CHEMO MINI SPIKE PLUS

K983794 · B. Braun of America, Inc. · LHI · Mar 23, 1999 · General Hospital

Device Facts

• Record ID: K983794
• Device Name: CHEMO MINI SPIKE PLUS
• Applicant: B. Braun of America, Inc.
• Product Code: LHI · General Hospital
• Decision Date: Mar 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Chemo Mini Spike Plus is an IV additive dispensing pin for aspiration from multidose containers or injection into IV systems (IV bag).

Device Story

Chemo Mini Spike Plus is an IV additive dispensing pin; used for aspiration from multidose containers or injection into IV systems (IV bags). Device facilitates fluid transfer; operated by healthcare professionals in clinical settings. No complex electronics or software; mechanical design ensures safe fluid handling. Benefits include simplified, standardized additive dispensing and fluid transfer.

Clinical Evidence

Bench testing only. Finished products undergo physical testing and visual examination in accordance with established Quality Control Test Procedures and cGMP requirements.

Technological Characteristics

Mechanical IV additive dispensing pin. Materials tested per EN Standard 30993. Device is a single-use, non-powered, manual fluid transfer component.

Indications for Use

Indicated for use as an IV additive dispensing pin for the aspiration of fluids from multidose containers or for injection into IV systems.

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

• I.V. Fluid Transfer Pin (K925401)

Submission Summary (Full Text)

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3/23/99

# II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

RIOF2

B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem. PA 18018 [phone]

September 28, 1998 K983794

Contact: Mark S. Alsberge, Regulatory Affairs Director

- Product Name: Chemo Mini Spike Plus
Chemo Mini Spike Plus Trade Name:

Classification name:

General Hospital Class II. 80LHI 21 CFR 880.5440

## SUBSTANTIAL EQUIVALENCE TO:

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| 4075AL | | Inc |

#### Device Description:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Chemo Mini is an IV additive dispensing pin for aspiration from multidose containers or injection into IV systems (IV bag).

## Material:

The Chemo Mini Spike Plus is composed of materials that have been tested in accordance with the EN Standard 30993 and have been determined to be suitable for the intended use of this product.

¹ The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

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#### Substantial equivalence:

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The Chemo Mini Spike Plus is similar in materials, form and intended use to the I.V. Fluid Transfer Pin currnetly marketed by B. Braun Medical, Inc. and cleared under K925401. There are no new issues of safety or effectiveness raised by Chemo Mini Spike Plus.

### Safety And Effectiveness:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.

The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control cGMP"s.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle. The eagle is facing to the right and has three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1999

Mr. Mark S. Alsberge Regulatory Affairs Director B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18103-9341

Re : K983794 Chemo Mini Spike Plus Trade Name: Regulatory Class: II Product Code: LHI February 10, 1999 Dated: Received: February 16, 1999

Dear Mr. Alsberge:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Alsberge

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Lumpe

&Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Plus Mini Spike lemo Device Name: Indications For Use: aspiration IV additive dispensing Ho injection containers multi-dose Ur trom sfems TV into

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Paltric Cucenta
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use .

(Optional Format 1-2-96)