(27 days)
Mac-Lab:
The Mac-Lab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from a hemodynamic procedure. Mac-Lab may be used in a variety of hospital and clinical settings to record hemodynamic data and measurements which may then be displayed and/or transmitted.
CardioLab:
The CardioLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from an electrophysiology procedure. CardioLab may be used in a variety of hospital and clinical settings to record electrophysiology data and measurements which may then be displayed and/or transmitted.
ComboLab:
The ComboLab system is indicated for use on patients of all ages when a physician determined that a patient would benefit from either a hemodynamic or electrophysiology procedure. Combol ab may be used in a variety of hospital and clinical settings to record hemodynamic and electrophysiology data and measurements which may then be displayed and/or transmitted.
MLCL Client Software:
The MLCL Client Software is intended for recording, documenting and/or reviewing clinical data for hemodynamic and electrophysiology procedures and may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations.
Mac-Lab and CardioLab are hemodynamic and electrophysiology (EP) recording systems, respectively. A third configuration, ComboLab, allows the user to access both CardioLab and Mac-Lab functions, though only one application may be accessed at a time.
These devices are used during interventional and related procedures to process, display and record hemodynamic and electrophysiology (EP) data depending on the type of procedure performed. The data is acquired and displayed real-time for multiple physiological parameters to allow the user to view the data. The data may be entered manually through the use of a dedicated keyboard/mouse/barcode scanner or acquired via procedural information devices, imaging devices and interfaced data devices, and may then be displayed, filtered, digitized, amplified, measured, and calculated.
A fourth configuration, called the MLCL Client Software, is the core Mac-Lab and CardioLab application software which is available for installation on a stand-alone workstation (i.e. outside of the Mac-Lab/CardioLab/ComboLab acquisition systems described above). The MLCL Review Software may be used to record, document, analyze, store and transmit data, including data from supported patient monitors.
Mac-Lab, CardioLab, ComboLab and the MLCL Client Software provide the ability to transmit patient data for storage, analysis and viewing at distributed locations within a clinical facility via network connectivity but may also be used stand-alone (not connected to a network).
Mac-Lab, CardioLab, ComboLab and the MLCL Client Software are not intended to be used as a patient monitor and are not intended to alert the licensed health care practitioner of a change in patient status.
The provided text is a 510(k) summary for the GE Healthcare Mac-Lab, CardioLab, ComboLab, and MLCL Client Software AltiX AI.i. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of, for example, diagnostic performance metrics (sensitivity, specificity, AUROC).
The changes described in this 510(k) are related to:
- Introduction of a new version of the EP amplifier.
- Updates to signal filtering and gain.
- Inclusion of opSens/HAEMONETICS Diastolic Pressure Ratio (dPR™).
- Introduction of PruckaStream.
- Utilization of Barco Nexxis OR™ for video distribution.
These are technical modifications to existing systems that process and display physiological data, not an AI/ML algorithm that provides a diagnostic output requiring specific performance metrics like sensitivity or specificity. Therefore, the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets them (typically relevant for AI/ML diagnostic devices) is largely not applicable in the traditional sense for this submission.
However, based on the non-clinical tests and statements, we can infer the "acceptance criteria" were met through compliance with recognized standards and internal quality processes.
Here's a breakdown of the requested information based on the provided text, indicating what is applicable and what is not:
1. A table of acceptance criteria and the reported device performance
This document does not present quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic AI model, nor does it report device performance against such metrics. The "performance" described is in terms of meeting electromagnetic compatibility, safety, and functionality standards.
