ASPISAFE GASTRIC TUBE

K961711 · B.Braun Medical, Inc. · BSS · Jun 11, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K961711
• Device Name: ASPISAFE GASTRIC TUBE
• Applicant: B.Braun Medical, Inc.
• Product Code: BSS · Gastroenterology, Urology
• Decision Date: Jun 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use is for the prophylaxis of pulmonary aspirations during induction and termination of general anesthesia.

Device Story

Aspisafe Gastric Tube is a nasogastric tube used for the prophylaxis of pulmonary aspiration during the induction and termination of general anesthesia. It is a mechanical device used in a clinical setting by healthcare professionals. The device functions by providing gastric access to manage stomach contents, thereby reducing the risk of aspiration into the lungs during anesthesia procedures. It is a passive device requiring no external power or software.

Clinical Evidence

No clinical data provided; bench testing only. Finished products undergo physical testing and visual examination per established Quality Control Test Procedures to ensure conformance with design specifications.

Technological Characteristics

Nasogastric tube composed of plastics tested in accordance with Tripartite Guidance for Plastics. Mechanical device; no energy source, software, or connectivity. Sterilization and specific dimensions not detailed.

Indications for Use

Indicated for patients undergoing induction and termination of general anesthesia to prevent pulmonary aspiration.

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

• Gastric Sump Tubes (K935688)

Submission Summary (Full Text)

{0}

K961711
10+2
June 11, 1997

April 29, 1996

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

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

CONTACT: Mark S. Alsberge, Regulatory Affairs Manager

PRODUCT NAME: Aspisafe Gastric Tube

TRADE NAME: Nasogastric Tube

CLASSIFICATION NAME:

General Hospital
Class II, 80 BSS
21 CFR 880.5440

SUBSTANTIAL EQUIVALENCE¹ TO:

| 510(k) number | Name | Applicant |
| --- | --- | --- |
| K935688 | Gastric Sump Tubes | Andersen 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 Aspisafe Gastric Tube. The Aspisafe Gastric Tube is designed to be used for the prophylaxis of pulmonary aspiration during induction and termination of general anesthesia.

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.

MATERIAL:

The Aspisafe Gastric Tube is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.

5

{1}

K96/711
2012

## SUBSTANTIAL EQUIVALENCE:

The Aspisafe Gastric Tube is identical in materials, form, and intended use to the Gastric Sump Tubes currently marketed by Andersen Products. There are no new issues of safety or effectiveness raised by Aspisafe Gastric Tube.

## 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.

{2}

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

JUN 11 1997

Mr. Mark S. Alsberge
Regulatory Affairs Manager
B. Braun Medical, Inc.
824 Twelfth Avenue
P.O. Box 4027
Bethlehem, Pennsylvania 18018-0027

Re: K961711
Aspisafe Gastric Tube
Dated: March 12, 1997
Received: March 13, 1997
Regulatory class: II
21 CFR §876.5980/Product code: 78 BSS

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 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 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

{3}

510(k) Number (if known): K 96/711

Device Name: Aspisafe Gastric Tube

Indications For Use:

The intended use is for the prophylaxis of pulmonary aspirations during induction and termination of general anesthesia.


(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 K96/711

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)