(388 days)
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 indicated for hemodialysis with or without ultrafiltration in the home.
The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.
All treatments must be administered under a physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
The NxStage System One with Therapeutic Plasma Exchange Cartridge provides therapeutic plasma exchange therapy when used with a commercially available TPE filter. The machine that controls the therapy is called the Cycler. The blood tubing set is the NxStage TPE Cartridge. The TPE Cartridge is a single use extracorporeal blood circuit and fluid management device without a pre-attached filter. Therapeutic plasma exchange requires the use of a commercially available therapeutic plasma exchange filter such as the Asahi Plasmaflo.
The provided text describes the NxStage System One with Therapeutic Plasma Exchange Cartridge. While it details the device's indications, substantial equivalence, and general performance claims, it does not include specific acceptance criteria or the study details to prove those criteria were met in a structured format.
The document states:
"Perfication and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met. Results of this testing have documented that the proposed NxStage System One with TPE Cartidge is substantially equivalent to the predicate devices and is suitable for the labeled indications for use."
However, it does not enumerate what those "predetermined acceptance criteria" were or provide any specifics about the "verification and validation testing" such as sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot populate the requested table and answer many of the specific questions about the study design because that information is not present in the provided text.
Based on the provided text, here's what can be extracted and what remains unknown:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in text | The device "met" predetermined acceptance criteria. |
| Not specified in text | The device is "substantially equivalent" to predicate devices. |
| Not specified in text | The device is "suitable for the labeled indications for use." |
2. Sample size used for the test set and the data provenance: Not specified in the text. The document refers to "verification and validation testing" but does not give details about "test sets" or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the text.
4. Adjudication method for the test set: Not specified in the text.
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. The device described is a medical system for therapeutic plasma exchange, not an AI-assisted diagnostic device requiring human reader performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical system, not an algorithm in the traditional sense for standalone performance evaluation against a ground truth in diagnostic imaging, for example.
7. The type of ground truth used: Not specified in the text. The testing appears to be primarily bench testing for characterizing device performance, rather than clinical ground truth for diagnostic accuracy.
8. The sample size for the training set: Not applicable/Not specified. This is a medical device, not a machine learning algorithm that typically uses a "training set" in the context of AI.
9. How the ground truth for the training set was established: Not applicable/Not specified.
In summary, the provided text confirms that "verification and validation testing" was performed and that "predetermined acceptance criteria" were met, leading to a determination of substantial equivalence. However, the specific details of these criteria and the methodology of the testing (including sample sizes, ground truth, and expert involvement) are not elaborated upon.
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October 15, 2010
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. | Submitter's Information:Name: | NxStage Medical, Inc. | |
|---|---|---|---|
| Address: | 439 South Union Street, 5th FloorLawrence, MA 01843United States | OCT 2 3 2010 | |
| FDA EstablishmentOwner/Operator Number: | 9045797 | ||
| Contact Person: | MaryLou StroumbosRegulatory Affairs Associate | ||
| Phone:Fax: | (978) 687-4872(978) 687-4750 | ||
| Manufacturer: | NxStage Medical, Inc.439 South Union St. 5th FloorLawrence, MA 01843United States | ||
| FDA EstablishmentRegistration Number: | 3003464075 | ||
| Sterilization Site: | Steris Isomedix1000 S. Sarah PlaceOntario, CA 91761 | ||
| B. | Device Name: | ||
| Trade/Proprietary Name: | NxStage System One with Therapeutic Plasma ExchangeCartridge | ||
| Device: | Dialyzer with High Permeability Hemodialysis System | ||
| Regulation Description: | High Permeability Hemodialysis System | ||
| Regulation Medical Specialty: | Gastroenterology/Urology Devices | ||
| Review Panel: | Gastroenterology/Urology | ||
| Product Code: | KDI | ||
| LKN | |||
| Submission Type: | 510(k) | ||
| Regulation Number: | 864.5860 | ||
| Device Class: | 2 | ||
510(k) Premarket Notification Submission NxStage Medical, Inc.
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C. Substantial Equivalence:
The proposed NxStage System One with Therapeutic Plasma Exchange Cartridge is substantially equivalent to the identified predicates indicated for therapeutic plasma exchange.
D. Device Description/Indications for Use:
The NxStage System One with Therapeutic Plasma Exchange Cartridge provides therapeutic plasma exchange therapy when used with a commercially available TPE filter. The machine that controls the therapy is called the Cycler. The blood tubing set is the NxStage TPE Cartridge. The TPE Cartridge is a single use extracorporeal blood circuit and fluid management device without a pre-attached filter. Therapeutic plasma exchange requires the use of a commercially available therapeutic plasma exchange filter such as the Asahi Plasmaflo.
Indications for use:
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 indicated for hemodialysis with or without ultrafiltration in the home.
The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.
All treatments must be administered under a physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
E. Technological Characteristics:
The proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate devices.
F. Summary of Non-Clinical Test/Performance Testing - Bench
NxStage believes that the information and data provided in this submission clearly describes the proposed device and demonstrates that the device is adequately designed for the labeled indications for use. Perfication and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met. Results of this testing have documented that the proposed NxStage System One with TPE Cartidge is substantially equivalent to the predicate devices and is suitable for the labeled indications for use.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Ms. Mary Lou Stroumbos Regulatory Affairs Manager NxStage Medical, Inc. 350 Merrimack Street LAWRENCE MA 01843
AUG 10 2012
Re: K093069 Trade/Device Name: NxStage System One with Cartridge Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: October 15, 2010 Received: October 18, 2010
Dear Ms. Stroumbos:
This letter corrects our substantially equivalent letter of October 23, 2010.
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 (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); medical device reporting (reporting of medical
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Page 2 - Ms. Mary Lou Stroumbos
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Vozni Mr. Whes
Senjamin 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): K093069
Device Name: NxStage System One with Cartridge
Indications for Use:
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 indicated for hemodialysis with or without ultrafiltration in the home.
The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.
All treatments must be administered under a physician's prescription, and must be observed 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)
Home M. Whan
uctive, Gastro-Renal, and
Page 1 of
§ 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.”