(269 days)
The SURDIAL DX Hemodialysis System is indicated for implementing hemodialysis treatments in patients with acute and chronic kidney (renal) failure. The system can be used in hospitals, healthcare facilities and outpatient dialysis centers when prescribed by a physician and used by qualified operators. The SURDIAL DX accommodates the use of both low flux and high flux hemodialysis.
The SURDIAL DX Hemodialysis System is a single patient dialysis unit that incorporates the mechanism of mixing and producing of dialysate by quantitative mixing method and the mechanism of ultrafiltration control by use of a piston pump. The SURDIAL DX consists of 4 sections: Panel operating section, Blood circuit control section, Liquid circuit control section and Power source control section. CAN communication is used for communication between each section.
This document is a 510(k) Summary for the NIPRO SURDIAL DX Hemodialysis System, demonstrating its substantial equivalence to a predicate device. It details performance specifications, but it does not describe a study involving a test set with ground truth established by experts, MRMC studies, or standalone algorithm performance, as these are typically associated with artificial intelligence/machine learning (AI/ML) device submissions.
The "performance data" section in this document refers to engineering and quality assurance testing (biocompatibility, electrical safety, software verification, environmental testing, human factors) to ensure the device functions as intended and meets established safety standards for a hemodialysis machine. It does not describe a study that would involve a "test set" and "ground truth" derived from expert consensus in the context of diagnostic accuracy, which is what your questions imply.
Therefore, for aspects related to AI/ML device evaluations (e.g., test set sample size, expert consensus, MRMC studies, standalone performance, training set details), the information is not available in the provided text.
Here's a breakdown of the available information based on your request, focusing on the device's engineering and safety performance rather than diagnostic accuracy:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the comparative table against the predicate device, where "Same" or "Similar" indicates meeting equivalence. Specific quantitative acceptance values are embedded within the "Subject Device: SURDIAL DX" column, and its performance is those reported values, as the testing confirmed it met those specifications.
| Aspect of Device Performance | Acceptance Criteria (from Subject Device Specifications) | Reported Device Performance (from Subject Device Specifications) |
|---|---|---|
| Water Supply | ||
| Pressure range | 0.5 – 7.4 bar | 0.5 – 7.4 bar (report indicates acceptable) |
| Temperature range | 5 - 30 °C / 41- 86 °F | 5 - 30 °C / 41- 86 °F (report indicates acceptable) |
| Alarm "No water" | Internally monitored by pressure sensor and flow regulator | Internally monitored by pressure sensor and flow regulator (report indicates acceptable) |
| Extracorporeal Circulation | ||
| Blood pump pumping rate | 0, 10 to 600 mL/min (5 mL/min increment) | 0, 10 to 600 mL/min (5 mL/min increment) (report indicates acceptable) |
| Tolerance interval (Blood Pressure) | < 10 % for blood pressure up to -200 mmHg | < 10 % for blood pressure up to -200 mmHg (report indicates meeting stricter tolerance than predicate) |
| Working pressure range (Inlet) | Inlet pressure up to: -500 mmHg | Inlet pressure up to: -500 mmHg (report indicates acceptable) |
| Working pressure range (Outlet) | Max. outlet pressure: +500 mmHg | Max. outlet pressure: +500 mmHg (report indicates acceptable) |
| Heparin pump pumping rate | 0.0 to 10.0 mL/h (0.1 mL/h increment) | 0.0 to 10.0 mL/h (0.1 mL/h increment), with specific bolus rates for 10, 20, 30 mL syringes (report indicates acceptable) |
| Heparin pump flow accuracy | Flow accuracy +/- 10 % | Flow accuracy +/- 10 % (report indicates acceptable) |
| Pressure range (Heparin pump) | 0 to 450 mmHg | 0 to 450 mmHg (report indicates acceptable) |
| Dialysate System | ||
| Flow (dialysate) | 100 to 800 mL/min (100 mL/min increment) | 100 to 800 mL/min (100 mL/min increment) (report indicates acceptable) |
| DF tolerance at dialysis machine | 0 to +10 % from the set value | 0 to +10 % from the set value (report indicates compliance with IEC standard) |
| Bridging time of protection system | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Ultrafiltration | ||
| Operating range | 0 to 4,000 mL/h | 0 to 4,000 mL/h (report indicates acceptable) |
| Overall accuracy | Fbal ± 0.15 mL/chamber cycle, FUF Ultrafiltration pump tolerance < 1 % | Fbal ± 0.15 mL/chamber cycle, FUF Ultrafiltration pump tolerance < 1 % (report indicates acceptable) |
| Dialysate Temperature | ||
| Temperature setting range | 34 - 39 °C/93 - 102 °F | 34 - 39 °C/93 - 102 °F (report indicates compliance with IEC standard) |
| Temperature tolerance | -0.5 °C to +31 °F to 33 °F | -0.5 °C to +31 °F to 33 °F (report indicates acceptable) |
| Heating power | 1800 W | 1800 W (report indicates acceptable) |
| Dialysate Conductivity | ||
| Operating range (Bicarbonate) | 2.4 – 7.0 mS/cm | 2.4 – 7.0 mS/cm (report indicates acceptable) |
