(65 days)
No
The summary describes a system of sensors and a display module for measuring physical properties of dialysate. There is no mention of AI, ML, or any algorithms that would suggest learning or intelligent decision-making beyond standard measurement and display functions. The performance studies focus on standard software and system validation, not AI/ML model performance.
No
The device is used to test the dialysate solution and concentrate, and water used in hemodialysis applications, specifically for installation and maintenance of hemodialysis delivery systems, not for direct patient treatment.
Yes
Explanation: The device tests the conductivity, temperature, pH, and flow of dialysate solutions used with hemodialysis delivery systems, as well as concentrates and water. This testing is for the "installation and maintenance of hemodialysis delivering systems," which implies identifying or troubleshooting issues, aligning with the definition of a diagnostic device in a technical/maintenance context.
No
The device description explicitly lists multiple hardware components including "different sensors and sensor-modules" and an "Android operating system based display module". While it includes a software component (SmartHDM-510 App), it is part of a larger system that includes hardware.
Based on the provided information, the SmartHDM-510 system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- SmartHDM-510's Intended Use: The SmartHDM-510 system is used to test the properties (conductivity, temperature, pH, flow) of the dialysate solution, dialysate concentrates, and water used in hemodialysis. These are external fluids and materials, not specimens taken from the human body.
- Purpose: The system's purpose is for the installation and maintenance of hemodialysis delivery systems, ensuring the equipment is functioning correctly and the fluids used are within specifications. It is explicitly stated that it does not include daily monitoring prior to treatment, which might be more directly related to patient care but still focuses on the equipment and fluids.
Therefore, the SmartHDM-510 system is a device used to test and maintain medical equipment and the fluids used with that equipment, rather than a device used to test human specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
The SmartHDM-510 system may be used by hemodialysis personnel to test the conductivity, temperature, pH and flow of the dialysate solution used with hemodialysis delivering systems.
The SmartHDM-510 system may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
The intended use is limited to periodic use for installation and maintenance of hemodialysis delivering systems and does not include the daily monitoring of hemodialysis delivering systems prior to treatment.
Product codes
FIZ
Device Description
The SmartHDM-510 System is designed for the installation and maintenance of hemodialysis delivering systems. The system consists of different sensors and sensor-modules to measure conductivity, temperature, pressure, pH and flow and an Android operating system based display module with SmartHDM-510 App.
The SmartHDM-510 system consists of:
- HDU-Sensors for Conductivity/Temperature, Pressure, pH and flow ●
- HDM-Sensor Modules for Conductivity/Temperature, Pressure,
- 90XL-Sensors for Conductivity/Temperature, Pressure and pH
- Android-based Display Module with SmartHDM-510 App.
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
hemodialysis personnel
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 performance testing for the SmartHDM-510 System includes software testing and code reviews, system verification and validation testing, and testing to compliance standards for electrical and electromagnetic safety. Traceability has been documented between the system specification to verification and validation test protocols. Verification and validation test procedures also address the user interface, user manual descriptions, usability, sensor communication and general performance including measuring accuracy.
The design of the device has been verified and validated both through testing and actual experience in international use.
The testing and international experience provided data that demonstrated substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K020909 HDM99 (Dialysis Meters), K020908 HDM97 (Dialysis Meters), K050812 90XL Instrumentation System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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September 2, 2020
Mesa Laboratories, Inc. % Johannes Pfingstmann Manager for Quality Assurance & Regulatory Affairs IBP Medical GmbH Ikarusallee 15 Hannover, Lower Saxony 30179 Germany
Re: K201765
Trade/Device Name: SmartHDM-510 System Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FIZ Dated: August 3, 2020 Received: August 3, 2020
Dear Johannes Pfingstmann:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 medical devices and radiation-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,
Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201765
Device Name SmartHDM-510 System
Indications for Use (Describe)
The SmartHDM-510 system may be used by hemodialysis personnel to test the conductivity, temperature, pH and flow of the dialysate solution used with hemodialysis delivering systems.
