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 clinician who is competent in the use of the device. The SC+ Hemodialysis System is also indicated for use in the home by trained patients in tandem with a trained care partner.

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 Tubeset is compatible only with the SC+ Hemodialysis System.

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℃ 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.

AI/ML Overview

The provided text is a 510(k) summary for the Quanta Dialysis Technologies SC+ Hemodialysis Device, Dialysate Cartridge, and Blood Tube Set. The core of this submission is to expand the indications for use of the SC+ Hemodialysis System to include home use.

This document does not include information about AI/ML device performance, interpretation by human readers, or specific quantitative acceptance criteria for features like accuracy, sensitivity, or specificity. Instead, it describes acceptance criteria related to safety and effectiveness for a medical device in a new use environment (home healthcare) and for new user groups (patients and caregivers).

Therefore, a table of acceptance criteria and reported device performance (in the context of AI metrics) cannot be extracted directly from this document. Similarly, details on sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable to the information provided.

However, I can extract the information related to the clinical study supporting the new indication for use, which serves as the "study that proves the device meets the acceptance criteria" in the context of this device.

Here's a breakdown of the relevant information from the document:

Study That Proves the Device Meets the Acceptance Criteria:

The study conducted to support the expansion of indications to home use was the HOME RUN clinical trial (G200362).

Type of Ground Truth Used: Clinical outcomes data (mean standardized weekly Kt/V for effectiveness, and rate of AEs for safety).
Sample Size Used for the Test Set (Clinical Study):
- Evaluable Population: n = 32 subjects. This included all subjects who were enrolled in the study and successfully completed at least 75% of their dialysis treatments.
Data Provenance:
- Country of Origin: Multi-center study in the US (13 sites).
- Retrospective or Prospective: Prospective.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts: Not applicable in the context of "ground truth" for an AI model. However, an Independent Safety and Clinical Ethics Committee (SCEC) was created to oversee trial safety.
- Qualifications of Experts: Comprised nephrologists with experience of hemodialysis, one of whom had significant experience in home hemodialysis.
Adjudication Method for the Test Set: The SCEC was blinded to whether AEs occurred in the in-clinic or in-home phase and had the authority to recommend changes to the trial. Details on specific adjudication rules for AEs (e.g., 2+1, 3+1) are not provided, but the SCEC served an oversight and review role.
If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device in the context of diagnostic interpretation. The study compared device performance (safety and effectiveness) in two settings (in-clinic vs. in-home).
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, and its performance is the "algorithm" in action (the hemodialysis process). The study evaluated its use by human users (patients/caregivers/clinicians).
The Sample Size for the Training Set: Not applicable. This document describes a clinical trial for device efficacy and safety, not an AI model requiring a training set.
How the Ground Truth for the Training Set was Established: Not applicable.

Acceptance Criteria and Reported Device Performance (as related to the clinical study):

The acceptance criteria for the expanded indication were based on demonstrating comparable safety and effectiveness in the home setting as in the clinic, considering the new use environment and user groups.

Acceptance Criteria (Implicit from Study Goals)	Reported Device Performance (HOME RUN Study)
Effectiveness: Mean standardized weekly Kt/V to be consistently above a target (implied from typical hemodialysis standards).	The primary effectiveness endpoint was the mean standardized weekly Kt/V. Result: The mean weekly standardized Kt/V was consistently above the target of 2.1 during all weeks of the in-clinic phase (≥2.3 in all phases C1-C8) and all weeks of the in-home phase (≥2.8 in all phases H1-H8).
Safety: Rate of AEs and prespecified AEs per 100 treatments to be not worse in the in-home phase compared to the clinic phase (upper bound of 95% CI of difference in AE rate below an acceptable threshold, e.g., 10%).	The primary safety endpoints were the rate of AEs and prespecified AEs per 100 treatments. Result: The study was deemed successful as the AE rate per 100 treatments was not worse in the in-home phase compared to in the clinic. The AE rate per 100 treatments was low and acceptable as the upper bound of the 95% CI of the difference in the least squares mean AE rate was below 10%, at 2.73%. One death was reported, which occurred during the clinical period and was ruled unrelated to the device or procedure (COVID-19). The SCEC concluded that no serious harm AEs related to use error were identified.
Human Factors/Usability: Safe and effective use by lay users (patients and caregivers) without critical errors.	A Human Factors Validation Study was conducted on lay users in a simulated home environment. Result: The results demonstrated that participants are able to safely and effectively use the SC+ Machine without making critical errors that could lead to a hazard.
Physical/Mechanical Robustness: Device can withstand different physical and mechanical forces in the home environment.	Shock and vibration testing, with subsequent Essential Performance and Basic Safety testing, was performed. Result: A summary of the bench testing was provided (details not explicitly given in this summary, but indicated as part of the V&V).

