Mac-Lab System: The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. ECG waveforms, heart rate, pulse oximetry (5p(2), respiration rate, EtCO2, temperature, valve gradients and areas, cardias output, hemodynamic measurements, invasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). The intornation can be displayed, trended, stored, printed, and or transmitted to other neworked hospital information systems. The system does not transmit alarns or arthythmias and does not have arthythmia detection capabilities.

CardioLab System: The Cardiol.ab System is intended to acquire, filler, digitize, amplify, display and record the electrical signals. Signal types acquired include ECG signals, direct cardials, temperature, ElCO2, and pressure recordings. Physiological parancers such as diastolic, systolic, and mean blood pressure, hear rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to montor the acquisition of data, and generate reports on the data. Additionally, the system may acquire, amplify, display and received from other interfaced medical devices typically used during thesy processed to such as imaging devices and ablation generators (i.e. RF and cryogenic).

The Cardiol.ab System does not coutrol the delivery of energy, administer drugs, perform any fife-sustaining functions, or analyze data acquired during the procedure. The Cardiol.ab System does not transmit alarms or arthythmias and does not have arrhythmia detection capabilities.

ComboLab System: The Combol.ab System is the combination of the both the Mac-Lab and CardioLab systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a ficensed healtheare practitioner. The User to run either the Mac-Lab System or the CardioLab System, although only one may be used at a time.

SpecialsLab System: The SpecialsLab is the same as the Mac-Lab. CardioLab systems. The SpecialsLab System is intended for use in cither a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healtheare practitioner. SpecialsLab executes the same software, and runs on the same hardware. Products designated SpecialsLab will support fewer options than the Mac-Lab. Curdiol ab or ComboLab.

Device Description

The product will be available in the following configurations: Mac-Lab application only, CardioLab application only, SpecialsLab only, or a combination of both CardioLab and Mac-Lab applications, marketed as Combol.ab. Products designated as SpecialsLab are identical to the Mac-Lab, Cardiol.ab or ComboLab Systems with the exception they will support fewer options. The SpecialsLab System performs the same intended use as the Mac-Lab, CardioLab or ComboLab, executes the same software, and runs on the same hardware. The product "CardioLab" was identified as "CardioLab EP" in the predicate device 510(k) submission K050093.

The Mac-Lab System: The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). The information can be displayed, trended, stored, printed, and or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures, such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine. 12 lead ECG and information systems.)

The CardioLab System: The CardioLab System is intended to acquire. filter, digitize, amplify, display and record the electrical signal types acquired include ECG signals, direct cardiac signals. temperature, EtCO2, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length mav be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and ablation generators (i.e. RF and cryogenic).

The CardioLab System does not control the delivery of energy, administer drugs, perform any lifesupporting or life-sustaining functions. or analyze data acquired during the procedure. The CardioLab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures. such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine. 12 lead ECG and information systems.)

The ComboLab System: The ComboLab contiguration is the combination of both CardioLab and Mac-Lab applications, though only one application may be used at a time (CardioLab for electrophysiological lab cases and Mac-Lab for catheterization lab cases).

The SpecialsLab System: The SpecialsLab is the same as the Mac-Lab. CardioLab or ComboLab systems. The SpecialsLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a ficensed healthcare practitioner. Specialst.ab executes the same software, and runs on the same hardware. Products designated SpecialsLab will support fewer options than the Mac-Lab. CardioLab or ComboLab.

AI/ML Overview

The provided text describes a 510(k) submission for the GE Healthcare Mac-Lab/CardioLab/ComboLab/SpecialsLab System. This submission focuses on demonstrating substantial equivalence to a predicate device (Mac-Lab/CardioLab EP/ComboLab System K050093) rather than proving a device meets specific acceptance criteria through a clinical performance study involving diagnostic accuracy metrics.

Here's a breakdown based on your request, highlighting what is and isn't available in the provided document:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, there are no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for a diagnostic AI model's performance stated, nor is there reported device performance against such criteria. The submission is a 510(k) for a medical system, not a diagnostic AI device requiring performance metrics.

