(437 days)
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. There are no known contraindications.
The proposed device provides for the treatment of acute or chronic renal failure when used with the commercially available B. Braun Dialog Series hemodialysis systems. The device is a single use blood tubing set pre-attached to a high flux (permeability) hollow-fiber dialyzer.
The provided document is a 510(k) Premarket Notification Submission for the NxStage Blood Tubing Set with Pre-Attached Dialyzer. It focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing.
Here's the breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission broadly states that performance, verification, and validation testing was conducted in accordance with the "Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions" guidance document issued on April 23, 2008.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predetermined acceptance criteria from the "Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions" guidance document (April 23, 2008) | "the predetermined acceptance criteria was met" and "Results of this testing have documented that the proposed device is equivalent to the predicate devices and is suitable for the labeled indication for use." |
Note: The document does not provide specific numerical acceptance criteria (e.g., burst pressure, flow rates) or detailed numerical results for the device's performance. It only offers a general statement that the criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "Performance, verification and validation testing" without detailing the study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the submission. The testing described is non-clinical bench testing, not a clinical study involving expert assessment of patient data.
4. Adjudication Method for the Test Set
This information is not applicable and is not provided in the submission, as the testing described is non-clinical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or conducted. The submission is for a medical device (blood tubing set with dialyzer) and focuses on non-clinical performance and substantial equivalence, not a diagnostic AI algorithm that would involve human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable, as the device is a physical medical device (blood tubing set with dialyzer), not an AI algorithm.
7. Type of Ground Truth Used
For the non-clinical testing, the "ground truth" would be established by the specified test methods and accepted industry standards outlined in the referenced FDA guidance document for hemodialysis blood tubing sets. Compliance with these physical and functional specifications serves as the ground truth for evaluating the device's performance.
8. Sample Size for the Training Set
This is not applicable, as the device is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as the device is a physical medical device, not an AI algorithm.
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K113023
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NxStage Medical, Inc. NxStage® Blood Tubing Set with Pre-Attached Dialyzer 510(k) Premarket Notification Submission
DEC 2 1 2012
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: October 7, 2011
A. Submitter's Information: Name:
NxStage Medical, Inc.
Mary Lou Stroumbos
(978) 687-4872
(978) 687-4750
9616074
Address:
439 South Union Street, 5th Floor Lawrence, MA 01843 United States
Sr. Regulatory Affairs Associate
9045797
FDA Establishment Owner/Operator Number:
Contact Person:
Phone:
Fax:
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:
Sterilization Site:
Steris Corporation Isomedix Services, Inc. 1000 S. Sarah Place Ontario, CA 91761
Contract sterilizer
FDA Establishment Registration Number:
B. Device Name:
Trade/Proprietary Name:
Device:
NxStage Streamline Airless System Set with Pre-Attached Dialyzer for B. Braun Dialog Series Hemodialysis Systems
Set, tubing, blood, with and without anti-regurgitation valve
Regulation Description:
Hemodialysis System and Accessories
510(k) Premarket Notification NxStage Medical, Inc.
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R113023
PG: 2 of 2
NxStage Medical, Inc. NxStage® Blood Tubing Set with Pre-Attached Dialyzer 510(k) Premarket Notification Submission
| Regulation Medical Specialty: | Gastroenterology/Urology Devices |
|---|---|
| Review Panel: | Gastroenterology/Urology |
| Product Code: | KDIFJKKOC |
| Submission Type: | 510(k) |
| Regulation Number: | 876.5860 |
| Device Class: | II |
C. Substantial Equivalence:
The proposed NxStage Blood Tubing Set with Pre-Attached dialyzer is substantially equivalent to the identified predicates.
D. Device Description/Indications for Use:
The proposed device provides for the treatment of acute or chronic renal failure when used with the commercially available B. Braun Dialog Series hemodialysis systems. The device is a single use blood tubing set pre-attached to a high flux (permeability) hollow-fiber dialyzer.
Indications for use:
The single use blood tubing set with pre-attached dialyzer is indicated for use with the B. The Single use blood tabing sol. was pro and the treatment of acute and chronic renal failure.
There are no known contraindications.
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 indication for use. Performance, verification and validation testing was for the laborou materials . Hemodialysis 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 ontona was most ratent to the predicate devices and is suitable for the labeled indication for use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. 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 21, 2012
NxStage Medical, Inc. % Ms. Mary Lou Stroumbos Senior Regulatory Affairs Manager 439 South Union Street, 5th Floor LAWRENCE MA 01843
K113023 Re:
Trade/Device Name: Streamline® Airless System Set with Pre-Attached Dialyzer for B. Braun Dialog® Series Hemodialysis Systems Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI, FJK, FOC Dated: December 20, 2012 Received: December 21, 2012
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, 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
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Page 2 - Ms. Mary Lou Stroumbos
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,
Herbert R. Lerner
Acting Director 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
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Indications for Use
KI13023 510(k) Number (if known):
Device Name:
Streamline® Airless System Set with Pre-Attached Dialyzer for B.Braun Dialog® Series Hemodialysis Systems
The single use blood tubing set with pre-attached dialyzer is Indications for Use: indicated for use with the B. Braun Dialog Series hemodialysis systems for the treatment of acute and chronic renal failure.
There are no known contraindications.
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)
Herbert R. Lerner
(Division Sign-Off) Division of Reproductive, Gastro-Re Page 18 . 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.”