COMBIPORT FLUID LAVAGE DEVICE

K971259 · B.Braun Medical, Inc. · KDH · Oct 27, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971259
• Device Name: COMBIPORT FLUID LAVAGE DEVICE
• Applicant: B.Braun Medical, Inc.
• Product Code: KDH · Gastroenterology, Urology
• Decision Date: Oct 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

THE COMBIPORT FLUID LAVAGE DEVICE IS INTENDED TO FLUSH FLUID INTO THE STOMACH DURING GASTRIC LAVAGE PROCEDURES.

Device Story

The CombiPort Fluid Lavage Device is a medical device used to facilitate the delivery of fluid into the stomach during gastric lavage procedures. It is intended for use in a clinical setting by healthcare professionals. The device functions by providing a pathway for fluid administration to the patient's stomach. It is a mechanical device without complex electronic or software components. The device is designed to meet established physical and visual release specifications to ensure safety and effectiveness during clinical use.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by bench testing, including physical testing and visual examination, conducted in accordance with established Quality Control Test Procedures and GMP requirements.

Technological Characteristics

Mechanical fluid lavage device. Materials tested for biocompatibility per ISO 10993. Device is subject to physical and visual release testing per internal Quality Control Test Procedures and GMP standards.

Indications for Use

Indicated for patients requiring gastric lavage procedures to flush fluid into the stomach.

Regulatory Classification

Identification

A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Special Controls

*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Easi-Lav (K951533)

Submission Summary (Full Text)

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

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

February 7, 1997

OCT 27 1997

Contact: Mark S. Alsberge, Regulatory Affairs Manager

Product Name: CombiPort Fluid Lavage Device

Trade Name: Gastrointestinal Tube and Accessories

Classification name:

Hospital
Class I, 80KDH
21 CFR 880.5980

SUBSTANTIAL EQUIVALENCE¹ TO:

| Gross Number | Name | Description |
| --- | --- | --- |
| K951533 | Easi-Lav | Ballard Medical Products |

## 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 CombiPort Fluid Lavage Device. The CombiPort is a device intended to flush fluid into the stomach during gastric lavage procedure.

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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## Material:

The CombiPort Fluid Lavage Device is composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.

## Substantial equivalence:

The CombiPort Fluid Lavage Device is similar in intended use to the Easi-Lav cleared by Ballard Medical Products. There are no new issues of safety or effectiveness raised by The CombiPort Fluid Lavage Device.

## 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 GMP*s.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

OCT 27 1997

Mr. Mark S. Alsberge
Director, Regulatory Affairs
B. Braun Medical, Inc.
824 12th Avenue
Bethlehem, Pennsylvania 18018-0027

Re: K971259
CombiPort Fluid Lavage Device
Dated: July 29, 1997
Received: August 1, 1997
Regulatory Class: II
21 CFR § 876.5980/Product Code: 78 KDH

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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,

Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K971259

Device Name: COMBIPORT FLUID LAVAGE DEVICE

Indications For Use:
THE COMBIPORT FLUID LAVAGE DEVICE
IS INTENDED TO FLUSH FLUID INTO
THE STOMACH DURING GASTRIC LAVAGE
PROCEDURES.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971259

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)