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The Press-Mate BX-10 and BX-10An are indicated for use on adult, pediatric, and neonatal patients by a trained and qualified healthcare professional in the hospital, outpatient surgery practitioner facilities, or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition.

The Press-Mate BX-10 patient monitor is intended to monitor a single patient's noninvasive blood pressure and pulse rate.

The Press-Mate BX-10An patient monitor is intended to monitor a single patient's noninvasive blood pressure as well as blood oxygen saturation and pulse rate via Nellcor's oximetry technology.

The Press-Mate BX-10 Series Monitor is a fully portable multiparameter monitoring device which provides the capability for nonitoring of adult, pediatric and neonatal patients in numerous hospital, nursing home and clinical settings. It is a prescription device intended for use only by health care professionals. The oscillometric method, upper arm measurement is employed. The Press-Mate BX-10 is configurable with Nellcor® oxygen saturation (Pulse Oximetry) utilizing the finger for the placement of the sensor. The monitor uses a single tube reusable cuff or may be optionally used with a disposable single tube cuff.

The Press-Mate BX-10 has an optional replaceable and rechargeable battery as well as an optional thermal printer to print displayed data, waveforms and trend information. A liquid crystal display (LCD) and (LED) provides high visibility and clarity in most light conditions. The available parameters displayed will depend on the mode selected by the user.

Visual and audible alarms are provided to alert the user to monitor operational conditions or should patient values exceed default or operator-set high/low limits.

Model BX-10: Non-Invasive Blood Pressure and Pulse Rate
Model BX-10-An: Non-Invasive Blood Pressure and Pulse Rate; and Nellcor® Pulse Oximetry.

This portable device includes an optional integrated printer and is capable of operation from an external AC power source or an internal rechargeable battery. The device uses the same technology and materials as the predicate devices, the Press -- Mate 8800 (K890876 cleared 6/22/89),Press -Mate Advantage (K 973637 cleared 9/25/98) and the Press-Mate Prodigy (K022537 cleared 9/13/02)

The following accessories are available for use with the device:

• 1. Power cord
• 2. Printer Paper
• 3. Operations Manual
• 4. Disposable cuffs
• 5. Reusable cuffs
• 6. Cuff extension hose
• 7. Finger Probe
• 8. Extension Cable

Here's a breakdown of the acceptance criteria and the study information for the Press-Mate BX-10 Vital Signs Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the device "successfully met AAMI SP-10 1992 Standards for accuracy." However, it does not provide specific numerical results (e.g., mean difference and standard deviation) from the clinical study that would directly quantify the accuracy achieved against the AAMI SP10 criteria. It relies on the previous clearance of the predicate devices which used the same NIBP algorithm.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set:
  • Clinical Study for NIBP Accuracy (on the new monitor): 85 adult and pediatric subjects were tested.
  • Clinical Study for NIBP Accuracy (from predicate Press-Mate 8800): A total of 85 adults, 85 pediatrics, and 15 neonates. (The NIBP algorithm is stated to be the same in the new monitor as in the 8800, 2100, and Advantage.)
• Data Provenance: Retrospective for the primary clinical accuracy study referenced (Press-Mate 8800), as the "accuracy of the NIBP algorithm was established in the adult, pediatric, and neonatal populations with the ANSI/AAMI SP10 clinical study for the Press – Mate 8800 and the Press – Mate Advantage monitors." A new, additional accuracy study was performed on the new monitor, also according to AAMI SP-10, with 85 adult and pediatric subjects.
• Country of Origin: The predicate device study was conducted at Baylor College of Medicine (USA). The Press-Mate Prodigy evaluation against arterial line was performed at the University of Tennessee Medical Center (USA).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts or their qualifications for establishing ground truth for the NIBP clinical accuracy studies. It only mentions that the studies were conducted under IRB approval with informed consent. For NIBP studies, ground truth is typically established by trained technicians using a reference method (e.g., auscultation with a mercury sphygmomanometer) as per AAMI standards.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method. For NIBP validation against AAMI SP10, it's common practice to have multiple observers perform auscultation, and their readings might be averaged or discrepancies resolved by a third party, but this is not detailed here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a vital signs monitor, not an AI diagnostic tool requiring human reader interpretation enhancement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study for the NIBP algorithm was performed, as evidenced by the "Clinical Study for Accuracy - Overall System Efficacy" which evaluated the device's NIBP algorithm directly against a reference standard in patients according to ANSI/AAMI SP10. The device itself automatically calculates blood pressure, so the focus is on this algorithmic performance.

7. Type of Ground Truth Used

• For NIBP Accuracy (predicate device studies and new device study): The implicit ground truth for NIBP accuracy, as per ANSI/AAMI SP10, is typically based on simultaneous auscultation measurements by trained observers using a reference sphygmomanometer.
• For Press-Mate Prodigy (PM-2100) mean blood pressure evaluation: Arterial line was used as the reference standard. This is a more direct and invasive measure of blood pressure.

