(81 days)
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No
The summary describes a standard blood gas and electrolyte analyzer with no mention of AI or ML capabilities. The performance studies focus on equivalence to a predicate device, not on validating an AI/ML algorithm.
No.
The device is used to analyze blood samples for diagnostic purposes and does not provide therapy.
Yes
The device is described as an "Analyzer" that measures various parameters (p02, pC02, pH, Na+, K+, iCa++, and hematocrit) from blood samples to aid in determining patient conditions, which falls under the definition of a diagnostic device. The "Intended Use" also states it's for analyzing patient samples by healthcare professionals in a clinical setting.
No
The device description clearly states it is a physical analyzer (12" x 10" x 16.5") that measures blood samples and uses a disposable reagent cartridge, indicating it is a hardware device with integrated software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to "rapidly analyze patient whole blood samples". This is a classic description of an in vitro diagnostic test, as it involves analyzing a biological sample taken from the patient outside of the body to provide information about their health status.
- Device Description: It measures various parameters (p02, pC02, pH, Na+, K+, iCa++, hematocrit) from a blood sample. These are all common analytes measured in clinical laboratories for diagnostic purposes.
- Clinical Setting: The device is intended for use "at the point of care, in a clinical setting," which is a common environment for IVD testing.
The fact that it analyzes a biological sample (whole blood) in vitro (outside the body) to provide diagnostic information about the patient's condition clearly places it in the category of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GEM Premier Plus is designed for use by health care professionals to rapidly analyze patient whole blood samples at the point of care, in a clinical setting.
Product codes
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Device Description
The GEM Premier Plus is a small (12" x 10" x 16.5") Blood Gas and Electrolyte Analyzer designed for use by non-laboratory medical personnel at the point of care. The device, along with its disposable reagent cartridge is capable of measuring p02, pC02, pH, Na+, K+, iCa++ and hematocrit from a single 200uL blood sample in 104 seconds. The device will also calculate the following derived parameters - HCO3, TCO2, Base Excess, O2 Sat. The system is self calibrating with all calibration solutions, sensors, pump tubing and waste bag contained within a disposable cartridge.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
health care professionals / point of care, in a clinical setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The GEM Premier Plus was tested at five clinical sites and compared to the predicate device, the GEM Premier. All tests were performed by health care professionals with limited training in the use of blood gas and electrolyte analyzers. Patient samples were run on both the GEM Premier Plus and the GEM Premier instruments.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Tests: The results from the clinical tests demonstrated that the GEM Premier Plus and the predicate device, the GEM Premier were substantially equivalent in performance.
Non Clinical Tests: The GEM Premier has been tested and found to comply with UL 544 and IEC1010-1
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
GEM® Premier
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '9', '6', '1', '3', '3', and '5'. The digits are written in a connected manner, with a slightly slanted orientation. The handwriting style appears casual and the contrast between the ink and the background is high, making the characters easily readable.
Section 2 510(k) Summary and Certification
The 2 8 1996
| Contact person : | Andrew C. Taylor
Director of Research and Development
Tel : (313) 973 7000
Fax : (313) 973 1368 |
|--------------------|----------------------------------------------------------------------------------------------------------|
| Date : | April 5, 1996 |
| Device Name : | GEM® Premier Plus
Blood Gas and Electrolyte Analyzer |
| Predicate Device : | GEM® Premier
Blood Gas and Electrolyte Analyzer |
Description :
The GEM Premier Plus is a small (12" x 10" x 16.5") Blood Gas and Electrolyte Analyzer designed for use by non-laboratory medical personnel at the point of care. The device, along with its disposable reagent cartridge is capable of measuring p02, pC02, pH, Na+, K+, iCa++ and hematocrit from a single 200uL blood sample in 104 seconds. The device will also calculate the following derived parameters - HCO3, TCO2, Base Excess, O2 Sat. The system is self calibrating with all calibration solutions, sensors, pump tubing and waste bag contained within a disposable cartridge.
Intended Use :
The GEM Premier Plus is designed for use by health care professionals to rapidly analyze patient whole blood samples at the point of care, in a clinical setting.
Technological Characteristics vs. Predicate Device :
The measurement technology used in the GEM Premier Plus is identical to that used in the predicate device, the GEM Premier
Non Clinical Tests to Support Equivalence Determination
The GEM Premier has been tested and found to comply with UL 544 and IEC1010-1
1
Clinical Tests to Support Equivalence Determination
The GEM Premier Plus was tested at five clinical sites and compared to the predicate device, the GEM Premier. All tests were performed by health care professionals with limited training in the use of blood gas and electrolyte analyzers. Patient samples were run on both the GEM Premier Plus and the GEM Premier instruments.
Conclusions Drawn From Clinical Tests
The results from the clinical tests demonstrated that the GEM Premier Plus and the predicate device, the GEM Premier were substantially equivalent in performance.
The manufacturer states that the device is safe and effective for its intended use as a Critical Care Blood Gas and Electrolyte Analyzer when operated per the GEM Premier Plus labeling.