NXSTAGE CARTRIDGE EXPRESS

K014152 · Nxstage Medical, Inc. · KDI · Dec 11, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K014152
• Device Name: NXSTAGE CARTRIDGE EXPRESS
• Applicant: Nxstage Medical, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Dec 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. The NxStage Therapy System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. The NxStage Cartridge Express is part of the NxStage Therapy System and is intended for use with the NxStage Cycler.

Device Story

NxStage Cartridge Express is an extracorporeal blood tubing set with a preconnected high-flux hollow-fiber filter. It functions as a disposable component of the NxStage Therapy System, specifically designed for use with the NxStage Cycler. The device facilitates the extracorporeal circulation of blood for hemofiltration and ultrafiltration procedures to treat renal failure or fluid overload. It is intended for clinical use by healthcare professionals. The device provides the necessary fluid path and filtration interface for the therapy system to perform its clinical function.

Clinical Evidence

No clinical data. Substantial equivalence is supported by in vitro bench testing characterizing the performance of the hemofilter compared to predicate devices.

Technological Characteristics

Extracorporeal blood tubing set with preconnected high-flux (high permeability) hollow-fiber filter. Designed for use with the NxStage Cycler. Configuration and design are similar to legally marketed hemofilters/hemodialyzers.

Indications for Use

Indicated for patients with renal failure or fluid overload requiring hemofiltration and/or ultrafiltration therapy.

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

• SYNTRA Dialyzer (K002210)
• Cobe Arylane Hemodialyzer (K982414)
• Renoflo® II Hemofilter (K923312)
• Prisma CFM System hemofilter (K942679)

Submission Summary (Full Text)

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## 510(k) Summary for the NxStage Cartridge Express Page 1 of 2

DEC 11 2002

| Submitter's Name and Address: | NxStage Medical Inc.<br>439 Union Street<br>Lawrence, MA 01483 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number: | 978-687-4700 |
| Telefax Number: | 978-687-4800 |
| Contact Person: | Karen St. Onge, Director Quality Assurance<br>and Regulatory Affairs |
| Date Summary Prepared: | December 17, 2001 |
| Device Trade Name: | NxStage Cartridge Express |
| Common name: | Extracorporeal Blood Circuit w/ Hemofilter |
| Classification Name: | High Permeability Hemodialysis System (21<br>CFR 876.5860) |
| Substantial Equivalence: | The proposed device is substantially<br>equivalent to other legally marketed<br>hemofilters/hemodialyzers previously<br>cleared by the FDA via the 510(k)<br>Notification process such as the SYNTRA<br>Dialyzer (Baxter Healthcare Corporation,<br>K002210), Cobe Arylane Hemodialyzer<br>(Gambro Healthcare, K982414), Renoflo® II<br>Hemofilter (Minntech Corp, K923312) and to<br>the Prisma CFM System hemofilter (Hospal<br>Renal Intensive Care, K942679) also<br>provided preconnected to the hemofiltration<br>system disposable tubing set. |
| Device Description: | The NxStage Cartridge Express is an<br>extracorporeal blood tubing set with<br>preconnected high flux (permeability)<br>hollow-fiber filter. |
| Intended Use: | For treatment of renal failure or fluid<br>overload using hemofiltration and/or<br>ultrafiltration. |
| Technological Characteristics: | The proposed device has the same<br>technological characteristics and is similar<br>in design and configuration compared with<br>the predicate devices. |

lxStage Cartridge Ex
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KO14152

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# 510(k) Summary for the NxStage Cartridge Express Page 2 of 2

| Summary of Non-clinical Test: | In vitro testing was conducted to<br>characterize performance of the NxStage<br>Hemofilter to provide a basis of comparison<br>to the predicate devices. Results of in vitro<br>studies have documented that the NxStage<br>Cartridge Express is substantially equivalent<br>to the predicate devices and is suitable for<br>the intended use specified. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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Clinical Data:

Not applicable

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

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

### Re: K014152

Trade/Device Name: NxStage Cartridge Express Regulation Number: 21 CFR 8876.5860 Regulation Name: High permeability hemodialysis ·· svstem Regulatory Class: II Product Code: 78 KDI Dated: September 11, 2002 Received: September 12, 2002

Dear Ms. LeMay:

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 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); 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.

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This letter will allow you to begin marketing your device as described in your 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:

| 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K014152

Device Name: NxStage Cartridge Express

Indications for Use:

The NxStage Therapy System is indicated for treatment of renal failure or fluid overload using hemofiltration and/or ultrafiltration. The NxStage Cartridge Express is part of the NxStage Therapy System and is intended for use with the NxStage Cycler.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Seggern

Prescription Use

OR

Over-The-Counter

Use

(Per 21 CFR 801.109)