The Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.

Device Description

Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies. The system consists of the Hemodialysis Machine in use with a blood tubing set designed for the machine, a dialyzer, a heparin-filled syringe, a BiCart® column (sodium bicarbonate powder), and other appropriate dialysate concentrates. The machine has many built-in features which are intended to enhance the ease of providing patient dialysis treatments. The Phoenix Hemodialysis Machine pumps blood from the patient, in a blood tubing set properly designed for the machine, through the dialyzer where purification takes place, and back to the patient. In the dialyzer, the blood and the dialysate fluid flow on opposite surfaces of a thin Semipermeable membrane. As the blood passes through the filter, the desired treatment processes take place. Depending upon the therapy in use, the treatment processes can include fluid removal and/or solute clearance. Phoenix has a modular structure. It is made up of five modules that carry out independent functions: Master Module, Hydraulic Module, Blood Module, Protection Module and Bio Module. The unit consisting of the Master, Hydraulic and Blood Modules is called the Control System. The Control System manages the implementation of the physical functions.

AI/ML Overview

The provided document describes a Special 510(k) submission for the Phoenix® Hemodialysis Delivery System - version 3.40. This type of submission is used when the modification to a previously cleared device (the predicate device, in this case, Phoenix® version 3.35) does not affect the intended use or fundamental scientific technology. Therefore, the acceptance criteria and the study performed focus on demonstrating that the updated software (version 3.40) maintains equivalence and does not degrade the safety or effectiveness of the device compared to the predicate.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this Special 510(k) are primarily based on maintaining the performance parameters of the predicate device (Phoenix® version 3.35) and ensuring that the new software version (3.40) does not negatively impact these. The "reported device performance" is essentially that the updated device meets or exceeds the specifications of the predicate.

Parameter	Acceptance Criteria (Predicate)	Reported Device Performance (Subject Device)
Indications for Use	Intended to provide high flux and low flux hemodialysis, hemofiltration, and ultrafiltration on patients ≥ 15 Kg. To be used with high or low permeability dialyzers by trained operators as prescribed by a physician in chronic/acute care facilities.	Identical to predicate. Software 3.40 facilitates correct display of actual values for low weight - low volume sets, eliminating prior mathematical calculations.
Dedicated Disposable Sets	Gambro Cartridge™ Blood Set: 003410-510, 003410-710, 003414-500, 003414-510 (Double Needle); 003409-410, 003429-500 (Single Needle); 003412-500 (75 ml volume); 003422-520 (LOW WEIGHT - LOW VOLUME)	Identical to predicate, with clarification for 003412-500 (75 ml volume) instead of (20-40 Kg weight) and inclusion of 003422-520.
Anticoagulation	Heparin Syringe Pump: 0/0.5 - 9.9 ml/hr; Accuracy: ± 5% or ± 0.2 ml/h	Identical.
Blood Flow Rate	10 - 580 ml/min; Accuracy ± 10% if pressure before pump not lower than -150 mmHg	10 - 580 ml/min (10 - 140 ml/min in LW-LV mode); Accuracy ± 10% if pressure before pump not lower than -150 mmHg. The LW-LV mode is an enhancement.
Fluid Removal Rate from Patient	0 – 4 Kg/h; Accuracy: Dialysate flow rate at 350 ml/min: ±(2% UF rate + 35 g/hr); 500 ml/min: ±(2% UF rate + 50 g/hr); 800 ml/min: ±(2% UF rate + 80 g/hr)	Identical.
Ultrafiltration Rate	0 - 4 Kg/h; Accuracy: ±2 % of actual value	Identical.
Dialysate Flow Rate	350 - 800 ml/min; Accuracy: ± 5%	Identical.
Transmembrane Pressure	-100 to +450 mmHg	Identical.
Dialysate Temperature	34 - 39.5 °C	Identical.
Dialysate Conductivity	13-17 mS/cm	Identical.
Arterial and Venous Pressure	Arterial: -400 to +150 mmHg; Venous: 0 to +450 mmHg	Identical.

The key "performance improvement" highlighted in relation to the acceptance criteria is the elimination of manual calculations for low weight - low volume sets with software version 3.40. Previously, users had to divide displayed blood flow, liters processed, and pump speed by 4 to get actual values. The new software directly displays the actual values, which is a usability and safety enhancement.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "sample size" in the conventional sense (e.g., number of patients or cases) for a test set. This is because no clinical studies were performed for this software modification (Page 4). The testing performed was non-clinical performance data, consisting of verification and validation activities for the software and the system.

