(252 days)
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No
The 510(k) summary describes a physical medical device (a vaginal stent) and contains no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is designed to maintain the vaginal canal after medical procedures, which is a therapeutic function aimed at restoring or improving a bodily function.
No
The device is a stent used to maintain the vaginal canal after treatment or surgery, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states "Silimed Vaginal Stent," which is a physical object, not software. The intended use also describes a physical device used in surgical procedures.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Silimed Vaginal Stent function: The Silimed Vaginal Stent is a physical device designed to be inserted into the body to maintain the shape and size of the vaginal canal. It does not analyze biological samples.
The provided information clearly describes a physical implant used for anatomical support and restoration, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Silimed Vaginal Stent is designed to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.
The surgeon is responsible for proper choice of size to meet the clinical and aesthetic needs of each case.
Product codes
85 KXP
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
vaginal canal / vagina
Indicated Patient Age Range
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Intended User / Care Setting
Physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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§ 884.3900 Vaginal stent.
(a)
Identification. A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three arms or lines extending upwards, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 5 1998
Silimed L.L.C. c/o Mr. E. J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114 Re: K974479
Silimed Vaginal Stent Dated: June 12, 1998 Received: June 12, 1998 Regulatory Class: II 21 CFR 884.3900/Procode: 85 KXP
Dear Mr. Smith:
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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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. this response to your premarket notification submission does not affect any obligation you might have under sections 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.
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) 594-4613. 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 mumber (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".
Sincerely yours
Lillian Yin Ph D
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known):K974479
Device Name: Silimed Vaginal Stent
Classification Panel: 85 KXP, 884.3900
Indications for Use:
The Silimed Vaginal Stent is designed to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.
The surgeon is responsible for proper choice of size to meet the clinical and aesthetic needs of each case.
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||
|---|---|---|---|---|
| Prescription Use | ||||
| ✓ | or | Over-the-Counter Use |
Colew m. Pollard
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological D 510(k) Number