| Acceptance Criteria (Inferred from non-clinical tests) | Reported Device Performance (Summary of results) |
|---|---|
| Compliance with IEC 60601-1-2 Ed 4.1 (EMC) | Compliance demonstrated |
| Compliance with IEC 60601-1 Ed 3.2 (General Safety) | Compliance demonstrated |
| Compliance with IEC 60601-2-27 Ed 3.0 (ECG Safety) | Compliance demonstrated |
| Compliance with IEC 60601-2-34 Ed 3.0 (BP Monitoring Safety) | Compliance demonstrated |
| Software Quality Assurance (Risk Analysis, Requirements Reviews, Design Reviews, Unit/Integration/Performance/System Testing) | Testing and results did not raise new or different questions of safety and effectiveness than the predicate device. |
| Functionality of new features (dPR, PruckaStream, Barco Nexxis OR integration, EP amplifier updates, filtering/gain) | Functionality verified to be safe and effective, comparable to predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is not an AI diagnostic algorithm, so there is no "test set" of patient data in the context of evaluating diagnostic performance. The testing involved non-clinical performance and safety testing against engineering and regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As this is not an AI diagnostic algorithm, there are no medical experts establishing ground truth for a test set of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. This is not an AI assistance device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device does not have a "standalone algorithm" performance as it is an integrated system for recording, displaying, and transmitting physiological data. Its function is to provide accurate data to clinicians, not to make independent diagnoses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" would relate to the accuracy of signal acquisition, processing, and display against known physical inputs or validated measurement standards, rather than medical diagnostic ground truth.
8. The sample size for the training set
Not applicable. This document describes hardware and software updates to a data acquisition and display system, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" described in the 510(k) submission to demonstrate device safety and effectiveness, and thus "meet acceptance criteria" for its intended purpose, is a comprehensive set of non-clinical tests and adherence to quality assurance measures.
-
Non-Clinical Tests: The device and its applications were independently tested for conformity with several voluntary standards:
- IEC 60101-1 Ed 3.2 2020-08 CONSOLIDATED VERSION (General requirements for basic safety and essential performance)
- IEC 60601-1-2 Ed 4.1 2020-09 CONSOLIDATED VERSION (Electromagnetic disturbances - Requirements and tests)
- IEC 60601-2-27 Ed 3.0 2011-03 (Requirements for the safety of electrocardiographic monitoring equipment)
- IEC 60601-2-34 Ed 3.0 2011-05 (Requirements for the safety of invasive blood pressure monitoring equipment)
- Additionally, partial applicability of IEC 80601-2-30 Ed 2.0 (Automated sphygmomanometers), IEC 80601-2-55 Second Edition (Respiratory gas monitors), IEC 80601-2-56 Second Edition (Clinical thermometers), and IEC 80601-2-61 Second Edition (Pulse oximeter equipment) was considered for specific features and functionality.
-
Quality Assurance Measures: The development process followed robust quality assurance, including:
- Risk Analysis
- Requirements Reviews
- Technical Design Reviews
- Formal Design Reviews
- Unit-level Testing (Module verification)
- Integration Testing (System verification)
- Performance Testing (Verification)
- System Testing (including Safety testing and System performance testing)
Conclusion from the Submission:
The manufacturer concluded that "The testing and results did not raise new or different questions of safety and effectiveness than those associated with the predicate device." They further determined that the proposed device is "as safe, as effective and performs as well as the legally marketed predicate device" due to these non-clinical tests, software documentation for a "Basic" level of concern, and quality system processes. No clinical studies were required to support substantial equivalence.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
December 12, 2024
GE Medical Systems Information Technologies, Inc. James Turner Sr. Regulatory Affairs Manager 3114 N Grandview Blvd Waukesha, Wisconsin 53188
Re: K243540
Trade/Device Name: Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i) Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 15, 2024 Received: November 15, 2024
Dear James Turner:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
{2}------------------------------------------------
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
Submission Number (if known)
K243540
Device Name
Mac-Lab (AltiX AI.i); CardioLab (AltiX Al.i); ComboLab (AltiX Al.i); MLCL Client Software (AltiX Al.i)
Indications for Use (Describe)
Mac-Lab:
The Mac-Lab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from a hemodynamic procedure. Mac-Lab may be used in a variety of hospital and clinical settings to record hemodynamic data and measurements which may then be displayed and/or transmitted.
CardioLab:
The CardioLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from an electrophysiology procedure. CardioLab may be used in a variety of hospital and clinical settings to record electrophysiology data and measurements which may then be displayed and/or transmitted.