8. Sample Size for the Training Set

The document does not provide information about a separate "training set" or its sample size. This is typical for medical devices relying on established algorithms (like oscillometric NIBP) that have been developed and refined over time. The "training" in such devices usually refers to the initial algorithm development and refinement, which might have involved a different set of data not detailed here, or iterative development based on general physiological principles. The focus of these submissions is typically on the validation of the final algorithm.

9. How the Ground Truth for the Training Set Was Established

Since no specific training set is mentioned as part of this submission, the method for establishing its ground truth is not described.

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The Press-Mate PM-2100 patient monitor is intended to monitor a single patient's vital signs in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device capable of monitoring:

Pulse rate (via oximetry data) Non-invasive pressure (systolic, diastolic and mean oscillometric NIBP) Temperature Blood oxygen saturation (Sp02 via finger oximeter)

This device is intended for use by qualified healthcare personnel trained in its use.

The Press-Mate PM-2100 Series Monitor is a fully portable multiparameter monitoring device which provides the capability for nonitoring of adult, pediatric and neonatal patients in numerous hospital, nursing home and clinical settings. It is a prescription device intended for use only by health care professionals. The oscillometric method, upper arm measurement is employed. The PM-2100 includes, temperature via ALARIS® electronic predictive thermometry and Nellcor® oxygen saturation (Pulse Oximetry) utilizing the finger for the placement of the sensor. The monitor uses a single tube reusable cuff or may be optionally used with a disposable single tube cuff.

The PM-2100 has an optional replaceable and rechargeable battery as well as an optional thermal printer to print displayed data, waveforms and trend information. A liquid crystal display (LCD) and (LED) provides high visibility and clarity in most light conditions. The available parameters displayed will depend on the mode selected by the user.

Visual and audible alarms are provided to alert the user to monitor operational conditions or should patient values exceed default or operator-set high/low limits.

Model 2100: Non - Invasive Blood Pressure and Pulse Rate

Model 2110: Non - Invasive Blood Pressure and Pulse Rate; and Nellcor® Pulse Oximetry and Pulse Rate

Model 2120: Non – Invasive Blood Pressure and Pulse Rate; and Monitor/Predictive Oral/Rectal Temperature

Model 2140: Non - Invasive Blood Pressure and Pulse Rate; and Monitor/Predictive Oral/Rectal Temperature and Nellcor® Pulse Oximetry and Pulse Rate

This portable device includes an optional integrated printer and is capable of operation from an external AC power source or an internal rechargeable battery. The device uses the same technology and materials as the predicate devices, the Press - Mate 8800 (K890876 cleared 6/22/89) and the Press - Mate Advantage (K 973637 cleared 9/25/98)

The following accessories are available for use with the device:

• 1. Power cord
• 2. Printer Paper
• 3. Operations Manual
• 4. Disposable cuffs
• 5. Reusable cuffs
• 6. Cuff extension hose
• 7. Temperature probe
• 8. Finger Probe
• 9. Extension Cable

Here's a breakdown of the acceptance criteria and study information for the Press-Mate PM-2100 Vital Signs Monitor, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

A new accuracy study was performed on the PM-2100 according to AAMI SP-10 for 85 adult and pediatric subjects, and the device passed. |
| Stability (Voltage Range, Life) | ANSI/AAMI SP10-1992 (4.2.4.1, 4.2.4.2) | Passed all tests. |
| Safety (Max Cuff Pressure, Deflation, Electrical, Conductive Components) | ANSI/AAMI SP10-1992 (4.3.1.1, 4.3.2, 4.3.2, 4.3.3) | Passed all tests. |
| Performance (Pressure Indicator Accuracy, Battery-Powered Devices) | ANSI/AAMI SP10-1992 (4.4.1, 4.4.3) | Passed all tests. |
| Environmental Performance | FDA Draft Reviewer Guidance (Nov 1993) | Met the requirements. |

Note: The provided document focuses heavily on the NIBP function's validation and substantial equivalence claims based on predicate devices. While other parameters like Pulse rate, Temperature, and SpO2 are listed as capabilities, detailed acceptance criteria and specific performance data for each in a standalone study for the PM-2100 are not explicitly provided in this summary. The inference is that these parameters are also substantially equivalent to the predicate devices due to shared technology (e.g., Nellcor® oximetry, ALARIS® thermometry).

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • NIBP Algorithm Accuracy: A new accuracy study was performed on the PM-2100 with 85 adult and pediatric subjects.
  • For the predicate devices (Press-Mate 8800 and Press-Mate Advantage), clinical studies for NIBP accuracy were established for adult, pediatric, and neonatal populations, but specific sample sizes for these prior studies are not detailed in this summary.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data for the PM-2100 or its predicate devices. It also doesn't specify if the data was retrospective or prospective, though "clinical study for accuracy" typically implies prospective data collection.

3. Number and Qualifications of Experts for Ground Truth

• The document does not specify the number of experts used to establish ground truth or their qualifications. For NIBP studies conforming to ANSI/AAMI SP10, ground truth is typically established by trained observers taking auscultatory measurements simultaneously with the device measurements. The qualifications of these observers (e.g., specific medical training, experience) are crucial but not detailed here.