| Operating range (Total) | 12.5 – 16.5 mS/cm | 12.5 – 16.5 mS/cm (report indicates acceptable) |
| Tolerance | ±0.2 mS/cm or less | ±0.2 mS/cm or less (report indicates acceptable) |
| ABPM Blood Pressure Monitoring | ||
| Cuff pressure range | 0 - 300 mmHg | 0 - 300 mmHg (report indicates acceptable) |
| Accuracy | Within ±3 mmHg | Within ±3 mmHg (report indicates acceptable) |
| Blood pressure determination time | Typical 25 seconds | Typical 25 seconds (report indicates acceptable) |
| Pulse rate determination | 40 – 200 bpm | 40 – 200 bpm (report indicates acceptable) |
| Pulse rate accuracy | The smaller of ±2% or ±2 bpm | The smaller of ±2% or ±2 bpm (report indicates acceptable) |
| Overpressure cut-off | In normal operation: 300 mmHg; In single failure: 330 mmHg | In normal operation: 300 mmHg; In single failure: 330 mmHg (report indicates acceptable) |
| Time of alarm suppression | < 1 second | < 1 second (report indicates acceptable) |
| Deactivation of acoustic signal | 120 seconds | 120 seconds (report indicates acceptable) |
| Transmembrane Pressure | ||
| Alarm limit (max. TMP) | 0 to +700 mmHg | 0 to +700 mmHg (report indicates acceptable) |
| Alarm limit (min. TMP) | -200 to +200 mmHg | -200 to +200 mmHg (report indicates acceptable) |
| Bridging time of protection system | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Deactivation of acoustic alarm | 120 seconds | 120 seconds (report indicates acceptable) |
| Degassing System | ||
| Tolerance | ± 20 mmHg | ± 20 mmHg (report indicates acceptable, tighter than predicate) |
| Arterial and Venous Pressure Monitoring | ||
| Arterial inlet pressure (PA) measurement tolerance | +/- 10 mmHg | +/- 10 mmHg (report indicates acceptable) |
| Venous return pressure (PV) measurement tolerance | +/- 10 mmHg | +/- 10 mmHg (report indicates acceptable) |
| Bridging time of protection system | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Bridging time of protective system (PV) | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Deactivation of acoustic alarm (PA) | 120 seconds | 120 seconds (report indicates acceptable) |
| Deactivation of acoustic alarm (PV) | 120 seconds | 120 seconds (report indicates acceptable) |
| Dialysate Conductivity Monitor | ||
| Limit | ±5 % (of set value) | ±5 % (of set value) (report indicates acceptable) |
| Bridging time of protection system | cannot be bridged during dialysis | cannot be bridged during dialysis (report indicates acceptable) |
| Deactivation of acoustic alarm | 120 seconds | 120 seconds (report indicates acceptable) |
| Ultrafiltration Controller | ||
| Protection system | Yes | Yes (report indicates acceptable) |
| Bridging time of protection system | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Deactivation of acoustic alarm | 120 seconds | 120 seconds (report indicates acceptable) |
| Air Detector System | ||
| Sensitivity | Alarms for single bubble > 10 µL or accumulated 0.3 µL+ over 1 min into volume of 1, 10, 50 or 300 µL; Default 10 µL | Specified sensitivity met (report indicates acceptable) |
| Protection system | Ultrasonic transmission method | Ultrasonic transmission method (report indicates acceptable) |
| Bridging time of protective system | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Blood Leak Detector | ||
| Measurement | Optical | Optical (report indicates acceptable) |
| Tolerance | +/- 100 ppm | +/- 100 ppm (report indicates acceptable) |
| Alarm threshold | Setting range: 50 to 500 ppm (10 ppm increment); Default: 280 ppm (Ht 32 %) | Specified alarm thresholds met (report indicates acceptable) |
| Bridging time of protective system | Not bridgeable during dialysis | Not bridgeable during dialysis (report indicates acceptable) |
| Deactivation of acoustic alarm | 120 seconds | 120 seconds (report indicates acceptable) |
| Temperature Monitor – Dialysate | ||
| Excessive-temperature protection | Lower limit 33°C/91°F; Upper limit 40°C/104 °F | Lower limit 33°C/91°F; Upper limit 40°C/104 °F (report indicates acceptable) |
| Protection system | Temperature sensor | Temperature sensor (report indicates acceptable) |
| Bridging time of protection system | Cannot be bridged during dialysis | Cannot be bridged during dialysis (report indicates acceptable) |
| Deactivation of acoustic alarm | 120 seconds | 120 seconds (report indicates acceptable) |
| Fail-safe design (power failure) | ||
| Battery | Power failure backup battery | Power failure backup battery (report indicates acceptable) |
2. Sample Size for Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/ML diagnostic study with patient data. The "performance data" refers to validation testing of the device itself (e.g., electrical, mechanical, software functionality, biocompatibility). Therefore, there is no sample size of patient data or data provenance (country, retrospective/prospective) relevant to a diagnostic AI model study.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. Ground truth from experts is not established for this type of device performance testing. The "ground truth" here is the engineering specification that the device must meet, tested through controlled experimental conditions in a lab.
