Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
All treatments administered via the Prismaflex® control unit must be prescribed by a physician.

Device Description

The Prismaflex control unit is a software controlled device that performs the following functions:

Loads and primes the Prismaflex disposable set automatically.
Pumps blood through the blood flow path of the Prismaflex disposable set.
Delivers anticoagulant solution into the blood flow path.
Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposable set according to therapy in use.
Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
Controls the patient fluid removal or plasma loss according to the therapy in use.
Monitors the system and alerts the operator to abnormal situations through alarms.
The Prismaflex® has a touch screen user interface that provides operating instructions.
The Prismaflex® provides color coding and bar-code identification of the filter sets that are automatically loaded. The Prismaflex continually monitors the operation of the machine and displays one of four (4) types of alarms if an abnormal situation occurs. The Prismaflex® has five (5) pumps that allow multiple therapeutic combinations; including a "pre-blood pump" that allows infusion of a supplemental solution for hemodilution or anticoagulation of the extracorporeal circuit.

AI/ML Overview

The provided text describes a 510(k) submission for the Prismaflex® System, a hemodialysis delivery system. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific clinical acceptance criteria through a comparative effectiveness study in the same way an AI/ML device might. Therefore, many of the requested elements for an AI/ML study, such as sample size for test sets and training sets, expert qualifications, adjudication methods, and MRMC studies, are not applicable or not provided in the document.

The "acceptance criteria" here are implicitly the performance specifications of the device as compared to its predicate devices, along with compliance with relevant international standards for medical electrical equipment. The "study that proves the device meets the acceptance criteria" is broadly referred to as "Complete software and system verification and validation including functional, performance and safety requirements" and "Compliance has been demonstrated to the following international standards."

Here's the information extracted and adapted to the best extent possible given the nature of the document:

1. Table of Acceptance Criteria (as implied by comparison to predicates) and Reported Device Performance

The device's performance is implicitly evaluated against the predicate devices for key operational parameters. The document focuses on demonstrating that the Prismaflex® (Software Version 5.10) performs similarly to or within acceptable ranges of the predicate devices.

Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (Prismaflex® v5.10)
Dialysate Flow Rate Accuracy	± 30 ml/hr
Replacement Flow Rate Accuracy	± 30 ml/hr
Blood Flow Rate Accuracy (CRRT)	±10% of user set point
Blood Flow Rate Accuracy (TPE)	±10% of user set rate (if inlet pressure > -250 mmHg, outlet pressure < +350 mmHg)
Pre-Blood Pump Accuracy	± 30 ml/hr
Patient Fluid Removal Performance Range Accuracy (CRRT/TPE)	± 30 ml/hr, ± 70 ml/3hr, ± 300 ml/24hr (Scales calibrated at ambient temperature with < ±3 °C change during treatment)
Access Pressure & Return Pressure Accuracy	±10% of reading or ± 8 mmHg (whichever is greater)
Anticoagulation	User-controllable as continuous or bolus
Dedicated Disposable Sets Available	M60/M100/M150, HF1000 & HF1400 (CRRT); TPE 2000 Set (TPE)
Syringe Sizes	10, 20, 30 & 50 ml
Therapies Supported	SCUF, CVVH, CVVHD, CVVHDF, TPE
Weight	Approximately 60 kg (132 lb) without fluid bags and set
Height	Approximately 162 cm (64 in)
Width	Approximately 49 cm (19 in)
Base	Approximately 60 cm x 63 cm (24 in x 25 in)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission details a medical device (a hemodialysis system) for which performance is typically verified through engineering tests, bench tests, and potentially clinical validation activities (which are not detailed here as a specific "test set" with patient data). The document states "Complete software and system verification and validation including functional, performance and safety requirements," but does not specify sample sizes or data provenance for these verification activities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device submission. Ground truth, in the context of expert consensus, is relevant for diagnostic devices that interpret signals or images. For a hemodialysis delivery system, "ground truth" would relate to accurate physical measurements and system functionality, not expert interpretation of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as an adjudication method for expert consensus is not relevant to the type of device and testing described.

5. 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

This information is not applicable. This is not an AI/ML diagnostic device, and therefore, an MRMC study with human readers assisting AI is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The Prismaflex® system is a physical medical device with software, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on engineering specifications, physical measurements, and compliance with recognized international standards. For example, the accuracy of flow rates would be verified against known calibrated standards, not expert consensus or pathology.

8. The sample size for the training set

This information is not provided and is largely not applicable in the context of device hardware and software verification for a 510(k) of this nature. "Training set" is primarily a concept used in AI/ML development.

9. How the ground truth for the training set was established

This information is not applicable. There is no "training set" in the AI/ML sense for this device. The system's functionality and performance are verified against pre-defined engineering requirements and industry standards.

