(269 days)
B Braun Dialog+® Hemodialysis System (K083460)
Not Found
No
The summary does not mention AI, ML, or any related technologies. The description focuses on the mechanical and control systems of the device.
Yes
The device is used for "implementing hemodialysis treatments in patients with acute and chronic kidney (renal) failure," which is a therapeutic intervention.
No
The device is described as a hemodialysis system used for treatment by mixing and producing dialysate and controlling ultrafiltration. Its intended use is to implement hemodialysis treatments for patients with kidney failure, not to diagnose a condition.
No
The device description clearly outlines hardware components (mixing mechanism, piston pump, control sections, CAN communication) and the performance studies include hardware-related testing (Biocompatibility, Electrical Safety, EMC, Environmental, Ship Testing, IEC 60601).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SURDIAL DX Hemodialysis System is for "implementing hemodialysis treatments in patients with acute and chronic kidney (renal) failure." This describes a therapeutic treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the mechanisms for mixing dialysate and controlling ultrafiltration, which are processes involved in filtering blood, not analyzing it for diagnostic purposes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The SURDIAL DX Hemodialysis System is a therapeutic device used to treat kidney failure by filtering the patient's blood.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KDI
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.
The SURDIAL DX Hemodialysis System is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, and alarms.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Kidney (renal)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The system can be used in hospitals, healthcare facilities and outpatient dialysis centers when prescribed by a physician and used by qualified operators.
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 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.
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
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
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.
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.
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.
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.
B Braun Dialog+® Hemodialysis System (K083460)
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.
Not Found
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
§ 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.”
0
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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
1
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
2
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-McLeod |
| Director, 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 of
Comparison | Subject Device:
SURDIAL DX | Predicate Device: B:
Braun Dialog+ | Discussion of
differences |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Specification | | | |
| Water supply | Water suitable
for dialysis per | Water suitable for
dialysis | Same |
| Item of
Comparison | Subject Device:
SURDIAL DX | Predicate Device: B
Braun Dialog+ | Discussion of
differences |
| | ANSI / AAMI
13959:2014 | | |
| Water supply
Pressure range | 0.5 – 7.4 bar | 0.5 - 6 bar | Subject device can
handle a larger range
of water supply
pressure, controlled
by regulator. No
impact on safety or
effectiveness. |
| Water supply
Temperature
range | 5 - 30 °C / 41-
86 °F | 10-30 °C /50-86 °F | Similar. The dialysis
fluid is controlled
with a heater. No
impact on safety or
effectiveness |
| Water supply
Alarm "No
water" | Internally
monitored by
pressure sensor
and flow
regulator | from separate
monitoring device | Similar. No impact on
safety or
effectiveness. |
| Concentrate
supply | 5 to 98 kPa
(0.05 - 0.98 bar) | from container or
central supply 0 - 1
bar | Similar. No impact on
safety or
effectiveness. |
| Extracorporeal circulation | | | |
| Blood pump | 2-roller
SDX only
available for 8/12
mm pump tube | 2-roller pump with
automatic motor
switch-off when lid
is opened,
backstop, low
hemolysis.
For 8/12 mm or
(optional) 7/10 mm
pump tubes | SDX only available for
8/12 mm pump tube |
| Blood pump
pumping rate | 0, 10 to 600
mL/min (5
mL/min
increment) | 50 - 600 mL/min
(8/12 mm)
50 - 400 mL/min
(7/10 mm) | Similar with finer
increments of
adjustments. |
| Item of
Comparison | Subject Device:
SURDIAL DX | Predicate Device: B
Braun Dialog+ | Discussion of
differences |
| | | Adjustable in 10 mL
steps | No impact on safety
or effectiveness. |
| Tolerance
interval | 50
µl, micro foam with
cumulated volume
Limit values
double needle:
0.2 mL at 0 - 200
mL/min SAD flow
0.3 mL at 200 – 400
mL/min SAD flow
0.5 mL at > 400
mL/min SAD flow
Limit values single
needle:
0.7 mL at 1200
mL/min constant
SAD flow | Similar. |
| Item of
Comparison | Subject Device:
SURDIAL DX | Predicate Device: B
Braun Dialog+ | Discussion of
differences |
| Protection
system | Ultrasonic
transmission
method | Ultrasound
detector,
automatic cyclical
checks during
entire operating
phase | Same |
| Bridging time of
protective
system | Not bridgeable
during dialysis | Not bridgeable
during dialysis
only in end phase
for approx. 30 mL
(has to be activated
at TSM) | Similar.
SURDIAL DX is not
permitted bridgeable. |
| Blood leak detector | | | |
| Measurement | Optical | Optical | Same |
| Tolerance | +/- 100 ppm | Tolerance 10 % | See below |
| Alarm threshold | Setting range: 50
to 500 ppm
(10 ppm
increment)
Detection point
(Default: 280
ppm), (Ht 32 %) | >0.5 mL/min blood
at Hkt 45 %
0.35 mL/min
blood at Hkt 25 %
(AAMI) | Similar
Threshold setting in
predicate device
(0.5ml/min at 45%
Hkt, 0.35ml/min at
25% Hkt) and by
calculation the
corresponding value
for 0.4ml/min at 32%
Hkt.
The threshold setting
in SDX between
0.05ml/min to 0.50
ml/min is 32% Hkt
which covers the
same range as
predicate device |
| Bridging time of
protective
system | Not bridgeable
during dialysis | Not bridgeable
during dialysis | Same |
| Deactivation of
acoustic alarm | 120 seconds | 120 seconds | Same |
| Item of
Comparison | Subject Device:
SURDIAL DX | Predicate Device: B
Braun Dialog+ | Discussion of
differences |
| Temperature monitor – dialysate | | | |
| Excessive-
temperature
protection | Lower limit
33°C/91°F
Upper limit
40°C/104 °F | 41 °C/106 °F | Similar.
No impact on safety
and effectiveness |
| Protection
system | Temperature
sensor | Temperature
sensor | Same |
| Bridging time of
protection
system | Cannot be
bridged during
dialysis | Cannot be bridged
during dialysis | Same |
| Deactivation of
acoustic alarm | 120 seconds | 120 seconds | Same |
| Fail-safe design feature in the event of power failure | | | |
| Battery | Power failure
backup battery | Power failure
backup 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 ●
19
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.