4. Adjudication Method for Test Set
Not applicable. There is no expert adjudication for the engineering performance and safety tests described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is for evaluating the impact of AI assistance on human reader performance, typically in diagnostic imaging. The SURDIAL DX Hemodialysis System is a treatment device, not a diagnostic AI system, and this document does not refer to any such studies.
6. Standalone Performance (Algorithm Only)
Not applicable. This device is a hemodialysis machine. While it contains software, its "performance" is its ability to conduct hemodialysis treatments safely and effectively, not to perform a standalone diagnostic algorithm. The software verification and validation section confirms software functions as intended for controlling the machine.
7. Type of Ground Truth Used
The "ground truth" for this device's performance testing is adherence to engineering specifications, recognized international standards (e.g., ISO, IEC), and documented functional requirements. For biocompatibility, it's the results of specific laboratory tests against established biological safety criteria. For software, it's the functionality of the code against its design specifications and requirements.
8. Sample Size for Training Set
Not applicable. This document does not describe an AI/ML model that would have a "training set" of data.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no AI/ML training set.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 19, 2019
Nipro Medical Corporation Jessica Oswald-McLeod Director, Quality and Regulatory 3150 NW 107th Ave. Doral, FL 33172
Re: K182940
Trade/Device Name: Surdial DX Hemodialysis System Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI Dated: June 14, 2019 Received: June 17, 2019
Dear Jessica Oswald-McLeod:
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
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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-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 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 Division 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182940
Device Name Surdial DX Hemodialysis System
Indications for Use (Describe)
The SURDIAL DX Hemodialysis System is indicated for implementing hemodialysis treatments in patients with acute and chronic kidney (renal) failure. The system can be used in hospitals, healthcare facilities and outpatient dialysis centers when prescribed by a physician and used by qualified operators. The SURDIAL DX accommodates the use of both low flux and high flux hemodialysis.
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 in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR §807.92.
5.1. Submitter's Information
| Name: | Nipro Medical Corporation |
|---|---|
| Address: | 3150 NW 107th Ave.Doral FL 33172 USA |
| Phone: | 305-599-7174 |
| Contact Person: | Jessica Oswald-McLeodDirector, Quality Assurance and Regulatory Affairs |
| Email: | JessicaO@nipromed.com |
| Preparation Date: | July 19, 2019 |
5.2. Device Name
| Trade Name: | SURDIAL DX Hemodialysis System |
|---|---|
| Common Name: | Dialyzer, High Permeability with or without Sealed Dialysate System |
| Classification Name: | High Permeability Hemodialysis System |
| Regulatory Class: | Class II per 21 CFR §876.5860 |
| Product Code: | KDI |
| Classification Panel: | Gastroenterology/Urology |
5.3. Legally Marketed Predicate Device
B Braun Dialog+® Hemodialysis System (K083460) is the predicate for the SURDIAL DX Hemodialysis Machine.
5.4. Device Description
The SURDIAL DX Hemodialysis System is a single patient dialysis unit that incorporates the mechanism of mixing and producing of dialysate by quantitative mixing method and the mechanism of ultrafiltration control by use of a piston pump. The SURDIAL DX consists of 4 sections: Panel operating section, Blood circuit control section, Liquid circuit control section and Power source control section. CAN communication is used for communication between each section.
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5.4.1. Device Characteristics
The SURDIAL DX Hemodialysis System is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, and alarms.
5.4.2. Environment of Use
The SURDIAL DX Hemodialysis System is to be used in hospitals and healthcare facilities by qualified operators.
5.4.3. Brief Written Description of the Device
The SURDIAL DX Hemodialysis System has a built-in dialysate preparation system and piston pump ultrafiltration (UF) control system. The SURDIAL DX controls and monitors the hydraulic circuit and extracorporeal blood circuit. It provides hemodialysis treatment by controlling and monitoring both the dialysate circuit and the extracorporeal blood circuit. The machine pumps blood from the patient's body through an extracorporeal circuit containing the dialyzer. The dialyzer contains a semi-permeable membrane that uses diffusion to transfer toxins and ultrafiltration to transport excess water from the dialysate circuit. The dialysate is mixed with purified water, then heated and degassed for delivery to the dialyzer. During hemodialysis, the venous and arterial blood pressures are monitored.
Accessories
- Pole and hanger ●
- Tray
- Dialyzer holder
- Chemical solution tank belt
- Potential equalization conductor cable
- Disinfection suction tubes ●
- Blood pressure cuff and hose,
- Nipro Blood Tubing Set A430/V912 with transducer protectors and priming set
- NIPRO ELISIO series dialyzer K131935
- NIPRO Cellentia series dialyzers K140191 and K160444
- NIPRO ULTRA FILTER CF+609N and NIPRO ULTRA FILTER CF+220
- NIPRO DISPOSABLE LUER LOCK SYRINGE 10, 20, 30 mL K944355
5.4.5. Materials of Use
The SURDIAL DX Hemodialysis System is composed of the following indirect, permanent contact, externally communicating materials:
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Plastic/rubber:
PPS Poly Phenylene Sulfid FKM Fluororubeer PSU Poly Sulfone VMQ Silicone Rubber PP Polypropylene PPSU Poly phenyl Sulfone PTFE Poly Tetra Fluoro Ethylene PVDF Poly Vinylidene Difluoride FEP Fluoropolymer GFRPPS Poly Phenylene Sulfid added glass fiber PPS (CF+PTFE) Poly Phenylene Sulfid added CF and PTFE
Stainless Steel Glass Ceramic
The hydraulic lines of the machines are in contact with the dialysate circuit. The dialysate circuit has prolonged, indirect blood contact. Biocompatibility testing was conducted on the contacting materials.
5.6. Indications for Use
The SURDIAL DX Hemodialysis System is indicated for implementing and monitoring hemodialysis treatments in patients with acute and chronic kidney (renal) failure. The system can be used in hospitals, healthcare facilities and outpatient dialysis centers when prescribed by a physician and used by qualified operators. The SURDIAL DX accommodates the use of both low flux and high flux hemodialysis.
5.7. Comparison of Technological Characteristics with the Predicate Device
A comparison of the technological characteristics of the SURDIAL DX Hemodialysis Machine with the B. Braun Dialog+ Hemodialysis Machine predicate device is provided in the following table.
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: B:Braun Dialog+ | Discussion ofdifferences |
|---|---|---|---|
| Performance Specification | |||
| Water supply | Water suitablefor dialysis per | Water suitable fordialysis | Same |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| ANSI / AAMI13959:2014 | |||
| Water supplyPressure range | 0.5 – 7.4 bar | 0.5 - 6 bar | Subject device canhandle a larger rangeof water supplypressure, controlledby regulator. Noimpact on safety oreffectiveness. |
| Water supplyTemperaturerange | 5 - 30 °C / 41-86 °F | 10-30 °C /50-86 °F | Similar. The dialysisfluid is controlledwith a heater. Noimpact on safety oreffectiveness |
| Water supplyAlarm "Nowater" | Internallymonitored bypressure sensorand flowregulator | from separatemonitoring device | Similar. No impact onsafety oreffectiveness. |
| Concentratesupply | 5 to 98 kPa(0.05 - 0.98 bar) | from container orcentral supply 0 - 1bar | Similar. No impact onsafety oreffectiveness. |
| Extracorporeal circulation | |||
| Blood pump | 2-rollerSDX onlyavailable for 8/12mm pump tube | 2-roller pump withautomatic motorswitch-off when lidis opened,backstop, lowhemolysis.For 8/12 mm or(optional) 7/10 mmpump tubes | SDX only available for8/12 mm pump tube |
