(111 days)
The Somatics Ventil-A™ oral protector is a single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, or for protection of the teeth, lips, tongue, and buccal mucosa (e.g., during cardioversion).
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Ventil-A," an oral protector. The letter indicates that the device has been found substantially equivalent to a predicate device. However, this document does not contain specific information about acceptance criteria or a study that proves the device meets those criteria.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval notice, not a performance study report.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 25 1999
Richard Abrams, M.D. Director Somatics, Inc. 910 Sherwood Drive, Unit 17 Lake Bluff, Illinois 60044
K992269 Re: Trade Name: Ventil - A Regulatory Class: II Product Code: JXL Dated: August 30, 1999 Received: September 13, 1999
Dear Dr. Abrams:
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 (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. 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 - Richard Abrams, M.D.
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,
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}------------------------------------------------
Page 1 of 1
510(k) Number (if known): K992269
Device Name: VENTIL-A
Indications For Use:
dications For Use:
The Somatics Ventil-A™ oral protector is a single-use (disposable) oral protector I he Somatics V Chili-A - oral procees- is a mulsive therapy, spontaneous seizures, lor use uning scizares madeed sprotection of the teeth, lips, tongue, and buccal mucosa (e.g., during cardioversion).
(PLEASE DO NOT WRITE BEI.OW 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 | K942269 |
|---|---|
| --------------- | --------- |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
§ 882.5070 Bite block.
(a)
Identification. A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.(b)
Classification. Class II (performance standards).