(92 days)
The OLpūr™ HD 190 Dialyzer is indicated for hemodialysis and hemodiafiltration of patients with acute or chronic renal failure.
The OLpur"M HD 190 Dialyzer is a sterile, non-pyrogenic, single use, high permeability hemodialyzer intended to be used in providing hemodiafiltration to patients with acute or chronic renal failure. This dialyzer is designed for use only with UF controlled dialysis equipment and is compatible with all models of this generic type of equipment currently in use in the US. The individual dialyzers are packaged in a pouch constructed of Polyamide/Polyethylene film and a Tyvek® backing. The individually packaged dialyzers are packaged twelve to a carton and thirty-six to a shipping container. The dialyzer membranes used in this device consist of polyethersulfone (PES). The hollow fiber membranes are potted in a polyurethane compound at each end within a polycarbonate dialyzer casing to form a tubesheet. A polycarbonate blood inlet header attached to the end of the casing directs the incoming blood into the hollow fibers. The blood then flows through the inside of the hollow fibers and exits out through the polycarbonate blood outlet header attached to the other end of the casing. Inlet and outlet dialysate (Hansen) ports on the dialyzer casing allow for the flow of dialysate around the outside of the hollow fibers counter-current to the blood flow. Uremic toxins and excess plasma water are removed from the blood across the semi-permeable hollow fibers. A combination of diffusion, due to the concentration differences between the blood and dialysate, and convection, due to the transmembrane pressure differential across the hollow fibers, leads to the toxin removal. The spent dialysate exits the device via the dialysate outlet port. As received by the customer, the dialyzer's blood and dialysate ports are covered with polyethylene sterility caps. Silicone o-rings are included in the connections between the headers and the dialyzer tubesheet at each end of the dialyzer to provide a fluid-tight seal between the headers and the tubesheet.
The provided text is a 510(k) summary for the Nephros OLpūr™ HD 190 Dialyzer. It focuses on demonstrating substantial equivalence to predicate devices based on nonclinical testing (biocompatibility, sterility, pyrogenicity, shelf life, and in vitro performance).
Crucially, this document does not contain information about a study proving the device meets acceptance criteria related to a specific performance metric like diagnostic accuracy with human readers or a standalone algorithm performance. It describes a medical device (a dialyzer), not an AI/ML-driven diagnostic or image analysis tool.
Therefore, I cannot fulfill most of your request regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, or MRMC comparative effectiveness, as these concepts are not applicable to the information provided in this 510(k) summary.
However, I can extract information relevant to the device's performance based on the nonclinical testing described:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate equivalence) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Equivalent to predicate devices | Testing supported substantial equivalence |
| Sterility | Equivalent to predicate devices | Testing supported substantial equivalence |
| Pyrogenicity | Equivalent to predicate devices | Testing supported substantial equivalence |
| Shelf Life | Equivalent to predicate devices | Testing supported substantial equivalence |
| In vitro Performance | Effective as a High Flux Hollow Fiber Hemodialyzer, comparable to predicate devices (e.g., clearance, ultrafiltration rates, etc.) | Testing supported substantial equivalence, device effective as a High Flux Hollow Fiber Hemodialyzer. |
The rest of the requested information cannot be provided from the given document:
- Sample sizes for test set and data provenance: Not applicable/not provided. The "test set" here refers to the dialyzer units themselves used for nonclinical testing, not patient data for an AI algorithm.
- Number of experts and qualifications for ground truth: Not applicable. Ground truth for a dialyzer involves lab measurements and existing standards, not expert clinical interpretation as would be for an AI diagnostic.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human performance in diagnostic tasks.
- Standalone (algorithm only) performance: Not applicable. This is a medical device, not an algorithm.
- Type of ground truth used: For in vitro performance, the ground truth would be established by controlled laboratory measurements and standard test methods for dialyzers, compared against the specifications or performance of predicate devices. For biocompatibility/sterility/pyrogenicity, it would be based on established international standards and test protocols.
- Sample size for the training set: Not applicable. This is not an AI/ML model.
- How the ground truth for the training set was established: Not applicable.
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510(k) Summary
Submitter
Nephros, Inc. 3960 Broadway New York, NY 10032 USA
Contact:
Nadia C. Greenidge Manager of Quality Assurance and Regulatory Affairs
Phone: 212-781-5113 Fax: 212-781-5166
Date summary was prepared:
3/8/05
Name(s) of the device
OLpūr™ HD 190 Dialyzer
Identification of predicate device(s)
The OLpur HD 190 Dialyzer is substantially equivalent to the following devices:
Gambro Polyflux 21S Dialyzer, 510(k) # K982414
Asahi APS 21R Dialyzer, 510(k) # K001250
Description of the device
The OLpur"M HD 190 Dialyzer is a sterile, non-pyrogenic, single use, high permeability hemodialyzer intended to be used in providing hemodiafiltration to patients with acute or chronic renal failure. This dialyzer is designed for use only with UF controlled dialysis equipment and is compatible with all models of this generic type of equipment currently in use in the US. The individual dialyzers are packaged in a pouch constructed of Polyamide/Polyethylene film and a Tyvek® backing. The individually packaged dialyzers are packaged twelve to a carton and thirty-six to a shipping container.
