(280 days)
No
The summary describes a system for forwarding medical device data and alarms. There is no mention of AI/ML in the intended use, device description, or performance studies. The focus is on data integration and forwarding.
No
The device is described as an integration solution that forwards information and alarms from other medical devices; it does not directly treat or diagnose patients.
No
Explanation: The device is intended to forward information and alarms from other medical devices to healthcare professionals. It does not generate new patient-related alarms or provide diagnostic insights itself; instead, it relays information from diagnostic or monitoring devices.
Yes
The device description explicitly states "Digistat Smart Central software acquires patient data and information through DIGISTAT Connect, a MDDS, from medical devices...". While it interacts with hardware (medical devices and display devices), the core functionality described is the software-based acquisition, formatting, and forwarding of data. The performance studies also focus on software verification and validation.
Based on the provided text, the Digistat Smart Central is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Digistat Smart Central's Function: The text clearly states that the Digistat Smart Central's intended use is to forward information from other medical devices (patient monitors, ventilators, infusion pumps) to display devices. It acts as an interface and a secondary alarm forwarding mechanism.
- No Specimen Analysis: There is no mention of the Digistat Smart Central analyzing any biological specimens. Its function is purely data transmission and display.
- No Direct Patient Contact: The description explicitly states that the device is "not in contact with the patient." IVD devices often involve handling patient specimens.
Therefore, the Digistat Smart Central falls under the category of a medical device, specifically one that facilitates the communication and display of data from other medical devices, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of the Digistat Smart Central is to provide an interface with clinical systems to forward information associated to the particular event from patient monitors, ventilators, and infusion pumps to the designated display device(s). For medical, near real time alarms, the Digistat Smart Central is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Digistat Smart Central does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert.
The Digistat Smart Central is intended for use as a secondary alarm. It does not replace the primary alarm function on the medical devices.
Product codes (comma separated list FDA assigned to the subject device)
MSX, PHC
Device Description
Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients' status and alarm conditions when they are away from the patient and associated medical devices.
Digistat Smart Central connects to the information sources through wired ethernet connections which are part of the customer's infrastructure. Digistat Smart Central software acquires patient data and information through DIGISTAT Connect, a MDDS, from medical devices including patient monitors, ventilators, and infusion pumps. The user configures Digistat Smart Central to determine which information, including alarm notifications, is delivered to which users. Digistat Smart Central then formats the data for delivery to the display devices.
Digistat Smart Central is not in contact with the patient. It is intended to forward the information generated by the connected medical devices and systems and it does not generate patient related alarms. As such, the patient population and patient conditions are established by the medical devices and systems to which the product is connected.
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
healthcare professionals
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)
Software: The Digistat Smart Central software is MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following guidance documents: FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05. FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99. FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02. FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14. Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) software, 14 Jan 05. Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 06 Sep 17. IEC 62304: 2006, Medical device software - Software life cycle processes. Test results indicate that the Digistat Smart Central software complies with its predetermined specifications and the applicable guidance documents.
Performance Testing – Bench: The Digistat Smart Central was tested for performance in accordance with internal requirements and the following standards: IEC 62366-1: 2015, Medical devices – Application of usability engineering to medical devices. Test results indicate that the Digistat Smart Central complies with its predetermined specifications and the applicable standards.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the Digistat Smart Central. The results of these activities demonstrate that the Digistat Smart Central is performs as well as the predicate devices. Therefore, the Digistat Smart Central is considered substantially equivalent to the predicate devices.
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.
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
§ 870.2300 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).
0
Image /page/0/Picture/0 description: The image contains 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 text and emblem on the right. The FDA part includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 23, 2018
ASCOM UMS srl unipersonale % Thomas Kroenke Principal Consultant Speed To Market, Inc. PO Box 3018 Nederland. Colorado 80466
Re: K180430
Trade/Device Name: Digistat Smart Central Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, PHC Dated: October 24, 2018 Received: October 25, 2018
Dear Thomas Kroenke:
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 mav, 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 avare 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
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Arielle Drummond -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K180430
Device Name: Digistat Smart Central
Indications For Use: The intended use of the Digistat Smart Central is to provide an interface with clinical systems to forward information associated to the particular event from patient monitors, ventilators, and infusion pumps to the designated display device(s). For medical, near real time alarms, the Digistat Smart Central is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Digistat Smart Central does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert.
