(120 days)
No
The summary describes a standard hemodialysis system with mechanical and fluid control components. There is no mention of AI, ML, or any data-driven decision-making or analysis beyond basic sensor feedback and control loops.
Yes
The device is indicated for treating patients with acute and/or chronic renal failure, which is a therapeutic purpose.
No
Explanation: The device is a hemodialysis system used for treating renal failure by filtering waste products from the blood, not for diagnosing medical conditions.
No
The device description explicitly details hardware components such as the SC+ Machine (water circuit, blood leak detector, air in blood detector, pneumatic interface, peristaltic blood pump, sensors), a disposable Dialysate Cartridge (conductivity monitors, pressure/temperature interfaces, membrane pumps), and a disposable Blood Tubeset (arterial/venous lines, connections, pressure transducer pods, drip chamber, heparin line). While software verification is mentioned in performance studies, the device is clearly a system with significant hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The SC+ Hemodialysis System is a therapeutic device used to treat patients with renal failure by filtering their blood directly within the system. It removes waste products and excess fluid from the blood.
- Intended Use: The intended use clearly states it's for "patients with acute and/or chronic renal failure" and describes the treatment types (Hemodialysis, SLED, PIRRT, etc.), which are all therapeutic procedures performed on the patient's body.
- Device Description: The description details the components involved in the blood filtration process (blood pump, dialyzer connections, blood tubeset) and the production of dialysate fluid used in this process.
- Lack of Diagnostic Testing: There is no mention of the device performing any tests on patient samples to diagnose or monitor a condition. Its function is to treat the condition.
While the system interacts with blood, it does so for the purpose of filtration and treatment, not for diagnostic testing of the blood itself.
N/A
Intended Use / Indications for Use
SC+ Hemodialysis Machine/ SC+ Dialysate Cartridge
The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, by a trained person who is competent in the use of the device.
Treatment types available include: Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED), Prolonged Intermittent Renal Replacement Therapy (PIRRT), Isolated Ultration including Slow Continuous Ultrafiltration (SCUF) and Continuous Venovenous Hemodialysis (CVVHD).
SC+ Blood Tube Set
The SC+ Blood Tube Set is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tube Set is compatible only with the SC+ Hemodialysis System.
Product codes (comma separated list FDA assigned to the subject device)
KDI, FJK
Device Description
The SC+ is a haemodialysis delivery system intended for the provision of acute and chronic dialysis therapy, with or without ultrafiltration. The SC+ system utilises incoming Dialysis Water from an external source, with industry standard dialysis concentrate consumables, to manufacture the dialysis fluid used to deliver the treatment. The SC+ system is for use in patients with arteriovenous (AV) fistulas or central venous catheter access.
The SC+ system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.
The SC+ Machine consists of a water circuit (heater, de-aeration module, etc) blood leak detector, air in blood detector, a pneumatic interface for the dialysate cartridges, a peristaltic blood pump and various other sensors. The dialysate cartridge contains the following; conductivity monitors, interfaces for pressure and temperature measurement, membrane pumps to perform mixing/proportioning in order to produce dialysis fluid and the controlled removal of fluid from a patient with acute and/or chronic renal failure based on a physician's prescription. The dialysate fluid is manufactured using dialysis water purified externally by reverse osmosis that is heated to approximately 37°C and subsequently deaerated within the machine before entering the cartridge.
The SC+ Blood Tubeset is a single use, sterile device consisting of an arterial line, a venous line, connections to a standard dialyzer, a saline line, three pressure transducer pods integrated into a single unit, a venous drip chamber, and a line for heparin infusion.
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
Treatments must be administered under physician's prescription, by a trained person who is competent in the use of the device.
acute or chronic care facility.
