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510(k) Data Aggregation
(261 days)
This instrument has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, EndoTherapy accessories such as an aspiration biopsy needle. This instrument is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus.
The BF-UC190F has been designed to be used with the video system center, light source, documentation equipment, display monitor, and Endo Therapy accessories such as an aspiration biopsy needle. The BF-UC190F is intended for endoscopic real-time ultrasound imaging for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus. The BF-UC190F is a flexible video endoscope and a modification of the XBF-UC180F-DT8 which was previously cleared under K070983. The BF-UC190F consists of three parts: the control section, the insertion section, and the connector section.
The Olympus BF-UC190F Endoscopic Ultrasound Bronchofibervideoscope underwent several performance tests to demonstrate its substantial equivalence to the predicate device, the XBF-UC180F-DT8 (BF-UC180F), and confirm its safety and effectiveness.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria alongside performance data in a direct comparative format for each test. Instead, it states that various tests were conducted and the device conforms to or complies with relevant standards and guidance documents, implying that meeting these standards served as the acceptance criteria.
| Acceptance Criteria (Implied from Compliance Statements) | Reported Device Performance (Summary) |
|---|---|
| Ultrasound Output Display: Conformance to IEC 60601-2-37 Edition 2.0 2007 and FDA Guidance Document, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." | Output Display for BF-UC190F conducted and conforms to the specified IEC standard and FDA guidance. |
| Reprocessing Validation Testing: Conformance to Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling." | Reprocessing instruction and method validation testing conducted, and documentation provided as recommended by the guidance. |
| Biocompatibility Testing: Conformance to FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." | Biocompatibility testing conducted in accordance with the specified FDA guidance and ISO standard. |
| Software Verification and Validation Testing: Conformance to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." | Software verification and validation testing conducted, and documentation provided as recommended by the FDA guidance. |
| Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with ANSI/AAMI ES60601-1:2005/A2:2012/(R)2012, IEC 60601-2-18:2009 (for safety), and IEC 60601-1-2:2007 (for EMC). | Electrical safety and EMC testing conducted; the system complies with the specified ANSI/AAMI and IEC standards. |
| Performance Testing - Bench (Thermal Safety, Mechanical Durability): Meets design specifications and requirements, including process verification, design verification, and design validation. | Thermal safety and mechanical durability bench tests conducted and performed as intended, meeting design specifications. |
| Risk Analysis: Conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007 and human factors validation in accordance with FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices." | Risk analysis conducted, design verification tests and acceptance criteria identified and performed based on this assessment. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the test sets (e.g., number of units tested for thermal safety or mechanical durability, number of biological samples for biocompatibility). It generally states that "testing were conducted."
Data provenance is not explicitly mentioned in terms of "country of origin of the data" or "retrospective or prospective." All tests appear to be prospective bench tests performed by the manufacturer to validate the device's design and compliance with regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The testing described (e.g., electrical safety, EMC, biocompatibility, mechanical durability) are typically engineering and laboratory-based tests that do not involve "experts to establish ground truth" in the clinical sense (like radiologists marking images). Instead, the "ground truth" for these tests is established by the relevant engineering standards and regulatory requirements.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple experts assess the same data to establish a consensus ground truth. Since the performance data presented are primarily from bench and laboratory tests rather than clinical performance evaluations involving human interpretation, an adjudication method is not applicable and therefore not mentioned in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate device through technological comparison and various non-clinical performance tests, not on comparing reader performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-In-The-Loop)
A standalone (algorithm only) performance study was not conducted or reported. The device, an endoscope, is a physical instrument for real-time imaging and aspiration, designed to be used by a medical professional. There is no mention of an independent algorithm component for which "standalone performance" without human interaction would be relevant.
7. Type of Ground Truth Used
The "ground truth" for the various performance tests is based on established engineering standards, regulatory guidance criteria, and design specifications. For example:
- Ultrasound output: Conformance to IEC 60601-2-37 limits.
- Reprocessing: Meeting efficacy requirements as outlined in FDA reprocessing guidance.
- Biocompatibility: Absence of adverse biological reactions as per ISO 10993-1.
- Software: Verification against software requirements specifications and cybersecurity guidelines.
- Electrical Safety/EMC: Conformity to IEC standards.
- Bench Performance (Thermal/Mechanical): Meeting predefined design requirements and durability targets.
