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510(k) Data Aggregation
(161 days)
The BioCare vTrust 701DH NIBP monitor is a compact, battery-powered monitor which measures noninvasive blood pressure (systolic and mean arterial pressure) and pulse rate based on the principle of plethysmography (oscillometric on inflation). This equipment is intended for use only by qualified medical providers in conjunction with established medical protocols. It is not intended for use in an MRU environment, or in an air transport environment.
The BioCare vTrust 701DH NIBP monitor is a compact, battery-powered monitor which measures noninvasive blood pressure (systolic, diastolic and mean arterial pressure) and pulse rate based on the principle of plethysmography (oscillometric on inflation). The oscillometric method detects volume displacements within the artery and senses pressure variations within the blood pressure cuff during inflation. The measurement is more quickly and with less patient discomfort than with monitors which measure NIBP during cuff deflation. Cycle time function enables you to pre-set measurement intervals. User can set alarm limits by selectable for high or low range.
1. Table of Acceptance Criteria and Reported Device Performance:
| Clause | Performance Characteristics | Max. permissible error or acceptance criteria | Reported Device Performance (Max. deviation) | Passed/Failed |
|---|---|---|---|---|
| 4.2.1 | Storage conditions: [23°F(-5°C)] for 24 hrs; [122°F(50°C)] for 24 hrs; RH: 90% (noncondensing) | ≤± 3 mmHg (±0.4 kPa) ≤± 4 mmHg for in use | -3.4 mmHg | Passed |
| 4.2.2 | Operating conditions: Temp: 50°F (10°C) | ≤± 3 mmHg (±0.4 kPa) ≤±4 mmHg for in use | ± 3 mmHg | Passed |
| 4.2.3 | Vibration and shock: ISTA-standard drop and vibration test IEC 60601-1, sections 21.5 & 21.6 | ISTA-1A: 14,200 vibratory impacts; drop test-10 drops; before and after transportation test within ±5 mmHg of the average reading. | no visible damage; SD ≤8 mmHg | Passed |
| 4.2.4.1 | Voltage range: Battery-powered devices-indication of battery condition | Red light: low battery; Blue light: batteries are charging; Green light: fully charged | 25 mmHg/sec | mmHg/sec |
| 4.3.2 | Electrical safety: | IEC 60601-1, 1988; Amendment 1, 1991; & Amendment 2, 1995. | N/A | Passed |
| 4.4.3.1.A | Range: 0 mmHg to at least 260 mmHg by visual inspection | NIBP pressure calibration | 0~300 mmHg | Passed |
| 4.4.3.2.A | Resolution: 1 mmHg by visual inspection | NIBP pressure calibration | 1 mmHg | Passed |
| 4.4.3.3.A | Accuracy of pressure measurement: Ambient temp 10°C~40°C; RH: 15%~90%; Pressure stages: 50, 100, 150, 200, 250, 300 mmHg | ≤±3 mmHg (±0.4 kPa) or 2% of the reading; ≤±4 mmHg for in use | ±3 mmHg | Passed |
| 4.4.3.4.A | Repeatability Cuff-Link simulator test for stability and reproduction of performance Adult: SYS120/DIA80/MAP90 mmHg, 80 BPM Neo: SYS80/DIA50/MAP62 mmHg, 120 BPM | Average difference ≤± 5 mmHg | 5 mmHg | Passed |
| 4.4.3.6.A | Leakage: Ambient temp 15°C | ≤6 mmHg/min | 1.2 mmHg/min | Passed |
| 4.4.4.B | Pressure transducer accuracy: Ambient temp 10℃~40℃; RH: 15%~90%; Pressure stages: 50, 100, 150, 200, 250, 300 mmHg | ≤±3 mmHg (±0.4 kPa) or 2% of the reading; ≤±4 mmHg for in use | ±3 mmHg | Passed |
| 4.4.5.B | Overall system efficacy-clinical testing (auscultatory method as the reference Std.) no fewer than 85 subjects with a minimum of 255(=3*85) observations | For systolic and diastolic: mean≤±5 mmHg; SD ≤8 mmHg | Mean: Sys/Dia 3.4/-4.5; SD: Sys/Dia 5.23/4.64 mmHg | Passed |
| 4.5.1 | Inflation source: pressure~300mmHg≤10s | NIBP pressure calibration: inflate at 5 mmHg/sec; Speed test: Inflation > 5 mmHg/sec | N/A | Passed |
| 4.5.4.3.B | Automated valves-Release rate: rapid exhaust with fully-opened valve | 260mmHg → 15mmHg ≤10 sec or 150mmHg → 5mmHg ≤5 sec | deflate at 25 mmHg/sec | Passed |
| IEC 60601-2-30 | Automatic cycling function 1. In long term automatic mode (normal condition) Adult 120/80(90)[SYS/DIA(MAP)]--long term Neonate 80/50(62)[SYS/DIA(MAP)]--long term 2. In long term automatic mode (single fault condition) 3. In short term automatic mode (stat mode) | 1. deflated time ≥30 sec; mean≤± 5 mmHg; 2. deflated time ≤30 sec; release cuff pressure to below 15mmHg(adult)/ 5mmHg(neo.); 3. deflated time≥2sec. after each determination | 1. average for adults 34 sec / for neonates 42 sec; -4mmHg; 2. |
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(71 days)
The Stripmax 1210 Urine Chemistry Analyzer is a semi-automatic urinalysis instrument intended for reading UriMate Reagent Strips for Urinalysis. The tests provided on UriMate Reagent Strips are considered routine urinalysis.
UriMate Reagent Strips for Urinalysis are dip-and-read test strips intended for use as an in vitro diagnostic aid using urine specimens. UriMate Reagent strips provide qualitative and semiquantitative tests for specific gravity, pH, Blood, leukocytes, nitrite, protein, bilirubin, ketone(acetoacetic acid), glucose, and urobilinogen by visual comparison to a color chart or by use of the Stripmax Urine Chemistry Analyzer. The tests provided are considered routine urinalysis.
The Stripmax 1210 Urine Chemistry Analyzer is a semi-automatic urinalysis instrument intended for reading UriMate Reagent Strips for Urinalysis. UriMate Reagent Strips for Urinalysis are dip-and-read test strips intended for use as an in vitro diagnostic aid using urine specimens.
The provided text describes a 510(k) premarket notification for the "Stripmax 1210 Urine Chemistry Analyzer" and "UriMate Reagent Strip for Urinalysis." However, it does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.
The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It lists the device name, regulation numbers, classification, product codes, and indications for use.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and the study that proves the device meets them based on the provided text. The requested information is simply not present in this regulatory clearance document.
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(29 days)
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