The document states:
"The results of these measurements demonstrate that the Mac-I ab/CardioLab/ComboLab/SpecialsLab System is as safe, as effective, and performs as well as the predicate device."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable. The submission explicitly states, "No clinical performance data has been used to support the substantial equivalence claims."
Data Provenance: Not applicable. The validation activities mentioned (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Clinical Use Validation, Integration Testing, Final acceptance testing, Performance testing, Safety testing, Environmental Testing) are internal quality assurance and engineering tests, not clinical studies with patient data.

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. No clinical test set with ground truth established by experts was used.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication was used.

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 study was done, as the submission explicitly states no clinical performance data was used. This device is a system for monitoring, calculating, and recording cardiovascular data, not an AI for assisting human readers in diagnostic tasks.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm being evaluated for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No clinical ground truth was established for a diagnostic performance evaluation. The "ground truth" equivalent in this submission relates to the correct functioning of the system against its specifications, evaluated through various engineering and quality assurance tests.

8. The sample size for the training set

Not applicable. This submission concerns a medical device system, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The provided document describes a 510(k) submission where GE Healthcare sought to demonstrate that their new Mac-Lab/CardioLab/ComboLab/SpecialsLab System is substantially equivalent to a legally marketed predicate device (Mac-Lab/CardioLab EP/ComboLab System, K050093). The primary method of proving this equivalence was through:

Technology Comparison: The system employs the "same functional scientific technology" as the predicate device.
Compliance with Standards: The device complies with voluntary standards detailed in Section 17.1 of their submission, "Specific Standards and Guidance's."
Quality Assurance Measures: A comprehensive set of quality assurance measures were applied, including:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Unit-level testing (Module verification)
- Clinical Use Validation (This likely refers to internal validation of the system's functions in a simulated clinical setting, not a formal clinical trial with patient data as explicitly stated later).
- Integration Testing (System verification)
- Final acceptance testing (Validation)
- Performance testing
- Safety testing
- Environmental Testing

The submission explicitly states: "No clinical performance data has been used to support the substantial equivalence claims."

Therefore, the "acceptance criteria" in this context are not quantitative diagnostic performance metrics but rather the demonstration of substantial equivalence to a predicate device through engineering tests, adherence to standards, and compliance with quality assurance protocols to ensure safety, effectiveness, and performance parity.

Summary

{0}------------------------------------------------

GE Healthcare 510(k) K061741 Submission -- Reply to Reviewer Questions / Requests 08312006 .

5.	510(k) Summary	SEP 15 2006
	Date:	Amended September 6, 2006
	Submitter:	GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA
	Contact Person:	Allen D. TaborQuality & Regulatory EngineerGE Medical Systems Information TechnologiesPhone: (414) 721-3957Fax: (414) 721-3862
	Device Trade Name:	Mac-Lab/CardioLab/ComboLab/SpecialsLab System
	Common/Usual Name:	Cardiac Catheterization Laboratory System
	Classification Names:	21 CFR 870.1425 Programmable Diagnostic Computer
	Predicate Device:	Mac-Lab/CardioLab EP/ComboLab System (K050093)

K061741

page 1 of 3

Page 12a (of a-d)

09/06/2006

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ice Descript

Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures. such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine. 12 lead ECG and information systems.)

041741 page 2 of B"

Page 12b (of a-d)

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Mac-Lab System: The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). The information can be displayed, trended, stored, printed, and or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

CardioLab System: The CardioLab System is intended to acquire, filter, digitize, amplify, display and record the electrical signal types acquired include ECG signals, direct cardiac signals, temperature, EtCO2, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and ablation generators (i.e. RF and cryogenic).

The CardioLab System does not control the delivery of energy. administer drugs, perform any lifesupporting or life-sustaining functions, or analyze data acquired during the procedure. The CardioLab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures. such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine. 12 lead ECG and information systems.)

ComboLab System: The ComboLab System is the combination of the both the Mac-Lab and CardioLab systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. The ComboLab System allows the user to run either the Mac-Lab System or the CardioLab System, although only one may be used at a time.

