(20 days)
The purchaser should thoroughly test products made in part or otherwise incorporating Sil-Tec medical grade tubing to determine the acceptability of the products performance in a specific application
Applications for Tubing include :
- Stillcone tubing has been used in artificial external or l .. internal blood circulatory systems where temporary substitution is needed for the heart, lungs, and arieriovenous system
- 2 Blood transfusions
- Suction drainage of surgical wounds 3
- Temporary tube gastrostomy following abdominal surgery 4
- Connecting glass tubing of different bores 5
Sil-Tec Medical Grade Tubing
This document is a marketing clearance letter from the FDA for a medical device called "Sil-Tec Medical Grade Tubing." It does not contain information about acceptance criteria or a study proving device performance in the way a typical medical device study report would.
Therefore, I cannot provide the requested information. This letter is a regulatory clearance, not a study report.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1997
Mr. Norbert D. Thompson President Technical Products, Inc. 2416 Park Central Boulevard Decatur, Georgia 30035
Re: K971613 Trade Name: Sil-Tec Medical Grade Tubing Regulatory Class: Unclassified Product Code: MIB Dated: April 30, 1997 Received: May 2, 1997
Dear Mr. Thompson:
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.
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Page 2 - Mr. Norbert D. Thompson
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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_10 of 34
510(k) Number (if known): K971613
Device Name: Sil-Tec Medical Grade Tubing
Indications For Use:
The purchaser should thoroughly test products made in part or otherwise incorporating Sil-Tec medical grade tubing to determine the acceptability of the products performance in a specific application
Applications for Tubing include :
- Stillcone tubing has been used in artificial external or l .. internal blood circulatory systems where temporary substitution is needed for the heart, lungs, and arieriovenous system
- 2 Blood transfusions
- Suction drainage of surgical wounds 3
- Temporary tube gastrostomy following abdominal surgery 4
- Connecting glass tubing of different bores 5
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-O
Division of General Restorative Devices
Prescription Use
(Per 21 CFR 801.109)
:-
OR Over-The-Counter Use
(Optional Format 1-2-96)
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.