(75 days)
The GEM Premier 3000 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++, Glucose, Lactate and Hct. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
The GEM Premier 3000 is designed as a portable system for use by health care professionals to rapidly analyze whole blood samples, in central laboratory or point-of-care clinical settings. The instrument provides both measured and calculated results for blood gases, hematocrit, electrolytes, glucose, and lactate.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GEM Premier 3000 device, formatted to answer your questions.
It's important to note that this document is a 510(k) summary for a special FDA submission, specifically for an operating system update. Therefore, the details about original device validation and comprehensive performance studies might be summarized or assumed to be met from the predicate device.
Acceptance Criteria and Study for GEM Premier 3000 (Software V6.3.0 Update)
This submission describes an update to the GEM Premier 3000 device's software (V6.3.0) and operating system (Linux Fedora Core 21) due to component obsolescence. The primary focus of the provided text is to demonstrate that these changes do not alter the previously established performance and safety of the device.
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states: "No change to labeled performance claims." This indicates that the performance criteria for the updated device are identical to those of the predicate device (GEM Premier 3000, K052121), which was already cleared by the FDA. The submission's goal is to prove that the software/OS update maintains these pre-existing performance claims.
Therefore, the acceptance criteria are not new performance metrics but rather the demonstration that the updated device performs equivalently to the predicate device across all its established parameters. The "reported device performance" in this context refers to the verification and validation activities showing that the device continues to meet those original, unlabeled performance claims.
| Parameter/Test | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (for v6.3.0) |
|---|---|---|
| Measurement Performance | All labeled performance claims for pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate, Hct as established for the predicate device (K052121). | "Testing verified that the SW V6.3.0 change meets requirements and that no new hazards have been introduced." (Implies equivalent measurement performance) |
| Functional Equivalence | Device operates as intended with the new software and OS, without new hazards. | Demonstrated through software verification and validation activities. |
| User Interface | Same menu-driven touch screen functionality as predicate. | "Same" (stated in comparison table) |
| Controls Compatibility | Compatible with existing GEM CVP 1-4 controls. | "Same" (stated in comparison table) |
2. Sample Size Used for the Test Set and the Data Provenance
The document details software verification and validation activities. However, it does not specify a particular sample size for a "test set" in terms of patient samples or clinical data from a specific geographic region. The testing appears to be focused on software functionality and its impact on performance rather than a new clinical study with patient samples.
- Sample Size: Not explicitly stated for testing of the updated software/OS in a clinical or laboratory setting with a defined number of cases. The testing appears to be centered on software function verification and validation.
- Data Provenance: Not specified. Given it's a software/OS update, the "data" would primarily be software test results rather than patient data. The original predicate device presumably had data provenance established during its clearance.
- Retrospective/Prospective: Not applicable to the software/OS update described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The nature of this submission (a Special 510(k) for an OS update) means that new ground truth establishment by external experts for device performance is likely not required, as the performance claims are carried over from the predicate device. The verification and validation would be internal engineering and quality assurance activities.
4. Adjudication Method for the Test Set
This information is not provided and is unlikely to be relevant for a software/OS update focused on maintaining equivalence to a predicate device's performance. Adjudication methods are typically used in clinical studies where multiple human readers interpret data that requires consensus for ground truth.
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
No, an MRMC comparative effectiveness study was not done. This device is an analyzer for blood samples, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, the concept of "human readers improve with AI" does not apply here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device itself, the GEM Premier 3000, is a standalone instrument that provides quantitative measurements. The update discussed here is for its internal operating system and software. The "standalone" performance for the measurements is inherent to the device's function, and the submission's purpose is to confirm this performance is maintained after the software/OS update. It is not an AI algorithm in the typical sense.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the original predicate device's performance, the ground truth for parameters like pH, pCO2, pO2, Na+, K+, Ca++, Glucose, Lactate, and Hct would typically be established through reference methods (e.g., highly accurate laboratory methods, calibrated standards). The current submission relies on the established performance of the predicate device, implying that the ground truth for its performance was originally established via these reference methods and that the updated device continues to align with those.