ComboLab:
The ComboLab system is indicated for use on patients of all ages when a physician determined that a patient would benefit from either a hemodynamic or electrophysiology procedure. Combol ab may be used in a variety of hospital and clinical settings to record hemodynamic and electrophysiology data and measurements which may then be displayed and/or transmitted.
MLCL Client Software:
The MLCL Client Software is intended for recording, documenting and/or reviewing clinical data for hemodynamic and electrophysiology procedures and may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
er-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" inside. To the right of the emblem is the text "GE HealthCare" in a matching purple color. The text is clean and modern, reflecting the company's focus on healthcare solutions.
510(k) Summary – K243540
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 15 November 2024 |
|---|---|
| Submitter: | GE HealthCareGE Medical Systems Information Technologies, Inc.3114 N Grandview BlvdWaukesha, WI 53188USA |
| Primary Contact Person: | Mr. James T. Turner, MSSr. Regulatory Affairs ManagerGE HealthCare(GE Medical Systems Information Technologies, Inc.)Telephone: 414 491 9895Email: james.t.turner@gehealthcare.com |
| Secondary ContactPerson: | Ms. Michelle HuettnerRegulatory Affairs DirectorGE HealthCareTelephone: 901 558 8035Email: michelle.huettner@gehealthcare.com |
| Device Trade Name:(Brand) | Mac-Lab™CardioLab™ComboLabMLCL Client Software |
| Model/Version | AltiX Al.i |
| Common/Usual Name: | Hemodynamic and Electrophysiology (EP) Recording Systems |
| Classification Name:Product Code: | 21 CFR 870.1425 – Computer, Diagnostic ProgrammableDQK |
| Predicate Device: | K213972 – Mac-Lab, CardioLab, ComboLab & MLCL Client Software AltiX |
| Reference Devices: | K202943 – OptoMonitor3 (Opsens, Inc., now part of Haemonetics)K173381 – Nexxis OR (Barco N.V.) |
| Marketed Devices: | Mac-Lab, CardioLab, ComboLab and MLCL Client Software AltiX Al.i aremodifications of the cleared predicate devices (K213972). The primarychanges are related to the introduction of a new version of the EPamplifier, updates to signal filtering and gain, inclusion of opSens/HAEMONETICS Diastolic Pressure Ratio (dPR™), introduction ofPruckaStream, and utilization of Barco Nexxis OR™ for videodistribution. |
| Device Description: | Mac-Lab and CardioLab are hemodynamic and electrophysiology (EP)recording systems, respectively. A third configuration, ComboLab,allows the user to access both CardioLab and Mac-Lab functions, thoughonly one application may be accessed at a time. |
| These devices are used during interventional and related procedures toprocess, display and record hemodynamic and electrophysiology (EP)data depending on the type of procedure performed. The data isacquired and displayed real-time for multiple physiological parametersto allow the user to view the data. The data may be entered manuallythrough the use of a dedicated keyboard/mouse/barcode scanner oracquired via procedural information devices, imaging devices andinterfaced data devices, and may then be displayed, filtered, digitized,amplified, measured, and calculated. | |
| A fourth configuration, called the MLCL Client Software, is the core Mac-Lab and CardioLab application software which is available forinstallation on a stand-alone workstation (i.e. outside of the Mac-Lab/CardioLab/ComboLab acquisition systems described above). TheMLCL Review Software may be used to record, document, analyze, storeand transmit data, including data from supported patient monitors. | |
| Mac-Lab, CardioLab, ComboLab and the MLCL Client Software providethe ability to transmit patient data for storage, analysis and viewing atdistributed locations within a clinical facility via network connectivitybut may also be used stand-alone (not connected to a network). | |
| Mac-Lab, CardioLab, ComboLab and the MLCL Client Software are notintended to be used as a patient monitor and are not intended to alertthe licensed health care practitioner of a change in patient status. | |
| Intended Use: | The intended use of the subject devices have not changed from that ofthe cleared predicate devices. |
| Mac-Lab | |
| The Mac-Lab system is indicated for use on patients of all ages when aphysician determines that a patient would benefit from a hemodynamicprocedure. Mac-Lab may be used in a variety of hospital and clinicalsettings to record hemodynamic data and measurements which maythen be displayed and/or transmitted. | |
| CardioLab | |
