MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION

K053286 · Nxstage Medical, Inc. · KPO · Dec 22, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K053286
• Device Name: MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION
• Applicant: Nxstage Medical, Inc.
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Dec 22, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Device Story

NxStage PureFlow-B Solution consists of non-pyrogenic dialysis solutions with bicarbonate buffer; provided in single-use flexible bags. Used with renal replacement therapy systems requiring sterile premixed dialysate. Allows physicians to prescribe specific electrolyte compositions to meet individual patient needs. Device is a consumable fluid component for hemodialysis systems.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control certification and comparison to predicate.

Technological Characteristics

Non-pyrogenic dialysis solution with bicarbonate buffer; supplied in single-use flexible bags. Electrolyte composition is variable based on physician prescription.

Indications for Use

Indicated for use with renal replacement therapy systems utilizing sterile premixed dialysate during hemodialysis. No specific patient population, age, or contraindications provided.

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

• K042045

Submission Summary (Full Text)

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K053286

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DEC 2 2 2005

## Section 7

# 510(K) Summary of Safety Effectiveness

This 510(k) summary of safety and effectiveness information is being summitted in The UTG(K) Bammary of the Safe Medical Device Act (SMDA) of 1990. The accordance with the requirements have been provided in conformance with 21 CFR \$807.92.

| Date: | November 23, 2005 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Premixed Dialysate for Hemodialysis |
| Trade/Proprietary Name: | NxStage PureFlow-B Solution |
| Classification Name: | Hemodialysis systems and accessories<br>(21 CFR 876.5820) |
| Device Classification: | Class II |
| Product Code: | 78 KPO - Dialysate Concentrate for Hemodialysis<br>(Liquid or Powder) |
| Device Panel: | Gastroenterology-Urology (GU)/Gastro-Renal<br>(GRDB) |
| 510(k) Sponsor &<br>Owner/Operator: | NxStage Medical, Inc<br>439 South Union St, Suite 501<br>Lawrence, MA 01843<br>Owner/Operator No. 9045797<br>Establishment Registration #3003464075 |
| Contact Person: | Norma LeMay<br>Manager, Regulatory Affairs |

### Device Description:

The NxStage PureFlow-B Solutions (with bicarbonate buffer) are non-pyrogenic dialysis solutions provided in single use flexible bags. The PureFlow-B Solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate. The range of constituents allows the physician to prescribe different electrolyte compositions that meet the specific needs of individual patients.

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K053286 Poper 2012

### Substantial Equivalence:

Substantial Equivalence:
This submission is a Special 510(k) Device Modification as described in FDA's guidance This Submison is a creatigm - Alternate Approaches to Demonstrating document entilliou "The Free Market Notifications." In support of this 510(k), NxStage Substantial Equivalierson of compliance to 21 CFR 820.30 Design Control requirements. nas provided cortined. For the more that the modified device that the modified device meets Design validations. The modified NxStage PureFlow-B Solution has been compared to the baseline as cleared in K042045 and found to be substantially equivalent.

### Conclusion:

Oonoloon: characteristics, and design control certification, the modified NxStage PureFlow-B Solution has been shown to meet the minimum requirements that are considered Obliation The been of one and found to be substantially equivalent to the baseline device.

Confidential

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2005

Ms. Norma LeMay Manager, Regulatory Affairs NxStage Medical, Inc. 439 South Union Street Suite 501 LAWRENCE MA 01843

Re: K053286

K055260
Trade/Device Name: NxStage PureFlow-B Solution Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: November 23, 2005 Received: November 25, 2005

Dear Ms. LeMay:

We have reviewed your Section 510(k) premarket notification of intent to maket the device for use attend in We have reviewed your Section Fronty promation in the indications for use stated in
above and have determined the device is substantially equivalent (for the stated in above and nave determined the device is accessions of the state commerce prior to the enclosure) to legally marketcc predical Device Anendments, or to devices that have been May 28, 1976, the enactinent date of the Federal Food, Dugg, and Cosmetic Act (Act) that the reclassified in accordance with the provisions of application (PMA). You may, therefore, market the A do not require approval of a prematics approval approvations (The general controls provisions of the Act device, subject to the general controls provisions of devices, good manufacturing practice, labeling, metade requires against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (see above) micelar existing major regulations affecting your Approval), if may be subject to such additions, Title 21, Parts 800 of 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Parts 800 nove device can be found in the Code of Footerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA STISualles of a substances with other requirements of the Act of all FDA has made a decemmation mar your do rout we frederal agencies. You must comply with all the Federal statutes and regulations administered of other and listing (21 CFR Part 807); labeling (4) Act's requirements, including, but not mined to regultements as set forth in the quality systems (QS)
(21 CFR Part 801); good manufacturing practice requirements as set forcu (21 CFR Part 801); good manufacturing practice requires.
regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
. This letter will allow you to ocgn marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivals and thus, pe premarket notification. The FDA miding of substantial or 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), pleased
ation in the may be and the fill of the first anymbers, becad on the reg If you desire specific advice for your device on our laborating any in 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" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general information on John September Assistance at its toll-free number (800) Division 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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Ko53286

### Indications for USE

310ik) Number (if known):

ිevice Name: .

...

NxStage PureFlow-B Solution

m.lications for User

NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

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ANDIOR

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)

David A. Legum

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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