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 following performance testing, developed in accordance with appropriate FDA guidance documents and relevant standards, has been performed on the Modified Device to support the determination of substantial equivalence:
- Essential Performance testing for dialysate composition ●
- Essential Performance testing for dialysate flow rate
- Essential Performance testing for Blood Flow Rate ●
- Essential Performance testing for Net Fluid Removal ●
- Essential Performance testing for Treatment Time ●
- Essential Performance testing for Consumables duration testing ●
- Blood Loss to Dialysate protective system testing ●
- Net Fluid Removal Protective system testing ●
- Patient Leakage Current testing ●
- Hemolysis testing ●
- Software verification ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 10, 2022
Quanta Dialysis Technologies Ltd. Sam Drew Risk and Regulatory Manager Tything Road, Alcester Warwickshire B49 6EU UNITED KINGDOM
Re: K222067
Trade/Device Name: SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI, FJK Dated: October 10, 2022 Received: October 11, 2022
Dear Sam Drew:
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-regulatory-information/postmarketing-safetyreporting-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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.
Gema Gonzalez -S
Gema Gonzalez, MS Acting 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 Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K222067
Device Name SC+ Hemodialysis Machine SC+ Dialysate Cartridge SC+ Blood Tube Set
Indications for Use (Describe)
SC+ Hemodialysis Machine/ SC+ Dialysate Cartridge
The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, by a trained person who is competent in the use of the device.
Treatment types available include: Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED), Prolonged Intermittent Renal Replacement Therapy (PIRRT), Isolated Ultration including Slow Continuous Ultrafiltration (SCUF) and Continuous Venovenous Hemodialysis (CVVHD).
SC+ Blood Tube Set
The SC+ Blood Tube Set is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tube Set is compatible only with the SC+ Hemodialysis System.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K222067 Page 1 of 6
Quanta Dialysis Technologies SC+ Hemodialysis Premarket Notification - Traditional 510(k) K222067
Image /page/3/Picture/2 description: The image shows the word "QUANTA" in a stylized font. The letters are a combination of dark blue and teal colors, with each letter split between the two colors. The "TM" symbol is located in the upper right corner of the image, next to the letter "A".
5 510(k) Summary
The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92
Date prepared: November 10, 2022
5.1 Manufacturer Details
Quanta Dialysis Technologies Ltd Tything Road, Alcester, Warwickshire, B49 6EU, United Kingdom
5.2 Contact Details
Mr. Chris Rule +44 (0)1789 336 752 chris.rule@quantadt.com
Mr. Sam Drew +44 (0)1789 336 752 sam.drew@quantadt.com
5.3 Device Information
5.3.1
SC+ Machine & Dialysate Cartridge
| Trade Name | SC+ Machine & SC+ Dialysate Cartridge |
|---|---|
| Common Name | Hemodialysis Delivery System |
| Product Code | KDI |
| Device | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Classification Name | |
| Regulation Number | 21 CFR §876.5860 |
| Device Class | Class II |
| Review Panel | Gastroenterology/Urology |
Table 1: SC+ Device and Dialysate Cartridge general device information
Predicate Device Information:
| Manufacturer | Name of Predicate Device | 510(k)# | Date of Clearance |
|---|---|---|---|
| Quanta Dialysis | |||
| Technologies Ltd | SC+ Machine & Dialysate | ||
| Cartridge | K210661 | 2021-08-12 |
4
Image /page/4/Picture/1 description: The image shows the text 'K222067' and 'Page 2 of 6' at the top. Below that is the logo for QUANTA, with the letters in a mix of dark blue and teal. The logo is stylized and modern.
