(88 days)
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No
The summary describes a simple silicone elastomer rod for surgical repair and reconstruction, with no mention of AI, ML, image processing, or any computational analysis.
No
The device is described as an inert, flexible rod for reconstruction and surgical repair procedures, such as temporary stents for tendon sheath formation, which indicates a supportive/restorative role rather than a direct therapeutic one (e.g., treating a disease or condition).
No
The device is described as a silicon elastomer rod for reconstruction and surgical repair procedures, such as temporary stents. It is an implantable material, not a device used to determine the presence or nature of a disease or condition.
No
The device description clearly states it is a "silicon elastomer rod," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Sil-Tec Medical Grade rod is a "soft, translucent silicon elastomer rod intended for reconstruction and surgical repair procedures." It is an implantable device used within the body for structural support and repair.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its function is purely mechanical and structural within the body.
Therefore, the Sil-Tec Medical Grade rod falls under the category of a surgical implant or medical device used for repair, not an in vitro diagnostic.
N/A
Intended Use / 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:
- The short term rods carry a catalog number with a suffix ST for short term procedures requiring implantation for less than 30 days.
- The long term rods carry a catalog number with a suffix LT for implantation procedures requiring longer than 30 days.
Some uses have been:
- As temporary stents for the formation of new tendon sheaths
- Other surgical repair procedures demanding a highly inert and flexible rod shaped material
Product codes
MIB
Device Description
Sil-Tec Medical Grade rod is a soft, translucent silicon elastomer rod. The rod is made in two grades of material: short term rods (suffix ST) for implantation less than 30 days, and long term rods (suffix LT) for implantation longer than 30 days.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/2 description: The image shows a partial view of the Department of Health & Human Services logo. The text "DEPARTMENT OF HEALTH & H" is visible, arranged vertically along the left side of the image. To the right of the text is a stylized graphic of a human face in profile, represented by three curved lines.
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 (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,
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:
- The short term rods carry a catalog number with a suffix ST for short term procedures requiring implantation for less than 30 days.
- The long term rods carry a catalog number with a suffix LT for implantation procedures requiring longer than 30 days.
Some uses have been:
- As temporary stents for the formation of new tendon sheaths
- 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 | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |