PESSARY

K132313 · Eis Corporation · HHW · Dec 5, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K132313
• Device Name: PESSARY
• Applicant: Eis Corporation
• Product Code: HHW · Obstetrics/Gynecology
• Decision Date: Dec 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.3575
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women

Device Story

Silicone vaginal pessary; removable structure placed in vagina to provide mechanical support for pelvic organs. Used to treat uterine prolapse, cystocele, rectocele, and stress urinary incontinence. Available in multiple shapes (cube, dish, donut, marland, oval, gellhorn, gellhorn short, shaatz, ring) and sizes. Intended for use by clinicians to manage pelvic floor conditions; provides structural support to alleviate symptoms of prolapse and incontinence.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, intracutaneous (intradermal) reactivity, skin sensitization, and acute systemic toxicity. Shelf life testing also conducted.

Technological Characteristics

Material: Silicone. Form factor: Various shapes (cube, dish, donut, marland, oval, gellhorn, gellhorn short, shaatz, ring). Principle: Mechanical support via vaginal insertion. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for women requiring treatment for uterine prolapse (including cystocele, rectocele, and procidentia) and stress urinary 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

• PANPAC VAGINAL PESSARY (K092981)

Submission Summary (Full Text)

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Image /page/0/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 an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 5, 2014

EIS Corporation % Ho Dong, Yang CEO Onbix Corporation #821 Samil Plaza 837-26 Yeuksam-dong, Gangnam-gu (135-768), Seoul Korea

Re: K132313 Trade/Device Name: Pessary Regulation Number: 21 CFR 884.3575 Regulation Name: Vaginal Pessary Regulatory Class: Class II Product Code: HHW Dated: October 31, 2014 Received: November 6, 2014

Dear Ho Dong, Yang

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

510(k) Number (if known):

Device Name: Pessary

Indications for Use:

EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________ (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off Office of Device Evaluation

page 1 of 1

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### 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

| Submitter Information: | EIS Corporation<br>Suite #603, #610 Woori Venture Town II, 82-29<br>Mullae-Dong 3ga, YoungDungPo-Ku, Seoul, 150-700, Korea<br>Tel: [phone]<br>Fax: [phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho Dong, Yang<br>Onbix Corporation<br>#821 Samil Plaza, 837-26 Yeuksam-dong<br>Gangnam-gu, Seoul, Korea<br>Tel: *82-2-566-3360 / Fax: *82-2-6280-3360<br>Email: [e-mail] |

#### Date Summary Prepared: Nov 24, 2014

#### Device Name:

| Trade Name(s): | Pessary |
|----------------------|-----------------------|
| Classification Name: | Vaginal pessary |
| Panel: | Obstetrics/Gynecology |
| Product code: | HHW |
| Regulation: | 21 CFR 884.3575 |

#### Predicate Device Information:

K092981 / PANPAC VAGINAL PESSARY (Panpac Medical Corporation)

#### Device Description:

The subject device is a silicone vaqinal pessary. The submission includes the following designs: cube, dish, donut, marland, oval, gellhorn, gellhorn short, shaatz, and ring.

#### Intended Use:

EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele, as well as stress urinary incontinence in women.

#### Comparison to Predicate Device(s):

This subject device is equivalent to the predicate device in its intended use and technological characteristics. The following table compares the technological characteristics of the subject and predicate device.

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| No | Item | Pessary<br>(new device, K132313) | PANPAC VAGINAL<br>PESSARY (K092981) |
|----|---------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 1 | Manufacturer | EIS Corporation | Panpac Medical Corporation |
| 2 | Material | silicone | Silicone |
| 3 | Shape | Various and similar | Various and similar |
| 4 | Size | Various and similar | Various and similar |
| 5 | Class | Class 2 | Class 2 |
| 6 | Indications for use | Effective support for<br>cystocele, rectocele, uterine<br>prolapsed or procidentia,<br>urinary incontinence | Effective support for<br>cystocele, rectocele, uterine<br>prolapsed or procidentia,<br>urinary incontinence |

#### Non-Clinical Study performance

The performance testing provided included shelf life and biocompatibility testing per ISO 10993-1. The completed biocompatibility tests included the following:

> Cytotoxicity Intracutaneous (intradermal) reactivity Skin sensitization Acute systemic toxicity

#### Conclusion

Based on the information provided in this summary we conclude that pessary is substantially equivalent to the predicate device K092981 (PANPAC VAGINAL PESSARY - Panpac Medical Corporation).