(59 days)
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, filtered, digitized, amplified, measured, and calculated and/or transmitted for storage, analysis and viewing at distributed locations.
The CardioLab system is indicated for use on patients of all ages when a physician determines that a patient would benefft 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 filtered, amplified, measured, and calculated and/or transmitted for storage, analysis and viewing at distributed locations.
The ComboLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from either a hemodynamic or electrophysiology procedure. ComboLab may be used in a variety of hospital and clinical settings to record hemodynamic and electrophysiology data and measurements, which may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations.
The MLCL Client Software is indicated for use on patients of all ages when a physician determines that a patient would benefit from either a hemodynamic or electrophysiology procedure. MLCL Client Software may be used in a variety of hospital and clinical settings to record, document and/or review hemodynamic and electrophysiology data and measurements, which 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 describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Mac-Lab Recording Systems, CardioLab Recording Systems, ComboLab Recording Systems, and MLCL Client Software.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics. The overall reported device performance is that the device is "as safe, as effective, and performs as well as the legally marketed predicate device."
Summary of Reported Device Performance and Equivalence Claims:
| Aspect | Reported Device Performance |
|---|---|
| Safety & Efficacy | The proposed device is considered "as safe, as effective and performs as well as the legally marketed predicate device." Nonclinical tests and results "did not raise new or different questions of safety and effectiveness than those associated with the predicate device." |
| Technological Equivalence | The device "employs the same fundamental scientific technology, basic design, construction, materials, energy source control mechanism, and operating principles as the predicate devices...in recording and displaying hemodynamic and electrophysiology data." The technological characteristics "do not create new questions of safety or effectiveness, and did not introduce any new risks/hazards, warnings or limitations." The changes "do not create a new Intended Use and represent similar technological characteristics, with no impact on the control mechanisms, operating principle, and energy type." |
| Software Level of Concern | Software documentation for a "Moderate" level of concern was considered and compared to the predicate device. |
| Compliance with Standards | The device "conforms to voluntary standards" including IEC 60601-1 Ed. 3.1, IEC 62366:2015, IEC 62304:2006/A1:2015, IEC 82304-1:2016-10, ISO 15223-1:2016, IEC 60601-2-27:2011, and IEC 60601-2-34:2011. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "The subject of this premarket submission, Mac-Lab, CardioLab and ComboLab AltiX, did not require clinical studies to support comparability to the predicate device." Therefore, there is no sample size for an external "test set" and no direct data provenance related to a clinical study. The evaluation primarily relied on non-clinical testing and comparison to the predicate device.
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)
Since no clinical studies were performed to establish a "test set" with ground truth from experts, this information is not applicable and not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set requiring expert ground truth or adjudication was conducted, this information is 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
No MRMC comparative effectiveness study was done. The device is a recording system for hemodynamic and electrophysiology data and measurements, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "Performance testing (Verification)" and "System performance testing (Verification)" as part of the non-clinical tests. These would likely involve evaluating the algorithm's performance in isolation or as part of the system. However, specific standalone performance metrics or a detailed description of "algorithm-only" performance is not provided beyond the general statement of performing "as well as" the predicate. The device's primary function is data acquisition, display, and processing, not automated diagnosis that would typically warrant a standalone algorithmic performance study distinct from the system's overall function.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" for verification and validation would be established by reference to engineering specifications, established standards (e.g., IEC 60601 series), and the performance of the legally marketed predicate device. This is primarily technical or functional ground truth, rather than clinical ground truth (like pathology or outcomes data).
8. The sample size for the training set
The document does not mention any "training set" as part of an AI/machine learning model. The device is described as a recording system, and the changes primarily involve hardware updates (new EP amplifier) and inclusion of existing technology (DFR technology). There is no indication of machine learning components that would require a distinct training set.
9. How the ground truth for the training set was established
As there is no mention of a training set for an AI/machine learning component, this information is not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
February 17, 2022
GE Healthcare Information Technologies, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K213972
Trade/Device Name: Mac-Lab Recording Systems, CardioLab Recording Systems, ComboLab Recording Systems, MLCL Client Software Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: December 18, 2021 Received: December 20, 2021
Dear Prithul Bom:
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. 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 located 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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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-regulatoryassistance/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.
for
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
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510(k) Number (if known) K213972
Device Name
Мас-Lab™
Indications for Use (Describe)
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, filtered, digitized, amplified, measured, and 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) | ❍ Over-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
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510(k) Number (if known) K213972
Device Name
CardioLab™
Indications for Use (Describe)
The CardioLab system is indicated for use on patients of all ages when a physician determines that a patient would benefft 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 filtered, amplified, measured, and 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) |
| Over-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
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510(k) Number (if known) K213972
Device Name
ComboLab
Indications for Use (Describe)
The ComboLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from either a hemodynamic or electrophysiology procedure. ComboLab may be used in a variety of hospital and clinical settings to record hemodynamic and electrophysiology data and measurements, which 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) | Over-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
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510(k) Number (if known) K213972
Device Name
MLCL Client Software
Indications for Use (Describe)
The MLCL Client Software is indicated for use on patients of all ages when a physician determines that a patient would benefit from either a hemodynamic or electrophysiology procedure. MLCL Client Software may be used in a variety of hospital and clinical settings to record, document and/or review hemodynamic and electrophysiology data and measurements, which 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) |
|---|
| Over-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
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Image /page/6/Picture/2 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are decorative swirls around the edge of the circle. The logo is simple and recognizable.
