(70 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on water purification and dialysate preparation, not data analysis or algorithmic decision-making.
No.
The device prepares dialysate for hemodialysis, and while hemodialysis is a therapeutic procedure, the device itself is an accessory that prepares the necessary fluid, not directly treating the patient or performing the therapeutic action.
No
The device is described as an accessory that prepares dialysate for use during hemodialysis. There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly lists multiple hardware components (Control Unit, Pre-Treatment Unit, OPTA Kit, Purification Pack, Dialysate Sack) that are part of the device.
Based on the provided text, 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 treatment process, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the components involved in preparing water and mixing it with concentrate to create dialysate. This is a manufacturing/preparation process, not a diagnostic process.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions. This device's function is to prepare a fluid used in a treatment, not to perform a diagnostic test.
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
78 FKR, FKR
Device Description
The NxStage PureFlow SL module is an optional accessory to the NxStage System One used to prepare water for hemodialysis that meets ANSI/AAMI/ISO 13959:2009 and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI/ISO 11663:2009. The PureFlow SL 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, verification and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria were met. Results of this testing have documented that the proposed NxStage PureFlow SL is substantially equivalent to the predicate device and is suitable for the labeled indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 modifications meets design specifications.
§ 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.
0
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: March 5, 2014 Date Name: NxStage Medical, Inc. 350 Merrimack Street Address: Lawrence, MA 01843 FDA Establishment 9045797 Owner/Operator Number: Contact Person: Mary Lou Stroumbos Director, Regulatory Affairs Phone: (978) 687-4872 Fax: (978) 687-4750 MEDIMEXICO, S. DE R.L. DE C.V. Manufacturer: Av. Valle imperial No. 10523 Parque industrial Valle Sur Tijuana, B.C., Mexico 22180
FDA Establishment Registration Number:
9616074
Sterilization Site:
Steris Isomedix, Inc. 1000 S. Sarah Place Ontario, CA 91761
Contract Sterilizer
510(k) Device Modification NxStage Medical, Inc.
1
| B. Device Name: | |
|---|---|
| Trade/Proprietary Name: | NxStage PureFlow SL |
| Common/Usual Name: | Subsystem, proportioning |
| Classification Name: | Hemodialysis systems and accessories |
| Regulation Number: | 21 CFR 876.5820 |
| Product Code: | 78 FKR |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology-Urology (GU)/ |
| Gastro-Renal (GRDB) |
C. Substantial Equivalence:
P
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 modifications meets design specifications. The NxStage PFSL module with modifications has been compared to the legally marketed predicate device as cleared through K111174 (September 19, 2011) and was found to be substantially equivalent.
D. Device Description/Indications for Use:
The NxStage PureFlow SL module is an optional accessory to the NxStage System One used to prepare water for hemodialysis that meets ANSI/AAMI/ISO 13959:2009 and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI/ISO 11663:2009. The PureFlow SL 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.
510(k) Device Modification NxStage Medical, Inc.
2
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 proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate device.
| Table 1
| Device Technological Characteristics Comparison Table | ||
|---|---|---|
| Feature | Proposed | |
| NxStage PFSL Module | ||
| (subject of this 510(k)) | NxStage PFSL Module | |
| (K111174) | ||
| Indication for Use | Same | 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. | ||
| Water Purification | ||
| Water purification | ||
| technology | Same | Deionization |
| Ultrafiltration | Same | Redundant ultrafiltration replaced |
| within 12- weeks | ||
| Water Quality | Same | Meets or exceeds requirements |
| per ANSI/AAMI/ISO 26722:2009 | ||
| Water treatment equipment for | ||
| hemodialysis applications | ||
| Dialysate Proportioning : | ||
| Proportioning | ||
| method | Same | Mixed to use Batch via |
| volumetric dosing of purified | ||
| water with specified amount of | ||
| electrolyte concentrate | ||
| Table 1 | ||
| Device Technological Characteristics Comparison Table | ||
| Feature | Proposed | |
| NxStage PFSL Module | ||
| (subject of this 510(k)) | NxStage PFSL Module | |
| (K111174) | ||
| Conductivity | ||
| Measurement | Same | Yes - the System measures final |
| batch conductivity prior to each | ||
| treatment per ANSI/AAMI/ISO | ||
| 26722:2009 | ||
| Concentrate | ||
| Dialysate | ||
| Concentrate | Same | Standard hemodialysis |
| concentrate per ANSI/AAMI/ISO | ||
| 13958:2009 | ||
| Packaging | Same | Packaged in flexible LLDPE |
| bags with standard luer lock | ||
| connector. Ranging in size from | ||
| 20L to 60L | ||
| Buffer | Same | Lactate |
| Point of Use Dialysate Quality | ||
| Mix-to-Use Time | Same | 96-hours |
| Bioburden | Same | AAMI/ANSI/ISO 11663: |