BILLY BOY MALE LATEX CONDOM

K103119 · Sheila Pickering PHD · HIS · Feb 24, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K103119
• Device Name: BILLY BOY MALE LATEX CONDOM
• Applicant: Sheila Pickering PHD
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Feb 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Billy Boy condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The condoms are available in Cylindrical shape, in transparent color and with Nivesse aroma. The models include the BillyBoy, BillyBoy Scented, BillyBoy Special Comfort and BillyBoy Extra Lubricated.

Device Story

Billy Boy male condoms are natural rubber latex sheaths designed to cover the penis; they feature a reservoir tip and are available in cylindrical or contoured shapes. The device is intended for over-the-counter use by individuals for contraception and STI prevention. The condoms are lubricated with silicone oil and may include Nivesse aroma. The device functions as a physical barrier; it is used during sexual activity to prevent the exchange of bodily fluids. The healthcare provider does not operate the device; it is for patient self-use. The device benefits the patient by providing a barrier method for pregnancy and STI protection.

Clinical Evidence

Bench testing only. The device was tested according to ASTM D3492 standards for male condoms, including air burst pressure and volume testing. All samples passed the required specifications.

Technological Characteristics

Material: Natural rubber latex. Design: Cylindrical or contoured sheath with reservoir tip. Dimensions: Length 175-185mm, width 52-55mm, thickness 0.04-0.08mm. Lubricant: Silicone oil. Standards: Compliant with ASTM D3492 and ISO 10993 for biocompatibility. Packaging: Foil. No software or electronic components.

Indications for Use

Indicated for use as a contraceptive and prophylactic to help prevent pregnancy and the transmission of sexually transmitted infections 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

• Twin Lotus Male Latex Condoms (K081413)
• Kimono Maxx (K943064, K904375)
• Trojan Her Pleasure (K073016, K071313, K071272, K023405)

Submission Summary (Full Text)

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K103119
pg. 1 of 3

## II. 510(k) SUMMARY

| Submitted by: | MAPA GmbH<br>Industriestrasse<br>Zeven Germany<br>49 4281 730 213 | FEB 2 4 2011 |
|----------------------|-------------------------------------------------------------------|--------------|
| Contact Person: | German Frank, Director of Quality Management | |
| Date Prepared: | February 23, 2011 | |
| Proprietary Name: | Billy Boy Male Latex Condoms | |
| Common Name: | Latex Condom | |
| Classification Name: | Condom (21 CFR §884.5300) Code HIS | |

### Predicate Devices:

| Manufacturer | Device Name | Applicable<br>510(k) # | SE |
|--------------------------------------------------|----------------------------------|---------------------------------------------|-----|
| Dalian Latex<br>Company Ltd. | Twin Lotus Male<br>Latex Condoms | K081413 | Yes |
| Mayer<br>Laboratories | Kimono Maxx | K943064,<br>K904375 | Yes |
| Church & Dwight<br>co., Inc. and<br>Armkel, llc. | Trojan Her<br>Pleasure | K073016,<br>K071313,<br>K071272,<br>K023405 | Yes |

Description of the Device: The BillyBoy condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is shaped with a reservoir end and is Cylindrical. These condoms have a length of 175 -185mm ±10mm, a width of 52.0 -55.0 mm ±2.0mm. The thickness is 0.04-0.08 mm. The air burst test pressure is ≥1 k Pa and air burst test volume is ≥18 dm². The primary packaging material is a foil package. The on surface lubricant is silicon oil.

Intended Use of the Device: The Billy Boy condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The condoms are available in cylindrical shape in transparent color and with Nivesse aroma. The models include the BillyBoy, BillyBoy Scented, BillyBoy Special Comfort and BillyBoy Extra Lubricated.

Technological Characteristics: The tables below show that the submission device has the same core technological characteristics as the predicate condoms identified above. The design of the submission device is in conformance with ASTM Latex Condom Standard D3492 and is made of natural rubber latex. The similarities and differences of

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K103119
Pg. 2 of 3

the features and technological characteristics of the condom are compared to the predicate condoms below.

