(90 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on physical components and equivalence to predicate devices.
Yes
The device is described as being used in "renal supportive therapies," which are treatments aimed at supporting kidney function or replacing it, thus falling under the definition of a therapeutic device.
No
The device is a filter used for renal supportive therapies (hemofiltration and hemodialysis) that removes solutes or fluid from the blood. It is a treatment device, not one that diagnoses a condition.
No
The device description explicitly refers to a "Filter," which is a physical component used in renal therapies, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove solutes or fluid in renal supportive therapies. This is a therapeutic intervention performed directly on the patient's blood, not a test performed on a sample of the patient's body.
- Device Description: The device is described as a "Filter" used in therapies like hemofiltration and hemodialysis. These are extracorporeal blood purification techniques.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
- Using reagents or assays
The device is clearly intended for treatment rather than diagnosis.
N/A
Intended Use / Indications for Use
Intended for use in removing solutes or fluid in renal supportive therapies in an acute setting. This filter can be used for intermittent and continuous therapies.
The RAC 100 Filter is intended for use in the following continuous veno-venous therapies:
- continuous veno-venous hemofiltration (CVVH)
- continuous veno-venous hemodialysis (CVVHD)
The RAC 100 Filter is intended for use in the following intermittent therapies, e.g. slow low efficiency dialysis (SLED) or other renal supportive therapies of less than 8 hours duration.
Product codes
78KDI
Device Description
The Fresenius Renal Acute Care (RAC 100) Filter is substantially equivalent in construction, design, materials, and intended use to the commercially available Fresenius Optiflux F160NR, Gambro Hospal Multiflow 100 Hemofilter and the Gambro M100 Hemofilter.
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 of the Fresenius Renal Acute Care (RAC 100) Filter indicates that it is safe and effective for its intended use.
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
APR 2 4 2007
Image /page/0/Picture/2 description: The image shows the logo and text for Fresenius Medical Care. The text below the logo reads "Fresenius Renal Acute Care (RAC 100) Filter" and "510(k) Summary". The logo is a stylized image of a filter.
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
| Name: | Fresenius Medical Care North America | |
|---|---|---|
| Address: | 920 Winter Street | |
| Waltham, MA 02451-1457 | ||
| Phone: | 1-781-699-4475 | |
| Fax: | (781) 699-9635 | |
| Contact Person: | Janet C. Kay RAC Regulatory Affairs Manager | |
| Date of Preparation: | January 23, 2007 |
- B. Device Name:
Proprietary Name:
Common Name:
Fresenius Renal Acute Care (RAC 100) Filter
Dialyzer, High Permeability with or without Sealed Dialysate System
Product Code/Classification Panel:
78KDI/Gastroenterology-Urology
Classification:
Class 11 per §876.5860
510(k) for Fresenius Renal Acute Care (RAC 100) Filter 31
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Image /page/1/Picture/1 description: The image shows a logo with a geometric design above the text. The geometric design consists of three stacked, inverted trapezoids, creating a layered effect. The text below the design appears to be the beginning of a word, with only the letters 'us Med' visible, suggesting it is part of a larger company or brand name.
Fresenius Medical Care Fresenius Renal Acute Care (RAC 100) Filter 510(k) Summary
C. Predicate Devices
The Fresenius Renal Acute Care (RAC 100) Filter is substantially equivalent to the Fresenius Optiflux F160NR, Gambro Hospal Multiflow 100 Hemofilter and the Gambro M100 Hemofilter.
Gambro Hospal Multifiow 100:
- K980386 (2/24/99) .
Gambro M100
- · K032431 (9/15/03)
Optiflux F160NR
- · K003498 (1/4/01)
D. Indications for Use/Intended Use:
Intended for use in removing solutes or fluid in renal supportive therapies in an acute setting. This filter can be used for intermittent and continuous therapies.
The RAC 100 Filter is intended for use in the following continuous veno-venous therapies:
- . continuous veno-venous hemofiltration (CVVH)
- continuous veno-venous hemodialysis (CVVHD) �
The RAC 100 Filter is intended for use in the following intermittent therapies, e.g. slow low efficiency dialysis (SLED) or other renal supportive therapies of less than 8 hours duration.
E. Substantial Equivalence:
1. Is the product a device?
YES - The Fresenius Renal Acute Care (RAC 100) Filter is a device pursuant to 21 CFR §201 [321] (h).
