(256 days)
The dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. There are no known contraindications.
The proposed device is a single use high flux (permeability) hollow-fiber dialyzer.
The provided text is a 510(k) Premarket Notification Submission for the NxStage® 1.6m² Dialyzer. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria through a study involving human subjects or AI algorithms.
Therefore, many of the requested categories in your prompt are not applicable to this type of submission. This document details non-clinical bench testing to demonstrate that the device functions comparably to existing, legally marketed devices.
Here's an attempt to answer your questions based only on the provided text, indicating where information is not present:
1. Table of acceptance criteria and the reported device performance
The document states: "Performance, verification and validation testing was conducted to characterize performance of the proposed device, consistent with FDA's Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, dated August 7, 1998, and the predetermined acceptance criteria was met."
However, the specific acceptance criteria for each test parameter (e.g., clearance rates, ultrafiltration coefficients) and the detailed results demonstrating that these criteria were met are not explicitly listed in the provided text. The submission focuses on a comparative table of technological characteristics, asserting substantial equivalence.
| Parameter | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Implied as meeting criteria) |
|---|---|---|
| Performance Testing (General) | Consistent with FDA Guidance, Predetermined Acceptance Criteria Met | Met |
| Verification & Validation Test | Consistent with FDA Guidance, Predetermined Acceptance Criteria Met | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "Performance, verification and validation testing" but does not detail the number of devices tested.
- Data Provenance: Not explicitly stated, given it's a bench test. The manufacturer address is in Lawrence, MA, USA, and the sterilization site is Ontario, CA, USA. The manufacturer is NxStage GmbH & Co. KG in Germany.
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)
Not applicable. This submission is for a medical device (dialyzer) and involves non-clinical bench testing, not an AI algorithm or clinical study requiring expert ground truth for interpretation of images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, no expert adjudication for ground truth is described.
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
Not applicable. This is a medical device (dialyzer) submission, not an AI diagnostic or assistive device. No human reader studies are described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dialyzer, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" refers to established engineering specifications and performance standards (e.g., clearance rates for various solutes) as outlined in FDA guidance for dialyzers. The document states that testing was "consistent with FDA's Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers." The "ground truth" would be the expected physical and chemical performance characteristics of a high-permeability hemodialyzer.
8. The sample size for the training set
Not applicable. This submission is for a medical device (dialyzer), not an AI algorithm that requires training data.
9. How the ground truth for the training set was established
Not applicable. As above, no training set or AI algorithm is described.
{0}------------------------------------------------
NxStage Medical, Inc. NxStage® Dialyzer 510(k) Premarket Notification Submission
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 | April 12, 2013 |
|---|---|
| B. Submitter's Information:Name: | NxStage Medical, Inc. |
| Address: | 350 Merrimack StreetLawrence, MA 01843United States |
| FDA EstablishmentOwner/Operator Number: | 9045797 |
| Contact Person: | Nnamdi NwachukwuRegulatory Affairs Engineer |
| Phone: | (978) 332-8477 |
| Fax: | (978) 687-4750 |
| Manufacturer: | NxStage GmbH & Co. KGAnna-Vandenhoeck-Ring 2437081 GoettingenBundesrepublik Deutschland |
| FDA EstablishmentRegistration Number: | An application for an establishment registrationnumber will be submitted prior tocommercialization. |
| Sterilization Site: | Steris Isomedix1000 S. Sarah PlaceOntario, CA 91761 |
| C. Device Name:Trade/ProprietaryName: | NxStage® 1.6m2 Dialyzer |
| Common/Usual Name: | Dialyzer, High Permeability |
| Classification Name: | High Permeability Hemodialysis System |
| Regulation Number: | 21 CFR 876.5860 |
| Product Code : | 78 KDI - Dialyzer, High Permeability with or Without |
510(k) Premarket Notification NxStage Medical, Inc.
, ... .......... 2014-01-28
.
{1}------------------------------------------------
NxStage Medical, Inc. NxStage® Dialyzer 510(k) Premarket Notification Submission
| Sealed Dialysis System | |||
|---|---|---|---|
| Submission Type: | 510(k) | ||
| Device Class: | II | ||
| Device Panel: | Gastroenterology-Urology (GU)/ Gastro-Renal | ||
| (GRDB) |
D. Predicate Devices:
NxStage Cartridge Express K061837 K113023 NxStage Streamline Airless System Set w/ Pre-Attached Dialyzer K062079 Baxter Xenium Dialyzer
E. Substantial Equivalence:
The proposed NxStage® 1.6m² Dialyzer is substantially equivalent in design, function and operation to the identified predicates.
F. Device Description/Indications for Use:
The proposed device is a single use high flux (permeability) hollow-fiber dialyzer.
Indications for use: The dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. There are no known contraindications.
