HemoCare Hemodialysis System

K233557 · Deka Research and Development · KDI · Jul 12, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K233557
• Device Name: HemoCare Hemodialysis System
• Applicant: Deka Research and Development
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jul 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HemoCare® Hemodialysis System is indicated for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare Hemodialysis System is indicated for use in chronic dialysis facilities, self-care dialysis facilities, and the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed with the assistance or observation of an individual who has been trained and is considered competent in the use of the device. The HemoCare Hemodialysis System is not indicated for solo hemodialysis in the home setting.

Device Story

Self-contained, software-controlled hemodialysis system for renal failure patients. Comprises Treatment Device, Water Device (vapor compression distillation), and Blood Treatment Set. Inputs: EPA drinking water, liquid acid/powder bicarbonate concentrates. Transforms inputs into infusion-grade dialysate; manages extracorporeal blood flow via diaphragm pumps. Used in clinics or home settings by trained operators/observers. Features 2-way cloud communication for patient registration, prescription delivery, and status monitoring. Provides alarms, air detection, blood pressure/leak monitoring, and access disconnect sensing. Output: Hemodialysis therapy; clinical data for provider review. Benefits: Enables flexible treatment schedules (short daily/nocturnal) in non-clinical settings while maintaining safety standards.

Clinical Evidence

Prospective, multi-center, open-label, cross-over study evaluating safety and efficacy during home use without trained medical professional assistance. Primary endpoints for safety and efficacy were met.

Technological Characteristics

System includes Treatment Device, Water Device (vapor compression distillation), and Blood Treatment Set (up to 16 uses). Materials comply with ISO 10993-1. Connectivity: 2-way cloud communication. Safety: Alarms, air/leak detection, BP monitoring, access disconnect sensing. Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-11, 60601-2-16, AIM 7351731. Software: IEC 62304 compliant.

Indications for Use

Indicated for hemodialysis treatment (short daily and nocturnal) in renal failure patients. For use in chronic dialysis facilities, self-care facilities, and home settings. Requires physician prescription and trained operator/observer. Not indicated for solo home hemodialysis.

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

• Aksys PHD (K010131)
• Nephros HDF Assist Module (K210575)
• NxStage System One (K141752)
• Outset Tablo (K211370)

Submission Summary (Full Text)

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July 12, 2024

Deka Research and Development Paul Smolenski Regulatory Affairs 340 Commercial Street Manchester, NH 03101

Re: K233557

> Trade/Device Name: HemoCare® Hemodialysis System Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI, FIP, FJK Dated: June 12, 2024 Received: June 13, 2024

Dear Paul Smolenski:

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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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.

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

K233557

Device Name

HemoCare® Hemodialysis System

#### Indications for Use (Describe)

The HemoCare® Hemodialysis System is indicated for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare Hemodialysis System is indicated for use in chronic dialysis facilities, self-care dialysis facilities, and the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed with the assistance or observation of an individual who has been trained and is considered competent in the use of the device. The HemoCare Hemodialysis System is not indicated for solo hemodialysis in the home setting.

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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Image /page/4/Picture/1 description: The image shows the logo for DEKA Research & Development Corp. The logo is in black and features the word "DEKA" in a bold, stylized font. The "A" in DEKA is designed with an arrow pointing to the left. Below the logo, the full name of the company, "DEKA Research & Development Corp.", is written in a smaller, simpler font.