510(k) for Frescnius Renal Acute Care (RAC 100) Filter 32
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K070222 3 OF 4 PAGE
Image /page/2/Picture/1 description: The image shows the logo and text for Fresenius Medical Care. Below the logo, the text reads "Fresenius Medical Care" followed by "Fresenius Renal Acute Care (RAC 100) Filter". The last line of text says "510(k) Summary".
2. Does the new device have the same intended use?
YES -- The intended use for the Fresenius Renal Acute Care Filter is equivalent to that of the Gambro Hospal Multiflow 100 Hemofilter, Gambro M100 Hemofilter.
Fresenius Renal Acute Care Filter - Intended Use
Intended for use in removing solutes or fluid in renal supportive therapies in an acute setting. This filter can be used for intermittent and continuous therapies.
The RAC 100 Filter is intended for use in the following continuous veno-venous therapies:
- continuous veno-venous hemofiltration (CVVH) .
- continuous veno-venous hemodialysis (CVVHD) .
The RAC 100 Filter is intended for use in the following intermittent therapies, e.g. slow low efficiency dialysis (SLED) or other renal supportive therapies of less than 8 hours duration.
Gambro Hospal Multiflow 100 - Intended Use
The Hospal Multiflow 100 is indicated for use whenever continuous veno-venous hemofiltration or hemodialysis is indicated. This can be used for acute hemodialysis and hemofiltration. In these therapies, monitoring of patient vital signs, the therapy delivery system, heparin administration, and clotting times should be performed under the direction of a physician.
Gambro M100 - Intended Use
Indicated for use with the Prisma Control Unit in providing continuous fluid management and renal replacement therapies for patients who have acute renal failure, fluid overload, or both.
3
Image /page/3/Picture/1 description: The image shows the logo and text for Fresenius Medical Care. The text below the logo reads "Fresenius Renal Acute Care (RAC 100) Filter" and "510(k) Summary". The logo is a stylized image of a filter.
3. Does the device have technological characteristics that raise new types of safety or effectiveness questions?
NO -The technological characteristics of the Fresenius Renal Acute Care (RAC 100) Filter are equivalent to those of the Fresenius Optiflux F160NR, Gambro Hospal Multiflow 100 Hemofilter and the Gambro M100 Hemofiter 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 Renal Acute Care (RAC 100) Filter and that the performance characteristics and other information supplied demonstrates that it is substantially equivalent to the Fresenius Optiflux F160NR, Gambro Hospal Multiflow 100 Hemofilter and the Gambro M100 Hemofilter.
F. Safety Summary
The Fresenius Renal Acute Care (RAC 100) Filter is substantially equivalent in construction, design, materials, and intended use to the commercially available Fresenius Optiflux F160NR, Gambro Hospal Multiflow 100 Hemofilter and the Gambro M100 Hemofilter. In addition, testing of the Fresenius Renal Acute Care (RAC 100) Filter indicates that it is safe and effective for its intended use.
G. General Safety and Effectiveness Concerns
The device labeling contains a package insert, which includes indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. This information promotes safe and effective use of the Fresenius Renal Acute Care (RAC 100) Filter.
Janet C Kay
Janet C. Kav RAC Regulatory Affairs Manager
4/19/07
Date
Date
510(k) for Fresenius Renal Acute Care (RAC 100) Filter 34
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Janet C. Kay Regulatory Affairs Manager Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451-1457
Re: K070222
Trade/Device Name: Fresenius Renal Acute Care (RAC 100) Filter Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: January 23, 2007 Received: January 24, 2007
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, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.
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Protecting and Promoting Public Health
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 of 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
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Fresenius Medical Car Fresenius Renal Acute Care (RAC 100) Filter
Device Name:
Fresenius Renal Acute Care (RAC 100) Filter
Indications for Use:
Intended for use in removing solutes or fluid in renal supportive therapies in an acute setting. This filter can be used for intermittent and continuous therapies.
The RAC 100 Filter is intended for use in the following continuous veno-venous therapies:
- continuous veno-venous hemofiltration (CVVH) .
- continuous veno-venous hemodialysis (CVVHD) ●
The RAC 100 Filter is intended for use in the following intermittent therapies, e.g. slow low efficiency dialysis (SLED) or other renal supportive therapies of less than 8 hours duration.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Nancy C. Brogdon
(Division Sign Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number