KOLPEXIN SPHERE

K032644 · Adamed , Ltd. · HHW · May 28, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K032644
• Device Name: KOLPEXIN SPHERE
• Applicant: Adamed , Ltd.
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: May 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The KOLPEXIN™ Sphere is a vaginal pessary that is indicated for the conservative management of vaginal prolapse and pelvic floor muscular weakness.

Device Story

KOLPEXIN Sphere is a circular, medical-grade polycarbonate vaginal pessary; available in six sizes (28mm-44mm); includes attached nylon string for removal. Device functions as a mechanical support for vaginal prolapse and a training aid for pelvic floor muscle/Kegel exercises. Used by female patients for conservative management of prolapse and muscular weakness. Clinical benefit derived from physical support of pelvic structures and resistance-based muscle training.

Clinical Evidence

Multicenter study conducted to confirm safety, efficacy, and functionality in women with vaginal prolapse. Study concluded the device is safe and effective for the conservative management of vaginal prolapse and pelvic floor muscular weakness.

Technological Characteristics

Circular vaginal pessary; material: medical grade polycarbonate (LEXAN 144R-111); sizes: 28mm, 32mm, 36mm, 39mm, 42mm, 44mm; includes nylon removal string. Mechanical support device; non-powered.

Indications for Use

Indicated for conservative management of vaginal prolapse and pelvic floor muscular weakness in females.

Regulatory Classification

Identification

A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.

Predicate Devices

• Weighted vaginal training aids for the pelvic floor muscle (Milex Products, Inc.)
• Gellhorn pessary (Milex Products, Inc.)

Submission Summary (Full Text)

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MAY 2 8 2004

K032644

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# 510(k)-KOLPEXIN* Sphere - New Device

# 510(k) SUMMARY

KOLPEXIN* Sphere

(Indication for management of vaginal prolapse and pelvic floor muscular weakness)

## 1. DATE PREPARED

August 20, 2003

## 2. SUBMITTER

ADAMED Ltd. Pienkow 149, 05-152 Czosnow Poland

# 3. CONTACT

Norman 1. Bruckner, [phone] Study Manager, Consultant

# NAME OF THE MEDICAL DEVICE 4.

| Classification name: | Vaginal Weight/Vaginal Pessary |
|----------------------|-----------------------------------------------------------------------------------------------|
| Common/Usual Name: | Training Aid for Pelvic Floor Muscle or<br>Kegel Exercise and Pessary for Vaginal<br>Prolapse |
| Proprietary name: | KOLPEXIN* Sphere |

## DEVICE CLASSIFICATION న.

The KOLPEXIN* Sphere has been classified by the FDA under the headings of Perineometer HIR and Vaginal Pessary HHW, both Class II devices.

# STATEMENT OF SUBSTANTIAL EQUIVALENCE 6.

KOLPEXIN* Sphere with indications for conservative management of vaginal prolapse and pelvic floor muscular weakness in females is substantially equivalent in function to weighted vaginal training aids for the pelvic floor muscle or Kegel exercise and Gellhorn pessary both marketed by Milex Products, Inc. *Trademark

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K032644
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# 510(k)-KOLPEXIN* Sphere - New Device

## INDICATIONS FOR USE 7.

The KOLPEXIN* Sphere is indicated for the conservative management of vaginal prolapse and pelvic floor muscular weakness.

#### PHYSICAL DESCRIPTION 8.

The KOLPEXIN* Sphere is symmetrically circular shaped with an attached nylon string for device removal. The device is made from medical grade polycarbonate, LEXAN 144R-111, GE Plastics, and is available in six sizes; 44mm, 42mm, 39mm, 36mm, 32mm and 28mm.

# BIOCOMPATIBILITY TESTING 9.

Materials manufacturer safety tests demonstrate that the KOLPEXIN* Sphere is non-sensitizing, non-irritating and suitable for its intended use.

# 10. CLINICAL STUDY

A multicenter study to confirm the safety, efficacy, and functionality of the KOLPEXIN* Sphere in women with vaginal prolapse was performed. The study was entitled "A Multicenter Evaluation of the COLPEXIN* Vaginal Sphere in Females with Vaginal Prolapse."

The study concluded the KOLPEXIN* Sphere is a safe and effective device for the conservative management of vaginal prolapse and pelvic floor muscular weakness.

*Trademark

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2004

Adamed Ltd. c/o Norman I. Bruckner, Ph.D. Study Manager, Consultant Bruckner & Associates, LLC. 3432 Brookshire Drive PLANO TX 75075

Re: K032644

Trade/Device Name: KOLPEXIN™ Sphere Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: II Product Code: 85 HHW Dated: February 25, 2004 Received: March 1, 2004

Dear Dr. Bruckner:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave lovice for over your been and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass statod in the excircular)76, the enactment date of the Medical Device Amendments, or to oonimered processified in accordance with the provisions of the Federal Food, Drug, de necs that have boon that do not require approval of a premarket approval application (PMA). and Cosmetion (i re-) the (i re-) that 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 general obtires, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it your device is easonited (old wortrols. 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 l'ederal agencies. You must or any 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 (QS) 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 Section 510(k) This lefter will allow you to ocgin marketing your device of your device to a legally premarket notification. The FDA miding of saction 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 on If you desire specific advice for your dones on the following numbers, based on the regulation number at the top of the 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 Additionally, for questions on the promotion in and please note the regulation entitled, "Misbranding
Office of Compliance at [phone]. Also, possesses Other of Compliance at (501) 57 - 1057. Part 807.97) you may obtain. Other geteral by relected to prematically (DTSFA: in and r the Act may be obtained from the Division of Small information on your responsionalities and consumer Assistance at its toll-free mumber [phone] or
emation of International and Consumer Assistance at its toll-ofference Manufacturers, International and Collisanter - 25-

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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# Indications for Use

510(k) Number (if known): k032644

Device Name: KOLPEXIN™ Sphere

Indications For Use:

The KOLPEXIN™ Sphere is a vaginal pessary that is indicated for the conservative management of vaginal prolapse and pelvic floor muscular weakness.

Prescription Use (Part 21 CFR 801 Subpart D)

ANBYOR

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)

David R. Lygum

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

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