(119 days)
The DSU-H and SSU-H Ultrafilters are intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP sterile water.
The DSU-H and SSU-H Ultrafilters are hollow fiber ultrafilters that retain bacteria, viruses, endotoxin and particulate from water used for washing and drinking.
The provided text describes a medical device, the DSU-H and SSU-H Ultrafilters, but it does not include information about AI algorithms, reader studies, ground truth establishment for AI, or training/test sets for AI. Therefore, I cannot fulfill most of your request regarding acceptance criteria and studies that prove the AI device meets acceptance criteria.
However, I can extract the acceptance criteria for the Ultrafilters themselves as stated in the submission documents, which are based on their filtration performance.
Here's what I can provide based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance (for the Ultrafilters)
The document primarily performs a substantial equivalence comparison to a predicate device (MainStream™ Water Purification Device – K012716) and refers to its own reference device (DSU and SSU Filters – K110285). The "acceptance criteria" can be inferred from the "Retention" section of the comparison table, where the device must demonstrate at least equivalent or superior reductions for various contaminants.
| Characteristic | Acceptance Criteria (Inferred from Predicate/Reference) | Reported Device Performance (Subject Device: DSU-H and SSU-H Ultrafilters) |
|---|---|---|
| Bacteria Reduction | > 10^7^ (Predicate) / > 10^11^ (Reference) | > 10^11^ |
| Virus Reduction | > 10^4^ (Predicate) / > 10^8^ (Reference) | > 10^8^ |
| Endotoxin Reduction | > 10^4^ (Predicate) / > 10^5^ (Reference) | > 10^5^ |
| Organic Reduction | < 1 ppm (Predicate) | N/A (Not designed for organic reduction) |
| Ion Reduction | > 10^3^ dissociable ions (Predicate) | N/A (Not designed for ion reduction) |
Explanation of Inference:
The submission states "Based on non-clinical performance testing, the DSU-H and SSU-H Ultrafilters have been found to be substantially equivalent to the predicate PrisMedical MainStream Filter (K012716)." For the characteristics where the subject device also performs, it must meet or exceed the predicate's performance. Furthermore, the subject device's performance aligns with its own reference device (K110285), which indicates its expected retention capabilities.
The following points cannot be answered as the provided text pertains to a physical water purification device and does not involve AI or a diagnostic algorithm evaluated through an AI specific study:
- Sample size used for the test set and the data provenance: Not applicable. This is for a physical filter, not an AI algorithm. The performance data would come from laboratory testing of the filter medium with controlled contaminant challenges.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical filter's performance is established through standard microbiological and chemical testing, not expert consensus on medical images or diagnoses.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance data presented (bacteria, virus, endotoxin reduction), the ground truth would be established by quantitative laboratory analysis of contaminant levels before and after filtration, using validated assays (e.g., CFU counts for bacteria, TCID50 for viruses, LAL test for endotoxin).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2014
Nephros Incorporated Mr. Jim Summerton Manager Product Development 41 Grand Avenue River Edge, NJ 07661
Re: K141731
Trade/Device Name: DSU-H and SSU-H Ultrafilters Regulation Number: 21 CFR 876.5665 Regulation Name: Water Purification Device, General Medical Use Regulatory Class: II Product Code: NHV Dated: September 24, 2014 Received: September 26, 2014
Dear Mr. Summerton:
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.
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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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K141731
Device Name: DSU-H and SSU-H Ultrafilters
Indications For Use:
The DSU-H and SSU-H Ultrafilters are intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP sterile water.
