(93 days)
The GEM Premier 3000, which is an upgraded version of the existing GEM Premier Plus (K961335), is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+, Ca++, and Hct. These parameters along with derived parameters Base Excess, HCO3, TCO2 and sO2 aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
The GEM Premier 3000, which is an upgraded version of the existing GEM Premier Plus (K961335), is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH. pCO2, pO2, Na+, K+, Ca++, and Hct. These parameters along with derived parameters Base Excess, HCO3, TCO2 and sO2 aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
Here's an analysis of the acceptance criteria and study detailed in the provided text for the GEM Premier 3000 device:
Acceptance Criteria and Device Performance for GEM Premier 3000
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for precision and method comparison. Instead, it presents the results of the studies and implicitly suggests that these results were deemed acceptable by the FDA for substantial equivalence. The predicate device (IL Synthesis and manual spun hematocrit) serves as the de facto acceptance benchmark.
Below are the reported performance metrics from the studies:
Precision Data (Combined Within Run and Total %CV / SD)
| Parameter | Mean (Level 1) | Within Run %CV/SD (L1) | Total %CV/SD (L1) | Mean (Level 2) | Within Run %CV/SD (L2) | Total %CV/SD (L2) | Mean (Level 3) | Within Run %CV/SD (L3) | Total %CV/SD (L3) |
|---|---|---|---|---|---|---|---|---|---|
| pH | 7.0886 | 0.0066 (SD) | 0.0180 (SD) | 7.4276 | 0.0038 (SD) | 0.0049 (SD) | 7.6263 | 0.0040 (SD) | 0.0082 (SD) |
| pCO₂ (mmHg) | 66.02 | 1.95 | 2.82 | 36.37 | 2.37 | 2.45 | 16.79 | 2.89 | 3.76 |
| pO₂ (mmHg) | 64.42 | 2.14 | 2.77 | 103.69 | 0.86 | 1.63 | 155.65 | 0.82 | 1.20 |
| Na+ (mmol/L) | 118.55 | 0.63 | 0.98 | 135.51 | 0.42 | 0.72 | 152.61 | 0.63 | 1.18 |
| K+ (mmol/L) | 2.32 | 1.92 | 2.04 | 3.782 | 0.62 | 0.92 | 6.143 | 0.57 | 0.83 |
| Ca++ (mmol/L) | 0.753 | 2.16 | 2.68 | 1.071 | 0.94 | 1.50 | 1.387 | 0.88 | 1.30 |
| Hct (%) | 24.34 | 1.18 | 1.43 | 43.93 | 1.11 | 1.57 | NA | NA | NA |
Method Comparison Data (GEM Premier 3000 vs. Predicate Device)
| Parameter | n | Slope | Intercept | r | Sample Range |
|---|---|---|---|---|---|
| pH | 128 | 1.0660 | -0.4754 | 0.9931 | 7.10 - 7.60 |
| pCO₂ (mmHg) | 130 | 0.9721 | 2.1653 | 0.9935 | 24.6 - 99.6 |
| pO₂ (mmHg) | 128 | 0.9977 | 1.3552 | 0.9990 | 32 - 538 |
| Na+ (mmol/L) | 85 | 1.0181 | -3.9552 | 0.9820 | 110 - 182 |
| K+ (mmol/L) | 84 | 0.9474 | 0.0736 | 0.9987 | 1.20 - 14.60 |
| Ca++ (mmol/L) | 80 | 0.9756 | 0.0202 | 0.9927 | 0.73 - 4.01 |
| Hct (%) | 117 | 1.0841 | -3.4184 | 0.9548 | 16.0 - 54.0 |
Based on the FDA's decision to clear the device (K992834), the reported precision and method comparison results for the GEM Premier 3000 were considered sufficient to demonstrate substantial equivalence to the predicate devices. The implicit acceptance criteria were therefore met.
2. Sample Size Used for the Test Set and Data Provenance
Precision Study:
- Sample Size: 60 replicates (4 per day for 14 days, twice on Day 1) on each of 7 different IL GEM 3000 instruments, totaling 420 replicates for each parameter at each control level.