The SmartHDM-510 system may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
The intended use is limited to periodic use for installation and maintenance of hemodialysis delivering systems and does not include the daily monitoring of hemodialysis delivering systems prior to treatment.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Submitter | Mesa Laboratories, Inc. | ||
|---|---|---|---|
| Address | 12100 West 6th Avenue | ||
| Lakewood, CO 80228 | |||
| Internet | www.mesalabs.com | ||
| Contact Person | Johannes Pfingstmann | ||
| johannes.pfingstmann@ibpmt.com | |||
| Phone number | +49 511 957 336 0 | ||
| Date preparation | June 24, 2020 | ||
| Name of the | |||
| device | SmartHDM-510 System | ||
| Common Name | Hemodialysis Service System | ||
| Classification | Classification Name: | Hemodialysis System and Accessories | |
| Product Code: | FIZ | ||
| Device Class: | 2 | ||
| Regulation Number: | 21 CFR 876.5540 | ||
| Medical Specialty: | Gastroenterology | ||
| Predicate | |||
| Devices | K020909 HDM99 (Dialysis Meters) primary device | ||
| K020908 HDM97 (Dialysis Meters) | |||
| K050812 90XL Instrumentation System |
Devices Description
The SmartHDM-510 System is designed for the installation and maintenance of hemodialysis delivering systems. The system consists of different sensors and sensor-modules to measure conductivity, temperature, pressure, pH and flow and an Android operating system based display module with SmartHDM-510 App.
4
The SmartHDM-510 system consists of:
- HDU-Sensors for Conductivity/Temperature, Pressure, pH and flow ●
- HDM-Sensor Modules for Conductivity/Temperature, Pressure,
- 90XL-Sensors for Conductivity/Temperature, Pressure and pH
- Android-based Display Module with SmartHDM-510 App.
Indication for Use
The SmartHDM-510 system may be used by hemodialysis personnel to test the conductivity, temperature, pressure, pH and flow of the dialysate solution used with hemodialysis delivering systems.
The SmartHDM-510 system may also be used to test the conductivity/temperature and pH of acid and sodium bicarbonate dialysate concentrates and water used in hemodialysis applications.
The intended use is limited to periodic use for installation and maintenance of hemodialysis delivering systems and does not include the daily monitoring of hemodialysis delivering systems prior to treatment.
Comparative Analysis
In comparison to the predicate device, the SmartHDM-510 System has a highresolution screen.
Based on the high-resolution screen, the clear display of the measurement conditions makes the reading of the measured values more reliable. The improved graphical display of the measured values makes errors on the device to be serviced more visible. Information texts and messages make the operation safer.
Listed below are the major attributes of the SmartHDM-510 System compared to the predicate devices listed:
5
SmartHDM-510 System 510(k) Summary
| Specification | Predicate
Device 1 | Predicate
Device 2 | Predicate
Device 3 | New Device |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| | HDM99
(Primary) | HDM97 | 90XL | SmartHDM-510
