(60 days)
Not Found
No
The description focuses on data aggregation, display, and communication, with no mention of AI/ML terms or functionalities like prediction, analysis beyond simple display, or learning from data.
No
The device is a monitoring system that displays information from other single-patient monitoring systems; it does not provide any therapy or treatment.
No.
The device is a monitoring system that displays physiological parameters and alarm indications from other single-patient monitoring systems. It does not provide a diagnosis.
Yes
The device is described as Aulisa-developed software installed on a standard personal computer that interlinks multiple single-patient monitoring systems for remote display. It explicitly states it uses "standard off-the-shelf communication and IT hardware for data transmission," implying the medical device itself is the software component.
Based on the provided information, the Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000, is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the MP1000 clearly states its purpose is to monitor and display physiological parameters and alarm indications recorded by single-patient monitoring systems. It does not involve the analysis of biological specimens.
- The intended use and device description focus on data aggregation and display from other monitoring devices. The system receives information about vital signs (which are measured directly from the patient, not from a specimen) and presents it on a central screen.
- There is no mention of any laboratory testing, reagents, or analysis of biological samples.
Therefore, the MP1000 falls under the category of a patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000, is intended to provide remote central monitoring and display of information as recorded by multiple Aulisa single-patient monitoring systems, on a central remote screen. The system can be used in a hospital type and clinic environment.
Product codes
MSX, MWI
Device Description
The Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000, operates through an Aulisa-developed software installed on a standard personal computer. The system interlinks multiple Aulisa single-patient monitoring systems to display the information as recorded by each single-patient monitoring system on a central remote screen. The system uses standard off-theshelf communication and IT hardware for data transmission.
The information transmitted from single-patient monitoring systems to the MP1000 system includes the physiological parameters and alarm indications. Adjusting alarm settings can only be performed on the Aulisa Display Unit of the single-patient monitoring system. If configured, the MP1000 screen can also be accessed through remote devices, such as other PCs. In addition, patient history data and report files can be viewed, exported, and/or printed.
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
Not Found
Intended User / Care Setting
hospital type and clinic environment.
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
all testing was completed and the software has been verified and validated per FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Further, risk management assessment on the subject device was performed per ISO 14971, Medical Devices- Risk Management to verify that it does not raise any new safety and effectiveness issues in comparison to its predicate device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Aulisa Multiple Patient Digital Vital Sign Monitoring System is a medical device stand-alone software; all testing was completed and the software has been verified and validated per FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Further, risk management assessment on the subject device was performed per ISO 14971, Medical Devices- Risk Management to verify that it does not raise any new safety and effectiveness issues in comparison to its predicate device.
Test results indicate that the subject device complies with its predetermined specifications and the applicable guidance document and standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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October 30, 2020
Taiwan Aulisa Medical Devices Technologies, Inc. Don Mizota Consultant 725 Morninghome Road Danville, California 94526
Re: K202497
Trade/Device Name: Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, MWI Dated: August 25, 2020 Received: August 31, 2020
Dear Don Mizota:
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.
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
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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 (OS) 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 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,
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, & Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202497
Device Name
Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000
Indications for Use (Describe)
The Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000, is intended to provide remote central monitoring and display of information as recorded by multiple Aulisa single-patient monitoring systems, on a central remote screen. The system can be used in a hospital type and clinic environment.
| 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) |
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Section 5: 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92
5.1. General Information
| Date of Preparation: | August 25, 2020 |
|---|---|
| Submitted by: | Taiwan Aulisa Medical Devices Technologies, Inc. |
| Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St., | |
| Nangang Dist.,Taipei City 115 TW | |
| Phone: 886-2-2655-7297 | |
| FAX: 886-2-2655-7260 | |
| Contact Person: | Paul Liu |
| Regulatory Affairs Supervisor | |
| Taiwan Aulisa Medical Devices Technologies, Inc. | |
| Rm. 1052, Bldg. H, 10F., No.3-2, YuanQu St., | |
| Nangang Dist.,Taipei City 115 TW | |
| Phone: 886-2-2655-7297 | |
| FAX: 886-2-2655-7260 | |
| Email: paul.liu@aulisa.com |
5.2. Trade/Device Name
Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000
5.3. Regulatory Information
| Regulation Number | Regulation Name | Regulation Class | Product Code |
|---|---|---|---|
| 21 CFR 870.2300 | System, Network and | ||
| Communication, | |||
| Physiological Monitors | Class II | MSX | |
| 21 CFR 870.2300 | Monitor, Physiological, | ||
| Patient (Without Arrhythmia | |||
| Detection or Alarms) | Class II | MWI |
5.4. Predicate Device
Predicate
K151006, EarlySense Central Display Station, EarlySense Ltd.
