(68 days)
Not Found
No
The document describes an "Intelligent Quality Management (iQM)" system, but the description focuses on automated process control, error detection, and correction based on predefined parameters and calibrations, not on learning from data or adapting its behavior in a way characteristic of AI/ML. The software updates mentioned are related to remote service and support functionalities. There is no mention of AI, ML, or related concepts like training or test sets.
No
The device is an analytical system designed to measure various blood parameters, aiding in diagnosis and management, but it does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides measurements that "aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity" and that "Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin," and "In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus." These phrases clearly indicate its role in diagnosis.
No
The device description clearly states it is a "portable critical care system" and an "instrument" that analyzes blood samples, indicating it is a hardware device with integrated software, not a software-only medical device. The software updates mentioned are for remote service and support functionalities of the existing hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Analyzes biological samples: The device analyzes whole blood and heparinized plasma samples.
- Provides quantitative measurements: It provides quantitative measurements of various parameters (pH, blood gases, electrolytes, metabolites, hematocrit, total bilirubin, and CO-Oximetry).
- Aids in diagnosis and management: The intended use explicitly states that these parameters "aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity" and that total bilirubin measurements are used "in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin." It also mentions aiding in assessing the risk of kernicterus in neonates.
- Used in a clinical setting and central laboratory: The device is intended for use by healthcare professionals in clinical settings and central laboratories, which are typical environments for IVD testing.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The GEM Premier 4000 clearly fits this definition.
N/A
Intended Use / Indications for Use
The GEM® Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb. OHb. COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions. Iiver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates. the level of total bilirubin is used to aid in assessing the risk of kernicterus.
Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.
As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.
Product codes (comma separated list FDA assigned to the subject device)
CHL, JGS, CEM, JFP, CGZ, CGA, KHP, GKF, GHS, GKR, GLY, CIG, MQM
Device Description
Software V3.0.0 introduces the following new functionality to further improve the service and support of the GEM® Premier 4000:
- Remote desktop sharing to allow real-time sharing of the analyzer screen with IL service
- Remote software upgrades to facilitate deployment of future software versions
- Remote diagnostics to capture data for service diagnostic and trending purposes
- Remote LIS tracing to facilitate service diagnostics
NOTE: Software V3.0.0 also allows remote cartridge data (Copy IL Data) transfer. Copy IL Data is already available locally on the currently marketed GEM® Premier 4000 with GEMweb (standalone instruments) and GEMweb Plus data management system (server connected instruments) and is used to transmit data for service and complaint review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonates
Intended User / Care Setting
health care professionals, point of health care delivery in a clinical setting and in a central laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
For the implementation of the changes described above, design control principles (risk management, verification and validation) have been applied which support that the software release has no impact to the performance of the GEM® Premier 4000. Therefore, the performance data on record for the predicate device (K112995) still apply.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows three logos. The first logo is a circular shape with horizontal lines inside, and the text "Werfen Group" is written below it. The second logo is a geometric shape that looks like a cube with some parts missing. The third logo has the text "Instrumentation Laboratory" written in a bold, sans-serif font.
ﺔ
JAN 1 3 2014
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.
1. Applicant Contact Information:
| Applicant:
Address: | Instrumentation Laboratory Co.
180 Hartwell Road
Bedford, MA 01730 |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Contact Person:
Phone Number:
Fax Number:
E-mail: | Carol Marble, Regulatory Affairs Director
781-861-4467
781-861-4207
cmarble@ilww.com |
| Preparation Date: | December 13 2013 |
2. Proprietary Name:
GEM® Premier 4000
Regulatory Information: 3.
- . Common Name: Blood gases (pCO2 and pO2) and blood pH test system
- . Classification Panel: Clinical Chemistry (75) and Hematology (81)
- Device Classifications, Classes and Product Codes are as follows: .
| Description | Classification | Class | Product Code |
|---|---|---|---|
| Blood gases and blood pH | 862.1120 | Class II | CHL |
| Sodium test system | 862.1665 | Class II | JGS |
| Potassium test system | 862.1600 | Class II | CEM |
| Calcium test system | 862.1145 | Class II | JFP |
| Chloride test system | 862.1170 | Class II | CGZ |
| Glucose test system | 862.1345 | Class II | CGA |
| Lactic acid test system | 862.1450 | Class I | KHP |
| Automated hematocrit instrument | 864.5600 | Class II | GKF |
| Carboxyhemoglobin assay | 864.7425 | Class II | GHS |
| Automated hemoglobin system | 864.5620. | Class II | GKR |
| Whole blood hemoglobin assays | 864.7500 | Class II | GLY |
| Bilirubin (Total or Direct) | |||
| Test System | 862.1110 | Class II | CIG |
| (Total and Unbound) in the Neonate | |||
| Test System | 862.1113 | Class I, Reserved | MQM |
1
Description of Device Modification: 4.
