SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET

K013733 · Chf Solutions, Inc. · KDI · Jun 3, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013733
• Device Name: SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET
• Applicant: Chf Solutions, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jun 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

Device Story

System 100 is an ultrafiltration system designed to remove excess fluid from patients with fluid overload. The system comprises an S-100 console, UF 500 set, venous access catheters, catheter extension set, flushing port, and insertion kit. It operates by performing ultrafiltration to remove fluids; unlike the predicate device, it does not remove solutes. The device is intended for temporary use (up to 8 hours). It is used in a clinical setting to manage fluid status, potentially benefiting patients by reducing fluid overload. Healthcare providers operate the system to provide treatment.

Clinical Evidence

Clinical data confirm the device is safe and effective for its intended use. Non-clinical testing included extensive safety, software, and performance testing to demonstrate functional specifications were met.

Technological Characteristics

High permeability hemodialysis system. Components include S-100 console, UF 500 set, and venous access catheters. Designed for fluid removal only. Incorporates current technology relative to the predicate PRISMA system. Software-controlled operation.

Indications for Use

Indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• PRISMA Continuous Fluid Management System (K981681)
• PRISMA M60 Set

Submission Summary (Full Text)

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# JUN 0 3 2002

## 510(k) Summary for CHF Solutions' System 100

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| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | CHF Solutions, Inc. |
| Contact Person | Dianna Thomsen<br>King & Spalding<br>1730 Pennsylvannia Ave.<br>Washington, D.C. 20006<br>Telephone: [phone]<br>FAX: [phone] |
| Date Prepared | November 9, 2001 |
| Name | System 100 |
| Classification Name | High permeability hemodialysis system |
| Device Classification | Classification: Class II<br>Classification Panel: Gastroenterology Devices<br>Regulation Number: 21 C.F.R. §876.5680 |
| Predicate Devices | <ul><li>PRISMA Continuous Fluid Management System (K981681; cleared 1998)</li><li>PRISMA M60 Set</li></ul> |
| Performance Standards | Performance standards have not been established by the FDA under section 514 of the Federal, Food, Drug and Cosmetic Act. |

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## 510(k) Summary for CHF Solutions' System 100

K013733

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| Device Description | System 100 consists of the:<br>• S-100 console<br>• UF 500 set<br>• Venous access catheters<br>• Catheter extension set<br>• Needless flushing port<br>• Catheter insertion kit |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | System 100 is indicated for temorary (up to 8 hours) ultrafiltration<br>treatment of patients with fluid overload. |
| Technological<br>Characteristics | System 100 contains features and functions that were previously-cleared<br>in PRISMA's device. Minor modifications were made to System 100<br>because the device is designed to only remove fluids (the predicate<br>device removes fluids and solutes) and to incorporate current technology. |
| Non-clinical and<br>Clinical<br>Performance Data | CHF Solutions, Inc. performed non-clinical testing on System 100 to<br>demonstrate that the device met its functional and performance<br>specification. System 100 was subjected to extensive safety, software,<br>and performance testing. Clinical data confirm that the device is safe and<br>effective for its intended use. |
| Conclusion | System 100 is substantially equivalent to the currently cleared and<br>marketed PRISMA system. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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3 2002 JUN

Food and Drug Administration . 9200 Corporate Boulevard Rockville MD 20850

CHF Solutions. Inc. c/o Ms. Dianna Thomsen King and Spalding 1730 Pennsylvania Avenue, N.W. WASHINGTON DC 20006-4706

Re: K013733

Trade/Device Name: System 100 with UF 500 Set, Venous Access Catheters, Catheter Extension Set, and Catheter Insertion Kit Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: March 5, 2002 Received: March 5, 2002

Dear Ms. Thomsen:

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 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in your catheter insetion kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. 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

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Page 2 – Ms.. Dianna Thomsen

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.

In addition, we have determined that your device kit contains povidone iodine swabsticks, which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with these drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

> Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone]

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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification''(21 CFR Part 807.97). 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 [phone] or [phone], or at its Internet address http://www.fda.gov/cdrh.dsma/dsmamain.html.

Sincerely yours.

Daniel A. Bergman

Nancy C. Brogdon 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 Statement

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Page 1 of 1

510(k) Number: K013733

Device Name: System 100

Indications for Use:

System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Prescription Use*

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013733