(148 days)
Not Found
No
The summary describes a standard hemodialysis machine with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
Yes.
The device is used for acute and chronic hemodialysis therapy, which constitutes a medical treatment.
No
Explanation: The device description clearly states that the 2008K2 Hemodialysis Machine is used for hemodialysis therapy and pumps blood to remove toxins and excess water. This is a therapeutic function, not a diagnostic one. While it monitors pressures and presence of air/blood, this monitoring is part of the therapy delivery and not for diagnosing a medical condition.
No
The device description clearly outlines hardware components like pumps, circuits, membranes, and balancing chambers, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The 2008K2 Hemodialysis Machine is a therapeutic device. It directly treats the patient by filtering their blood through an external circuit and dialyzer. It does not analyze samples taken from the patient to provide diagnostic information.
- Intended Use: The intended use clearly states it is for "acute and chronic hemodialysis therapy." This is a treatment, not a diagnostic process.
- Device Description: The description details the process of pumping blood, using a semi-permeable membrane, and managing dialysate fluid. This is a description of a therapeutic intervention.
While the machine monitors parameters like blood pressure and the presence of air and blood, this monitoring is for the safe and effective delivery of the therapy, not for diagnostic purposes.
N/A
Intended Use / Indications for Use
The 2008K2 Hemodialysis Machine is indicated for acute and chronic hemodialysis therapy in a healthcare facility. Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg and ≤ 40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing
§ 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.”
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2016
Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451
Re: K153449
Trade/Device Name: 2008K2 Hemodialysis Machines Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Dated: March 31, 2016 Received: April 1, 2016
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.
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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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 R. Fisher -S
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
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Indications for Use
510(k) Number (if known) K153449
Device Name 2008K2 Hemodialysis Machines
Indications for Use (Describe)
The 2008K2 Hemodialysis Machine is indicated for acute and chronic hemodialysis therapy in a healtheare facility.
Additional therapy options for patients receiving hemodialysis include: Isolated Ultration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing ≤ 40 kg. The 2008K2 Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
510(K) SUMMARY 5.
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 § 807.92.
5.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| Regulatory Affairs – Devices | |
| Preparation Date: | 27 November 2015 |
5.2. Device Name
| Trade Name: | 2008K2 Hemodialysis Machine |
|---|---|
| Common Name: | Dialyzer, High Permeability With Or |
| Without Sealed Dialysate | |
| Classification Name : | High Permeability Hemodialysis System |
| Regulatory Class: | Class II per 21 CFR § 876.5860 |
| Product | |
| Code/Classification | |
| Panel: | KDI |
| KDI/Gastroenterology-Urology |
5.3. Legally Marketed Predicate Device
2008K Hemodialysis Machine, originally cleared under K994267. The 2008K Hemodialysis Machine was most recently cleared under K150708 for hardware, mechanical, software and labelling modifications required to address issues identified in the field.
5.4. Device Description
5.4.1. Device Identification:
The 2008K2 Hemodialysis Machine will be available in the configurations described in Table 1.
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| 2008K2 Hemodialysis Machine |
|---|
| Traditional 510(k) |
| Product
| Line | Code | Part Number Description |
|---|---|---|
| 2008K2 | 190610 | 2008K2 Hemodialysis System Online Clearance (OLC)/Diasafe |
| Plus (DP) | ||
| 2008K2 | 190628 | 2008K2 OLC only with Heparin Pump (HP) |
| 2008K2 | 190630 | 2008K2 Machine, Short Cabinet, OLC/DP, HP |
| 2008K2 | 190633 | 2008K2 Hemodialysis System, Optional Module* |
| Table 1: | 2008K2 Hemodialysis Machines |
|---|---|
| ---------- | ------------------------------ |
*The optional module indicates a version where the heparin pump is placed in a lower cabin bay area.
5.4.2. Device Characteristics
The machine described in this submission is medical electrical equipment containing a programmable electrical medical system. Software controls the functions of the machines during hemodialysis treatment, including fluid flow, mixing, heating, and alarms.
5.4.3. Environment of Use
The 2008K2 Hemodialysis Machine is to be used in healthcare facilities.
5.4.4. Brief Written Description of the Device
The 2008K2 Hemodialysis machines is used for dialysis therapy. The machine pumps blood from the patient through an extracorporeal circuit containing a semi-permeable membrane (dialyzer). This membrane acts as an artificial kidney to transport toxins (diffusion) and excess water (ultrafiltration) from the blood into a separate fluid (dialysate) circuit. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood. In the dialysate circuit, the dialysate concentrates are mixed with purified water, heated, degassed, and delivered to the dialyzer. Balancing chambers control the incoming flow and outgoing flow of the dialysate fluid during ultrafiltration.
5.4.5. Materials of Use
The 2008K2 Hemodialysis Machine's hydraulic system is composed of the following indirect, prolonged contact, externally communicating materials:
Plastic/Rubber:
PAEK (Polyaryletherketone) PEI (Polyetherimide) PESU (Polyethersulfone) PSU (Polysulfone) PET (Polyethylene terephthalate) PUR (Polyurethane)
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Image /page/5/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left is a blue icon that looks like three chevrons stacked on top of each other, pointing downwards. To the right of the icon, also in blue, is the text "FRESENIUS MEDICAL CARE" stacked on two lines.
PET (Polyethylene terephthalate) PP (Polypropylene) PPO (Polyphenylene oxide) PPS (Polyphenylene Sulfide) PPSU (Polyphenylsulfone) PTFE (Polytetrafluoroethylene) PVDF (Polyvinylidene fluoride) EPDM (Ethylene Propylene Diene Monomer Rubber) Silicone
Metals: Stainless Steel Titanium Tantalum Tungsten
Glass: Borosilicate Glass
The hydraulic lines of the machines are in contact with the dialysate circuit. The dialysate circuit has prolonged, indirect blood contact. No modifications to the dialysate circuit are proposed.
5.4.6. Key Performance Specifications/Characteristic
Key performance characteristics of the 2008K2 Hemodialysis Machine are:
- Blood flow rates
- Dialysis fluid flow rates ●
- Net fluid removal ●
- Dialysis time ●
- Dialysis fluid composition ●
- Dialysis fluid temperature ●
- Heparin delivery rate ●
5.5. Intended Use
The Fresenius 2008K2 Hemodialysis Machine is intended for acute and chronic dialysis therapy.
The intended use is identical to the predicate device's intended use.
5.6. Indications for Use
The 2008K2 Hemodialysis Machine is indicated for acute and chronic hemodialysis therapy in a healthcare facility.
6
Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg and ≤ 40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing