(31 days)
Not Found
Not Found
No
The provided text describes a silicone tissue expander, a physical implant, and contains no mention of software, algorithms, image processing, AI, or ML.
Yes
The device is described as aiding in reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities, which are all therapeutic applications.
No
The device, Silicone Tissue Expanders, is intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage, aiding in reconstruction and treatment of tissue deformities. This is a therapeutic or reconstructive function, not a diagnostic one that identifies or characterizes a disease or condition.
No
The intended use clearly describes a physical implantable device (Silicone Tissue Expanders) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device for temporary subcutaneous implantation to expand tissue for surgical reconstruction. This is a procedure performed on the body (in vivo).
- IVD Definition: In vitro diagnostics (IVDs) are tests performed outside of the body (in vitro) on specimens such as blood, urine, or tissue to diagnose diseases or other conditions.
The description clearly indicates a device used within the body for a surgical purpose, which is the opposite of an IVD.
N/A
Intended Use / Indications for Use
Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.
Product codes
LCJ
Device Description
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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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle or other bird with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 1998
T. Jan Varner ·President Specialty Surgical Products, Inc. 302 North First Street Hamilton, Montana 59840
Re: K982067 Trade Name: Magnetic Port Silicone Tissue Expander Regulatory Class: Unclassified Product Code: LCJ
Dated: June 2, 1998 Received: June12, 1998
Dear Mr. Varner:
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 requirement, as set forth in the Quality System Regulation (OS) 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.
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.
1
Page 2 - T. Jan Varner
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 Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
982067
Device Name: Silicone Tissue Expanders
Indications For Use:
Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K982067 |
Image /page/2/Picture/7 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR 801.109)" in a smaller font. There is a symbol that looks like an X over the text. The text is left-aligned and the symbol is to the right of the text.
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)