Software V3.0.0 introduces the following new functionality to further improve the service and support of the GEM® Premier 4000:
- . Remote desktop sharing to allow real-time sharing of the analyzer screen with IL service
- . Remote software upgrades to facilitate deployment of future software versions
- . Remote diagnostics to capture data for service diagnostic and trending purposes
- . Remote LIS tracing to facilitate service diagnostics
- NOTE: Software V3.0.0 also allows remote cartridge data (Copy IL Data) transfer. Copy IL Data is already available locally on the currently marketed GEM® Premier 4000 with GEMweb (standalone instruments) and GEMweb Plus data management system (server connected instruments) and is used to transmit data for service and complaint review.
5. Indications for Use (No Change from K112995):
The GEM® Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCQ2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb. OHb. COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions. Iiver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates. the level of total bilirubin is used to aid in assessing the risk of kernicterus.
Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.
As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.
Attachment A
2
6. Substantial Equivalence:
The GEM® Premier 4000 with remote features is substantially equivalent in Indications for Use, fundamental scientific technology and performance characteristics to the predicate:
GEM® Premier 4000 510(k): K112995
| Similarities | ||
|---|---|---|
| Characteristic | Predicate Device | Modified Device |
| Indications for Use | Identical Indications for Use | Same |
| Intended Use Site | Laboratory and point-of-care | Same |
| Performance | ||
| Characteristics | Identical Performance Characteristics | Same |
| Test Principle | • Potentiometry: pH, pCO2, Na+, K+, Cl-, Ca++ | |
| • Amperometry: pO2, Glu, Lac | ||
| • Conductivity: Hematocrit | ||
| • Spectrophotometry: CO-Oximetry and tBili | Same | |
| Sample Type | Whole blood for all analytes; | |
| Plasma for CO-Oximetry and tBili | Same | |
| Dimensions | 18 (H) x 12 (W) x 15 (D) inches | Same |
| Weight | 44 pounds | Same |
| User Interface | Menu Driven Touch Screen | Same |
| Software | ||
| Operating System | Fedora Core 9 (Linux) | Same |
| Sample | ||
| Introduction | Aspiration | Same |
| Controls | In conjunction with iQM: | |
| • GEM CVP 1 and 2 with CO-Ox | ||
| • GEM CVP 3 and 4 Hematocrit | ||
| • GEM CVP 5 tBili | Same | |
| Differences | ||
| Characteristic | Predicate Device | Modified Device |
| Software | V2.3.0 | V3.0.0 |
| Remote Features | Not Available | • Remote desktop sharing to |
| allow real-time interface | ||
| between IL and customer | ||
| • Remote software upgrades to | ||
| facilitate future upgrades | ||
| • Remote diagnostics to capture | ||
| data for service diagnostic | ||
| and trending purposes | ||
| • Remote LIS tracing to | ||
| facilitate service diagnostics |
7. Conclusion:
For the implementation of the changes described above, design control principles (risk management, verification and validation) have been applied which support that the software release has no impact to the performance of the GEM® Premier 4000. Therefore, the performance data on record for the predicate device (K112995) still apply.
Special 510(k) K133407: GEM® Premier 4000
3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2014
INSTRUMENTATION LABORATORY CO. CAROL MARBLE REGULATORY AFFAIRS DIRECTOR 180 HARTWELL ROAD BEDFORD MA 01730
Re: K133407
Trade/Device Name: GEM Premier 4000 Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases and blood pH Regulatory Class: II Product Code: CHL, JGS, CEM, JFP, CGZ, CGA, KHP, GKF, GHS, GKR, GLY, CIG, MQM Dated: December 13, 2013 Received: December 16, 2013
Dear Ms. Marble:
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 ffor 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 The The general controls provisions of the Act include requirements for annual registration. Ilsting 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2-Ms. Marble
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
CourtneyH.Lias-S
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
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Naine
GEM® Premier 4000
Indications for Use (Describe)
The GEM® Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MctHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus.
Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed.
As part of this program, GEM CV.P (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge callbration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, metabolites, total bilirubin. CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.
Type of Use (Select one or hoth, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (9/13)
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