4. Adjudication Method

• The document does not specify an adjudication method. For NIBP studies following ANSI/AAMI SP10, a comparison is made between the device readings and simultaneous auscultatory readings from human observers. Discrepancies might be handled through established protocols within the standard, but specific adjudication (e.g., 2+1, 3+1) is not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study is mentioned. This type of study is more common for diagnostic imaging AI devices where human readers interpret and compare with and without AI assistance. This device is a vital signs monitor, which typically involves direct measurement and comparison to reference methods rather than diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done for the NIBP algorithm. The "new accuracy study... according to AAMI SP-10 in which 85 adult and pediatric subjects were tested" assesses the device's (algorithm's) performance against a reference standard. The fact that "the NIBP parameter of the new monitor has the same NIBP algorithm... as the Press - Mate 8800... and the Press - Mate Advantage" further supports that the algorithm's performance was evaluated independently during the predicate device's clearance and subsequently confirmed for the new device.

7. Type of Ground Truth Used

• For NIBP, the ground truth used for the clinical accuracy studies (both for the current device and predicate devices as per ANSI/AAMI SP10) is auscultatory measurement performed by human observers. This is considered the reference standard for non-invasive blood pressure measurement.

8. Sample Size for the Training Set

• The document does not provide information about a training set since it explicitly states that the NIBP algorithm is the same as in the predicate devices. Therefore, the algorithm itself was developed and "trained" (if machine learning was involved, which is unlikely for early 2000s oscillometric NIBP algorithms) and validated significantly during the development and clearance of the Press-Mate 8800 and Press-Mate Advantage. The PM-2100's study served as a confirmatory accuracy study for its implementation of this existing algorithm.

9. How Ground Truth for Training Set Was Established

• As a training set is not mentioned in the context of the PM-2100 (which reuses an existing algorithm), information on how ground truth was established for algorithm development is not provided in this summary. For the original algorithm development, it would have been established through a similar process of comparing oscillometric readings to auscultatory reference measurements across a diverse patient population.

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The PressMate Advantage monitors non-invasive blood pressure (NIBP), Oxygen saturation (Sp02), ECG, Respiration Rate and Body Temperature of an Adult, Pediatric or Neonate in the clinical setting.

The PressMate Advantage Monitor measures, displays and (optionally) prints the following parameters:

1. NIBP (systolic, Diastolic, Mean and Pulse Rate)
2. ECG
3. Body Temperature
4. Sp02 ( Oxygen Saturation and Pulse Rate)

The provided 510(k) summary for the PressMate Advantage does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a detailed study report. The document is a premarket notification for substantial equivalence, focusing on comparisons to predicate devices and general regulatory compliance rather than in-depth performance study results.

However, based on the information provided, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "The design of the PressMate Advantage has been thoroughly validated at the unit and system level. Non-clinical tests were conducted to determine the complete system and has been tested to the electrical safety requirements and the Electromagnetic Compatibility requirements of EN 60601."

And "The testing of the PressMate Advantage demonstrates that the performance is substantially equivalent to predicate devices cited above."

This indicates that acceptance criteria likely involved meeting relevant electrical safety and EMC standards (EN 60601) and demonstrating performance equivalent to the predicate devices (PressMate Model 8800 and Escort Model 102). However, specific numerical acceptance criteria (e.g., accuracy ranges for NIBP, SpO2) and the corresponding reported performance values for the PressMate Advantage are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide any information on the sample size used for clinical performance testing, data provenance, or whether the study was retrospective or prospective. The focus is on non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable or not provided. The document describes non-clinical engineering and comparison testing, not a study involving human expert ground truth for medical interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable or not provided as there is no mention of clinical readings requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an automated vital signs monitor, not an AI-assisted diagnostic tool for human readers. There is no mention of any MRMC study or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document refers to "Non-clinical tests" and "testing of the PressMate Advantage" demonstrating its performance. This implies standalone testing of the device's measurement capabilities. However, specific details of this testing (e.g., number of subjects, accuracy metrics) are not provided. The phrase "algorithm only" is not directly applicable as it's a hardware device with embedded software for measurements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For non-invasive blood pressure, SpO2, ECG, and temperature, the "ground truth" would typically involve validated reference devices (e.g., invasive arterial pressure lines for NIBP, CO-oximeters for SpO2, calibrated temperature probes). However, the document does not specify the type of ground truth used in its "Nonclinical Tests." It only states the device uses "the standard oscillometric technique for obtaining. NIBP Nellcor Sp02 technology for Oxygen saturation, standard ECG technology and YSI temperature probes," implying a comparison to these established gold standards.

8. The sample size for the training set

This is not applicable or not provided. The device in question is a vital signs monitor, not typically a machine learning model that requires a "training set" in the conventional sense. Its "training" would be through design, calibration, and engineering validation.

9. How the ground truth for the training set was established

This is not applicable or not provided for the same reasons as point 8.

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