(125 days)
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.
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.
The provided document describes the acceptance criteria and a study demonstrating that the Billy Boy Male Latex Condoms meet those criteria, primarily through compliance with ASTM D3492.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Billy Boy Male Latex Condoms are defined by their compliance with ASTM D3492, which is the standard for male latex condoms. The reported device performance is that the condoms passed all required specifications of this standard.
| Acceptance Criteria (Defined by ASTM D3492) | Reported Device Performance (Billy Boy Male Latex Condoms) |
|---|---|
| Compliant with ASTM D3492 | Passed all required specifications of ASTM D3492 |
| Air burst test pressure ≥ 1 k Pa | ≥ 1 k Pa (stated as characteristic, implicitly passed) |
| Air burst test volume ≥ 18 dm² | ≥ 18 dm² (stated as characteristic, implicitly passed) |
Additionally, specific dimensional characteristics are detailed and compared to predicate devices for substantial equivalence:
| Characteristic | ASTM D3492/Predicate Criteria (examples) | Billy Boy Performance |
|---|---|---|
| Length | 160mm (Twin Lotus), 195mm (Kimono Maxx), 205mm (Trojan Her Pleasure) | 175 - 185mm ±10mm (BillyBoy), ≥ 175 mm (Special Comfort) |
| Width | 52 ± 2mm (Twin Lotus), 52mm (Kimono Maxx), 55mm (Trojan Her Pleasure) | 52.0 - 55.0 mm ±2.0mm (BillyBoy), (55 ± 2) mm (Special Comfort) |
| Thickness | 0.08 ± 0.01 mm (Twin Lotus), 0.07 mm (Kimono Maxx) | 0.04-0.08 mm |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "BillyBoy condoms were tested to the standard and passed all required specifications." However, it does not specify the sample size used for this functional testing.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the device is not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for condom performance is established by objective physical testing against a recognized standard (ASTM D3492).
4. Adjudication Method for the Test Set
This information is not applicable for physical device testing against a standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable as this is not an AI/imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a physical device and not an algorithm.
7. The Type of Ground Truth Used
The ground truth used is based on objective performance measurements against established engineering and material standards, specifically ASTM D3492 for male latex condoms. This standard covers physical properties such as dimensions, air burst pressure and volume, and biocompatibility.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI device that requires a training set. The manufacturing process of condoms involves quality control and testing, but these are not referred to as "training sets" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is not an AI device.
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K103119
pg. 1 of 3
II. 510(k) SUMMARY
| Submitted by: | MAPA GmbHIndustriestrasseZeven Germany49 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 | Applicable510(k) # | SE |
|---|---|---|---|
| Dalian LatexCompany Ltd. | Twin Lotus MaleLatex Condoms | K081413 | Yes |
| MayerLaboratories | Kimono Maxx | K943064,K904375 | Yes |
| Church & Dwightco., Inc. andArmkel, llc. | Trojan HerPleasure | K073016,K071313,K071272,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 CondomsK081413 | Billy BoyMale Latex Condoms | |
| FDAclassification | Class II §884.5300 | Class II §884.5300 |
| ClassificationCode | HIS | HIS |
| Intended Use | The device is used forcontraceptive and for prophylacticpurposes (to help preventpregnancy and the transmission ofsexually transmitted diseases). | The Billy Boy condom is used forcontraceptive and for prophylacticpurposes (to help prevent pregnancyand the transmission of sexuallytransmitted 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,black, orange | Natural (transparent) |
| Flavor | Banana, Strawberry, Orange,Chocolate, Mint, Vanilla, JuicyPeach, Pineapple, Apple, Cherry | Nivesse (scent) |
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| Billy Boy SpecialComfort | KimonoMaxx | Trojan Her Pleasure | |
|---|---|---|---|
| FDAClassification | Class II § 884.5300 | Class II § 884.5300 | Class II § 884.5300 |
| Classificationcode | HIS | HIS | HIS |
| Material | Natural latex rubber | Natural latex rubber | Natural Rubber Latex |
| Shape | contoured shape withreservoir | contoured shapewith reservoir | Comfort shape TaperedBase w/ Reservoir Tip |
| Length | $\ge$ 175 mm | 195 mm | 205 |
| Flat Width (at30 mm) | (55 ± 2) mm | 52 mm | 55mm |
| Max. width | (61.5 ± 2) mm | 59 mm | 65mm |
| Narrowest flatwidth | (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 (800) 638-2041 or (301) 796-7100 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 |
§ 884.5300 Condom.
(a)
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.(b)
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.