INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450

K972112 · Taut, Inc. · GBW · Dec 1, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972112
• Device Name: INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450
• Applicant: Taut, Inc.
• Product Code: GBW · General, Plastic Surgery
• Decision Date: Dec 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1

Intended Use

THE DEVICE IS INTENDED FOR USE AS AN ABDOMINAL ACCESS PORT DURING LAPARASCOPIC PROCEDURE AND THE VALVE FOR ATTACHING INSUFFLATION TUBING TO MAINTAIN PNEUMOPERITONEAL PRESSURE.

Device Story

Introducer Port SC functions as abdominal access port during laparoscopic surgery; provides valve interface for insufflation tubing; maintains pneumoperitoneal pressure throughout procedure; used by surgeons in clinical/OR settings; facilitates instrument entry while preserving surgical field integrity.

Indications for Use

Indicated for use as an abdominal access port during laparoscopic procedures to maintain pneumoperitoneal pressure via an insufflation tubing valve.

Regulatory Classification

Identification

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Glenn B. Miller ·RA/QA Director TAUT Inc. 2571 Kaneville Court Geneva, Illinois 60134

DEC - 1 1997

Re: K972112 Trade Name: Introducer Port SC Regulatory Class: II Product Code: GBW Dated: September 8, 1997 Received: September 9, 1997

Dear Mr. Miller:

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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.

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## Page 2 - Mr. Glenn B. Miller

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,

Sincerely yours,

Celia 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Glenn B. Miller ·RA/QA Director TAUT Inc. 2571 Kaneville Court Geneva, Illinois 60134

DEC - 1 1997

Re: K972112 Trade Name: Introducer Port SC Regulatory Class: II Product Code: GBW Dated: September 8, 1997 Received: September 9, 1997

Dear Mr. Miller:

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 requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.

{3}------------------------------------------------

## Page 2 - Mr. Glenn B. Miller

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,

Sincerely yours,

Celia 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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Pagc 1 of I 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ 4972112 Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

THE DEVICE IS INTENDED FOR USE AS AN ABDOMINAL ACCESS PORT DURING
LAPARASCOPIC PROCEDURE AND THE VALVE FOR ATTACHING INSURELATION LAPARASCOPIC PROCEDURE AND THE VALVE FOR ATTACHING INSUFFLATION
TUBING TO MAINTAIN PREUMOPERITONEAL POR ATTACHING INSUFFELATION TUBING TO MAINTAIN PNEUMOPERITONEAL PRESSURE.

Glenn B. Miller
RA/QA Director

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number: `K972112

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)