(266 days)
No
The summary describes a system for acquiring, displaying, and recording physiological data with basic calculations and alarms. There is no mention of AI, ML, or any advanced analytical techniques that would typically involve these technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a diagnostic and monitoring system used to display, measure, and record physiological data during medical procedures, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This system is used in the diagnosis and treatment of cardiovascular, peripheral vascular, and cardiac diseases." It also mentions "diagnostic and interventional procedures." The device measures and records various physiological data, which is used to aid in diagnosis.
No
The device description explicitly states that the system consists of off-the-shelf computer hardware, a Patient Data Module (PDM) that acquires patient vitals from accessories, and transmits them to the Merge Hemo Monitor. This indicates the presence of dedicated hardware components beyond just software running on a general-purpose computing platform.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Merge Hemo system measures and records physiological data directly from the patient during invasive procedures. It acquires vital signs like ECG, blood pressure, temperature, and cardiac output through electrodes, transducers, and probes connected to the patient.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The data acquired is physiological data from the living patient.
Therefore, the Merge Hemo system falls under the category of a patient monitoring and data acquisition system used during medical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Merge Hemo displays, measures, and records physiological data from patients undergoing invasive catheter-based diagnostic and interventional procedures.
The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO2 and Pleth waveforms, invasive blood pressure, temperature, non-invasive blood pressure (NIBP), Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture 12 Lead resting ECG to visualize arrhythmias, and ST-segment changes. Some Hemo systems have an option to measure and display Side-stream End Tidal Carbon Dioxide (EtCO2) along with apnea and respiration rates calculated from the EtCQ2 waveforms. The system can also perform specified calculations from captured or manually entered values.
The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC.
All vital parameters are acquired in the PDM. This data is then transmitted to the Merge Hemo Monitor PC. All data can then be displayed on the Merge Hemo Monitor PC. User-adjustable visual alarms available in the system alert the operator to anomalous occurrences and facilitate timely responses.
Patient allergies and current medication information can be entered by the user and displayed by the system. If desired and using a third-party database, the Hemo system can display drug or drug-to-allergy interaction information.
The Merge Hemodynamic system is intended for use in invasive catheter-based diagnostic and interventional procedure laboratories and in pre- and post-procedure care areas in professional health care facilities. The Merge Hemo system is intended for use under the close supervision of qualified medical personnel. The system is not intended patient monitoring or in situations where arrhythmia detection is required. This system is used in the diagnosis and treatment of cardiovascular, peripheral vascular, and cardiac diseases. The system is designed for patients of Infant to Adult ages. The system is to be used in invasive procedural laboratories under the direct supervision of physicians, nurses, and technicians.
Product codes
DQK
Device Description
The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.
The device consists of off-the-shelf computer hardware such as personal computers and servers, a Patient Data Module (PDM) that acquires patient vitals received from accessories such as ECG electrodes, invasive catheters/pressure transducers, and temperature probes, and transmits them to the Merge Hemo Monitor.
The Merge Hemo system includes a Record Station with options to add a Procedure Room Hemo Monitor or a Remote Operators Terminal (ROT). The Record Station Workstation for Merge Hemo, Model RCSV2 is made up of medical grade Hemo Client and Hemo Monitor All-in-One computers with built-in display monitors.
The new PDM component, the ARGUS PB-3000 manufactured by Schiller AG, acquires the following patient vitals: ECG, Invasive Blood Pressure, SpO2, Non-Invasive Blood Pressure, Temperature, Cardiac Output, and CO2, digitizes the signals, and transmits them to the Hemo Monitor in the Record Station. The Client side of the Record Station is responsible for the documentation, display, storage, and distribution of the data acquired during the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Infant to Adult ages.
Intended User / Care Setting
The Merge Hemo system is intended for use in invasive catheter-based diagnostic and interventional procedure laboratories and in pre- and post-procedure care areas in professional health care facilities. The Merge Hemo system is intended for use under the close supervision of qualified medical personnel. The system is to be used in invasive procedural laboratories under the direct supervision of physicians, nurses, and technicians.
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)
The following non-clinical performance data were provided in support of the substantial equivalence determination:
Electrical safety and electromagnetic compatibility (EMC) tests were conducted on Merge Hemo, Model RCSV2 for the Record Station Workstation, Procedure Room Hemo Monitor, and Remote Operators Terminal (ROT) hardware configurations and associated components. The system complies with the current editions of applicable standards.
Software verification and validation testing performed on the Merge Hemo software application, including testing with defined hardware configurations, demonstrated that the software meets its design requirements, and no new issues of safety and effectiveness were discovered. Formal software development processes that comply with the requirements of IEC 62304 for medical device software life cycles are followed.
