(241 days)
No
The summary describes a blood gas analyzer that uses potentiometric and ion-selective electrode technology to measure pH. There is no mention of AI or ML in the device description, intended use, or performance studies. The studies described are standard analytical performance and method comparison studies, not studies related to AI/ML model training or validation.
No.
This device is an in vitro diagnostic (IVD) device used for measuring the pH of pleural fluid samples, which provides information for diagnosis and management, but does not directly treat or cure a disease or condition.
Yes
The device is intended for in vitro testing of pleural fluid samples for pH, which is stated to be a "clinically useful tool in the management of patients with parapneumonic effusions" and provides "important information for the diagnosis of exudative pleural effusions." This directly indicates its use for diagnostic purposes.
No
The device is described as a "blood gas analyzer" and utilizes "ion selective electrode (ISE) technology" for measurement, indicating it is a hardware device with software functionality. The software update adds a new measurement capability to an existing hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the systems are "intended for in vitro testing of pleural fluid samples for the pH parameter." "In vitro" means "in glass" or "outside of the body," which is a key characteristic of IVD devices.
- Sample Type: The device analyzes "pleural fluid samples," which are biological specimens taken from the body.
- Purpose: The testing is performed to provide "clinically useful tool in the management of patients with parapneumonic effusions" and "important information for the diagnosis of exudative pleural effusions." This indicates the results are used for medical purposes related to diagnosis and patient management.
- Device Description: The description further clarifies that the system is a "point-of-care and laboratory testing blood gas analyzer" and that the pleural fluid pH measurement is added to its capabilities. Blood gas analyzers are typically considered IVD devices.
- Testing Method: The device uses the "potentiometric method using ion selective electrode (ISE) technology" to measure pH, which is a common analytical technique used in IVD testing.
- Performance Studies: The document describes analytical performance studies and method comparison studies, which are standard types of studies performed to validate the performance of IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K110416; ABL835 FLEX Analyzer With Pleural pH) is a strong indicator that this is a submission for a medical device, and specifically an IVD, as predicate devices are used in the regulatory pathway for many IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RAPIDPoint® 400/405/500 systems are intended for in vitro testing of pleural fluid samples for the pH parameter. Test systems are intended for use in point of care or laboratory settings.
The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.
The following critical value applies to pleural fluid pH: pH > 7.3 is measured in uncomplicated parapneumonic effusions. All pleural fluids with a pH measurement
§ 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.
0
510(k) Summary
APR 1 9 2013
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1.0 Submitter Information
Owner
Siemens Healthcare Diagnostics, Inc. Point of Care (POC) Business Unit 2 Edgewater Drive Norwood, MA 02062
Contact
Primary: Amy Goldberg Regulatory Technical Specialist 781-269-3544 TEL
Secondary: Steven Goldberg Manager Regulatory Affairs steven.goldberg@siemens.com
Date Summary Prepared
2.0 Device Information
| Proprietary Name | RAPIDPoint® 400/405/500 Systems |
|---|---|
| Common Name | Blood Fluid = U |
Common Name Pleural Fluid pH Main Classification Name Blood gases (PCO2, PO2) and blood pH test system 21 CFR 862.1120, Class II Product Code CHL
781-269-3941 TEL
March 21, 2013
Subsequent Classifications
3.0 Predicate Device
| Predicate Device | |
|---|---|
| Device Name | ABL835 FLEX Analyzer With Pleural pH |
| Common Name | Pleural Fluid pH |
| 510(k) Number | K110416 |
| Manufacturer | Radiometer Medical ApS |
4.0 Device Description
The RP400/405/500 system is a point-of-care and laboratory testing blood gas analyzer and currently measures a variety of parameters. With this planned release of software, the ability to measure pH in Pleural Fluid will be added to the system.
1
The pleural fluid pH measurement provides important information for the diagnosis of exudative pleural effusions. The RAPIDPoint® 400/405/500 system is intended for in vitro testing of pleural fluid samples for the pH parameter. This test system is intended for use in point of care or laboratory settings. Pleural fluid pH testing follows the same principles as whole blood pH testing. The notation of pH expresses the hydrogen ion activity in a solution as the negative logarithm of the hydrogen ion concentration. The pleural fluid pH measurement uses the potentiometric method using ion selective electrode (ISE) technology.
5.0 Intended Use Statement
RAPIDPoint® 400/405/500 systems are intended for in vitro testing of pleural fluid samples for the pH parameter. Test systems are intended for use in point of care or laboratory settings.
The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.
The following critical value applies to pleural fluid pH: pH > 7.3 is measured in uncomplicated parapneumonic effusions. All pleural fluids with a pH measurement 7.3 is measured in
uncomplicated parapneumonic
effusions. All pleural fluids with a pH
measurement 7.3 is measured in
uncomplicated parapneumonic effusions.
All pleural fluids with a pH measurement
7.3 is measured in uncomplicated parapneumonic effusions. All pleural fluids with a pH measurement 7.3 is measured in uncomplicated parapneumonic effusions. All pleural fluids with a pH measurement