(364 days)
Not Found
No
The document describes a mechanical ultrafiltration system and associated catheters. There is no mention of AI, ML, or any related computational techniques for data analysis, decision-making, or control.
Yes.
The device performs "ultrafiltration treatment of patients with fluid overload," which is a medical treatment.
No
The device is indicated for "ultrafiltration treatment" of patients with fluid overload, which is a therapeutic intervention, not a diagnostic one. It functions to remove fluid from the body, not to identify or characterize a disease or condition.
No
The device description clearly outlines hardware components such as catheters, a console, and blood circuits, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for ultrafiltration treatment of patients with fluid overload. This is a therapeutic procedure performed directly on the patient's blood within their body, not a test performed on a sample of bodily fluid or tissue outside the body to diagnose or monitor a condition.
- Device Description: The device description focuses on the physical components and their function in facilitating blood flow and ultrafiltration. It describes a catheter inserted into a vein and connected to a system that filters the blood. This is a medical device used for treatment, not for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing. The device's function is purely mechanical/physical in removing fluid from the blood.
In summary, the System 100 and its components are designed for a therapeutic intervention (ultrafiltration) performed directly on the patient, which is the defining characteristic of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-
- The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.
-
- The dual lumen ultrafiltration catheter [A1537] is indicated for use in attaining short-term (less than 30 days) percutaneous vascular access of the central circulatory system for ultrafiltration with the System 100.
(INSERTION SITES) The dual lumen ultrafiltration catheter may be inserted percutaneously and is primarily placed in the internal juqular vein of an adult patient. Alternate insertion sites include subclavian or femoral veins as required. Use should be limited to areas within the hospital where patients with a central venous catheter are routinely managed.
- The dual lumen ultrafiltration catheter [A1537] is indicated for use in attaining short-term (less than 30 days) percutaneous vascular access of the central circulatory system for ultrafiltration with the System 100.
-
- The catheter extension [A1513] mav also be used to connect commercially available CVC of the appropriate flow rate to the System 100 UF500 blood filter circuits.
-
- The System 100 S-100 console [A1100] may be used when either peripheral or central venous access is employed.
-
- The UF 500 circuit [A1500 and A1550] may be used when either peripheral or central venous access is employed.
Product codes
KDI, MPB
Device Description
The System 100 Ultrafiltration Catheters are part of the fluid pathway and intended for blood withdrawal and infusion when repeat venous access over a period of
§ 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
Page 1 of 1
NOV 2 0 2003
510(k) Summary Prepared on August 20, 2003
This 510(k) Summary is submitted in accordance with 21 CFR 807.92.
| Trade Names: | System 100 and System 100 Ultrafiltration Catheter | |
|---|---|---|
| Manufacturer: | Chf Solutions, Inc., Suite 170 - 7601 Northland Drive, Brooklyn Park, MN 55428 | |
| Official | ||
| Contact: | Amy Peterson | |
| Vice President, RA/QA/CR | Telephone: 763-463-4620 | |
| Fax: 763-463-4606 | ||
| Device | ||
| Generic Name: | High permeability hemodialysis system and short-term/non-implanted blood | |
| access device. | ||
| Classification: | System 100 - Accessory Class: II (21 CFR 876.5860) Panel: Gastroenterology-Urology Product code: KDI | Non-implanted Blood Access Device Class: II (21 CFR 876.5540 (b)(2)) Panel: Gastroenterology-Urology Product code: MPB |
| Predicate | ||
| Devices: | CHF Solutions, System 100 | |
| (K013733, K023224, K024124) Prisma (K981681) | medComp ®, Schon XL Soft-line | |
| Double Lumen Catheter /Duo- | ||
| Flow™ (K974236) | ||
| Device | ||
| Description: | The System 100 Ultrafiltration Catheters are part of the fluid pathway and intended for | |
| blood withdrawal and infusion when repeat venous access over a period of ≤ 30 days is | ||
| medically desired. Common medical practice is to exchange the catheter every seven | ||
| days to minimize infection. The CVC catheter is percutaneously introduced into the | ||
| subclavian vein or the internal jugular vein with the distal tip ending in the mid to lower | ||
| superior vena cava. The proximal end with the proprietary connectors resides outside | ||
| the body connecting to the withdrawal and infusion blood lines of the UF500 blood | ||
| circuits which engages the System 100 pump console for ultrafiltration in patients with | ||
| fluid overloaded. The catheter extension (A1513) may also be used to connect other | ||
| commercially available CVC of the appropriate flow rate to the System 100 UF500 blood | ||
| filter circuits. | ||
| Indication | ||
| for Use: | The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of | |
| patients with fluid overload. The System 100 UF Catheter is indicted for attaining short- | ||
| term (less than 30 days) percutaneous vascular access of the central circulatory system | ||
| for ultrafiltration with the System 100. | ||
| Safety & | ||
| Performance: | The UF catheter and primary predicate device are similar in materials of construction and | |
| identical for packaging and sterilization. The UF catheter is provided sterile and | ||
| nonpyrogenic. Bench tests demonstrate the UF catheter is compatible with the System |
- Other CVC with an acceptable flow rate would also be compatible with the System
- Use of a CVC is expected to be performed in hospital environments where CVC
use is common. | |
| Conclusion: | Based on the similar intended use, patient population, technology characteristics
including well understood CVC medical risks, and performance as access with bench
testing the catheter has been shown to be safe and effective for its intended use. This
product is substantially equivalent¹ and considered acceptable for the intended use. | |
1 This document uses the term "substantial equivalent" as intended in 21 CFR 807.87 and not as defined in Title 36 of the U.S. Code.
1
Image /page/1/Picture/1 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 a stylized image of three human figures in profile, facing to the right. The figures are stacked on top of each other, with the top figure being the most prominent.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2003
Ms. Amy Peterson (Official Correspondent) Vice-President RA/QA/CR CHF Solutions, Incorporated Suite170-7601 Northland Drive BROOKLYN PARK MN 55428
Re: K023874
Trade/Device Name: System 100 Ultrafiltration Catheter and System 100 for Use with Central Venous Access Regulation Number: 21 CFR§ 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: 78 KDI Dated: August 20, 2003 Received: August 22, 2003
Dear Ms. Peterson:
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 (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. 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.
2
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours.
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
Page 2
3
INDICATIONS FOR USE STATEMENT (Page 1 of 1)
510(k) Number (if know): __K023874
Device Name: System 100 and System 100 Ultrafiltration Catheter
FDA's Statement of the Indication For Use for Device:
In association with central venous access:
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510(k) Number
-
- The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.
-
- The dual lumen ultrafiltration catheter [A1537] is indicated for use in attaining short-term (less than 30 days) percutaneous vascular access of the central circulatory system for ultrafiltration with the System 100.
(INSERTION SITES) The dual lumen ultrafiltration catheter may be inserted percutaneously and is primarily placed in the internal juqular vein of an adult patient. Alternate insertion sites include subclavian or femoral veins as required. Use should be limited to areas within the hospital where patients with a central venous catheter are routinely managed.
-
- The catheter extension [A1513] mav also be used to connect commercially available CVC of the appropriate flow rate to the System 100 UF500 blood filter circuits.
-
- The System 100 S-100 console [A1100] may be used when either peripheral or central venous access is employed.
-
- The UF 500 circuit [A1500 and A1550] may be used when either peripheral or central venous access is employed.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
----------Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
David R. Saypm
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices