SUCTION CATHETER

K981910 · Ni-Med, Inc. · BSY · Aug 24, 1998 · Anesthesiology

Device Facts

• Record ID: K981910
• Device Name: SUCTION CATHETER
• Applicant: Ni-Med, Inc.
• Product Code: BSY · Anesthesiology
• Decision Date: Aug 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6810
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The intended use of the NI-MED suction catheter kit is for the physician to aspirate liquids or semi-solids from a patient's upper airway.

Device Story

NI-MED suction catheter kit is a medical device used by physicians to aspirate liquids or semi-solids from a patient's upper airway. The device is intended for prescription use. It functions as a manual or suction-assisted tool to clear airway obstructions, facilitating improved patient breathing. The kit is used in clinical settings. It does not involve complex electronic processing or automated decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Suction catheter kit; manual aspiration device; non-electronic; no software; no specific materials or standards cited.

Indications for Use

Indicated for use by physicians to aspirate liquids or semi-solids from the upper airway of patients requiring airway clearance.

Regulatory Classification

Identification

A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 1998

Mr. Michael Giblin Director of Quality Assurance Ni-Med, Inc. P.O Box 871 1601 Air Park Drive Farmington, MO 63640-0871

Re: K981910 Suction Catheter Requlatory Class: I (one) Product Code: 73 BSY Dated: May 29, 1998 Received: June 1, 1998

Dear Mr. Giblin:

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 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 You may, therefore, market the device, subject to the Act (Act). general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices:

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## Page 2 - Mr. Michael Giblin

General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 the 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/dsma/dsmamain.html".

Sincerely yours,

DAspgh

for Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/3 description: The image shows a logo for NI-MED, INC. The logo consists of a black square with a white plus sign inside, followed by the text "NI-MED, INC." in black. The plus sign is centered within the square and is formed by two intersecting rectangles.

- August 20, 1998 K981910 Suction Catheter Kit

## INDICATIONS FOR USE

The intended use of the NI-MED suction catheter kit is for the physician to aspirate liquids or semi-solids from a patient's upper airway.

\✓ Prescription Use

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(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number .

P.O. BOX 871 1601 AIR PARK DR FARMINGTON, MO 63640-0871 PHONE: [phone] FAX: [phone]