The data provenance is internal to the manufacturer's development and testing processes; there's no mention of external data sources or country of origin for a specific "test set" in the context of clinical data. It falls under "retrospective" in the sense that the testing was based on the existing device design and specifications.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical studies were performed and the testing was non-clinical, there isn't a "ground truth" derived from expert clinical opinion in the traditional sense for a test set of patient data.

Instead, the "ground truth" for the non-clinical testing was established by:

System and software requirements and specifications.
International safety standards (IEC 60601-1-2, 60601-2-16, 60601-1-4, 60601-1-6, 62366).
The performance of the legally marketed predicate device (version 3.35).

The experts involved would be the manufacturer's software engineers, quality assurance personnel, regulatory affairs specialists, and potentially clinical representatives who defined and verified these requirements and standards. Their qualifications would be in their respective technical and domain expertise.

4. Adjudication Method for the Test Set

Again, given the non-clinical nature of the testing, there was no "adjudication method" in the sense of multiple experts reviewing and reaching a consensus on clinical outcomes or images.

The verification and validation activities inherently involve review and approval processes by qualified personnel. These would include:

Static activities: impact analysis, final phase reviews, code inspections.
Dynamic tasks: baseline verification, system and software test protocols execution, regression testing, Graphical User Interface and Use Cases test execution.

These processes ensure that the software performs as intended and meets specifications, which is a form of "adjudication" through technical review and testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed for the software modification." Therefore, there is no effect size reported for human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a hemodialysis delivery system, which is a piece of medical equipment, not an AI algorithm in the contemporary sense. It is microprocessor-controlled and performs automated functions, but it always operates with a human-in-the-loop (trained operators). The "standalone" performance thus encompasses the device's ability to execute its programmed functions accurately and safely on its own, but within the context of human use and oversight.

The non-clinical performance data focuses on this "standalone" (device-only) functionality through:

Static activities (code reviews, impact analysis).
System and software functional tests.
Regression testing.
Graphical User Interface and Use Cases test execution.

These tests verify the algorithm's (software's) internal logic and its interaction with the hardware.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

Technical specifications and performance requirements defined by the manufacturer.
Compliance with international safety standards (relevant IEC standards listed).
Functional equivalence to the legally marketed predicate device (Phoenix® version 3.35).
Usability requirements verified through formative and summative usability validation.

It is not based on expert consensus for clinical diagnosis, pathology, or patient outcomes data, as no clinical studies were performed.

8. The Sample Size for the Training Set

This question is not applicable in the context of this device and submission. The Phoenix® Hemodialysis Delivery System is a hardware/software medical device that performs defined physiological functions, it is not an AI/Machine Learning algorithm that undergoes a "training phase" with a "training set" of data in the manner typically associated with such terms.

The software development would involve stages of coding, unit testing, integration testing, and system testing, which are forms of continuous verification and validation, but not "training" with a distinct "training set" of data for learning purposes.

9. How the Ground Truth for the Training Set Was Established

As established in point 8, there is no "training set" in the context of this device. Therefore, the ground truth for a training set was not established.

Summary

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

K103832

MAY 2 0 2011

Special 510(k)

510(k) SUMMARY

Submitter's Name	Gambro Renal Products, Inc
Address	14143 Denver West Parkway, Suite 400Lakewood, Colorado 80401
EstablishmentRegistration Number	2087532
Contact Person	Kae Miller, Regulatory Affairs Manager
Telephone Number	(303) 222.6724
Fax Number	(303) 222.6914
Date of Summary	December 27, 2010

Subject Device
Name of the Device	Phoenix® Hemodialysis Delivery System - version 3.40
Catalogue Number	6023006700
Common or Usual Name	Hemodialysis Delivery System
Classification Name	High Permeability Hemodialysis System
Device Class	II
Product Code	78KDI
Regulation Number	876.5860

	Legally Marketed Device (Predicate Device)
Name of the Device	Phoenix® Hemodialysis Delivery System – version 3.35
Catalogue Number	6023006700
Common or Usual Name	Hemodialysis Delivery System
Classification Name	High Permeability Hemodialysis System
Device Class	II
Product Code	78KDI
Regulation Number	876.5860
510(k) number	K070643

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

K103832

Special 510(k) Phoenix® System

page 2 of 6

510(k) SUMMARY, continued

Device Description

Gambro Renal Products, Inc.

Lakewood, Colorado 80401

14143 Denver West Parkway, Suite 400

Image /page/1/Picture/5 description: The image shows a dialysis machine. The machine is white and has a screen on the top half of the machine. There are tubes and other attachments on the side of the machine. The machine is on a stand with wheels.