# 510(k) Summary

This 510(k) Summary of Safety and Effectiveness information is prepared in accordance with the requirements of 21 CFR Part 807.92.

| 1 | Submitter | |
|---|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Name: | DEKA Research and Development, Corp.<br>340 Commercial Street<br>Manchester, NH 03101<br>USA |
| | Primary Contact: | Paul Smolenski<br>Regulatory Affairs<br>DEKA Research & Development Corporation<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| | Alternate Contact: | William Calhoun<br>Regulatory Affairs<br>DEKA Research & Development Corporation<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| | Date Prepared: | June 6, 2024 |
| 2 | Device<br>Trade Name:<br>Common Name:<br>Classification Regulation: | HemoCare® Hemodialysis System<br>Hemodialysis delivery system<br>21 CFR § 876.5860 - High Permeability Hemodialysis<br>System<br>21 CFR § 876.5665 - Water Purification System for<br>Hemodialysis<br>21 CFR § 876.5820 - Hemodialysis System and<br>Accessories |

KDI, FIP, FJK Regulatory Class: Class II

510(k) Summary

Product Codes:

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#### Predicate Device 3

Predicate Device comparisons were made to the following four devices:

- Aksys PHD (K010131, cleared on March 26, 2002) is indicated for the same therapy, the . same user population and in the same use environments. The Aksys PHD establishes predicate features, including dialysate proportioning (self-priming and delivery), online replacement fluid generation for bolus delivery, blood flow control, ultrafiltration, reusable blood treatment set, and automatic post-treatment device disinfection.
- Nephros HDF Assist Module (K210575, cleared May 13, 2022) provides a predicate . device that performs online generation of substitution fluid from commercially available (510(k) cleared) chemical concentrates.
- NxStage System One (K141752, cleared 12/19/2014) provides a predicate device that has ● the same home, nocturnal hemodialysis indication.
- Outset Tablo (K211370, cleared July 29, 2022) provides a predicate device since it features integrated water purification, and two-way wireless data transfer with its cloud, like the HemoCare Hemodialysis System.

#### Device Description ব

The HemoCare® Hemodialysis System is a self-contained, software-controlled device that provides hemodialysis treatments, including short daily and nocturnal hemodialysis, for patients with renal failure. The device is intended for use by a single patient in chronic dialysis facilities, self-care dialysis facilities, and the home setting. The HemoCare® Hemodialysis System is composed of the following components:

- . The HemoCare® Treatment Device is a hemodialysis delivery system. When provided a source of water for dialysis, it produces infusion grade dialysate using liquid acid and powder bicarbonate concentrates. The Treatment Device provides secure, 2-way communication with the cloud for transmitting patient registration, physician-prescribed dialysis treatments, patient monitoring, and device status information.
- The HemoCare® Water Device is a water purification system that produces water for ● dialysis through distillation of EPA drinking water. The Water Device interfaces with the Treatment Device.
- The Blood Treatment Set connects to the patient access site and interfaces with the Treatment Device to provide extracorporeal blood flow through a dialyzer for dialysis treatment. The Blood Treatment Set is terminally sterilized and includes displacement blood pumps, a heparin delivery system, and an access disconnect sensor. The Blood Treatment set can be used for up to 16 treatments.

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The following accessories are for use with the HemoCare® System:

- Centrisol Acid Concentrate (45x)
- Optiflux® F200 NR Dialyzer
- HemoCare Bicarbonate Concentrate Set ●

Conventional dialysis treatment supplies are also needed to perform dialysis treatments (e.g. gloves, alcohol swabs, chlorine test strips, access needles, scale, blood pressure cuff, etc.)

#### 5 Indications for Use

The HemoCare® Hemodialysis System is indicated for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare® Hemodialysis System is indicated for use in chronic dialysis facilities, self-care dialysis facilities, and the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed with the assistance or observation of an individual who has been trained and is considered competent in the use of the HemoCare® Hemodialysis System is not indicated for solo hemodialysis in the home setting.