The "ground truth" for the software update itself is that the software performs its functions correctly and reliably, and that no regression or new hazards are introduced. This is verified through software testing against design specifications.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The GEM Premier 3000 is a measurement device, not a machine learning or AI algorithm that requires a "training set" in the context of developing a diagnostic model. The software update is for an operating system and application software, not for an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of this device and its software update.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
INSTRUMENTATION LABORATORY CO. NIKITA MALLADI REGULATORY AFFAIRS SPECIALIST II 180 HARTWELL ROAD BEDFORD MA 01730
September 14, 2016
Re: K161818 Trade/Device Name: GEM Premier 3000 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, CHL, JGS, CEM, JFP, KHP, KFG Dated: August 12, 2016 Received: August 15, 2016
Dear Nikita Malladi:
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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Katherine Serrano -S
For:
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161818
Device Name GEM Premier 3000
Indications for Use (Describe)
The GEM Premier 3000 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++, Glucose, Lactate and Hct. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
| Submitter's Information | Instrumentation Laboratory (IL) Co.180 Hartwell RoadBedford, MA 01730, USA |
|---|---|
| ------------------------- | ------------------------------------------------------------------------------------ |
| Contact Person | Nikita MalladiRegulatory Affairs Specialist IIPhone: 781-674-3245Fax: 781-861-4207Email: nmalladi@ilww.com |
|---|---|
| ---------------- | ---------------------------------------------------------------------------------------------------------------------------- |
| Preparation Date | September 12, 2016 |
|---|---|
| ------------------ | -------------------- |
| Device Trade Names | GEM Premier 3000 |
|---|---|
| -------------------- | ------------------ |
| Predicate Device | GEM Premier 3000 | K052121 |
|---|---|---|
| ------------------ | ------------------ | --------- |
| Regulatory Information | |||||
|---|---|---|---|---|---|
| Analyte | RegulationSection | Regulatory Description | Class | ProductCode | Panel |
| pH, pCO2, pO2 | 862.1120 | Blood Gases (pCO2, pO2) and Blood pH system | II | CHL | 75 |
| Sodium | 862.1665 | Sodium test system | II | JGS | |
| Potassium | 862.1600 | Potassium test system | II | CEM | |
| Ionized Calcium | 862.1145 | Calcium test system | II | JFP | |
| Glucose | 862.1345 | Glucose test system | II | CGA | |
| Lactate | 862.1450 | Lactic acid test system | I | KHP | |
| Hematocrit | 864.5600 | Automated hematocrit instrument | II | GKF | 81 |
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Device Description
The GEM Premier 3000 is designed as a portable system for use by health care professionals to rapidly analyze whole blood samples, in central laboratory or point-of-care clinical settings. The instrument provides both measured and calculated results for blood gases, hematocrit, electrolytes, glucose, and lactate.
Indications for Use / Intended Use
The GEM Premier 3000 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 *, Glucose, Lactate and Hct. These parameters along with derived parameters aid in the diagnosis of a patient's acid/base status, oxygen delivery capacity, and electrolyte and metabolite balance.
Reason for Submission
This Special 510(k) is being submitted to update the operating system from Linux Fedora Core 7 to Linux Fedora Core 21 for GEM Premier 3000 Instruments. The operating system is being updated to accommodate a change in the single-board computer due to obsolescence.
The submission meets the criteria for a Special 510(k) based on the following:
- No change in indications for use or intended use
- No change in operating principle
- No change to labeled performance claims
- No change to data reduction software
- No change to fluidic design
- No change to GEM cartridges or CVP material
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| Comparison to Predicate | ||
|---|---|---|
| Item | Predicate (K052121) | Updated Device Subject of this Submission |
| Similarities | ||
| Trade Names | GEM Premier 3000 | Same |
| Indications for Use | See above | Same |
| Intended User | Central Laboratory and Point-of-Care | Same |
| Blood Gas Measurement | Potentiometry: pH and pCO2Amperometry: pO2 | Same |
| Electrolyte Measurement | Potentiometry: Na+, K+, Ca++ | Same |
| Metabolite Measurement | Amperometry: Glucose and Lactate | Same |
| Hematocrit Measurement | Conductivity | Same |
| Sample Introduction | Aspiration | Same |
| Test Principle | Potentiometry: pH, pCO2, Na+, K+, Ca++ Amperometry: pO2, Glu, Lac Conductivity: Hematocrit | Same |
| Sample Type | Whole blood for all analytes | Same |
| Dimensions | GEM3000 - 17 (H) x 12 (W) x 12 (D)" | Same |
| Weight | GEM3000 – 29.5 pounds | Same |
| User Interface | Menu Driven Touch Screen | Same |
| Sample Introduction | Aspiration | Same |
| Controls | In conjunction with iQM:GEM CVP 1, GEM CVP 2,GEM CVP 3 and GEM CVP 4 | Same |
| Differences | ||
| Software | GEM Premier 3000 V6.2.5 | GEM Premier 3000 V6.3.0 |
| Operating System Software | Linux Fedora Core 7 | Linux Fedora Core 21 |
| Single Board Computer | Win Enterprises 90140 Intel Pentium® M® / Celeron® M processor, 400MHz - ETX Module | Seco Q7-BT Rel. 2.0 Module with the Intel® Atom™ E3800 |
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| Declaration of Conformance toDesign Controls | As required by the risk analysis, all verification and validation activities wereperformed and the results demonstrated that the predeterminedacceptance criteria were met. |
|---|---|
| Verification and ValidationSummary | Software verification and validation was performed according as defined inthe GEM Premier 3000 V6.3.0 Project Software Verification Plan (DocumentNo. L0024004020, See Section 32) and in accordance with the SoftwareDesign Verification Procedure. Software Validation was performed asdefined in the GEM 3X00 Software Design and Development Plan for SBCProject (Document No. L0024003937, See Section 30).Testing verified that the SW V6.3.0 change meets requirements and that nonew hazards have been introduced. This is documented in the GEMPremier 3000 V6.3.0 Software Verification report (Document No.L0024004116, See Section 33), and the GEM Premier 3000 V6.3.0 SoftwareValidation Assessment (Document No. L0024005866, See Section 35). |
| Conclusion | Based on the shared indications for use, operating principle andperformance claims, the GEM Premier 3000 with software V6.3.0 runningon the Linux Fedora Core 21 operating system can be concluded to besubstantially equivalent to the cleared and currently marketed predicatedevice, GEM Premier 3000. |
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.