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 and ultrafiltration-only 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. Phoenix® has a modular structure.

AI/ML Overview

The provided text describes a 510(k) submission for the Phoenix® Hemodialysis Delivery System 3.35. This document focuses on demonstrating substantial equivalence to a predicate device and includes information about nonclinical testing.

Here's an analysis to extract the requested information:

1. A table of acceptance criteria and the reported device performance

The document uses the predicate device (Phoenix® Hemodialysis Delivery System Version 3.00) as a benchmark for acceptance criteria and performance. The performance metrics for the modified device (Version 3.35) are compared directly against those of the predicate. The "Accuracy" values for the modified device represent the reported device performance.

Parameter	Acceptance Criteria (Predicate V3.00)	Reported Device Performance (Modified Device V3.35)
Anticoagulation (Heparin Pump)	Range: 0.5 - 10 ml/hrAccuracy: ± 5% or ± 0.2 ml/h	Range: 0/0.5 - 10 ml/hrAccuracy: ± 5% or ± 0.2 ml/h
Blood Flow Rate	Range: 10 - 500 ml/minAccuracy: ± 10%	Range: 10 - 580 ml/minAccuracy: ± 10% if pressure before the pump is not lower (more negative) than – 150 mmHg
Fluid Removal Rate from Patient	Range: 0 - 4 Kg/hAccuracy: ± 2.5 % of actual value or ± 50 ml/h, whichever is greater	Range: 0 - 4 Kg/hDialysate 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 800 ml/min: Accuracy (on total Weight removed): ±(2% UF rate + 80 g/hr)
Dialysate Flow Rate	Range: 350 - 1000 ml/minAccuracy: ± 5%	Range: 350 - 800 ml/minAccuracy: ± 5%
Transmembrane Pressure	Range: -200 to +500 mmHg	Range: -100 to +450 mmHg
Ultrafiltration Rate	Range: 0 - 4 Kg/hAccuracy: ± 2.5 % of actual value or ± 50 ml/h, whichever is greater	Range: 0 - 4 Kg/hAccuracy: ± 2 % of actual value.
Dialysate Temperature	Range: 34 - 40 °C	Range: 34 - 39.5 °C
Dialysate Conductivity	Range: 13-17 mS/cm	Range: 13-17 mS/cm
Arterial Pressure	Range: -400 to +150 mmHg	Range: -400 to +150 mmHg
Venous Pressure	Range: 100 to +450 mmHg	Range: 0 to +450 mmHg

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

The document mentions "component level hardware testing," "static and dynamic software testing (e.g., unit testing, code inspections, testing targeted to the changes implemented in software version 3.35, regression testing)," and "human factors evaluations." However, it does not specify sample sizes for these tests, nor the country of origin or whether the data was retrospective or prospective. The information points to internally conducted engineering and software verification and validation 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)

The document states that testing was performed by "internal and external independent personnel with the appropriate skills" for the nonclinical testing and human factors evaluations. However, it does not specify the number of experts, their qualifications, or their role in establishing a ground truth for a test set. The context is about engineering and system performance validation, not clinical image interpretation or diagnosis.

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

The document does not describe any adjudication method for a test set. This type of method is typically associated with studies involving human interpretation (e.g., radiology reads) where discrepancies need resolution. The testing described is primarily technical performance validation.

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

No MRMC comparative effectiveness study was done or mentioned. This submission is for a medical device (hemodialysis system), not an AI-powered diagnostic tool, and therefore, the concept of "human readers improving with AI assistance" is not applicable to the context of this device.

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

This refers to the performance of the device itself (the "algorithm only" in this context refers to the device's automated functions). The entire nonclinical testing section, which evaluated parameters like flow rates, accuracies, and pressures, represents standalone performance testing of the Phoenix® System 3.35. The tables directly report these standalone performance metrics.

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

For the nonclinical testing, the "ground truth" would be established by controlled engineering measurements against known standards and specifications. For example, a calibrated flow meter would provide the "ground truth" for blood flow rate accuracy, or a calibrated pressure sensor for pressure measurements. These are physical and electrical measurements, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

The document does not mention a training set sample size. This is not an AI/machine learning device that typically requires a large training dataset. The development and testing revolve around hardware and software engineering principles.

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

Since there is no mention of a training set, there is no information on how its "ground truth" was established.

Summary

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K070643 PAGE 1 OF 4

Gambro
10810 West Collins Avenue
Lakewood, CO 80215

Traditional 510(k)
Phoenix® System 3.35

NOV - 2 2007

5.0 510(K) SUMMARY

Submitter's Name	Gambro
Address	10810 West Collins AvenueLakewood, CO 80215
EstablishmentRegistration Number	2087532
Date of Summary	March 7th, 2007
Telephone Number	(303) 231-4094
Fax Number	(303) 542-5138
Contact Person	Thomas B. Dowell, Regulatory Affairs Project Manager
Name of the Device	Phoenix® Hemodialysis Delivery System 3.35Catalogue Number: 6023006700
Common or Usual Name	Hemodialysis Delivery System
Classification Name	Classification Name: High Permeability Hemodialysis SystemDevice Class: IIProduct Code: 78KDIRegulation Number: 876.5860
Indications for Use	The Phoenix® Hemodialysis delivery system is intended to be usedto provide high flux and low flux hemodialysis, hemofiltration andultrafiltration on patients weighing 15 Kilograms or more. The Phoenixsystem is to be used with either high or low permeability dialyzers.The device is intended to be used by trained operators whenprescribed by a physician, in a chronic care dialysis facility or acutecare unit.
Identification of theLegally Marketed Device(Predicate Device)	Phoenix® Hemodialysis Delivery System 3.00Catalogue Number: 6023006700Classification Name: High Permeability Hemodialysis SystemDevice Class: IIProduct Code: 78KDIRegulation Number: 876.5860

