OKAMOTO ULTRA THIN

K090259 · Okamoto USA, Inc. · HIS · Mar 31, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K090259
• Device Name: OKAMOTO ULTRA THIN
• Applicant: Okamoto USA, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Mar 31, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).

Device Story

Natural rubber latex sheath; straight-walled, teat-ended, silicone-lubricated; designed to cover penis. Used for contraception and STI prevention. Subject device features reduced nominal thickness (0.04mm) compared to previous models (0.05mm).

Clinical Evidence

Bench testing only; device conforms to ASTM Standard D3492-03 specifications for male condoms.

Technological Characteristics

Natural rubber latex; straight-walled, teat-ended, silicone-lubricated; min length 160mm, max width 54mm, min thickness 30μm. Conforms to ASTM D3492-03.

Indications for Use

Indicated for use by individuals for contraception and the prevention of sexually transmitted infections.

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

• BEYOND SEVEN® (K872812/A)
• CROWN® (K872812/A)
• KIMOTO MICRO THIN® (K946374)

Submission Summary (Full Text)

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#### 2100 SUMMARY

MAR 3 1 2009 OKAMOTO U.S.A., INC. Submitted by: 18King Street Stratford, CT 06615 Phone: [phone] Mr. Jeffery N. Gibbs, Esq., Hyman Phelps & McNamara Contact Person: Ms. Jennifer Calderon, Okamoto USA., Inc. December 1, 2008 Date Prepared: OKAMOTO ULTRA THIN Proprietary Name: Male Latex Condom Common Nams Condom (21 CFR §884.5300) Classification Name: Predicate Device: BEYOND SEVEN®, CROWN® 1) Brand Name: OKAMOTO INDUSTRIES, INC. Company Name: 510(k) Document Control Number: K872812/A *Beyond Seven® and Crown® are under the same 510(k) Number. 2) Brand Name: KIMOTO MICRO THIN® SAGAMI RUBBER INDUSTRIES CO., LTD. Company Name: 510(k) Document Control Number: K946374

#### 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 device is smooth surfaced, straight-walled, teat-ended, silicone lubricated condom with minimum length 160mm, maximum width 54mm, and minimum thickness of 30μm as required by ASTM Standard D3492.

#### Intended Use of the Device:

The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).

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#### Reason for 510(k) submission:

The nominal thickness of the currently marketed product is 0.05+/-0.01mm. Recently the market is demanding thinner condoms, and therefore, we decided to submit a new 510(k) for thinner condoms with nominal thickness of 0.04+/-0.01 mm.

### Technological Charactoristics:

The subject condom has the same technological characteristics as the prodicate condoms. The design of this condom is in conformance with ASTM Standard D3492-03 Specification for Rubber Contraceptives (Male Condoms) and the condoms are made of natural rubber latex. The comparison with the predicate condoms is provided in Exhibit #I .

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Image /page/2/Picture/0 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 image of an eagle with three stripes representing the bird's wing and body. The eagle is facing to the right.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 3 1 2009

Okamoto USA, Inc. c/o Jeffrey N. Gibbs, Esq. Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W. Suite 1200 WASHINGTON DC 20005

Re: K090259

Trade/Device Name: OKAMOTO ULTRA THIN Male Natural Latex Condom Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: January 30, 2009 Received: February 2, 2009

Dear Mr. Gibbs:

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.

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 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.

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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 (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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Acting 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 STATEMENT

510(k) Number.

259

Device Name: OKAMOTO ULTRA THIN Male Natural-Latex Condom

#### Intended Use of the Devices

The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 5801.109)

Over-The-Counter Use

Hess

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K0902-