510(k) Summary
This 510(k) Summary of Safety and Effectiveness information is submitted in accordance with 21 CFR 807.87(h).
| Date: | 06 October 2021 |
|---|---|
| Submitter: | GE HealthcareGE Medical Systems Information Technologies, Inc9900 West Innovation DriveWauwatosa, WI 53226USA |
| Primary Contact Person: | Mr. James T. Turner, MS, RACSr. Regulatory Affairs ManagerGE Healthcare(GE Medical Systems Information Technologies, Inc.)Telephone: 414 491 9895Email: james.t.turner@ge.com |
| Secondary ContactPerson: | Mr. Philip MalcaRegulatory Affairs DirectorGE HealthcareTelephone: 33(0) 1 3070 4207Email: philip.malca@ge.com |
| Device Trade Name:(Brand) | Mac-Lab™CardioLab™ComboLabMLCL Client Software |
| Common/Usual Name: | Hemodynamic and Electrophysiology (EP) Recording Systems |
| Device Classification | Class II |
| Regulation Number:Product Code: | 21 CFR 870.1425 - Computer, Diagnostic ProgrammableDQK |
| Predicate Device: | K130626 – GE's Mac-Lab, CardioLab, ComboLab, SpecialsLab RecordingSystems v6.9.5 |
| Reference Device: | K191008 – Boston Scientific's iLab Polaris Multi-Modality GuidanceSystem |
| Marketed Device(s): | Mac-Lab, CardioLab and ComboLab AltiX, and MLCL Client SoftwareAltiX are modifications of the predicate device. The primary changesare related to the introduction of a new EP amplifier and the inclusion ofBoston Scientific's Diastolic Hyperemia-Free Ratio (DFR) technology. |
| 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, 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. | |
| Intended Use: | Mac-Lab™ |
| The Mac-Lab system is intended for recording hemodynamic clinical data, and may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations. | |
| CardioLab™ | |
| The CardioLab system is intended for recording electrophysiology clinical data, and may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations. | |
| ComboLab | |
| The ComboLab system is the combination of both the Mac-Lab and CardioLab systems intended for recording hemodynamic and electrophysiology clinical data, respectively and may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage analysis and viewing at distributed locations. | |
| 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: | 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 whena physician determines 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 bedisplayed, filtered, digitized, amplified, measured, calculated and/ortransmitted for storage, analysis and viewing at distributed locations. | |
| MLCL Client Software | |
| The 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: | Mac-Lab, CardioLab and ComboLab AltiX employ the same fundamentalscientific technology, basic design, construction, materials, energysource control mechanism, and operating principles as the predicate |
| devices, Mac-Lab, CardioLab and Combolab v6.9.5, in recording anddisplaying hemodynamic 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, or may be used in a stand-alone(non-networked) mode. | |
| The table below summarizes the substantive feature/technologicaldifferences between the predicate device and the proposed device: | |
| ConfigurationPredicate Device FeaturesProposed Device Features | |
| ■ Diastolic Hyperemia-Free Ratio· Includes Diastolic Hyperemia-Mac-Lab(DFR) technology not supportedFree Ratio (DFR) technology | |
| CLAB II Plus EP Amplifier or■ CLAB II Plus EP AmplifierCardioLabロ■ Utilizes only 3″d party ECG trunkPrucka 3 EP Amplifier, ECG■ Includes GE ECG trunk cablescables▪ Cycle Length supported on■ Cycle Length supported on upchannels 1 & 2 onlyto 10 channels■ 2 real-time windows available■ 1 real-time window available■ 5 review windows available■ 2 review windows available■ ClearMatch/Signal Overlay not▪ Includes ClearMatch/SignalsupportedOverlay feature | |
| ComboLab utilizes the combined hardware and software featuresnoted in the table above for both CardioLab and Mac-Lab on a singleplatform. The MLCL Client Software utilizes the combined softwarefeatures from the table above but does not include the hardwarefeatures (Prucka 3 EP amplifier and ECG trunk cables).The device's technological characteristics do not create new questionsof safety or effectiveness, and did not introduce any new risks/hazards,warnings or limitations. | |
| Data Supporting Safety | Summary of Non-Clinical Tests: |
| & Efficacy: | The subject device and its applications have been independently testedand conforms to voluntary standards: |
| ■ IEC 60601-1 Ed. 3.1 applicable Collateral and Particular Standards,■ IEC 62366:2015■ IEC 62304:2006/A1:2015■ IEC 82304-1:2016-10■ ISO 15223-1:2016■ IEC 60601-2-27:2011■ IEC 60601-2-34:2011 | |
| 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)- Simulated use testing (Validation) | |
| 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 "Moderate" 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 andComboLab AltiX, did not require clinical studies to supportcomparability to the predicate device. | |
| Conclusion: | GE Healthcare considers the Mac-Lab, CardioLab and ComboLab AltiXto be as safe, as effective, and performance is comparable to thepredicate device(s). |
| The changes associated with the Mac-Lab, CardioLab and ComboLabAltiX and the MLCL Client Software do not create a new Intended Useand represent similar technological characteristics, with no impact onthe control mechanisms, operating principle, and energy type. GE'squality system's design verification, and risk management processesdid not identify any new questions of safety or effectiveness, hazards,unexpected results, or adverse effects stemming from the changes tothe 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, as the legally marketedpredicate and reference devices. |
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Image /page/9/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script font, enclosed within a blue circle. The circle has a white border and is surrounded by four stylized white flourishes, one at each cardinal direction. The logo is simple and recognizable, representing the multinational conglomerate corporation.
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§ 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).