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5.5. Device Description
The Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000, operates through an Aulisa-developed software installed on a standard personal computer. The system interlinks multiple Aulisa single-patient monitoring systems to display the information as recorded by each single-patient monitoring system on a central remote screen. The system uses standard off-theshelf communication and IT hardware for data transmission.
The information transmitted from single-patient monitoring systems to the MP1000 system includes the physiological parameters and alarm indications. Adjusting alarm settings can only be performed on the Aulisa Display Unit of the single-patient monitoring system. If configured, the MP1000 screen can also be accessed through remote devices, such as other PCs. In addition, patient history data and report files can be viewed, exported, and/or printed.
5.6. Intended Use
The Aulisa Multiple Patient Digital Sign Monitoring System. MP1000, is intended to provide remote central monitoring and display of information as recorded by multiple Aulisa singlepatient monitoring systems, on a central remote screen. The system can be used in a hospital type and clinic environment.
5.7. Comparison with Predicate
The subject device has similar intended use and technology characteristics to the predicate device, which is to provide remote central monitoring through the display of physiological parameters as recorded by individual monitoring units on a central remote screen. The physiological parameters displayed on the subject device are similar to the parameters displayed by the predicate device, EarlySense Central Display Station. Both devices classify as stand-alone software and run on an off-the-shelf computer, with the subject device operating on a Windows 10 operating system and the predicate device on a Linux operating system. The communication method used on both devices for data transmission is either via standard wired or via wireless LAN. The subject device provides the accessibility to remotely view the central remote screen from additional PCs, like its predicate device.
Additionally, the MP1000 and its predicate device are used in the same clinical environmentshospitals or hospital type and clinic environment.
Further, audio/visual alarm notification is provided for both subject and predicate devices. Both devices do not perform analysis of data, but only duplicate the data received from the individual monitoring units. The subject device does not allow for the adjustment of the monitoring unit's settable parameters from the remote station, whereas the predicate device does. These differences do not affect the safety and effectiveness of the device when used as labeled.
The comparison table for the subject device versus the predicate device, EarlySense Central Display Station (K151006) is shown in Table 5.1.
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| Table 5.1 - Comparison with Predicate | ||
|---|---|---|
| Item | Subject Device | Predicate Device |
| Item | Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000 | EarlySense Central Display Station, (K151006) |
| Indication for use | The Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000, is intended to provide remote central monitoring and display of information as recorded by multiple Aulisa single-patient monitoring systems, on a central remote screen. The system can be used in a hospital type and clinic environment. | The EarlySense Central Display System is intended to provide remote central monitoring and display of information as recorded by multiple EarlySense bedside units, on a central remote screen. The system can be used in hospitals or hospital type and clinic environment. |
| Environment of use | Hospitals or hospital type and clinic environment | Hospitals or hospital type and clinic environment |
| Alarms | Visual and auditory alarms | Visual and auditory alarms |
| Operating System | Windows 10 | Linux Debian |
| Communication Method | LAN and wireless LAN | LAN and wireless LAN |
| Alarm Adjustment Capability | No | Yes |
Summary of Performance Testing 5.8.
Yes
Remote Accessibility
Aulisa Multiple Patient Digital Vital Sign Monitoring System is a medical device stand-alone software; all testing was completed and the software has been verified and validated per FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Further, risk management assessment on the subject device was performed per ISO 14971, Medical Devices- Risk Management to verify that it does not raise any new safety and effectiveness issues in comparison to its predicate device.
Yes
Test results indicate that the subject device complies with its predetermined specifications and the applicable guidance document and standards.
5.9. Substantially Equivalent Conclusion
Based on the testing summarized in this 510 (k) submission, the results demonstrate that the subject device is substantially equivalent to the predicate device. The differences do not raise any questions of safety or effectiveness when compared to its predicate device.