In summary, this FDA clearance document primarily focuses on the clinical validation and human factors validation required to expand the intended use of a hemodialysis device to a home setting, rather than AI/ML performance metrics. The "acceptance criteria" here relate to demonstrating equivalent safety and effectiveness in the new use environment.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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 1, 2024

Quanta Dialysis Technologies, Ltd. Chris Rule Director of Quality and Regulatory Affairs The Woods. Havwood Road Warwick, Warwick CV34 5AH United Kingdom

Re: K242269

Trade/Device Name: SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: October 3, 2024 Received: October 4, 2024

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 (the 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 available 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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Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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, Maura Rooney -S

Maura Rooney 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

Submission Number (if known)

K242269

Device Name

SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)

Indications for Use (Describe)

SC+ Hemodialysis Device/ Dialysate Cartridge:

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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Quanta Dialysis Technologies SC+ Hemodialysis Premarket Notification – Traditional 510(k) K242269

510(k) Summary 1

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

Date prepared: October 28th, 2024

Manufacturer Details

Quanta Dialysis Technologies Ltd The Woods, Haywood Road, Warwick, Warwickshire, CV34 5AH, United Kingdom

Contact Details

Mr. Sam Drew +44 (0)1789 336 752 sam.drew@quantadt.com

Mr. Chris Rule +44 (0)1789 336 752 chris.rule@quantadt.com

Device Information

1.3.1 SC+ Machine & Dialysate Cartridge

Trade Name	SC+ Hemodialysis Device (SC-14269); DialysateCartridge (SC-14656); Blood Tube Set (SC-14651)
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

Table 1: SC+ Device and Dialysate Cartridge general device information

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Predicate Device Information:

Manufacturer	Name of Predicate Device	510(k)#	Date of Clearance
Quanta DialysisTechnologies Ltd	SC+ Machine & DialysateCartridge	K210661	2021-08-12

1.3.2 SC+ Blood Tube Set

Trade Name	SC+ Blood Tubeset (SC-14651)
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 DialysisTechnologies Ltd	SC+ Machine & DialysateCartridge	K210661	2021-08-12

Device Description

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

1.4.1 SC+ Hemodialysis System

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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Device Modification

The differences contained within this submission regard the addition of home use to the SC+ Hemodialysis System's indications for use. The addition of home use to the indications expands both the locations and facilities in which treatment can be delivered (to encompass the home environment) and the potential users who can use the device (to include patients and caregivers).

Indications for Use

SC+ Haemodialysis Machine & Dialysate Cartridge 1.6.1

1.6.2 SC+ Blood Tubeset

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Technological Characteristics

1.7.1 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 Cartridge (K210661). A summary of the similarities and differences is provided in the table below.

Characteristic	Subject DeviceThis submission	Predicate DeviceSC+ (K210661)
The SC+ Hemodialysis System is also indicatedfor use in the home by trained patients intandem with a trained care partner.	✓	X
Use of purified water for dialysate production	✓	✓
Use of third-party accessories, includingdialyzers, endotoxin retentive filters, acid andbicarbonate	✓	✓
Application of consensus standards	✓	✓
Device is software controlled and utilize GraphicUser Interface (GUI).	✓	✓
Design and Construction – Blood pump, alarms,alerts, air detector mechanism, and blood leakdetectors.	✓	✓
Disinfection Method Heat: 80°C (Max)	✓	✓
Dialysate Temperature: Default Value 36.5 °C,Range: 35.0 - 37.5 °C	✓	✓
Dialysate Composition Control: 13.7mS/cm(low), 14.1mS/cm (high)	✓	✓
Dialysate Composition Protective System:12mS/cm -16mS/cm	✓	✓
Dialysate Composition control: Conductivity	✓	✓
Bicarbonate Proportioning Default: 35 mEq/L(fixed), Minimum: 24 mEq/ L, Maximum: 40mEq/ L	✓	✓
Blood flow rate Range: 50-450ml/min selectable	✓	✓
Accuracy: +/- 10%	✓	✓
Dialysate flow rate: Low Dialysis Fluid Flow =300 mL/min ± 10%, High Dialysis Fluid Flow =500 mL/min ± 10%	✓	✓
Ultrafiltration Range: 50 to 1000g/hr	✓	✓
Ultrafiltration mode: With dialysis fluid flow only	✓	✓
UF Accuracy: ± 400g/treatment. ± 100g/hr	✓	✓

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Fluid Removal Volume: Minimum 0g, Maximum4000g, Interval 10g	✓	✓
Venous Pressure Monitor: Minimum -100mmHg,Maximum 600mmHg, Interval 10 mmHg,Accuracy ± 20mmHg	✓	✓

Table 3 - Technological Characteristics of the SC+ Machine and Predicate

Pre-clinical and clinical data demonstrates that changed risk profile associated with the new use environment and user groups is acceptable with regards to safe and effective use.

