(90 days)
The DSU Dual Stage Ultrafilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU Ultrafilter assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore, it must be used in conjunction with other water treatment equipment (i.e., RO, DI, etc.).
The DSU Dual Stage Ultrafilter is a hollow fiber filter that removes bacteria, viruses, endotoxin and particulate from water and bicarbonate concentrate used in hemodialysis.
The provided text describes the DSU Dual Stage Ultrafilter, a device intended to filter water or bicarbonate concentrate used in hemodialysis. The information primarily focuses on its regulatory submission and equivalence to a predicate device. While it mentions various tests conducted, it does not provide detailed acceptance criteria with numerical thresholds or specific performance results in a comparative table format. Therefore, some information requested cannot be fully extracted from the provided text.
Here's the information that can be extracted, and an indication of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flow Rate versus Pressure Drop | Not specified | Tested |
| Bicarbonate Composition Effect | Not specified | Tested |
| Pyrogen Removal | Not specified | Tested |
| Virus Challenge Test | Not specified (implied to meet requirements for substantial equivalence) | Tested |
| Bacteria Challenge Test | Not specified (implied to meet requirements for substantial equivalence) | Tested |
| Chemical Compatibility | Not specified | Tested |
2. Sample Size for the Test Set and Data Provenance
The document mentions that the DSU Dual Stage Ultrafilter "has been tested for performance." However, it does not specify the sample size used for the test set for any of the mentioned tests (Flow Rate, Bicarbonate Composition, Pyrogen Removal, Virus Challenge, Bacteria Challenge, Chemical Compatibility).
The data provenance is also not explicitly stated. It's a regulatory submission to the FDA (USA), implying the testing was conducted by the manufacturer (Nephros Inc. in River Edge, NJ, USA). It does not indicate if the data is retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This device is a physical filter, not an AI/software device that relies on expert interpretation for ground truth. Therefore, this information is not applicable to this type of medical device submission. The performance is assessed through laboratory testing against physical and biological contaminants.
4. Adjudication Method for the Test Set
As this is a physical device with laboratory performance testing, adjudication methods typically used for human interpretation of medical images or data are not applicable. Test results would be objectively measured.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
This is not applicable as the device is a physical filter, not an AI-assisted diagnostic tool involving human readers.
6. Standalone Performance Study
Yes, the studies mentioned (Flow Rate, Bicarbonate Composition Effect, Pyrogen Removal, Virus Challenge Test, Bacteria Challenge Test, and Chemical Compatibility) represent standalone performance testing of the DSU Dual Stage Ultrafilter. The text states: "The DSU Dual Stage Ultra Filter has been tested for performance." This indicates that the algorithm (in this case, the device's physical mechanism) was evaluated directly without human intervention to complete its primary function.
7. Type of Ground Truth Used
The ground truth for the stated tests would be based on objective laboratory measurements and established scientific standards for water purification and filtration efficacy (e.g., bacterial count reduction, virus removal, pyrogen levels, flow rate consistency). For example, for the "Virus Challenge Test" and "Bacteria Challenge Test," the ground truth would be the known concentration of viruses or bacteria in the input water and the measured concentration in the output water after filtration, adhering to specific test protocols.
8. Sample Size for the Training Set
This information is not applicable as this is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is a physical medical device, not an AI/machine learning algorithm.
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K090885 pgs lot 2
Traditional 510(k) Premarket Notification
JUN 29 2009
| Submitter: | Nephros Inc.41 Grand AveRiver Edge, NJ 07661Establishment Registration # 3003337893 |
|---|---|
| Contact Person | Vikki M. O'Connor, Director QA/RA41 Grand AveRiver Edge, NJ 07661201-207-2490 (p)201-343-5207 (f)vhoffman@nephros.com |
| Date Prepared | March 30, 2009 |
| Trade Name | DSU Dual Stage Ultrafilter |
| Proposed Class | Class II |
| Classification Nameand Number | 21 CFR Part 876.5665 Water Purification System forHemodialysis |
| Product Code | FIP |
| Predicate Devices | FiberFlo™ Hollow Fiber Cartridge Water Filters - K983126 |
| Device Description | The DSU Dual Stage Ultrafilter is a hollow fiber filter thatremoves bacteria, viruses, endotoxin and particulate fromwater and bicarbonate concentrate used in hemodialysis. |
| Intended Use | The DSU Dual Stage Ultrafilter is intended to be used tofilter water or bicarbonate concentrate used inhemodialysis devices. The DSU assists in providinghemodialysis quality water or bicarbonate concentrate. Thedevice is not a complete water treatment system, butserves to remove biological contaminants. Therefore itmust be used in conjunction with other water treatmentequipment (i.e., RO, DI, etc.). |
| Summary of theTechnologicalCharacteristics | The proposed device has the same technologicalcharacteristics and is similar in design as compared to thepredicate device. |
| Assessment ofNon-clinicalPerformance Data /SubstantialEquivalence | The DSU Dual Stage Ultra Filter has been tested forperformance. The tests conducted include Flow Rateversus Pressure Drop, Bicarbonate Composition Effect,Pyrogen Removal, Virus Challenge Test, BacteriaChallenge Test and Chemical Compatibility. This filter wasfound to be substantially equivalent to the predicateMinntech Fiberflo Filter (K983126). |
510(k) Summary: DSU Dual Stage Ultrafilter
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K090885 page 2 of 2
Nephros Inc. DSU Dual Stage Ultrafilter
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Traditional 510(k) Premarket Notification
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vikki M. O'Connor Director, OA/RA Nephros, Inc. 41 Grand Avenue RIVER EDGE NJ 07661
Re: K090885
Trade/Device Name: Nephros Inc. DSU Filter Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: March 30, 2009 Received: April 3, 2009
Dear Ms. O'Connor:
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.
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 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 of medical
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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 hitp://www.fda.gov/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation -Center for Devices and Radiological Health
Enclosure
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K09085 page lot 1
Traditional 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): K 090885 Device Name: Nephros Inc. DSU Filter
Indications For Use:
The DSU Dual Stage Ultrafiter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU Ultrafilter assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore, it must be used in conjunction with other water treatment equipment (i.e., RO, DI, etc.).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
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)
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§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.