(168 days)
Not Found
No
The summary describes a physical medical device (dialyzer and tubing set) and its intended use with existing hemodialysis systems. There is no mention of software, algorithms, or data processing that would suggest the incorporation of AI or ML. The performance studies focus on the physical characteristics and equivalence to predicate devices, not on algorithmic performance.
Yes
The device is indicated for the "treatment of acute and chronic renal failure," which is a therapeutic purpose.
No
The device, a dialyzer with blood tubing, is described for the "treatment of acute and chronic renal failure," indicating a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it is a "single use high flux (permeability) hollow-fiber dialyzer pre-attached to a blood tubing set," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of acute and chronic renal failure" using hemodialysis. This is a therapeutic treatment performed directly on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The device is a "single use high flux (permeability) hollow-fiber dialyzer pre-attached to a blood tubing set." This describes a component used in the process of filtering blood, which is a therapeutic action.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
Therefore, the device described is a therapeutic medical device used in hemodialysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The single use dialyzer with pre-attached blood tubing set is indicated for use with the Fresenius 2008 Series hemodialysis systems for the treatment of acute and chronic renal failure.
Product codes (comma separated list FDA assigned to the subject device)
KDI, FJK, KOC
Device Description
The proposed device provides for the treatment of acute or chronic renal failure when used with the commercially available Fresenius 2008 Series hemodialysis systems. The device is a single use high flux (permeability) hollow-fiber dialyzer pre-attached to a blood tubing set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance, verification and validation testing was conducted following the FDA's Guidance document entitled: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions issued on: April 23, 2008 to characterize performance of the proposed device 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
NxStage Medical, Inc. NxStage® Streamline Express 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
| Date: | ||
|---|---|---|
| A. Date | December 20, 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 | |
| Director, Regulatory Affairs | ||
| Phone: | (978) 687-4872 | |
| Fax: | (978) 687-4750 | |
| Manufacturing Site: | MEDIMEXICO, S. DE R.L. DE C.V. | |
| Av. Valle imperial No. 10523 | ||
| Parque industrial Valle Sur | ||
| Tijuana, B.C., Mexico 22180 | ||
| FDA Establishment | ||
| Registration Number: | 9616074 | |
| Sterilization Site: | Steris Corporation | |
| Isomedix Services, Inc. | ||
| 1000 S. Sarah Place | ||
| Ontario, CA 91761 | ||
| FDA Establishment | ||
| Registration Number: | Contract sterilizer | |
| C. Device Name: | ||
| Trade/Proprietary Name: | NxStage Streamline Express for Fresenius 2008 | |
| Series Hemodialysis Systems | ||
| Device: | Set, tubing, blood, with and without anti-regurgitation | |
| valve | ||
| Regulation Description: | Hemodialysis System and Accessories |
510(k) Premarket Notification NxStage Medical, Inc.
FEB - 4 2014
1
NxStage Medical, Inc. NxStage® Streamline Express 510(k) Premarket Notification Submission
| Regulation Medical
| Specialty: | Gastroenterology/Urology Devices |
|---|---|
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KDI |
| FJK | |
| KOC | |
| Submission Type: | 510(k) |
| Regulation Number: | 876.5860 |
| Device Class: | II |
D. Predicate Devices:
| Streamline Airless System Set with Pre-Attached Dialyzer
| for B.Braun Dialog Series Hemodialysis Systems | K113023 |
|---|---|
| Blood Tubing Sets | K080807 |
| Reverso | K994306 |
E. Substantial Equivalence:
The proposed NxStage dialyzer with pre-attached blood tubing set is substantially equivalent to the identified predicates.
F. Device Description/Indications for Use:
The proposed device provides for the treatment of acute or chronic renal failure when used with the commercially available Fresenius 2008 Series hemodialysis systems. The device is a single use high flux (permeability) hollow-fiber dialyzer pre-attached to a blood tubing set.
Indications for use:
The single use dialyzer with pre-attached blood tubing set is indicated for use with the Fresenius 2008 Series hemodialysis systems for the treatment of acute and chronic renal failure.
G. Technological Characteristics:
The proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate devices.
2
K132602
Page 3 of 6
| Device Technological Characteristics Comparison Table | ||
|---|---|---|
| Parameter | Proposed Device | |
| Streamline Express for Fresenius 2008 Series | ||
| Hemodialysis Systems | Predicate Device | |
| Streamline Airless System Set with | ||
| Pre-Attached Dialyzer for B. Braun Dialog Series | ||
| Hemodialysis Systems | ||
| (K113023) | ||
| Intended use | The single use dialyzer with pre-attached blood | |
| tubing set is indicated for use with the Fresenius | ||
| 2008 Series Hemodialysis Systems for the | ||
| treatment of acute and chronic renal failure. | The single use blood tubing set with pre-attached | |
| dialyzer is indicated for use with the B. Braun Dialog | ||
| Series Hemodialysis Systems for the treatment of | ||
| acute and chronic renal failure. | ||
| Principle of Operation | Removal of solutes via diffusion or convection | Removal of solutes via diffusion or convection |
| Product configuration | Arterial and venous side ports on filter end caps | |
| (ports configured perpendicular to blood flow) | Arterial and venous side ports on filter end caps | |
| (ports configured perpendicular to blood flow) | ||
| How supplied | Pre-connected to the Streamline Blood Tubing Set | |
| with standard Hansen connectors | Pre-connected to the Streamline Blood Tubing Set | |
| with standard Hansen connectors | ||
| Dialyzer | ||
| Number of fibers | Same | 10,900 ± 200 |
| Fiber internal diameter | Same | 200 μm |
| Fiber wall thickness | Same | 30 μm |
| Fiber length | Same | 23 cm |
| Effective surface area | Same | 1.6 m² |
| Priming volume | Same | 91 ml |
| Max. Transmembrane | ||
| Pressure | Same | 500 mmHg |
| In-vitro Performance | ||
| Pressure Drop Blood | ||
| Compartment (mmHg) | Same | Trade/Device Name: NxStage® Streamline® Express for Fresenius 2008 Series Hemodialysis Systems Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI, FJK, KOC Dated: December 20, 2013 Received: December 23, 2013 |
Dear Mary Lou 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, 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.
7
Page 2 - 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for 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
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132602
Device Name
NxStage® Streamline® Express for Fresenius 2008 Series Hemodialysis Systems
Indications for Use (Describe)
The single use dialyzer with pre-attached blood tubing set is indicated for use with the Fresenius 2008 Series Hemodialysis systems for the treatment of acute and chronic renal failure.
Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
...
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/8/Picture/11 description: The image shows the name "Herbert P. Lerner" in bold font. Below the name, the date and time "2014.02.04 07:08:35" are displayed, followed by "-05:00". The text is clear and easily readable.
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.