(70 days)
The i-STAT CHEM8+ Cartridge is intended to be used by medical professionals for the quantitative measurement of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, total carbon dioxide, creatinine, and hematocrit in arterial, venous, and capillary blood. The i-STAT CHEM8+ Cartridge is useful for monitoring a variety of conditions. The panel of tests is used to assess kidney function, the hydration state, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.
The modified device is the i-STAT CHEM8+ Cartridge. The modifications comprise a combination of several tests, all of which are on the market and reside in other i-STAT cartridges, into a new panel of tests. The new i-STAT CHEM8+ Cartridge contains a panel comprised of nine reported tests and two calculated tests as is indicated on the labeling for this device. Of these nine reported test, eight tests (glucose, ionized calcium, sodium, potassium, chloride, carbon dioxide, urea nitrogen and creatinine) are commonly referred to as a "basic metabolic panel". The two tests to be reported as calculated parameters are anion gap and hemoglobin. The i-STAT CHEM8+ Cartridge is a single-use device that is to be used with the i-STAT 1 Analyzer. As with other i-STAT Cartridges, two or three drops of venous, arterial or capillary blood is dispensed into the cartridge, the blood are sealed inside the cartridge with the snap closure, and the cartridge is then inserted into the analyzer. The analysis cycle is automatic and is controlled by software in the analyzer. Cartridges are calibrated at the factory. This cartridge is similar in design to the other i-STAT cartridges that are used for the same or similar in vitro diagnostic tests. The i-STAT CHEM8+ Cartridge is manufactured using the same process technology and equipment that is used for existing i-STAT cartridges.
The provided text is a 510(k) summary for the i-STAT CHEM8+ Cartridge, which is a medical device intended for quantitative measurement of various metabolic parameters in blood. The document describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, it does not contain the detailed study information, acceptance criteria, or performance data that would allow for a complete answer to the request. The summary states: "Hazards were identified and the associated risk was evaluated; all unacceptable risks were controlled to an acceptable level by design features and/or labeling. Users needs in the form of design inputs were defined and served as the basis for a design validation." This indicates that validation studies were performed, but the results and specifics are not provided in this excerpt.
Therefore, I cannot fully answer the request with the given input. I will highlight what information is not present in the document.
Here's an attempt to answer based on the provided text, indicating where information is missing:
Acceptance Criteria and Device Performance Study for i-STAT CHEM8+ Cartridge
The provided 510(k) summary for the i-STAT CHEM8+ Cartridge demonstrates substantial equivalence to existing i-STAT devices. The document implies that design validation was performed to ensure the device meets user needs and controls identified risks. However, specific acceptance criteria and detailed performance data from a study proving these criteria are met are not provided in this summary.
The summary states, "The performance of the tests contained in the modified (i-STAT CHEM8+) device and in the existing devices are equivalent for all diagnostic purposes." This suggests that performance studies were conducted to show equivalence, but the actual data, acceptance criteria, and study methodology are absent.
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given 510(k) summary. The document does not list specific numerical acceptance criteria (e.g., accuracy, precision, bias limits) for each analyte, nor does it present a table of the reported performance results against such criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. Details such as the number of samples, their origin (e.g., country), and whether the data was retrospective or prospective are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given 510(k) summary. For in vitro diagnostic devices like the i-STAT CHEM8+ Cartridge, ground truth is typically established by reference laboratory methods, not usually by medical experts in the same way it would be for imaging interpretation. However, the document does not specify the method for establishing ground truth or the involvement of experts.
4. Adjudication Method for the Test Set
This information is not provided in the given 510(k) summary. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is generally not the primary method for establishing ground truth for quantitative laboratory tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. The i-STAT CHEM8+ Cartridge is an in vitro diagnostic device for quantitative chemical analysis, not an imaging device requiring human interpretation. Therefore, a study comparing human readers with and without AI assistance is not relevant here.
6. Standalone Performance Study
The 510(k) summary implies that a standalone performance study was conducted to establish the equivalence of the i-STAT CHEM8+ Cartridge to existing predicate devices. It states: "The performance of the tests contained in the modified (i-STAT CHEM8+) device and in the existing devices are equivalent for all diagnostic purposes." This suggests that the algorithm (cartridge and analyzer) performance was assessed independently. However, the specific details, methodology, and results of such a standalone study are not included in this document.
7. Type of Ground Truth Used
For in vitro diagnostic devices like the i-STAT CHEM8+ Cartridge, the ground truth is typically established using reference laboratory methods (e.g., validated laboratory analyzers, mass spectrometry, or other established analytical techniques) rather than expert consensus, pathology, or outcomes data. However, the specific type of ground truth used for the studies is not explicitly stated in the provided summary.
8. Sample Size for the Training Set
This information is not provided in the given 510(k) summary. The i-STAT CHEM8+ Cartridge is an in vitro diagnostic device that uses established electrochemical sensor technology; the concept of a "training set" in the context of machine learning for image analysis or predictive algorithms typically does not directly apply here. The device's calibration is factory-set.
9. How the Ground Truth for the Training Set Was Established
As discussed above, the concept of a "training set" in the machine learning sense is generally not applicable to this type of device. The device's calibration is factory-set, and its performance is validated against reference methods. Details on calibration and validation methodologies are not provided in the summary.
