The RAPIDPoint® 500 System measurement cartridge with calibrators is an in vitro diagnostic product for the calibration of the analytes on the RAPIDPoint® 500 System. The analytes measured are partial pressure of carbon dioxide (pCO2), partial pressure of oxygen (pO2), pH, Sodium (Na*), Potassium (K*), ionized Calcium (Ca**), Chloride (Cl7), Glucose (Glu), total hemoglobin (tHb), Neonatal Bilirubin and Lactate (Lac).

Device Description

The RAPIDPoint® 500 System consists of four (4) calibrators contained in the measurement cartridge and wash/waste cartridge that are used to calibrate the following analytes: pH, partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), Sodium (Na ), Potassium (K ), ionized Calcium (Ca *), Chloride (Cl), Glucose (Glu), total hemoglobin (tHb) and Lactate (Lac). There is no unique calibration measurement for Neonatal Bilirubin (nBili) as the tHb calibration is used.

The measurement cartridge contains the following calibrators: 200 Cal, Reagent C and Low Sulfite Zero Cal. The wash/waste cartridge contains the wash reagent.

AI/ML Overview

The provided text describes the RAPIDPoint® 500 System Measurement Cartridge with Calibrators, an in vitro diagnostic product intended for the calibration of analytes on the RAPIDPoint® 500 System. The document is a 510(k) summary submitted to the FDA for market clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria and reported device performance in the same manner one might expect for a clinical study comparing an AI device to ground truth. Instead, the "acceptance criteria" are implied by the process of establishing traceability and stability for the calibrators, and the "reported device performance" is the successful demonstration that these criteria were met.

The key acceptance criteria for this type of device (calibrator) relate to stability and traceability of the assigned values.

Acceptance Criteria Category	Specific Criteria/Procedure	Reported Device Performance
Stability	Stability protocols and acceptance criteria established for each calibrator type.	Testing data met predetermined acceptance criteria for stability.
	Duration for `200 Cal`	12 months at 2° to 8°C
	Duration for `Low Sulfite Zero Cal (LSZC)`	12 months at 2° to 8°C
	Duration for `Reagent C`	15 months at 2° to 30°C
Traceability	Each analyte in the calibrator must be traceable to established reference materials or methods.	Successfully demonstrated traceability for all analytes (pH, pCO2, pO2, K+, Na+, Ca++, Cl-, Glucose, tHb, Lactate, nBili (via tHb)). Specific methods are detailed below.
Value Assignment	Calibrator values must be assigned through a robust, multi-measurement process.	"Calibrator values are assigned by multiple measurements using multiple test systems such a flame photometry, mass spectrometry and others."

Traceability Methods (which inherently function as acceptance criteria for the accuracy of calibrator values):

pH: Traceable to NIST SRM186 reference materials via the IFCC blood reference method.
pCO2: Traceable to tonometered aqueous standards prepared using NIST traceable temperature and pressure standards and gravimetrically prepared precision gas standards.
pO2: Traceable to tonometered aqueous standards prepared using NIST traceable temperature and pressure standards and gravimetrically prepared precision gas standards.
K+: Traceable to NIST SRM 918 reference materials using flame photometry.
Na+: Traceable to NIST SRM 919 reference material using flame photometry.
Ca++: Traceable to gravimetrically prepared internal standards using NIST SRM 915 and ISE methods embodied in Siemens blood gas analyzers.
Cl-: Traceable to NIST SRM 919 or 918 reference materials using a Coulometric reference method.
Glucose: Traceable to NIST SRM 917 reference materials using the Hexokinase method.
tHb: Traceable to internal standards calibrated against the CLSI Cyanmethemoglobin method.
Lactate: Traceable to high purity lactate using the Lactate dehydrogenase spectrophotometric method.
Neonatal Bilirubin (nBili): No unique calibrator; associated with tHb, which is traceable as noted above.

Study Type:

The "study" described is primarily a validation process to ensure the calibrators meet predefined performance specifications related to stability, traceability, and value assignment. This is not a typical clinical trial with patient cohorts, but rather a quality control and analytical performance validation for an in vitro diagnostic calibrator.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not refer to a "test set" or "training set" in the context of an AI/algorithm. Instead, it discusses the testing of calibrator lots to confirm their stability and the methods used to establish their traceability and assigned values.