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KC 70643
PAGE 2 OF 4

Traditional 510(k) Phoenix® System 3.35

Gambro 10810 West Collins Avenue Lakewood, CO 80215

510(k) SUMMARY, continued

Device Description

Device Comparison Table

	Predicate	Modified Device
	Phoenix® Hemodialysis Delivery	Phoenix® Hemodialysis Delivery System
	System Version 3.00	Version 3.35
Indication forUse	The Phoenix® Hemodialysis	The Phoenix® Hemodialysis delivery
	Delivery System is indicated for	system is intended to be used to provide
	patients in acute or chronic renal	high flux and low flux hemodialysis,
	failure and when the physician	hemofiltration and ultrafiltration on
	prescribes hemodialysis or	patients weighing 15 Kilograms or more.
	ultrafiltration. The Phoenix®	The Phoenix system is to be used with
	Hemodialysis Delivery System	either high or low permeability dialyzers.
	may be used with both high	The device is intended to be used by
	permeability and lowpermeability (conventional)dialyzers.	trained operators when prescribed by aphysician, in a chronic care dialysis facilityor acute care unit.
DedicatedDisposable Sets	Gambro Cartridge® Blood Set	Gambro Cartridge® Blood Set
Anticoagulation	Heparin Syringe Pump	Heparin Syringe Pump
	0.5 - 10 ml/hr	0/0.5 - 10 ml/hr
	Accuracy:± 5% or ± 0.2 ml/h	Accuracy:± 5% or ± 0.2 ml/h

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KC76627
PAGE 3 of 4

Gambro
10810 West Collins Avenue
Lakewood, CO 80215

. '

Traditional 510(k)
Phoenix® System 3.35

	Predicate	Modified Device
	Phoenix® Hemodialysis Delivery System Version 3.00	Phoenix® Hemodialysis Delivery System Version 3.35
Blood Flow Rate	10 - 500 ml/minAccuracy: ± 10%	10 - 580 ml/minAccuracy ± 10% if pressure before the pump is not lower (more negative) than – 150 mmHg
Fluid RemovalRate fromPatient	0 - 4 Kg/hAccuracy:±2.5 % of actual value or ±50 ml/h, whichever is greater	0 - 4 Kg/hDialysate 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 800 ml/min:Accuracy (on total Weight removed):±(2% UF rate + 80 g/hr)
Dialysate FlowRate	350 - 1000 ml/minAccuracy: ± 5%	350 - 800 ml/minAccuracy: ± 5%
TransmembranePressure	-200 to +500 mmHg	-100 to +450 mmHg
UltrafiltrationRate	0 - 4 Kg/hAccuracy:±2.5 % of actual value or ±50 ml/h, whichever is greater	0 - 4 Kg/hAccuracy:±2 % of actual value.
DialysateTemperature	34 - 40 °C	34 - 39.5 °C
DialysateConductivity	13-17 mS/cm	13-17 mS/cm
Arterial andVenous Pressure	Arterial: -400 to +150 mmHgVenous: 100 to +450 mmHg	Arterial: -400 to +150 mmHgVenous: 0 to +450 mmHg

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2070627
PAGE 4 OF 4

Gambro 10810 West Collins Avenue Lakewood, CO 80215

Traditional 510(k) Phoenix® System 3.35

510(k) SUMMARY, continued

Description and Conclusion of Testing

Nonclinical Testing:

The nonclinical testing performed for the Phoenix® System 3.35 included component level hardware testing, testing required to support the declarations of conformity to standards contained in this 510(k) submission, testing required by process to ensure compliance with other international standards applicable to hemodialysis machines as well the static and dynamic software testing, e.g. unit testing, code inspections, testing targeted to the changes implemented in software version 3.35, regression testing, human factors evaluations and testing that was performed by internal and external independent personnel with the appropriate skills.

Conclusion:

The successful non-clinical testing demonstrates the safety and effectiveness of the Phoenix® Hemodialysis Delivery System 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2007

Mr. Thomas B. Dowell Regulatory Affairs Project Manager Gambro 14143 Denver West Parkway LAKEWOOD CO 80401

Re: K070643

Trade/Device Name: Phoenix® Hemodialysis Delivery System 3.35 Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: October 25, 2007 Received: October 26, 2007

Dear Mr. Dowell:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Nancy C Brogdon

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Gambro 10810 West Collins Avenue Lakewood, CO 80215

Traditional 510(k) Phoenix® System 3.35

Indications for Use

510(k) Number (if known):

Device Name: Phoenix® Hemodialysis Delivery System 3.35

Indications for Use:

Over-The-Counter Use Prescription 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)

Lonii Pérez

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Page 17 of 134

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.”