| Blood pumppumping rate | 0, 10 to 600mL/min (5mL/minincrement) | 50 - 600 mL/min(8/12 mm)50 - 400 mL/min(7/10 mm) | Similar with finerincrements ofadjustments. |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| Adjustable in 10 mLsteps | No impact on safetyor effectiveness. | ||
| Toleranceinterval | < 10 % forblood pressureup to -200mmHg | < 10 % for bloodpressure up to -150mm HgTolerance between10% and 25% forblood pressure upto -200 mmHg | Better control, tightertolerance. |
| Workingpressure range | Inlet pressure upto: -500 mmHgMax. outletpressure(pumpingpressure) :+500 mmHg | Intake pressure upto –390 mmHgPumping pressure0 – 1725 mmHg | Represents pumppressure which issufficient formaximum arterial andvenous pressureclinical requirementsand capable ofmeeting alarmrequirements. alsosafe for useconsidering maximumtransmembranepressure (TMP) of thedialyzer which islimited to max 500mmHg. |
| Heparin pump | Nipro syringe10 mL, 20 mL,30 mL | 10 – 30 mL syringes | Same |
| Heparin pumppumping rate | 0.0 to 10.0 mL/h(0.1 mL/hincrement)Default 2.0 ml/hBolus10 mL: Approx.550 mL/h(Approx. 9mL/min) | 0.1 – 10 mL/h insteps of 0.5 mL/hor 0.1 mL/h,at bolus: 600 mL/h | Similar with greatercapacity of bolus,operator selectable.Finer increments ofcontrol available tooperator. |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| 20 mL: Approx.900 mL/h(Approx. 15mL/min)30 mL: Approx.1200 mL/h(Approx. 20mL/min) | |||
| Toleranceinterval | Flow accuracy +/-10 % | < ±10 % | Same |
| Pressure range | 0 to 450 mmHg | 0 to +480 mmHg | Similar. No impact onsafety oreffectiveness. |
| Dialysate system | |||
| Flow (dialysate) | 100 to 800 mL/min(100 mL/minincrement) | 300 – 800 mL/min | Similar. Lower flowrate available.No safety oreffectiveness impact. |
| DF tolerance atdialysis machine | 0 to +10 % fromthe set value | ±5 % (of specifiedvalue) at 300 - 800mL/min | The SURDIAL DX DFtolerance is selectedto comply withIEC60601-2-16 clause201.4.3.103 DIALYSISFLUID flow |
| Bridging time ofprotectionsystem | Not bridgeableduring dialysis | Not bridgeable viabalance chamberfilling times duringdialysis | Same |
| Ultrafiltration | Volume-controlled viabalancechambers,ultrafiltrationthroughultrafiltrationpump UF profilefeatureincorporated | Volume-controlledvia balancechambers,ultrafiltrationthroughultrafiltrationpumpSequentialultrafiltration | Same |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| Operating range | 0 to 4,000 mL/h | 0 - 4,000 mL/h | Same |
| Overall accuracy* | F= Fbal + FUFFbal ± 0.15mL/chambercycleFUFUltrafiltrationpumptolerance <1 % | F= Fbal + FUFFbal ± 0.2mL/chamber cycleFUF Ultrafiltrationpump tolerance<1 %* The overallaccuracy F is thesum of twodifferent errors: F= Fbal +FUFFbal = balancechamber deviation(measures perchamber cyclesand depends onthe dialysate flow)FUF = UF pumperror | Similar |
| Dialysate Temperature | |||
| Temperaturesetting range | 34 - 39 °C/93 -102 °F | 33 - 40 °C/91 -104 °F | The SURDIAL DXTemperature settingrange is selected tocomply with IEC60601-2-16 clause201.12.4.4.102DIALYSIS FLUID andSUBSTITUTION FLUIDtemperature |
| Temperaturetolerance | -0.5 °C to | -0.5 °C to +1.5 °C/+29 °F to 33 °F | Similar. |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| standardambienttemperature | +31 °F to 33 °F | No impact on safetyor effectiveness. | |
| Heating power | 1800 W | 1800 W | Same |
| Dialysate conductivity | |||
| Operating range | Bicarbonate2.4 – 7.0 mS/cmTotal dialysate12.5 – 16.5mS/cm | Conductivitybicarbonate 2-4mS/cm, 4-7 mS/cmOverallconductivity12.5 – 16 mS/cm | Similar.No impact on safetyor effectiveness. |
| Tolerance | ±0.2 mS/cm orless | ±0.2 mS/cm | Same |
| Measurement | Temperature-compensated(referencetemperature25 °C/77 °F) | Temperature-compensated(referencetemperature25 °C/77 °F) | Same |
| ABPM blood pressure monitoring | |||
| Cuff pressurerange | 0 - 300 mmHg | 0 – 320 mmHg | Similar.No impact on safetyor effectiveness. |
| Inflationpressure duringfirst cuffinflation | 180 mmHg | 200 mmHg | Similar.No impact on safetyor effectiveness. |
| Inflationpressure duringsubsequentmeasurements | Last SYS pressure+40 mmHg | Last SYS pressure+30 mmHg | Similar.No impact on safetyor effectiveness. |