Clinical testing was not required to demonstrate the safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 21, 2024
Merge Healthcare Incorporated Carol Nakagawa Senior Regulatory Affairs Manager 900 Walnut Ridge Drive Hartland, Wisconsin 53029
Re: K233326
Trade/Device Name: Merge Hemo, Model RCSV2 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: September 29, 2023 Received: September 29, 2023
Dear Carol Nakagawa:
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.
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).
1
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.
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-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,
Robert T. Kazmierski -S
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
2
510(k) - Merge Healthcare Incorporated - Merge Hemo, Model RCSV2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Merge Hemo, Model RCSV2
Indications for Use (Describe)
Merge Hemo displays, measures, and records physiological data from patients undergoing invasive catheter-based diagnostic and interventional procedures.
The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO2 and Pleth waveforms, invasive blood pressure, temperature, non-invasive blood pressure (NIBP), Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture 12 Lead resting ECG to visualize arrhythmias, and ST-segment changes. Some Hemo systems have an option to measure and display Side-stream End Tidal Carbon Dioxide (EtCO2) along with apnea and respiration rates calculated from the EtCQ2 waveforms. The system can also perform specified calculations from captured or manually entered values.
The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC.
All vital parameters are acquired in the PDM. This data is then transmitted to the Merge Hemo Monitor PC. All data can then be displayed on the Merge Hemo Monitor PC. User-adjustable visual alarms available in the system alert the operator to anomalous occurrences and facilitate timely responses.
Patient allergies and current medication information can be entered by the user and displayed by the system. If desired and using a third-party database, the Hemo system can display drug or drug-to-allergy interaction information.
The Merge Hemodynamic system is intended for use in invasive catheter-based diagnostic and interventional procedure laboratories and in pre- and post-procedure care areas in professional health care facilities. The Merge Hemo system is intended for use under the close supervision of qualified medical personnel. The system is not intended patient monitoring or in situations where arrhythmia detection is required. This system is used in the diagnosis and treatment of cardiovascular, peripheral vascular, and cardiac diseases. The system is designed for patients of Infant to Adult ages. The system is to be used in invasive procedural laboratories under the direct supervision of physicians, nurses, and technicians.
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.
3
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
510(k) Summary
| I. Submitter Information | |
|---|---|
| Submitter: | Merge Healthcare Incorporated |
| 900 Walnut Ridge Drive | |
| Hartland, Wisconsin 53209 USA | |
| Phone: 262-367-0700 | |
| Contact Person: | Carol Nakagawa |
| Principal, Regulatory Affairs | |
| Phone: 289-902-0129 | |
| Email: carol.nakagawa@merative.com | |
| Email: med.reg.contact@merative.com | |
| Secondary Contact Person: | Nadia Marchant |
| VP, Regulatory Affairs and Quality Assurance | |
| Phone: 262-367-0700 | |
| Email: nadia.marchant@merative.com | |
| Date Prepared: | May 24, 2024 |
| II. Device | |
| Device Trade Name: | Merge Hemo™, Model RCSV2 |
| Common Name: | Hemodynamic monitoring system |
Classification Name: Regulation Number: Device Class: Product Code:
Programmable diagnostic computer 21 CFR 870.1425 Class II DQK
Merge Healthcare Inc. 900 Walnut Ridge Drive Hartland, WI, USA 53029 2.03 510(k) Summary Page 1 of 7 Merge Healthcare Inc.
Merge Hemo™ 510(k) Premarket Notification K233326
5
III. Predicate Device
| Device Trade Name: | Merge Hemo |
|---|---|
| 510(k) Number: | K152864 |
| Regulation Number: | 21 CFR 870.1425 |
| Device Class: | Class II |
| Product Code: | DQK |
IV. Device Description
The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.
The device consists of off-the-shelf computer hardware such as personal computers and servers, a Patient Data Module (PDM) that acquires patient vitals received from accessories such as ECG electrodes, invasive catheters/pressure transducers, and temperature probes, and transmits them to the Merge Hemo Monitor.
The Merge Hemo system includes a Record Station with options to add a Procedure Room Hemo Monitor or a Remote Operators Terminal (ROT). The Record Station Workstation for Merge Hemo, Model RCSV2 is made up of medical grade Hemo Client and Hemo Monitor All-in-One computers with built-in display monitors.
The new PDM component, the ARGUS PB-3000 manufactured by Schiller AG, acquires the following patient vitals: ECG, Invasive Blood Pressure, SpO2, Non-Invasive Blood Pressure, Temperature, Cardiac Output, and CO2, digitizes the signals, and transmits them to the Hemo Monitor in the Record Station. The Client side of the Record Station is responsible for the documentation, display, storage, and distribution of the data acquired during the procedure.
2.03 510(k) Summary Page 2 of 7 Merge Healthcare Inc.
6
V. Indications for Use / Intended Use
Indications for Use / Intended Use Statement
The Merge Hemo System displays, measures, and records physiological data from patients underqoing invasive catheter-based diagnostic and interventional procedures.
