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

Intended 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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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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803) 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 ([e-mail]) or phone [phone] 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 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.

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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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <div><span style="font-size:120%">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div><span style="font-size:120%">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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# 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.<br>Point of Care (POC) Diagnostics<br>2 Edgewater Drive<br>Norwood, MA 02062 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts: | Primary: Lois Parillon<br>Regulatory Affairs Technical Specialist<br>EMAIL: [e-mail]<br>PHONE: [phone]<br>FAX: [phone] |
| | Alternative: Amy Goldberg<br>Senior Manager Regulatory Affairs<br>EMAIL: [e-mail]<br>PHONE: [phone]<br>FAX: [phone] |
| 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 | | | | | |
|--------------------------------------------|-----------------------------------------------------|-----------------------|-----------------|-----------------|-------------------------------|
| Measured<br>Analytes | Classification<br>Name | Regulation<br>Section | Product<br>Code | Device<br>Class | Classification<br>Panel |
| pCO2, pO2, pH | Blood gases (pCO2, pO2)<br>and blood pH test system | 21 CFR §<br>862.1120 | CHL | II | |
| Sodium (Na+) | Sodium test system | 21 CFR §<br>862.1665 | JGS | II | |
| Potassium (K+) | Potassium test system | 21 CFR §<br>862.1600 | CEM | II | |
| Ionized Calcium<br>(Ca2+) | Calcium test system | 21 CFR §<br>862.1145 | JFP | II | |
| Chloride (Cl-) | Chloride test system | 21 CFR §<br>862.1170 | CGZ | II | Clinical<br>Chemistry<br>(75) |
| Glucose (Glu) | Glucose test system | 21 CFR §<br>862.1345 | CGA | II | |
| Total hemoglobin<br>(tHb) | Automated hemoglobin<br>system | 21 CFR §<br>864.5620 | GKR | II | |
| Neonatal bilirubin | Bilirubin in the neonate<br>test system | 21 CFR §<br>862.1113 | MQM | I | |
| Lactate (Lac) | Lactic acid test system | 21 CFR §<br>862.1450 | KHP | I | |

#### DEVICE DESCRIPTION 4.0

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.

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Image /page/6/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 word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

#### 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:

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 acidosis (abnormally high acidity of the blood).

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.

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.

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Image /page/7/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 arranged in a circular pattern.

Chloride: Chloride measurements are used in the diagnosis and treatment of electrolyte 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 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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Image /page/8/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 arranged in a circular pattern.

## 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<br>(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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Image /page/9/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 words is a graphic of orange dots arranged in a circular pattern.

