MEGA BIG BOY CONDOM

K140379 · Okamoto USA, Inc. · HIS · Jul 1, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K140379
• Device Name: MEGA BIG BOY CONDOM
• Applicant: Okamoto USA, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Jul 1, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

This latex condom has the same intended use as the predicate condom. This Mega Big Boy condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy, HIV/AIDS and the transmission of sexually transmitted infections).

Device Story

Mega Big Boy Condom is a natural rubber latex sheath designed to cover the penis; features smooth surface, flared closed end with reservoir tip, and silicone lubrication. Device acts as a physical barrier for contraception and prophylaxis against pregnancy and sexually transmitted infections. Used by individuals in an over-the-counter context. Provides mechanical protection; efficacy relies on material integrity and proper usage. Benefits include reduction of risk for pregnancy and disease transmission.

Clinical Evidence

Bench testing only. Conformance to ASTM D3492:2008 demonstrated via air burst pressure (> 1 kPa) and air burst volume (> 19 dm3) testing. Biocompatibility testing per ISO 10993 confirmed device is non-toxic, non-sensitizing, and non-irritating (cytotoxicity, irritation, sensitization, acute systemic toxicity). Stability studies established a 5-year shelf life.

Technological Characteristics

Natural rubber latex sheath; silicone lubricated (350 cps viscosity); cornstarch dressing. Dimensions: 200 mm length, 57 mm flat width, 0.065 mm thickness. Conforms to ASTM D3492:2008. Biocompatibility per ISO 10993. Mechanical barrier principle.

Indications for Use

Indicated for contraceptive and prophylactic use to help prevent pregnancy, HIV/AIDS, and sexually transmitted infections in the general adult population.

Regulatory Classification

Identification

A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.

Special Controls

*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.

Predicate Devices

• TROJAN EXTRA LARGE LATEX CODOM (K001212)

Submission Summary (Full Text)

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#### II. ' 510(k) SUMMARY

OKAMOTO U.S.A., INC. Submitted by: 3130 West Monroe Street Sandusky. OH 44870 Phone: [phone]

Mr. Hirofumi Chiba, Okamoto USA., Inc. Contact Person:

Date Prepared: June 25, 2014

Proprietary Name: Mega Big Boy Condom

Male Latex Condom Common Name:

Classification Name: Condom (21 CFR §884.5300)

# Predicate Device:

TROJAN EXTRA LARGE LATEX CODOM Brand Name: Company Name: Church & Dwight Co., Ltd. 510(k) Document Control Number: K001212

### Description of the Device:

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is smooth surface, flared at the closed end with reservoir tip, silicone lubricated condom with nominal length 200 mm, nominal flat width 57 mm, and nominal thickness of 0.065 mm. The air burst pressure is > 1 kPa and air burst volume is > 19 dm3. It is lubricated with silicone (viscosity 350 cps) and cornstarch is used as a dressing material. This condom conforms to current established national standard ASTM D3492: 2008.

# Intended Use of the Device:

This latex condom has the same intended use as the predicate condom. This Mega Big Boy condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy, HIV/AIDS and the transmission of sexually transmitted infections).

## Technological Characteristics:

The subject condom has nearly identical technological characteristics to the predicate condom. It is identical in terms of manufacturing process. As indicated in the table below, the only differences from the user's perspective are the mean length and thickness. These differences do not affect the safety or effectiveness or affect performance of the subject condom as compared to the predicates. Testing on condoms differing only with respect to dimensions is conducted to demonstrate conformance with ISO 10993, Biological Evaluation of Medical

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Devices for a device in contact for 24 hours or less for cytotoxicity, irritation and sensitization, acute systemic toxicity, and sample preparation and reference material. Testing also shows these condoms are non-toxic, non-sensitizing, and non-irritating. Stability studies were conducted to establish shelf life of the device at 5 years. The differences in dimension do not affect cytotoxicity, irritation, sensitization, acute systemic toxicity, or shelf life.

The similarities and differences of the features and technological characteristics of the condom as compared to the predicate condom are shown below.

| Item | Submission Device | Similar Device in US market |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Brand Name | MEGA BIG BOY | TROJAN® MAGNUM XL |
| 510(k) Number | K140379 | K001212 |
| Manufacturer | OKAMOTO RUBBER<br>PRODUCTS CO., LTD. | CHURCH & DWIGHT CO., INC. |
| Common Name | Male Latex Condom | Male Latex Condom |
| FDA Classification<br>Name | Condom (21 CFR §884.5300) | Condom (21 CFR §884.5300) |
| Indications for Use | To be used for contraceptive<br>and prophylactic purposes (to<br>help prevent pregnancy,<br>HIV/AIDS and the transmission<br>of sexually transmitted<br>infections). | To be used for contraceptive and prophylactic<br>purposes (to help reduce the risk of pregnancy<br>and the transmission of sexually transmitted<br>diseases, STDs) by men who feel that current<br>regular and larger sized condoms are too<br>small. |
| Principal Raw<br>Material of Condom<br>Sheath | Natural Rubber Latex | Natural Rubber Latex |
| Color | No color | No color |
| Raw Material of<br>Lubricant | Silicone | Silicone |
| Shape | Tapered wall &<br>Reservoir-ended | Tapered wall &<br>Reservoir-ended |
| Surface Texture | Smooth Surface | Smooth Surface |
| Mean Length (mm) | 200 | 194 |
| Mean Width (mm) at<br>30mm from open end | 57 | 57 |
| Mean Thickness<br>(mm) at 80mm from<br>open end | 0.063 | 0.081 |
| Shelf Life | 5 Years | 5 Years |

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All product testing demonstrates that the device is in conformance with all relevant performance standards, and that the device is expected to be safe for its intended use. The subject device characteristics and intended use are identical or very similar to the referenced predicate device. Accordingly, the subject device is substantially equivalent to the predicate device.

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Public Health Service

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

July 1, 2014

Okamoto USA, Inc. % Jeffrey N. Gibbs Director Hyman, Phelps & McNamara, P.C. 700 13th Street, N.W., Suite 1200 Washington, DC 20005

Re: K140379

> Trade/Device Name: Mega Big Boy Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: June 4, 2014 Received: June 4, 2014

Dear Jeffrey N. Gibbs,

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave review 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 for use stated in the one of the enactment date of the Medical Device Amendments, or to commerce provide to may 2011/11/11 accordance with the provisions of the Federal Food, Drug, de recs that have been require approval of a premarket approval application (PMA). and Cosmetic Fer (rec) that the device, subject to the general controls provisions of the Act. The Tou may, therefore, market the Act include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and actives, good manatablaring practions mot 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 your device is enaomics na controls. Existing major regulations affecting your device can be It may be stogeet to additions, Title 21, Parts 800 to 898. In addition, FDA may found in the over of concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease or advised that I Dri 3 issumes or our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I ederal statutes and regulations, including, but not limited to: registration and listing Compry with an the Act 3 requirements, to 1); medical device reporting (reporting of medical

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Page 2 - Jeffrey N. Gibbs

device-related 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR 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/Resourcesfor You/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

### Indications for Use

510(k) Number (if known) K140379

Device Nama

Mega Big Boy Condom

Indications for Use (Describe)

Mega Big Boy condom is used for contraceptive and prophylactic purpose (to help prevent pregnancy, HIV/ADS and the transmission of sexually transmitted infections).

Type of Use (Select one or both, es applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Herbert P. Lerner S 2014.07.01 15:05:45 -04'00'

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