The BillyBoy male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The BillyBoy condoms are Dotted/Beaded and New Condom models.

Device Description

This 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 flat with a cylindrical shape. These condoms have a length of ≥175mm, a width of 52mm. The thickness is 0.10 mm. The air burst test pressure is ≥1 k Pa and air burst test volume is ≥18 dm. The primary packaging material is a foil package. The on surface lubricant is silicon oil. The term Dotted refers to the irregular surface of the condom. 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 condom. This results in an exterior surface that has a pattern of small raised areas best described as a dotted pattern. The New Condom is defined as a condom of increased thickness relative to some of the other BillyBoy types.

AI/ML Overview

The provided document describes a 510(k) summary for BillyBoy Dotted (Beaded) Condoms and BillyBoy New Condoms. This summary focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving a device meets acceptance criteria through a clinical study with human or image data. Therefore, many of the requested categories regarding clinical studies, expert involvement, and ground truth are not applicable to this type of regulatory submission.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document states that the device's performance was evaluated against specific standards. The acceptance criteria are essentially defined by these standards, and the reported performance is "passed all."

Acceptance Criteria (Standard)	Reported Device Performance
ASTM D3492 (tensile force, elongation, tensile strength (before and after aging), bursting volume, bursting pressure, freedom from holes, microbiological cleanliness, length, wall thickness, visual characteristics)	Passed all
ISO 10993 (Biocompatibility)	Compliant with ISO 10993
FDA's guidance for male latex condoms	Test plans developed to meet specified requirements

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify the exact sample size used for the performance testing. It generally refers to "the devices" being evaluated.
Data Provenance: The testing was conducted by MAPA GmbH in Zeven, Germany. The data provenance is from internal testing reports and certificates. The studies were likely prospective, as they involved testing newly manufactured condoms to ensure compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical device (condom), and its performance is assessed against engineering and biological standards, not through expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Performance testing for condoms involves objective measurements and adherence to specifications, not adjudications by experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by the specified requirements and methodologies outlined in the ASTM D3492 standard for male latex condoms and the ISO 10993 standard for biocompatibility. These standards define the acceptable physical and biological properties.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. No training set exists for this device.

Summary

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510(k) Summary

JUN - 3 2011

KI11093

age 116

Submitted by:	MAPA GmbHIndustriestrasseZeven Germany49 4281 730 213
Contact Person:	German Frank, Director of Quality Management
Date Prepared:	March 24, 2011; revised June 1, 2011
Proprietary Name:	BillyBoy Dotted (Beaded) Condom;BillyBoy New Condom
Common Name:	Latex Condom
Classification Name:	Condom (21 CFR §884.5300)

Predicate Devices:

Device	Mfg	K #
Billy Boycondoms	MAPAGmbH	K103119
SLAM Condommanufactured by;	NipponRubberIndustry	K011253
Lifestyles ExtraStrength) UltraThick MaleLatex Condom	AnsellInc.	K871304

Description of the Device: This 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 flat with a cylindrical shape. These condoms have a length of ≥175mm, a width of 52mm. The thickness is 0.10 mm. The air burst test pressure is ≥1 k Pa and air burst test volume is ≥18 dm. The primary packaging material is a foil package. The on surface lubricant is silicon oil. The term Dotted refers to the irregular surface of the condom. 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 condom. This results in an exterior surface that has a pattern of small raised areas best described as a dotted pattern. The New Condom is defined as a condom of increased thickness relative to some of the other BillyBoy types.

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K111093
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Intended Use of the Device: The BillyBoy male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections). The BillyBoy condoms are Dotted/Beaded and New Condom models.

Technological Characteristics: The table below shows that the submission device has the similar 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 the features and technological characteristics of the condom is compared to the predicate condoms below.

