Who is the manufacturer of NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS?

Nxstage Medical, Inc. filed the 510(k) submission for NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS (K123395).

What is the FDA product code for NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS?

KDI. It is classified under 21 CFR 876.5860 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS

Q: What are the predicate devices for NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS?

NxStage Cartridge Express (K061387); Gambro Cartridge Blood Set Low Weight - Low Volume Set (K100364); Gambro Prisma M60 Set (K032431); Minntech HF Junior Hemofilter (K071298); Minntech High Permeability Dialyzer (K923312).

K123395 · Nxstage Medical, Inc. · KDI · Mar 7, 2013 · Gastroenterology, Urology

Device Facts

Record ID	K123395
Device Name	NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
Applicant	Nxstage Medical, Inc.
Product Code	KDI · Gastroenterology, Urology
Decision Date	Mar 7, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5860
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The NxStage System One Low Volume Cartridge Express is indicated for use only with the NxStage System One, in a chronic care dialysis facility or acute care unit. It is indicated for use in adult patients for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

Device Story

Single-use extracorporeal blood circuit and fluid management device; includes pre-attached high-flux hollow-fiber filter; mounts integrally within NxStage System One cycler. Operates by removing solutes via diffusion or convection; provides continuous/intermittent hemofiltration, hemodialysis, and ultrafiltration. Used in chronic care dialysis facilities or acute care units; operated by trained, qualified personnel under physician prescription. Output consists of processed blood returned to patient; clinical benefit includes management of renal failure and fluid overload.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included integrity/pressure leak, priming volume, tensile strength, kink resistance, hemocompatibility, pressure drop, ultrafiltration rates, clearance determination, and sieving coefficients. Simulated use testing confirmed device performance met all acceptance criteria.

Technological Characteristics

Disposable extracorporeal circuit with polyethersulfone hollow-fiber filter. Fiber internal diameter: 200 μm; wall thickness: 30 μm; effective surface area: 0.21 m². Priming volume: 15 mL (filter), 70 mL (total set). Max transmembrane pressure (TMP): 500 mmHg. Sterilized for single use. Integrates with NxStage System One cycler.

Indications for Use

Indicated for adult patients with acute or chronic renal failure or fluid overload requiring hemofiltration, hemodialysis, or ultrafiltration in chronic care or acute care facilities.

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 Cartridge Express (K061387)
Gambro Cartridge Blood Set Low Weight - Low Volume Set (K100364)
Gambro Prisma M60 Set (K032431)
Minntech HF Junior Hemofilter (K071298)
Minntech High Permeability Dialyzer (K923312)

