KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED

K113686 · Mayer Laboratories, Inc. · HIS · Mar 6, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K113686
• Device Name: KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED
• Applicant: Mayer Laboratories, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Mar 6, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases.)

Device Story

Natural rubber latex sheath; straight-walled with reservoir end; lubricated with water-based lubricant system. Designed for use by individuals for contraception and prevention of sexually transmitted diseases. Device functions as a physical barrier. No electronic or software components.

Clinical Evidence

Bench testing only. Physical testing, air inflation testing, and in-process/final release testing performed in accordance with ASTM D3492 and ISO 4074 standards.

Technological Characteristics

Natural rubber latex sheath; straight-walled; reservoir end. Nominal length 190mm +/- 10mm; nominal width 52mm +/- 2mm; nominal thickness 0.049mm +/- 0.01mm (MicroThin) or 0.065mm +/- 0.01mm (Reality Ultra). Water-based lubricant. Conforms to ASTM D3492 and ISO 4074.

Indications for Use

Indicated for contraception and prophylaxis against pregnancy and sexually transmitted diseases in individuals using male latex condoms.

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

• Kimono MicroThin (K946374)
• Orion/XT-12 (K872356/B)

Submission Summary (Full Text)

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# MAR - 6 2012

Abbreviated 510(k) Notification-Rev.2
Kimono MicroThin with Aqua Lube Reality Ultra Lubricated

13686

#### II. 510(k) SUMMARY

| Submitted by: | Mayer Laboratories, Inc.<br>1950 Addison Street, Suite 101<br>Berkeley, CA 94704-1182 USA<br>Telephone:[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David P. Mayer, President<br>Email: [e-mail] |
| Date Prepared: | December 12, 2011 |
| Proprietary Name: | Kimono MicroThin with Aqua Lube<br>Reality Ultra Lubricated |
| Common Name: | Latex Condom |
| Classification Name: | Condom (21 CFR §884.5300) |
| Predicate Device: | Kimono MicroThin<br>510(k) number: K946374<br>Orion/XT-12<br>510(k) number: K872356/B<br>Original 510(k) submission clearance attached as<br>Attachment 5. |
| Description of Device: | This condom is made of a natural rubber latex<br>sheath, which completely covers the penis with a<br>closely fitted membrane. This condom is<br>lubricated by a water based lubricant system.<br><br>Typical (Average) Product Characteristics are as<br>follows:<br>• Straight walled, reservoir end<br>• Nominal length (mm): 190mm+/-10mm<br>• Nominal width (mm): 52 mm +/- 2mm<br>• Nominal thickness (mm) .04 -0.01<br>Kimono MicroThin with Aqua Lube:<br>.049mm +/- 0.01<br>Reality Ultra Lubricated: .065mm +/- 0.01mm |

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Abbreviated 510(k) Notification-Rev. 2 Kimono MicroThin with Aqua Lube Reality Ultra Lubricated

### 510(k) SUMMARY (continued)

Intended Use: This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases.) Technological Characteristics: The basic design, composition (natural rubber latex) and manufacturer of these condoms are the same as the predicate male latex condoms, except that these condoms are lubricated with a water based lubricant system. The condom design conforms to the current edition of national and international standards: ASTM D3492 and ISO 4074. All physical testing, air inflation testing, and other in-process and final release testing revealed results in conformance with required standards and Company specifications. Accordingly, when compared to the predicate male latex condoms, the condoms intended to be introduced do not incorporate any significant changes in intended use, method of operations, materials, or design that could affect safety and effectiveness.

I:\QualityMgmlSystem\Device Master Records\Latex Condoms\Latex Condoms with Aqua Lube\510(k) submission Nov. 2011\Post Submission Communications\510(k) Abbreviated Notification-Rev.2.docx

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

Mr. David P. Mayer President and CEO Mayer Laboratories, Inc. 1950 Addison Street, Suite 101 BERKELEY CA 94704

MAR - 6 2012

Re: K113686

Trade/Device Name: Kimono MicroThin with Aqua Lube / Reality Ultra Lubricated/Male Natural Rubber Latex Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: February 23, 2012 Received: February 28, 2012

Dear Mr. Mayer:

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 for abound in 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). and Oosmeter For (. 10.) has 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 your device is elabellional 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 roublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso or ac nove a determination that your device complies with other requirements of the Act that I Dri has made a avon regulations administered by other Federal agencies. You must or any I vath all the Act's requirements, including, but not limited to: registration and listing Comply with an the Act 5 re (21 CFR Part 801); medical device reporting (reporting of medical

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerély vours,

Sincerely yours,

Benjamin K. Ticho

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 STATEMENT VII.

| 510(k) Number: | K113686 | |
|----------------|---------|--|
|----------------|---------|--|

Kimono MicroThin with Aqua Lube / Reality Ultra Device Name: Lubricated/Male Natural Rubber Latex Condom

Indications For Use: Kimono MicroThin with Aqua Lube / Reality Ultra Lubricated condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR §801.109)

Over-The-Counter Use

Domiln Whay

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K113686

OR

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