NXSTAGE DOSING CALCULATOR

K130460 · Nxstage Medical, Inc. · FKP · Jul 11, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K130460
• Device Name: NXSTAGE DOSING CALCULATOR
• Applicant: Nxstage Medical, Inc.
• Product Code: FKP · Gastroenterology, Urology
• Decision Date: Jul 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The NxStage Dosing Calculator is intended to provide chronic hemodialysis prescription options with the NxStage System One and Cartridge with pre-attached dialyzer based on patient and treatment parameters. With a specified set of algorithms, it automatically performs calculations that are typically done by a physician or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.

Device Story

Software modeling program assisting physicians/licensed practitioners in prescribing chronic hemodialysis therapy; inputs include patient and treatment parameters; utilizes established scientific literature formulas to model treatment frequencies, durations, and fluid volumes; outputs prescription options for NxStage System One and Cartridge with pre-attached dialyzer; tool serves as decision support; does not replace independent clinical judgment; used in clinical settings by healthcare professionals.

Clinical Evidence

Bench testing only. Verification and validation testing conducted to characterize performance, including software readiness, software design review, and usability. All predetermined acceptance criteria were met.

Technological Characteristics

Software modeling program; utilizes established scientific literature formulas for hemodialysis prescription calculations; standalone software tool; intended for use with NxStage System One and Cartridge with pre-attached dialyzer.

Indications for Use

Indicated for chronic hemodialysis patients requiring prescription options for treatment frequency, duration, and fluid volume when using the NxStage System One and Cartridge with pre-attached dialyzer.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• Fresenius Pack H Hemodialysis Urea Kinetic Modeling Software Program (K955423)

Submission Summary (Full Text)

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JUL 1 1 2013

This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content contained in this 510(k) summary has been provided in conformance with 21 CFR §807.92

| A. | Date: | June 5, 2013 |
|----|------------------------------------------------|--------------------------------------------------------------------------------------|
| B. | Submitter's Information:<br>Name: | NxStage Medical, Inc. |
| | Address: | 350 Merrimack Street<br>Lawrence, MA 01843<br>United States |
| | FDA Establishment<br>Owner/Operator<br>Number: | 9045797 |
| | Contact Person: | Gregor Dzialas<br>Regulatory Affairs Manager |
| | Phone:<br>Fax: | [phone]<br>[phone] |
| | Manufacturer: | NxStage Medical, Inc.<br>350 Merrimack Street<br>Lawrence, MA 01843<br>United States |
| | FDA Establishment<br>Registration Number: | 3003464075 |
| | Sterilization Site: | Not Applicable |

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## C. Device Name:

| Trade/Proprietary Name: | NxStage Dosing Calculator |
|-------------------------|-------------------------------------------------------|
| Common/Usual Name: | Dosing Calculator |
| Classification Name: | Hemodialysis System and Accessories |
| Regulation Number: | 21 CFR 876.5820 |
| Product Code: | FKP -Hemodialysis System and<br>Accessories |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology-Urology (GU)/Gastro-<br>Renal (GRDB) |

## D. Substantial Equivalence:

The NxStage System Dosing Calculator is substantially equivalent to the Fresenius Pack H Hemodialysis Urea Kinetic Modeling Software Program, K955423.

## E. Device Description/Indications for Use:

#### Device Description:

The NxStage Dosing Calculator is a software modeling program designed to assist physicians and licensed healthcare practitioners in prescribing chronic hemodialysis therapy with the NxStage System One and NxStage Cartridge with pre-attached dialyzer. It allows physicians and licensed healthcare practitioners to determine a range of appropriate treatment frequencies, treatment durations, and therapy fluid volumes. The program incorporates formulas that have been published in peer reviewed journals of medicine and models treatment parameters for a range of possible treatment frequencies, volumes, and durations. This is a tool only and does not replace the need for the physician or licensed healthcare practitioner to make an independent determination of the therapy best suited for the patient.

## Indications for Use:

The NxStage Dosing Calculator is intended to provide chronic hemodialysis prescription options with the NxStage System One and Cartridge with pre-attached dialyzer based on patient and treatment parameters. With a specified set of algorithms, it automatically performs calculations that are typically done by a physician or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.

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## F. Technological Characteristics:

The proposed device has the same technological characteristics and is similar in design and configuration as the predicate device.

## G. Summary of Non-Clinical Test/Performance Testing - Bench

The information and data provided in this submission clearly describe the proposed device and demonstrate that the device is adequately designed for the labeled indications for use and substantially equivalent to predicate device. Performance, verification and validation testing was conducted to characterize performance of the proposed device. Verification and validation testing was conducted to characterize performance of the proposed device. This included testing for software readiness, software design review, and usability.

All predetermined acceptance criteria were met. Results of this testing also document that the proposed NxStage Dosing Calculator is substantially equivalent to the predicate device and is suitable for the labeled indications for use.

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Public Health Service

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

#### July 11, 2013

NxStage Medical, Inc. % Gregor Dzialas Regulatory Affairs Manager 350 Merrimack Street Lawrence, MA 01843

Re: K130460

Trade/Device Name: NxStage Dosing Calculator Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FKP Dated: June 5, 2013 Received: June 7, 2013

Dear Gregor Dzialas:

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.

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Page 2 - Gregor Dzialas

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 (reporting of medical device-related 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin BFisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K130460

NxStage Dosing Calculator Device Name:

Indications for Use:

The NxStage Dosing Calculator is intended to provide chronic hemodialysis prescription options with the NxStage System One and Cartridge with pre-attached dialyzer based on patient and treatment parameters. With a specified set of algorithms, it automatically performs calculations that are typically done by a physician or licensed healthcare practitioner. The algorithms used have been established and documented in scientific literature.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

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)

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# Benjamin R. Fish 2013.07 11 16:47: 3 -04'00'

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130460 510(k) Number