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.

SC+ Blood Tube Set:

The SC+ Blood Tubeset is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System

Device Description

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.

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 37oC and subsequently de-aerated 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA, outlining the substantial equivalence determination for the Quanta SC+ Hemodialysis System. It does not contain the type of acceptance criteria and study data typical for an AI/ML medical device submission, which would include metrics like sensitivity, specificity, AUC, and details on ground truth establishment and expert adjudication.

Therefore, I cannot extract the information required by your prompt regarding acceptance criteria and a study that proves the device meets them, specifically for an AI/ML component. The information provided heavily focuses on the comparison of a hemodialysis machine and its components to predicate devices based on technological characteristics and general performance testing (e.g., dialysate quality, electrical safety, biocompatibility, sterilization, human factors).

To directly address your prompt, using only the provided text, I must state that the document does not contain the requested information about an AI/ML enabled device's acceptance criteria and study as described. It's a regulatory clearance for a traditional medical device, not an AI/ML diagnostic or prognostic tool.

Summary

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December 23, 2020

Quanta Dialysis Technologies Ltd. Chris Rule, Regulatory Manager Tything Road Alcester, Warwickshire B49 6EU UNITED KINGDOM

Re: K193670

Trade/Device Name: SC+ Hemodialysis System, comprised of the SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, and SC+ Blood Tubeset Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI, FJK Dated: November 20, 2020 Received: November 23, 2020

Dear Chris Rule:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193670

Device Name

SC+ Hemodialysis System, comprised of the SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, and SC+ Blood Tubeset

Indications for Use (Describe)

SC+ Machine and SC+ Dialysate Cartridge:

SC+ Blood Tube Set:

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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б 510(K) SUMMARY

The content of this traditional 510(k) summary is provided in conformance with 21 CFR Part 807.92.

6.1 Submitter's Information

Submitter's Name:	Quanta Dialysis Technologies Ltd
Company:Address:	Tything Road, Alcester, Warwickshire, B49 6EU,United Kingdom
Contact person:	Mr. Chris Rule
Phone:	+44 (0)1789 400 043
E-mail:	chris.rule@quantadt.com
Date of summary preparation	22nd December 2019

6.2 Device Name

SC+ Hemodialysis System, comprised of the SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, and SC+ Blood Tubeset

6.2.1 SC+ Machine & Dialysate Cartridge

6.2.1.1 General Device Information

Trade Name	SC+ Machine & SC+ Dialysate Cartridge
Common Name	Hemodialysis Delivery System
Product Code	KDI
Device	Dialyzer, High Permeability With Or WithoutSealed Dialysate System
Classification Name	High permeability hemodialysis system
Regulation Number	21 CFR §876.5860
Device Class	Class II
Review Panel	Gastroenterology/Urology

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6.2.2.1 Predicate Device Information

Trade Name	Tablo Console
Common Name	Hemodialysis Delivery System
510(k) Clearance Number	K140866
Product Code	KDI
Device	Dialyzer, High PermeabilityWithOrWithout Sealed Dialysate System
Regulation Number	21 CFR §876.5860
Classification Name	High permeability hemodialysis system
Device Class	Class II
Review Panel	Gastroenterology/Urology

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6.2.3 SC+ Blood Tubeset

General Device Information 6.2.3.1

Trade Name	SC+ Blood Tubeset
Common Name	Blood Tubing Set
Product Code	FJK
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

6.2.3.2 Predicate Device Information

Trade Name	Tablo Cartridge
Common Name	Blood Tubing Set
510(k) Clearance Number	K140841
Product Code	FJK
Device	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Regulation Number	21 CFR §876.5820
Classification Name	Hemodialysis system and accessories
Device Class	Class II
Review Panel	Gastroenterology/Urology

6.2.3.3 Reference Device Information

Trade Name	NIPROBLOOD TUBING SET WITHTRANSDUCER PROTECTOR AND PRIMINGSET, MODEL A201-A219, V801-V806,5M9634, 5M9693
Common Name	Blood Tubing Set

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510(k) Clearance Number	K072024
Product Code	FJK
Device	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Regulation Number	21 CFR §876.5820
Classification Name	Set, Tubing, Blood, with and without Anti-regurgitation valve
Device Class	Class II
Review Panel	Gasteroenterology/Urology

Device Description 6.3

6.3.1 SC+ Hemodialysis System

The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.

6.4 Indications for Use

6.4.1 SC+ Hemodialysis 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

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facility. Treatments must be administered under physician's prescription, by a trained person who is considered competent in the use of the device.

6.4.2 SC+ Blood Tubeset

Technological Characteristics 6.5

The SC+ Hemodialysis machine and Dialysate Cartridge are predicated against the Outset Tablo Console (K140866).

The SC+ Blood Tubeset is predicated against the Outset Tablo Cartridge (K140841). For mechanical hemolysis testing, the reference devices used for comparison was the Nipro tubing set (K072024).

6.5.1 SC+ Machine vs Tablo console (K140866)

The technological characteristics of the SC+ Machine and SC+ Dialysate Cartridge are considered to be equivalent to the predicate device, the Tablo Console (K140866). A summary of the similarities and differences is provided in the table below.

