(45 days)
Not Found
No
The device description and performance studies focus on the physical properties and testing of a latex condom, with no mention of AI or ML technology.
No.
Explanation: The device is intended for contraceptive and prophylactic purposes, not for treating or rehabilitating a medical condition.
No
Explanation: The device is a male latex condom used for contraception and prophylaxis, not for diagnosing a medical condition.
No
The device description clearly details a physical product made of natural rubber latex with specific dimensions and material properties, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prevention of sexually transmitted infections. This is a physical barrier device used in vivo (on the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details the physical characteristics and materials of a condom, not a diagnostic test kit or instrument.
- Performance Studies: The performance studies focus on the physical properties and integrity of the condom (tensile strength, bursting volume, freedom from holes, etc.), not on the accuracy of detecting a biological marker or condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with IVD devices.
This device is a Class II medical device regulated by the FDA, but it falls under the category of a barrier contraceptive, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HIS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
JUN - 3 2011
KI11093
age 116
| Submitted by: | MAPA GmbH
Industriestrasse
Zeven Germany
49 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 Boy | ||
| condoms | MAPA | |
| GmbH | K103119 | |
| SLAM Condom | ||
| manufactured by; | Nippon | |
| Rubber | ||
| Industry | K011253 | |
| Lifestyles Extra | ||
| Strength) Ultra | ||
| Thick Male | ||
| Latex Condom | Ansell | |
| Inc. | 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.
1
K111093
Page 2/6
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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Page 3/6
| 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 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 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. | ||
| 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 | BillyBoy, BillyBoy Scented; | |
| BillyBoy Special Comfort and | ||
| BillyBoy Extra Lubricated | Dotted (Beaded); New | |
| Condom | ||
| Shape | Straight walled with reservoir tip; | |
| Flared or Cylindrical | Straight walled with | |
| reservoir 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 Extra | |
| Lubricated which has 0.33g | 0.49g silicon oil | |
| Color | Transparent | None |
| Scent | Nivesse or none | None |
3
/ 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
7
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
8
510(k) Number (if known): K11093
Device Name: BillyBoy Dotted (Beaded) Condom; BillyBoy New Condom
Indications for Use:
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.
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
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