(122 days)
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.
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.
The provided 510(k) summary for the NxStage System One Low Volume Cartridge Express details non-clinical bench testing to demonstrate substantial equivalence to predicate devices. However, it does not explicitly define specific quantitative acceptance criteria or provide the detailed results of each test in a table format as requested. Instead, it offers a general statement that "All predetermined acceptance criteria were met."
Therefore, I cannot populate a table with specific acceptance criteria and reported device performance directly from the provided text. I can only infer the types of testing performed and the general outcome.
Here's a breakdown of the information that can be extracted based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Integrity of strength between connections (pressure leak testing) | "All predetermined acceptance criteria were met." |
| Priming volume assessment | "All predetermined acceptance criteria were met." |
| Tensile testing of joints and materials of tubing segments | "All predetermined acceptance criteria were met." |
| Tubing clamps testing | "All predetermined acceptance criteria were met." |
| Kink resistance testing | "All predetermined acceptance criteria were met." |
| Hemocompatibility testing | "All predetermined acceptance criteria were met." |
| Pressure drop determination | "All predetermined acceptance criteria were met." |
| Ultrafiltration rates determination | "All predetermined acceptance criteria were met." |
| Clearance determination | "All predetermined acceptance criteria were met." |
| Sieving coefficients testing | "All predetermined acceptance criteria were met." |
| Simulated use testing | "All predetermined acceptance criteria were met." and "suitable for the labeled indications for use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "Performance, verification and validation testing was conducted" and refers to "bench" testing. It does not specify the sample size for any of the tests, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective study design). This appears to be non-clinical, in-vitro testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The study described is a non-clinical bench test of a medical device (dialysis cartridge), not a study involving expert assessment of patient data or images to establish a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically associated with studies requiring human interpretation or subjective assessment. The tests performed are objective, quantitative bench tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. An MRMC study is not mentioned as this submission is for a medical device (dialysis cartridge), not an AI-assisted diagnostic tool or an imaging device requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not directly applicable in the context of an "algorithm only" performance because the device is a physical medical component, not a software algorithm. However, the bench testing conducted can be considered "standalone" in that it evaluates the device's performance independently, without human interaction during the test itself (though humans operate the testing equipment).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the bench tests would be the established scientific and engineering principles, material specifications, and regulatory standards for a high permeability hemodialysis system. For instance, for "priming volume assessment," the ground truth would be the accurately measured volume according to standardized procedures. For "pressure drop," the ground truth is the physically measured pressure differential. These are objective physical measurements rather than subjective assessments.
8. The sample size for the training set
This section is not applicable. The device is a physical medical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set for this type of device submission.
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510K Summar
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 StreetLawrence, MA 01843United States |
| FDA EstablishmentOwner/OperatorNumber: | 9045797 |
| Contact Person: | Mary Lou StroumbosRegulatory Affairs Manager |
| Phone: | (978) 687-4872 |
| Fax: | (978) 687-4750 |
| Manufacturer: | NxStage Medical, Inc.350 Merrimack StreetLawrence, MA 01843United States |
| FDA EstablishmentRegistration Number: | 3003464075 |
| Sterilization Site: | Steris Isomedix1000 S. Sarah PlaceOntario, CA 91761 |
510(k) Premarket Notification NxStage Medical, Inc.
Page 1 of 7
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NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification
C. Device Name:
| Trade/Proprietary Name: | NxStage System One Low VolumeCartridge Express |
|---|---|
| Common/Usual Name: | Dialyzer with High PermeabilityHemodialysis System |
| Classification Name: | High Permeability Hemodialysis System |
| Regulation Number: | 21 CFR 876.5860 |
| Product Code: | 78 KDI – Dialyzer, High Permeability withor 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.
