The RAPIDPoint® 500e Blood Gas System is in vitro diagnostic use and is designed to provide the determination in whole blood for the following parameters:

Partial pressure of carbon dioxide ●
Partial pressure of oxygen
pH
Sodium ●
Potassium
lonized Calcium ●
Chloride .
Glucose ●
. Lactate
. Total Hemoglobin and fractions: FO2Hb, FCOHb, FMetHb, FHHb
. Neonatal Bilirubin

The RAPIDPoint 500e Blood Gas System is also intended for in vitro testing of pleural fluid samples for 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 > 7.3 is measured in uncomplicated parapneumonic effusions. All pleural fluids with a pH measurement < 7.3 are referred to as complicated parapneumonic effusions and are exudative in nature. This test system is intended for use in point of care or laboratory settings.

The following list includes the Indications for Use information for each analyte measured on the RAPIDPoint 500e Blood Gas System:

Lactate: A lactic acid test system is a device intended to measure lactic acid in whole blood. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidsis (abnormally high acidity of the blood).)

Neonate Bilirubin: A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

pCO2, p02, pH: Measurements of blood gases (pCO2, p02) and blood pH are used in the diagnosis and treatment of lifethreatening acid-base disturbances.

Sodium: Sodium measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidis (chronic excretion of tillute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Potassium: Potassium measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Chloride: Chloride measurements are used in the diagnosis and metabolic disorders such as cystic fibrosis and diabetic acidosis.

lonized calcium: Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Glucose: Glucose measurements are used in the diagnosis and treatment of carbohydrate including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Total hemoglobin: Total hemoglobin measurements are used to determine the hemoglobin content of human blood.

Oxyhemoglobin: Oxyhemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

Carboxyhemoglobin: Carboxyhemoglobin measurements are used to determine the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

Device Description

The RAPIDPoint 500e Blood Gas System is a compact, bench-top analyzer designed for in vitro diagnostic testing and is suitable for professional use in a point-of-care or central laboratory environment. This system measures the following: blood gases, electrolytes, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Additionally, the RAPIDPoint 500e Blood Gas System measures pH in pleural fluid.

The RAPIDPoint 500e Blood Gas System incorporates a cartridge-based design with no external reagent bottles or gas tanks. The system uses self-contained measurement and wash/waste cartridges that are replaced when depleted. The system automatically calibrates the measurement sensors and reports results within 60 seconds for display on a color touch screen for easy viewing.

AI/ML Overview

The provided text concerns the FDA 510(k) summary for the RAPIDPoint® 500e Blood Gas System. This document describes a modification to an existing device (RAPIDPoint 500 System) and asserts its substantial equivalence for FDA clearance. Therefore, a study to prove the device meets specific acceptance criteria for a new clinical claim (such as disease diagnosis accuracy based on images) is not applicable here.

The submission is a Special 510(k), meaning the changes are minor and do not alter the intended use, fundamental scientific technology, labeling, or principle of operation. The primary changes are an operating system update and minor hardware/software enhancements.

Key points from the document regarding "acceptance criteria" and "study:

No new performance claims: The document explicitly states: "There is no change to labeled performance claims." This implies that the performance criteria previously established for the predicate device (RAPIDPoint 500 System) are still considered valid and met by the modified device.
Verification and validation activities: The document states: "All verification and validation activities were performed in accordance to relevant standards, established plans and protocols and Siemens Design Control procedures. Testing verified all acceptance criteria were met." This refers to internal engineering and design control testing to ensure the modifications haven't negatively impacted the known performance characteristics of the device.

Given this context, I cannot generate a table of acceptance criteria and reported device performance in the typical sense of a clinical diagnostic study with new performance endpoints. The "acceptance criteria" here refers to demonstrating that the modified device performs comparably to the predicate for all existing measurements and that the new software/hardware features function as intended without compromising safety or effectiveness.

Therefore, the requested information elements cannot be fully addressed in the way they would for a device making new diagnostic claims based on a primary clinical study.

Here's an attempt to answer the questions based on the available information, noting where specific details are not provided:

A table of acceptance criteria and the reported device performance

As this is a Special 510(k) for a modified device with "no change to labeled performance claims" and "no change to principle of operation," there isn't a new set of clinical performance acceptance criteria and reported performance figures presented in this summary document. The acceptance criteria implicitly refer to demonstrating that the modified device's performance is substantially equivalent to the predicate device across all analytes and clinical uses, meaning it continues to meet the predicate's established performance specifications. The document states: "Performance testing results were also comparable."

