OKAMOTO STUDDED CONDOM

K141256 · Okamoto USA, Inc. · HIS · Jul 23, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K141256
• Device Name: OKAMOTO STUDDED CONDOM
• Applicant: Okamoto USA, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Jul 23, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

This Okamoto Studded condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Device Story

Okamoto Studded Condom is a natural rubber latex sheath designed to cover the penis. Features include a tapered shape, reservoir tip, and an exterior dotted texture created during the molding process using an engraved glass mold. The device is lubricated with silicone oil and uses cornstarch/MgO as a dusting agent. It is intended for over-the-counter use by individuals for contraception and the prevention of sexually transmitted infections. The device functions as a physical barrier. Safety and effectiveness are supported by conformance to ASTM D3492:2008 standards and biocompatibility testing (ISO 10993) for cytotoxicity, irritation, sensitization, and acute systemic toxicity.

Clinical Evidence

Bench testing only. Conformance to ASTM D3492:2008 for air burst pressure (≥ 1 kPa) and volume (≥ 17 dm3). Biocompatibility testing per ISO 10993 (cytotoxicity, irritation, sensitization, acute systemic toxicity) confirmed the device is non-toxic, non-sensitizing, and non-irritating. Stability studies support a 5-year shelf life.

Technological Characteristics

Natural rubber latex sheath; tapered shape with reservoir tip; dotted surface texture; silicone lubricant (200 cps); cornstarch and MgO dusting agent. Nominal length 180 mm; nominal flat width 54 mm; thickness 0.070 mm. Conforms to ASTM D3492:2008. No electronic components or software.

Indications for Use

Indicated for contraceptive and prophylactic use to prevent pregnancy and sexually transmitted infections in the general 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

• BillyBoy Dotted (Beaded) condom (K111093)

Reference Devices

• Crown condom (K893039)

Submission Summary (Full Text)

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

K141256 page 1 of 3

# JUL 2 3 2014

#### II. 510(k) SUMMARY

| Submitted by: | OKAMOTO U.S.A., INC.<br>3130 West Monroe Street<br>Sandusky, OH 44870<br>Phone: [phone] |
|----------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph W. Cormier, JD, PhD / Hyman, Phelps & McNamara<br>Mr. Hirofumi Chiba, Okamoto USA., Inc. |
| Date Prepared: | July 21, 2014 |
| Proprietary Name: | Okamoto Studded Condom |
| Common Name: | Male Latex Condom |
| Classification Name: | Condom (21 C.F.R. § 884.5300) |
| Predicate Device: | |
| Brand Name: | BillyBoy Dotted (Beaded) condom |
| 1) | |

Company Name: MAPA GmbH

510(k) Document Control Number: K111093

### 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 textured surface (dotted), tapered shape with reservoir tip, silicone lubricated condom with nominal length 180 mm, nominal flat width 54 mm measured at 30 mm from the open end, a maximum width of 58 mm at the closed end, and nominal thickness of 0.070 mm. The air burst pressure is ≥ 1 kPa and air burst volume is ≥ 17 dm3. It is lubricated with silicone (viscosity 200 cps) and cornstarch is used as a dressing This condom conforms to current established national standard ASTM D3492: 2008. material.

The term Studded refers to the irregular surface of the irregular surface is not applied externally but is achieved in the molding process. The glass mold has an engraved pattern of semispherical pits replicated as a pattern of small round tips on the surface of the

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

This results in an exterior surface that has a pattern of small raised areas best condom. described as a dotted pattern. The new condom is defined as a condom of increased thickness relative to some of other Okamoto condoms (e.g., Crown condom, K893039),

### Intended Use of the Device:

This Okamoto Studded condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy 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 additives and manufacturing process. The subject and predicate condoms have the same indications for use. As indicated in the table below, the only differences are the shape, nominal width and length, the quantity of lubrication, and the latex formulation. These differences do not affect the safety or effectiveness or affect performance of the subject condom as compared to the predicate. Testing on the subject condom demonstrates conformance with ISO 10993, Biological Evaluation of Medical Devices for a device in contact for 24 hours or less for cytotoxicity, irritation and sensitization, acute systemic toxicity testing, and sample preparation and reference material. Testing shows these condoms are non-toxic, non-sensitizing, and non-irritating. Stability studies conducted on the similar condoms established a shelf life of the device at 5 years. The differences in dimension, latex formulation, and quantity of lubrication do not affect cytotoxicity, irritation, sensitization, or shelf life. Furthermore, because the differences in characteristics are common for natural rubber latex male condoms, the differences do not raise new questions of safety or effectiveness.

The results of biocompatibility testing for cytotoxicity, irritation and sensitization, and acute systemic toxicity as well as airburst testing demonstrate that the subject device is substantially equivalent to the predicate device in term of safety and effectiveness.

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

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

.

| | | Table 1- Characteristics of Submission Device and Predicate Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| | Submission device:<br>Okamoto Studded Male Latex<br>Condom | Predicate device:<br>Billy Boy Male Latex Condom<br>K111093 |
| FDA Classification | Class II; 884.5300 | Identical |
| Classification code | HIS | Identical |
| Intended Use | For contraceptive and<br>prophylactic purposes (to help<br>prevent pregnancy and the<br>transmission of sexually<br>transmitted infections). | Identical |
| Material | Natural rubber latex | Identical |
| Performance | Complied with ASTM<br>D3492:2008 | Identical |
| Type | Dotted | Dotted (beaded) |
| Shape | Tapered shape with reservoir tip;<br>dotted | Straight walled with reservoir<br>tip; cylindrical; dotted/beaded |
| Length | 170-190 mm | > 175 mm |
| Width | 54 ± 2 mm measured 30 mm<br>from open end,<br>Maximum width of 58 ± 2 mm<br>at the closed end | 52 mm |
| Thickness | 0.070 ± 0.010 mm | 0.100 ± 0.010 mm |
| Lubricant | 0.550 g silicone oil | 0.49 g silicone oil |
| Color | None | Identical |
| Scent | None | Identical |
| Latex Formulation | Natural Rubber Latex | Comparable |
| Dusting Agent | Cornstarch and MgO | Identical |

.

.

and the comments of the comments of

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.

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

July 23, 2014

Okamoto USA, Inc. % Joseph W. Cormier Law Offices of Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street N.W., Suite 1200 Washington, DC 20005-5929

Re: K141256 Trade Name: Okamoto Studded Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: May 14, 2014 Received: May 14, 2014

Dear Joseph W. Cormier,

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 general bonders profisions 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 (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{4}------------------------------------------------

Page 2 - Joseph W. Cormier

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Image /page/4/Picture/8 description: The image shows the name "Benjamin R Fisher -S" in a bold, sans-serif font. The letters are black against a white background, making them easily readable. The text appears to be a signature or a nameplate.

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

{5}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K 141256

Device Name Okamoto Studded Condom

Indications for Use (Describe)

The Okamoto Studded Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Type of Use (Select one or both, as 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)

11

. : ... .

# Benjamin R. Fisher -S 2014.07.23 15:57:22 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the The builden fine for this oclicens of mornizatia sources, gather and maintain the data needed and complete line to review the collection. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."