	SubjectDevice	PredicateDevice
	SC+	Tablo Console
Indicated for use in patients with acuteand/or chronic renal failure, with orwithout ultrafiltration in an acute orchronic care facility	✓	✓
Use of purified water for dialysateproduction	✓	✓
Use of third-party accessories,including dialyzers, endotoxin retentivefilters, acid and bicarbonate	✓	✓
Application of consensus standards	✓	✓

Technological Characteristics of the SC+ Machine

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Device is software controlled and utilizeGraphic User Interface (GUI).	✓	✓
Design and Construction – Blood pump,alarms, alerts, air detector mechanism,and blood leak detectors.	✓	✓

Differences between the subject device and the predicate device include:

. The subject device utilizes purified water from an external source, for dialysate production, whereas the predicate device internally purifies the water.
. The subject device incorporates a validated heat disinfection process to clean the water circuit as opposed to a chemical disinfection process utilized by the predicate device.
The dialysate cartridge pump differs to that of the predicate device. ● The SC+ Machine uses positive displacement pumps contained within the disposable Dialysate Cartridge, which use a combination of the reciprocating action of a membrane diaphragm between two hard surfaces and suitable valves to mix Dialysate Water with concentrates to generate dialysis fluid and to pump dialysis fluid to and from the dialyzer.
In order to allow for the use of the Dialysate Cartridge with a compliant membrane and to allow for a higher dialysate flow rate, the flow balance control mechanism in the SC+ differs to that of the predicate device. The control and accuracy of the flow balance process has been fully validated to meet the requirements defined in IEC 60601-2-:16:2012.
The SC+ Machine calculates the net fluid removal rate from the . required mass for removal and the desired treatment time up to a maximum as stated in IEC 60601-2-16:2012. The accuracy of net fluid removal rate is independent of the dialysate flow rate. Although this is different from the predicate device, the SC+ System has undergone extensive Net Fluid Removal testing and conforms to the same standards as the predicate device.

In summary, the SC+ machine has the same intended use and is considered equivalent with regards to the technological characteristics as the predicate. The SC+ system has been fully validated and, therefore, where there are minor differences, the differences do not raise any new questions with regards to safety or effectiveness.

6.5.2 SC+ Blood Tubeset vs Tablo Cartridge (K140841)

The SC+ Blood Tubeset is predicated against the Outset Tablo Cartridge (K140841).

Technological Characteristics of the SC+ Blood Tubeset

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	SubjectDevice	PredicateDevice
	SC+	TabloCartridge
Intended Use: To provide extracorporealaccess during hemodialysis	✓	✓
Materials: Primary fluid path materials arePolyvinyl Chloride (PVC) and Polypropylene(PP).	✓	✓
Design & Construction: Polyvinyl Chloride(PVC) tubing of various lengths anddiameters, with color coded pinch clamps,color coded injection ports, heparin line,saline line, and pressure monitoringcomponents.	✓	✓
Sterility: Sterile, single use, non-pyrogenic.	✓	✓
Priming Volume:	≤165ml	≤200 mL
Needle configuration: Double needle	✓	✓

The SC+ Blood Tubeset is considered to have equivalent technological characteristics to the predicate device. The minor differences between the devices include:

. Subject Device is mounted directly onto the blood platen of the SC+ Machine. The predicate has an organizer to facilitate interface with the machine's front panel.
The pressure measuring component of the SC+ Blood Tubeset is ● different from that of the Predicate as it has been designed specifically to fit the SC+ Machine. The SC+ Blood Tubeset has been validated as part of the system and there is no impact on safety or performance.
The maximum prime volume in the SC+ Blood Tubeset is less than . that of the Predicate. This has no impact on performance and reduces the total amount of blood loss in the event the circuit needs to be discarded without returning blood back to the patient.

Comparison to the reference device demonstrated that the SC+ Blood tube set had lower hemolysis values.

None of these differences raise questions with regards to safety or effectiveness.

6.6 Performance Data

Extensive design verification and validation activities have been performed on the SC+ System. Performance testing, developed in accordance with appropriate FDA quidance documents and relevant standards, has been

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performed on the SC+ System to support the determination of substantial equivalence, testing has included:

Performance testing for dialysate quality, essential performance testing, ● and all the key functions/design features/components.
. Testing to confirm compliance with electrical and electromagnetic safety standards and performance of alarms and alerts.
Performance testing for software and the touchscreen. .
Biocompatibility testing. .
Packaging and shelf life testing. ●
Sterilization validation including pyrogenicity testing for the blood fluid path.
. Human factors testing.

Conclusion 6.7

The Performance Testing demonstrates that the SC+ Hemodialysis System (including the SC+ Blood Tubeset) meets all performance specifications and complies with applicable standards and FDA Guidance Documents. The SC+ Hemodialysis System is considered to be substantially equivalent to the predicate devices and the minor differences in the technological characteristics of the SC+ System and the predicate devices do not raise any new or different questions of safety or effectiveness.

Regulation Number and Section

§ 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.”