Search Results

To power the functions of various devices for which batteries or battery packs are configured.

Since rechargeable batteries and battery packs are "device specific", and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, charge, or install these devices.

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals, EMT's, etc. therefore know that the intended use is as a replacement battery.

Only replacement battery 2L226 in this submission (Patient Monitor) is provided Over-the-Counter (OTC).

All other replacement batteries, specifically; 5L375, 6L577, 7L991, 9L977, 9L990, and 9L998 in this submission (Defib/AED's) are provided by prescription only.

Amco rechargeable and non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d -c power source for portable as well as stationary medical equipment.

The provided document is a 510(k) summary for "life+cel" or "lifecel" Battery Packs, which are replacement battery packs for various medical devices. The document describes the testing protocols and performance criteria used to demonstrate substantial equivalence to predicate devices.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes several testing protocols:

• Incoming Inspection: "All cells are inspected..." and "Cases are also inspected...". This implies 100% inspection of incoming cells and cases.
• Cadex Testing: "Any samples that do not meet the criteria are rejected, and subsequently, the entire lot is tested in this manner." This suggests lot-based testing where if a sample fails, the entire lot is tested. The specific sample size for a given lot is not provided, but it's not a fixed test set in the traditional sense, but rather an ongoing QC process.
• Voltage Testing (Completed Packs): "All Battery Packs are tested 100% for correct voltage / polarity prior to shipment." This indicates a 100% test set of all manufactured units.
• Defibrillator Testing: "Independent testing (Beta Tests), as well as random tests on finished packs..." This suggests both an unspecified "Beta Test" sample and a "random" sample from finished production.
• Life Cycle, Temperature, Mechanical & Electrical Component Integrity: The wording "Normal testing would involve..." and "The replacement battery must..." suggests design validation and verification activities, likely involving a representative sample, but the specific sizes are not mentioned.

Data Provenance: The testing appears to be conducted by Amco International Manufacturing & Design, Inc./Phoenix Technology, likely at their facility in Elizabeth, Colorado, USA. The data is prospective in the sense that it's part of their manufacturing and quality control process for the battery packs being submitted.

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

This information is not provided in the document. The "ground truth" for these battery packs is based on objective measurements against specified performance criteria (e.g., voltage, capacity, number of shocks, temperature function, mechanical integrity) and comparison to OEM specifications. It does not involve expert clinical interpretation or consensus.

4. Adjudication Method for the Test Set:

This information is not applicable as the testing described relates to objective engineering and performance verification against predefined specifications, not subjective interpretation requiring adjudication among experts. The "adjudication" is essentially a pass/fail based on quantitative measurements.

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 information is not applicable. The device is a battery pack, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

This information is not applicable. The device is a battery pack, not an algorithm. The performance described is its inherent function as a power source.

7. The Type of Ground Truth Used:

The ground truth used for evaluating the battery packs is based on objective engineering and performance specifications, primarily:

• Quantitative measurements: Voltage, capacity (e.g., 90% threshold for Cadex testing), number of shocks for defibrillator batteries.
• Functional performance: Correct function across specified temperature ranges.
• Structural integrity: Resistance to mechanical damage (e.g., drop tests).
• Comparison to OEM specifications: The replacement devices "must meet or exceed these benchmark results consistently" from OEM battery packs.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a battery pack and does not involve AI or machine learning models that require a training set. The descriptions are for manufacturing and quality control testing.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The 750C monitor is intended to continuously calculate and display the following physiological vital signs: end tidal carbon dioxide, respiration rate, capnograph waveform, functional arterial oxygen saturation, pulse rate, plethysmograph waveform and an optional non-invasive blood pressure measurement of systolic, diastolic, mean arterial pressures along with pulse rate derived from a NIBP pressure waveform. The 750C is intended for monitoring of adult, pediatric and neonatal patients in the care of health care professionals.