| The CardioLab system is indicated for use on patients of all ages when aphysician determines that a patient would benefit from anelectrophysiology procedure. CardioLab may be used in a variety ofhospital and clinical settings to record electrophysiology data andmeasurements which may then be displayed and/or transmitted. | |
| ComboLab | |
| The ComboLab system is indicated for use on patients of all ages when aphysician determined that a patient would benefit from either ahemodynamic or electrophysiology procedure. ComboLab may be usedin a variety of hospital and clinical settings to record hemodynamic andelectrophysiology data and measurements which may then be displayedand/or transmitted. | |
| MLCL Client Software | |
| The MLCL Client Software is intended for recording, documentingand/or reviewing clinical data for hemodynamic and electrophysiologyprocedures and may then be displayed, filtered, digitized, amplified,measured, calculated and/or transmitted for storage, analysis andviewing at distributed locations. | |
| Indications for Use: | The indications for use of the subject devices have not changed fromthat of the cleared predicate devices. |
| Mac-Lab™ | |
| The Mac-Lab system is indicated for use on patients of all ages when aphysician determines that a patient would benefit from a hemodynamicprocedure. Mac-Lab may be used in a variety of hospital and clinicalsettings to record hemodynamic data and measurements, which maythen be displayed, filtered, digitized, amplified, measured, andcalculated and/or transmitted for storage, analysis and viewing atdistributed locations. | |
| CardioLab™ | |
| The CardioLab system is indicated for use on patients of all ages when aphysician determines that a patient would benefit from anelectrophysiology procedure. CardioLab may be used in a variety ofhospital and clinical settings to record electrophysiology data andmeasurements, which may then be displayed filtered, digitized,amplified, measured, and calculated and/or transmitted for storage,analysis and viewing at distributed locations. | |
| ComboLab | |
| The ComboLab system is indicated for use on patients of all ages when aphysician determines that a patient would benefit from either ahemodynamic or electrophysiology procedure. ComboLab may be used |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the text "GE HealthCare" is written in a matching purple color. The text is in a clean, sans-serif font.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the GE Healthcare logo. The logo consists of a purple circle with the letters "GE" inside, and the words "GE Healthcare" in purple next to the circle. The logo is simple and modern, and it is easily recognizable.
GE HealthCare
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image contains the GE Health logo. The logo consists of a purple circular emblem with a stylized "GE" monogram inside. To the right of the emblem, the words "GE Health" are written in a simple, sans-serif font, also in purple. The overall design is clean and modern.
GE HealthCare
| in a variety of hospital and clinical settings to record hemodynamic andelectrophysiology data and measurements, which may then bedisplayed, filtered, digitized, amplified, measured, calculated and/ortransmitted for storage, analysis and viewing at distributed locations.MLCL Client SoftwareThe MLCL Client Software is indicated for use on patients of all ageswhen a physician determines that a patient would benefit from either ahemodynamic or electrophysiology procedure. MLCL Client Softwaremay be used in a variety of hospital and clinical settings to record,document and/or review hemodynamic and electrophysiology data andmeasurements, which may then be displayed, filtered, digitized,amplified, measured, calculated and/or transmitted for storage, analysisand viewing at distributed locations. | |||
|---|---|---|---|
| Technology: | The Mac-Lab, CardioLab and ComboLab Recording Systems AltiX Al.iemploy the same fundamental scientific technology, basic design,construction, materials, energy source, control mechanism, andoperating principles as the predicate devices, Mac-Lab, CardioLab,Combolab and MLCL Client Software AltiX, in recording and displayinghemodynamic and electrophysiology data.The basic systems can acquire data from a variety of inputs which maythen be displayed, filtered, digitized, amplified, measured andcalculated. These systems also provide the ability to transmit patientdata for storage, analysis and viewing.The table below summarizes the substantive feature/technologicaldifferences between the predicate and proposed devices: | ||
| Configuration | Predicate Device Features | Proposed Device Features | |
