K963287 · Swift Delivery Products · HDB · Oct 28, 1996 · Obstetrics/Gynecology
Device Facts
Record ID
K963287
Device Name
VACUUM CUP (004SD)
Applicant
Swift Delivery Products
Product Code
HDB · Obstetrics/Gynecology
Decision Date
Oct 28, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.4340
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Vacuum Extractor Cup used in child birth
Device Story
Vacuum extractor cup; used during childbirth to assist vaginal delivery; physician-operated; design modification of Mityvacuum (004M) featuring relocated vacuum tubing attachment point; cup and stem design substantially equivalent to predicate; intended to improve clinical utility based on physician feedback.
Clinical Evidence
No clinical data. Non-clinical evidence consists of a physician survey across nine states identifying the need for the design improvement.
Technological Characteristics
Vacuum extractor cup; design modification of predicate; relocated vacuum tubing attachment point; cup and stem materials equivalent to predicate.
Indications for Use
Indicated for use by physicians to assist mothers in safe vaginal delivery during childbirth.
Regulatory Classification
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.
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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 Mityvacuum Extractor 004M
Description of the device: The new Tulip Cup is a design change to the current Mityvacuum (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 Mityvacuum and 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.