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) | |
|---|---|
| -------------------------------------------------------- | -- |
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Attachment 3
005: 510(k) Summary
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| Submitter: | Nephros Inc.41 Grand AveRiver Edge, NJ 07661Establishment Registration # 3003337893 |
|---|---|
| Contact Person | Jim Summerton, Manager Product Development41 Grand AveRiver Edge, NJ 07661201-343-5202 (p)201-343-5207 (f)summerton@nephros.com |
| Date Prepared | September 22, 2014 |
| Trade Name | DSU-H and SSU-H Ultrafilters |
| Proposed Class | Class II |
| Classification Nameand Number | 21 CFR Part 876.5665 Water Purification Device, GeneralMedical Use |
| Product Code | NHV |
| Predicate Device | MainStream™ Water Purification Device – K012716 |
| Reference Devices | DSU and SSU Filters – K110285 |
| Device Description | The DSU-H and SSU-H Ultrafilters are hollow fiber ultrafiltersthat retain bacteria, viruses, endotoxin and particulate from waterused for washing and drinking. |
| Intended Use | The DSU-H and SSU-H Ultrafilters are intended to be used tofilter EPA quality drinking water. The filters retain bacteria,viruses and endotoxin. By providing ultrapure water for washingand drinking, the filters aid in infection control. The filtersproduce water that is suitable for wound cleansing, cleaning ofequipment used in medical procedures and washing of surgeon'shands. The filters are not intended to provide water that can beused as a substitute for USP sterile water. |
510(k) Summary: DSU-H and SSU-H Ultrafilters
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| Summary of the | The proposed device contains a polysulfone hollow fiber |
|---|---|
| Technological | membrane encased in an ABS housing that retains bacteria, |
| Characteristics | viruses and endotoxin. Retention of contaminants is through size |
| exclusion. Further details of the technology can be found in | |
| Section 11 'Device Description'. | |
| Assessment of Non- | Based on non-clinical performance testing, the DSU-H and SSU- |
| clinical Performance | H Ultrafilters have been found to be substantially equivalent to |
| Data / Substantial | the predicate PrisMedical MainStream Filter (K012716). |
| Equivalence |
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SUBJECT - PREDICATE COMPARISON TABLES
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k)Number | K141731 | K012716 | K110285 |
| ManufacturerName | Nephros Inc. | PrisMedical | Nephros Inc. |
| Indicationsfor Use | The DSU-H and SSU-HUltrafilters are intendedto be used to filter EPAquality drinking water.The filters retainbacteria, viruses andendotoxin. Byproviding ultrapurewater for washing anddrinking, the filters aidin infection control. Thefilters produce waterthat is suitable forwound cleansing,cleaning of equipmentused in medicalprocedures and washingof surgeon's hands. Thefilters are not intendedto provide water thatcan be used as asubstitute for USPsterile water. | To produce from EPAgrade drinking water,sterile purified water tobe used within 24 hoursof collection that issuitable for:- Cleaning and rinsingopen wounds- Infection control(cleaning equipmentused in medicalprocedures, medicalpersonnel's hands)- Use as a diluent forenteral, nutritional,oral vaccine, or oraldrug preparations- All other uses ofsterile purified waterthe practitioner orclinician deemsnecessary- Not for parenteraladministration | The DSU and SSUFilters are intended tobe used to filter wateror bicarbonateconcentrate used inhemodialysis devices.They assist inprovidinghemodialysis qualitywater or bicarbonateconcentrate. Thedevice is not acomplete watertreatment system, butserves to removebiologicalcontaminants.Therefore it must beused in conjunctionwith other watertreatment equipment(RO, DI, etc.). |
| Subject Device | Predicate Device | Reference Device | |
| Operation | |||
| Feed WaterSource | In-line plumbing | Gravity feed | In-line plumbing |
| Use Life | up to 3 Mo. (SSU-H)up to 6 Mo. (DSU-H) | 3 Liters | 1 Year |
| MaximumInlet Pressure | 75 psi (SSU-H)100 psi (DSU-H) | < 10 psi | 75 psi |
| Flow Rateand PressureDrop | See Section 18 forsubject device flowcurves | 30 ml/min at 5 psi | Same as subjectdevice |
| Materials | |||
| Casing | ABS | Polycarbonate | ABS |
| Filter | Polysulfone | Ultrafiltration Sheet | Polysulfone |
| Element(s) | Ultrafiltration HollowFiber | UltrafiltrationMembranePolypropylene meshActivated CarbonDeionization ResinBeads | Ultrafiltration HollowFiber |
| Retention | |||
| BacteriaReduction | > 1011 | > 107 | > 1011 |
| VirusReduction | > 108 | > 104 | > 108 |
| EndotoxinReduction | > 105 | > 104 | > 105 |
| OrganicReduction | N/A | TOC reduced to < 1 ppm | N/A |
| Ion Reduction | N/A | > 103 dissociable ions | N/A |
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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.