(221 days)
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No
The document describes a standard in vitro diagnostic blood gas analyzer and does not mention any AI or ML components in its description, intended use, or performance studies.
No.
The device is described as an "in vitro diagnostic use" system, which means it is used for testing samples outside of the body to diagnose conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is in vitro diagnostic use" and describes how its measurements are used in the "diagnosis and treatment" of various conditions, such as acid-base disturbances, aldosteronism, diabetes insipidus, cystic fibrosis, and diabetes mellitus.
No
The device description clearly states it is a "compact, bench-top analyzer" and incorporates "cartridge-based design," indicating it is a hardware device with integrated software, not a software-only medical device.
Yes, the RAPIDPoint® 500e Blood Gas System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The RAPIDPoint® 500e Blood Gas System is in vitro diagnostic use..."
- Measurement of Analytes in Biological Samples: The device is designed to measure various parameters (blood gases, electrolytes, hemoglobin, bilirubin, etc.) in whole blood and pH in pleural fluid. These are biological samples.
- Clinical Use for Diagnosis and Treatment: The "Indications for Use" for each analyte clearly describes how the measurements are used in the diagnosis and treatment of various diseases and conditions. This is a key characteristic of IVD devices.
- Intended for Professional Use: The "Intended User / Care Setting" specifies professional use in point-of-care or central laboratory environments, which aligns with the typical use of IVD devices.
Therefore, based on the provided text, the RAPIDPoint® 500e Blood Gas System is definitively an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 parapneumenic 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.
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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 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 ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
Point of Care (POC) Diagnostics
2 Edgewater Drive
Norwood, MA 02062 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts: | Primary: Lois Parillon
Regulatory Affairs Technical Specialist
EMAIL: lois.parillon@siemens-healthineers.com
PHONE: 781-269-3917
FAX: 781-269-3599 |
| | Alternative: Amy Goldberg
Senior Manager Regulatory Affairs
EMAIL: amy.goldberg@siemens-healthineers.com
PHONE: 781-269-3544
FAX: 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 | |||||
|---|---|---|---|---|---|
| Measured | |||||
| Analytes | Classification | ||||
| Name | Regulation | ||||
| Section | Product | ||||
| Code | Device | ||||
| Class | Classification | ||||
| Panel | |||||
| 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 | Clinical | ||
| Chemistry | |||||
| (75) | |||||
| Glucose (Glu) | Glucose test system | 21 CFR § | |||
| 862.1345 | CGA | II | |||
| Total hemoglobin | |||||
| (tHb) | Automated hemoglobin | ||||
| system | 21 CFR § | ||||
| 864.5620 | GKR | II | |||
| Neonatal bilirubin | Bilirubin in the neonate | ||||
| test system | 21 CFR § | ||||
| 862.1113 | MQM | I | |||
| Lactate (Lac) | Lactic acid test system | 21 CFR § | |||
| 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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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 is measured in
uncomplicated parapneumonic effusions. All
pleural fluids with a pH measurement 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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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.