#### 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<br>(PREDICATE DEVICE) | RAPIDPoint 500e Blood Gas<br>System (MODIFIED DEVICE) | | |
| Intended Use | The RAPIDPoint 500 System is intended for in<br>vitro diagnostic use and is designed to provide<br>the determination in whole blood for the<br>following parameters:<br>Partial pressure of carbon dioxide<br>●<br>Partial pressure of oxygen<br>●<br>pH<br>●<br>Sodium<br>●<br>Potassium<br>●<br>lonized Calcium<br>●<br>Chloride<br>●<br>Glucose<br>●<br>Lactate<br>●<br>Total Hemoglobin and fractions: FO2Hb,<br>●<br>FCOHb, FMetHb, FHHb<br>Neonatal Bilirubin<br>The RAPIDPoint 500 System is also intended<br>for in vitro testing of pleural fluid samples for<br>the pH parameter. The pH measurement of<br>pleural fluid can be a clinically useful tool in<br>the management of patients with<br>parapneumonic effusions.<br>The following critical value applies to pleural<br>fluid pH: pH > 7.3 is measured in<br>uncomplicated parapneumonic effusions. All<br>pleural fluids with a pH measurement < 7.3<br>are referred to as complicated<br>parapneumonic effusions and are exudative<br>in nature. This test system is intended for use<br>in point of care or laboratory settings.<br>The following list includes the Indications for<br>Use information for each analyte measured<br>on the RAPIDPoint 500e Blood Gas System:<br>Lactate: A lactic acid test system is a device<br>intended to measure lactic acid in whole<br>blood. Lactic acid measurements that<br>evaluate the acid-base status are used in the<br>diagnosis and treatment of lactic acidosis<br>(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<br>(PREDICATE DEVICE) | RAPIDPoint 500e Blood Gas<br>System (MODIFIED DEVICE) |
| | Neonate Bilirubin: A bilirubin (total and<br>unbound) in the neonate test system is a<br>device intended to measure the levels of<br>bilirubin (total and unbound) in the blood<br>(serum) of newborn infants to aid in<br>indicating the risk of bilirubin encephalopathy<br>(kernicterus). | |
| | pCO2, p02, pH: Measurements of blood<br>gases (pCO2, p02) and blood pH are used in<br>the diagnosis and treatment of life-<br>threatening acid-base disturbances. | |
| | Sodium: Sodium measurements obtained by<br>this device are used in the diagnosis and<br>treatment of aldosteronism (excessive<br>secretion of the hormone aldosterone),<br>diabetes insipidus (chronic excretion of large<br>amounts of dilute urine, accompanied by<br>extreme thirst), adrenal hypertension,<br>Addison's disease (caused by destruction of<br>the adrenal glands), dehydration,<br>inappropriate antidiuretic hormone secretion,<br>or other diseases involving electrolyte<br>imbalance. | |
| | Potassium: Potassium measurements<br>obtained by this device are used to monitor<br>electrolyte balance in the diagnosis and<br>treatment of diseases conditions<br>characterized by low or high blood potassium<br>levels. | |
| | Chloride: Chloride measurements are used<br>in the diagnosis and treatment of electrolyte<br>and metabolic disorders such as cystic<br>fibrosis and diabetic acidosis. | |
| | Ionized calcium: Calcium measurements are<br>used in the diagnosis and treatment of<br>parathyroid disease, a variety of bone<br>diseases, chronic renal disease and tetany<br>(intermittent muscular contractions or<br>spasms). | |
| 5-4 Substantial Equivalency | | |
| FEATURE | RAPIDPoint 500 System<br>(PREDICATE DEVICE) | RAPIDPoint 500e Blood Gas<br>System (MODIFIED DEVICE) |
| | Glucose: Glucose measurements are used in<br>the diagnosis and treatment of carbohydrate<br>metabolism disorders including diabetes<br>mellitus, neonatal hypoglycemia, and idiopathic<br>hypoglycemia, and of pancreatic islet cell<br>carcinoma. | |
| | Total hemoglobin: Total hemoglobin<br>measurements are used to determine the<br>hemoglobin content of human blood. | |
| Sample Type | • Whole blood (Arterial, Venous and Capillary<br>for all analytes)<br>• Pleural Fluid (for pH only) | Same |
| Sample Volume | • 100 μL (capillary)<br>• 200 μL (syringe) | Same |
| Principle of<br>Measurement | ELECTROCHEMISTRY:<br>Analytes: (pH, Ca++, pCO2, pO2, Na+, K+, Cl-,<br>Glucose, Lactate) Potentiometry,<br>amperometry & conductimetric methods to<br>convert the potential generated by the sensor<br>to an electrical signal. | Same |
| | OPTICAL:<br>(Co-ox Fractions and Neonatal Bilirubin)<br>Automated co-oximetry using spectral analysis<br>from on-board visible absorption | |
| Sensors | Contained in Measurement Cartridges | Same |
| Reagent<br>Consumables | Measurement Cartridge<br>AutomaticQC Cartridge<br>Waste/Wash Cartridge | Same |
| Quality Control | Manual and automatic | Same |
| Calibration | 1-point, 2-point and full calibration using<br>automated on-board reagent | Same |
| 5-4 Substantial Equivalency | | |
| FEATURE | RAPIDPoint 500 System<br>(PREDICATE DEVICE) | RAPIDPoint 500e Blood Gas System<br>(MODIFIED DEVICE) |
| Operating<br>System<br>Software | Windows 7 Embedded Operating<br>System | Windows 10 IoT (Internet of Things)<br>Enterprise embedded Operating<br>System |
| Barcode | Integrated - 1D, 2D<br>External - 1D | Integrated - same<br>External - 1D, 2D |
| Exterior Design | | UPDATED exterior (skins) and display<br>screen (user interface) design with new<br>color scheme for Siemens Healthineers<br>branding.<br><br><i>No change to workflow.</i> |

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Image /page/12/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.

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Image /page/13/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 series of orange dots arranged in a circular pattern.

#### 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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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.