Sample size: The document mentions "multiple measurements" and "multiple test systems" for value assignment, and "testing data" for stability. It does not provide specific numerical sample sizes for these tests (e.g., number of calibrator vials tested, number of measurements per vial, number of lots).
Data provenance: Not specified. Given it's a product from Siemens Healthcare Diagnostics Inc., based in Norwood, MA, USA, the testing would likely have been conducted in their labs or by accredited partners. The "retrospective or prospective" nature usually applies to patient data collections; here, it would be a prospective manufacturing and quality control process for each lot of calibrator.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device. The "ground truth" for the calibrators is established through traceability to internationally recognized reference materials (e.g., NIST SRMs) and validated reference methods (e.g., IFCC, CLSI). It does not involve human expert interpretation of images or clinical cases. The "experts" involved would be analytical chemists, metrologists, and quality control professionals with expertise in these highly standardized laboratory techniques.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept pertains to resolving discrepancies among human readers or between human readers and an AI algorithm in diagnostic accuracy studies. For calibrator validation, the "adjudication" is inherent in the rigorous, multi-measurement, and traceable methods used to assign values and confirm stability, following established quality management systems.

5. 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 is not an AI-powered diagnostic device, but a calibrator for a blood gas analysis system. Therefore, MRMC studies and "human reader improvement with AI assistance" are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm. It is a physical calibrator used within an analytical instrument (RAPIDPoint 500 System).

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the calibrator values is based on traceability to primary and secondary reference materials and reference methods, rather than expert consensus, pathology, or outcomes data.

For instance, pH is traceable to NIST SRM186.
Sodium (Na+) is traceable to NIST SRM 919.
Hemoglobin (tHb) is traceable to internal standards calibrated against the CLSI Cyanmethemoglobin method.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set in that context.

9. How the ground truth for the training set was established

Not applicable. As there is no AI training set, this question is not relevant. The "ground truth" for the performance characteristics of the calibrator itself is established through the rigorous metrological traceability and analytical validation processes outlined above.

Summary

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65.

510(k) Summary

に

OCT 12 2012

510(k) Summary of Safety and Effectiveness for the RAPIDPoint 500 System Cartridge Calibrators

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

A. 510(k) Number: K122398

B. Date of Preparation: October 10, 2012

C. Proprietary and Established Names: RAPIDPoint® 500 System Measurement Cartridge with Calibrators

D. Applicant:

Siemens Healthcare Diagnostics Inc., Point-of-Care Business Unit 2 Edgewater Drive Norwood, MA 02062 Primary Contact: Amy Goldberg, Technical Specialist, Regulatory Affairs Tel: (781) 269-3544 Fax: (781) 269-3210

Secondary Contact: Noor Malki, Vice President, Clinical, Regulatory and Quality Tel: (781) 269-3401 Fax: (781) 269-3210

E. Requlatory Information:

1. Regulation Section: 21 CFR § 862.1150 Calibrator
1. Classification: Class II
1. Product Code: JIX calibrator, multi-analyte mixture
1. Panel: Clinical Chemistry

F. Predicate Device:

The predicate device used to demonstrate substantial equivalence is the Dimension Vista® LOCI 7 Calibrator, Models: K6456 and KC605, cleared under K100344.

G. Device Description:

The measurement cartridge contains the following calibrators: 200 Cal, Reagent C and Low Sulfite Zero Cal. The wash/waste cartridge contains the wash reagent.

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510(k) Summary

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H. Intended Use:

The RAPIDPoint® 500 System measurement cartridge with calibrators is an in vitro diagnostic product for the calibration of the analytes on the RAPIDPoint® 500 System. The analytes measured are partial pressure of carbon dioxide (pCO2), partial pressure of oxygen (pO2), pH, Sodium (Na ), Potassium (K'), ionized Calcium (Ca), Chloride (Cl), Glucose (Glu), total hemoglobin (tHb), Neonatal Bilirubin (nBili) and Lactate (Lac).

