RAPIDPoint 500e Blood Gas System

K192240 · Siemens Healthcare Diagnostics, Inc. · CHL · Mar 27, 2020 · Clinical Chemistry

Device Facts

• Record ID: K192240
• Device Name: RAPIDPoint 500e Blood Gas System
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Mar 27, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The RAPIDPoint 500e Blood Gas System is intended for use by healthcare professionals in a clinical setting for the in vitro quantitative measurement of pH, pCO2, pO2, sodium, potassium, calcium, chloride, glucose, lactate, total hemoglobin, and neonatal bilirubin in whole blood samples.

Device Story

RAPIDPoint 500e Blood Gas System is a point-of-care diagnostic analyzer; measures pH, blood gases, electrolytes, metabolites, total hemoglobin, and neonatal bilirubin from whole blood samples. Device utilizes electrochemical sensors to transform chemical concentrations into electrical signals; processes data via internal main board components (FPGA, CPLD). Operated by healthcare professionals in clinical settings; provides quantitative results on an integrated display screen. Modifications include OS update to Windows 10 IoT, upgraded barcode scanning, and cybersecurity enhancements (encrypted data transmission). Output supports clinical decision-making regarding patient metabolic and respiratory status. Benefits include rapid, accurate diagnostic information at the point of care.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design control activities, risk analysis, and verification/validation testing of the modified hardware and software components.

Technological Characteristics

Point-of-care blood gas analyzer. Electrochemical sensing principle. Components include FPGA, CPLD, and solid-state hard drive. Connectivity includes encrypted data transmission to POCcelerator and USB port control. OS: Windows 10 IoT. Supports 1D/2D barcode scanning.

Indications for Use

Indicated for use by healthcare professionals for in vitro quantitative measurement of blood gases (pH, pCO2, pO2), electrolytes (Na, K, Ca, Cl), metabolites (glucose, lactate), total hemoglobin, and neonatal bilirubin in whole blood samples.

Regulatory Classification

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.

Predicate Devices

• RAPIDPoint 500 System (K122539)

Submission Summary (Full Text)

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

I Background Information:

A 510(k) Number
K192240

B Applicant
Siemens Healthcare Diagnostics, Inc.

C Proprietary and Established Names
RAPIDPoint® 500e Blood Gas System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CHL | Class II | 21 CFR 862.1120 - Blood gases (pCO2, pO2) and Blood pH Test System | CH - Clinical Chemistry |
| JGS | Class II | 21 CFR 862.1665 - Sodium Test System | CH - Clinical Chemistry |
| CEM | Class II | 21 CFR 862.1600 -Potassium Test System | CH - Clinical Chemistry |
| JFP | Class II | 21 CFR 862.1145 - Calcium Test System | CH - Clinical Chemistry |
| CGZ | Class II | 21 CFR 862.1170 - Chloride Test System | CH - Clinical Chemistry |
| CGA | Class II | 21 CFR 862.1345 - Glucose Test System | CH - Clinical Chemistry |
| GKR | Class II | 21 CFR 864.5620 -Total hemoglobin Test System | CH - Clinical Chemistry |
| MQM | Class I reserved | 21 CFR - 862.1113 Bilirubin in the neonate Test System | CH - Clinical Chemistry |
| KHP | Class I | 21 CFR 862.1450 - Lactic Acid Test System | CH - Clinical Chemistry |

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## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own: CLASS II, device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device are RAPIDPoint 500 System and K122539.

2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. The changes included the following:

- A design change was made to update the Operating System (OS) software from Microsoft Windows 7 Embedded to Windows 10 IoT (internet of Things).
- Upgraded Barcode to support external and onboard 1D and 2D barcode scanners.
- Updated selected instrument main board parts due to obsolescence:
- EXT (Embedded Technology Extended)
- FPGA (Field Programmable Gate Array)
- CPLD (Complex programmable Logic Device)
- Solid state Hard Drive will have a different model due to obsolescence.
- Sodium sensor interferent detected message
- Encrypted data transmission with POCcelerator (Cybersecurity enhancement)
- USB port ON/OFF capability
- Required QC after cartridge change
- Notification when (Automatic quality control) AQC is disabled.
- AQC automatic printing.
- Restricted QC override.
- Updated exterior and display screen design with new color scheme.

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4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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