(103 days)
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No
The device description and performance studies focus on the physical properties and testing of a male condom, with no mention of AI or ML technology.
No.
The intended uses are contraception and reducing the risk of STI transmission, which are prophylactic and not therapeutic.
No
Explanation: The device is a male condom used for contraception and prophylactic purposes to reduce the risk of pregnancy and STIs. It does not diagnose any conditions.
No
The device description clearly states it is a physical condom made from synthetic rubber, a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Skyn Original Polyisoprene Lubricated Male Condom is a physical barrier device used during sexual activity to prevent pregnancy and reduce the transmission of STIs. It does not perform any diagnostic tests on bodily samples.
- Intended Use: The intended use clearly states "for contraception and for prophylactic purposes," which aligns with a barrier method, not a diagnostic test.
- Device Description: The description focuses on the physical characteristics and materials of the condom, not on any testing or analytical capabilities.
- Performance Studies: The performance studies described focus on the mechanical properties, shelf-life, and biocompatibility of the condom as a physical device, not on the accuracy or reliability of a diagnostic test.
Therefore, based on the provided information, the Skyn Original Polyisoprene Lubricated Male Condom is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Skyn Original Polyisoprene Lubricated Male Condom - Flavored is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).
Product codes (comma separated list FDA assigned to the subject device)
MOL
Device Description
The Skyn Original Polyisoprene Lubricated Male Condom – Flavored is a male contraceptive and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with flavor oil provides a pleasant aroma/flavor for the end user. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190±10mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3 year shelf-life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing conducted to assess the addition of flavor oil to the condom lubricant followed ISO 23409:2011, "Male Condoms – Requirements and test methods for condoms made from synthetic materials," and FDA Guidance Document, "Testing guidance for Male Condoms Made from New Material (Non-Latex)." Results of testing showed that the mechanical properties of the subject device were equivalent to the predicate device. Shelflife testing demonstrated the device met its three-year shelf-life specification. In addition, biocompatibility tests conducted to assess the addition of flavor oil to the condom lubricant (cytotoxicity, sensitization, irritation, and acute systemic toxicity) had passing results. The remainder of the performance testing outlined in the guidance document was deemed not needed to support the addition of flavor oil to the condom lubricant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with lines above them that could represent hair or wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2017
Ansell Healthcare Products LLC. Robert Mahler Director. Regulatory Affairs 111 Wood Avenue South, Suite 210 Iselin. NJ 08830
Re: K171172
Trade/Device Name: Skyn Original Polyisoprene Lubricated Male Condom - Flavored Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: July 7, 2017 Received: July 12, 2017
Dear Robert Mahler:
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.
1
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 (reporting of medical 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Joyce M. Whang -S
for
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K171172
Device Name
Skyn Original Polyisoprene Lubricated Male Condom - Flavored
Indications for Use (Describe)
Skyn Original Polyisoprene Lubricated Male Condom - Flavored is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510k Summary
Submitter:
Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830, USA Phone: 732-345-2174 Rob.mahler@ansell.com
Contact Person:
Robert S. Mahler Director Regulatory Affairs for the Americas Phone: 732-345-2174 Rob.mahler@ansell.com
Date Prepared:
August 1, 2017
Device Name:
| Proprietary Name: | Skyn Original Polyisoprene Lubricated Male Condom - Flavored |
|---|---|
| Common Name: | Condom, Synthetic |
| Classification Name: | Condom |
| Regulation: | 21 CFR 884.5300 |
| Device Class: | Class II |
| Product Code: | MOL |
| Classification Panel: | Obstetrics/Gynecology |
Predicate Device:
K160399 – Skyn Original Polyisoprene Male Condom
Reason for 510(k) Submission:
The subject device is a modified version of predicate device (K160399). The new lubricant coating of subject device contains flavor oils to improve the aroma and minimize the odor profile of the device for the end user. Four variants would be available; Mango, Coconut, Passion Fruit, and Cherry. The flavor oils have not been utilized previously in the predicate device.
Device Description:
The Skyn Original Polyisoprene Lubricated Male Condom – Flavored is a male contraceptive
4
and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with flavor oil provides a pleasant aroma/flavor for the end user. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190±10mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3 year shelf-life.
Indications for Use:
The Skyn Original Polyisoprene Lubricated Male Condom - Flavored is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, (STI's).
Technological Characteristics:
The technological characteristics of the Skyn Original Polyisoprene Lubricated Male Condom are identical to the predicate device. The only difference is replacement of flavor oil for the fragrance masking agent to the lubricant coating of subject device. This difference in technological characteristics does not raise different questions of safety or effectiveness as compared to the predicate device.
Performance Data:
Performance testing conducted to assess the addition of flavor oil to the condom lubricant followed ISO 23409:2011, "Male Condoms – Requirements and test methods for condoms made from synthetic materials," and FDA Guidance Document, "Testing guidance for Male Condoms Made from New Material (Non-Latex)." Results of testing showed that the mechanical properties of the subject device were equivalent to the predicate device. Shelflife testing demonstrated the device met its three-year shelf-life specification. In addition, biocompatibility tests conducted to assess the addition of flavor oil to the condom lubricant (cytotoxicity, sensitization, irritation, and acute systemic toxicity) had passing results. The remainder of the performance testing outlined in the guidance document was deemed not needed to support the addition of flavor oil to the condom lubricant.
Conclusion:
Performance data demonstrated that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.