(255 days)
Not Found
No
The device description and performance studies focus on the physical components and functional verification of fluid pathways, with no mention of AI or ML technologies.
No.
The device is an accessory that provides a fluid pathway for concentrates and acetic acid to hemodialysis machines, which are therapeutic devices. However, the wands themselves do not directly treat a patient but rather facilitate the function of the hemodialysis machine. Additionally, one of the wands is specifically for cleaning the machine and is not used during patient treatment.
No
The device, Wand Assemblies, provides a fluid pathway for concentrates and acetic acid to hemodialysis machines and is used as an accessory to prepare dialysate or for machine cleaning. It does not perform any diagnostic function.
No
The device description clearly describes physical components (wands, sub-assemblies) that provide a fluid pathway and connect to canisters and hemodialysis machines. It is a hardware accessory.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Wand Assemblies are used with hemodialysis machines to provide a fluid pathway for concentrates and acetic acid. This is a mechanical function related to the delivery of solutions for dialysis treatment and machine maintenance.
- Device Description: The description reinforces this by explaining how the wands connect to canisters and supply solutions to the hemodialysis machine for dilution and cleaning.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. IVDs are specifically designed for testing biological samples (blood, urine, tissue, etc.) to gain diagnostic insights.
The Wand Assemblies are accessories to a hemodialysis machine, which is a therapeutic device used to treat renal failure. They facilitate the delivery of necessary fluids for the dialysis process and machine maintenance, but they do not perform any diagnostic function on patient samples.
N/A
Intended Use / Indications for Use
The Wand Assemblies are intended to be used with the 2008 Series Hemodialysis Machines to provide a Nuid pathway for the concentrates and acetic acid from the canisters to the acid and bicarbonate lines of the 2008 Series Hemodialysis Machines. The Wand Assemblies are designed to be used as an accessory to the 2008 Series Hemodialysis Machines for the patients receiving dialysis therapy for acute and chronic renal failure.
Product codes
KDI
Device Description
The Acid Concentrate, Bicarbonate Concentrate and Acetic Acid wands are sub-assemblies intended to be used with the concentrate and acetic acid canisters as accessories to the 2008 Series Hemodialysis Machines.
The wands allow the 2008 Series Hemodialysis Machines to attach to the canisters and supply bicarbonate (blue wand), acid concentrate (red wand), and acetic acid (white wand).
During a dialysis treatment, the blue and red Canister-Wand Assemblies provide connectivity to supply the 2008 Series Hemodialysis Machines with Acid Concentrate and Bicarbonate Concentrate solutions. The Hemodialysis Machine will dilute these solutions with Reverse Osmosis (RO) water to produce the final dialysate solution.
The white acetic acid Wand Assembly is used to supply Acetic Acid to the 2008 Series Hemodialysis Machines while running an Acid Cleaning Program as part of regular maintenance procedures. The Acid Clean Program flushes the machine with white distilled vinegar, 5% acetic or 5% citric acid for 10-60 minutes to prevent build of bicarbonate in the hydraulic system after treatment. During the cleaning program, the patient is not connected to the hemodialysis machine.
The device description information included in this submission conforms to the applicable requirements of 21 CFR Section 876.5860, declared guidance and standards.
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
Testing was selected through the application of a risk management process, applicable guidance documents and relevant standards. The following tests were conducted to support the determination of substantial equivalence:
- Performance Functional Verification
- Biological Safety (per ISO 10993 and G95-1) Biocompatibility (GLP) and Chemical Evaluations
Results from the functional testing and biocompatibility testing demonstrate that the differences between the proposed and the predicate device do not raise any new concerns with regard to safety or effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Wand Assemblies Traditional 510(k)
K133299 Page 1 of 4
510(k) Summary
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92.
Submitter's Information
Name:
Address:
Phone:
Fax:
Contact Person:
Date of Preparation:
Device/Trade Name: Common Name: Classification Name:
Classification Number: : : Product Code/Classification Panel: Fresenius Medical Care – Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451-1457
(781) 699-4479
(781) 699-9635 Denise Oppermann, Senior Director Regulatory Affairs - Devices Renal Therapies Group July 1, 2014
Wand Assembly Connector Cap High permeability hemodialysis system ; Class II per 21 CFR § 876.5860 KDI; Gastroenterology/Urology Panel
1
Wand Assemblies Traditional 510(k)
Legally Marketed Predicate Device (unmodified device)
2008 series Hemodialysis Machines: 2008T Hemodialysis Machine (K121341), 2008K@home Hemodialysis Machine with bibag (K124035), and 2008K Hemodialysis Machine (K994267).
Device Description
The Acid Concentrate, Bicarbonate Concentrate and Acetic Acid wands are sub-assemblies intended to be used with the concentrate and acetic acid canisters as accessories to the 2008 Series Hemodialysis Machines.
The wands allow the 2008 Series Hemodialysis Machines to attach to the canisters and supply bicarbonate (blue wand), acid concentrate (red wand), and acetic acid (white wand).