FIGURE 1: Phoenix Hemodialysis Machine Phoenix is a self-contained, microprocessor-controlled device that provides hemodialysis, hemofiltration and ultrafiltration therapies. The system consists of the Hemodialysis Machine in use with a blood tubing set designed for the machine, a dialyzer, a heparin-filled syringe, a BiCart® column (sodium bicarbonate powder), and other appropriate dialysate concentrates.

The machine has many built-in features which are intended to enhance the ease of providing patient dialysis treatments.

The Phoenix Hemodialysis Machine pumps blood from the patient, in a blood tubing set properly designed for the machine, through the dialyzer where purification takes place, and back to the patient.

In the dialyzer, the blood and the dialysate fluid flow on opposite surfaces of a thin Semipermeable membrane. As the blood passes through the filter, the desired treatment processes take place. Depending upon the therapy in use, the treatment processes can include fluid removal and/or solute clearance.

Phoenix has a modular structure. It is made up of five modules that carry out independent functions: Master Module, Hydraulic Module, Blood Module, Protection Module and Bio Module. The unit consisting of the Master, Hydraulic and Blood Modules is called the Control System. The Control System manages the implementation of the physical functions.

The Phoenix machine can carry out the following therapies:

Ultrafiltration; the body's excess fluid is removed through the dialyzer membrane by means . of a pressure gradient between the blood and dialysate compartments in the dialyzer.
Hemofiltration: accumulated metabolic products are removed from blood by the process of . convective transport as a consequence of ultrafiltration of fluid across a dialyzer semipermeable membrane of high-flux type. The volume of filtered fluid that exceeds the desired weight loss is replaced by sterile pyrogen-free infusion solution infused into the blood flowpath.
Hemodialysis; the chemical composition of blood is corrected by removing accumulated . metabolic products, normalizing ionic content and adding buffer through the process of diffusive transport.

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

Physical Characteristics

Special 510(k)
Phoenix
® System 3.40

page 3 of 6

Parameter	Dimension
Height	1440 mm (56.7 in)
	1970 mm (77.4 in) with "IV Pole"
Width	610 mm (24.0 in) with "Dialyzerholder" in working position
Depth of base	710 mm (27.9 in)
	930 mm (36.5 in) with "ChemicalContainer Shelf"
Total floor surface covered by base	433100 mm² (671.3 in²)
	567300 mm² (879.3 in²)
Dry weight	120 kg (264.5 lb)

510(k) SUMMARY, continued

Indications For Use of the predicate device: Phoenix version 3.35

Indications For Use of the subject device: Phoenix version 3.40

Note:

The Indications For Use of the proposed device and of the predicate device are identical. There is no change of the indications for use, intended use of hemodialysis system, or affect on the fundamental scientific technology. Due to the physical characteristics of the low weight - low volume set, the user must currently divide the following displayed parameter values by 4 to determine the actual parameter values: blood flow, liters processed, and pump speed. With the 3.40 version of the software, there is no need to perform any mathematical calculations; all displayed values are the actual for the low weight - low volume set.

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

K103832 Special 510(k)

510(k) SUMMARY, continued

Device Comparison Table

In the following table the proposed device Phoenix® Hemodialysis Delivery System – version 3.35 (K070643).

	Subject device – Phoenix sw 3.40	Predicate device – Phoenix sw 3.35
	The Phoenix® Hemodialysis deliverysystem is intended to be used toprovide high flux and low fluxhemodialysis, hemofiltration andultrafiltration on patients weighing 15Kilograms or more. The Phoenixsystem is to be used with either highor low permeability dialyzers. Thedevice is intended to be used bytrained operators when prescribed bya physician, in a chronic care dialysisfacility or acute care unit.	The Phoenix® Hemodialysis deliverysystem is intended to be used toprovide high flux and low fluxhemodialysis, hemofiltration andultrafiltration on patients weighing 15Kilograms or more. The Phoenixsystem is to be used with either highor low permeability dialyzers. Thedevice is intended to be used bytrained operators when prescribed bya physician, in a chronic care dialysisfacility or acute care unit.
Indications for Use
	Gambro Cartridge™ Blood Set:003410-510 Double Needle003410-710 Double Needle003414-500 Double Needle003414-510 Double Needle	Gambro Cartridge™ Blood Set:003410-510 Double Needle003410-710 Double Needle003414-500 Double Needle003414-510 Double Needle
Dedicated DisposableSets	003409-410 Single Needle003429-500 Single NeedleConversion Kit	003409-410 Single Needle003429-500 Single NeedleConversion Kit
	003412-500 Double Needle(75 ml VOLUME)	003412-500 Double Needle(20-40 Kg weight)
	003422-520 Double Needle(LOW WEIGHT - LOW VOLUME)

