(54 days)
Not Found
Not Found
No
The device description and intended use are for simple silicone gel pads with no mention of any computational or analytical capabilities, let alone AI/ML.
Yes
The device is intended to "help reduce pressure and friction against bony prominences" and "can also be used as scar management," which are therapeutic benefits.
No
Explanation: The device is described as silicone gel pads used to reduce pressure and friction, and for scar management. Its function is not to diagnose any condition or disease.
No
The device description clearly states it is a physical product made of silicone gel sheets, not software.
Based on the provided information, the TENDER TOUCH™ Silicone Gel Pads are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- TENDER TOUCH™ Function: The description clearly states that these pads are applied on the body to reduce pressure and friction, and for scar management. They do not involve the examination of specimens taken from the body.
Therefore, the function and intended use of the TENDER TOUCH™ Silicone Gel Pads fall outside the scope of an IVD device.
N/A
Intended Use / Indications for Use
TENDER TOUCH™ Silicone Gel Pads are designed to be worn on the body to help reduce pressure and friction against bony prominences, and they can also be used as scar management. This is not a wound covering or dressing and is not sterile.
Product codes
MDA, FMP
Device Description
TENDER TOUCH™ Silicone Gel Pads are soft silicone gel sheets that are applied over bony prominences. The sheets are not made of medical grade silicone and are not sterile. The sheets are square and rectangular and come in three sizes, 9cm x 9 cm, 6 cm x 6 cm and 3.5 cm x 6 cm. They are approximately .125 of an inch thick. The customers will determine which size sheet is best for their own application. The pad helps reduce friction and pressure against the skin. They can also be used as scar management.
The sheets are not for use on an open wound, are not sterile but can be washed. They can be used under casting and splints and can be cut to other shapes if necessary.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
on the body, bony prominences, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
510(k) SUMMARY
| Submitter's Data: | Capital Marketing Technologies, inc.
3630 South Interstate 35, Suite A
Waco, Texas 76706 | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Telephone: | 1-800-887-3370 or (254) 662-1752 | |
| Fax: | (254) 662-1760. | |
| Contact person(s): | John Snyder or Vonna Muesse | |
| Date prepared: | November, 1998 | |
| State of intended use: | TENDER TOUCH™ Silicone Gel Pads are designed to be worn on the
body to help reduce pressure and friction against bony prominences, and
they can also be used as scar management. This is not a wound covering
or dressing and is not sterile. | |
| Device Description: | TENDER TOUCH™ Silicone Gel Pads are soft silicone gel sheets that are
applied over bony prominences. The sheets are not made of medical grade
silicone and are not sterile. The sheets are square and rectangular and
come in three sizes, 9cm x 9 cm, 6 cm x 6 cm and 3.5 cm x 6 cm. They are
approximately .125 of an inch thick. The customers will determine which
size sheet is best for their own application. The pad helps reduce friction
and pressure against the skin. They can also be used as scar management.
The sheets are not for use on an open wound, are not sterile but can be
washed. They can be used under casting and splints and can be cut to other
shapes if necessary. | |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1999
Mr. John Snyder Capital Marketing Technologies, Inc. 3630 South I 35, Suite A Waco, Texas 76706
Re: K991478 Trade Name: Tender Touch™ Silicone Gel Pads Regulatory Class: Unclassified Product Code: MDA and FMP Dated: April 21, 1999 Received: April 28, 1999
Dear Mr. Snyder:
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 (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.
2
Page 2 - Mr. John Snyder
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 vour 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
3
Page 1 of 1 :
991478 510(k) Number (if known):_
Device Name: _TENDER_TOUCH_TM_SILICONE_GEL_PADS
Indications For Use:
TENDER TOUCH™ Silicone Gel Pads are designed to be worn on the body to help reduce TENDER TOOCH™ Sincone Oct adds me donger to they can also be used as scar management. prossure and invering or dressing and is not sterile.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)
Acaleto
Division S 510(k) Num