(6 days)
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, 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.
The Acuson SC2000™ has been designed to meet the following product safety standards: UL 60601-1, Safety Requirements for Medical Equipment; IEC 60601-2-37 Diagnostic Ultrasound Safety Standards; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUM/NEMA UD-3. Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound; Safety and EMC Requirements for Medical Equipment; IEC 60601-1; IEC 60601-1-1; IEC 60601-1-2; IEC 1157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.
This 510(k) summary for the ACUSON SC2000 Diagnostic Ultrasound System is a Special 510(k), indicating a minor change to a previously cleared device. Therefore, a comprehensive de novo clinical study demonstrating performance against acceptance criteria for a novel device is not part of this submission. Instead, the performance data section explicitly states: "No performance data required to support this modification, as there is no change to any hardware or software, or method of use."
The submission focuses on demonstrating substantial equivalence to a previously cleared device (K123622) by only renaming three transducers. As such, the typical elements of a study proving a device meets acceptance criteria (like a test set, ground truth, experts, and statistical results) are not provided in this document.
However, I can extract the acceptance criteria implied by this type of submission, which is the determination of substantial equivalence to the predicate device for the specified indications for use.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Implied for a Special 510(k) for Renaming Transducers): The modified device, specifically the renamed transducers, must demonstrate substantial equivalence to the previously cleared predicate device concerning intended use and technological characteristics, with no changes to hardware, software, or method of use.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate | The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics. This modification is intended only to rename three transducers. |
| No Change in Hardware/Software/Method of Use | Confirmed: "No performance data required to support this modification, as there is no change to any hardware or software, or method of use." |
| Continued Adherence to Safety Standards | The Acuson SC2000™ has been designed to meet the following product safety standards: UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 1157, ISO 10993-1. |
| Intended Use Remaining Consistent | The Indications for Use for the overall system and the individual transducers remain largely consistent with previously cleared indications. (P = Previously Cleared) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No new performance testing with a specific test set was conducted for this Special 510(k) given the nature of the modification (renaming transducers).
- Data Provenance: Not applicable. No new data was generated or analyzed for this submission. The basis for substantial equivalence relies on the established performance of the predicate device and the claim that the changes are confined to nomenclature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No new ground truth establishment was required as no new performance data was generated.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This submission does not describe an MRMC comparative effectiveness study.
- Effect Size of Human Readers Improvement: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable. This device is an ultrasound imaging system, not an AI algorithm requiring standalone performance evaluation in the context of this submission.
- The document states there is "no change to any hardware or software," implying no new algorithms or software features are being introduced that would require such testing.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable for new performance evaluation. The "ground truth" for this Special 510(k) is implicitly the established safety and effectiveness of the predicate device (K123622), to which the modified device (with renamed transducers) is claimed to be substantially equivalent without any functional changes.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document does not describe the development or training of any new algorithms or software components.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable.
§ 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.