(84 days)
The NxStage System One is indicated for 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's prescription.
The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit.
The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The NxStage Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollow-fiber filter.
This is an interesting case where the provided document (a 510(k) summary for a medical device) doesn't contain a conventional study demonstrating the device meets specific performance acceptance criteria. Instead, it details a "Special 510(k) Device Modification" which relies on different evidence.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance
This document does not present a table of specific quantitative acceptance criteria (e.g., "filtration rate >= X L/hr") and corresponding reported device performance values. Instead, the "acceptance criteria" here is met through a "design control certification" and demonstration of "substantial equivalence" to a predicate device.
The overarching acceptance criterion is Substantial Equivalence to the predicate device (cleared in K032356). The device performance is deemed acceptable because it meets design specifications and the modified device (NxStage Cartridge Express) is found to be substantially equivalent to the baseline device (the predicate).
Study Details
Given this context of a "Special 510(k) Device Modification," many of the standard study questions for a new device's efficacy or diagnostic accuracy are not applicable in the usual sense.
1. Table of Acceptance Criteria and Reported Device Performance
As explained above, no such quantitative table is provided in this document. The "acceptance criteria" revolve around demonstrating design control compliance and substantial equivalence.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly mentioned as a distinct "test set" for performance evaluation in the traditional sense. The document refers to "Design validation testing," which implies testing was done, but the sample size of units/cartridges tested is not specified.
- Data Provenance: Not specified. It's implied to be internal testing by NxStage Medical, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is not a study requiring expert readers or ground truth establishment for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring expert reader adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done, as this is not a diagnostic imaging device requiring human interpretation.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This is an electro-mechanical device and fluid circuit, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the typical sense of a diagnostic or predictive device. The "ground truth" here is compliance with "design specifications" and the functionality/performance matching that of the predicate device for "substantial equivalence."
8. Sample Size for the Training Set
Not applicable. This document does not describe a machine learning algorithm or a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
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JUN 1 3 2005
K050727
Page 1 of 2
Section 7
510(K) Summary of Safety Effectiveness
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 $807.92.
| Date: | March 18, 2005 |
|---|---|
| Common/Usual Name: | Dialyzer with High Permeability HemodialysisSystem |
| Trade/Proprietary Name: | NxStage Cartridge Express |
| Classification Name: | High Permeability Hemodialysis System (21 CFR876.5860) |
| Device Classification:Product Code: | Class II78 KD I - Dialyzer, High Permeability with orwithout Sealed Dialysate System |
| Device Panel: | Gastroenterology-Urology (GU)/Gastro-Renal(GRDB) |
| 510(k) Sponsor &Owner/Operator: | NxStage Medical, Inc439 South Union St, Suite 501Lawrence, MA 01843Owner/Operator No. 9045797Establishment Registration #3003464075 |
| Contact Person: | Norma LeMayManager, Regulatory Affairs |
Device Description:
The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit.
The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The NxStage
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Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollow-fiber filter.
The System (and all components) is intended for treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration in both acute and chronic environments, as prescribed by the treating physician.
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 Premarket Notifications." In support of this 510(k), NxStage has provided certification of compliance to 21 CFR 820.30 Design Control requirements. Design validation testing has been performed to ensure that the modified device meets design specifications. The modified NxStage Cartridge Express has been compared to the baseline as cleared in K032356 and found to be substantially equivalent.
Conclusion:
Based on the device indications for use, comparison of descriptive and technological characteristics, and design control certification, the modified NxStage Cartridge Express has been shown to meet the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to the baseline device.
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Image /page/2/Picture/2 description: The image shows a logo with a stylized bird figure. The bird is depicted with three curved lines forming its body and wings. To the left of the bird, there is text arranged in a circular fashion, likely the name of an organization or company. The overall design is simple and abstract, with a focus on conveying movement and flight through the bird symbol.
JUN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Norma LeMay Manager, Regulatory Affairs NxStage Medical, Inc. 439 South Union Street, Suite 501 LAWRENCE MA 01843
K050727 Re:
Trade/Device Name: NxStage Cartridge Express Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: May 12, 2005 Received: May 13, 2005
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 (Premarket Approval), it may be subject to such 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 Section 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
510(k) Number (if known):
Device Name:
NxStage System One with Cartridge Express
The NxStage System One is indicated for treatment of renal Indications for Use: failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered by a health care provider, under physician's prescription.
Prescription Use X (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)
Daniel A. Lipman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
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§ 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.”