Anticoagulation	Heparin Syringe Pump0/0.5 - 9.9 ml/hr	Heparin Syringe Pump0/0.5 - 9.9* ml/hr
	Accuracy:$\pm$ 5% or $\pm$ 0.2 ml/h	Accuracy:$\pm$ 5% or $\pm$ 0.2 ml/h
Blood Flow Rate	10 - 580 ml/min(10 - 140 ml/min in LW-LV mode)	10 - 580 ml/min
	Accuracy $\pm$ 10% if pressure before thepump is not lower (more negative)than - 150 mmHg	Accuracy $\pm$ 10% if pressure before thepump is not lower (more negative)than - 150 mmHg

	Proposed device - Phoenix sw 3.40	Predicate device - Phoenix sw 3.35
Fluid Removal Ratefrom Patient	0 – 4 Kg/h	0 – 4 Kg/h
	Dialysate flow rate at 350 ml/min:Accuracy (on total Weight removed):±(2% UF rate + 35 g/hr)	Dialysate flow rate at 350 ml/min:Accuracy (on total Weight removed):±(2% UF rate + 35 g/hr)
	Dialysate flow rate at 500 ml/min:Accuracy (on total Weight removed):±(2% UF rate + 50 g/hr)	Dialysate flow rate at 500 ml/min:Accuracy (on total Weight removed):±(2% UF rate + 50 g/hr)
	Dialysate flow rate at 800 ml/min:Accuracy (on total Weight removed):±(2% UF rate + 80 g/hr)	Dialysate flow rate at 800 ml/min:Accuracy (on total Weight removed):±(2% UF rate + 80 g/hr)
	Dialysate Flow Rate	350 - 800 ml/minAccuracy: ± 5%
TransmembranePressure		-100 to +450 mmHg
Ultrafiltration Rate	0 - 4 Kg/hAccuracy:±2 % of actual value	0 - 4 Kg/hAccuracy:±2 % of actual value
	DialysateTemperature	34 - 39.5 °C
	DialysateConductivity	13-17 mS/cm
Arterial and VenousPressure	Arterial: -400 to +150 mmHgVenous: 0 to +450 mmHg	Arterial: -400 to +150 mmHgVenous: 0 to +450 mmHg

*Note: submission (K070643) noted this as 10 ml/hr in summary, but actual value without rounding is 9.9 as reflected in Operator's Manual. This value has not changed between software versions.

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

K103832
Special 510(k)

Phoenix® System 3.40

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

510(k) SUMMARY, continued

Non-clinical performance data

The non-clinical testing for this new software version allowed to determine the substantial equivalence with the predicate device and consisted of verification and validation activities for the software and the system, with static tasks (impact analysis, final phase reviews, code inspections, system and software test protocols preparation) and dynamic tasks (baseline verification, system and software test protocols execution, regression testing, Graphical User Interface and Use Cases test execution), verification and validation of the labeling, Usability validation (formative and summative), risk management activities, and compliance with applicable international safety standards for dialysis equipment.

Clinical performance data

No clinical studies were performed for the software modification.

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

K103832
Special 510(k)

Phoenix® System 3.40

510(k) SUMMARY, continued

Conclusion of Safety and Effectiveness

The successful completion of the following verification and validation activities:

. Static activities code reviews;
System and software functional tests; .
Labeling evaluations as part of usability testing; .
. Standards compliance to IEC standards 60601-1-2, 60601-2-16, 60601-1-4, 60601-1-6, 62366; and
Usability validation, .

demonstrates the safety and effectiveness of the Gambro Phoenix® Hemodialysis Delivery System - version 3.40 when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.

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

Image /page/6/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

MAY 2 0 2011

K103832 Re:

Trade/Device Name: Phoenix® Hemodialysis Delivery System - version 3.40 Regulation Number: 21 CFR §876.5860 . . . Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: April 19, 2011 Received: April 21, 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

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

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,

Herbert 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

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

page 1 of 1

Special 510(k) Phoenix® System 3.40

Indications for Use

510(k) Number (if known): K103832

Device Name: Phoenix® Hemodialysis Delivery System - version 3.40

Indications for Use:

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

Aonf. An. Wtz
(Division Sign-Off)

RA 10-068

(Division Bign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K103832

Page 19 of 125

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.”