| | Table 2 - BillyBoy Substantial Equivalence Comparison to the Twin Lotus Male Latex |
|--------|-------------------------------------------------------------------------------------|
| Condom | |

| | Predicate Device | Submission Device |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Twin Lotus Male Latex Condoms<br>K081413 | Billy Boy<br>Male Latex Condoms |
| FDA<br>classification | Class II §884.5300 | Class II §884.5300 |
| Classification<br>Code | HIS | HIS |
| Intended Use | The device is used for<br>contraceptive and for prophylactic<br>purposes (to help prevent<br>pregnancy and the transmission of<br>sexually transmitted diseases). | The Billy Boy condom is used for<br>contraceptive and for prophylactic<br>purposes (to help prevent pregnancy<br>and the transmission of sexually<br>transmitted infections) |
| Material | Natural Latex Rubber | Natural Latex Rubber |
| Biocompatibility | Compliant with ISO 10993 | Compliant with ISO 10993 |
| Performance | Compliant with ASTM D3492 | Compliant with ASTM D3492 |
| Types | Plain, Dotty, Ribbed, Combination | Cylindrical |
| Shape | Straight walled with reservoir tip | Straight walled with reservoir tip |
| Length | 160mm | 185mm ±10mm |
| Width | 52 ± 2mm | 52.0mm ±2.0mm |
| Thickness | 0.08 ± 0.01 mm | 0.04-0.08mm |
| Color | Red, yellow, green, blue, violet,<br>black, orange | Natural (transparent) |
| Flavor | Banana, Strawberry, Orange,<br>Chocolate, Mint, Vanilla, Juicy<br>Peach, Pineapple, Apple, Cherry | Nivesse (scent) |

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| | Billy Boy Special<br>Comfort | Kimono<br>Maxx | Trojan Her Pleasure |
|--------------------------|-----------------------------------|-----------------------------------|------------------------------------------------|
| FDA<br>Classification | Class II § 884.5300 | Class II § 884.5300 | Class II § 884.5300 |
| Classification<br>code | HIS | HIS | HIS |
| Material | Natural latex rubber | Natural latex rubber | Natural Rubber Latex |
| Shape | contoured shape with<br>reservoir | contoured shape<br>with reservoir | Comfort shape Tapered<br>Base w/ Reservoir Tip |
| Length | $\ge$ 175 mm | 195 mm | 205 |
| Flat Width (at<br>30 mm) | (55 ± 2) mm | 52 mm | 55mm |
| Max. width | (61.5 ± 2) mm | 59 mm | 65mm |
| Narrowest flat<br>width | (55 ± 2) mm | 52 mm | 55mm |
| Thickness | 0.04-0.08 mm | 0.07 mm | 0.07mm |

Table 3 - Substantial Equivalence of the width of the Billy Boy Special Comfort flared shank version to the Kimono Maxx and Trojan Her Pleasure.

#### Comparison of Dimensions

These additional natural latex rubber condom predicates demonstrate that the maximum width of the Billy Boy Special Comfort flared shank version falls in between that of two predicate devices (Kimono Maxx and Trojan Her Pleasure) that have been cleared and that are commercially available in the US. The width at 30mm and at the narrowest flat width for the BillyBoy Special Comfort is the same as the widths for the Trojan Her Pleasure. As the maximum width is smaller and all other widths and thickness dimensions are the same or similar to the Trojan Her Pleasure, the Billy Boy Special Comfort flared version should not affect slippage or breakage. Therefore, the Billy Boy Special Comfort does not raise new issues of safety or effectiveness as their dimensions are substantially equivalent to the Trojan Her Pleasure.

#### Discussion of Similarities and Differences

As can be seen from the comparison tables above, the devices have the same basic technology, the same intended use and are compliant with the same recognized and required standards. Also specific length and width dimensions of the BillyBoy are substantially equivalent to those of other legally marketed devices.

#### Performance Data

The functional testing of male condoms is conducted according to ASTM D3492. Like the predicate devices, BillyBoy condoms were tested to the standard and passed all required specifications.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6( Silver Spring, MD 20993-0002

MAPA GmbH c/o Mr. Mark A. Job Responsible Third Party Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313

FEB 2 4 2011

Re: K103119

Trade Name: Billy Boy Male Latex Condom Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product code: HIS Dated: February 4, 2011 Received: February 7, 2011

Dear Mr. Job:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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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.

Sincerely yours,

Hubert Lemmer MD

erbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# VII. INDICATIONS FOR USE STATEMENT

K103119 510(k) (if known) Number: Device The Billy Boy Male Natural Rubber Latex Condom Name:

Indications The Billy Boy condom is used for contraceptive and for For Use: prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The condoms are available in Cylindrical shape, in transparent color and with Nivesse aroma. The models include the BillyBoy, BillyBoy Scented, BillyBoy Special Comfort and BillyBoy Extra Lubricated.

Prescription Use (Per 21 CFR §801.109)

OR

Over-The-Counter Use_ ×

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---------------------------------------------|--------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K103119 |