NXSTAGE PUREFLOW SL

K140571 · Nxstage Medical, Inc. · FKR · May 15, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K140571
• Device Name: NXSTAGE PUREFLOW SL
• Applicant: Nxstage Medical, Inc.
• Product Code: FKR · Gastroenterology, Urology
• Decision Date: May 15, 2014
• 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 is an accessory to the NxStage System One hemodialysis system. It functions as a water proportioning and purification subsystem. It takes tap water as input, which is processed through a Pre-Treatment Unit and a Purification Pack (PAK) using deionization and ultrafiltration to meet hemodialysis water quality standards. The device then mixes the purified water with electrolyte concentrate to produce dialysate. The system includes a Control Unit (CU) for monitoring, an integrated fluid warming pad, and uses flexible LLDPE bags for dialysate storage. It is intended for use in clinical or home settings as prescribed by a physician. The system performs automated conductivity measurements on the final batch prior to treatment to ensure safety and quality. The output is dialysate, which is used by the NxStage System One to perform hemodialysis, potentially benefiting patients by enabling home-based or flexible dialysis therapy.

Clinical Evidence

Bench testing only. Performance, verification, and validation testing were conducted to characterize the device and ensure it meets predetermined acceptance criteria. No clinical data was required or provided.

Technological Characteristics

Water purification via deionization and redundant ultrafiltration. Proportioning via volumetric dosing of purified water and electrolyte concentrate. Conductivity measurement per ANSI/AAMI/ISO 26722:2009. Materials include LLDPE bags. Integrated fluid warming pad. Batch size 20-60L. Meets ANSI/AAMI/ISO 13959:2009, 11663:2009, and 13958:2009 standards.

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 PFSL Module (K111174)

Submission Summary (Full Text)

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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. Submitter's Information: March 5, 2014 Date Name: NxStage Medical, Inc. 350 Merrimack Street Address: Lawrence, MA 01843 FDA Establishment 9045797 Owner/Operator Number: Contact Person: Mary Lou Stroumbos Director, Regulatory Affairs Phone: [phone] Fax: [phone] MEDIMEXICO, S. DE R.L. DE C.V. Manufacturer: Av. Valle imperial No. 10523 Parque industrial Valle Sur Tijuana, B.C., Mexico 22180

FDA Establishment Registration Number:

9616074

Sterilization Site:

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

Contract Sterilizer

510(k) Device Modification NxStage Medical, Inc.

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

### C. Substantial Equivalence:

P

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 modifications meets design specifications. The NxStage PFSL module with modifications has been compared to the legally marketed predicate device as cleared through K111174 (September 19, 2011) and was found to be substantially equivalent.

### D. Device Description/Indications for Use:

The NxStage PureFlow SL module is an optional accessory to the NxStage System One used to prepare water for hemodialysis that meets ANSI/AAMI/ISO 13959:2009 and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI/ISO 11663:2009. The PureFlow SL 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.

510(k) Device Modification NxStage Medical, Inc.

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

| Table 1<br>Device Technological Characteristics Comparison Table | | |
|------------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Proposed<br>NxStage PFSL Module<br>(subject of this 510(k)) | NxStage PFSL Module<br>(K111174) |
| Indication for Use | Same | The NxStage PureFlow SL<br>module is an optional accessory<br>to the NxStage System One that<br>prepares dialysate for use during<br>hemodialysis, as prescribed by<br>the physician. |
| Water Purification | | |
| Water purification<br>technology | Same | Deionization |
| Ultrafiltration | Same | Redundant ultrafiltration replaced<br>within 12- weeks |
| Water Quality | Same | Meets or exceeds requirements<br>per ANSI/AAMI/ISO 26722:2009<br>Water treatment equipment for<br>hemodialysis applications |
| Dialysate Proportioning : | | |
| Proportioning<br>method | Same | Mixed to use Batch via<br>volumetric dosing of purified<br>water with specified amount of<br>electrolyte concentrate |
| Table 1<br>Device Technological Characteristics Comparison Table | | |
| Feature | Proposed<br>NxStage PFSL Module<br>(subject of this 510(k)) | NxStage PFSL Module<br>(K111174) |
| Conductivity<br>Measurement | Same | Yes - the System measures final<br>batch conductivity prior to each<br>treatment per ANSI/AAMI/ISO<br>26722:2009 |
| Concentrate | | |
| Dialysate<br>Concentrate | Same | Standard hemodialysis<br>concentrate per ANSI/AAMI/ISO<br>13958:2009 |
| Packaging | Same | Packaged in flexible LLDPE<br>bags with standard luer lock<br>connector. Ranging in size from<br>20L to 60L |
| Buffer | Same | Lactate |
| Point of Use Dialysate Quality | | |
| Mix-to-Use Time | Same | 96-hours |
| Bioburden | Same | AAMI/ANSI/ISO 11663:<br><100 CFU/ml |
| Endotoxin | Same | AAMI/ANSI/ISO 11663:<br><0.5 EU/ml |
| Batch size | Same | Range – 20 to 60 L<br>(40, 50 and 60L currently<br>available) |
| Fluid warming | | |
| Method | Same | Integrated fluid warming pad |

510(k) Device Modification NxStage Medical, Inc.

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# NxStage Medical, Inc.

510(k) Device Modification
NxStage Medical, Inc.

.

Confidential

.

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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, verification and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria were met. Results of this testing have documented that the proposed NxStage PureFlow SL is substantially equivalent to the predicate device and is suitable for the labeled indications for use.

510(k) Device Modification NxStage Medical, Inc.

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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

May 15, 2014

NxStage Medical, Inc. Mary Lou Stroumbos Director, Regulatory Affairs 350 Merrimack Street Lawrence, MA 01843

Re: K140571

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: April 17, 2014 Received: April 18, 2014

Dear Mary Lou 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: CDRFI 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 - Mary Lou Stroumbos

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 (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 hup://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/McdicalDevices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for Beniamin 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): K140571

NxStage® PureFlow™ SL Device Name:

The NxStage PureFlow SL module is an optional Indications for Use: accessory to the NxStage System One™ that prepares dialysate for use during hemodialysis, as

prescribed by the physician.

Prescription Use Use (Part 21 CFR 801 Subpart D) Over-The-Counter

(21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner-S
2014.05.15 15:31:51 -04'00'

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