IP-16

K980301 · Servizi Medico Estetici Italinai Srl. · BTA · Mar 24, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980301
• Device Name: IP-16
• Applicant: Servizi Medico Estetici Italinai Srl.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Mar 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1P-16 infiltration/suction pump is indicated for fluid infiltration and aspiration

Device Story

The IP-16 Infiltration/Suction Pump is a medical device designed for fluid management, specifically fluid infiltration and aspiration. It operates as a peristaltic pump, utilizing mechanical action to move fluids through tubing. The device is intended for use by healthcare professionals in clinical environments. By providing controlled suction or infusion, the pump assists in surgical or procedural fluid management, potentially improving clinical efficiency and patient outcomes during procedures requiring precise fluid handling.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Peristaltic pump mechanism; electromechanical design; intended for fluid infiltration and aspiration; classified as Class II, Product Code BTA.

Indications for Use

Indicated for fluid infiltration and aspiration in clinical settings requiring suction or infusion capabilities.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 1998

Mr. James. E. Lenick, Esquire Attorney at Law 257 North Calderwood Street, Suite 337 Alcoa, Tennessee 37701

Re: K980301 Peristalic Infiltration/Suction Pump Trade Name: Regulatory Class: II Product Code: BTA Dated: January 21, 1998 Received: January 27, 1998

Dear Mr. Lenick:

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 reguirements 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. ਜੋ 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 In addition, FDA may publish further announcements action. 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 requlations.

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Page 2 - Mr. Lenick

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 requlation (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,

Stephen Plurks
Lo. Celia M. Witton, Ph.D.

elia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K 980 301

Device Name IP-16 Infiltration/Suction Pump

Indications for Use:

1P-16 infiltration/suction pump is indicated for fluid infiltration and aspiration

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Perscription Use X (Per 21 CFR 801.109) OR

Over-The-Counter use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Stephen Oludelu