(260 days)
No
The summary describes a programmable electro-mechanical device for hemodiafiltration and filter reprocessing, with no mention of AI or ML capabilities.
Yes
The device is indicated for "treatment of patients with chronic renal failure," which is a therapeutic purpose.
No
This device is used for hemodiafiltration in patients with chronic renal failure, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is a "programmable electro-mechanical medical device" and describes physical components and connections (water supply, drain, electricity). This indicates it is a hardware device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "treatment of patients with chronic renal failure" and for "hemodiafiltration of patients with chronic renal failure." This describes a therapeutic treatment performed directly on a patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The description details an "electro-mechanical medical device" that works with a hemodialysis machine to generate substitution fluid and reprocess filters. This aligns with a device used in a treatment setting, not a laboratory setting for analyzing samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for use in a clinical setting to perform a medical treatment (hemodiafiltration) on patients with chronic renal failure.
N/A
Intended Use / Indications for Use
The OLpūr H₂H Hemodiafiltration (HDF) Module is indicated for use, with a UF controlled hemodialysis machine that provides ultrapure dialysate in accordance with current ANSI/AAMI/ISO standards, for treatment of patients with chronic renal failure as prescribed by a physician. The OLpūr MD 220 Hemodiafilter is indicated for use for hemodiafiltration of patients with chronic renal failure. The OLpūr MD 220 Hemodiafilter is only to be used with the OLpūr H₂H Hemodiafiltration Module. Selection of patients, as well as treatment operating parameters, are a medical decision and the responsibility of the prescribing physician.
The OLpūr H₂H Hemodiafiltration (HDF) Module works in conjunction with a qualified host (UF controlled) hemodialysis machine and it's accessories (i.e., bloodlines, dialysate, concentrates, etc.), the H₂H Module accessories (water and substitution fluid filters, infusion / rinse line, and optional blood extension line), appropriately prepared water and ultrapure dialysate for hemodialysis, and a high permeability hemodialyzer / hemodiafilter (i.e., the OLpūr MD 220 Hemodiafilter).
Product codes
FIP, KDI
Device Description
The H₂H™ Hemodiafiltration Module is a programmable electro-mechanical medical device designed to work in conjunction with and in close proximity to a hemodialysis machine during patient treatments. Upon installation, the H₂H Module is placed next to the hemodialysis machine (which can be on either side depending upon type and model of the hemodialysis machine) and is connected to the clinic's water supply, drain, and electricity.
The H₂H Hemodiafiltration Module serves two basic functions. The Module's primary function is to generate on-line substitution fluid for hemodiafiltration. The H₂H Module does this by ultrafiltering dialysate, provided by the hemodialysis machine, through a reusable substitution filter. The secondary function of the H₂H Hemodiafiltration Module is to serve as a substitution filter reprocessing machine. These steps are performed when the H₂H Hemodiafiltration Module is not connected to the hemodialysis machine. More detailed descriptions of the device, its accessories and how the system functions can be found in Section 11 (Device Description) of this submission.
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
Physician / clinic
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K090885, K945136, K003957, K974090, K983126, K033301, K072024
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
510(k) Summary: Nephros OLpūr® H₂H H₂H Hemodiafiltration (HDF) Module and OLpūr MD 220 Hemodiafilter
| Submitter: | Nephros Inc.
41 Grand Ave, Suite 201
River Edge, NJ 07661
Establishment Registration # 3003337893 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Gregory Collins Ph.D., V.P. of R&D
41 Grand Ave, Suite 201
River Edge, NJ 07661
201-343-5202 (p)
201-343-5207 (f)
collins@nephros.com |
| Date Prepared | August 10, 2011 |
| Trade Name | Nephros OLpūr H2H Hemodiafiltration (HDF) Module and OLpūr
MD 220 Hemodiafilter |
| Proposed Class | Class II |
| Classification Name
and Number | 21 CFR Part 876.5665 Water Purification System for
Hemodialysis; 21 CFR Part 876.5860 Dialyzer, High
Permeability With or Without Sealed Dialysate System |
| Product Code | FIP, KDI |
| Predicate Devices | ➤ Predicate for the Nephros MD 220 Hemodiafilter -
Nephros OLpūr HD190 (K050603)
➤ Predicate for the H2H Module with qualified UF-
Controlled Hemodialysis Machine - Aksys PHD Personal
Hemodialysis System (K010131)
➤ Predicate for the H2H Module in the stand-alone
configuration - Aksys PHD Personal Hemodialysis
System (K010131)
➤ Predicates for the H2H Substitution Fluid Filter --
Nephros DSU Dual Stage Ultrafilter (K090885), Minntech |
Nephros_510k_K112314_RFI Response-2
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Page 573 of 579
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| Device Description | Renaguard Dialysate Filter (K945136), Gambro Diaclear
Ultrafilter (K003957), Fresenius Citric Acid Dialyzer
Reprocessing (K974090)
➤ Predicates for the H₂H Water Filter - Nephros DSU Dual
Stage Ultrafilter (K090885), Minntech FiberFlo Hollow
Fiber Capsule Water Filter (K983126)
➤ Predicates for the Disposable H₂H Infusion Line and
Blood Tubing Extension Set - Codan IV Administration
Sets (K033301), Nipro Blood Tubing Set w/Transducer
Protector and Priming Set (K072024) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The H₂H™ Hemodiafiltration Module is a programmable electro-
mechanical medical device designed to work in conjunction with
and in close proximity to a hemodialysis machine during patient
treatments. Upon installation, the H₂H Module is placed next to
the hemodialysis machine (which can be on either side
depending upon type and model of the hemodialysis machine)
and is connected to the clinic's water supply, drain, and
electricity.
