(145 days)
Not Found
No
The summary describes a system for preparing dialysate for hemodialysis, focusing on water treatment and proportioning. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies. The performance metrics are related to bioburden and endotoxin levels, not algorithmic performance.
No.
The device prepares dialysate for use during hemodialysis; it does not directly perform a therapeutic function on the patient.
No
The device prepares dialysate for hemodialysis, which is a treatment process, not a diagnostic one. It treats water and proportions it with dialysate concentrate, and performance tests relate to bioburden and endotoxin levels of the prepared dialysate, not the diagnosis of a patient's condition.
No
The device description explicitly lists multiple hardware components (Control Unit, water Pre-Treatment Unit, OPTA Kit, Purification Pack, Dialysate Sack) that are part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "prepare dialysate for use during hemodialysis." This is a process that prepares a fluid for direct use in a medical treatment (hemodialysis), not for testing a sample taken from the human body to provide diagnostic information.
- Device Description: The description details a system for treating water and mixing it with concentrate to produce dialysate. This is a manufacturing or preparation process, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample from a patient (blood, urine, tissue, etc.) or providing information about a patient's health status, disease, or condition.
- Performance Metrics: The key metrics provided (
N/A
Intended Use / Indications for Use
The NxStage PureFlow SL module is an optional accessory to the NxStage System One™ that prepares dialysate for use during hemodialysis, as prescribed by the physician.
Product codes (comma separated list FDA assigned to the subject device)
FKR
Device Description
The NxStage PFSL module is an optional accessory to the NxStage System One that is used to treat water for hemodialysis per ANSI/AAMI/ISO 13959:2009 and ANSI/AAMI/ISO 26722:2009 and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI/ISO 11663:2009. The PFSL module consists of the Control Unit (CU), the water Pre-Treatment Unit, the optional OPTA Kit, the Purification Pack (PAK), and the Dialysate Sack (SAK) with Dialysate Concentrate.
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 and verification and validation testing was conducted to characterize performance of the proposed device. This included stability, bioburden and endotoxin testing on validation batches of dialysate to support the extension of the MTU duration to 96-hours. All predetermined acceptance criteria were met. The NxStage PureFlow SL meets the ANSI/AAMI/ISO 11663:2009 requirements of
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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K111174
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SEP 19 2011
This 510(k) Summary is being submitted in accordance with the requirements of the SafeSEP 1 9 2011
Modied Baying Art (OMDA) of 1999 - The section at including this all in Medical Device Act (SMDA) of 1990. The content contained in this 510(k) summary has been provided in conformance with 21 CFR §807.92.
9045797
Mary Lou Stroumbos
(978) 687-4872
(978) 687-4750
Date of Summary: August 26, 2011
A. Submitter's Information:
| Name: | NxStage Medical, Inc. |
|---|---|
| Address: | 439 South Union Street, 5th Floor |
| Lawrence, MA 01843 |
FDA Establishment Owner/Operator Number:
Contact Person:
Phone: Fax:
Manufacturer:
Entrada Group/NxStage Carretera Fresnillo A Plateros, KM2 Fresnillo, Zacatecas 99059 Mexico
Sr. Regulatory Affairs Associate
FDA Establishment Registration Number:
3006546166
Sterilization Site:
Steris Isomedix, Inc. 1000 S. Sarah Place Ontario, CA 91761
- B. Subject Device Name: Trade/Proprietary Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Classification: Device Panel:
NxStage PureFlow SL Subsystem, proportioning Hemodialysis systems and accessories 21 CFR 876.5820 78 FKR Class II Gastroenterology-Urology (GU)/Gastro-Renal (GRDB)
510(k) Summary NxStage Medical, Inc.
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C. Substantial Equivalence:
This submission is a Special 510(k) Device Modification as described in the FDA's Guidance document entitled, "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this Special 510(k), NxStage has provided certification of compliance to 21 CFR §820.30 Design Control Requirements. Design validation testing was performed to ensure that the NxStage PureFlow SL (PFSL) module with modification to increase the mix to use (MTU) time of the prepared dialysate from 72-hours to 96-hours meets design specifications. The NxStage PFSL module with modifications has been compared to the legally marketed PFSL predicate device as cleared through K080919 (October 15, 2008) and was found to be substantially equivalent.
D. Device Description/Indications for Use:
The NxStage PFSL module is an optional accessory to the NxStage System One that is used to treat water for hemodialysis per ANSI/AAMI/ISO 13959:2009 and ANSI/AAMI/ISO 26722:2009 and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI/ISO 11663:2009. The PFSL module consists of the Control Unit (CU), the water Pre-Treatment Unit, the optional OPTA Kit, the Purification Pack (PAK), and the Dialysate Sack (SAK) with Dialysate Concentrate.
Indications for use:
The NxStage PureFlow SL module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
E. Technological Characteristics:
The indications for use of the proposed device and of the predicate device are identical. There is no change to the indications for use or intended use of the PureFlow SL module, and the modification has no affect on the fundamental scientific technology of the device. The proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate device.
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. Performance and verification and validation testing was conducted to characterize performance of the proposed device. This included stability, bioburden and endotoxin testing on validation batches of dialysate to support the extension of the MTU duration to 96-hours. All predetermined acceptance criteria were met. The NxStage PureFlow SL meets the ANSI/AAMI/ISO 11663:2009 requirements of