Inferred Acceptance Criteria (based on substantial equivalence to predicate):
The modified device (RAPIDPoint 500e Blood Gas System) must demonstrate performance comparable to the legally marketed predicate device (RAPIDPoint 500 System) for all measured analytes (pCO2, pO2, pH, Sodium, Potassium, Ionized Calcium, Chloride, Glucose, Lactate, Total Hemoglobin and fractions, Neonatal Bilirubin) in whole blood and pH in pleural fluid. This comparability would typically be assessed by demonstrating agreement (e.g., bias, precision, linearity) within acceptable limits as defined for the predicate device.

Reported Device Performance:
The document states: "Performance testing results were also comparable." Specific numerical performance data (e.g., accuracy, precision) for each analyte for the modified device are not provided in this 510(k) summary, as the submission focuses on substantial equivalence of the modified device to the predicate, rather than establishing new performance specifications.
Sample size used for the test set and the data provenance

Not explicitly stated in the provided document. The document refers to "verification and validation activities" and "performance testing results," but does not detail the sample sizes or the provenance (e.g., country of origin, retrospective/prospective) of the data used for establishing "comparable" performance. Given it's a diagnostic device for blood analysis, samples would typically be human blood and pleural fluid.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable or not specified. For laboratory diagnostic devices like blood gas analyzers, "ground truth" is typically established by reference methods or highly accurate laboratory instruments, not by a panel of human experts interpreting data.
Adjudication method for the test set

Not applicable or not specified. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies for endpoint determination (e.g., presence of disease from images) based on multiple expert opinions. For a blood gas system, the performance is evaluated by comparing measurements against reference methods, not subjective adjudication.
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

Not applicable. This device is an in vitro diagnostic (IVD) blood gas system, not an AI-assisted diagnostic imaging or interpretation device that involves human "readers."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This device is an automated in vitro diagnostic system. Its "standalone" performance means the accuracy and reliability of its measurements of various blood parameters. While the document mentions software changes and cybersecurity enhancements, it is not an algorithm that interprets human-generated data or makes a diagnosis. Its performance is inherent to its measurement capabilities. The 510(k) summary asserts that its performance is "substantially equivalent" to the predicate, implying successful internal testing to confirm this.
The type of ground truth used

For IVD devices measuring physiological parameters, "ground truth" is typically established by:
- Reference methods: Highly accurate and validated analytical methods (e.g., gas chromatography for blood gases, gravimetric methods for electrolytes) or
- Comparison to predicate/established devices: Comparing measurements from the device under evaluation to a legally marketed and well-characterized predicate device or other established clinical laboratory instruments.
This document explicitly states the modified device is "substantially equivalent to the comparative method" (referring to the predicate device).
The sample size for the training set

Not applicable or not specified. This is a measurement device for chemical and physiological parameters, not a machine learning model that requires a distinct "training set" of clinical data in the typical sense. Any internal developmental data would be for engineering optimization rather than model training.
How the ground truth for the training set was established

Not applicable (as it's not an AI/ML device requiring a training set in that context).

Summary

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March 27, 2020

Siemens Healthcare Diagnostics, Inc. Lois Parillon Regulatory Technical Specialist 2 Edgewater Drive Norwood, MA 02062

Re: K192240

Trade/Device Name: RAPIDPoint® 500e Blood Gas System Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: Class II Product Code: CHL, KHP, JGS, CEM, JFP, CGZ, CGA, GKR, MQM Dated: February 24, 2020 Received: February 26, 2020

Dear Lois Parillon:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K192240

Device Name

RAPIDPoint® 500e Blood Gas System

Indications for Use (Describe)

The RAPIDPoint® 500e Blood Gas System is in vitro diagnostic use and is designed to provide the determination in whole blood for the following parameters:

Partial pressure of carbon dioxide ●
Partial pressure of oxygen
pH
Sodium ●
Potassium
lonized Calcium ●
Chloride .
Glucose ●
. Lactate
. Total Hemoglobin and fractions: FO2Hb, FCOHb, FMetHb, FHHb
. Neonatal Bilirubin

The following list includes the Indications for Use information for each analyte measured on the RAPIDPoint 500e Blood Gas System:

pCO2, p02, pH: Measurements of blood gases (pCO2, p02) and blood pH are used in the diagnosis and treatment of lifethreatening acid-base disturbances.

Chloride: Chloride measurements are used in the diagnosis and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Total hemoglobin: Total hemoglobin measurements are used to determine the hemoglobin content of human blood.