The CAS 750C Series Monitor is a multi-parameter patient monitor based on the exterior design and platform of the CAS 740 Vital Signs Monitor. The 750C features a capnograph equivalent to the Oridion Polaris 2004 End-Tidal C02 for the continuous non-invasive measurement and monitoring of carbon dioxide concentration of expired and inspired breath. Monitors in the series also have a choice of MasimoSET® or Nellcor® OxiMAX® Sp02 technology, and CAS MAXNIBP®. All four monitors in the 750C series have end-tidal C02 and a pulse oximeter. Two of the four have an additional third parameter consisting of noninvasive blood pressure. Blood pressure measurement is based on the CAS oscillometric technology, and is identical to that which is found in the CAS 740 series vital signs monitors (K033048).

The 750C monitor is a rugged, portable and lightweight unit widely adaptable for many applications and mounting schemes. Used for spot-checking or continuous monitoring, its features include an easily replaceable Nickel Metal Hydride rechargeable battery pack, wireless infrared printer communication, and a backlit LCD display with both waveform and a numeric display.

The provided 510(k) summary (K050844) describes the CAS 750C Series Monitor, a multi-parameter patient monitor. The submission primarily focuses on establishing substantial equivalence to predicate devices, particularly concerning its capnography and pulse oximetry components, and demonstrating compliance with various safety and performance standards.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table format as one might expect for a new diagnostic or AI device comparing performance metrics. Instead, it refers to compliance with established medical device standards and the demonstrated accuracy of OEM modules. The "performance" is implicitly demonstrated through adherence to these standards and the equivalence to predicate devices.

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

The document does not specify a distinct "test set" in the context of a new algorithm evaluation with a specific sample size. Instead, it relies on:

• Clinical data from OEM module manufacturers: The submission states that OEM parameter suppliers for EtCO2 and SpO2 have demonstrated successful clinical performance in their own premarket submissions. This implies their original submissions included clinical data, though specific sample sizes, provenance, or retrospective/prospective nature for those studies are not provided in this K050844 document.
• NIBP parameter: "The NIBP parameter has been demonstrated to meet the clinical accuracy of AAMI SP10: 2002." AAMI SP10 outlines requirements for clinical testing, usually involving a sample of human subjects (e.g., typically 85 subjects with specific gender and age distributions for accuracy studies). However, the specific sample size, country of origin, or retrospective/prospective nature for the CAS NIBP testing is not detailed here, only that it "meets" the standard.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a physiological monitor, not an interpretive diagnostic device that requires expert consensus for ground truth. The "ground truth" for the physiological parameters (e.g., CO2 concentration, SpO2, blood pressure) would have been established by reference methods or validated equipment during the OEM module development and NIBP validation.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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

No. This is a physiological monitoring device, not an imaging or interpretive diagnostic device that would typically involve a multi-reader, multi-case study to compare human performance with and without AI assistance.

6. Standalone Performance

The performance described for the EtCO2, SpO2, and NIBP components refers to their inherent measurement capabilities. The submission implies standalone performance of the OEM modules and the CAS NIBP technology, which were then integrated into the 750C monitor. "Fully configured model 750 devices were sent to each OEM module manufacturer for performance testing," which suggests verification of the integrated system's performance, but the fundamental "standalone" performance benchmarks belong to the individual components.

7. Type of Ground Truth Used

• Capnography (EtCO2): Likely a reference gas analyzer or a highly accurate laboratory instrument.
• Pulse Oximetry (SpO2): Likely a co-oximeter (which measures arterial oxygen saturation directly from a blood sample) as the reference, often paired with controlled hypoxia studies.
• Non-Invasive Blood Pressure (NIBP): AAMI SP10 typically requires comparison against direct intra-arterial measurements or auscultatory measurements conducted by trained observers (auscultator ground truth) using a mercury sphygmomanometer.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning device in the contemporary sense that would require a "training set" for an algorithm to learn from data. Its functionality is based on established physiological measurement principles and signal processing.

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

Not applicable, as there is no "training set."

Ask a specific question about this device