I. Substantial Equivalence Information:

The RAPIDPoint® 500 System measurement cartridge with calibrators was compared to the predicate device, Dimension Vista® LOCI 7 Calibrator. The following table provides the similarities and differences

Feature	DeviceRAPIDPoint® 500 SystemMeasurement Cartridge withCalibrators	Predicate DeviceDimension Vista®LOCI 7 CalibratorK100344
Intended Use	The RAPIDPoint® 500 Systemmeasurement cartridge withcalibrators is an in vitrodiagnostic product for thecalibration of the analytes on theRAPIDPoint® 500 System. Theanalytes measured are partialpressure of carbon dioxide(pCO2), partial pressure ofoxygen (pO2), pH, Sodium (Na+),Potassium (K+), ionized Calcium(Ca++), Chloride (Cl-), Glucose(Glu), total hemoglobin(tHb), Neonatal Bilirubin(nBili) and Lactate (Lac).	The LOCI 7 CAL is anin vitro diagnosticproduct for thecalibration of CancerAntigen 15-3 (CA 15-3)and Cancer Antigen 19-9 (CA 19-9) methods onthe Dimension Vista®system.
Matrix	Aqueous salt solution	Bovine Serum Albumin
Format/Preparation	Liquid	Same
Storage/Shelf-life	Store at 2 to 8°C	Store at -25 to -15°C

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510(k) Summary

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J . Traceability:

Analyte	Traceability Method
pH	Traceable to NIST SRM186 reference materialsvia the IFCC blood reference method.
pCO2	Traceable to tonometered aqueous standardsprepared using NIST traceable temperature andpressure standards and gravimetrically preparedprecision gas standards.
pO2	Traceable to tonometered aqueous standardsprepared using NIST traceable temperature andpressure standards and gravimetrically preparedprecision gas standards.
K+	Traceable to NIST SRM 918 reference materialsusing flame photometry.
Na+	Traceable to NIST SRM 919 reference materialusing flame photometry.
Ca++	Traceable to gravimetrically prepared internalstandards using NIST SRM 915 and ISE methodsembodied in Siemens blood gas analyzers.
Cl-	Traceable to NIST SRM 919 or 918 referencematerials using a Coulometric reference method.
Glucose	Traceable to NIST SRM 917 reference materialsusing the Hexokinase method.
tHb	Traceable to internal standards calibrated againstthe CLSI Cyanmethemoglobin method.
Lactate	Traceable to high purity lactate using the Lactatedehydrogenase spectrophotometric method.
NeonatalBilirubin	There is no unique calibrator for nBili. It is anoptical measurement that is associated with tHb,which is traceable as noted above.

K. Value Assignment:

Calibrator values are assigned by multiple measurements using multiple test systems such a flame photometry, mass spectrometry and others.

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510(k) Summary - Revised

L. Stability:

The stability protocols and acceptance criteria were included and testing data met predetermined acceptance criteria. The following table lists the stability/shelf life for each calibrator:

Calibrator	Stability/Shelf Life
200 Cal	12 months at 2° to 8°C
Low Sulfite Zero Cal(LSZC)	12 months at 2° to 8°C
Reagent C	15 months at 2° to 30°C

M. Performance Characteristics:

The calibrator target levels, protocol, value assignment procedure, acceptance criteria. stability and traceability for the following analytes: pH, partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), Sodium, (Na*), Potassium (K*), ionized Calcium (Ca**), Chloride (Cl7), Glucose (Glu) , total hemoglobin (tHb) and Lactate (Lac) have been validated following procedures of Siemens Healthcare Diagnostics Inc. Point-of-Care Business Unit. There is no unique calibration measurement for nBili as the tHb calibration is used.

N. Conclusion:

The RAPIDPoint® 500 System measurement cartridge with calibrators is substantially equivalent to the Dimension Vista® LOCI 7 Calibrator previously cleared under K100344.

Siemens Healthcare Diagnostics - Point-of-Care (POC) Business Unit RAPIDPoint 500 Calibrators / Traditional 510(k)

Vol. 1, Page 4 of 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics, Inc. c/o Amy Goldberg 2 Edgewater Drive Norwood, MA 02062

OCT 1 2 2012

Re: K122398

Trade Name: RAPIDPoint® 500 System Measurement Cartridge with Calibrators Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX Dated: August 6, 2012 Received: August 7, 2012

Dear Ms. Goldberg:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you a sen o effice of In Vitro Diagnostic Devices and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, productions the regarding regarding postmarket surveillance, please contact CDRH'S (21 CL Par of Surveillance and Biomeric's (OSB's) Division of Postmarket Surveillance at (301) 796-576-. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

You may obtain other general information on your responsibilities under the Act from the I va may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800 638-2041 or (301) 796-5680 or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K122398

Device Name: RAPIDPoint® 500 System Measurement Cartridge with Calibrators

Intended Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Yung Chan

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

K122398 510(k).

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.