{2}------------------------------------------------
G. Technological Characteristics:
The proposed device has the same technological characteristics and is similar in design and configuration as the predicate devices.
| Parameter | NxStage 1.6m2DialyzerSubject of this510(k) | Predicate DeviceNxStage CartridgeExpressK061837 | Predicate DeviceStreamline AirlessSystem Set withPre-attacheddialyzerK113023 | Predicate DeviceBaxter XeniumDialyzer 150K062079 |
|---|---|---|---|---|
| Indicationsfor Use | The dialyzer isindicated for thetreatment of acuteand chronic renalfailure or fluidoverload usinghemofiltration,hemodialysis,and/orultrafiltration.There are noknowncontraindications. | The NxStage SystemOne is indicated forthe treatment ofacute and chronicrenal failure or fluidoverload usinghemofiltration,hemodialysis, and/orultrafiltration, in anacute or chronic carefacility. The System isalso indicated forhemodialysis with orwithout ultrafiltrationin the home. | The single use bloodtubing set with pre-attached dialyzer isindicated for use withthe B. Braun DialogSeries hemodialysissystems for thetreatment of acuteand chronic renalfailure. There are noknowncontraindications. | Hemodialysis withXenium dialyzers isindicated forpatients with acuteor chronic renalfailure whenconservativetherapy is judged tobe inadequate. Italso may beindicated in thetreatment ofpatients intoxicatedwith poisons ordrugs. |
| Principle ofOperation | Removal ofsolutes viadiffusion orconvection | Removal of solutesvia diffusion orconvection | Removal of solutesvia diffusion orconvection | Removal of solutesvia diffusion orconvection |
| ProductConfiguration | Single usedisposabledialyzer withstandard dialysisconnectors thatare connected toblood tubing setsprior to use. | Single usedisposable consistingof a pre-attacheddialyzer and tubingset for use on theNxStage SystemOne. | Single usedisposable consistingof a pre-attacheddialyzer and tubingset for use on the B.Braun Dialog Serieshemodialysissystems. | Single usedisposable dialyzerwith standarddialysis connectorsthat are connectedto blood tubing setsprior to use. |
| HowSupplied | Individuallypackaged dialyzer. | Dialyzer pre-connected todisposable NxStageCartridge tubing set. | Dialyzer pre-connected todisposable B. Brauntubing set. | Individuallypackaged dialyzer. |
| Device Comparison Table | ||||
| Parameter | NxStage 1.6m²Dialyzer | Predicate DeviceNxStageCartridgeExpress(K061837) | Predicate DeviceStreamline AirlessSystem Set withPre-attacheddialyzer(K113023) | Predicate DeviceBaxter XeniumDialyzer 150(K062079) |
| Connectors | StandardISO8637 DINBlood andDialysate HansenConnectors | Blood anddialysate lines pre-bonded | Blood lines pre-bonded, StandardISO8637 DialysateHansen Connector | Standard ISO8637 DINBlood and DialysateHansen Connector |
| SterilizationMethod | Gamma | Gamma | Gamma | Gamma |
| Fibers | PolyethersulfoneMembranaPurema H | PolyethersulfoneMembranaPurema H | PolyethersulfoneMembranaPurema H | PolyethersulfoneMembranaPurema H |
| Fiber ID | 200 μm | 200 μm | 200 μm | 200 μm |
| Fiber WallThickness | 30 μm | 30 μm | 30 μm | 30 μm |
| EffectiveSurfaceArea | 1.6 m² | 1.6 m² | 1.6 m² | 1.5 m² |
| PrimingVolume | 91 ml | 91 ml | 91 ml | 91 ml |
| Max. TMP | 500 mmHg | 500 mmHg | 500 mmHg | 500 mmHg |
{3}------------------------------------------------
.... ----------
.
{4}------------------------------------------------
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 is substantially equivalent to the predicate devices. Performance, verification and validation testing was conducted to characterize performance of the proposed device, consistent with FDA's Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, dated August 7, 1998, and the predetermined acceptance criteria was met. Results of this testing have documented that the proposed device is substantially equivalent to the predicate devices and is suitable for the labeled indication for use.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 27, 2013
NxStage Medical, Inc. Laura F. Plath Regulatory Affairs Manager 350 Merrimack Street Lawrence, MA 01843
Re: K131050
Trade/Device Name: NxStage® 1.6m2 Dialyzer Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: KDI Dated: December 6, 2013 Received: December 9, 2013
Dear Laura F. Plath,
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. 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. 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
{6}------------------------------------------------
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Benjamin R. Fisher -S
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
{7}------------------------------------------------
Indications for Use
510(k) Number (if known): K131050
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
NxStage® 1.6m² Dialyzer Device Name:
Indications for Use: The dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. There are no known contraindications.
X 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. Fisher -S 2013.12.30 09:55:53 -05'00'
§ 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.”