During a dialysis treatment, the blue and red Canister-Wand Assemblies provide connectivity to supply the 2008 Series Hemodialysis Machines with Acid Concentrate and Bicarbonate Concentrate solutions. The Hemodialysis Machine will dilute these solutions with Reverse Osmosis (RO) water to produce the final dialysate solution.
The white acetic acid Wand Assembly is used to supply Acetic Acid to the 2008 Series Hemodialysis Machines while running an Acid Cleaning Program as part of regular maintenance procedures. The Acid Clean Program flushes the machine with white distilled vinegar, 5% acetic or 5% citric acid for 10-60 minutes to prevent build of bicarbonate in the hydraulic system after treatment. During the cleaning program, the patient is not connected to the hemodialysis machine.
The device description information included in this submission conforms to the applicable requirements of 21 CFR Section 876.5860, declared guidance and standards.
Indications for Use
The Wand Assemblies are intended to be used with the 2008 Series Hemodialysis Machines to provide a fluid pathway for the concentrates and acetic acid from the canisters to the acid and bicarbonate lines of the 2008 Series Hemodialysis Machines. The Wand Assemblies are designed to be used as an accessory to the 2008 Series Hemodialysis Machines for the patients receiving dialysis therapy for acute and chronic renal failure.
Intended Use
The intended use of the Wand Assemblies is described in this submission the same as the intended use of the Wand Assemblies on the predicate devices. Both devices are intended to
2
be used with the 2008 Series Hemodialysis Machines as accessories to provide a fluid pathway between the concentrate and acetic acid canisters and the 2008 Series Hemodialysis Machine.
Technological Characteristics
The subject Wand Assemblies and the predicate assemblies have similar technological characteristics:
- Intended Use As an accessory to provide a concentrate fluid pathway between the . concentrate and acetic acid canisters and the 2008 series Hemodialysis Machine.
- Design/Configuration Patient Fluid contacting and non-patient contacting components . designed and sub-assembled to provide an interface for connection between concentrate and acetic acid canisters and the 2008 Series Hemodialysis Machines ι concentrate lines.
- Fundamental Scientific Technology/Operating Principle: The Acid Concentrate, . Bicarbonate and Acetic Acid wands are sub-assemblies intended to be used with canisters as accessories of the 2008 Series Hemodialysis Machines. The Canister-Wand
- Assemblies allow the 2008 Series Hemodialysis Machines to attach to the canisters and 、 supply the machine with bicarbonate (blue wand), acid concentrate (red wand), and acetic acid (white wand).
- Materials -- Fluid-Contacting: Polypropylene, Silicone, PVDF, Non-Fluid Contacting: . HDPE, Stainless Steel.
The differences between the subject Wand Assemblies and Predicate Wand Assemblies are as follows:
- Design/Configuration The proposed wand assemblies are comprised of similar . � component types as the predicates. The jug adapter portions of the proposed wand assemblies have different mold geometry.
- Materials The proposed wand assemblies utilize different colorants and a different . polypropylene resin. All material types remain the same as the predicate.
Performance Data
Testing was selected through the application of a risk management process, applicable guidance documents and relevant standards. The following tests were conducted to support the determination of substantial equivalence:
- Performance Functional Verification .
- Biological Safety (per ISO 10993 and G95-1) Biocompatibility (GLP) and Chemical � Evaluations
Conclusion
Results from the functional testing and biocompatibility testing demonstrate that the differences between the proposed and the predicate device do not raise any new concerns with regard to safety or effectiveness.
3
で
Wand Assemblies Traditional 510(k)
Image /page/3/Picture/2 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked on top of each other, with the top chevron being the largest and the bottom chevron being the smallest.
FMC-RTG concludes that, within the meaning of the Medical Device Amendments Act of 1976, the Wand Assemblies are substantially equivalent to the assemblies cleared for use as accessories of the 2008 Series Hemodialysis Machine.
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2014
Fresenius Medical Care, North America - Renal Therapies Group Denise Oppermann Senior Director, Regulatory Affairs - Devices 920 Winter Street Waltham, MA 02451
Re: K133299
Trade/Device Name: Wand Assembly Regulation Number: 21 CFR$ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: June 2, 2014 Received: June 3, 2014
Dear Denise Oppermann,
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 or any Federal statutes and regulations administered by other Federal agencies.
5
Page 2 - Denise Oppermann
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 go to http://www.fda.gov/AboutFDA/CentersOffices/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/ReportalProblem/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,
Herbert P.Lerner -S
for 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
6
Indications for Use
510(k) Number (if known) K133299
Device Name Wand Assembly
Indications for Use (Describe)
The Wand Assemblies are intended to be used with the 2008 Series Hemodialysis Machines to provide a Nuid pathway for the concentrates and acetic acid from the canisters to the acid and bicarbonate lines of the 2008 Series Hemodialysis Machines. The Wand Assemblies are designed to be used as an accessory to the 2008 Series Hemodialysis Machines for the patients receiving dialysis therapy for acute and chronic renal failure.
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| 1 | or both |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Herbert P. Lerner -S 2014.07.07 07:37:56 -04
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