SWIFT DELIVERY PRODUCT #300

K973942 · Swift Delivery Products · HDB · Dec 12, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K973942
• Device Name: SWIFT DELIVERY PRODUCT #300
• Applicant: Swift Delivery Products
• Product Code: HDB · Obstetrics/Gynecology
• Decision Date: Dec 12, 1997
• 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 by physicians during childbirth to assist vaginal delivery. Device connects to electric vacuum pumps via an included adaptor and 6 feet of tubing. Operates by creating suction to assist delivery in cases of uterine inertia, maternal exhaustion, or fetal/maternal distress. Provides physician with improved cup design and increased tubing length compared to previous models. Benefits include increased delivery safety and reduced delivery time.

Clinical Evidence

No clinical data. Evidence consists of a physician survey conducted in nine states confirming the clinical need for the adaptor and increased tubing length.

Technological Characteristics

Vacuum extractor cup with integrated vacuum release valve. Includes 6 feet of tubing and an adaptor for connection to electric vacuum pumps. Mechanical device; no software or electronic components.

Indications for Use

Indicated for use in childbirth for uterine inertia, maternal exhaustion (ineffective voluntary effort), vertex presentation, and engagement of the head. Optional indications include maternal distress and fetal distress.

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

• Swift Vacuum Extractor with release valve (K970170)

Submission Summary (Full Text)

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K973942

Swift Delivery Products Submitters Name: 6824 Elk Canyon Road, Okla. City, Okla. 73162 Address: 405-721-8227 Phone : [phone] Fax : Richard G. Lindsay (Ric Lindsay) Contact Person: This summary was prepared 9-21-97 Date: Swift Delivery Product #003 Name of Device: Common Name: Vacuum Extractor Cup OB/GYN Classification Panel: Product Code: 85HDB (884.4340) C.F.R. Section: CFR - 21 -Device Class: Class Il Indication Use: Vacuum Extractor Cup used in child birth Equivalence to: K970170 Swift 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, vacuum release valve and an adaptor for electric vacuum pumps.

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

sarison of our 002 Cup and our new 003 Cup: The cup and stem on both ,ducts are substantial equivalent. The tubing attachment locations and vacuum release valves are the same. The new #003 product has 6 feet of tubing (instead of 4 feet) and an adaptor to connect to electric pumps.

Non-Clinical Performance Data: A survey was distributed to a select group of physicians in nine states. They indicated this improvement (an adaptor and 2 extra feet of tubing) was needed in our vacuum delivery product.

Conclusions drawn from non-clinical data: The vacuum delivery products now in use can be improved. The new 003 product WILL INCREASE the SAFETY of delivery for the baby, REDUCE the AMOUNT OF TIME of delivery for the mom, provide an IMPROVED CUP for the physician and be allow the hospital to use existing approved electric vacuum pumps.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 1997

Mr. Richard Lindsay President Swift Delivery Products, Inc. 6824 Elk Canyon Road Oklahoma City, Oklahoma 73162 Re: K973942

Swift Delivery Tulip Vacuum Cup (Product #003) Dated: September 21, 1997 Received: September 26, 1997 Regulatory class: II 21 CFR §884.4340/Product code: 85 HDB

Dear Mr. Lindsay:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements conceming your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K973942

(vice Name: Swift Delivery Product #003 - Vacuum Extractor Cup with Vacuum Release Valve
Indications For Use: 6 feet of tubing and an Adaptor for electric
vacuum pumps.
The Indications For Use for this vacuum device in childbirth are the following:
Uterine inertia
Maternal Exhaustion - ineffective voluntary effort
Vertex Presentation
Engagement of the Head
Optional:
A. Maternal distress
B. Fetal distress

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K97.3942

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------------------|-------------------------|
| Prescription Use (Per 21 CFR 801.109) | X |
| OR | |
| Over-The-Counter Use | |

(Optional Format 1-2-96)