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Oxyhemoglobin: Oxyhemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" are several orange dots arranged in a circular pattern.

Section 5 – 510(k) SUMMARY

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

Submitter	Siemens Healthcare Diagnostics, Inc.Point of Care (POC) Diagnostics2 Edgewater DriveNorwood, MA 02062
Contacts:	Primary: Lois ParillonRegulatory Affairs Technical SpecialistEMAIL: lois.parillon@siemens-healthineers.comPHONE: 781-269-3917FAX: 781-269-3599
	Alternative: Amy GoldbergSenior Manager Regulatory AffairsEMAIL: amy.goldberg@siemens-healthineers.comPHONE: 781-269-3544FAX: 781-269-3599
Date Summary Prepared	March 26, 2020

1.0 SUBMITTER INFORMATION

2.0 DEVICE INFORMATION

Proprietary Name	RAPIDPoint® 500e Blood Gas System
Common Name	Blood Gases ( $pCO_2$ , $pO_2$ ) and Blood pH Test System

3.0 REGULATORY INFORMATION

Table 5-1 below highlights the classification and regulatory information for all analytes that are measured on the RAPIDPoint 500e Blood Gas System, which is unchanged from the legally marketed predicate device: RAPIDPoint 500 System.

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5-1 Regulatory Information- Classification
MeasuredAnalytes	ClassificationName	RegulationSection	ProductCode	DeviceClass	ClassificationPanel
pCO2, pO2, pH	Blood gases (pCO2, pO2)and blood pH test system	21 CFR §862.1120	CHL	II
Sodium (Na+)	Sodium test system	21 CFR §862.1665	JGS	II
Potassium (K+)	Potassium test system	21 CFR §862.1600	CEM	II
Ionized Calcium(Ca2+)	Calcium test system	21 CFR §862.1145	JFP	II
Chloride (Cl-)	Chloride test system	21 CFR §862.1170	CGZ	II	ClinicalChemistry(75)
Glucose (Glu)	Glucose test system	21 CFR §862.1345	CGA	II
Total hemoglobin(tHb)	Automated hemoglobinsystem	21 CFR §864.5620	GKR	II
Neonatal bilirubin	Bilirubin in the neonatetest system	21 CFR §862.1113	MQM	I
Lactate (Lac)	Lactic acid test system	21 CFR §862.1450	KHP	I

DEVICE DESCRIPTION 4.0

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5.0 INTENDED USE STATEMENT

The RAPIDPoint 500e Blood Gas System is intended for in vitro diagnostic use and is designed to provide the determination in whole blood for the following parameters:

Partial pressure of carbon dioxide ●
Partial pressure of oxygen ●
pH ●
Sodium ●
Potassium ●
lonized Calcium
Chloride
Glucose
Lactate
Total Hemoglobin and fractions: FO2Hb, FCOHb, FMetHb, FHHb .
Neonatal Bilirubin ●

The RAPIDPoint 500e Blood Gas System is also intended for in vitro testing of pleural fluid samples for the pH parameter. 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 are referred to as complicated parapneumonic effusions and are exudative in nature. This test system is intended for use in point of care or laboratory settings.

The following list includes the Indications for Use information for each analyte measured on the RAPIDPoint 500e Blood Gas System:

Neonate Billirubin: A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

pCO2, pO2, pH: Measurements of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Sodium: Sodium measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

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Chloride: Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Glucose: Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Total hemoglobin: Total hemoglobin measurements are used to determine the hemoglobin content of human blood.

Oxyhemoglobin: Oxyhemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

Carboxyhemoqlobin: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

SPECIAL CONDITIONS FOR USE STATEMENT(S): 6.0

. For prescription use only
. For in vitro diagnostic use only
For point-of-care (POC) or clinical laboratory settings .

7.0 REASON FOR SUBMISSION

This Special 510(k) is being filed to seek FDA clearance for the RAPIDPoint 500e Blood Gas System, a modified version of the existing RAPIDPoint 500 System, which is currently cleared. A design change was made to update the Operating System (OS) software from Microsoft Windows 7 Embedded to Windows 10 loT (Internet of Things), which is the primary reason for this Special 510(k) submission. The following minor enhancements/modifications will be introduced with the RAPIDPoint 500e Blood Gas System:

NON-SOFTWARE RELATED:

A. Updated exterior (skins) and display screen (user interface) design with new color scheme for Siemens Healthineers branding.
B. Updated the following instrument main board parts due to obsolescence:
- . ETX (Embedded Technology eXtended)
- FPGA (Field Programmable Gate Array) ●
- CPLD (Complex Programmable Logic Device)