#### Substantial Equivalence Discussion 6

#### Comparison of Intended Use and Indications for Use 6.1

| | Subject Device<br>(HemoCare® Hemodialysis System) | Predicate Device<br>(Aksys PHD, K210575) | NxStage System One (K141752) | Comparison |
|---------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Intended to deliver<br>high permeability<br>hemodialysis<br>therapy to patients<br>with renal failure | Intended to deliver<br>high permeability<br>hemodialysis<br>therapy to patients<br>with renal failure | Intended to deliver<br>high permeability<br>hemodialysis<br>therapy to patients<br>with renal failure | Same |
| Prescription Use | Yes | Yes | Yes | Same |
| Intended Population | Renal failure<br>patients | Renal failure<br>patients | Renal failure<br>patients | Same |
| Use Environment | Clinical care<br>facilities and home<br>use | Clinical care<br>facilities and home<br>use | Clinical care<br>facilities and home<br>use | Same |
| Operator Training | Operator training<br>required | Operator training<br>required | Operator training<br>required | Same |

Table 1. Comparison of Intended Use and Indications for Use

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| | Subject Device<br>(HemoCare®<br>Hemodialysis<br>System) | Predicate Device<br>(Aksys PHD,<br>K210575) | NxStage System<br>One (K141752) | Comparison |
|---------------|---------------------------------------------------------|---------------------------------------------|---------------------------------|-------------------------------------------------------------------------------------------------------|
| Nocturnal Use | Yes | No | Yes | The NxStage<br>System One<br>Predicate Device<br>is indicated for<br>home, nocturnal<br>hemodialysis. |

## 6.2 Comparison of Technical Characteristics

A summary of the technological similarities and differences between the Subject and Predicate Devices is provided in the following tables.

Table 2. SE Comparison with Aksys PHD

| | Subject Device (HemoCare®<br>Hemodialysis System) | Predicate Device (Aksys<br>PHD, K210575) | Comparison |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Codes | KDI | KDI | Same |
| Dialysis Delivery<br>System | Conventional, high<br>permeability dialysis with or<br>without ultrafiltration | Conventional, high<br>permeability dialysis with or<br>without ultrafiltration | Same |
| User Interface | Digital Touchscreen | Digital Touchscreen | Same |
| Software controlled | Yes | Yes | Same |
| Dialysate production | Yes, proportioning of standard<br>acid and bicarbonate chemical<br>concentrates (45x) and purified<br>water | Yes, proportioning of standard<br>acid and bicarbonate chemical<br>concentrates (45x) and purified<br>water | Same |
| Substitution fluid | Online prepared infusion<br>quality dialysate used for<br>priming extracorporeal circuit,<br>bolus infusions, and rinseback | Online prepared infusion<br>quality dialysate used for<br>priming extracorporeal circuit,<br>bolus infusions, and rinseback | Same.<br>The Nephros HDF<br>Assist Module<br>Predicate Device<br>produces online<br>substitution fluid for<br>infusion from<br>commercially<br>available chemical<br>concentrates. |
| Blood Tubing Set<br>Compatibility | Device-specific blood tubing<br>set | Device-specific blood tubing<br>set | Same |

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| | Subject Device (HemoCare®<br>Hemodialysis System) | Predicate Device (Aksys<br>PHD, K210575) | Comparison |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Blood pump | Diaphragm pump | Peristaltic/Rotary Pump | Substantially<br>Equivalent. Both<br>pumps produce the<br>same maximum<br>blood flow rates and<br>both pumps are bio-<br>and hemocompatible,<br>as defined by ISO<br>10993-1. |
| Patient Access<br>Compatibility | A/V fistula or central venous<br>catheter | A/V fistula or central venous<br>catheter | Same |
| Safety Features | • Alarms and Alerts<br>• Air detection<br>• Blood pressure monitor<br>• Blood leak detection<br>• Tube Clamps<br>• Blood flow occluder<br>• Conductivity and temperature<br>monitoring<br>• Access Disconnect<br>Monitoring | • Alarms and Alerts<br>• Air detection<br>• Blood pressure monitor<br>• Blood leak detection<br>• Tube Clamps<br>• Blood flow occluder<br>• Conductivity and temperature<br>monitoring | Substantially<br>Equivalent. Subject<br>Device's additional<br>safety feature does<br>not change the<br>hemodialysis therapy<br>or limit the use of the<br>device within the<br>intended population. |
| Material<br>Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
| Standards<br>Compliance | • IEC 60601-1<br>• IEC 60601-1-2<br>• IEC 60601-1-6<br>• IEC 60601-1-8<br>• IEC 60601-1-11<br>• IEC 60601-2-16<br>• AIM 7351731 | • IEC 60601-1<br>• IEC 60601-1-2<br>• IEC 60601-1-4<br>• IEC 60601-2-5<br>• IEC 60601-2-16<br>• IEC 60601-2-30 | Substantially<br>Equivalent<br>Both systems<br>meet applicable<br>standards. |