Related Devices

K061837 — NXSTAGE CARTRIDGE EXPRESS · Nxstage Medical, Inc. · Jul 31, 2006
K050727 — MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS · Nxstage Medical, Inc. · Jun 13, 2005
K032356 — NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS · Nxstage Medical, Inc. · Oct 28, 2003
K050525 — NXSTAGE SYSTEM ONE · Nxstage Medical, Inc. · Jun 24, 2005
K040696 — MODIFICATION TO NXSTAGE SYSTEM ONE · Nxstage Medical, Inc. · May 26, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ # 510K Summar K123395 # NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification MAR 0 7 2013 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. Date: | March 4, 2013 | |------------------------------------------------|--------------------------------------------------------------------------------------| | B. Submitter's Information: | | | Name: | NxStage Medical, Inc. | | Address: | 350 Merrimack Street Lawrence, MA 01843 United States | | FDA Establishment Owner/Operator Number: | 9045797 | | Contact Person: | Mary Lou Stroumbos Regulatory Affairs Manager | | Phone: | (978) 687-4872 | | Fax: | (978) 687-4750 | | Manufacturer: | NxStage Medical, Inc. 350 Merrimack Street Lawrence, MA 01843 United States | | FDA Establishment Registration Number: | 3003464075 | | Sterilization Site: | Steris Isomedix 1000 S. Sarah Place Ontario, CA 91761 | 510(k) Premarket Notification NxStage Medical, Inc. Page 1 of 7 {1}------------------------------------------------ # NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification ### C. Device Name: | Trade/Proprietary Name: | NxStage System One Low Volume Cartridge Express | |-------------------------|---------------------------------------------------------------------------------| | Common/Usual Name: | Dialyzer with High Permeability Hemodialysis System | | Classification Name: | High Permeability Hemodialysis System | | Regulation Number: | 21 CFR 876.5860 | | Product Code: | 78 KDI – Dialyzer, High Permeability with or without Sealed Dialysate System | | Device Classification: | Class II | | Device Panel: | Gastroenterology-Urology (GU)/Gastro- Renal (GRDB) | ### D. Predicate Devices: | NxStage Cartridge Express | K061387 | |--------------------------------------------------------|---------| | Gambro Cartridge Blood Set Low Weight - Low Volume Set | K100364 | | Gambro Prisma M60 Set | K032431 | | Minntech HF Junior Hemofilter | K071298 | | Minntech High Permeability Dialyzer | K923312 | ### E. Substantial Equivalence: The NxStage System One Low Volume Cartridge Express device is substantially equivalent in design, function and operation to the identified predicates. ### F. Device Description/Indications for Use: The NxStage System One Low Volume Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollow-fiber filter that mounts integrally within the NxStage Cycler. {2}------------------------------------------------ ### NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification ### Indications for use: The NxStage System One Low Volume Cartridge Express is indicated for use only with the NxStage System One, in a chronic care dialysis facility or acute care unit. It is indicated for use in adult patients for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician. ### G. Technological Characteristics The proposed device has the same technological characteristics and is similar in design and configuration as the predicate devices. | Device Comparison Table | | | | | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Parameter | NxStage System One Low Volume Cartridge Express | Predicate Device NxStage Cartridge Express K061837 | Predicate Device *Gambro Cartridge Blood Set Low Weight Low Volume K100364 | Predicate Device Gambro Prisma M60 Disposable Set K032431 | | PRODUCT | Disposable extracorporeal circuit for use with the NxStage System One. Consists of dialyzer and disposable NxStage Cartridge. | Disposable extracorporeal circuit for use with the NxStage System One. Consists of dialyzer and disposable NxStage Cartridge. | Disposable, extracorporeal circuit for use with the Phoenix Dialysis Delivery System | Disposable, extracorporeal circuit for use with the Prismaflex system. Consists of AN69 hollow fiber hemofilter dialyzer and tubing lines. | | Device Comparison Table | | | | | | Parameter | NxStage System One Low Volume Cartridge Express | Predicate Device NxStage Cartridge Express K061837 | Predicate Device *Gambro Cartridge Blood Set Low Weight Low Volume K100364 | Predicate Device Gambro Prisma M60 Disposable Set K032431 | | INDICATIONS FOR USE | The NxStage System One Low Volume Cartridge Express is indicated for use only with the NxStage System One in a chronic care dialysis facility or acute care unit. It is indicated for use in adult patients for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. | The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is also indicated for hemodialysis with our without ultrafiltration in the home. | The Gambro Cartridge Blood Set Low Weight- Low Volume is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System. The Low-Weight Low Volume model is used when a low extra-corporeal blood volume is recommended. The Low Weight- Low Volume model with a priming volume of 40 ml is indicated for patients with a body weight greater than 15 kg and lower or equal to 20 kg. | Indicated for use with the Prisma control unit in providing continuous fluid management and renal replacement therapies for patients who have acute renal failure, fluid overload, or both. | | | All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician. | All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician. | | | | Device Comparison Table | | | | | | Parameter | NxStage System One Low Volume Cartridge Express | Predicate Device NxStage Cartridge Express K061837 | Predicate Device *Gambro Cartridge Blood Set Low Weight Low Volume K100364 | Predicate Device Gambro Prisma M60 Disposable Set K032431 | | THERAPIES INDICATED | Continuous/ intermittent hemofiltration and/or ultrafiltration. Continuous/ intermittent hemodialysis and/or ultrafiltration and slow continuous ultrafiltration | Continuous/ intermittent hemofiltration and/or ultrafiltration. Continuous/ intermittent hemodialysis and/or ultrafiltration and slow continuous ultrafiltration | Hemodialysis | SCUF-slow continuous ultrafiltration CVVH-continuous venovenous hemofiltration CVVHD- continuous hemodialysis CVVHDF- continuous venovenous hemodiafiltration | | PRINCIPLE OF OPERATION | Removal of solutes via diffusion or convection | Removal of solutes via diffusion or convection | Removal of solutes via diffusion | Removal of solutes via diffusion and/or convection | | HOW SUPPLIED | Dialyzer pre- connected to disposable NxStage Cartridge | Dialyzer pre- connected to disposable NxStage Cartridge | Sterile non pyrogenic blood pathway is supplied sealed in plastic package | The Prismaflex M60 set consists of an AN69 hollow fiber hemofilter dialyzer and tubing lines | | PRIMING VOLUME | 15 mL (filter) 70 mL (cartridge set total) | 91 mL (filter) 175 – 200 mL (cartridge set total) | 40 mL (blood tubing set) | 42mL ± 10% (filter) 93 mL (Set total) | {3}------------------------------------------------ # K123395 # NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification 510(k) Premarket Notification NxStage Medical, Inc. {4}------------------------------------------------ # NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification *Note: K100364 does not feature a pre-attached dialyzer. : {5}------------------------------------------------ # K123395 ### NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification | Device Comparison Table | | | | | | |-------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------| | Parameter | NxStage System One Low Volume Cartridge Express | Predicate Device NxStage Cartridge Express K061837 | Predicate Device Gambro Prisma M60 Disposable Set K032431 | Predicate Device Minntech HF Junior Hemofilter K071298 | Predicate Device Minntech High Permeability Dialyzer K923312 | | FIBERS | Polyethersulfone | Polyethersulfone | Acrylonitrile and sodium methallyl sulfonate copolymer | Polysulfone | Polysulfone | | FIBER INTERNAL DIAMETER | 200 μm | 200 μm | 240 μm | 200 μm | 200 μm | | FIBER WALL THIICKNESS | 30 μm | 30 μm | 50 μm | Not available | Not available | | FIBER LENGTH | 10 cm | 23 cm | 27 cm overall dimension | 15 cm overall dimension | 9.42 cm | | EFFECTIVE SURFACE AREA | 0.21 m² | 1.6 m² | 0.60 m² | 0.09 m² | 0.30 m² | | PRIMING VOLUME | 15 ml (filter) 70 ml (cartridge) | 91 ml (filter) 175 – 200 ml (cartridge) | 42 ml ± 10% (blood priming volume in filter) (93 ml blood volume in set) | 8 ml (filter) | 28 ml (filter) | | MAX. TMP | 500 mmHg | 500 mmHg | 450 mmHg | 500 mmHg | 500 mmHg | ### H. Summary of Non-Clinical Test/Performance Testing - Bench The information and data provided in this submission clearly describe the proposed device and demonstrate that the device is adequately designed for the labeled indications for use and substantially equivalent to predicate devices. Performance, verification and validation testing was conducted to characterize performance of the proposed device. This included testing for the integrity of the strength between connections (pressure leak testing); priming volume assessment; tensile testing of joints and materials of tubing segments; tubing clamps testing; kink resistance testing; hemocompatibility {6}------------------------------------------------ ### NxStage Medical, Inc. . NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification testing; pressure drop, ultrafiltration rates, clearance determination, and sieving coefficients testing, as well as simulated use testing. All predetermined acceptance criteria were met. Results of this testing also document that the proposed NxStage System One Low Volume Cartridge Express device is substantially equivalent to the predicate devices and is suitable for the labeled indications for use. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 7, 2013 NxStage Medical, Inc. % Ms. Mary Lou Stroumbos Regulatory Affairs Manager 350 Merrimack Street LAWRENCE MA 01843 Re: K123395 Trade/Device Name: NxStage System One Low Volume Cartridge Express Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: January 31, 2013 Received: February 5, 2013 Dear Ms. 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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH 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. {8}------------------------------------------------ Page 2 - Ms. 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 (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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://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/MedicalDevices/Safety/ReportaProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Image /page/8/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a stylized font. The name is written in black ink and is easily readable. The letters "R" and "F" are stylized with a geometric design. Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ### Indications for Use #### 510(k) Number (if known): K123395 Device Name: NxStage System One Low Volume Cartridge Express Indications for Use: The NxStage System One Low Volume Cartridge Express is indicated for use only with the NxStage System One in a chronic care dialysis facility or acute care unit. It is indicated for use in adult patients for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician. Prescription Use × (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) Page 1 of 1 Benjamin R. 2013.03.07 16: (Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123395 510(k) Number ________________________________________________________________________________________________________________________________________________________________

NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

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NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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