SYSTEM 100 ULTRAFILTRATION CATHETER by CHF SOLUTIONS, INC.

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.
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.

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.

AI/ML Overview

The provided text describes the System 100 Ultrafiltration Catheter and System 100 device. However, it is a 510(k) summary for a medical device and not a study report on device performance or an AI/software device. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria for an AI or software product.

Based on the provided document, I can only extract limited information about "acceptance criteria" and "device performance" as it pertains to substantial equivalence for a physical medical device (catheter and ultrafiltration system). The document focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria with detailed study data.

Here's an attempt to answer your request based only on the provided text, highlighting where information is missing due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Similar materials of construction to predicate device	UF catheter and primary predicate device are similar in materials of construction.
Identical packaging to predicate device	UF catheter and primary predicate device are identical for packaging.
Identical sterilization to predicate device	UF catheter and primary predicate device are identical for sterilization.
Provided sterile	The UF catheter is provided sterile.
Provided nonpyrogenic	The UF catheter is provided nonpyrogenic.
Compatible with the System 100 console/system	Bench tests demonstrate the UF catheter is compatible with the System 100.
Acceptable flow rate (for CVCs used with System 100)	Other CVC with an acceptable flow rate would also be compatible with the System 100.
Safe and effective for intended use	Catheter has been shown to be safe and effective for its intended use (via substantial equivalence).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document mentions "Bench tests," but does not provide details on the number of samples or tests performed.
Data Provenance: Not specified. It's likely laboratory bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. This document describes bench testing for a physical device, not an AI or software device that would require expert-established ground truth for a test set.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This document describes bench testing for a physical device, not an AI or software device that would require an adjudication method for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No. This document describes a 510(k) submission for a physical medical device (catheter and ultrafiltration system), not an AI or software device. Therefore, an MRMC comparative effectiveness study is not relevant or mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This document is for a physical medical device. There is no "algorithm only" performance component to evaluate.

7. The Type of Ground Truth Used

Type of Ground Truth: For the "bench tests," the ground truth would be established by the physical measurements and specifications of the device and its compatibility with the System 100. This is based on engineering and manufacturing standards, not expert consensus, pathology, or outcomes data in the context of an AI study.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI or software device, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. This is not an AI or software device, so there is no training set or associated ground truth.

Summary of Device Safety and Performance from the Document:

The safety and performance of the System 100 Ultrafiltration Catheter are primarily established through substantial equivalence to its predicate device (System 100, K013733, K023224, K024124) and other commercially available catheters. The document states:

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 100.
The use of CVCs (Central Venous Catheters) is expected to be performed in hospital environments where CVC use is common, implying standard medical practice and known risks.

The conclusion is that "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 indicates that simple bench testing for compatibility and adherence to material/sterilization similarities to predicate devices were sufficient for demonstrating substantial equivalence for this type of physical medical device.

Summary

{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
OfficialContact:	Amy PetersonVice President, RA/QA/CR	Telephone: 763-463-4620Fax: 763-463-4606
DeviceGeneric Name:	High permeability hemodialysis system and short-term/non-implanted bloodaccess 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
PredicateDevices:	CHF Solutions, System 100(K013733, K023224, K024124) Prisma (K981681)	medComp ®, Schon XL Soft-lineDouble Lumen Catheter /Duo-Flow™ (K974236)
DeviceDescription:	The System 100 Ultrafiltration Catheters are part of the fluid pathway and intended forblood withdrawal and infusion when repeat venous access over a period of ≤ 30 days ismedically desired. Common medical practice is to exchange the catheter every sevendays to minimize infection. The CVC catheter is percutaneously introduced into thesubclavian vein or the internal jugular vein with the distal tip ending in the mid to lowersuperior vena cava. The proximal end with the proprietary connectors resides outsidethe body connecting to the withdrawal and infusion blood lines of the UF500 bloodcircuits which engages the System 100 pump console for ultrafiltration in patients withfluid overloaded. The catheter extension (A1513) may also be used to connect othercommercially available CVC of the appropriate flow rate to the System 100 UF500 bloodfilter circuits.
Indicationfor Use:	The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment ofpatients 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 systemfor ultrafiltration with the System 100.
Safety &Performance:	The UF catheter and primary predicate device are similar in materials of construction andidentical for packaging and sterilization. The UF catheter is provided sterile andnonpyrogenic. Bench tests demonstrate the UF catheter is compatible with the System100. Other CVC with an acceptable flow rate would also be compatible with the System100. Use of a CVC is expected to be performed in hospital environments where CVCuse is common.
Conclusion:	Based on the similar intended use, patient population, technology characteristicsincluding well understood CVC medical risks, and performance as access with benchtesting the catheter has been shown to be safe and effective for its intended use. Thisproduct 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:

��

510(k) Number

1. The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.
1. 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.

1. 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.
1. The System 100 S-100 console [A1100] may be used when either peripheral or central venous access is employed.
1. 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

K023874

Regulation Number and Section

§ 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.”