System |
| General | | | | |
| 510(k) Number | K020909 | K020908 | K050812 | |
| Design | Handheld device with
connectors for internal and
external sensors | | Handheld display unit with
connectors for external sensors | |
| Display - General functions | | | | |
| Operating System | R-THOS | None | None | Android |
| Automated security patches | N/A | N/A | N/A | Yes |
| Battery status reading | Yes | Yes | Yes | Yes |
| Display size | 37 x 137 mm
1.46 x 5.39 " | 55 x 43 mm
2.16 x 1.69 " | 57 x 76 mm
2.24 x 2.99 " | HDC64 5.7"
HDC85 8" |
| Color Display | No | No | No | Yes |
| Hint Texts | No | No | No | Yes |
| Display selection
of connected sensors | Yes | Yes | No | Yes |
| Display single value | Yes | Yes | Yes | Yes |
| Display single value
including graphic | Yes | No | No | Yes |
| Display several values as list | Yes | No | Yes | Yes |
| Display graphic reading as list | No | No | No | Yes |
| Selection of time range for graphic
display | Yes | No | No | Yes |
| Selection of y- range for
graphic display | Yes | No | No | Yes |
| Statistic values | No | No | No | Yes |
| User hints | No | No | No | Yes |
| Display - measuring functions | HDM99
(Primary) | HDM97 | 90XL | SmartHDM-510
System |
| Conductivity adjustment | Yes | Yes | Yes | Yes |
| Conductivity adjustment reset | Yes | Yes | No | Yes |
| Selection Conductivity/
Temperature Compensation
by vendor name | Yes | Yes | No | Yes |
| Conductivity resolution
selection | Yes | No | No | Yes |
| Pressure unit selection | Yes | Yes | Yes | Yes |
| Pressure resolution selection | Yes | Yes | No | Yes |
| Pressure Tare function | Yes | Yes | Yes | Yes |
| Pressure change
measurement | No | Yes | No | Yes |
| pH adjustment | Yes | Yes | Yes | Yes |
| pH adjustment points | 3 | 3 | 2 | 3 |
| pH temperature compensation
selection | Yes | Yes | No | Yes |
| Flow accumulation display | Yes | Yes | Not Applicable | Yes |
| Flow accumulation reset | Yes | Yes | Not Applicable | Yes |
| HDU-Sensors and HDM18/19 Modules | | | | |
| | HDM99 | HDM97 and
HDM18/19 | 90XL | HDU-Sensor |
| Conductivity/Temperature
measuring via Dialyzer
Connector | Yes | Yes | Yes | Yes |
| Conductivity Measuring
Range | 0 to 24 mS/cm | 0 to 30 mS/cm | 0 to 200 mS/cm | 0 to 200 mS/cm |
| Conductivity Range
Accuracy | 0 to 249.9 uS/cm
$\pm$ 0.6 uS/cm | 0 to 199 uS/cm
$\pm$ 0.6 uS/cm | 0 to 1.99 mS
$\pm$ 0.35% of reading
- 0.002 mS/cm | 0 to 199.9 uS/cm
$\pm$ 0.6 uS/cm |
| | 250 to 2499 uS/cm
$\pm$ 6 uS/cm | 200 to 1999 uS/cm
$\pm$ 6 uS/cm | 2 to 29.99 mS/cm
$\pm$ 0.20% of reading - 0.002, | 200 to 1999 uS/cm
$\pm$ 6 uS/cm |
| | 2.5 to 16.99 mS/cm
$\pm$ 0.06 mS/cm | 2 to 11.99 mS/cm
$\pm$ 0.06 mS/cm | > 30 mS/cm
$\pm$ 0.50% of reading | 2 to 11.99 mS/cm
$\pm$ 0.06 mS/cm |
| | 17 to 24 mS/cm
$\pm$ 0.06 mS/cm | 12 to 15.99 mS/cm
$\pm$ 0.03 mS/cm | | 12 to 19.99 mS/cm
$\pm$ 0.03 mS/cm |
| | | 16 to 30 mS/cm
$\pm$ 0.06 mS/cm | | 20 to 200 mS/cm
$\pm$ 0.60% of reading |
| Remark to measuring
ranges | The important range for hemodialysis is 14 to 16 mS/cm.
The measuring range of predicate HDM97 and HDM18/19 are identical.
