(285 days)
No
The summary explicitly states that the changes are limited to the user interface and that all functional options and control parameters remain unchanged from the predicate device. There is no mention of AI or ML.
Yes
The device is indicated for chronic and acute dialysis therapy, which is a treatment for renal failure.
No
The device is a hemodialysis machine used for treatment (acute and chronic dialysis therapy), not for diagnosing conditions.
No
The device description explicitly states it is a "hemodialysis machine," which is a hardware device. The changes mentioned are to the user interface, but the core device remains a physical machine.
Based on the provided information, the Fresenius 2008T is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "acute and chronic dialysis therapy." This is a therapeutic treatment performed on a patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The description clearly states it's a "hemodialysis machine" used for "patients with acute or chronic renal failure." This reinforces its role in treatment.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (like blood, urine, etc.) to provide diagnostic information. IVD devices are designed to examine these samples to determine the state of a person's health.
Therefore, the Fresenius 2008T is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
Product codes
KDI
Device Description
The Fresenius 2008T represents the next genesis of the Fresenius 2008K model hemodialysis machine. Hemodialysis is prescribed by physicians for patients with acute or chronic renal failure, when conservative therapy is judged inadequate. Dialysis therapy may be intermittent or continuous.
The 2008T has the same indications for use and same intended use as the predicate device the 2008K (K994267).
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
Operators of the 2008T Hemodialysis machine must be trained to administer hemodialysis at the direction of a physician. In addition, the operator should be:
- Knowledgeable of hemodialysis methodology and relevant physiology.
- Proficient in healthcare procedures regarding aseptic techniques.
- Thoroughly familiar with the contents of the Operator's manual.
- Fully trained and qualified to operate this machine, and able to distinguish between normal and abnormal operation.
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)
The Fresenius modified 2008T hemodialysis machine incorporates changes with regards to the user interface only and all water requirements, module options. functional options, performance limits, control parameters, compatible bloodlines, and language options remain unchanged from the predicate device, the 2008K (K994267). A Risk Analysis has been completed and potential hazards associated with the modifications have been identified, mitigated and where applicable mitigations have been verified. All potential risks were deemed acceptable after mitigation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.”
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KC80964
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JAN 1 4 2009
510(k) Summary
A. Submitter's Information:
Name: Fresenius Medical Care North America Address: 920 Winter Street Waltham, MA 02451 Phone: (781)-699-9505
| Phone: | (781) 699-9635 |
|---|---|
| Fax: | (781) 699-9635 |
| Contact Person: | Randolph Quinn, Sr. Regulatory Affairs Specialist |
| Date of Preparation: | 3/18/2008 |
B. Device Name:
| Trade Name: | Fresenius 2008T Hemodialysis Machine |
|---|---|
| Common/Usual Name: | Hemodialysis Machine |
| Classification Name: | High Permeability Hemodialysis system |
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KC80964
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510(k) Summary
C. Predicate Device Name:
The Fresenius 2008T is a modified version of the Fresenius 2008K Dialysate Delivery System, which was cleared under the following premarket notification:
Fresenius 2008K #K994267 (3/16/2000) o
D. Device Description/Indications for Use:
The Fresenius 2008T represents the next genesis of the Fresenius 2008K model hemodialysis machine. Hemodialysis is prescribed by physicians for patients with acute or chronic renal failure, when conservative therapy is judged inadequate. Dialysis therapy may be intermittent or continuous.
The 2008T has the same indications for use and same intended use as the predicate device the 2008K (K994267) and is as follows:
The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
E. Substantial Equivalence:
1. Is the product a device?
YES - The Fresenius 2008T is a device pursuant to 21 CFR §201 [321] (h).
-
- Does the new device have the same intended use?
- YES The intended use for the Fresenius 2008T is equivalent to that for the Fresenius 2008K Dialysate Delivery System and is as follows:
Fresenius 2008T - Intended Use
Fresenius 2008T is indicated for acute and chronic dialysis therapy.
Fresenius 2008K - Intended Use
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KC8C964
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510(k) Summary
Fresenius 2008K is indicated for acute and chronic dialysis therapy.
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO - The Fresenius 2008T is a modified version of the Fresenius 2008K Dialysate Delivery System. The performance and technological characteristics of the Fresenius 2008T are equivalent to those of the Fresenius 2008K Dialysate Delivery System and raise no new types of safety or effectiveness questions.
4. Does descriptive or performance information demonstrate equivalence?
YES - Fresenius Medical Care North America believes that the information provided in this submission clearly describes the Fresenius 2008T and demonstrates that it is substantially equivalent to the Fresenius 2008K Dialysate Delivery system.
F. Safetv Summary
The Fresenius modified 2008T hemodialysis machine incorporates changes with regards to the user interface only and all water requirements, module options. functional options, performance limits, control parameters, compatible bloodlines, and language options remain unchanged from the predicate device, the 2008K (K994267). A Risk Analysis has been completed and potential hazards associated with the modifications have been identified, mitigated and where applicable mitigations have been verified. All potential risks were deemed acceptable after mitigation.
G. General Safety and Effectiveness Concerns
Operators of the 2008T Hemodialysis machine must be trained to administer hemodialysis at the direction of a physician. In addition, the operator should be:
- Knowledgeable of hemodialysis methodology and relevant physiology.
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510(k) Summary
- Proficient in healthcare procedures regarding aseptic techniques. 0
- Thoroughly familiar with the contents of the Operator's manual. o
- Fully trained and qualified to operate this machine, and able to . distinguish between normal and abnormal operation.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2009
Ms. Janet C. Kay Manager, Regulatory Affairs Renal Therapies Group Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451
Re: K080964
Trade/Device Name: Fresenius 2008T Hemodialysis Delivery System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Product Code: KDI Dated: December 16, 2008 Received: December 18, 2008
Dear Ms. Kay:
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. Drue, 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. Insting 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 such 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.
5
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; 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures. 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.suppor/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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Indications for Use
K080964 510(k) Number (if known): _
Device Name:
Fresenius 2008T Hemodialysis Machine
Indications for Use:
Fresenius 2008T is indicated for acute and chronic dialysis therapy.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ _ ot
(Posted November 13, 2003)
Fresenius Medical Care North America
Corporate Headquarters: 920 Winter Street Waltham, MA 02451 (781) 699-9000
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices |
| 510(k) Number | K080964 |
|---|---|
| --------------- | --------- |
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