(56 days)
The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.
pH, p02 and pC02: pH, pC02 and p02 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Potassium (cK): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Sodium (cNa ): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration. inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
Calcium (cCa2'): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany,
Chloride (cCT): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.
Glucose (cGlu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.)
Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
sO>: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.
FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.
FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
FMetHb: methemoglobin as a fraction of total hemoglobin.
FHHb: reduced hemoglobin as a fraction of total hemoglobin.
Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.
The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2 , pCO2, potassium, sodium, calcium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).
The integration with Netop™ allows remote operators to access a specific ABL90 Flex analyser and to execute a number of predefined functions.
This 510(k) submission describes a device modification to the ABL90 Flex, specifically the integration with Netop™ for remote access functionalities. The crucial point articulated in the document is that "No performance characteristics are affected by the change. The performance data submitted in K092686 still apply."
This statement fundamentally changes how we address your request. Typically, an acceptance criteria table and a description of a study proving the device meets those criteria would involve new performance data. However, for this specific submission, the "study" demonstrating the device meets acceptance criteria is essentially the assertion that no new performance data is needed because the modification does not impact performance.
Therefore, the answers below are structured to reflect this nature of the submission.
1. A table of acceptance criteria and the reported device performance
Given the statement that "No performance characteristics are affected by the change," new acceptance criteria and performance data for the modified device were not generated. The acceptance criteria and reported device performance for the ABL90 Flex remain as established in the original 510(k) K092686. The table below represents the original performance characteristics and their acceptance, as implied by the substantial equivalence argument, rather than new data for this specific modification.
| Parameter | Performance Characteristic (from K092686 - summarized) | Acceptance Criteria (from K092686 - summarized) | Reported Device Performance (from K092686 - summarized) |
|---|---|---|---|
| pH | Accuracy, Precision | Clinically acceptable limits (e.g., within X standard deviation of reference method) | Met established clinical performance |
| pO2 | Accuracy, Precision | Clinically acceptable limits | Met established clinical performance |
| pCO2 | Accuracy, Precision | Clinically acceptable limits | Met established clinical performance |
| Potassium (cK+) | Accuracy, Precision | Clinically acceptable limits | Met established clinical performance |
| Sodium (cNa+) | Accuracy, Precision | Clinically acceptable limits | Met established clinical performance |
| Calcium (cCa2+) | Accuracy, Precision | Clinically acceptable limits | Met established clinical performance |
| Chloride (cCl-) | Accuracy, Precision | Clinically acceptable limits | Met established clinical performance |
| Glucose (cGlu) | Accuracy, Precision | Clinically acceptable limits | Met established clinical performance |
| Lactate (cLac) | Accuracy, Precision | Clinically acceptable limits | Met established clinical performance |
| Total Hemoglobin (ctHb) | Accuracy, Precision | Clinically acceptable limits | Met established clinical performance |
| Oxygen Saturation (sO2) | Accuracy, Precision | Clinically acceptable limits | Met established clinical performance |
| Hemoglobin fractions (FO2Hb, FCOHb, FMetHb, FHHb, FHbF) | Accuracy, Precision | Clinically acceptable limits | Met established clinical performance |
| Remote Access Functions (via Netop™) | Functionality (e.g., perform calibrations, QC measurements, approve results) | Software performs intended functions without affecting core analytical performance. | No adverse impact on current performance characteristics of the ABL90 Flex. |
Study Proving Acceptance Criteria Met (for this K120197 submission):
The "study" proving the device meets acceptance criteria for this specific 510(k) (K120197) is the lack of further performance testing due to the nature of the modification. The manufacturer asserts that the integration with Netop™ for remote access does not impact the analytical performance characteristics of the ABL90 Flex. The FDA's clearance implies agreement with this assertion, based on the provided information comparing the modified device to the predicate.
2. Sample size used for the test set and the data provenance
For this 510(k) (K120197): Not applicable for new performance data. No new clinical or analytical test set was evaluated, as the modification did not affect performance characteristics. The safety and effectiveness data from the predicate device (K092686) would have been based on performance studies, but details of those are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For this 510(k) (K120197): Not applicable for new performance data. Ground truth for the original performance of the ABL90 Flex (K092686) would have been established using reference methods and potentially expert review in clinical studies as appropriate for an in vitro diagnostic device, but specific details are not available in this modification summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
For this 510(k) (K120197): Not applicable for new performance data. Adjudication methods are typically relevant for human interpretation of results or image-based diagnostics. For an automated analyzer, the "ground truth" is predominantly based on highly accurate reference methods.
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
For this 510(k) (K120197): Not applicable. This device is an automated blood gas analyzer, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
For this 510(k) (K120197): Not applicable for new performance data. However, the core ABL90 Flex device is a standalone automated analyzer. The modification (Netop™ integration) adds remote access capabilities but does not introduce an "algorithm only" performance study in the context of typical AI/software submissions. The performance of the analyzer itself is inherently standalone.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this 510(k) (K120197): Not applicable for new data. For the original device (K092686), the ground truth for blood gas and chemistry measurements would have been established by highly accurate and traceable reference methods (e.g., primary standard gases, gravimetric methods, recognized laboratory reference instruments) for accuracy studies, and repeated measurements for precision studies.
8. The sample size for the training set
For this 510(k) (K120197): Not applicable. This modification involves software integration for remote access to existing functions, not an AI/machine learning model requiring a training set.
9. How the ground truth for the training set was established
For this 510(k) (K120197): Not applicable, as no training set was used for this modification.
§ 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.