(87 days)
Not Found
No
The document describes a system for acquiring, displaying, and recording physiological data and does not mention any AI or ML capabilities for analysis or interpretation.
No
This device is for monitoring, calculating, and recording cardiovascular data; it does not control energy delivery, administer drugs, or perform life-sustaining functions, which are typical characteristics of therapeutic devices.
Yes
The device is intended for "monitoring, calculating and recording cardiovascular data" and to "acquire, filter, digitize, amplify, display and record electrical signals" as well as derive and display physiological parameters. These are all functions critical to diagnosing a medical condition by providing information for a medical diagnosis.
No
The device description explicitly states that the system "runs on the same hardware" and acquires data via "interfaced devices," indicating it is a system that includes both software and hardware components.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The descriptions of the Mac-Lab, CardioLab, ComboLab, and SpecialsLab systems clearly state their purpose is to monitor, acquire, calculate, display, and record physiological data directly from patients undergoing procedures. This includes things like ECG waveforms, blood pressure, heart rate, and data from interfaced medical devices.
- The systems are used during invasive cardiac procedures. This is a key indicator that they are monitoring and recording real-time physiological signals, not analyzing samples in a lab setting.
- The descriptions focus on signal acquisition, processing, display, and recording. There is no mention of analyzing biological samples or performing tests on them.
The device is a cardiovascular monitoring and data acquisition system used in a clinical setting, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
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.)
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. 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.)
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DQK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed healthcare practitioner, catheterization laboratory, electrophysiological laboratory and related specialty laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 Technologies | |
| 8200 West Tower Avenue | ||
| Milwaukee, WI 53223 USA | ||
| Contact Person: | Allen D. Tabor | |
| Quality & Regulatory Engineer | ||
| GE Medical Systems Information Technologies | ||
| Phone: (414) 721-3957 | ||
| Fax: (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) |
:
page 1 of 3
:
Page 12a (of a-d)
09/06/2006
1
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).
ice Descript
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.
041741 page 2 of B"
Page 12b (of a-d)
2
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.
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.)
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
6
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).
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.
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
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