(121 days)
The NxStage TPE Cartridge is indicated for use only with the NxStage System One 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 TPE Cartridge provides therapeutic plasma exchange therapy when used with a commercially available TPE filter. The blood tubing set is the NxStage TPE Cartridge. The TPE Cartridge is a single use extracorporeal blood circuit and fluid management device available without a pre-attached filter. Therapeutic plasma exchange requires the use of a commercially available Therapeutic Plasma Exchange filter such as such as the Asahi Plasmaflo OP-05W (A) wet filter (PMA P820033 S005 approved on March 16, 2010).
The provided document describes the NxStage Therapeutic Plasma Exchange (TPE) Cartridge and its path to 510(k) clearance. The focus of the study is to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy through a comparative effectiveness study involving human readers or standalone AI performance.
Therefore, many of the requested categories are not applicable to this submission.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method (Acceptance Criteria) | Reported Device Performance (Result) |
|---|---|
| Pressure leak testing demonstrating the blood tubing can withstand pressures up to 1.5 times the maximum labeled positive and negative pressures | Pass – Results within acceptance criteria |
| Endurance testing of pump segment at maximum labeled blood flow rates and pressures | Pass - Results within acceptance criteria |
| Endurance testing under both positive and negative pressures of any injection ports (if applicable) using the largest recommended gauge needle identified in the labeling | Pass - Results within acceptance criteria |
| Priming volume assessment | Pass - Results within acceptance criteria |
| Tensile testing of joints and materials of all tubing segments | Pass - Results within acceptance criteria |
| The ability of pressure transducers to withstand leakage when subject to pressures up to 2 times the maximum labeled pressure e.g. “strikethrough” | Pass – Results within acceptance criteria |
| Performance testing to evaluate the ability of tubing to resist kinking after repeated clamping, particularly in the post-pump tubing segment | Pass – Results within acceptance criteria |
| Performance testing of the device's clamps to demonstrate that they can successfully occlude blood tubing | Pass – Results within acceptance criteria |
| Hemocompatibility (i.e., mechanical hemolysis) for new or significantly altered hemodialysis tubing design that affects the pattern of blood flow | Pass – Results within acceptance criteria |
| Structural integrity testing on gamma sterilized and thermally stressed samples. ISTA 2A ship testing (Packaging Qualification) | Pass – Results within acceptance criteria |
| Biocompatibility (Cytotoxicity) | Conclusion: Substantially equivalent |
| Biocompatibility (Hemolysis) | Conclusion: Substantially equivalent |
| Biocompatibility (USP Physicochemical) | Conclusion: Substantially equivalent |
| Biocompatibility (FTIR) | Conclusion: Substantially equivalent |
2. Sample size used for the test set and the data provenance
The document specifies "The following tables outline the testing performed on the CAR-510-C to support the determination of substantial equivalence to the predicate device." However, specific sample sizes for each test within the performance and functional tables (Table 2 and Table 3) are not explicitly stated. The testing described appears to be laboratory-based engineering and material testing, not patient data trials. Therefore, data provenance such as country of origin or retrospective/prospective is not applicable in the context of this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This point is not applicable. The "ground truth" for the tests described relates to engineering specifications and material properties, not diagnostic interpretations from experts. The testing involved measuring physical properties and verifying performance against predefined technical requirements.
4. Adjudication method for the test set
This point is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical studies involving expert interpretation of medical images or patient outcomes. The tests in this document are technical performance evaluations.
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
This point is not applicable. This submission is for a medical device (a TPE Cartridge) and is not an AI/CADe/CADx device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable. This device is a Therapeutic Plasma Exchange Cartridge, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the various performance and functional tests (e.g., pressure leak, endurance, tensile strength, priming volume, hemocompatibility, packaging integrity) was based on pre-defined engineering specifications, regulatory standards, and manufacturing tolerances. For biocompatibility, it was based on accepted biological evaluation standards (ISO 10993).
8. The sample size for the training set
This point is not applicable. This device does not involve a training set as it is not an AI/machine learning device.
