SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE

K970170 · Richard G. Lindsay · HDB · Mar 28, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K970170
• Device Name: SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE
• Applicant: Richard G. Lindsay
• Product Code: HDB · Obstetrics/Gynecology
• Decision Date: Mar 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4340
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

Vacuum Extractor Cup used in child birth

Device Story

Vacuum extractor cup used during childbirth; assists physician in vaginal delivery. Device features modified vacuum tubing attachment point and vacuum release valve location compared to predicate. Design changes intended to reduce cup detachment (pop-offs), improve physician control, and enable single-handed vacuum regulation. Used by obstetricians in clinical delivery settings. Benefits include increased safety for neonate and reduced delivery time for mother.

Clinical Evidence

No clinical data. Non-clinical performance evidence consists of a physician survey across nine states confirming the need for design improvements.

Technological Characteristics

Vacuum extractor cup and stem assembly. Mechanical device; no energy source or software. Design modifications focus on ergonomic placement of vacuum tubing and release valve.

Indications for Use

Indicated for use in childbirth to assist in vaginal delivery.

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

• Mityvac Vacuum Extractor with release valve (K890307)

Submission Summary (Full Text)

{0}

K 970170

MAR 28 1997

# Premarket Notification (510k) Summary

| Submitters Name: | Swift Delivery Products |
| --- | --- |
| Address: | 6824 Elk Canyon Road, Okla. City, Okla. 73162 |
| Phone: | 405-721-8227 |
| Fax: | 405-721-8781 |
| Contact Person: | Richard G. Lindsay (Ric Lindsay) |
| Date: | This summary was prepared 1-1-97 |
| Name of Device: | Swift Delivery Product #002 |
| Common Name: | Vacuum Extractor Cup |
| Classification Panel: | OB/GYN |
| Product Code: | 85HDB |
| C.F.R. Section: | CFR - 21 (884.4340) |
| Device Class: | Class II |
| Indication Use: | Vacuum Extractor Cup used in child birth |
| Equivalence to: | K890307 Mityvac Vacuum Extractor with release valve |

Description of the Device: The new product is an improved vacuum extractor cup. The improvement is found in the location of the vacuum tubing attachment point and vacuum release valve.

Description of use: This vacuum device is used in child birth to allow a physician to assist the mother in a safe vaginal delivery.

Duration of Mityvac and our new 002 Cup: The cup and stem on both products are substantial equivalent. The tubing attachment locations are different. This new location will reduce cup pop-offs and increase physician comfort and control of the cup. The new vacuum release valve location and design allow easy single handed delivery and vacuum control.

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 delivery product.

Conclusions drawn from non-clinical data: The vacuum delivery products now in use can be improved. The new 002 product WILL INCREASE the SAFETY of delivery for the baby, REDUCE the AMOUNT OF TIME of delivery for the mom and provide an IMPROVED CUP for the physician.