5.3.2 SC+ Blood Tube Set
| Trade Name | SC+ Blood Tubeset |
|---|---|
| Common Name | Blood Tubing Set |
| Product Code | FJK |
| Device | SC+ Blood Tubeset |
| Classification Name | Set, tubing, blood, with and without anti- |
| regurgitation valve | |
| Regulation Number | 21 CFR §876.5820 |
| Device Class | Class II |
| Review Panel | Gastroenterology/Urology |
Table 2: SC+ Blood Tubeset general device information
Predicate Device Information:
| Manufacturer | Name of Predicate Device | 510(k)# | Date of Clearance |
|---|---|---|---|
| Quanta Dialysis | |||
| Technologies Ltd | SC+ Machine & Dialysate | ||
| Cartridge | K210661 | 2021-08-12 |
Reference Device Information:
| Manufacturer | Name of Predicate Device | 510(k)# | Date of Clearance |
|---|---|---|---|
| Gambro Renal | |||
| Products Inc. | Prismaflex M150 set | K080519 | 2008-13-06 |
5.4 Device Description
The SC+ is a haemodialysis delivery system intended for the provision of acute and chronic dialysis therapy, with or without ultrafiltration. The SC+ system utilises incoming Dialysis Water from an external source, with industry standard dialysis concentrate consumables, to manufacture the dialysis fluid used to deliver the treatment. The SC+ system is for use in patients with arteriovenous (AV) fistulas or central venous catheter access.
The SC+ system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.
SC+ Hemodialysis System 5.4.1
The SC+ Hemodialysis System is intended for acute and chronic dialysis therapy, with or without ultrafiltration, utilizing Dialysis Water (from standalone Reverse Osmosis (RO) units or a central RO ring main) to produce dialysate. The SC+ Hemodialysis system is for use in patients with arteriovenous (AV) fistula or central venous catheter access.
The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.
5
Image /page/5/Picture/1 description: The image shows the text "K222067 Page 3 of 6" at the top. Below the text is the Quanta logo. The logo is in a stylized font and is split into two colors, dark blue and teal.
The SC+ Machine consists of a water circuit (heater, de-aeration module, etc) blood leak detector, air in blood detector, a pneumatic interface for the dialysate cartridges, a peristaltic blood pump and various other sensors. The dialysate cartridge contains the following; conductivity monitors, interfaces for pressure and temperature measurement, membrane pumps to perform mixing/proportioning in order to produce dialysis fluid and the controlled removal of fluid from a patient with acute and/or chronic renal failure based on a physician's prescription. The dialysate fluid is manufactured using dialysis water purified externally by reverse osmosis that is heated to approximately 37°C and subsequently deaerated within the machine before entering the cartridge.
The SC+ Blood Tubeset is a single use, sterile device consisting of an arterial line, a venous line, connections to a standard dialyzer, a saline line, three pressure transducer pods integrated into a single unit, a venous drip chamber, and a line for heparin infusion.
5.5 Device Modification
This 510(k) covers the following modifications:
- Extension of permitted dialysate conductivity range ●
- Extended Treatment Time Range ●
- Increased Maximum Ultrafiltration Rate
- Increased Max Ultrafiltration Volume ●
- Additional (lower) Dialysate Flow Rates ●
- Isolated Ultrafiltration ●
- Dialysate composition settable by mEq/l Sodium content and by acid type
- Use Mode switching ●
- . Adjustable settings mid-treatment
- Addition of blood leak override function
- Expansion of treatment types permitted in indications .
5.6 Indications for Use
5.6.1 SC+ Haemodialysis Machine & Dialysate Cartridge
The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, by a trained person who is considered competent in the use of the device.
Treatment types available include: Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), Isolated Ultrafiltration including Slow Continuous Ultrafiltration (SCUF) and Continuous Venovenous Hemodialysis (CVVHD).
6
Image /page/6/Picture/1 description: The image shows the text "K222067 Page 4 of 6" at the top. Below the text is a logo that says "QUANTA" in a stylized font. The logo is two-toned, with the left side in a dark blue and the right side in a teal color. The TM symbol is located to the right of the logo.
SC+ Blood Tubeset 5.6.2
The SC+ Blood Tubeset is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tube Set is compatible only with the SC+ Hemodialysis System.
5.7 Technological Characteristics
5.7.1 Changed SC+ device vs SC+ device as cleared in K210661
The technological characteristics of the SC+ Machine and SC+ Dialysate Cartridge are considered to be equivalent to the predicate device, SC+ device and dialysate cartirige (K210661). A summary of the similarities and differences is provided in the table below.
