NXSTAGE PUREFLOW SL

K111174 · Nxstage Medical, Inc. · FKR · Sep 19, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K111174
• Device Name: NXSTAGE PUREFLOW SL
• Applicant: Nxstage Medical, Inc.
• Product Code: FKR · Gastroenterology, Urology
• Decision Date: Sep 19, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NxStage PureFlow SL module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.

Device Story

The NxStage PureFlow SL (PFSL) is an accessory to the NxStage System One hemodialysis system. It processes water and proportions it with dialysate concentrate to produce dialysate for hemodialysis. The system comprises a Control Unit, water Pre-Treatment Unit, optional OPTA Kit, Purification Pack (PAK), and Dialysate Sack (SAK). The device is used to prepare dialysate for clinical or home hemodialysis settings. This modification extends the mix-to-use (MTU) time of prepared dialysate from 72 to 96 hours. The healthcare provider uses the produced dialysate for patient treatment; the device ensures the dialysate meets specific purity standards, potentially benefiting patients by extending the duration of dialysate availability.

Clinical Evidence

Bench testing only. Testing included stability, bioburden, and endotoxin analysis on validation batches of dialysate to support the 96-hour MTU duration. Results confirmed compliance with ANSI/AAMI/ISO 11663:2009 requirements, specifically < 100 CFU/ml bioburden and < 0.5 EU/ml endotoxin (LAL).

Technological Characteristics

The system includes a Control Unit, water Pre-Treatment Unit, Purification Pack, and Dialysate Sack. It functions by water treatment and proportioning of dialysate concentrate. It adheres to ANSI/AAMI/ISO 13959:2009, 26722:2009, and 11663:2009 standards. The modification involves firmware/control logic changes to support a 96-hour MTU duration.

Indications for Use

Indicated for patients requiring hemodialysis, as prescribed by a physician, using the NxStage System One.

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

• NxStage PureFlow SL (K080919)

Submission Summary (Full Text)

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K111174
page 1 of 2

SEP 19 2011

This 510(k) Summary is being submitted in accordance with the requirements of the SafeSEP 1 9 2011
Modied Baying Art (OMDA) of 1999 - The section at including this all in Medical Device Act (SMDA) of 1990. The content contained in this 510(k) summary has been provided in conformance with 21 CFR §807.92.

9045797

Mary Lou Stroumbos

[phone]

[phone]

Date of Summary: August 26, 2011

A. Submitter's Information:

| Name: | NxStage Medical, Inc. |
|----------|---------------------------------------------------------|
| Address: | 439 South Union Street, 5th Floor<br>Lawrence, MA 01843 |

FDA Establishment Owner/Operator Number:

Contact Person:

Phone: Fax:

Manufacturer:

Entrada Group/NxStage Carretera Fresnillo A Plateros, KM2 Fresnillo, Zacatecas 99059 Mexico

Sr. Regulatory Affairs Associate

FDA Establishment Registration Number:

3006546166

Sterilization Site:

Steris Isomedix, Inc. 1000 S. Sarah Place Ontario, CA 91761

- B. Subject Device Name: Trade/Proprietary Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Classification: Device Panel:
NxStage PureFlow SL Subsystem, proportioning Hemodialysis systems and accessories 21 CFR 876.5820 78 FKR Class II Gastroenterology-Urology (GU)/Gastro-Renal (GRDB)

510(k) Summary NxStage Medical, Inc.

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K111174
page 2 of 2

### C. Substantial Equivalence:

This submission is a Special 510(k) Device Modification as described in the FDA's Guidance document entitled, "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this Special 510(k), NxStage has provided certification of compliance to 21 CFR §820.30 Design Control Requirements. Design validation testing was performed to ensure that the NxStage PureFlow SL (PFSL) module with modification to increase the mix to use (MTU) time of the prepared dialysate from 72-hours to 96-hours meets design specifications. The NxStage PFSL module with modifications has been compared to the legally marketed PFSL predicate device as cleared through K080919 (October 15, 2008) and was found to be substantially equivalent.

# D. Device Description/Indications for Use:

The NxStage PFSL module is an optional accessory to the NxStage System One that is used to treat water for hemodialysis per ANSI/AAMI/ISO 13959:2009 and ANSI/AAMI/ISO 26722:2009 and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI/ISO 11663:2009. The PFSL module consists of the Control Unit (CU), the water Pre-Treatment Unit, the optional OPTA Kit, the Purification Pack (PAK), and the Dialysate Sack (SAK) with Dialysate Concentrate.

### Indications for use:

The NxStage PureFlow SL module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.

### E. Technological Characteristics:

The indications for use of the proposed device and of the predicate device are identical. There is no change to the indications for use or intended use of the PureFlow SL module, and the modification has no affect on the fundamental scientific technology of the device. The proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate device.

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

NxStage believes that the information and data provided in this submission clearly describes the proposed device and demonstrates that the device is adequately designed for the labeled indications for use. Performance and verification and validation testing was conducted to characterize performance of the proposed device. This included stability, bioburden and endotoxin testing on validation batches of dialysate to support the extension of the MTU duration to 96-hours. All predetermined acceptance criteria were met. The NxStage PureFlow SL meets the ANSI/AAMI/ISO 11663:2009 requirements of < 100 CFU/ml bioburden and < 0.5 EU/ml endotoxin (LAL). Results of this testing have documented that the proposed NxStage PureFlow SL with 96-hour MTU time is substantially equivalent to the predicate device and is suitable for the labeled indications for use.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "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. Mary Lou Stroumbos Sr. Regulatory Affairs Associate NxStage Medical. Inc. 439 South Union Street, 5th Floor LAWRENCE MA 01843

SEP 1 9 2JU

Re: K11174

Trade/Device Name: NxStage® PureFlow™ SL Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FKR Dated: August 26, 2011 Received: August 29, 2011

Dear Ms. Stroumbos:

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

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adverse events) (21 CFR 803); 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.

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Hubert H Humphrey

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

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#### INDICATIONS FOR USE

| 510(k) Number (if known): | K111174 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | NxStage® PureFlow™ SL |
| Indications for Use: | The NxStage PureFlow SL module is an optional<br>accessory to the NxStage System One™ that prepares<br>dialysate for use during hemodialysis, as prescribed by the<br>physician. |

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aayú M. When

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(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111174