SpecialsLab System: The SpecialsLab is the same as the Mac-Lab, CardioLab or ComboLab systems.. The SpecialsLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. SpecialsLab executes the same software, and runs on the same hardware. Products designated SpecialsLab will support fewer options than the Mac-Lab. CardioLab or ComboLab.

ou 1741 page 3 of $\frac{4}{8}$

tended U

Page 12c (of a-d)

{3}------------------------------------------------

The proposed Mac-Lab/ComboLab/SpecialsLab System employs the same functional scientific technology as the predicate device Mac-Lab/CardioLab EP/ComboLab System (K050093).

The Mac-Lab/CardioLab/ComboLab/SpecialsLab System complies with the voluntary standards as detailed in Section 17.1 of this submission, "Specific Standards and Guidance's". The following quality assurance measures are applied to the device and the results thereof used in the determination of substantial equivalence to the predicate device:

0 Risk Analysis
0 Requirements Reviews
est Summa o Design Reviews
- o Testing on unit level (Module verification)
- o Clinical Use Validation
- o Integration Testing (System verification)
- o Final acceptance testing (Validation)
- o Performance testing
- o Safety testing
- o Environmental Testing

No clinical performance data has been used to support the substantial equivalence claims

The results of these measurements demonstrate that the Mac-

I ab/CardioLab/ComboLab/SpecialsLab System is as safe, as effective, and performs as well as the predicate device.

Conclusion

echnolog

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2006

GE Medical Systems Information Technologies c/o Mr. Allen D. Tabor Quality & Regulatory Engineer GE Healthcare Interventional, Surgical & Cardiology 8200 West Tower Avenue Milwaukee, Wisconsin 55223

Re: K061741

Trade Name: Mac-Lab/CardioLab/ComboLab/SpecialsLab System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: September 6, 2006 Received: September 8, 2006

Dear Mr. Tabor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{5}------------------------------------------------

Page 2 - Mr. Allen D. Tabor

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 or any I cation beth all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 820) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you t the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimsimon for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4 Indications for Use Statement

06174//

page 10 fl

Device Name: Mac-Lab/CardioLab/ComboLab/SpecialsLab System

Mac-Lab System:

The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. ECG waveforms, heart rate, pulse oximetry (5p(2), respiration rate, EtCO2, temperature, valve gradients and areas, cardias output, hemodynamic measurements, invasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). The intornation can be displayed, trended, stored, printed, and or transmitted to other neworked hospital information systems. The system does not transmit alarns or arthythmias and does not have arthythmia detection capabilities.

Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures, such as maging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, position emission tomography, nuclear medicine, 12 lead ECG and information systems.)

CardioLab System:

The Cardiol.ab System is intended to acquire, filler, digitize, amplify, display and record the electrical signals. Signal types acquired include ECG signals, direct cardials, temperature, ElCO2, and pressure recordings. Physiological parancers such as diastolic, systolic, and mean blood pressure, hear rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to montor the acquisition of data, and generate reports on the data. Additionally, the system may acquire, amplify, display and received from other interfaced medical devices typically used during thesy processed to such as imaging devices and ablation generators (i.e. RF and cryogenic).

Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in coujunction with these procedures, such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine, 12 lead ECG and information systems.)

ComboLab System:

The Combol.ab System is the combination of the both the Mac-Lab and CardioLab systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a ficensed healtheare practitioner. The User to run either the Mac-Lab System or the CardioLab System, although only one may be used at a time.

SpecialsLab System:

The SpecialsLab is the same as the Mac-Lab. CardioLab systems. The SpecialsLab System is intended for use in cither a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healtheare practitioner. SpecialsLab executes the same software, and runs on the same hardware. Products designated SpecialsLab will support fewer options than the Mac-Lab. Curdiol ab or ComboLab.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

B. Hemmerana

vision Sign-Off
Division of Cardiovascular Devices
510(k) Number K041741

| |

Regulation Number and Section

§ 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).