Table 3. SE Comparison with Nephros HDF Assist Module

| Characteristic | HemoCare Hemodialysis<br>System<br>(Subject Device) | Nephros HDF Assist<br>Module<br>(Predicate Device) | Comparison |
|----------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------|
| Product Code | KDI | KDI | Same |
| Regulation<br>Number | 876.5860 | 876.5860 | Same |
| Intended Use | Deliver high permeability<br>hemodialysis therapy to<br>patients with renal failure | Deliver high permeability<br>hemodialysis therapy to<br>patients with renal failure | Same |
| Prescription Use | Yes | Yes | Same |

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| Characteristic | HemoCare Hemodialysis<br>System<br>(Subject Device) | Nephros HDF Assist<br>Module<br>(Predicate Device) | Comparison | |
|----------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|------|
| Online generation<br>of replacement<br>fluid | Yes | Yes | Same | |
| | Chemical<br>Concentrates | 510(k) cleared acid and<br>bicarbonate concentrates | 510(k) cleared acid and<br>bicarbonate concentrates | Same |

#### Table 4. SE Comparison with Outset Tablo Hemodialysis System

| | Subject Device (HemoCare®<br>Hemodialysis System) | Predicate Device (Tablo<br>Hemodialysis System,<br>K211370) | Comparison |
|------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Codes | KDI | KDI | Same |
| Dialysis Delivery<br>System | Conventional, high<br>permeability dialysis with or<br>without ultrafiltration | Conventional, high<br>permeability dialysis with or<br>without ultrafiltration | Same |
| 2-way cloud<br>communication | Yes | Yes | Same |
| Blood Tubing Set<br>Use Life | Up to 16 treatments | 1 treatment | Substantially<br>Equivalent. Clinical<br>testing, verification<br>bench testing, and<br>cleaning validation<br>have demonstrated<br>that use of the blood<br>tubing up to 16 uses<br>is safe and effective. |
| Dialyzer | High permeability,<br>commercially available, single<br>use | High permeability,<br>commercially available, single<br>use | Same |
| Extracorporeal<br>volume (without<br>dialyzer) | 116.5 mL | 140 mL | Substantially<br>equivalent. The<br>Subject Device's<br>smaller volume<br>results in less blood<br>loss compared to the<br>Predicate Device's if<br>blood cannot be<br>returned. |
| Blood returned<br>following power loss | Yes | Yes | Same |
| Disinfection method | Heat and chemical disinfection | Heat and chemical disinfection | Same |

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#### DEKA Research & D

| DEKA Research & Development Corp. | | | |
|------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device (HemoCare®<br>Hemodialysis System) | Predicate Device (Tablo<br>Hemodialysis System,<br>K211370) | Comparison |
| Water Purification<br>Mechanism | Vapor Compression Distillation | Reverse Osmosis | Substantially<br>equivalent. Both<br>devices produce<br>water for dialys<br>that meets the<br>quality standards<br>specified in ISO<br>23500-3. |
| Chlorine/Chloramine<br>removal | Carbon Filter | Carbon Filter | Same |
| Water Device Source<br>Water Quality | EPA Drinking Water | EPA Drinking Water | Same |
| Water Device<br>Product Water<br>Quality | ISO 23000-3 Water for Dialysis | ISO 23000-3 Water for Dialysis | Same |
| Safety Features | • Alarms and Alerts<br>• Air detection<br>• Blood pressure monitor<br>• Blood leak detection | • Alarms and Alerts<br>• Air detection<br>• Blood pressure monitor<br>• Blood leak detection | Substantially<br>Equivalent.<br>Additional safety<br>feature does not |