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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 SystemOne LowVolumeCartridgeExpress | PredicateDeviceNxStageCartridgeExpressK061837 | PredicateDevice*GambroCartridgeBlood Set LowWeight LowVolumeK100364 | PredicateDevice GambroPrisma M60Disposable SetK032431 |
| PRODUCT | Disposableextracorporealcircuit for use withthe NxStageSystem One.Consists ofdialyzer anddisposableNxStageCartridge. | Disposableextracorporealcircuit for usewith the NxStageSystem One.Consists ofdialyzer anddisposableNxStageCartridge. | Disposable,extracorporealcircuit for usewith the PhoenixDialysis DeliverySystem | Disposable,extracorporealcircuit for use withthe Prismaflexsystem. Consistsof AN69 hollowfiber hemofilterdialyzer andtubing lines. |
| Device Comparison Table | ||||
| Parameter | NxStage SystemOne Low VolumeCartridgeExpress | PredicateDeviceNxStageCartridgeExpressK061837 | PredicateDevice*GambroCartridgeBlood Set LowWeight LowVolumeK100364 | PredicateDevice GambroPrisma M60Disposable SetK032431 |
| INDICATIONSFOR USE | The NxStageSystem One LowVolume CartridgeExpress isindicated for useonly with theNxStage SystemOne in a chroniccare dialysis facilityor acute care unit.It is indicated foruse in adultpatients for thetreatment of acuteand chronic renalfailure or fluidoverload usinghemofiltration,hemodialysis,and/orultrafiltration. | The NxStageSystem One isindicated for thetreatment ofacute andchronic renalfailure or fluidoverload usinghemofiltration,hemodialysis,and/orultrafiltration, inan acute orchronic carefacility. TheSystem is alsoindicated forhemodialysiswith our withoutultrafiltration inthe home. | The GambroCartridge BloodSet Low Weight-Low Volume isintended forsingle use in ahemodialysistreatment usingthe PhoenixDialysis DeliverySystem.The Low-WeightLow Volumemodel is usedwhen a lowextra-corporealblood volume isrecommended.The Low Weight-Low Volumemodel with apriming volumeof 40 ml isindicated forpatients with abody weightgreater than 15kg and lower orequal to 20 kg. | Indicated for usewith the Prismacontrol unit inprovidingcontinuous fluidmanagement andrenal replacementtherapies forpatients whohave acute renalfailure, fluidoverload, or both. |
| All treatments mustbe administeredunder a physician'sprescription, andmust be performedby a trained andqualified person,considered to becompetent in theuse of this deviceby the prescribingphysician. | All treatmentsmust beadministeredunder aphysician'sprescription, andmust beperformed by atrained andqualified person,considered to becompetent in theuse of thisdevice by theprescribingphysician. | |||
| Device Comparison Table | ||||
| Parameter | NxStage SystemOne LowVolumeCartridgeExpress | PredicateDeviceNxStageCartridgeExpressK061837 | PredicateDevice*GambroCartridgeBlood Set LowWeight LowVolumeK100364 | PredicateDevice GambroPrisma M60Disposable SetK032431 |
| THERAPIESINDICATED | Continuous/intermittenthemofiltrationand/orultrafiltration.Continuous/intermittenthemodialysisand/orultrafiltration andslow continuousultrafiltration | Continuous/intermittenthemofiltrationand/orultrafiltration.Continuous/intermittenthemodialysisand/orultrafiltration andslow continuousultrafiltration | Hemodialysis | SCUF-slowcontinuousultrafiltrationCVVH-continuousvenovenoushemofiltrationCVVHD-continuoushemodialysisCVVHDF-continuousvenovenoushemodiafiltration |
| PRINCIPLEOFOPERATION | Removal ofsolutes viadiffusion orconvection | Removal ofsolutes viadiffusion orconvection | Removal ofsolutes viadiffusion | Removal ofsolutes viadiffusion and/orconvection |
| HOWSUPPLIED | Dialyzer pre-connected todisposableNxStage Cartridge | Dialyzer pre-connected todisposableNxStageCartridge | Sterile nonpyrogenic bloodpathway issupplied sealedin plasticpackage | The PrismaflexM60 set consistsof an AN69hollow fiberhemofilterdialyzer andtubing lines |
| PRIMINGVOLUME | 15 mL (filter)70 mL (cartridgeset total) | 91 mL (filter)175 – 200 mL(cartridge settotal) | 40 mL (bloodtubing set) | 42mL ± 10%(filter)93 mL (Set total) |
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K123395
NxStage Medical, Inc. NxStage System One Low Volume Cartridge Express 510(k) Premarket Notification
510(k) Premarket Notification NxStage Medical, Inc.
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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 | NxStageSystem OneLow VolumeCartridgeExpress | PredicateDeviceNxStageCartridgeExpressK061837 | PredicateDeviceGambroPrisma M60DisposableSetK032431 | PredicateDeviceMinntechHF JuniorHemofilterK071298 | PredicateDeviceMinntechHighPermeabilityDialyzerK923312 |
| FIBERS | Polyethersulfone | Polyethersulfone | Acrylonitrileand sodiummethallylsulfonatecopolymer | Polysulfone | Polysulfone |
| FIBERINTERNALDIAMETER | 200 μm | 200 μm | 240 μm | 200 μm | 200 μm |
| FIBER WALLTHIICKNESS | 30 μm | 30 μm | 50 μm | Notavailable | Not available |
| FIBERLENGTH | 10 cm | 23 cm | 27 cmoveralldimension | 15 cmoveralldimension | 9.42 cm |
| EFFECTIVESURFACEAREA | 0.21 m² | 1.6 m² | 0.60 m² | 0.09 m² | 0.30 m² |
| PRIMINGVOLUME | 15 ml (filter)70 ml(cartridge) | 91 ml (filter)175 – 200 ml(cartridge) | 42 ml ± 10%(bloodprimingvolume infilter)(93 ml bloodvolume inset) | 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
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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.
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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.
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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
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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 ________________________________________________________________________________________________________________________________________________________________
§ 876.5860 High permeability hemodialysis system.
(a)
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).
(b)
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.”