The Merge Hemo System can visualize and capture vital sign values including ECG, impedance respiration. SpO2 and Pleth waveforms, invasive blood pressure, temperature, non-invasive blood pressure (NIBP), Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture 12 Lead resting ECG to visualize arrhythmias, and ST-seqment changes. Some Hemo systems have an option to measure and display Side-stream End Tidal Carbon Dioxide (EtCO2) along with apnea and respiration rates calculated from the EtCO2 waveforms. The system can also perform specified calculations from captured or manually entered values.
The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC.
All vital parameters are acquired in the PDM. This data is then transmitted to the Merge Hemo Monitor PC. All data can then be displayed on the Merge Hemo Monitor PC. User-adjustable visual alarms available in the system alert the operator to anomalous occurrences and facilitate timely responses.
Patient allergies and current medication information can be entered by the user and displayed by the system. If desired and using a third-party database, the Hemo system can display drug to drug or drug-to-allergy interaction information.
The Merge Hemo system is intended for use in invasive catheter-based diagnostic and interventional procedure laboratories and in pre-and post-procedure care areas in professional health care facilities. The Merge Hemo system is intended for use under the close supervision of qualified medical personnel. The system is not intended for unattended patient monitoring or in situations where arrhythmia detection is required. This system is used in the diagnosis and treatment of cardiovascular, peripheral vascular, and cardiac diseases. The system is designed for patients of Infant to Adult ages. The system is to be used in invasive procedural laboratories under the direct supervision of physicians, nurses, and technicians.
Comparison
The Indications for Use statement for Merge Hemo Model RCSV2 is not identical to the predicate device. The Indications for Use statement for the subject device was revised to reflect technological changes made to the subject device, to add the circumstances when hemodynamic monitoring is performed, to modernize references to reflect how invasive catheterization procedures and procedure room (cath lab) environments are described, and to remove unnecessary information. The differences do not change the intended use of the device and do not affect the safety and effectiveness of the device compared to the predicate. The subject and predicate devices are both intended to perform hemodynamic recording and display for patients undergoing invasive catheterization procedures in the cath lab.
Merge Healthcare Inc. 900 Walnut Ridge Drive Hartland, WI, USA 53029 2.03 510(k) Summary Page 3 of 7 Merge Healthcare Inc.
Merge Hemo™ 510(k) Premarket Notification K233326
7
VI. Comparison of Technological Characteristics with the Predicate Device
The subject device Merge Hemo. Model RCSV2, is a line extension of the predicate device, which is Merge Healthcare's 510(k) cleared Merge Hemo (K152864).
The subject and predicate devices share the same technological principles used to perform hemodynamic monitoring and recording with Merge Hemo software running on personal computer hardware and on a computer server, as well as for receiving digitized patient vitals signals from a Patient Data Module manufactured by Schiller AG.
- . The same patient vital parameters are monitored
- Full Disclosure recordings are captured by the Hemo Monitor computer .
- Calculations of the same physiological parameters are performed using the same ● software algorithms
- The same physiological waveforms are displayed (ECG, respiration rate, IBP, Mean IBP, Pleth, CO2, Temperatures) using the same software algorithms
- Interface to drug-to-drug and allergy-to-drug interaction database ●
- Configurable reports
- . Inventory management
- Reqistry data collection and export .
The technological differences between the subject and predicate devices are listed:
- The personal computer hardware used in the cath lab (Procedure Room and . Control Room) are medical grade All-in-One integrated PC/display monitors or medical grade terminals with widescreen displays and antimicrobial housings
- A new model of the PDM from the same manufacturer (Schiller AG) is integrated: . Argus PB-3000 (510(k) K221056)
- Visual technical and user-customizable visual alarms are added
- Temperature signals acquired by esophageal temperature probes are added
- The Merge Hemo software is updated to a new version 11 to accommodate ● interfaces with the updated hardware components
- Computer operating systems and SOUP are updated to current versions ●
- There is no enclosure for the Merge Hemo Record Station because there are no ● tower PCs to house
VII. Performance Data
The following non-clinical performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC tests were conducted on Merge Hemo, Model RCSV2 for the Record Station Workstation, Procedure Room Hemo Monitor, and Remote Operators Terminal (ROT) hardware configurations and associated components such as
2.03 510(k) Summary Page 4 of 7 Merge Healthcare Inc.
8
uninterruptible power supplies and/or isolation transformers, KVM extenders and cables, the PB-3000 PDM, and Merge Hemo software. The system complies with the current editions of applicable standards.
