NXSTAGE PUREFLOW SL

K080919 · Nxstage Medical, Inc. · FKR · Oct 15, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080919
• Device Name: NXSTAGE PUREFLOW SL
• Applicant: Nxstage Medical, Inc.
• Product Code: FKR · Gastroenterology, Urology
• Decision Date: Oct 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

NxStage PureFlow SL (PFSL) module functions as an optional accessory to the NxStage System One hemodialysis system. Device treats water and proportions it with dialysate concentrate to produce dialysate for hemodialysis. Components include a Control Unit (CU), water Pre-Treatment Unit, Purification Pack (PAK), and Dialysate Sack (SAK). System operates to meet ANSI/AAMI RD52:2004 and RD62:2006 standards. Used in clinical or home settings under physician prescription to facilitate hemodialysis therapy.

Clinical Evidence

Bench testing only. Performance, verification, and validation testing were conducted to characterize the modified PFSL module and demonstrate substantial equivalence to the predicate device.

Technological Characteristics

System comprises a Control Unit, water Pre-Treatment Unit, Purification Pack, and Dialysate Sack. Produces dialysate per ANSI/AAMI RD52:2004 and ANSI/AAMI RD62:2006. Operates as an accessory to the NxStage System One.

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 (K060296)

Submission Summary (Full Text)

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K0806919
PAGE 1 OF 2

### NxStage Medical, Inc. NxStage PureFlow SL (PFSL) 510(k) Device Modification

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:

| Name: | NxStage Medical Inc. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------|
| Address: | 439 South Union Street, 5th Floor<br>Lawrence, MA 01843 |
| FDA Establishment<br>Owner/Operator Number: | 9045797 |
| Contact Person: | Michael Doyle<br>Manager, Regulatory Affairs |
| Phone:<br>Fax: | [phone]<br>[phone] |
| Manufacturing Site: | Entrada Group/NxStage<br>Carretera Fresnillo A Plateros, KM2<br>Fresnillo, Zacatecas 99059<br>Mexico |
| FDA Establishment<br>Registration Number: | 3006546166 |
| Manufacturing/Sterilization<br>Site: | Steris Isomedix, Inc.<br>1000 S. Sarah Place<br>Ontario, CA 91761 |
| B. Device Name: | |
| Trade/Proprietary Name: | NxStage PureFlow SL |
| Common/Usual Name: | Subsystem, proportioning |
| Classification Name: | Hemodialysis Systems & Accessories |
| Regulation Number: | 876.5820 |
| Product Code: | 78 FKR |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology/Urology |

Special 510(k)

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# NxStage Medical, Inc. NxStage PureFlow SL (PFSL) Special 510(k) Device Modification

- C. Substantial Equivalence/Predicate Devices:
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 predicated device as cleared through K060296 (March 31, 2006) 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 and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI RD52:2004 and ANSI/AAMI RD62: 2006. The PFSL module consists of the Control Unit (CU), the water Pre-Treatment Unit, the Purification Pack (PAK), and the Dialysate Sack (SAK) with Dialysate Concentrate.

### Indications for use:

The NxStage PFSL 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. The proposed device is designed with similar components and features also used in the predicate device.

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

NxStage Medical, Inc. 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 PFSL to provide a basis of comparison to the predicate device as all features are not identical. Results of this testing have documented that the proposed PFSL module is substantially equivalent to the predicate device and is suitable for the labeled indications for use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it.

OCT 15 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael J. Doyle Manager, Regulatory Affairs NxStage Medical, Inc. 439 South Union Street, 5th Floor LAWRENCE MA 01843

K080919 Re:

> 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 12, 2008 Received: August 13, 2008

Dear Mr. Doyle:

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.

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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### Page 2

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 (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.

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (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 Biometrics' (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 vours.

Jorgu M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K08919 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | NxStage PureFlow SL |
| Indications for Use: | The NxStage PureFlow SL module is an optional accessory to<br>the NxStage System One that prepares dialysate for use during<br>hemodialysis, as prescribed by the physician. |

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)

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

510(k) Number K080919

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Special 510(k)

NxStage Page 19