Summary

{0}------------------------------------------------

Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, CO 80401

Traditional 510(k) for the Prismaflex® System

JUN 1 7 2011

5.0 510(k) SUMMARY

Submitter's Name	Gambro Renal Products, Inc.
Address	14143 Denver West Parkway, Suite 400Lakewood, Colorado 80401
Establishment RegistrationNumber	2087532
Contact Person	Kae MillerRegulatory Affairs Manager, Americas
Telephone Number	303.222.6724
Fax Number	303.222.6916
Date of Summary	March 21, 2011

	Device under clearance
Name of the Device	Prismaflex®Catalogue Number: 113081
Common or Usual Name	Hemodialysis Delivery System
Classification Name	Classification Name: High Permeability Hemodialysis System
Device Class	II
Product Code	78KDI
Regulation Number	876.5860

{1}------------------------------------------------

Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, CO 80401

Traditional 510(k) for the Prismaflex® System

510(k) SUMMARY, continued

	Predicate Device Information (1)
Name of the Device	Prisma System R 03.10A
Catalogue Number:	018089-507
510(k) Number:	K062090
Classification Name	High Permeability Hemodialysis System
Device Class	II
Product Code	78KDI
Regulation Number	876.5860

Predicate Device Information (2)
Name of the Device	Prismaflex® System 3.20
Catalogue Number:	107493
510(k) Number:	K072093
Classification Name	High Permeability Hemodialysis System
Device Class	II
Product Code	78KDI
Regulation Number	876.5860

{2}------------------------------------------------

K110823

Traditional 510(k) for the

Prismaflex® System

Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, CO 80401

510(k) SUMMARY, continued

Image /page/2/Picture/4 description: The image shows a piece of medical equipment. The equipment has a screen at the top, followed by a series of buttons and controls. Below the controls, there are three levers or handles. The equipment is mounted on a stand or base.

DEVICE DESCRIPTION:

The Prismaflex control unit is a software controlled device that performs the following functions:

· Loads and primes the Prismaflex disposable set automatically.
· Pumps blood through the blood flow path of the Prismaflex disposable set.
· Delivers anticoagulant solution into the blood flow path.
· Pumps sterile infusion solutions into the blood flow path of the Prismaflex disposable set according to therapy in use.
· Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
· Controls the patient fluid removal or plasma loss according to the therapy in use.
· Monitors the system and alerts the operator to abnormal situations through alarms.

The Prismaflex® has a touch screen user interface that provides operating instructions.

The Prismaflex® provides color coding and bar-code identification of the filter sets that are automatically loaded. The Prismaflex continually monitors the operation of the machine and displays one of four (4) types of alarms if an abnormal situation occurs. The Prismaflex® has five (5) pumps that allow multiple therapeutic combinations; including a "pre-blood pump" that allows infusion of a supplemental solution for hemodilution or anticoagulation of the extracorporeal circuit.

PHYSICAL CHARACTERISTICS OF PRISMAFLEX®:

WEIGHT:	Approximately 60 kg (132 lb) without fluid bags and Prismaflex disposable set
HEIGHT:	Approximately 162 cm (64 in)
WIDTH:	Approximately 49 cm (19 in)
BASE:	Approximately 60 cm x 63 cm (24 in x 25 in)

INDICATIONS FOR USE:

The Prismaflex® control unit is intended for:

· Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
· Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.

All treatments administered via the Prismaflex® control unit must be prescribed by a physician

{3}------------------------------------------------

Tra

Gambro Renal Products, Inc.
4143 Denver West Parkway, Suite 400
Lakewood, Colorado 80401

raditional 510(k)
Prismaflex®

0(k) SUMMARY, continuo

5.1

Device Comparison Table
In the following table the Prismallex " with software version 5.10 is compared for the TPE therapy with the predicate Prisma System R 03.
add for the

and for the CRRT therapies with the predicate Prismaflex® System 3.20.
	DEVICE	PREDICATE [for TPE]Prisma System R 03.10A	PREDICATE [for CRRT]Prismaflex® System 3.20
	Prismaflex®
	The Prismaflex control unit is intended for:	The Prisma System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload and for therapeutic plasma exchange in patients with disease where removal of plasma components is indicated.	The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician.
Indication for Use	Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
	All treatments administered via the Prismaflex control unit must be prescribed by a physician.
Dedicated DisposableSets Available in U.S.	For CRRT:M60/M100/M150HF1000 & HF1400For TPE:TPE 2000 Set	Gambro TPE Set with Plasmafilter PF2000N	M60/M100HF1000 & HF1400
Syringe	10, 20, 30 & 50 ml	20 ml	10, 20, 30 & 50 ml