Electrical Safety
| FDA Recognition
| Number | Title of Standard |
|---|---|
| 19-49 | IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION - Medical |
| electrical equipment - Part 1: General requirements for basic safety and | |
| essential performance |
Electromagnetic Compatibility
| FDA Recognition
| Number | Title of Standard |
|---|---|
| 19-36 | IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION - |
| Medical electrical equipment - Part 1-2: General requirements for basic | |
| safety and essential performance - Collateral Standard: Electromagnetic | |
| disturbances - Requirements and tests |
Particular and Additional Standards
| FDA Recognition
| Number | Title of Standard |
|---|---|
| 5-132 | IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION - |
| Medical electrical equipment - Part 1-6: General requirements for basic | |
| safety and essential performance - Collateral standard: Usability | |
| 5-131 | IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION - |
| Medical electrical equipment - Part 1-8: General requirements for basic | |
| safety and essential performance - Collateral Standard: General | |
| requirements tests and guidance for alarm systems in medical electrical | |
| equipment and medical electrical systems | |
| 19-19 | IEC TR 60601-4-2 Edition 1.0 2016-05 - Medical electrical equipment - |
| Part 4-2: Guidance and interpretation - Electromagnetic immunity: | |
| performance of medical electrical equipment and medical electrical | |
| systems (considered during evaluation) | |
| 3-126 | IEC 60601-2-27 Edition 3.0 2011-03 - Medical electrical equipment - Part |
| 2-27: Particular requirements for the basic safety and essential | |
| performance of electrocardiographic monitoring equipment [Including: | |
| Corrigendum 1 (2012)] | |
| 3-123 | IEC 80601-2-30 Edition 2.0 2018-03 - Medical electrical equipment - Part |
| 2-30: Particular requirements for the basic safety and essential | |
| performance of automated non-invasive sphygmomanometers |
Merge Healthcare Inc. 900 Walnut Ridge Drive Hartland, WI, USA 53029 2.03 510(k) Summary Page 5 of 7 Merge Healthcare Inc.
Merge Hemo™ 510(k) Premarket Notification K233326
9
| FDA Recognition
| Number | Title of Standard |
|---|---|
| 3-115 | IEC 60601-2-34 Edition 3.0 2011-05 - Medical electrical equipment - Part |
| 2-34: Particular requirements for the basic safety including essential | |
| performance of invasive blood pressure monitoring equipment | |
| 1-140 | ISO 80601-2-55 Second edition 2018-02 - Medical electrical equipment - |
| Part 2-55: Particular requirements for the basic safety and essential | |
| performance of respiratory gas monitors | |
| 6-421 | ISO 80601-2-56 Second edition 2017-03 - Medical electrical equipment - |
| Part 2-56: Particular requirements for basic safety and essential | |
| performance of clinical thermometers for body temperature | |
| measurement. [Including: Amendment 1 (2018)]. | |
| 1-139 | ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) - |
| Medical electrical equipment - Part 2-61: Particular requirements for | |
| basic safety and essential performance of pulse oximeter equipment | |
| N/A | IEC 80601-2-49:2018 - Medical electrical equipment - Particular |
| requirements for the basic safety and essential performance of | |
| multifunction patient monitoring equipment (as applicable to the system | |
| integrator) | |
| 5-129 | IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION - Medical |
| devices - Part 1: Application of usability engineering to medical devices | |
| 5-125 | ISO 14971 Third Edition 2019-12 - Medical devices - Application of risk |
| management to medical devices | |
| 5-134 | ISO 15223-1 Fourth edition 2021-07 - Medical Devices - Symbols to be |
| used with information to be supplied by the manufacturer - Part 1: | |
| General requirements | |
| N/A | CISPR 11:2015/A1:2016/A2:2019, Group 1, Class A – Industrial, |
| scientific and medical equipment - Radio-frequency disturbance | |
| characteristics - Limits and methods of measurement | |
| N/A | ISO 13485:2016 MDSAP – Medical Devices – Quality management |
| systems. Requirements for regulatory purposes |
Software Verification and Validation
Verification and validation testing performed on the Merge Hemo software application, including testing with defined hardware configurations, demonstrated that the software meets its design requirements, and no new issues of safety and effectiveness were discovered.
Formal software development processes that comply with the requirements of IEC 62304 for medical device software life cycles are followed.
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| FDA Recognition
| Number | Title of Standard |
|---|---|
| 13-79 | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION – Medical |
| device software – Software life cycle processes |
Software Life Cycle Process
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of Merge Hemo, Model RCSV2.
VIII. Conclusions
Comparison of the Intended Use / Indications for Use and the technological characteristics of the subject and predicate devices demonstrates that no new intended uses are created, and that modifications to the technology do not raise new issues of safety and effectiveness.
The results of safety and performance testing, software verification and validation, bench testing and usability testing established that the subject device meets its design and performance specifications, and no new issues of safety and effectiveness were identified.
Therefore, Merge Hemo, Model RCSV2 is substantially equivalent to the legally marketed predicate device.