| | • Blood pressure monitor<br>• Blood leak detection<br>• Tube Clamps<br>• Blood flow occluder<br>• Conductivity and temperature<br>monitoring<br>• Access Disconnect<br>Monitoring | • Blood pressure monitor<br>• Blood leak detection<br>• Tube Clamps<br>• Blood flow occluder<br>• Conductivity and temperature<br>monitoring | Additional safety<br>feature does not<br>change the<br>hemodialysis<br>therapy or limit the<br>use of the device<br>within the intended<br>population. |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material<br>Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
| Standards<br>Compliance | • IEC 60601-1<br>• IEC 60601-1-2<br>• IEC 60601-1-6<br>• IEC 60601-1-8<br>• IEC 60601-1-11<br>• IEC 60601-2-16<br>• AIM 7351731 | • IEC 60601-1<br>• IEC 60601-1-2<br>• IEC 60601-1-6<br>• IEC 60601-1-8<br>• IEC 60601-1-11<br>• IEC 60601-2-16<br>• AIM 7351731 | Same |

#### 7 Performance Data

The following performance data were provided to support the substantial equivalence determination:

Biocompatibility Testing

Biocompatibility testing was performed in accordance with ISO 10993-1:2018 and FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and

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testing within a risk management process" (2023). The following endpoints were evaluated to support the biological safety of the HemoCare® System:

- Cytotoxicity ●
- Sensitization
- Irritation ●
- Acute Systemic Toxicity ●
- Subacute, Subchronic and Chronic System Toxicity ●
- Pyrogenicity
- Genotoxicity
- Hemocompatibility ●
- Carcinogenicity ●
- Chemical Characterization ●
- Toxicological Risk Assessment .

#### Electrical Safety and Electromagnetic Compatibility

Testing to support electrical safety and EMC was conducted in compliance with FDA Guidance, Electromagnetic Compatibility (EMC) of Medical Devices (2022), and the following standards:

- . IEC 60601-1
- IEC 60601-1-2 ●
- IEC 60601-1-6 ●
- IEC 60601-1-8
- IEC 60601-1-11 ●
- IEC 60601-2-16 ●
- AIM 7351731 ●

## Software Verification and Validation Testing

Software verification and validation testing was performed in compliance with IEC 62304. Testing results demonstrate that the device meets all software performance requirements.

#### Bench Performance Testing

Benchtop verification testing was performed to verify specified performance across the following areas:

- . Alarm and Alerts
- Safety Systems .
- Dialysate Quality and Flow .
- Ultrafiltration Accuracy .
- Water Quality
- Microbiological Safety
- Blood Flow
- Heparin Delivery ●
- System Disinfection ●
- . Storage and Distribution

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## Sterilization and Shelf Life

Testing was performed in compliance with ISO 11137-1 (2018), ISO 11137-2 (2013), ISO 11737-1 (2021), ISO 11737-2 (2019), ANSVAAMI ST72:2019, and ISO 11607-1:2019 to demonstrate the blood treatment set is properly sterilized for its labeled shelf life.

#### Human Factors

Human Factors validation testing was performed according to the FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices (2016), and in compliance with ISO 62366 (2020). Testing demonstrated that the HemoCare® System's user interface supports safe and effective use for its intended users, uses, and use environments.

#### Clinical Testing

A prospective, multi-center, open label, cross-over study was performed to evaluate the safety and efficacy of the HemoCare® System during home use without the assistance of trained medical professionals. The study's primary endpoints for safety and efficacy were met.

#### Conclusion 8

The results of clinical and non-clinical testing demonstrate that the HemoCare® Hemodialysis System meets all performance specifications and is safe and effective. The HemoCare® System does not raise any new or different questions of safety or effectiveness. The HemoCare® System is substantially equivalent to the Predicate Devices.