SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

K222067 · Quanta Dialysis Technologies, Ltd. · KDI · Nov 10, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K222067
• Device Name: SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
• Applicant: Quanta Dialysis Technologies, Ltd.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Nov 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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). 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.

Device Story

SC+ Hemodialysis System provides acute/chronic dialysis therapy. Inputs: dialysis water (from external RO), dialysis concentrate, patient blood via AV fistula or central venous catheter. Operation: machine heats/deaerates water; dialysate cartridge performs mixing/proportioning via membrane pumps; peristaltic pump drives blood flow. System monitors conductivity, pressure, temperature, blood leak, and air-in-blood. Output: treated blood returned to patient; controlled fluid removal. Used in acute/chronic care facilities by trained operators. Healthcare providers use GUI to set treatment parameters (conductivity, flow rates, ultrafiltration, time). Benefits: flexible treatment modalities (IHD, SLED, PIRRT, SCUF, CVVHD) for renal failure management.

Clinical Evidence

Bench testing only. Performance testing included essential performance verification for dialysate composition, dialysate/blood flow rates, net fluid removal, treatment time, and consumables duration. Safety testing included blood loss to dialysate protective system, net fluid removal protective system, patient leakage current, hemolysis testing, and software verification.

Technological Characteristics

Materials: PVC and PP (blood tubing). Sensing: conductivity, pressure, temperature, blood leak, air-in-blood. Energy: electrical (machine), pneumatic (cartridge interface). Connectivity: standalone system using external RO water. Software: GUI-controlled, algorithm-based. Sterilization: sterile, single-use consumables. Form factor: hemodialysis delivery system with disposable cartridge and bloodline set.

Indications for Use

Indicated for patients with acute and/or chronic renal failure requiring hemodialysis or ultrafiltration in acute or chronic care facilities. Administered by trained personnel under physician prescription.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• SC+ Machine & Dialysate Cartridge (K210661)

Reference Devices

• Prismaflex M150 set (K080519)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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)

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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 [phone] [e-mail]

Mr. Sam Drew [phone] [e-mail]

# 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<br>Technologies Ltd | SC+ Machine & Dialysate<br>Cartridge | K210661 | 2021-08-12 |

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#### 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-<br>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<br>Technologies Ltd | SC+ Machine & Dialysate<br>Cartridge | K210661 | 2021-08-12 |

### Reference Device Information:

| Manufacturer | Name of Predicate Device | 510(k)# | Date of Clearance |
|-------------------------------|--------------------------|---------|-------------------|
| Gambro Renal<br>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.

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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).

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#### 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<br>chronic renal failure, with or without ultrafiltration<br>in an acute or chronic care facility | ✓ | ✓ |
| Use of purified water for dialysate production | ✓ | ✓ |
| Use of third-party accessories, including<br>dialyzers, endotoxin retentive filters, acid and<br>bicarbonate | ✓ | ✓ |
| Application of consensus standards | ✓ | ✓ |
| Device is software controlled and utilize Graphic<br>User Interface (GUI). | ✓ | ✓ |
| Design and Construction - Blood pump, alarms,<br>alerts, air detector mechanism, and blood leak<br>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

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#### 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<br>access during hemodialysis | ✓ | ✓ |
| Materials: Primary fluid path materials are<br>Polyvinyl Chloride (PVC) and Polypropylene<br>(PP). | ✓ | ✓ |
| Design & Construction: Polyvinyl Chloride<br>(PVC) tubing of various lengths and diameters,<br>with color coded pinch clamps, color coded<br>injection ports, heparin line, saline line, and<br>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 ●

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## 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.