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SOFTWARE RELATED:

	5-2 New Features in RAPIDPoint 500e Software Version 5.0
1	Upgrading the operating system to Windows embedded (IoT) 10 Operating System(Enterprise)
2	Support of 1D and 2D barcodes (onboard and external barcode scanners)
3	Updated User Interface assets with new colors / branding design
4	Sodium sensor interferent detected message
6	Encrypted data transmission with POCcelerator (Cybersecurity enhancements)
7	USB port ON/OFF capability (Cybersecurity enhancements)
8	Required QC after cartridge change
9	Notification when AQC is disabled
10	AQC automatic printing
11	Restricted QC Override

A Special 510(k) Premarket Notification is the ideal pathway for this submission based on the following:

. There is no change to the intended use or indications for use.
There is no change to the fundamental scientific technology. .
There is no change to labeled performance claims. .
. There is no change to principle of operation.
There is no change to cartridge calibrator formulation and technology. .

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SUBSTANTIAL EQUIVALENCE INFORMATION 8.0

5-3 Predicate Device Information
ELEMENT	PREDICATE DEVICE
Predicate Device Name	RAPIDPoint 500 System
Common Name	Blood Gasses (pCO2) (pO2) and Blood pH Test System
FDA Product Codes	CHL, JGS, CEM, JFP, CGZ, CGA, GKR, MQM, KHP
510(k) Number	K122539
Manufacturer	Siemens Healthcare Diagnostics Inc.

The RAPIDPoint 500e Blood Gas System is substantially equivalent in intended use/indications for use, fundamental scientific technology, reagents, principle of operation, and performance claims to the predicate device. Table 5-4 below lists the similarities and differences between the RAPIDPoint 500e Blood Gas System and the RAPIDPoint 500 System (Predicate device), respectively.

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Image /page/10/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.

5-4 Substantial Equivalency
FEATURE	RAPIDPoint 500 System(PREDICATE DEVICE)	RAPIDPoint 500e Blood GasSystem (MODIFIED DEVICE)
Intended Use	The RAPIDPoint 500 System is intended for invitro diagnostic use and is designed to providethe determination in whole blood for thefollowing parameters:Partial pressure of carbon dioxide●Partial pressure of oxygen●pH●Sodium●Potassium●lonized Calcium●Chloride●Glucose●Lactate●Total Hemoglobin and fractions: FO2Hb,●FCOHb, FMetHb, FHHbNeonatal BilirubinThe RAPIDPoint 500 System is also intendedfor in vitro testing of pleural fluid samples forthe pH parameter. The pH measurement ofpleural fluid can be a clinically useful tool inthe management of patients withparapneumonic effusions.The following critical value applies to pleuralfluid pH: pH > 7.3 is measured inuncomplicated parapneumonic effusions. Allpleural fluids with a pH measurement < 7.3are referred to as complicatedparapneumonic effusions and are exudativein nature. This test system is intended for usein point of care or laboratory settings.The following list includes the Indications forUse information for each analyte measuredon the RAPIDPoint 500e Blood Gas System:Lactate: A lactic acid test system is a deviceintended to measure lactic acid in wholeblood. Lactic acid measurements thatevaluate the acid-base status are used in thediagnosis and treatment of lactic acidosis(abnormally high acidity of the blood).	Same

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Image /page/11/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

