NXSTAGE SYSTEM ONE

K041424 · Nxstage Medical, Inc. · KDI · Jul 2, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041424
• Device Name: NXSTAGE SYSTEM ONE
• Applicant: Nxstage Medical, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jul 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NxStage System One, consisting of hardware, software and a sterile disposable cartridge, is indicated for the treatment of renal failure or fluid overload using hemofiltration, hemodialysis and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.

Device Story

NxStage System One is a hemodialysis system comprising hardware, software, and a sterile disposable cartridge. It performs hemofiltration, hemodialysis, and ultrafiltration to treat renal failure or fluid overload. The device is operated by a healthcare provider under physician prescription. It processes blood and dialysate through the disposable cartridge to manage patient fluid and solute levels. The system provides therapy to patients in clinical settings, assisting healthcare providers in managing renal conditions and fluid balance.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design control certification and comparison of technological characteristics.

Technological Characteristics

System consists of hardware, software, and a sterile disposable cartridge. Functions as a high permeability hemodialysis system (21 CFR 876.5860).

Indications for Use

Indicated for patients with renal failure or fluid overload requiring hemofiltration, hemodialysis, or ultrafiltration. Must be administered by a healthcare provider under physician prescription.

Regulatory Classification

Identification

A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ” (2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,” (3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,” (4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and (5) “Guidance for Hemodialyzer Reuse Labeling.”

Predicate Devices

• NxStage System One (K030470)
• Fresenius 2008K

Submission Summary (Full Text)

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K041424
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# Section 7 510(K) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The contents of this 510(k) summary have been provided in conformance with 21 CFR 1807.92.

| Date: | May 27, 2004 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Hemodialysis System |
| Trade/Proprietary Name: | NxStage System One |
| Classification Name &<br>Device Classification: | Dialyzer, High Permeability with or without<br>Dialysate System; Class II |
| Product Code: | KDI |
| 21 CFR Ref.: | 876.5860 |
| 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>South Lawrence, MA 01843<br>Owner/Operator No. 9045797 |
| Contact Person: | Norma LeMay<br>Manager, Regulatory Affairs |

## Device Description:

The NxStage System One, consisting of hardware, software and a sterile disposable cartridge, is indicated for the treatment of renal failure or fluid overload using hemofiltration, hemodialysis and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.

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KC41424
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#### Substantial Equivalence:

This submission is a Special 510(k) Device Modification as described in FDA's guidance document entitled *The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Pre-Market Notifications." In support of this 510(k), NxStage has provided certification of compliance to 21 CFR 820.30 Design Control requirements. The NxStage System One, with one modified warning, has been compared to the Fresenius 2008K and the baseline NxStage System One (K030470) and found to be substantially equivalent.

#### Conclusion:

Based on the device's indication for use, a comparison of descriptive and technological characteristics to the baseline and Fresenius 2008K, and design control certification, the modified NxStage System One device labeling has been shown to meet the minimum requirements that are considered acceptable for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings. The eagle is facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2004

Ms. Norma LeMay Manager, Regulatory Affairs NxStage Medical, Inc. 439 South Union Street 5th Floor LAWRENCE MA 01843

Re: K041424

Trade/Device Name: NxStage System One Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: May 27, 2004 Received: May 28, 2004

Dear Ms. LeMay:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclobare) to tegans to the Medical Device Amendments, or to conninered provide to may 20, 1978) in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act that do not require approval approval application (PMA). and Cosmette for (10) that do nev sequent to the general controls provisions of the Act. The r ou may, atorely 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 cither class II (Special Controls) or class III (PMA), it your dovied is bluestilied were are as . 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 r lease of as now a had i bermination that your device complies with other requirements of the Act that I Dr Has Interes and regulations administered by other Federal agencies. You must or urf I vatin bathere is requirements, including, but not limited to: registration and listing Comply with an the Not 11st Progantially, t 801); good manufacturing practice requirements as set (21 CFR Part 820) regulation (21 CFR Part 820); and if applicable, the electronic rordly in the quality by stations (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 ocgin marketing of substantial equivalence of your device to a legally premarket notification. The PDA mioning of backless of the results 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 It you desire specific advice for your dones on one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, Tor questions of the promotion in the regulation entitled, "Misbranding
Office of Compliance at [phone]. Also, please note the regulation entitled, "Mis Othce of Compliance at (301) 57 + 1059. Fact 807.97) you may obtain. Other general by reference to prematical nonitodion (2) ex extenned from the Division of Strall information on your responsionalis and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Collisanter - Leaver - Leaver - Schools - School

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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### Indications for Use

510(k) Number (if known):

K041424

Device Name:

NxStage System One

Indications for Use:

The NxStage System One is indicated for the treatment of renal failure or fluid overload using hemofiltration, hemodialysis and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.

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)

Nancy C brogdon

Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041424

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