The measuring range of predicate 90XL- and HDU-Conductivity/Temperature
sensors are identical. | | | |
| Temperature Measuring
Range | 0 to 100 °C | 0 to 100 °C | 10 to 90°C | 0 to 100 °C |
| Temperature Accuracy | ± 0,1 °C | ± 0.1°C | ± 0.1°C | ± 0.1°C |
| Pressure Measuring Range | -700 to +1500 mmHg | -700 to + 1900
mmHg | -600 to +1600
mmHg | -672 to +1551
mmHg |
| Pressure Accuracy | -700 to +1500 mmHg
± 0.5% of reading | HDM97
0 to 300 mmHg
± 1 mmHg
otherwise
± 2 mmHg
HDM18/19
Internal
± 2 mmHg
External
0 to 300 mmHg
± 1 mmHg
otherwise
± 2 mmHg | 0 to 199 mmHg
±1.0 mmHg,
200 to 300
mmHg
± 1.5 mmHg
above 300
mmHg and
below 0 mmHg
± 0.5% of
reading + 1
mmHg | 0 to 300 mmHg
± 1 mmHg
otherwise
± 2 mmHg |
| Flow Measuring Range | 100 to 2000 ml/min | 100 to 2000
ml/min | Not Applicable | 100 to 2000
ml/min |
| Flow Measuring Accuracy | 100 to 2000 ml/min
± 0.5 % full scale | ± 2.0 %
of reading | Not Applicable | ± 2.0 %
of reading |
| pH Measuring Range | 0...14 pH | 0...14 pH | 0...14 pH | 0...14 pH |
| pH Measuring | ± 0.02 pH | ± 0.02 pH | ± 0.1 pH | ± 0.02 pH |
| Communication Interface | | | | |
| USB | Yes | Yes | No | Yes |
| Bluetooth | No | Only HDM19 | No | No |
| WIFI | No | No | No | Yes |
| Remark to WIFI | SmartHDM-510 uses WIFI / Internet connections by HTTPS protocol, TCP port 443.
These connections are for displaying manuals, or a registration page for a user
or legal information which are not stored in the App itself.
The servers of Mesa Laboratories offer TLS1.2, TLS1.1, TLS1.0 as the encryption
method. WIFI is not used for measuring purposes or other SmartHDM-510 use
cases at all. | | | |
| Cybersecurity | Not applicable | Not applicable | Not applicable | Applicable |
| Remark to Cybersecurity | • SmartHDM-510 has no open incoming network ports
• SmartHDM-510 interacts only with HTTPS secured Mesa Laboratories websites
on user action (outgoing connection) such as Mesa Laboratories WEB pages and
Mesa Laboratories PDF's for: User manuals and legal information.
• SmartHDM-510 is updated by Google Play Store functionalities only
• SmartHDM-510-App is signed by Mesa Laboratories development and Google
and only spread by Google Play Store
• Bluetooth (LE) is only used for a special purpose and is not open to other devices
except these of Mesa Laboratories | | | |
6
7
SmartHDM-510 System 510(k) Summary
8
Performance Testing
The performance testing for the SmartHDM-510 System includes software testing and code reviews, system verification and validation testing, and testing to compliance standards for electrical and electromagnetic safety. Traceability has been documented between the system specification to verification and validation test protocols. Verification and validation test procedures also address the user interface, user manual descriptions, usability, sensor communication and general performance including measuring accuracy.
The design of the device has been verified and validated both through testing and actual experience in international use.
The testing and international experience provided data that demonstrated substantial equivalence to the predicate devices.
Conclusion
The characteristics of the SmartHDM-510 System are identical to those of the predicate devices in almost all categories. The device has the same intended use as its primary predicate device. Also, it has similar measuring ranges and measuring accuracy as the predicate.
Different to HDM99 and the HDM97, where the display unit, all measuring electronic and pressure sensor are integrated into one housinq, and identical to the 90XL, the SmartHDM-510 System consist of separate devices for the display unit and external connected sensors with integrated measuring electronic. However, SmartHDM-510 System passed all performance tests and hence is as safe as its predicate devices.
The performance of the SmartHDM-510 System is substantially equivalent to that of the predicate devices and do not raise any new questions of safety or effectiveness and performs as well or better than the predicate devices.
Therefore, we conclude that it is substantially equivalent to its cleared predicate devices.