VACUUM CUP (004SD)

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

Intended 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.

Predicate Devices

• Mityvacuum Extractor 004M (K890307)

Submission Summary (Full Text)

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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: [phone]
Fax: [phone] 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.