| Blood pressuremeasurementrange | Systolic (SYS)60 – 250 mmHgAverage (MAP)45 – 235 mmHgDiastolic (DIA)40 – 200 mmHg | Systolic45 – 280 mmHgMAP 25 – 240mmHgDiastolic15 – 220 mmHg | Similar.No impact on safetyor effectiveness. |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| Accuracy | Within ±3 mmHg | ±3 mmHg or ±2% | Same |
| Blood pressuredeterminationtime | Typical 25 seconds(Adult with bloodpressure 120/80and 80 BPM) | Typical 25 seconds(Adult with bloodpressure 120/80and 80 BPM) | Same |
| Pulse ratedetermination | 40 – 200 bpm | 30 – 240 bpm | Similar.No impact on safetyor effectiveness. |
| Pulse rateaccuracy | The smaller of±2% or ±2 bpm | ±2% or 2 BPM | Same |
| Overpressurecut-off | In normaloperation:300 mmHgIn single failure:330 mmHg | 300 mmHg + 10% | Similar.No impact on safetyor effectiveness. |
| Time of alarmsuppression | < 1 second | < 1 second | Same |
| Deactivation ofacoustic signal | 120 seconds | 120 seconds | Same |
| Safety class | Safety class I,Type BF | Safety class I, TypeBF | Same |
| Important safety/effectiveness information | |||
| Disinfection/Cleaning | |||
| Disinfection/cleaning | Automaticprogram withenforced rinse-outThe parametersfor thedisinfectant usedcan be set in thesystem menu. | Automatic programwith enforcedrinse-outThe parameters forthe disinfectantused can be set inthe serviceprogram. | Same |
| Chemicaldisinfection | Yes | Yes | Same |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| Thermaldisinfection | 96°C /205°F(fixed)Setting time 29to 60 min | Automatic programcycle at approx.85 °C/185 °F at thedialyzer couplingsapprox. 40 minutes | Similar.No impact on safetyor effectiveness. |
| Externalcleaning | Clean housing/enclosureutilizing 1:100ratio of 6%bleach (sodiumhypochloriteconcentrate) towater mixture.Use cleaning anddisinfectionagents only inaccordance withthe respectiveUser Manual.Ensure that thedisinfectant/cleaning agentwill be wiped offfrom the screencompletely. | Clean housingparts, monitor,inside and outsideof the rinse bucketwith ethanol(max. 70 %),isopropanol (60 %to 70 %) basedcleaning agents, or1:100 bleachsolution (5:25sodiumhypochlorite) asper clinic policy andprocedure.Use cleaning anddisinfection agentsonly in accordancewith the respectiveInstructions forUse. Ensure thatthe disinfectant/cleaning agent willbe wiped off fromthe screencompletely. | Cleaning method forthe SURDIAL DXproduces acceptableresults as per cleaningvalidation study.No impact on safetyor effectiveness. |
| Transmembrane pressure | |||
| Alarm limit(max. TMP) | 0 to +700 mmHg | +300 to +700mmHg | Similar – broader limitrange. |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| Alarmlimit(min.TMP) | -200 to+200 mmHg | -100 mmHg | Similar – broaderlimit range providefor user who setslimit. |
| Limit window | AdjustableUpper: 20 to+500 mmHgLower: -300 to+20 mmHg | Adjustable (2 % -99 %) | Similar.SURDIAL DX utilizes abroader limit range,which is set bymanufacturerabsolute value.The predicate deviceis based on the rangeestablished by variousdialyzer'smanufacturer. |
| Tolerance | Calculatedthrough PD andPV | Calculated throughPDA and PV | Same |
| Bridging time ofprotectionsystem | Not bridgeableduring dialysis | Not bridgeableduring dialysis | Same |
| Deactivation ofacoustic alarm | 120 seconds | 120 seconds | Same |
| Degassingsystem | Vacuumdeaerationmethod | Mechanicallyregulated throughthe degassingpump | Same |
| Tolerance | ± 20 mmHg | ± 50 mmHg | Similar – tightertolerance thanpredicate device.No safety oreffectiveness impact. |
| Arterial and Venous pressure monitoring | |||
| Pressuremeasurementat arterial inletof dialyzer(DBE) | N/A | Electronic pressuresensor | PBE was designed tomeasure the pressureincrease of blood intothe dialyzer caused byclotting in a dialyzer |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| in earlier versions ofdialyzers.Currently availabledialyzers have betterperformancepreventing clottinginside the equipmenthence the state-of-the-art dialyzers nolonger require thisadditional PBEfunction. | |||
| Operating range | N/A | 0 – 700 mmHg | Same as above |
| Toleranceinterval | N/A | ±10 mmHg | Same as above |
| Limit | N/A | Adjustable withinoperating range | Same as above |
| Protectionsystem | N/A | Test prior to startof therapy | Same as above |