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510(k) Summary
Applicant
i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520 Phone (609) 443-9300 Fax (609) 443-9310
Contact person
Paul VanDerWerf, Ph.D. Director Requlatory Affairs
Date summary prepared
07 October 2005
Summary
Trade Name: i-STAT CHEM8+ Cartridge
Common Name: metabolic panel
This Special 510(k) demonstrates that the modified device (i-STAT CHEM8+ Cartridge), comprising tests for sodium, chloride, ionized calcium, glucose, urea nitrogen, total carbon dioxide, creatinine, and hematocrit is equivalent to those same tests that are present in the existing i-STAT CG8+, i-STAT EC9+, and i-STAT CREA Cartridges. The i-STAT CHEM8+ Cartridge is intended to be used by medical professionals for the quantitative measurement of sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, total carbon dioxide, creatinine, and hematocrit in arterial, venous, and capillary blood. The modified device was developed following the requirements for design controls in 21 CFR 820.3. Hazards were identified and the associated risk was evaluated; all unacceptable risks were controlled to an acceptable level by design features and/or labeling. Users needs in the form of design inputs were defined and served as the basis for a design validation. The i-STAT CHEM8+ Cartridge is compatible with the i-STAT Model 300 (i-STAT1) Analyzer.
A comparison of the modified device with the existing un-modified devices shows that the modified device is substantially equivalent in safety and effectiveness. The modified device is not altered with respect to intended use or the technology employed. A table that compares the existing, unmodified devices and the modified device is included.
# (0) Windsor Ceiter Drive, Iras Windsor, NJ 08520 • Tel: (69-443-9300 • Tas: 6(9-443-9310 • Web: http://www.i-STAT.com™
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DESCRIPTION OF THE MODIFIED DEVICE
The modified device is the i-STAT CHEM8+ Cartridge. The modifications comprise a combination of several tests, all of which are on the market and reside in other i-STAT cartridges, into a new panel of tests. The modified device and the cleared devices, together with the tests that are in each cartridge type, are shown in Table 2. The tests that are indicated by an "X" in Table 2 are to be incorporated into the modified device. The tests indicated by a "y" are reported in the existing devices but will not be reported in the modified device.
| CLEARED DEVICES | MODIFIEDDEVICE | |||
|---|---|---|---|---|
| TEST/ANALYTE | i-STAT Crea | i-STAT CG8+ | i-STAT EC8+ | i-STATCHEM8+ |
| Creatinine | X | X | ||
| Ionized Calcium | X | X | ||
| Sodium | X | X | X | |
| Potassium | X | X | X | |
| Chloride | X | X | ||
| Urea Nitrogen | X | X | ||
| Glucose | X | X | X | |
| Hematocrit | X | X | X | |
| PCO2 | y | y | ||
| pH | y | y | ||
| Total CO2 | X | X | X | |
| Anion Gap | X | X | ||
| Hemoglobin | X | X | X | |
| Base Excess | y | y | ||
| HCO3 | y | y | ||
| PO2 | y | |||
| sO2 | y |
Table 2. Comparison of the Existing, Legally-Marketed, i-STAT Devices with the Modified Device.
As is shown in Table 2, the new i-STAT CHEM8+ Cartridge contains a panel comprised of nine reported tests and two calculated tests as is indicated on the labeling for this device. Of these nine reported test, eight tests (glucose, ionized calcium, sodium, potassium, chloride, carbon dioxide, urea nitrogen and creatinine) are commonly referred to as a "basic metabolic panel". The two tests to be reported as calculated parameters are anion gap and hemoglobin.
The performance of the tests contained in the modified (i-STAT CHEM8+) device and in the existing devices are equivalent for all diagnostic purposes. The i-STAT CHEM8+ Cartridge is a single-use device that is to be used with the i-STAT 1 Analyzer. As with other i-STAT Cartridges, two or three drops of venous, arterial or capillary blood is dispensed into the cartridge, the blood are sealed inside the cartridge with the snap closure, and the cartridge is then inserted into the analyzer. The analysis cycle is automatic and is controlled by software in the analyzer. Cartridges are calibrated at the factory. This cartridge is similar in design to the other i-STAT cartridges that are used for the same or similar in vitro diagnostic tests. The i-STAT CHEM8+ Cartridge is manufactured using the same process technology and equipment that is used for existing i-STAT cartridges.
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DEPARTMENT OF HEAL TH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN I 3 2006
Paul VanDerWerf, Ph.D. Director Regulatory Affairs i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520
Re: K053110
Trade/Device Name: i-STAT CHEM8+ Cartridge Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS, CEM, CGZ, JFP, CGA, CGL, JFL, CDS, JPI Dated: December 16, 2005 Received: December 19, 2005
Dear Dr. VanDerWerf:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you to FDA finding of substantial equivalence of your device to a legally premarket notification " "I selection for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, rr you coons on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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2. INDICATIONS FOR USE
510(k) Number (if known): K053110
Device Name: i-STAT CHEM8+ Cartridge
The i-STAT CHEM8+ Cartridge is useful for monitoring a variety of conditions. The FSTAT CHEMOT Outfination is assess kidney for every hidney function, The panel of tests is used in the noophal string and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ann Chappie
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Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
-10(k)________________________________________________________________________________________________________________________________________________________________________
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. 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.(b)
Classification. Class II.