DOW CORNING SILASTIC ELASTOMER Q7-4750

K973166 · Technical Products, Inc. · MIB · Nov 21, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K973166
• Device Name: DOW CORNING SILASTIC ELASTOMER Q7-4750
• Applicant: Technical Products, Inc.
• Product Code: MIB · Ear, Nose, Throat
• Decision Date: Nov 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sil-Tec Medical Grade rod is a soft, translucent silicon elastomer rod intended for reconstruction and surgical repair procedures. The rod is made in two grades of material: 1. The short term rods carry a catalog number with a suffix ST for short term procedures requiring implantation for less than 30 days. 2. The long term rods carry a catalog number with a suffix LT for implantation procedures requiring longer than 30 days. Some uses have been: 1. As temporary stents for the formation of new tendon sheaths 2. Other surgical repair procedures demanding a highly inert and flexible rod shaped material

Device Story

Sil-Tec Rod is a soft, translucent silicone elastomer rod used in surgical reconstruction and repair. It functions as a passive implant, specifically serving as a temporary stent for tendon sheath formation or other surgical applications requiring flexible, inert material. Available in two grades: short-term (ST) for implantation <30 days and long-term (LT) for implantation >30 days. Used by surgeons in clinical/OR settings. Provides structural support or space maintenance during healing; benefits patient by facilitating tissue repair and reconstruction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Medical grade silicone elastomer. Form factor: Rod. Grades: Short-term (ST) and long-term (LT) based on implantation duration. Passive device; no energy source or software.

Indications for Use

Indicated for patients undergoing reconstruction and surgical repair procedures requiring a flexible, inert rod-shaped implant, including use as temporary stents for tendon sheath formation.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 21 1997

Mr. Norbert D. Thompson President Technical Products, Inc. 2416 Park Central Boulevard Decatur, Georgia 30035

Re: K973166

Trade Name: Sil-Tec Rod Regulatory Class: Unclassified -Product Code: MIB Dated: August 20, 1997 Received: August 25, 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 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. Norbert D. Thompson

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,

Maria Pflueger, MSPT

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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| 510(k) Number (if known): | K-973166 |
|---------------------------|-------------|
| Device Name: | Sil-Tec Rod |
| Indications For Use: | |

Sil-Tec Medical Grade rod is a soft, translucent silicon elastomer rod intended for reconstruction and surgical repair procedures.

The rod is made in two grades of material:

1. The short term rods carry a catalog number with a suffix ST for short term procedures requiring implantation for less than 30 days.
2. The long term rods carry a catalog number with a suffix LT for implantation procedures requiring longer than 30 days.

Some uses have been:

1. As temporary stents for the formation of new tendon sheaths
2. Other surgical repair procedures demanding a highly inert and flexible rod shaped material

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">✓</span> | OR | Over-The-Counter Use |
|----------------------|---------------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |