MEDELA SINGLE USE SILC CUP, MODEL 077.0791

K041579 · Medela AG · HDB · Apr 21, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K041579
• Device Name: MEDELA SINGLE USE SILC CUP, MODEL 077.0791
• Applicant: Medela AG
• Product Code: HDB · Obstetrics/Gynecology
• Decision Date: Apr 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4340
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The Medela® Single Use Silc Cup is intended to be used to facilitate the delivery of the fetus during childbirth. 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. It is powered by an external vacuum source and indicated for using during vaginal or cesarean delivery.

Device Story

Sterile, single-use elastomer suction cup; 60mm inner diameter; connects to external vacuum pump and tubing. Used by clinicians during vaginal or cesarean delivery to facilitate fetal extraction. Cup features internal projections to ensure firm adhesion to fetal scalp; longitudinal ridge allows rotation monitoring. Soft material deforms to optimize adhesion and minimize scalp trauma. Device applies traction to fetal head via vacuum suction. Benefits include assisted delivery in cases of fetal distress or maternal delay.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and biocompatibility assessment.

Technological Characteristics

Elastomer suction cup; 60mm inner diameter; sterile, single-use. Operates via external vacuum source. Features internal projections for adhesion and external longitudinal ridge for rotation monitoring. No electronic components or software.

Indications for Use

Indicated for fetal distress in the second stage, maternal delay in the second stage, or maternal conditions requiring a short second stage. Conditions for use include vertex presentation with well-flexed head, ruptured membranes, gestational age > 36 weeks, fully dilated cervix, and fully engaged head.

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

• OB Vacuum Extractor (K841492)
• Ameda/Egnell Dolphin Dispo-Soft Vacuum Extractor (K895700)

Submission Summary (Full Text)

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Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Appliaan:
Contact Person: Werner Frei, Te! [phone] ext. 247; Fax [phone] [e-mail]

510(k) Submission for Medela® Obsteirical Vacuum Delivery System

# APR 2 1 2005

KO41579

## Section E - 510(k) Summary

Medela Obstetrical Vacuum Delivery System

#### Sponsor's Name, Address and Contact Person: 1

Contact Person Sponsor: Werner Frei Medela AG Manager Regulatory Affairs Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland [phone] ext. 228 Phone: Fax: [phone]

Date Summary Prepared: March 01 2004

#### Name of Device(s) 2

| Trade Name: | Medela® Single Use Silc Cup |
|-------------|-----------------------------|
| | Fetal Vacuum Extractor |

| Common Name: | Obstetrical Vacuum Delivery System |
|----------------------|-------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Fetal Vacuum Extractor, Obstetrical and Gynecological Surgical<br>(Classified Class II, per 21 CFR Section § 884.4340). |

### Product Code 3

HDB

#### Name of the predicate Device(s) 4

| Medela Inc. | OB Vacuum Extractor<br>(K841492) |
|----------------|---------------------------------------------------------------|
| Hollister Inc. | Ameda/Egnell Dolphin Dispo-Soft Vacuum Extractor<br>(K895700) |

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Description of Device 5

The Medela® Single Use Silc Cup is a sterile, disposable device made of an elastomer and available in one size, 60mm inner diameter. The instrument is elastomer and consists of a handle and a suction cup to be used with an external vacuum pump and tubing.

The cup has a smooth external surface with a small longitudinal ridge, which makes it possible to observe any rotation. The inside of the cup is lined with mance it possible to objections enable the air between the cup and the child's Small projoctions: The projections that the cup sucks firmly against the child's head. The soft suction cup deforms, thereby ensuring optimal adhesion and minimizing trauma to the fetal scalp.

#### Intended Use of the Device රි

The Medela® Single Use Silc Cup is intended to be used to facilitate the delivery of the fetus during childbirth. 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. It is larmedd by an external vacuum source and indicated for using during vaginal or cesarean delivery.

### The Indications for use are

- Fetal distress in the second stage ﻬ
- Maternal delay in the second stage +
- Maternal conditions requiring a short second stage .

## Conditions for use of the Single Use Silc Cup

- Vertex presentation, with the head well-flexed �
- Ruptured membranes +
- Gestational age > 36 weeks .
- Cervix fully dilated ↓
- Head fully engaged abdominally +

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510(k) Submission for Medela® Obstetrical Vacuum Delivery System

#### Summary of Technological Characteristics 7

The Technology of the Medela® Single Use Silc Cup is identical to the predicate rne Toomology of the no technical differences which would raise new aspects regarding safety and effectiveness.

Based upon the information presented in section I - Biocompatibility, the materi-Dased upon the miomation prose Single Use Silc Cup are considered as appropriate for their intended use.

#### Conclusion 8

Based upon the information presented above, it is concluded that the proposed Medela® Single Use Silc Cup is safe and effective for the intended use and is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2005

Medela AG % Mr. Stefan Preiss Responsible Third Party TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K041579

Trade/Device Name: Medela® Single Use Silc Cup Regulation Number: 21 CFR 884.4340 Regulation Name: Fetal vacuum extractor Regulatory Class: II Product Code: HDB Dated: April 1, 2005 Received: April 6, 2005

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w that to review of 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 the cholosate) to regardy man date of the Medical Device Amendments, or to devices that have been May 20, 1970, and chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that roomstitud in approval of a premarket approval application (PMA). You may, therefore, market the do not roquite approvisions of the Act. The general controls provisions of the Act active, subjoct to the general 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 (Premarket n your are ree subject to such additional controls. Existing major regulations affecting your Apploval), it the 70 be 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 I lease be advisod that i Dr. I one device complies with other requirements of the Act or any I DA has made a decorninations administered by other Federal agencies. You must comply with all the I car a satues and regulations as annual in ited to registration and listing (21 CFR Part 807); labeling ACC STEQuirements, moduling, but novements as set forth in the quality systems (QS) (27 CFR Part 801); 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 Section 510(k) I his letter will anow you to ocgin maneting your interest of your device to a legally premarket nothication. The I DA miding of backannel.
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 If you desire specific advice for your device of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premaket notification the Also, please note the regulation entired, "Thiseration on your responsibilities under the Act from the 180 807.97). You may outain other general meanst on your Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

Enclosure

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Page 1 of_1

510(k) Number (if known): 4041579

Device Name: Medela® Single Use Silc Cup

Indications For Use:

· Fetal distress in the second stage

• Maternal delay in the second stage

• Maternal conditions requiring a short second stage

The Medela® Obstetrical Vacuum Delivery System (Single Use Silc Cup) is a sterile, disposable I de Medita@ Obscerred. Tacation of the delivery of the fetus during childbirth. The device enables that the device miended to be ascu to the birth canal) by means of a suction cup attached to the traction to be applice to the team note (in isource and indicated for using during vaginal or cesarean delivery.

ﯿﮟ

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

David b. Symm

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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number