\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR

K022536 · Fresenius Medical Care · KOC · Oct 30, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022536
• Device Name: \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
• Applicant: Fresenius Medical Care
• Product Code: KOC · Gastroenterology, Urology
• Decision Date: Oct 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

The Fresesnius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement. The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure. It may be used in conjunction with access devices, such as; the Fresenius Online Clearance Monitor", the CritLine® from HemaMetrics, or the HD01 Hemodialysis Monitor from Transonic Systems when flow reversal is required.

Device Story

The Fresenius Access Flow Reversing Connector (AFRC) is a manually operated valve used during hemodialysis to enable access flow measurement. It is integrated into bloodline tubing sets or used as a standalone component. The device features a valve mechanism that, when manually rotated 180°, reverses the direction of blood flow between the arterial and venous vascular access sites. This eliminates the need to physically disconnect and reconnect bloodlines during testing procedures. The AFRC is compatible with monitoring systems such as the Fresenius Online Clearance Monitor, HemaMetrics CritLine, and Transonic Systems HD01 Hemodialysis Monitor. By simplifying the flow reversal process, the device reduces the risk of contamination associated with line disconnection and improves clinical efficiency in obtaining access flow measurements.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manually operated valve; 180-degree rotation mechanism; integrated into hemodialysis bloodline tubing sets or standalone; materials substantially equivalent to predicate; non-electronic/mechanical device.

Indications for Use

Indicated for patients undergoing hemodialysis requiring access flow measurement; facilitates flow reversal without disconnecting bloodlines.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• Medisystems Blood Tubing Set Accessories (Revers~™); K994306

Reference Devices

• Fresenius Online Clearance Monitor
• CritLine® from HemaMetrics
• HD01 Hemodialysis Monitor from Transonic Systems

Submission Summary (Full Text)

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## Fresenius Combilines with Access Flow Reversing Connector 510(k) Premarket Notification

# 510K Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the Fresenius Combiset with Access Flow Reversing Connector.

Company: Fresenius Medical Care North America 95 Hayden Ave. Lexington, MA 02420 July 29, 2002 Date: Trade Name: Fresenius Access Flow Reversing Connector Common Name: Blood Tubing Accessories Classification Name and Reference: 21 CFR §876.5820 Blood Tubing Set, with or without Anti-Regurgitation Valve - Class II Device Product Code and Panel Code: KOC, 78 Predicate Device: Medisystems Blood Tubing Set Accessories (Revers~™); K994306, SE 3/20/2000

## Description:

The Fresenius Access Flow Reversing Connector is designed to be used during hemodialysis when an access flow measurement is required. The AFRC facilitates the test procedure by eliminating the need to disconnect the arterial and venous lines and reconnecting them to facilitate the switch in flow direction. The device contains a valve that allows reverse blood flow to and from vascular access sites. The device is manually operated and turns 180° to reverse the blood flow communication. The Fresenius Access Flow Reversing Connector will be available as both a standalone and as a component in the Combilines Hemodialysis bloodline tubing sets.

#### Intended Use:

The Fresesnius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement.

The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure.

It may be used in conjunction with access devices, such as; the Fresenius Online Clearance Monitor", the CritLine® from HemaMetrics, or the HD01 Hemodialysis Monitor from Transonic Systems when flow reversal is required.

#### Safety and Performance:

The intended use, technological characteristics, design features, and material are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the Fresenius Access Flow Reversing Connector is supported by the substantial equivalence information, materials data, device description, and performance testing.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2002

Mr. Arthur Eilinsfeld Director of Regulatory Affairs Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02420

Re: K022536

Trade/Device Name: Fresenius Access Flow Reversing . Connector Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KOC Dated: July 30, 2002 Received: August 1, 2002

Dear Mr. Eilinsfeld:

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.

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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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,

Nancy C. Bogdon

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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Image /page/3/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized downward-pointing triangle made up of three horizontal lines that decrease in length from top to bottom. Below the triangle is the text "Fresenius Medical Care" in a simple, sans-serif font. The text is left-aligned and appears to be the primary identifier for the brand.

# Indications for Use Statement

Device Name:

Fresenius Access Flow Reversing Connector

Indications for Use:

The Frese ،ius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the انان od flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement.

The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure.

It may be used in conjunction with access devices, such as; the Fresenius Online Clearance Monitor"", the CritLine® from HemaMetrics, or the HD01 Hemodialysis Monitor from Transonic Systems when flow reversal is required.

David A. Simon

ivision of Reproductive and Radiological Devi

V Prescription Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Fresenius Medical Care North America

wis (leadquarters: 95 Hayden Avenue Lexington, MA 02420 [phone]