- Data Provenance: The data was generated using "three levels of controls (GEM Check Plus) for pH, pCO2, pO3, Na+, K+, Ca++ and two levels of controls (GEM critCheck) for hematocrit." It is an in-vitro study using manufactured control materials. The country of origin is not explicitly stated but implies a controlled laboratory setting.
Method Comparison Study:
- Sample Size:
- pH, pCO₂, pO₂: n = 128-130
- Na+, K+, Ca++: n = 80-85
- Hct: n = 117
- Data Provenance: The samples were from "arterial, venous, heart bypass and liver transplant blood samples from hospital patients using heparinized syringes and from healthy volunteers using heparinized vacutainer tubes." This indicates a prospective collection of human whole blood samples in a clinical setting. The country of origin for the hospital patients and healthy volunteers is not specified, but it's likely within the US given the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (blood gas analyzer) does not typically involve human "experts" to establish ground truth in the same way an imaging or diagnostic AI device does. The ground truth for the method comparison study was established by measurements from the predicate devices:
- For pH, pCO2, pO2, Na+, K+, and Ca++: the IL Synthesis (an existing, legally marketed blood gas analyzer).
- For Hct: manual spun hematocrit (a standard laboratory method).
No specific "experts" with defined qualifications were involved in establishing the ground truth beyond the inherent calibration and standard operating procedures of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of interpretations (e.g., by multiple readers). The "ground truth" was obtained through direct measurements from the predicate devices.
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. The GEM Premier 3000 is an automated blood gas analyzer, not an AI-powered diagnostic tool that assists human readers/interpreters in a multi-reader, multi-case study context. It directly measures and reports values.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence, the entire performance evaluation is a "standalone" assessment of the device's accuracy and precision. The GEM Premier 3000 operates as an automated system; its outputs are the direct measurements it provides. The method comparison study compares its standalone performance against established analytical methods (predicate devices), and the precision study evaluates its inherent measurement variability.
7. The Type of Ground Truth Used
The ground truth used for the method comparison study was comparative measurements from a legally marketed predicate device (IL Synthesis) and a standard laboratory method (manual spun hematocrit). This constitutes an established reference method or reference standard for the parameters being measured in the clinical laboratory context.
8. The Sample Size for the Training Set
Not applicable. The GEM Premier 3000 is a physical medical device (an analyzer) and not a machine learning or AI algorithm that requires a "training set" in the computational sense. Its underlying hardware and software are designed and validated through engineering processes, not by statistical training on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device. The device's operational parameters and calibration are established through engineering design, manufacturing standards, and internal validation, not through a data-driven training process.
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Section 3 GEM Premier 3000 - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4464 Fax:
Contact Person:
Carol Marble. Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4464
Summary Prepared:
August 20, 1999
Name of the device:
GEM Premier 3000
Classification name(s):
| 75CHL | Electrode measurement, blood-gases (PCO2, PO2) and blood pH | Class II |
|---|---|---|
| 862.1120 | Blood-Gases (PCO2, PO2) and blood pH test system | |
| 75JGS | Electrode, ion specific, sodium | Class II |
| 862.1665 | Sodium test system | |
| 75CEM | Electrode, ion specific, potassium | Class II |
| 862.1600 | Potassium test system | |
| 75JFO | Electrode, ion specific, calcium | Class II |
| 862.1145 | Calcium test system | |
| 81GKF | Instrument, hematocrit, automated | Class II |
| 864.5600 | Automated hematocrit instrument |
Identification of predicate device(s):
IL Synthesis (except for hematocrit, which used manual spun hematocrit) K963800
Description of the device/intended use(s):
The GEM Premier 3000, which is an upgraded version of the existing GEM Premier Plus (K961335), is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH. pCO2, pO2, Na+, K+, Ca++, and Hct. These parameters along with derived parameters Base Excess, HCO3, TCO2 and sO2 aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The GEM Premier 3000 is substantially equivalent in performance, intended use, safety and effectiveness to the IL Synthesis (predicate device) for the quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+ and Ca++, and to manual spun hematocrit (predicate device) for Hct.
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Summary of performance data:
Precision
Blood gas precision data were generated by using three levels of controls (GEM Check Plus) for pH, pCO2, pO3, Na+, K+, Ca++ and two levels of controls (GEM critCheck) for hematocrit. Control levels were run in replicates of 4 once a day for 14 days (twice on Day 1) for a total of 60 replicates on each of 7 different IL GEM 3000 instruments (total n=420). The table below shows the combined within run and total %CV of the seven instruments. NOTE: SD is used for pH since differences are so small that %CV would be misleading.
| Level 1 | Level 2 | Level 3 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Parameter | Mean | WithinRun %CV | Total%CV | Mean | WithinRun %CV | Total%CV | Mean | WithinRun %CV | Total%CV |
| pH | 7.0886 | 0.0066(SD) | 0.0180(SD) | 7.4276 | 0.0038(SD) | 0.0049(SD) | 7.6263 | 0.0040(SD) | 0.0082(SD) |
| pCO₂(mmHg) | 66.02 | 1.95 | 2.82 | 36.37 | 2.37 | 2.45 | 16.79 | 2.89 | 3.76 |
| pO₂(mmHg) | 64.42 | 2.14 | 2.77 | 103.69 | 0.86 | 1.63 | 155.65 | 0.82 | 1.20 |
| Na+(mmol/L) | 118.55 | 0.63 | 0.98 | 135.51 | 0.42 | 0.72 | 152.61 | 0.63 | 1.18 |
| K+(mmol/L) | 2.32 | 1.92 | 2.04 | 3.782 | 0.62 | 0.92 | 6.143 | 0.57 | 0.83 |
| Ca++(mmol/L) | 0.753 | 2.16 | 2.68 | 1.071 | 0.94 | 1.50 | 1.387 | 0.88 | 1.30 |
| Hct(%) | 24.34 | 1.18 | 1.43 | 43.93 | 1.11 | 1.57 | NA | NA | NA |
Method Comparison
The method comparison data included arterial, venous, heart bypass and liver transplant blood samples from hospital patients using heparinized syringes and from healthy volunteers using heparinized vacutainer tubes. All samples were analyzed on the GEM Premier 3000 using an IL Synthesis as the predicate device with the exception of the hematocrit parameter, which used manual spun hematocrit as the predicate device. The GEM Premier 3000 was shown to be statistically similar to the predicate devices for the parameters listed below:
| Parameter | n | Slope | Intercept | r | Sample Range |
|---|---|---|---|---|---|
| pH | 128 | 1.0660 | -0.4754 | 0.9931 | 7.10 - 7.60 |
| pCO₂ (mmHg) | 130 | 0.9721 | 2.1653 | 0.9935 | 24.6 - 99.6 |
| pO₂ (mmHg) | 128 | 0.9977 | 1.3552 | 0.9990 | 32 - 538 |
| Na+ (mmol/L) | 85 | 1.0181 | -3.9552 | 0.9820 | 110 - 182 |
| K+ (mmol/L) | 84 | 0.9474 | 0.0736 | 0.9987 | 1.20 - 14.60 |
| Ca++ (mmol/L) | 80 | 0.9756 | 0.0202 | 0.9927 | 0.73 - 4.01 |
| Hct (%) | 117 | 1.0841 | -3.4184 | 0.9548 | 16.0 - 54.0 |
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three wavy lines, which are meant to represent the human form.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 4 1999
Ms. Carol Marble Manager, Regulatory Affairs Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125
Re: K992834 Trade Name: GEM Premier 3000 Regulatory Class: II Product Code: CHL, JGS, CEM, JFO, GKF Dated: November 11, 1999 Received: November 12, 1999
Dear Ms. Marble:
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 (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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman
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 Statement
510(k) Number (if known): K992834
Device Name: GEM Premier 3000
Indications for Use:
The GEM Premier 3000, which is an upgraded version of the existing GEM Premier Plus (K961335), is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides quantitative measurements of whole blood pH, pCO2, pO2, Na+, K+, Ca++, and Hct. These parameters along with derived parameters Base Excess, HCO2, TCO2 and sO2 aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
Seun Cooper
(Division Sign-Off)
Division of Clin 'aboratory ices
510(k) Numbe: K 9942834
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.019)
Over-The-Counter Use
GEM Premier 3000 510(k)
OR
§ 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.