SPLIT SEPTUM INJECTION SITES

K041042 · Fresenius Medical Care North America · FPA · Jul 16, 2004 · General Hospital

Device Facts

• Record ID: K041042
• Device Name: SPLIT SEPTUM INJECTION SITES
• Applicant: Fresenius Medical Care North America
• Product Code: FPA · General Hospital
• Decision Date: Jul 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

Venous Blood Tubing Set The Fresenius Venous Bloodlines are intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Hemodialysis Venous Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment. Arterial Blood Tubing Set The Fresenius Arterial Bloodlines are intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Fresenius Bloodlines are intended to for use with Hemodialysis arterial blood tubing sets in conventional and high flux negative pressure hemodialyzer equipment. CombiSets Hemodialysis Blood Tubing Set The Fresenius CombiSets are intended for use as the extracorporeal blood circuit during Hemodialysis. They are intended for single use only. The CombiSets are indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

Device Story

Split Septum Injection Sites are components of Fresenius hemodialysis blood tubing sets. The device features a tapered split septum plug designed to accommodate 21-gauge metal needles or plastic needles with 19% priming volume. Used during hemodialysis procedures in clinical settings; operated by healthcare professionals. The injection site allows for needle access to the extracorporeal circuit. The modification to the septum design enables compatibility with specific needle types while maintaining the function of the existing blood tubing set. Benefits include improved versatility for clinicians accessing the hemodialysis circuit.

Clinical Evidence

Bench testing only. Validation testing was performed to confirm the performance of the modified injection site.

Technological Characteristics

Injection site component for hemodialysis blood tubing sets. Features a tapered split septum plug. Compatible with 21-gauge metal needles and plastic needles. Designed for single-use extracorporeal circuits. Complies with 21 CFR 820.30 design controls.

Indications for Use

Indicated for patients undergoing hemodialysis requiring an extracorporeal blood circuit using conventional or high flux negative pressure hemodialyzer equipment.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Fresenius CombiSets® Hemodialysis Blood Tubing Sets (K962081)
• Fresenius CombiSets® Hemodialysis Blood Tubing Sets (K001107)
• Fresenius CombiSets® Hemodialysis Blood Tubing Sets (K000451)
• Fresenius Arterial Blood Tubing Sets (K971313)
• Fresenius Venous Blood Tubing Sets (K971687)
• Fresenius Single Use Arterial Bloodline Sets with Alternate Pump Segment Material (K012242)

Submission Summary (Full Text)

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K041042

JUL 1 6 2004

# Split Septum Injection Sites "Special" 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 April 20, 2004 Date: Trade Name: Split Septum Injection Sites Common Name: Blood Tubing for Hemodialysis 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 and FJK, 78 Predicate Device(s):

- · Fresenius CombiSets® Hemodialysis Blood Tubing Sets; K962081, SE 11/01/96
- · Fresenius CombiSets® Hemodialysis Blood Tubing Sets: K001107. SE 06/23/00
- · Fresenius CombiSets® Hemodialysis Blood Tubing Sets; K000451, SE 05/09/00
- · Fresenius Arterial Blood Tubing Sets; K971313, SE 10/27/97
- · Fresenius Venous Blood Tubing Sets; K971687, SE 07/29/97
- · Fresenius Single Use Arterial Bloodline Sets with Alternate Pump Segment Material, K012242, 08/16/01

### Description:

The Split Septum Injection Sites are designed for use during hemodialysis with either a 21 gauge metal needle or plastic needles that have a 19% priming volume. The injection site plug features a tapered split to accommodate either needle described above. This is the only change to the Fresenius Hemodialysis Blood Tubing Sets currently offered. The housing and septa are identical to that of the current standard injection site.

## Intended Use:

### Venous Blood Tubing Set

The Fresenius Venous Bloodlines are intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Hemodialysis Venous Blood Tubing Set is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

### Arterial Blood Tubing Set

The Fresenius Arterial Bloodlines are intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Fresenius Bloodlines are intended to for use with Hemodialysis arterial blood tubing sets in conventional and high flux negative pressure hemodialyzer equipment.

### CombiSets Hemodialysis Blood Tubing Set

The Fresenius CombiSets are intended for use as the extracorporeal blood circuit during Hemodialysis. They are intended for single use only. The CombiSets are indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

## Safety and Performance:

The intended use, technological characteristics, design features, and materials are substantially equivalent to the predicate device. In support of this Special 510K, Fresenius Medical North America has provided certification of compliance to 21 CFR 820.30-Design Control requirements, and a summary of the results of validation testing (performance testing) for the minor device modification.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2004

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

Re: K041042

:

Trade/Device Name: Fresenius Split Septum Injection Sites Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Product Code: 78 FJK and KOC Regulation Number: 21 CFR §880.5440 Regulation Name: Intravascular administration set Product Code: 78 FPA Regulatory Class: II Dated: June 15, 2004 Received: June 16, 2004

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 Section SI0(k) I ms letter will and your te FDA finding of substantial equivalence of your device to a legally premately nonification. The 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 rryou desire specific as not of the following numbers, based on the regulation number at the top of the 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 Addisonally, 1001) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general of receitos to premation of your responsibilities under the Act may be obtained from the Division of Small mioritation on your responser Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsmaldsmamain.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

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# Indications for Use Statement

## Device Name:

Split Septum Injection Sites (a component of Fresenius Bloodlines)

## Indications for Use:

## CombiSets Hemodialysis Blood Tubing Set

The Fresenius CombSets are intended for use as the extracorporeal blood circuit during Hemodialysis, They are intended for single use only. The CombiSets are indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

## Venous Blood Tubing Set

The Fresenius Venous Bloodline is intended for use as the extracorporeal blood circuit during It is intended for single only use. The Hemodialysis Venous Blood Tubing Set is Hemodialysis. indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

## Arterial Blood Tubing Set

The Fresenius Arterial Bloodline is intended for use as the extracorporeal blood circuit during Hemodialysis. It is intended for single only use. The Fresenius Arterial Bloodline is intended to for use with conventional and high flux negative pressure hemodialyzer equipment.

# 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

000034

# Fresenius Medical Care North America

510(k) Number

Corporate Headquarters: Lexington, MA 02420 [phone] Division Sign Off oroductive and Radiological Device