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| This submission | SC+ (K210661) | |
| Indicated for use in patients with acute and/or | ||
| chronic renal failure, with or without ultrafiltration | ||
| in an acute or chronic care facility | ✓ | ✓ |
| Use of purified water for dialysate production | ✓ | ✓ |
| Use of third-party accessories, including | ||
| dialyzers, endotoxin retentive filters, acid and | ||
| bicarbonate | ✓ | ✓ |
| Application of consensus standards | ✓ | ✓ |
| Device is software controlled and utilize Graphic | ||
| User Interface (GUI). | ✓ | ✓ |
| Design and Construction - Blood pump, alarms, | ||
| alerts, air detector mechanism, and blood leak | ||
| detectors. | ✓ | ✓ |
Table 3 - Technological Characteristics of the SC+ Machine and Predicate
Differences between the subject device and the predicate device:
- The subject device has a broader range of user settable treatment settings and ● Essential Performance characteristics:
- Dialysate conductivity range o
- Dialysate flow rate O
- Treatment time range o
- Ultrafiltration rate O
- Ultrafiltration volume O
- Settable dialysate composition (via acid and sodium target) O
- The subject device has additional features: ●
- o Isolated Ultrafiltration
- Blood leak override O
7
Image /page/7/Picture/1 description: The image shows the document number "K222067" and the page number "Page 5 of 6" at the top. Below that is the logo for "QUANTA" in a stylized font. The logo is in two colors, a dark blue and a teal color.
5.7.2 Changed SC+ Blood Tube Set vs SC+ device as cleared in K210661
The technological characteristics of the SC+ Machine and SC+ Dialysate Cartridge are equivalent to the predicate device, SC+ device and dialysate cartridge (K210661). A summary of the similarities and differences is provided in the table below.
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| This submission | SC+ (K210661) | |
| Intended Use: To provide extracorporeal | ||
| access during hemodialysis | ✓ | ✓ |
| Materials: Primary fluid path materials are | ||
| Polyvinyl Chloride (PVC) and Polypropylene | ||
| (PP). | ✓ | ✓ |
| Design & Construction: Polyvinyl Chloride | ||
| (PVC) tubing of various lengths and diameters, | ||
| with color coded pinch clamps, color coded | ||
| injection ports, heparin line, saline line, and | ||
| pressure monitoring components. | ✓ | ✓ |
| Sterility: Sterile, single use, non-pyrogenic. | ✓ | ✓ |
| Priming Volume: ≤165ml | ✓ | ✓ |
| Needle configuration: Double needle | ✓ | ✓ |
Table 4 - Technological Characteristics of the SC+ Machine and Predicate
5.8 Summary of V&V
The following performance testing, developed in accordance with appropriate FDA guidance documents and relevant standards, has been performed on the Modified Device to support the determination of substantial equivalence:
- Essential Performance testing for dialysate composition ●
- Essential Performance testing for dialysate flow rate
- Essential Performance testing for Blood Flow Rate ●
- Essential Performance testing for Net Fluid Removal ●
- Essential Performance testing for Treatment Time ●
- Essential Performance testing for Consumables duration testing ●
- Blood Loss to Dialysate protective system testing ●
- Net Fluid Removal Protective system testing ●
- Patient Leakage Current testing ●
- Hemolysis testing ●
- Software verification ●
8
Image /page/8/Picture/1 description: The image shows the text "K222067 Page 6 of 6" at the top. Below that is the word "QUANTA" in a stylized font. The letters are a combination of dark blue and teal colors. There is a trademark symbol to the right of the letter A.
5.9 Conclusion
This 510(k) has demonstrated the SC+ Hemodialysis System as modified provides reasonable assurance of safety and effectiveness to demonstrate it is at least as safe and effective as the predicate device and therefore is substantially equivalent.