9. How the ground truth for the training set was established
This point is not applicable for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
NxStage Medical, Inc. Randall J. Covill Manager, Regulatory Affairs 350 Merrimack Street Lawrence, MA 01843
Re: K143313
Trade/Device Name: NxStage® Therapeutic Plasma Exchange (TPE) Cartridge Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI, LKN Dated: February 24, 2015 Received: February 25, 2015
Dear Randall J. Covill,
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.
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Joyce M. Whang -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
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INDICATIONS FOR USE
510(k) Number (if known): K143313 NxStage® Therapeutic Plasma Exchange (TPE) Device Name: Cartridge Indications for Use: The NxStage TPE Cartridge is indicated for use only with the NxStage System One 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 807 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
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NxStage Medical, Inc. NxStage Therapeutic Plasma Exchange Cartridge 510(k) Premarket Notification
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary has been provided in conformance with 21 CFR §807.92
| A. Date Prepared: | November 18, 2014 |
|---|---|
| B. Submitter's Information:Name: | NxStage Medical, Inc. |
| Address: | 350 Merrimack StreetLawrence, MA 01843 |
| FDA EstablishmentOwner/OperatorNumber: | 9045797 |
| Contact Person: | Randall J. CovillManager, Regulatory Affairs |
| Phone:Fax: | (978) 298-4163(978) 687-4750 |
| Manufacturer: | NxStage Medical, Inc.350 Merrimack StreetLawrence, MA 01843 |
| FDA EstablishmentRegistration Number: | 3003464075 |
| Sterilization Site: | Steris Isomedix (NxStage Cartridge)1000 S. Sarah PlaceOntario, CA 91761 |
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
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NxStage Medical, Inc. NxStage Therapeutic Plasma Exchange Cartridge 510(k) Premarket Notification
| C. Device Name: | |
|---|---|
| Trade/Proprietary | NxStage Therapeutic Plasma Exchange |
| Name: | Cartridge |
| Common/Usual Name: | High Permeability Hemodialysis System |
| Classification Name: | High Permeability Hemodialysis System |
| Regulation Number: | 876.5860 |
| Product Code: | KDI |
| LKN | |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology/Urology |
D. Legally Marketed Predicate Device
NxStage TPE Cartridge, 510k number K093069 cleared on October 23, 2010
E. Device Description/Indications for Use:
The NxStage TPE Cartridge provides therapeutic plasma exchange therapy when used with a commercially available TPE filter. The blood tubing set is the NxStage TPE Cartridge. The TPE Cartridge is a single use extracorporeal blood circuit and fluid management device available without a pre-attached filter. Therapeutic plasma exchange requires the use of a commercially available Therapeutic Plasma Exchange filter such as such as the Asahi Plasmaflo OP-05W (A) wet filter (PMA P820033 S005 approved on March 16, 2010).
Indications for use:
The NxStage TPE Cartridge is indicated for use only with the NxStage System One 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.
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F. Comparison of Technological Characteristics with the Predicate Device:
The proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate NxStage TPE Cartridge (510k number K093069 cleared on October 23, 2010) when used with a commercially available plasma filter such as the Asahi Plasmaflo OP-05W (A) wet filter (PMA P820033 S005 approved on March 16, 2010). The proposed device is designed with similar components and features as used in the predicate device as shown below in Table 1.