RA 11-019

{4}------------------------------------------------

Gambro Renal Products, Inc.
14143 Denver West Parkway, Suite 400
Lakewood, CO 80401

raditional 510(k) for the
Prismaflex® System

	DEVICEPrismaflex®	PREDICATE [for TPE]Prisma System R 03.10A	PREDICATE [for CRRT]Prismaflex® System 3.20
Anticoagulation	User-controllable as continuous orbolus	Delivered continuously or in bolus	User-controllable as continuous orbolus
Dialysate Flow Rate	CVVH & CVVHDF:Range: 0 to 8000 ml/hrIncrement: 50 ml/hr	Not for TPE.	CVVHD & CVVHDF:Range: 0 to 8000 ml/hrIncrement: 50 ml/hr
Dialysate Flow RateAccuracy	± 30 ml/hr	Not for TPE.	± 30 ml/hr
Replacement solutionFluid Flow Rate	CVVH & CVVHDF:Range: 0 to 8000 ml/hrIncrement: 50 ml/hrTPE:Range: 0 to 5000 ml/hrIncrement: 10 ml/hr	TPE:up to 2000 ml/hr.	CVVH & CVVHDF:Range: 0 to 8000 ml/hrIncrement: 50 ml/hr
Replacement FlowRate Accuracy	± 30 ml/hr	± 30 ml/hr	± 30 ml/hr
Blood Flow Rate	Range: 10-450 ml/min.	Up to 180 ml/min.	Range: 10-450 ml/min.Flow rate depends on the Prismaflextherapy/set combination selected byoperator
Blood Flow RateAccuracy	±10% of user set rateThe accuracy of blood flow ismaintained if:- the inlet pressure is higher (lessnegative) than -250 mmHg;- the outlet pressure is lower than+350 mmHg	±25% of user set rate.	±10% of user set pointTreatment time up to 72 hours

RA 11-019

{5}------------------------------------------------

Gambro Renal Products, Inc.
14143 Denver West Parkway, Suite 400
Lakewood, CO 80401

raditional 510(k) for th
Prismaflex® System

	DEVICEPrismaflex®	PREDICATE [for TPE]Prisma System R 03.10A	PREDICATE [for CRRT]Prismaflex® System 3.20
Pre-Blood PumpFlow Rate	SCUF, TPE:Range: 0 to 1000 ml/hrNote: Total PBP Volume is2000 ml/treatment for TPECVVH, CVVHD, CVVHDF:Range: 0 to 4000 ml/hr	This pump is not available with Prisma	SCUF:0 to 1000 ml/hrCVVH, CVVHD, CVVHDF:0 to 8000 ml/hr
Pre-Blood PumpAccuracy	$\pm$ 30 ml/hr	This pump is not available with Prisma	$\pm$ 30 ml/hr
Effluent Pump FlowRate	0 to 10000 ml/hr depending on thetherapy	0, or 1000 to 5500 ml/hr	0 to 10000 ml/hr depending on thetherapy
ECG Discharger	YES	Electrodes with low contact impedanceare required	YES
Therapies	SCUFCVVHCVVHDCVVHDFTPE	SCUFCVVHCVVHDCVVHDFTPE	SCUFCVVHCVVHDCVVHDF
Pumps	PBP solutionReplacement solutionDialysate solutionEffluentBlood	DialysateReplacementEffluentBlood	PBP solutionReplacement solutionDialysate solutionEffluentBlood
Scales	DialysateReplacementEffluent	DialysateReplacementEffluent	DialysateReplacementEffluent

