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.

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, Remote software upgrades, Remote diagnostics, Remote LIS tracing, Remote cartridge data (Copy IL Data) transfer.

AI/ML Overview

Here's an analysis of the provided text regarding the GEM® Premier 4000 device, focusing on the acceptance criteria and study information:

Key Finding: This submission (K133407) is a Special 510(k) for a software modification only. It asserts that the modifications have no impact on the performance of the device and therefore, the performance data from the predicate device (K112995) still applies. As such, the document does not contain new acceptance criteria or new study data to demonstrate the device meets acceptance criteria for its analytical performance. It focuses on the verification and validation of the new software features.

Given this, I will extract information related to the device's original performance as described, but it's important to note that this document doesn't provide new studies for analytical performance.

Acceptance Criteria and Device Performance (Based on Predicate Device K112995)

Since this K133407 submission is a modification of a previously cleared device (K112995) and claims "Identical Performance Characteristics" and that the software changes "have no impact to the performance," the acceptance criteria and reported device performance are implicitly those established and accepted for the predicate device. However, this document does not explicitly list performance acceptance criteria or detailed performance reports for the analytes.

The document states:

"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." This indicates that IL (Instrumentation Laboratory) has internal specifications that must be met for quality control (GEM CVP) to ensure accuracy.

Therefore, a table of acceptance criteria and reported device performance for the analytes cannot be fully created from this document. The document specifically states that "the performance data on record for the predicate device (K112995) still apply." To find the detailed acceptance criteria and performance, one would need to refer to the K112995 submission.

Study Details (for the K133407 Software Modification)

This special 510(k) focuses on the software modification and its impact, not on the analytical performance of the device.

Sample size used for the test set and the data provenance:
- Test set for analytical performance: Not applicable for this submission, as full analytical performance studies were not conducted. The submission states that the software changes have no impact on analytical performance, so the performance data of the predicate device (K112995) is referenced.
- Test set for software verification/validation: The document mentions "design control principles (risk management, verification and validation) have been applied," but it does not specify sample sizes or data provenance for the software testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for a software modification submission. No human expert "ground truth" was established for analytical performance in this specific document.
Adjudication method for the test set:
- Not applicable.
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. This device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The "standalone" performance of the analytical functions refers to the predicate device K112995. This submission K133407 focuses on software features (remote desktop sharing, remote upgrades, remote diagnostics, remote LIS tracing, remote cartridge data transfer) that improve service and support, not the core analytical algorithm's standalone performance.
The type of ground truth used:
- For the analytical performance (referenced from K112995), the ground truth for blood gas, electrolyte, and metabolite measurements in IVDs typically involves reference methods, calibrated standards, or comparative studies against established laboratory instruments using patient samples. This document does not specify the type of ground truth used for the original analytical performance.
- For the software modifications in this K133407, the ground truth would be adherence to functional and non-functional requirements established during the software development and verification process.
The sample size for the training set:
- Not applicable. This is an IVD device, not a machine learning model that requires a training set in the AI sense.
How the ground truth for the training set was established:
- Not applicable.

Summary of what's provided for K133407:

This document is a "Special 510(k)" for a software update (V3.0.0) to the GEM® Premier 4000. The primary claim is that the software changes (remote desktop sharing, remote upgrades, remote diagnostics, remote LIS tracing, remote cartridge data transfer) do not impact the fundamental scientific technology or performance characteristics of the device. Therefore, no new analytical performance studies were conducted, and the previous performance data (from K112995) still applies. The document emphasizes that "design control principles (risk management, verification and validation)" were applied to ensure the software release's safety and effectiveness, but it does not provide details on the specific testing performed for these software features (e.g., sample sizes of test cases, specific test protocols, or acceptance criteria for the software functions themselves).

Summary

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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 RoadBedford, MA 01730
Contact Person:Phone Number:Fax Number:E-mail:	Carol Marble, Regulatory Affairs Director781-861-4467781-861-4207cmarble@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 NeonateTest System	862.1113	Class I, Reserved	MQM

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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):

Attachment A

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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
PerformanceCharacteristics	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
SoftwareOperating System	Fedora Core 9 (Linux)	Same
SampleIntroduction	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 toallow real-time interfacebetween IL and customer• Remote software upgrades tofacilitate future upgrades• Remote diagnostics to capturedata for service diagnosticand trending purposes• Remote LIS tracing tofacilitate 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

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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.

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K133407

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.

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.

CHANNELLA MILLING COLLECTION CARDER COLLECTION CONTROLLERS CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTR
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CHANNELLA MILLING COLLECTION CARDER COLLECTION CONTROLLERS CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTRACTOR CONTR

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FORM FDA 3881 (9/13)

PSC Publishing Services (3.0), 443-6740 GF

Regulation Number and Section

§ 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.