(68 days)
Vacuum Extractor Cup used in child birth
The new Tulip Cup is a design change to the current Mityvace (004M) vacuum extractor cup. The change is found in the location of the vacuum tubing attachment point.
I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device called "The Tulip Cup" and its comparison to an existing device, Mityvac. It mentions a survey of physicians indicating an improvement was needed in vacuum products, but it does not provide details about acceptance criteria, device performance metrics, sample sizes for testing or training, ground truth establishment, or any studies demonstrating the device meets specific acceptance criteria in a structured scientific manner.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image is a black and white drawing of a stork carrying a baby in a sling. The stork is standing on one leg and has a long beak. The baby is wrapped in a blanket and is being carried in a sling that is attached to the stork's beak. The drawing is simple and cartoonish.
OCT 28 1996
K963287
Premarket Notification (510k) Summary
| Submitters Name: | Swift Delivery Products |
|---|---|
| Address: | 6824 Elk Canyon Road, Oklahoma City, OK 73162 |
| Phone: | 405/721-8227 |
| Fax: | 405/721-8227 or 405/721-8032 |
| Contact Person: | Richard G. Lindsay (Ric Lindsay) |
| Date: | This summary was prepared 8/15/96 |
| Name of Device: | The Tulip Cup |
| Common Name: | Vacuum Extractor Cup |
| Classification Panel: | OB/GYN |
| Product Code: | 85HDB |
| C.F.R. Section: | CFR - 21 (884.4340) |
| Device Class: | Class 11 |
| Indication Use: | Vacuum Extractor Cup used in child birth |
| Equivalence to: | K890307 Mityvac®Vacuum Extractor 004M |
Description of the device: The new Tulip Cup is a design change to the current Mityvace (004M) vacuum extractor cup. The change is found in the location of the vacuum tubing attachment point.
Description of use: This vacuum device is used in child birth to allow a physician to assist the mother in a safe vaginal delivery.
Comparison of Mityvac Cand our new Tulip Cup: The cup and stem on both products are substantial equivalent The tubing attachment locations are different.
Non-clinical performance data: A survey was distributed to a select group of physicians in nine states. They indicated this improvement was needed in the vacuum products.
Conclusions drawn from non-clinical data: The vacuum delivery products now in use can be improved. The new Tulip Cup is a design modification.
§ 884.4340 Fetal vacuum extractor.
(a)
Identification. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.(b)
Classification. Class II (performance standards).