| Table 1Comparison of Technological Characteristics with the PredicateDevice | ||
|---|---|---|
| Parameter | Proposed DeviceNxStage TPECartridge (Subject ofthis 510K) | Predicate NxStage TPECartridge(K093069) |
| Intended Use | Therapeutic PlasmaExchange | Therapeutic PlasmaExchange |
| Technology /ComponentsPlasma separatorfilter used | Asahi Plasmaflo OP-05W (A) wet filter (PMAP820033 S005approved on March 16,2010) | Asahi Plasmaflo AP-05H(L) dry filter (PMAP820033 approved onJanuary 8, 1986) |
| Blood volume | Same | 55 ml nominal, exclusiveof filter |
| Blood pumpsegment internaldiameter | Same | 8 mm (0.315 in) |
| Patient line internaldiameter | Same | 3.1 mm (0.122 in) |
| Maximum venouspressure | Same | 400 mmHg at all flowrates |
| Therapy fluid flowrates | 0.1 to 4.0 L/hr | 0.1 to 3.6 L/hr |
| Input infusiontemperature range | Same | 15° to 37° C |
| Sterilization method | Same | Gamma 10-6 SAL |
| Non-Pyrogenic | Same | Yes, (LAL) |
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
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G. Performance Data
The following tables outline the testing performed on the CAR-510-C to support the determination of substantial equivalence to the predicate device.
| Table 2Performance and Functional Testing Per FDA Guidance for Industry andFDA Staff: Hemodialysis Blood Tubing Sets | ||
|---|---|---|
| Test Method | Test Objective | Result |
| Pressure leak testing demonstrating the blood tubing can withstand pressures up to 1.5 times the maximum labeled positive and negative pressures | Ensure that the blood tubing is capable of withstanding extreme positive and negative pressure conditions | Pass – Results within acceptance criteria |
| Endurance testing of pump segment at maximum labeled blood flow rates and pressures | Ensure that pump segment is capable of withstanding maximum labeled blood flow rates and pressures | Pass - Results within acceptance criteria |
| Endurance testing under both positive and negative pressures of any injection ports (if applicable) using the largest recommended gauge needle identified in the labeling | Ensure that injection ports are capable of withstanding both positive and negative pressures | Pass - Results within acceptance criteria |
| Priming volume assessment | To assess and measure the priming volume | Pass - Results within acceptance criteria |
| Tensile testing of joints and materials of all tubing segments | Ensure that tubing failure (leaking) does not occur | Pass - Results within acceptance criteria |
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
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NxStage Medical, Inc. NxStage Therapeutic Plasma Exchange Cartridge 510(k) Premarket Notification
| Table 2 | ||
|---|---|---|
| Performance and Functional Testing Per FDA Guidance for Industry andFDA Staff: Hemodialysis Blood Tubing Sets | ||
| Test Method | Test Objective | Result |
| The ability of pressuretransducers to withstandleakage when subject topressures up to 2 timesthe maximum labeledpressure e.g.“strikethrough” | Ensure that pressuretransducers withstandleakage when subject topressures up to 2 timesthe maximum labeledpressure | Pass – Results withinacceptance criteria |
| Performance testing toevaluate the ability oftubing to resist kinkingafter repeated clamping,particularly in the post-pump tubing segment | Ensure that tubingfailure (kinking) does notoccur | Pass – Results withinacceptance criteria |
| Performance testing ofthe device's clamps todemonstrate that theycan successfullyocclude blood tubing | Ensure that deviceclamps can successfullyocclude the blood tubing | Pass – Results withinacceptance criteria |
| Hemocompatibility (i.e.mechanical hemolysis)for new or significantlyaltered hemodialysistubing design thataffects the pattern ofblood flow | Evaluate the hemolyticproperties of the device | Pass – Results withinacceptance criteria |
Traditional 510(k) Premarket Notification NxStage Medical, Inc.
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| Table 3Packaging Qualification and Ship Testing | ||
|---|---|---|
| Test Method | Test Objective | Result |
| Structural integritytesting on gammasterilized and thermallystressed samples. ISTA2A ship testing. | Ensure that the packagedesign is robust andprevents productdamage. | Pass – Results withinacceptance criteria |
Biocompatibility Testing
The biocompatibility evaluation for the NxStage TPE Cartridge was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," as recognized by the FDA. The battery of testing included the following tests.
- Cytotoxicity ●
- Hemolysis ●
- USP Physicochemical ●
- FTIR .
Conclusion: Results of the non-clinical testing have demonstrated that the proposed NxStage TPE cartridge is substantially equivalent to the predicate device and is suitable for the labeled indications for use.
§ 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.”