SWIFT LOW PROFILE CUP (PRO CUP)

K013460 · Swift Delivery Products · HDB · Jan 17, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K013460
• Device Name: SWIFT LOW PROFILE CUP (PRO CUP)
• Applicant: Swift Delivery Products
• Product Code: HDB · Obstetrics/Gynecology
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4340
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Non-reassuring fetal status. 2. Failure of the fetus to deliver spontaneously following an appropriately managed second stage. 3. Maternal need to avoid voluntary expulsive effort. 4. Inadequate maternal expulsive effort. 5. Selective shortening of the second stage when the fetal head is at the outlet as defined by ACOG technical bulletin # 196 Aug. 1994.

Device Story

Swift Low Profile Cup (Pro Cup) is a fetal vacuum extractor used during labor and delivery. Device consists of a suction cup applied to the fetal scalp to assist delivery. Available in two configurations: model 004 (without vacuum release valve) and model 005 (with vacuum release valve). Operated by obstetricians or trained clinicians in clinical/hospital settings. Device applies suction to the fetal head to facilitate extraction when spontaneous delivery is delayed or contraindicated. Benefits include reduced maternal expulsive effort and shortened second stage of labor. Clinician monitors fetal status and applies vacuum pressure to assist descent and delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fetal vacuum extractor; low profile cup design; available with or without vacuum release valve. Mechanical device; no software or electronic components.

Indications for Use

Indicated for use in patients requiring assisted delivery due to non-reassuring fetal status, failure to deliver spontaneously, maternal need to avoid or inadequate voluntary expulsive effort, or for selective shortening of the second stage of labor when the fetal head is at the outlet.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Mr. Richard G. Lindsay President Swift Delivery Products, Inc. 6824 Elk Canyon Road OKLAHOMA CITY OK 73162 Re: K013460 Trade/Device Name: Swift Low Profile Cup (Pro Cup) 004 without the vacuum release valve; 005 with the vacuum release valve Regulation Number: 21 CFR §884.4340 Regulation Name: Fetal vacuum extractor Regulatory Class: II Product Code: 85 HDB Dated: October 10, 2001 Received: October 18, 2001

Dear Mr. Lindsay:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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KO13460. 510 (k) NUMBER (IF KNOWN) : SWIFT LOW PROFILE CUP (PRO CUP) with and without a vacuum release DEVICE NAME : valve. INDICATIONS FOR USE:

- 1. Non-reassuring fetal status.
- Failure of the fetus to deliver spontaneously following an appropriately 2. managed second stage.
- Maternal need to avoid voluntary expulsive effort. 3.
- 4. Inadequate maternal expulsive effort.
- Selective shortening of the second stage when the fetal head is at the outlet 5. as defined by ACOG technical bulletin # 196 Aug. 1994.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IT NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODD)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1.-2-96)

Nancie Burdon

(Division Sig Division of Repro and Radiological Devices 510(k) Number