FDA" under various earlier 510(k) notifications. This indicates that the current submission relies on the prior clearances for its claimed performance.
Therefore, since no new performance study is described in this document, the requested information cannot be provided based on the input text.
Here's a breakdown of why each section cannot be addressed based on the provided text:
- Table of acceptance criteria and reported device performance: Not available. The document is a 510(k) submission primarily establishing substantial equivalence to a predicate device and listing intended uses for transducers already cleared. It does not present new performance data or acceptance criteria in the context of a new study.
- Sample size used for the test set and data provenance: No new test set is described. The document refers to "previously cleared" applications, implying that any testing was conducted for earlier submissions.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no new test set with ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size: Not applicable. The document does not describe any MRMC study or AI assistance.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This document pertains to an ultrasound system, not an AI algorithm.
- Type of ground truth used: Not applicable, as no new ground truth establishment is described.
- Sample size for the training set: Not applicable, as no AI algorithm or training set is mentioned.
- How the ground truth for the training set was established: Not applicable.
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(13 days)
The CV70 ultrasound imaging system is intended for the following applications: Abdominal, Fetal, OB/GYN, Cardiac, Intracardiac, Transesophageal, Intraoperative, Small Parts, Transcranial, Cerebrovascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis of information that is used for clinical diagnosis purposes.
The CV70 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect an on-screen display for thermal and re primary or secondary harmonic ultrasound echo data and modiantinin B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, ulsplay it in. D Mode, it would (f Mode, a combination of modes, or Harmonic Imaging, or 3D imaging, on a CRT display.
This document is a 510(k) Premarket Notification summary for the ACUSON CV70™ Cardiovascular System, an ultrasound diagnostic system and its associated transducers. It establishes substantial equivalence to previously cleared predicate devices. Therefore, the document describes the device's intended use and technological comparison, rather than presenting a study proving performance against acceptance criteria for a novel AI/CAD device.
As such, the information required for this request (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC study details) is not applicable in this regulatory submission. This document pertains to the market clearance of a diagnostic ultrasound system based on its substantial equivalence to already approved predicate devices, not on a new performance study proving its diagnostic accuracy.
The key points from the provided document are:
- Device Name: ACUSON CV70™ Cardiovascular System
- Device Type: Diagnostic Ultrasound System with Accessories
- Regulation Numbers: 21 CFR 892.1550 (Ultrasonic pulsed doppler imaging system), 21 CFR 892.1560 (Ultrasonic pulsed echo imaging system), 21 CFR 892.1570 (Diagnostic ultrasound transducer), 21 CFR 870.1200 (Diagnostic intravascular catheter)
- Regulatory Class: II
- Product Codes: 90 IYN, IYO, ITX, and 74 DQO
- Predicate Devices: K042770 (ACUSON CV70™ Cardiovascular System) and K042593 (ACUSON Sequoia™ Diagnostic Ultrasound System). This indicates the device is considered substantially equivalent to existing devices, meaning its safety and effectiveness are established by comparison to these predicates rather than requiring a new clinical performance study as might be the case for a novel AI device.
- Intended Uses: Abdominal, Fetal, OB/GYN, Cardiac, Intracardiac, Transesophageal, Intraoperative, Small Parts, Peripheral, Cerebrovascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. It also provides for measurement of anatomical structures and analysis of information for clinical diagnosis.
- Technological Comparison: The CV70 is deemed "substantially equivalent" to the predicate devices. All systems transmit ultrasonic energy, perform post-processing to generate on-screen displays, and allow specialized measurements and calculations.
In summary, this document is a 510(k) clearance, which relies on demonstrating similarity to existing devices, not on a new performance study with acceptance criteria for diagnostic accuracy.
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