The dialyzer membranes used in this device consist of polyethersulfone (PES). The hollow fiber membranes are potted in a polyurethane compound at each end within a polycarbonate dialyzer casing to form a tubesheet. A polycarbonate blood inlet header attached to the end of the casing directs the incoming blood into the hollow fibers. The blood then flows through the inside of the
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hollow fibers and exits out through the polycarbonate blood outlet header attached to the other end of the casing. Inlet and outlet dialysate (Hansen) ports on the dialyzer casing allow for the flow of dialysate around the outside of the hollow fibers counter-current to the blood flow. Uremic toxins and excess plasma water are removed from the blood across the semi-permeable hollow fibers. A combination of diffusion, due to the concentration differences between the blood and dialysate, and convection, due to the transmembrane pressure differential across the hollow fibers, leads to the toxin removal. The spent dialysate exits the device via the dialysate outlet port.
As received by the customer, the dialyzer's blood and dialysate ports are covered with polyethylene sterility caps. Silicone o-rings are included in the connections between the headers and the dialyzer tubesheet at each end of the dialyzer to provide a fluid-tight seal between the headers and the tubesheet.
Intended Use
The OLDur™ HD 190 Dialyzer is indicated for hemodialysis and hemodiafiltration of patients with acute or chronic renal failure.
Comparison of device characteristics to predicate
The OLour HD 190 Dialyzer is substantially equivalent to the Gambro Polyflux 21S, in that they are both sterile, single use, high permeability hemodialyzers with the same intended use, of similar construction, made with the same type of membrane material and comparable in regard to their performance characteristics.
The OLDur HD 190 Dialyzer is also substantially equivalent to the Asahi APS 21R in that they are both sterile, high permeability hemodialyzers with similar intended use, of similar construction and materials, made with the same type of membrane material and comparable in regard to their performance characteristics.
Nonclinical testing
OLpur HD 190 Dialyzer was subjected to biocompatibility, sterility, pyrogenicity, shelf life, and in vitro performance testing to demonstrate its equivalence to the predicate devices. All of the testing supported the substantial equivalence by the test results. Both the subject devices and the predicate devices are effective as High Flux Hollow Fiber Hemodialyzers. Based on this data it was concluded that OLpur HD 190 Dialyzer is substantially equivalent to the Gambro Polyflux 21S Dialyzer and the Asahi APS 21R Dialyzer,
Conclusion
Based on the descriptive information and performance data provided in this premarket notification, it is concluded that the OLpur HD 190 Dialyzer is substantially equivalent to the predicate devices listed above.
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JUN 9 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nadia Greenidge Manager QA/RA Nephros, Inc. 3960 Broadway NEW YORK NY 10032
Re: K050603
Trade/Device Name: Nephrol OLpūr™ HD 190 Dialyzer Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: May 26, 2005 Received: May 27, 2005
Dear Ms. Greenidge:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave reviewed your becalled in oppy probstantially equivalent (for the indications for use stated in above and have decemined the ad predicate devices marketed in interstate commerce prior to the enclosule) to tegarry mattered produced Device Amendments, or to devices that have been May 20, 1970, the clascinonic dato of the Federal Food, Drug, and Cosmetic Act (Act) that recrassified in accordation warmatics approval application (PMA). You may, therefore, market the do not require approval or a premiation of the Act. The general controls provisions of the Act device, subjost to the gatedal controls provinces, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (300 additional controls. Existing major regulations affecting your Apployal), it may of subject to such aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA ucvice can be round in the concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please or advised that I DA 3 issualled of a sice complies with other requirements of the Act of all Federal statutes and regulations administered by other Federal agencies. You must comply with all the Federal statues and regulations administer of registration and listing (21 CFR Part 807); labeling Act s requirements, modulity, but hot million is regultements as set forth in the quality systems (QS) (ZF CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mo lotter with cation. The FDA finding of substantial equivalence of your device to a legally promatics notificate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you don't office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | - | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Anot produs neve the regulation on your responsibilities under the Act from the 60 : 77). " Ca may obtain ourers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K050603
Device Name: OLpūr™ HD 190 Dialyzer
Indications For Use:
The OLpūr™ HD 190 Dialyzer is indicated for hemodialysis and hemodiafiltration of patients with acute or chronic renal failure.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Colin m Pollard
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number.
§ 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.”