The Digistat Smart Central is intended for use as a secondary alarm. It does not replace the primary alarm function on the medical devices.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Page 1 of 1
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| Submission Date: | 07 November 2018 |
|---|---|
| Submission | |
| Number: | K180430 |
| Submitter: | ASCOM UMS srl unipersonale |
| Via Amilcare Ponchielli 29 | |
| 50018 Scandicci (FI), Italy | |
| Submitter | |
| Correspondents | Mr. Paolo Burchietti |
| Phone: +011 39 055 051 2161 | |
| Email: paolo.burchietti@ascom.com | |
| Mr. Ivan Liljegren | |
| Phone +011 (46) 31 55 93 11 | |
| Email: ivan.liljegren@ascom.com | |
| Application | |
| Correspondent | Speed To Market, Inc. |
| PO Box 3018 | |
| Nederland, CO 80466 | |
| Mr. Thomas Kroenke | |
| Phone: +1 (303) 956-4232 | |
| Email: tkroenke@speedtomarket.net | |
| Manufacturing Site: | ASCOM UMS srl unipersonale |
| Via Amilcare Ponchielli 29 | |
| 50018 Scandicci (FI), Italy | |
| Trade Name: | Digistat Smart Central |
| Primary | |
| Classification | |
| Name, Regulation, | |
| and Product Code: | System, Network and Communication, Physiological Monitors |
| 21 CFR §870.2300 | |
| MSX | |
| Secondary | |
| Classification | |
| Name, Regulation, | |
| and Product Code: | Infusion Safety Management Software |
| 21 CFR §880.5725 | |
| PHC |
4
| Substantially
Equivalent Devices: | New Ascom Model | Predicate
510(k) Number | Predicate
Manufacturer / Model |
|--------------------------------------|------------------------|----------------------------|-------------------------------------------------------------------|
| | Digistat Smart Central | K103634 | Ascom (US), Inc. /
ClinicalConneX
Cardiomax |
| | | K130208
(Reference) | Cardiopulmonary
Corporation / Bernoulli
Enterprise Software |
| | | K130707
(Reference) | iSirona, LLC / iSirona
Magellan |
Device Description: Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients' status and alarm conditions when they are away from the patient and associated medical devices.
Digistat Smart Central connects to the information sources through wired ethernet connections which are part of the customer's infrastructure. Digistat Smart Central software acquires patient data and information through DIGISTAT Connect, a MDDS, from medical devices including patient monitors, ventilators, and infusion pumps. The user configures Digistat Smart Central to determine which information, including alarm notifications, is delivered to which users. Digistat Smart Central then formats the data for delivery to the display devices.
Digistat Smart Central is not in contact with the patient. It is intended to forward the information generated by the connected medical devices and systems and it does not generate patient related alarms. As such, the patient population and patient conditions are established by the medical devices and systems to which the product is connected.
5
Indications for Use: The intended use of the Digistat Smart Central is to provide an interface with clinical systems to forward information associated to the particular event from patient monitors, ventilators, and infusion pumps to the designated display device(s). For medical, near real time alarms, the Digistat Smart Central is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Digistat Smart Central does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert.
The Digistat Smart Central is intended for use as a secondary alarm. It does not replace the primary alarm function on the medical devices.
Technology Comparison:
The Digistat Smart Central employs the same technological characteristics as the predicate device.
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Serves as secondary means of | ||
| annunciating patient events | Yes | Same. |
| Relays information from the | ||
| medical devices to desktops | ||
| and mobile caregivers | Yes, patient monitors | Yes, patient monitors, |
| ventilators, infusion | ||
| pumps, hemodialysis | ||
| machines, and infant | ||
| incubators. | ||
| Caregiver is alerted via | ||
| audible and/or vibratory | ||
| tones when mobile display | ||
| device receives an alarm | ||
| event transmission | Yes | Same |
| Alarm event notifications can | ||
| be stored on display device | ||
| for later reference | Last 10 - 50 stored | |
| depending upon display | ||
| device. | Complete history of | |
| events is stored in the | ||
| product database. | ||
| Display devices can show | ||
| full history of the events | ||
| for the patient. | ||
| Default filter shows just | ||
| the last hour of events. | ||
| Type of alarm | Yes | Same. |
| Vital signs | Yes | Same. |
| Waveform data | No | Same. |
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Summary of Performance Testing:
| Summary of Performance Testing: | |
|---|---|
| Software | The Digistat Smart Central software is MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following guidance documents: FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05. FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99. FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02. FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14. Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) software, 14 Jan 05. Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, 06 Sep 17. IEC 62304: 2006, Medical device software - Software life cycle processes Test results indicate that the Digistat Smart Central software complies with its predetermined specifications and the applicable guidance documents. |
| Performance | |
| Testing – Bench | The Digistat Smart Central was tested for performance in accordance with internal requirements and the following standards: IEC 62366-1: 2015, Medical devices – Application of usability engineering to medical devices. Test results indicate that the Digistat Smart Central complies with its predetermined specifications and the applicable standards. |
| Conclusion | Verification and validation activities were conducted to establish the performance and safety characteristics of the Digistat Smart Central. The results of these activities demonstrate that the Digistat Smart Central is performs as well as the predicate devices. |
Therefore, the Digistat Smart Central is considered substantially equivalent to the predicate devices. |