There is no mention of clinical ground truth types like expert consensus, pathology, or outcomes data, as this is a pre-market submission focused on fundamental device safety and performance rather than clinical effectiveness.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. The BF-UC190F is an endoscopic device, not an AI/Machine Learning algorithm that requires a "training set" of data. The "training" for such a device occurs during its design and development through iterative engineering, testing, and validation against established standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of this device. The "ground truth" for the device's development and validation (not a training set) involved adherence to engineering principles, scientific validation methods, and regulatory requirements (as outlined in point 7), established through industry standards, guidance documents, and internal design specifications.
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(37 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (Neurosurgery); Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac, Adult -TEE; Cardiac - Neonatal; Cardiac - Pediatric; Cardiac Pediatric, TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.
The Prosound F75, formerly named Aloka Prosound F75, Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display. The changes made to the Prosound F75 are the expanded indications: Adult/ Pediatric Cardiac- TEE, Neonatal/Pediatric, Cardiac, Intraoperative Neurosurgery, and Trans-esoph (non-cardiac).
The provided text is a 510(k) Summary of Safety and Effectiveness for the Hitachi Aloka Medical, Ltd. Prosound F75 Diagnostic Ultrasound System. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. Crucially, it explicitly states:
"No new hazards were identified with the addition of the added Indications. The clinical safety and effectiveness of the system and transducers have been identified in the previous Aloka Prosound F75 submission (K110207), with the above predicates as well as this submission. The clinical safety and effectiveness of the added indications are well accepted for use with ultrasound systems including the predicate device, Aloka Prosound F75 (K110207).
... 2. Clinical Tests: None Required."
This indicates that no new primary clinical study was conducted for this specific 510(k) submission (K123828) to establish effectiveness against acceptance criteria for the expanded indications. Instead, the submission relies on the established safety and effectiveness of the previously cleared device (K110207) and predicate devices, leveraging existing knowledge and accepted medical practice for ultrasound systems.
Therefore, many of the requested details about a study and acceptance criteria (such as reported performance, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) are not present in this document as no new clinical studies were performed for this specific submission.
Here's the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The acceptance criteria are implicitly met by demonstrating substantial equivalence to existing, legally marketed predicate devices, specifically the Aloka Prosound F75 (K110207) and other identified ultrasound systems (K033311, K032875). The key points for substantial equivalence, which serve as the "acceptance criteria" here, are:
- Indicated for diagnostic ultrasound imaging and fluid flow analysis.
- Same gray scale and Doppler capabilities.
- Uses essentially the same technologies for imaging, Doppler functions, and signal processing.
- Acoustic output levels below Track 3 FDA limits.
- Manufactured under equivalent quality and manufacturing systems.
- Manufactured of materials with equivalent biosafety.
- Designed and manufactured to the same electrical and physical safety standards.
Reported Device Performance:
The document does not provide specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the expanded indications. Instead, it states that the clinical safety and effectiveness are "well accepted for use with ultrasound systems" and have been "identified in the previous Aloka Prosound F75 submission (K110207)". This means the performance is considered equivalent to the predicate devices, which are presumed to have established acceptable performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No new test set data from a clinical study was presented for this 510(k) submission.
- Data Provenance: Not applicable for new clinical data. The submission relies on existing data from previous 510(k) submissions (K110207, K033311, K032875) which would have covered the safety and effectiveness of the base technology. The origin of that data is not specified in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No new test set requiring expert ground truth establishment was conducted for this 510(k) submission.
4. Adjudication Method for the Test Set
- Not applicable. No new test set was conducted for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done for this submission. The submission explicitly states "Clinical Tests: None Required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. The device is a diagnostic ultrasound system (hardware and software), not an algorithm-only device. No standalone performance study (in the sense of an AI algorithm) was conducted or needed for this hardware system and its expanded indications.
7. The Type of Ground Truth Used
- Not applicable for this specific submission to demonstrate effectiveness for the expanded indications. The "ground truth" for the current submission is the established safety and effectiveness of the predicate devices. Any ground truth used for the original predicate device (K110207) or other predicate devices for their respective clinical applications would have been established at that time (e.g., clinical diagnosis, surgical findings, pathology, or other accepted diagnostic methods for ultrasound). This document does not elaborate on that.
8. The Sample Size for the Training Set
- Not applicable. This device is a diagnostic ultrasound system, not a machine learning algorithm that requires a "training set" in the conventional sense. Its "effectiveness" is based on the established performance of the underlying ultrasound technology already cleared with predicate devices.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set" for this type of device.
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