(56 days)
The CARESCAPE V100 Vital Signs Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature.
The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. The CARESCAPE V100 Vital Signs Monitor can also be used in satellite areas, physicians' office, or alternate care settings.
The CARESCAPE V100 vital signs monitor provides a small, portable, easy-to-use monitoring alternative for sub-acute hospital and non-hospital settings. The monitor is for use on adult, pediatric, or neonatal patients-one at a time. The battery-operated monitor offers noninvasive determination of systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, oxygen saturation, and temperature. Monitors are available with or without integrated printers as well as the following parameters and technologies.
• NIBP, Pulse: SuperSTAT, Auscultatory, or Classic
• SpO2: Ohmeda TruSignal, Nellcor OxiMax, or Masimo SET
• Temperature: Alaris Turbo Temp, Alaris Tri-Site, or Exergen TemporalScanner Thermometer
The provided text is a 510(k) Premarket Notification Submission for the GE CARESCAPE V100 Vital Signs Monitor. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and device performance. Here's what can be extracted and what information is not available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not include a table of acceptance criteria or reported device performance in the way typically found in a clinical study report for new AI/algorithm-based devices. The submission focuses on demonstrating compliance with voluntary standards and substantial equivalence, not specific performance metrics against pre-defined clinical thresholds.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable/not provided. The document explicitly states: "The subject of this premarket submission, CARESCAPE V100 Vital Signs Monitor, did not require clinical studies to support substantial equivalence." This means there was no clinical "test set" in the context of evaluating algorithm performance on patient data.
- Data Provenance: Not applicable/not provided for a clinical test set. The submission is based on non-clinical tests and comparisons to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/not provided. Since no clinical studies were performed, there was no need for expert-established ground truth on a test set.
4. Adjudication Method for the Test Set:
- Not applicable/not provided. No clinical test set required adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document explicitly states: "The subject of this premarket submission, CARESCAPE V100 Vital Signs Monitor, did not require clinical studies to support substantial equivalence." Therefore, no MRMC study was conducted.
- Effect Size: Not applicable.
6. If a Standalone (Algorithm Only) Performance Study Was Done:
- No. The submission states that "The CARESCAPE V100 Vital Signs Monitor employs the same fundamental Technology: scientific technology as its predicate devices." and relies on non-clinical tests and compliance with voluntary standards. There is no mention of a standalone algorithm performance study.
7. The Type of Ground Truth Used:
- Not applicable/not provided. No clinical ground truth (expert consensus, pathology, outcomes data) was used or established for this submission. The device's performance is assumed to be substantially equivalent to predicates based on its design and non-clinical testing.
8. The Sample Size for the Training Set:
- Not applicable/not provided. This device is a vital signs monitor and its submission focuses on demonstrating equivalence to existing technology, not on an AI/machine learning algorithm requiring a "training set" in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/not provided. There is no mention of an algorithm requiring a training set or associated ground truth establishment.
Summary of Device Evaluation (based on the provided text):
The GE CARESCAPE V100 Vital Signs Monitor achieved 510(k) clearance by demonstrating substantial equivalence to predicate devices (K073203 CARESCAPE V100, K011291 Exergen TemporalScanner Thermometer, K050230 TurboTemp Trio).
The basis for this substantial equivalence was:
- The device employs the "same fundamental Technology: scientific technology as its predicate devices."
- Compliance with voluntary standards (as detailed in Sections 9, 11, and 17, though these sections are not included in the provided text).
- Non-clinical tests including:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Unit level testing (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
The submission explicitly states that clinical studies were not required to support substantial equivalence. Therefore, the detailed information requested regarding clinical study design, test set characteristics, expert involvement, and ground truth establishment is not present in this document.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).