(88 days)
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
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.
Here's an analysis of the provided FDA document regarding the Sil-Tec Rod, focusing on acceptance criteria and study details.
Based on the provided documents (K973166), there is no information about specific acceptance criteria or a study that proves the device meets those criteria.
The document is an FDA 510(k) clearance letter, which means the device was found to be substantially equivalent to a previously marketed predicate device. This type of clearance often relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate, rather than requiring new, full clinical trials with detailed acceptance criteria.
Therefore, most of your requested information cannot be extracted from these documents. I can only provide what can be inferred or explicitly stated.
Unable to Provide from the Given Documents:
- A table of acceptance criteria and the reported device performance: Not present. The 510(k) pathway focuses on substantial equivalence, not necessarily on specific performance metrics established through a formal study with acceptance criteria in the same way a PMA (Premarket Approval) might.
- Sample size used for the test set and the data provenance: Not present. No specific "test set" study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not present.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present (and irrelevant for a physical medical device).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present, as no detailed study is described.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
What is available or can be inferred from the documents:
The core of this submission is the claim of "substantial equivalence" to predicate devices already on the market. This means the device's safety and effectiveness are established by referring to existing, legally marketed devices.
Product Information:
- Trade Name: Sil-Tec Rod
- Regulatory Class: Unclassified
- Product Code: MIB
- Indications For Use: Soft, translucent silicone elastomer rod intended for reconstruction and surgical repair procedures, including:
- As temporary stents for the formation of new tendon sheaths
- Other surgical repair procedures demanding a highly inert and flexible rod-shaped material
- Grades:
- Short Term Rods (suffix ST): Implantation for less than 30 days.
- Long Term Rods (suffix LT): Implantation for longer than 30 days.
{0}------------------------------------------------
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.
{1}------------------------------------------------
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
{2}------------------------------------------------
| 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) |
§ 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.