PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35

K070643 · Gambro, Inc. · KDI · Nov 2, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070643
• Device Name: PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
• Applicant: Gambro, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Nov 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

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 Story

Phoenix® is a self-contained, microprocessor-controlled hemodialysis delivery system; provides hemodialysis, hemofiltration, and ultrafiltration. System integrates blood tubing set, dialyzer, heparin syringe pump, and dialysate concentrates (including BiCart® sodium bicarbonate). Operated by trained clinicians in acute or chronic care facilities. Device monitors and controls blood flow, fluid removal (ultrafiltration), dialysate flow, temperature, and conductivity. Microprocessor manages therapy parameters; provides real-time monitoring of arterial/venous pressures and transmembrane pressure. Output enables clinicians to deliver prescribed dialysis therapy; enhances treatment efficiency through modular design and automated control of fluid/solute exchange. Benefits include precise management of patient fluid balance and solute clearance during renal replacement therapy.

Clinical Evidence

Bench testing only. No clinical data presented. Evidence includes component-level hardware testing, software unit/regression testing, code inspections, and human factors evaluations to verify performance against specifications and international standards.

Technological Characteristics

Microprocessor-controlled hemodialysis delivery system. Modular structure. Features heparin syringe pump, dialysate preparation system (bicarbonate powder), and blood/fluid monitoring sensors. Connectivity: Standalone. Software: Embedded firmware (v3.35). Sterilization: Not applicable (device is a capital equipment system).

Indications for Use

Indicated for patients weighing ≥15 kg requiring high/low flux hemodialysis, hemofiltration, or ultrafiltration. Used in chronic care or acute care settings by trained operators under physician prescription.

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

• Phoenix® Hemodialysis Delivery System 3.00 (K070643)

Submission Summary (Full Text)

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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 Avenue<br>Lakewood, CO 80215 |
| Establishment<br>Registration Number | 2087532 |
| Date of Summary | March 7th, 2007 |
| Telephone Number | [phone] |
| Fax Number | [phone] |
| Contact Person | Thomas B. Dowell, Regulatory Affairs Project Manager |
| Name of the Device | Phoenix® Hemodialysis Delivery System 3.35<br>Catalogue Number: 6023006700 |
| Common or Usual Name | Hemodialysis Delivery System |
| Classification Name | Classification Name: High Permeability Hemodialysis System<br>Device Class: II<br>Product Code: 78KDI<br>Regulation Number: 876.5860 |
| Indications for Use | The Phoenix® Hemodialysis delivery system is intended to be used<br>to provide high flux and low flux hemodialysis, hemofiltration and<br>ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix<br>system is to be used with either high or low permeability dialyzers.<br>The device is intended to be used by trained operators when<br>prescribed by a physician, in a chronic care dialysis facility or acute<br>care unit. |
| Identification of the<br>Legally Marketed Device<br>(Predicate Device) | Phoenix® Hemodialysis Delivery System 3.00<br>Catalogue Number: 6023006700<br>Classification Name: High Permeability Hemodialysis System<br>Device Class: II<br>Product Code: 78KDI<br>Regulation 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

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.

## Device Comparison Table

| | Predicate | Modified Device |
|------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| | Phoenix® Hemodialysis Delivery | Phoenix® Hemodialysis Delivery System |
| | System Version 3.00 | Version 3.35 |
| Indication for<br>Use | 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 low<br>permeability (conventional)<br>dialyzers. | trained operators when prescribed by a<br>physician, in a chronic care dialysis facility<br>or acute care unit. |
| Dedicated<br>Disposable 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:<br>± 5% or ± 0.2 ml/h | Accuracy:<br>± 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/min<br>Accuracy: ± 10% | 10 - 580 ml/min<br>Accuracy ± 10% if pressure before the pump is not lower (more negative) than – 150 mmHg |
| Fluid Removal<br>Rate from<br>Patient | 0 - 4 Kg/h<br>Accuracy:<br>±2.5 % of actual value or ±50 ml/h, whichever is greater | 0 - 4 Kg/h<br>Dialysate flow rate at 350 ml/min:<br>Accuracy (on total Weight removed):<br>±(2% UF rate + 35 g/hr)<br>Dialysate flow rate at 500 ml/min:<br>Accuracy (on total Weight removed):<br>±(2% UF rate + 50 g/hr)<br>Dialysate flow rate at 800 ml/min:<br>Accuracy (on total Weight removed):<br>±(2% UF rate + 80 g/hr) |
| Dialysate Flow<br>Rate | 350 - 1000 ml/min<br>Accuracy: ± 5% | 350 - 800 ml/min<br>Accuracy: ± 5% |
| Transmembrane<br>Pressure | -200 to +500 mmHg | -100 to +450 mmHg |
| Ultrafiltration<br>Rate | 0 - 4 Kg/h<br>Accuracy:<br>±2.5 % of actual value or ±50 ml/h, whichever is greater | 0 - 4 Kg/h<br>Accuracy:<br>±2 % of actual value. |
| Dialysate<br>Temperature | 34 - 40 °C | 34 - 39.5 °C |
| Dialysate<br>Conductivity | 13-17 mS/cm | 13-17 mS/cm |
| Arterial and<br>Venous Pressure | Arterial: -400 to +150 mmHg<br>Venous: 100 to +450 mmHg | Arterial: -400 to +150 mmHg<br>Venous: 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 [phone] or [phone] 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:

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.

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

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