The H₂H Hemodiafiltration Module serves two basic functions.
The Module's primary function is to generate on-line substitution
fluid for hemodiafiltration. The H₂H Module does this by
ultrafiltering dialysate, provided by the hemodialysis machine,
through a reusable substitution filter. The secondary function of
the H₂H Hemodiafiltration Module is to serve as a substitution
filter reprocessing machine. These steps are performed when
the H₂H Hemodiafiltration Module is not connected to the
hemodialysis machine. More detailed descriptions of the device,
its accessories and how the system functions can be found in
Section 11 (Device Description) of this submission. | |
| Intended Use | The OLpür H₂H Hemodiafiltration (HDF) Module is indicated for
use, with a UF controlled hemodialysis machine that provides
ultrapure dialysate in accordance with current ANSI/AAMI/ISO
standards, for treatment of patients with chronic renal failure as
prescribed by a physician. The OLpūr MD 220 Hemodiafilter is
indicated for use for hemodiafiltration of patients with chronic
renal failure. The OLPûr MD 220 Hemodiafilter is only to be
used with the OLpūr H₂H Hemodiafiltration Module. Selection of
patients, as well as treatment operating parameters, are a
medical decision and the responsibility of the prescribing
physician.
The OLpür H₂H Hemodiafiltration (HDF) Module works in
conjunction with a qualified host (UF controlled) hemodialysis
machine and it's accessories (i.e., bloodlines, dialysate,
concentrates, etc.), the H₂H Module accessories (water and
substitution fluid filters, infusion / rinse line, and optional blood
extension line), appropriately prepared water and ultrapure
dialysate for hemodialysis, and a high permeability hemodiafil-
(i.e., the OLPūr MD 220 Hemodiafilter). |
| Summary of the
Technological
Characteristics | The proposed device has the same technological characteristics
and is similar in design as compared to the predicate devices
and already approved kidney dialysis therapy. |
| Assessment of Non-
clinical Performance
Data / Substantial | Refer to Section 18 of this application for Bench Analyses
performed on the subject devices. Refer to Section 20 of this
application for clinical data supporting substantial equivalence of |
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Nephros_510k_K112314_RFI Response-2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 27 2012
Greg Collins, Ph.D. V.P. of R&D Nephros, Inc. 41 Grand Ave. RIVER EDGE NJ 07661
. Re: K112314
Trade/Device Name: Nephros OLPur® H2H Hemodiafiltration (HDF) Module and OLPūr MD 220 Hemodiafilter
Regulation Number: 21 CFR& 876.5860
Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: April 26, 2012 Received: April 27, 2012
Dear Dr. Collins:
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.
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 that I Drines intess and regulations administered by other Federal agencies. You must of any I ederal statuated and regurements, including, but not limited to: registration and listing Compry will an the 100 b ag (21 CFR Part 801); medical device reporting (reporting of medical
4
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
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,
Benjamin K. Erhke
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K 112314
Device Name: Nephros OLPuro HzH Hemodiafiltration (HDF) Module and OLPūr MD 220 Hemodiafilter
Indications For Use:
The OLPur H2H Hemodiafiltration (HDF) Module is indicated for use, with a UF controlled hemodialysis machine that provides ultrapure dialysate in accordance with current ANSI/AAMI/ISO standards, for treatment of patients with chronic renal failure as prescribed by a physician. The OLPur MD 220 Hemodiafilter is indicated for use for hemodiafiltration of patients with chronic renal failure. The OLPur MD 220 Hemodiafilter is only to be used with the OLpur H2H Hemodiafiltration Module. Selection of patients, as well as treatment operating parameters, are a medical decision and the responsibility of the prescribing physician.
The OLPur H2H Hemodiafiltration (HDF) Module works in conjunction with a qualified host (UF controlled) hemodialysis machine and it's accessories (i.e., bloodlines, dialysate, concentrates, etc.), the HzH Module accessories (water and substitution fluid filters, infusion / rinse line, and optional blood extension line), appropriately prepared water and ultrapure dialysate for hemodialysis, and a high permeability hemodialyzer / hemodiafilter (i.e., the OLPur MD 220 Hemodiafilter).
Prescription Use x AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
Beijana R. Ruter
for Sign-Off n of Reproductive, Gastro-Renal, and