← Product Code [HDB](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB) · K963287

# VACUUM CUP (004SD) (K963287)

_Swift Delivery Products · HDB · Oct 28, 1996 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K963287

## Device Facts

- **Applicant:** Swift Delivery Products
- **Product Code:** [HDB](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB.md)
- **Decision Date:** Oct 28, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.4340
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology
- **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.

## Regulatory 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](/device/K890307.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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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.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K963287](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K963287)

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