(18 days)
The i-STAT System is used by trained medical professionals for running clinical chemistry tests for sodium, potassium, chloride, urea nitrogen, glucose, hematocrit, calcium, blood-gases (PCO2, PO2) and blood pH, creatinine, lactic acid, and activated whole blood clotting time in a variety of test panels contained in the i-STAT test cartridges.
The i-STAT System is used in conjunction with disposable i-STAT cartridges for determination of a variety of parameters in whole blood.
The provided text is a 510(k) summary for the i-STAT System, primarily focusing on a software modification to address interference in the PCO2 test. It does not contain a typical study design or acceptance criteria for a new device's performance directly. Instead, it references prior substantial equivalence determinations and focuses on the modification.
Therefore, many of the requested categories cannot be filled based on the provided document.
Here's an analysis of what information can be extracted or inferred, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or a detailed performance table for this specific software modification. It mentions that the software modification was made "to diminish the interference on the PCO2 test caused by the drugs thiopental sodium and propofol." This implies that the previous performance in the presence of these drugs was unsatisfactory, and the modification aims to improve it, but no specific targets (e.g., % reduction in error, specific bias limits) are provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document for this modification. The implied criterion is to diminish interference from thiopental sodium and propofol on PCO2 test results. | The software has been modified to diminish the interference on the PCO2 test caused by the drugs thiopental sodium and propofol. No quantitative performance data is provided for this specific improvement. |
2. Sample Size Used for the Test Set and Data Provenance:
Not specified in the document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not specified in the document.
4. Adjudication Method for the Test Set:
Not specified in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This device is a clinical analyzer, not an imaging device typically evaluated with MRMC studies comparing human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The i-STAT System is a standalone clinical analyzer. The software modification described likely refers to an improvement in the algorithm that processes the PCO2 measurement from the sensor, without direct human-in-the-loop performance being a separate evaluation step. However, the document does not detail a specific standalone performance study for this modification. The device itself operates in a standalone manner.
7. The Type of Ground Truth Used:
Not specified in the document. For a clinical analyzer, ground truth would typically be established by a reference method (e.g., a laboratory-based blood gas analyzer) for the PCO2 measurement.
8. The Sample Size for the Training Set:
Not applicable/Not specified. This document describes a software modification to an existing device, not the training of a new AI model in the typical sense that would involve a "training set" with ground truth in the context of machine learning. The modification likely involved algorithm adjustments based on observed interference, rather than a large-scale machine learning training pipeline.
9. How the Ground Truth for the Training Set Was Established:
Not applicable/Not specified (as above).
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AUG 2 0 2001
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 C.F.R. § 807.92.
The assigned 510(k) number is K012478
Summary Prepared on: 31 July 2001
Submitted by:
i-STAT Corporation
104 Windsor Center Drive
East Windsor, NJ 08520
Phone: 609-469-0242
Fax: 609-443-9310
Contact:
Paul VanDerWerf, Ph.D., Vice President Regulatory Affairs and Quality Assurance
Establishment Registration Number: 2245578
Identification of the Device
Device Name: i-STAT System (see Table 1 below) Proprietary/Trade Name: i-STAT System Common Name: Portable clinical analyzer Classification Name: See Table 1 Device Classification: ll Regulation Number: See Table 1 Clinical Chemistry (75) Panel: Product Code: See Table 1
| i-STAT Corporation104 Windsor Center DriveEast Windsor, NJ 08520 | |
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| Device Name | 510(k)Number | Classification | Regulation | ProductCode |
|---|---|---|---|---|
| Model 100 PortableClinical Analyzer and TestPack | K894914K912387 | Electrode, ion specific,sodium | 21 C.F.R. § 862.1665 | JGS |
| i-STAT Tests for Acid-BaseParameters; | K936081 | Electrodemeasurement, blood-gases (pCO2, pO2) andblood pH | 21 C.F.R. § 862.1120 | CHL |
| i-STAT 200 PortableClinical Analyzer | K940918 | Electrodemeasurement, blood-gases (pCO2, pO2) andblood pH | 21 C.F.R. § 862.1120 | CHL |
| i-STAT Creatinine Test | K973292 | Electrode, ion based,enzymatic, creatinine | 21 C.F.R. § 862.1225 | CGL |
| i-STAT Lactate Test | K982071 | Acid, lactic, enzymaticmethod | 21 C.F.R. § 862.1450 | KHP |
| i-STAT Model 200 PortableClinical Analyzer | K001154 | Electrode, ion specific,sodium | 21 C.F.R. § 862.1665 | JGS |
| i-STAT Model 300 PortableClinical Analyzer | K001387 | Glucose oxidase,glucose | 21 C.F.R. § 862.1345 | CGA |
| i-STAT System | K011478 | Acid, Lactic, EnzymaticMethod | 21 C.F.R. § 862.1450 | KHP |
TABLE 1
Identification of the Predicate Device.
The predicate device is the i-STAT System (see Table 1 above).
Description of the Device.
The i-STAT System is used in conjunction with disposable i-STAT cartridges for determination of a variety of parameters in whole blood.
Intended Use of the Device.
The i-STAT PCA is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in the i-STAT test cartridges.
Reason for Submission.
The software has been modified to diminish the interference on the PCO2 test caused by the drugs thiopental sodium and propofol.
Conclusion.
These labeling changes do not affect prior substantial equivalence determinations.
| i-STAT Corporation104 Windsor Center DriveEast Windsor, NJ 08520 | 14 | |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines emanating from the eagle's body.
AUG 2 0 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Paul VanDerWerf, Ph.D. Vice President, Regulatory Affairs and Quality Assurance i-STAT Corporation 104 Windsor Center Drive East Windsor, NJ 08520
Re: 510(k) Number: K012478 Trade/Device Name: i-STAT System Regulation Numbers: 862.1120, 862.1145, 862.1170, 862.1225, 862.1345, 862.1600, 862.1665, 862.1770, 864.6400, 864.7140, 862.1450 Regulatory Class: II Product Code: CHL, JGS, CDS, JPI, JBP, JFP, CGZ, CGL, CGA, CEM Regulatory Class: I Product Code: KHP Dated: July 31, 2001 Received: August 2, 2001
Dear Dr. VanDerWerf:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K012478
Device Name: i-STAT System
Indications for Use:
The i-STAT System is used by trained medical professionals for running clinical chemistry tests for sodium, potassium, chloride, urea nitrogen, glucose, hematocrit, calcium, blood-gases (PCO2, PO2) and blood pH, creatinine, lactic acid, and activated whole blood clotting time in a variety of test panels contained in the i-STAT test cartridges.
Kusia Alexander for JeanCrops
(Division Sign-Off)
Division of Clinical Laboratory Devices
a) Number K012478
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| i-STAT Corporation | |
|---|---|
| 104 Windsor Center Drive | |
| East Windsor, NJ 08520 |
12
§ 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.