| Arterial inletpressure (PA)measurement | Electronicpressure sensor | Electronic pressuresensor with digitalquasi-analoguedisplay | Same |
| Operating range | -500 to +500mmHg | -400 to +400mmHg | Similar – broader limitrange, useradjustable. |
| Tolerance | +/- 10 mmHg | +10 mmHg | Same |
| Limit | -500 to + 500mmHg | -400 to +400mmHgadjustable withinoperating range,adjustable intervalwidth for dynamiclimits window | Similar.No impact on safetyor effectiveness. |
| Protectionsystem | Electronicpressure sensor,test prior to startof therapy | Electronic pressuresensor, test prior tostart of therapy | Same |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| Deactivation ofacoustic alarm | 120 seconds | 120 seconds | Same |
| Venous returnpressure (PV)measurement | Electronicpressure sensor | Electronic pressuresensor with digitalquasi-analoguedisplay | Same |
| Operating range | -500 to +500mmHg | 20 - 390 mmHg(adjustable inservice program) | Similar.No impact on safetyor effectiveness. |
| Tolerance | +/- 10 mmHg | $\pm$ 10 mmHg | Same |
| Limit | -100 to + 480mmHgDefaultupper300 mmHglower -10 mmHg | Alarm windowaround operatingvalueConfigurable alarmwindow (20 - 200mmHg)After blood pumpadjustment, thealarm window is re-centered. | Similar.No impact on safetyor effectiveness. |
| Protectionsystem | Test prior to startof therapy | Test prior to startof therapyVenous window of20 - 390 mmHg.Venous limits aremonitored bythe function andcontrol systems. | Similar.No impact on safetyor effectiveness. |
| Bridging time ofprotectionsystem | Not bridgeableduring dialysis | Not bridgeableduring dialysis | Same |
| Deactivation ofacoustic alarm | 120 seconds | 120 seconds | Same |
| Dialysate conductivity monitor | |||
| Protectionsystem | Monitoringthrough secondconductivitysensor with | Monitoringthrough secondconductivity sensor | Same.Both use a secondarysensor |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| softwarecalibration. | with modifiedgeometry | ||
| Limit | ±5 % (of setvalue) | ±5 % (of set value) | Same |
| Bridging time ofprotectionsystem | cannot bebridged duringdialysis | cannot be bridgedduring dialysis | Same |
| Deactivation ofacoustic alarm | 120 seconds | 180 seconds | Similar.No impact on safetyor effectiveness. |
| Ultrafiltration controller | |||
| Protectionsystem | Yes | Yes | Same |
| Bridging time ofprotectionsystem | Not bridgeableduring dialysis | Not bridgeableduring dialysis | Same |
| Deactivation ofacoustic alarm | 120 seconds | 120 seconds | Same |
| Air detector system | |||
| Sensitivity | Alarms whenany singlebubble greaterthan 10 µL insize and whenbubbles of 0.3µL or larger,accumulateover a 1-minute periodinto a volumeof 1, 10, 50 or300 µL.Default settingis 10 µL. | Air bubbles at > 50µl, micro foam withcumulated volumeLimit valuesdouble needle:0.2 mL at 0 - 200mL/min SAD flow0.3 mL at 200 – 400mL/min SAD flow0.5 mL at > 400mL/min SAD flowLimit values singleneedle:0.7 mL at 1200mL/min constantSAD flow | Similar. |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| Protectionsystem | Ultrasonictransmissionmethod | Ultrasounddetector,automatic cyclicalchecks duringentire operatingphase | Same |
| Bridging time ofprotectivesystem | Not bridgeableduring dialysis | Not bridgeableduring dialysisonly in end phasefor approx. 30 mL(has to be activatedat TSM) | Similar.SURDIAL DX is notpermitted bridgeable. |
| Blood leak detector | |||
| Measurement | Optical | Optical | Same |
| Tolerance | +/- 100 ppm | Tolerance 10 % | See below |
| Alarm threshold | Setting range: 50to 500 ppm(10 ppmincrement)Detection point(Default: 280ppm), (Ht 32 %) | >0.5 mL/min bloodat Hkt 45 %>0.35 mL/minblood at Hkt 25 %(AAMI) | SimilarThreshold setting inpredicate device(0.5ml/min at 45%Hkt, 0.35ml/min at25% Hkt) and bycalculation thecorresponding valuefor 0.4ml/min at 32%Hkt.The threshold settingin SDX between0.05ml/min to 0.50ml/min is 32% Hktwhich covers thesame range aspredicate device |
| Bridging time ofprotectivesystem | Not bridgeableduring dialysis | Not bridgeableduring dialysis | Same |
| Deactivation ofacoustic alarm | 120 seconds | 120 seconds | Same |
