MARINA MEDICAL SILICONE PESSARY

K031463 · Marina Medical Instruments, Inc. · HHW · Nov 18, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K031463
• Device Name: MARINA MEDICAL SILICONE PESSARY
• Applicant: Marina Medical Instruments, Inc.
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: Nov 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is made out of silicone, and it 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. It is available with different sizes of the following models: CUBE (with and without drain), OVAL (with and without support), HODGE (with and without support), SHAATZ , GELLHORN (with and without drains), RING (with and without support), DONUT , GEHRUNG, DISH (with and without support), & MAR-LAND (with and without support). CUBE: indicated for use for the support of a third-degree prolapse. OVAL: indicated for use for the support of a first or mild second-degree prolapse. HODGE: indicated for use for the support of a uterine retroversion. SHAATZ; indicated for use for the support of a first or mild second-degree prolapse. GELLHORN: indicated for use for the support of a third-degree prolapse or procidentia. RING: indicated for use for the support of a first or mild second-degree prolapse. DONUT: indicated for use for the support of a third-degree prolapse. GEHRUNG: indicated for use for the support of cystocele or rectocele. DISH: indicated for use for the control of stress urinary incontinence or a first or mild seconddegree prolapse. It restores continence by applying gentle pressure to the urethra. MAR-LAND: indicated for use for the control of stress urinary incontinence or a first or mild second-degree prolapse. It restores continence by applying gentle pressure to the urethra.

Device Story

Silicone vaginal pessary; removable structure inserted into vagina to provide mechanical support to pelvic organs. Treats uterine prolapse, retroposition, gynecologic hernia, cystocele, rectocele, and stress urinary incontinence. Available in multiple models (Cube, Oval, Hodge, Shaatz, Gellhorn, Ring, Donut, Gehrung, Dish, Mar-Land) with varying support features. Physician-placed; provides structural support or applies gentle urethral pressure to restore continence. Benefits patient by alleviating symptoms of pelvic organ descent and incontinence without surgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate device.

Technological Characteristics

Material: Silicone. Form factor: Removable vaginal structure in various shapes (Cube, Oval, Hodge, etc.). Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for female patients with pelvic organ prolapse (uterine prolapse, uterine retroversion, cystocele, rectocele, gynecologic hernia) or stress urinary incontinence. Specific models indicated for varying degrees of prolapse (first, second, or third-degree) or incontinence.

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

• Bioteque Vaginal pessary (K013289)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary As Required by 21 section 807.92 ( c )

1-Submitter Name: Mansour Consulting LLC

- 1308 Morningside Park Dr 2-Address: Alpharetta, GA 30022 USA 3-Phone: [phone] (678) 623- 3765 4-Fax: 5-Contact Person: Jay Mansour 6-Date summary prepared: May 5th, 2003
- 7 Device Trade or Proprietary Name: MARINA MEDICAL SILICONE PESSARY
- 8-Device Common or usual name: PESSARY

9-Device Classification Name: VAGINAL PESSARY

10-Substantial Equivalency is claimed against the following device:

- Bioteque Vaginal pessary from BIOTEQUE AMERICA, INC., 510k # K013289 .
#### 11-Description of the Device:

This device is made out of silicone, and it 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. It is available with different sizes of the following models: CUBE (with and without drain), OVAL (with and without support). HODGE (with and without support), SHAATZ , GELLHORN (with and without drains), RING (with and without support), DONUT , GEHRUNG, DISH (with and without support), & MAR-LAND (with and without support).

All models with their dimensions are detailed within the labeling section of this submission.

#### 12-Intended use of the device:

This device is made out of silicone, and it 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.

CUBE: indicated for use for the support of a third-degree prolabse.

OVAL: indicated for use for the support of a first or mild second-degree prolabse.

HODGE: indicated for use for the support of a uterine retroversion.

SHAATZ: indicated for use for the support of a first or mild second-degree prolapse.

GELLHORN: indicated for use for the support of a third-degree profapse or procidentia.

RING: indicated for use for the support of a first or mild second-degree prolapse.

DONUT: indicated for use for the support of a third-degree prolapse.

GEHRUNG: indicated for use for the support of cystocele or rectocele.

DISH: indicated for use for the control of stress urinary incontinence or a first or mild second-degree prolapse. It restores continence by applying gentle pressure to the urethra. MAR-LAND: indicated for use for the control of stress urinary incontinence or a first or mild second-degree prolapse. It restores continence by applying gentle pressure to the urethra.

#### 13-Safety and Effectiveness of the device;

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol, with three abstract human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 8 2003

Marina Medical Instruments, Inc. % Mr. Jay Mansour Managing Member Mansour Consulting, LLC 1308 Morningside Park Dr. ALPHARETTA GA 30022

Re: K031463

Trade/Device Name: Marina Medical Pessaries Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal pessary Regulatory Class: II Product Code: 85 HHW Dated: September 29, 2003 Received: September 6, 2003

Dear Mr. Mansour:

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 indivations 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, Dry, 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, itstion cof 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 such additional controls. Existing major regulations affecting your devive 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1,000-2050.

{2}------------------------------------------------

Page 2

This letter will allow you to begin marketing your device as described in your Section 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 to regary 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 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Microsiding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtain. Other golleral Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdch/dsma/dsmamovin's.html.

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

Sincerely yours.

{3}------------------------------------------------

### 510(k) Number (if known): K 03146 3

#### Device Name: MARINA MEDICAL PESSARIES

Indications for Use:

This device is made out of silicone, and it 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. It is available with different sizes of the following models: CUBE (with and without drain), OVAL. (with and without support), HODGE (with and without support), SHAATZ , GELLHORN (with and without drains), RING (with and without support), DONUT , GEHRUNG, DISH (with and without support), & MAR-LAND (with and without support).

CUBE: indicated for use for the support of a third-degree prolapse. OVAL: indicated for use for the support of a first or mild second-degree prolapse. HODGE: indicated for use for the support of a uterine retroversion. SHAATZ; indicated for use for the support of a first or mild second-degree prolapse. GELLHORN: indicated for use for the support of a third-degree prolapse or procidentia. RING: indicated for use for the support of a first or mild second-degree prolapse. DONUT: indicated for use for the support of a third-degree prolapse. GEHRUNG: indicated for use for the support of cystocele or rectocele. DISH: indicated for use for the control of stress urinary incontinence or a first or mild seconddegree prolapse. It restores continence by applying gentle pressure to the urethra. MAR-LAND: indicated for use for the control of stress urinary incontinence or a first or mild second-degree prolapse. It restores continence by applying gentle pressure to the urethra.

Prescription Use

✓

Nancy Burgdon

---

(Division Sign-Off)

Division of Reproductive, Abd and Radiological Devices 510(k) Number

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

Concurence of CDRH, Office of Device Evaulation (ODE)

(Optional Formal 3-10-98)