5-4 Substantial Equivalency
FEATURE	RAPIDPoint 500 System(PREDICATE DEVICE)	RAPIDPoint 500e Blood GasSystem (MODIFIED DEVICE)
	Neonate Bilirubin: A bilirubin (total andunbound) in the neonate test system is adevice intended to measure the levels ofbilirubin (total and unbound) in the blood(serum) of newborn infants to aid inindicating the risk of bilirubin encephalopathy(kernicterus).
	pCO2, p02, pH: Measurements of bloodgases (pCO2, p02) and blood pH are used inthe diagnosis and treatment of life-threatening acid-base disturbances.
	Sodium: Sodium measurements obtained bythis device are used in the diagnosis andtreatment of aldosteronism (excessivesecretion of the hormone aldosterone),diabetes insipidus (chronic excretion of largeamounts of dilute urine, accompanied byextreme thirst), adrenal hypertension,Addison's disease (caused by destruction ofthe adrenal glands), dehydration,inappropriate antidiuretic hormone secretion,or other diseases involving electrolyteimbalance.
	Potassium: Potassium measurementsobtained by this device are used to monitorelectrolyte balance in the diagnosis andtreatment of diseases conditionscharacterized by low or high blood potassiumlevels.
	Chloride: Chloride measurements are usedin the diagnosis and treatment of electrolyteand metabolic disorders such as cysticfibrosis and diabetic acidosis.
	Ionized calcium: Calcium measurements areused in the diagnosis and treatment ofparathyroid disease, a variety of bonediseases, chronic renal disease and tetany(intermittent muscular contractions orspasms).
5-4 Substantial Equivalency
FEATURE	RAPIDPoint 500 System(PREDICATE DEVICE)	RAPIDPoint 500e Blood GasSystem (MODIFIED DEVICE)
	Glucose: Glucose measurements are used inthe diagnosis and treatment of carbohydratemetabolism disorders including diabetesmellitus, neonatal hypoglycemia, and idiopathichypoglycemia, and of pancreatic islet cellcarcinoma.
	Total hemoglobin: Total hemoglobinmeasurements are used to determine thehemoglobin content of human blood.
Sample Type	• Whole blood (Arterial, Venous and Capillaryfor all analytes)• Pleural Fluid (for pH only)	Same
Sample Volume	• 100 μL (capillary)• 200 μL (syringe)	Same
Principle ofMeasurement	ELECTROCHEMISTRY:Analytes: (pH, Ca++, pCO2, pO2, Na+, K+, Cl-,Glucose, Lactate) Potentiometry,amperometry & conductimetric methods toconvert the potential generated by the sensorto an electrical signal.	Same
	OPTICAL:(Co-ox Fractions and Neonatal Bilirubin)Automated co-oximetry using spectral analysisfrom on-board visible absorption
Sensors	Contained in Measurement Cartridges	Same
ReagentConsumables	Measurement CartridgeAutomaticQC CartridgeWaste/Wash Cartridge	Same
Quality Control	Manual and automatic	Same
Calibration	1-point, 2-point and full calibration usingautomated on-board reagent	Same
5-4 Substantial Equivalency
FEATURE	RAPIDPoint 500 System(PREDICATE DEVICE)	RAPIDPoint 500e Blood Gas System(MODIFIED DEVICE)
OperatingSystemSoftware	Windows 7 Embedded OperatingSystem	Windows 10 IoT (Internet of Things)Enterprise embedded OperatingSystem
Barcode	Integrated - 1D, 2DExternal - 1D	Integrated - sameExternal - 1D, 2D
Exterior Design		UPDATED exterior (skins) and displayscreen (user interface) design with newcolor scheme for Siemens Healthineersbranding.No change to workflow.

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RISK MANAGEMENT 9.0

The Risk Management was performed in compliance with EN ISO 14971:2012 Medical Devices - Application of Risk Management to Medical Devices. A series of risk assessments were performed in order to identify, or mitigate any potential risks associated to the design changes for the modified device. In addition, a Failure Mode, Effects and Criticality Analysis (FMECA) is performed for any identifiable risks.

10.0 VERIFICATION AND VALIDATION SUMMARY

All verification and validation activities were performed in accordance to relevant standards, established plans and protocols and Siemens Design Control procedures. Testing verified all acceptance criteria were met.

11.0 CYBERSECURITY INFORMATION

Cybersecurity design inputs for the RAPIDPoint 500e Blood Gas System were established as part of the Siemens Quality Management procedures for software validation and risk analysis activities. Risks were identified, assessed and controls were designed within the software, to

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Image /page/14/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a graphic of orange dots in a circular pattern.

mitigate potential security threats, system vulnerabilities, viral attacks and safeguard unauthorized access to patient data. The updated cybersecurity controls included in the RAPIDPoint 500e software are primarily designed to minimize risks to patients as in the cleared RAPIDPoint 500 System.

12.0 SUBSTANTIAL EQUIVALENCE STATEMENT

The RAPIDPoint 500e Blood Gas System shares identical intended use, indications for use, fundamental scientific technology, reagents, principle of operation, and performance claims to the predicate device, the RAPIDPoint 500 System. Performance testing results were also comparable. The similarities in these technical features and performance testing results demonstrate that, the RAPIDPoint 500e Blood Gas System (modified device) is substantially equivalent to the predicate device, the RAPIDPoint 500 System.

13.0 CONCLUSION

The performance of the RAPIDPoint 500e Blood Gas System is substantially equivalent to the comparative method.

Regulation Number and Section

§ 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.