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K111093

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	Predicate Device	Submission Device
	Billy Boy	Billy Boy
	Male Latex Condoms	Male Latex Condoms
	BillyBoy, BillyBoy Scented;	Dotted (Beaded);
	BillyBoy Special Comfort and	New Condom
	BillyBoy Extra Lubricated
	K103119
FDA classification	Class II §884.5300	Class II §884.5300
Classification Code	HIS	HIS
Intended Use	The device is used for contraceptive andfor prophylactic purposes (to helpprevent pregnancy and the transmissionof sexually transmitted infections). Thecondoms are available in cylindricalshape, in transparent color and withNivesse aroma. The models include theBillyBoy, BillyBoy Scented; BillyBoySpecial Comfort and BillyBoy ExtraLubricated	The BillyBoy male latexcondom is used forcontraceptive and forprophylactic purposes (to helpprevent pregnancy and thetransmission of sexuallytransmitted infections). TheBillyBoy condoms areDotted/Beaded and NewCondom models.
Material	Natural Latex Rubber	Natural Latex Rubber
Biocompatibility	Compliant with ISO 10993	Compliant with ISO 10993
Performance	Compliant with ASTM D3492	Compliant with ASTMD3492
Types	BillyBoy, BillyBoy Scented;BillyBoy Special Comfort andBillyBoy Extra Lubricated	Dotted (Beaded); NewCondom
Shape	Straight walled with reservoir tip;Flared or Cylindrical	Straight walled withreservoir tip; Cylindrical;Cylindrical Dotted / Beaded
Length	185mm ±10mm	≥175mm
Width	52.0mm ±2.0mm	52mm
Thickness	0.04-0.08 mm.	0.10mm.
Lubricant	0.24g silicon oil for all but ExtraLubricated which has 0.33g	0.49g silicon oil
Color	Transparent	None
Scent	Nivesse or none	None

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/<//093 Page 4/6

Comparison of Modified Device with
SLAM Predicate Device (K011253)

	SLAM CondomManufactured by NipponRubber Industry;K011253	Billy Boy with Dotted /Beaded Type
FDA Classification	Class II § 884.5300	Class II § 884.5300
Classification code	HIS	HIS
Material	Natural latex rubber	Natural latex rubber
Shape	Anatomical Shape (i.e.narrowed along length)	Cylindrical Shape
Surface	Dotted (Beaded)
Length	180 mm	≥ 175 mm
Flat Width (30mm)	55 mm	52mm
max. width	55 mm	52 mm
narrowest flatwidth	55 mm	52 mm
thickness	0.10 mm	0.10 mm
	information athttp://www.slamcondoms.com/v3/index.php?option=comcontent&view=article&id=

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K111093 Page 5/6

	PredicateLifestyles ExtraStrength Ultra ThickMale Latex CondomManufactured by AnsellInc.K871304	Submission DeviceBILLY BOY New Condom
FDAClassification	Class II § 884.5300	Class II § 884.5300
Classificationcode	HIS	HIS
Material	Natural latex rubber	Natural latex rubber
Shape	Cylindrical	Cylindrical
Length	200 mm	≥ 175 mm
Flat Width (30mm)	55 mm	52 mm
max. width	55 mm	52 mm
narrowest flatwidth	55 mm	52 mm
thickness	0.10 mm	0.10 mm

information at http://www.condomdepot .com/product/detail.cfm/n id/206/pid/2235

Comparison

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, thickness and width dimensions of the BillyBoy modifications are substantially equivalent to those of the other legally marketed predicate devices. Where differences exist, performance data has demonstrated that the differences do not raise any new issues of safety or efficacy.

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K111093

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Performance:

The materials testing for the BillyBoy was conducted in accordance with the relevant parts of ISO 10993. Certificates and test reports were provided demonstrating compliance with the standard. The sponsor followed FDA's guidance for male latex condoms and developed test plans to meet the specified requirements of the guidance. The functional testing of male condoms was conducted according to ASTM D3492. This testing included tensile force, elongation, tensile strength (both before and after aging) bursting volume, bursting pressure, freedom from holes and microbiological cleanliness using the ASTM standard acceptance criteria. In addition, the devices were evaluated for compliance with the standard with regard to length, wall thickness and visual characteristics. The BillyBoy condoms passed all materials, functional, and visual tests. In addition both accelerated and real time shelf life studies were performed with positive results.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

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

3 2011 IIIN

Re: K111093

Trade Name: BillyBoy Dotted (Beaded) Condom; BillyBoy New Condom Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product code: HIS Dated: May 17, 2011 Received: May 20, 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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Page 2

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 regilation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/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/ReportalProblem/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 Lemon MD

Herbert 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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510(k) Number (if known): K11093

Device Name: BillyBoy Dotted (Beaded) Condom; BillyBoy New Condom

Indications for Use:

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arne K. Witzke

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111093

Page / of /

Regulation Number and Section

§ 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.