The use of the device and the fundamental scientific concepts and technologies have not changed and the device performance remains identical to the predicate.

1.7.2 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 DeviceThis submission	Predicate DeviceSC+ (K210661)
Intended Use: To provide extracorporealaccess during hemodialysis	✓	✓
Indications: For use in the home environment	✓	×
Materials: Primary fluid path materials arePolyvinyl Chloride (PVC) and Polypropylene(PP).	✓	✓
Design & Construction: Polyvinyl Chloride(PVC) tubing of various lengths and diameters,with color coded pinch clamps, color codedinjection ports, heparin line, saline line, andpressure 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

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Summary of V&V

The addition of the Home Healthcare Environment prompts modifications to the testing for this type of device relative to the previously cleared product as identified in ANSI AAMI HA60601-1-11:2015, specifically that different physical and mechanical forces will be experienced within the home environment, due to the nature of the use environment.

Shock and vibration testing, with subsequent Essential performance and Basic Safety testing. A summary of the bench testing has been provided.

The addition of the Home Healthcare Environment also prompted a Human Factors Validation Study being conducted on lay users (patients and caregivers) in a simulated home environment. The following standards /FDA guidances were consulted in the study design: FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (2016), IEC 62366-1:2015 (Application of Usability Engineering to Medical Devices), and IEC 62366-2:2016 (Guidance on the application of usability engineering to medical devices). The Human Factors Engineering documents have been provided.

Quanta has demonstrated the SC+ Machine is appropriate for its intended use through the use of hazard analysis in accordance with ISO 14971. Verification and validation of the user interface was completed through a series of simulated use Formative Studies and a comprehensive Human Factors Validation Study. In the Validation study, the participants were either trained or completed self-training and the results demonstrated that participants are able to safely and effectively use the SC+ Machine without making critical errors that could lead to a hazard. Therefore, SC+ Machine meets its intended use and is safe for the intended user population.

Quanta also performed original Pivotal Study and Actual Use Human Factors Study (HOME RUN, G200362) for the SC+ Hemodialysis System (SC+ Machine) to support the expansion of indication to Home-use. The safety and effectiveness of use of the SC+ Machine was evaluated to determine safety and effectiveness when Quanta SC+ is used in the self-care home environment compared to a hemodialysis facility.

The HOME RUN clinical trial was a prospective, multi-center (13 sites in US), open-label assessment of efficacy of and safety of SC+ Machine for Home Hemodialysis. Safety and effectiveness were assessed on the evaluable population (n = 32), which included all subjects who were enrolled in the study and successfully completed at least 75% of their dialysis treatments.

The primary effectiveness endpoint of this study was the mean standardized weekly Kt/V measured for dialysis delivered during the in-clinic and in-home stages of the study. The study demonstrated that the mean weekly standardized Kt/V was consistently above the target of 2.1 during all weeks of the in-clinic phase (≥2.3 in all phases C1-C8) and all weeks of the in-home phase (≥2.8 in all phases H1-H8).

The primary safety endpoints of this clinical investigation were the rate of AEs and prespecified AEs per 100 treatments. The study was deemed successful as the AE rate per

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100 treatments was not worse in the in-home phase compared to in the clinic. The AE rate per 100 treatments was low and acceptable as the upper bound of the 95% Cl of the difference in the least squares mean AE rate was below 10%, at 2.73%. One death was reported that occurred during the clinical period and was unrelated to the device or procedure (i.e., infections and infestations: COVID-19).

An independent safety and clinical ethics committee (SCEC) was created, chartered and maintained whilst any AEs were reported or subjects were receiving study treatment to oversee trial safety, as per the study protocol. The SCEC comprised nephrologists with experience of hemodialysis, one of which had significant experience in home hemodialysis. The SCEC were blinded to whether AEs occurred in the in-clinic or in-home phase. The committee also had the authority to recommend that the trial continue with no changes, continue with changes to the protocol, or be suspended. For this study, the SCEC concluded that no serious harm AEs related to use error were identified and no recommendations were made that would indicate that the use of the Quanta SC+ hemodialysis system is a problem.

Results of the HOME RUN Study demonstrate SC+ Machine safely and effectively delivers treatment to subjects in both an in-clinic and in-home setting. There is no additional risks or safety concerns when using this device in a home setting with a care partner providing device competency has been achieved.

In summary, the clinical data provided in this submission support expansion of the general system indications to include specific indications for home-use. The data included in this submission demonstrate substantial equivalence to the predicate device listed above.

The nonclinical and clinical testing supplied as part of this submission demonstrate that the change in indications to include home healthcare environments is substantially equivalent with regards to safety and effectiveness when compared to the predicate devices.

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.

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.”