| Mac-Lab | • Diastolic Pressure Ratio(dPR) not supported onthe device | • Diastolic Pressure Ratio(dPR) incorporated in theMac-Lab software | |
| CardioLab | • Only a 128-channel optionis available for the Prucka3 EP amplifier• Does not support digitalwaveform streaming toexternal, only analogoutput, binary or CSV dataextraction• Included high and lowpass filters, powerlinefilters and gain settings | • Provides an option to useeither a 128- or 64-channelPrucka 3 EP amplifier• PruckaStream makesoriginal digital signal dataavailable from the EPamplifier and allows datareturn• Expanded customizations,settings and capabilities tohelp minimize noise andprovide better signal | |
| Mac-Lab &CardioLab | • Utilizes video distributionvia HDMI splitters andswitches to replicatedisplays | • Allows an alternate videodistribution system, BarcoNexxis OR, to route videosignals and allows use ofsingle command inputs(mouse, keyboard) forconnected devices | |
| ComboLab utilizes the combined hardware and software features notedin the table above for both CardioLab and Mac-Lab on a single platform.The MLCL Client Software utilizes the combined software features fromthe table above but does not include the hardware features (64-ChannelPrucka 3 EP amplifier).The device's technological characteristics do not create new questions | |||
| of safety or effectiveness, | |||
| Data Supporting Safety& Efficacy: | Summary of Non-Clinical Tests:The subject devices and applications have been independently testedand conform to the following voluntary standards:• IEC 60101-1 Ed 3.2 2020-08 CONSOLIDATED VERSON• IEC 60601-1-2 Ed 4.1 2020-09 CONSOLIDATED VERSION• IEC 60601-2-27 Ed 3.0 2011-03• IEC 60601-2-34 Ed 3.0 2011-05 | ||
| In addition, the following standards were used to analyze theeffectiveness of specific features and functionality of the subject deviceseven though the standards were not applicable in full:• IEC 80601-2-30 Ed 2.0 2018-03• IEC 80601-2-55 Second Edition 2018-02• IEC 80601-2-56 Second Edition 2017-03• IEC 80601-2-61 Second Edition 2017-12 (Corrected version) | |||
| The following quality assurance measures were applied to thedevelopment of the system:• Risk Analysis• Requirements Reviews• Technical Design Reviews• Formal Design Reviews• Testing on unit level (Module verification)• Integration testing (System verification)• Performance testing (Verification)• System Testing:- Safety testing (Verification)- System performance testing (Verification) |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram in a circle on the left, followed by the words "GE HealthCare" in a sans-serif font. The logo is purple in color.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image contains the GE Healthcare logo. The logo consists of a circular emblem on the left and the text "GE Healthcare" on the right. The emblem features a stylized "GE" monogram within a circular border. The text "GE Healthcare" is written in a sans-serif font and is purple.
GE HealthCare
| The testing and results did not raise new or different questions of safetyand effectiveness than those associated with the predicate device.Software documentation for a "Basic" level of concern was alsoconsidered as a point of comparison to the predicate device. Theconclusions drawn from the nonclinical tests demonstrate that theproposed device is as safe, as effective and performs as well as thelegally marketed predicate device. | |
|---|---|
| Summary of Clinical Tests: | |
| The subject of this premarket submission, Mac-Lab, CardioLab,ComboLab and MLCL Client Software AltiX AI.i, did not require clinicalstudies to support substantial equivalence. | |
| Conclusion: | GE HealthCare considers Mac-Lab, CardioLab, ComboLab and MLCLClient Software AltiX Al.i to be as safe, as effective, and performance iscomparable to the predicate device(s). |
| The changes associated with the Mac-Lab, CardioLab, ComboLab andMLCL Client Software AltiX Al.i do not create a new Intended Use andrepresent similar technological characteristics, with no impact on thecontrol mechanisms, operating principle, and energy type. GEHealthCare's quality system's design verification, and risk managementprocesses did not identify any new questions of safety or effectiveness,hazards, unexpected results, or adverse effects stemming from thechanges to the predicate. | |
| Based on development under GE HealthCare's quality system, thesuccessful system and software verification and validation testing,conformance to standards, and additional engineering bench testingdemonstrates that the subject device is comparable to, and hence assafe and as effective for its Intended Use. |
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).