{6}------------------------------------------------

400uite

Gambro Renal Products, Inc.
4143 Denver West Parkway
Lakewood, CO 80401

aditional 510(k) for th
Prismaflex® System

	DEVICEPrismaflex®	PREDICATE [for TPE]Prisma System R 03.10A	PREDICATE [for CRRT]Prismaflex® System 3.20
TransmembranePressureTMP (CRRT)TMPa (TPE)	TMP:User settable: +70 to +350 mmHgDefault: +350 mmHgTMPa:User settable: +50 to +100 mmHgDefault: +100 mmHg	TMPa:User settable: 0 to +100 mmHgDefault: +100 mmHg	TMP:User settable: +70 to +300 mmHgDefault: +300 mmHg
DialysateConductivity andTemperature	Dialysate Conductivity andTemperature are not controlled byPrismaflex	Dialysate Conductivity andTemperature are not controlled byPrisma	Dialysate Conductivity andTemperature are not controlled byPrismaflex
Patient FluidRemovalPerformance Range	0 to 2000 ml/hr maximum for CRRT0 to 1000 ml/hr for TPEIncrement: 10 ml/hr	0 to 2000 ml/hrIncrement: 10 ml/hr	0 to 2000 ml/hrIncrement: 10 ml/hr
Patient FluidRemovalPerformance RangeAccuracy	± 30 ml/hr± 70 ml/3hr± 300 ml/24hrScales calibrated at ambienttemperature at which they will be used.Ambient temperature change less than±3 °C(5.4 °F) during treatment.	± 30 ml/hrScales calibrated at ambienttemperature at which they will be used.Ambient temperature change less than±1°C (5.4 °F) during treatment.± 70 ml/3hr± 300 ml/24hrScales calibrated at ambienttemperature at which they will be used.Ambient temperature change less than±3°C (5.4 °F) during treatment.	± 30 ml/hr± 70 ml/3hr± 300 ml/24hrScales calibrated at ambienttemperature at which they will be used.Ambient temperature change less than±3°C (5.4 °F) during treatment.
Access Pressure andReturn Pressure	Access Pressure:-250 to +300 mmHgReturn Pressure:-50 to +350 mmHg	Access Pressure:-250 to +50 mmHgReturn Pressure:-50 to +350 mmHg	Access Pressure:-250 to +300 mmHgReturn Pressure:-50 to +350 mmHg
Access Pressure andReturn PressureAccuracy	±10% of reading or ± 8 mmHg(whichever is greater)	±10% of reading or ± 8 mmHg(whichever is greater)	±10% of reading or ± 8 mmHg(whichever is greater)

{7}------------------------------------------------

Gambro Renal Products, Inc.
14143 Denver, West Parkway, Suite 400
Lakewood, CO 80401

raditional 510(k) for the
Prismaflex® System

	DEVICEPrismaflex®	PREDICATE [for TPE]Prisma System R 03.10A	PREDICATE [for CRRT]Prismaflex® System 3.20
PE Settings:	Pre-treatment HematocritRange: 10 to 60%Increment: 1%Default: 30%	Pre-treatment HematocritRange: 10 to 60%Increment: 1%Default: 43%	N/A for CRRT.
	Total Replacement VolumeRange: 0 to 10,000 mlIncrement: 100 mlDefault: 3000 ml	Total Replacement VolumeRange: 0 to 10,000 mlIncrement: 100 mlDefault: 3000 ml	N/A for CRRT
	Patient Plasma Loss RateRange: 0, or 10 to 1000 ml/hrIncrement: 10 ml/hrDefault: 0 ml/hr	Patient Plasma Loss RateRange: 0, or 10 to 1000 ml/hrIncrement: 10 ml/hrDefault: 0 ml/hr	N/A for CRRT
	Replacement Container VolumeRange: 0 to 5000 mlIncrement: 10 ml	Replacement Container VolumeRange: 0 to 5000 mlIncrement: 10 ml	N/A for CRRT

Page 22 of 101

RA 11-019

{8}------------------------------------------------

Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, Colorado 80401

Traditional 510(k) Prismaflex®

510(k) SUMMARY, continued

Assessment of performance data

The testing performed for the Prismaflex® equipped with software version 5.10, in order to determine the substantial equivalence with predicate devices included:

· Complete software and system verification and validation including functional, performance and safety requirements;
· Compliance has been demonstrated to the following international standards;
- o IEC 60601-1: Medical electrical equipment: Part 1: General requirements for safety
- IEC 60601-1-1: Medical electrical equipment: Part 1-1: General requirements for o safety - Collateral standard: Safety requirements for medical electrical systems
- IEC 60601-1-2: Medical electrical equipment: Part 1-2: General requirements for o safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-4: Medical electrical equipment: Part 1-4: General requirements for ಂ Collateral Standard: Programmable electrical Medical Systems
- IEC 60601-2-16: Medical electrical equipment Part 2-16: Particular 0 requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

Conclusion

The successful testing of the Prismaflex® equipped with software version 5.10 demonstrates safety and effectiveness when used for the defined indications for use and is substantially equivalent to the predicate devices.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings, depicted with three curved lines representing the wings and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Kae Miller Regulatory Affairs Manager Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 LAKEWOOD CO 80401

Re: K110823

JUN 1 7 2011

Trade/Device Name: Prismaflex® Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: March 21, 2011 Received: March 24, 2011

Dear Ms. Miller:

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. 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 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

{10}------------------------------------------------

Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lemon MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

{11}------------------------------------------------

Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, CO 80401

Traditional 510(k) for the Prismaflex® System

Indications for Use

510(k) Number (if known): K110823

Device Name:

Prismaflex®

Indications for Use:

The Prismaflex® control unit is intended for:

Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more . with diseases where removal of plasma components is indicated.

All treatments administered via the Prismaflex® control unit must be prescribed by a physician.

Prescription Use (Part 21 CFR 801 Subpart D)	X
AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and Urological Devices
RA 11-019	Page 14 of 101
510(k) Number	K110823

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.”