| Item ofComparison | Subject Device:SURDIAL DX | Predicate Device: BBraun Dialog+ | Discussion ofdifferences |
| Temperature monitor – dialysate | |||
| Excessive-temperatureprotection | Lower limit33°C/91°FUpper limit40°C/104 °F | 41 °C/106 °F | Similar.No impact on safetyand effectiveness |
| Protectionsystem | Temperaturesensor | Temperaturesensor | Same |
| Bridging time ofprotectionsystem | Cannot bebridged duringdialysis | Cannot be bridgedduring dialysis | Same |
| Deactivation ofacoustic alarm | 120 seconds | 120 seconds | Same |
| Fail-safe design feature in the event of power failure | |||
| Battery | Power failurebackup battery | Power failurebackup battery | Same |
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5.8. Performance Data
The performance of the SURDIAL DX was evaluated according to Nipro procedures, and performance testing protocols. The device performed according to acceptance criteria in these tests, and confirmed that the device functions as intended.
5.8.1. Biocompatibility Testing
The SURDIAL DX Hemodialysis Machine's patient contacting components were evaluated to ISO 10993 requirements. The Unit Under Test (UUT) included the new hardware components (acid, bicarbonate and UF pumps, extended concentrate lines and ratio valves). The following testing was performed to support the biological safety of the SURDIAL DX machine:
- Cytotoxicity
- Sensitization ●
- Acute Systemic Toxicity
- ASTM Hemolysis
- Material Mediated Pyrogenicity
- Intracutaneous Reactivity
- Chemistry Characterization
- Biological Evaluation Report ●
- Toxicological Risk Assessment ●
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5.8.2. Electrical Safety and Electromagnetic Compatibility (EMC)
The SURDIAL DX Hemodialysis Machine was evaluated for electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2:2014. The following safety standards were also assessed for the machine:
- IEC 60601-1:2005+A1:2012 ANSI/AAMI ES 60601-1: A1:2012
- IEC 60601-1-8:2006 +A1:2012
- IEC 60601-2-16:2012 ●
- IEC 80601-2-30:2009 +A1:2013
5.8.3. Software Verification and Validation Testing
The software was determined to be legacy software, and therefore a gap assessment was performed to allow updates to the software going forward to be conducted under IEC 62304 software standards. The original SURDIAL DX Software was originally developed 10 to 15 years ago (mid 2000s). The target product market was Asia, Europe and South America. The SURDIAL DX hemodialysis machine has been deployed successfully in these markets for over 10 years, with a history of reliable clinical performance.
A detailed analysis of the software and available documentation was performed, and it was determined to perform independent verification and validation. Unit, integration, and system level software verification testing demonstrates that the machine functions as intended.
5.8.4. Environmental and Ship Testing
Performance testing was conducted at ambient room conditions to verify normal machine function. Transportation testing was performed to verify that the machine can withstand hazards associated with the typical shipping and distribution environment.
5.8.5. Human Factors Testing
Human Factors testing was performed on the SURDIAL DX and found that the usability of the machine was in line with its functions, and the professional users of the machine. Nipro therefore concludes that the machine is safe and effective for the intended users, uses, and use environments.
5.9. Conclusions
The SURDIAL DX Hemodialysis System indications for use, intended use, and its technological characteristics are substantially equivalent to those of the predicate device namely B. Braun Dialog+. The differences between the SURDIAL DX Hemodialysis System and the predicate device do not raise any new concerns with regard to safety or effectiveness; therefore, no clinical tests were deemed necessary. Essential performance of the machine was confirmed in the IEC 60601 testing. Nipro has concluded that the SURDIAL DX Hemodialysis System is substantially equivalent to the predicate device, the B. Braun Dialog+ (K083460) Hemodialysis System within the meaning of the Medical Device Amendments Act of 1976.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”