(90 days)
Not Found
No
The device description and performance studies focus on the material properties, dimensions, and biocompatibility of a physical condom, with no mention of AI or ML technologies.
No.
The device is described as a male contraceptive and prophylactic device used for contraception and to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs), which are preventative rather than therapeutic uses.
No
The device is a condom used for contraception and prophylaxis against STIs, not for diagnosing medical conditions.
No
The device description clearly states it is a physical male condom made from synthetic rubber polyisoprene latex, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and reducing the risk of STI transmission. This is a physical barrier method used in vivo (on or in the body), not a test performed in vitro (outside the body) on biological samples to diagnose or detect a condition.
- Device Description: The description details a physical device (a condom) made of synthetic rubber. It does not describe reagents, instruments, or software used to analyze biological samples.
- Performance Studies: The performance studies focus on the mechanical properties of the condom (burst strength, shelf-life) and biocompatibility, which are relevant to a physical barrier device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, this device falls under the category of a medical device, but specifically a contraceptive and prophylactic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthetic Polyisoprene Lubricated Male Condom - 5 Senses 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 Synthetic Polyisoprene Lubricated Male Condom – 5 Senses is a male contraceptive and prophylactic device made from synthetic rubber polyisoprene latex with a lubricant coating containing silicone gel with flavor and sensate. The subject condom is provided in a variety pack which includes three variants; Cooling, Tingling, and Warming.
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
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)
Performance testing to assess the addition of new fragrant and sensate chemicals to the subject device was conducted in accordance with ISO 23409:2011, "Male Condoms -Requirements and test methods for condoms made from synthetic materials," and the 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.
Shelf-life testing was also conducted to demonstrate the subject device met its three-year shelf-life specification. The shelf life testing included an assessment of the mechanical burst properties of the subject device following aging.
In addition, biocompatibility testing was conducted in accordance with ISO 10993-1 to assess the addition of fragrant and sensate additives to the condom lubricant. The following biocompatibility testing was conducted:
- Cytotoxicity (Extraction Method, ISO 10993-5: 2009)
- Sensitization (Guinea Pig Maximization Sensitization, ISO 10993-10:2010)
- Irritation (Dermal, Vaginal, and Penile Irritation Studies in Rabbits, ISO 10993-10:2010)
- Acute Systemic Toxicity (Tests for Systemic Toxicity, ISO 10993-11: 2006)
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.
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December 6, 2018
SXWELL USA LLC Robert Mahler Director, QA/RA North America and European Union 111 Wood Avenue South Iselin, New Jersey 08830
Re: K182438
Trade/Device Name: Synthetic Polyisoprene Lubricated Male Condom - 5 Senses Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: MOL Dated: August 14, 2018 Received: September 7, 2018
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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -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
510(k) Number (if known) K182438
Device Name
Synthetic Polyisoprene Lubricated Male Condom - 5 Senses
Indications for Use (Describe)
Synthetic Polyisoprene Lubricated Male Condom - 5 Senses 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510k Summary K182438
Submitter:
SXWELL USA LLC. 111 Wood Avenue South Iselin, NJ 08830, USA
Contact Person:
Robert S. Mahler Director of Quality Assurance & Regulatory Affairs for North America and the European Union Phone: 732-345-2174 Rob.mahler@lifestyles.com
Date Prepared:
December 4, 2018
Device Name:
| Proprietary Name: | Synthetic Polyisoprene Lubricated Male Condom – 5 Senses |
|---|---|
| Common Name: | Condom, Synthetic |
| Classification Name: | Condom |
| Classification Regulation: | 21 CFR 884.5300 |
| Device Class: | Class II |
| Product Code: | MOL (Condom, Synthetic) |
Predicate Device:
K171172 – Synthetic Polyisoprene Male Condom - Flavored
The predicate device has not been subject to a design-related recall.
Device Description:
The Synthetic Polyisoprene Lubricated Male Condom – 5 Senses is a male contraceptive and prophylactic device made from synthetic rubber polyisoprene latex with a lubricant coating containing silicone gel with flavor and sensate. The subject condom is provided in a variety pack which includes three variants; Cooling, Tingling, and Warming.
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.
4
Indications for Use:
The Synthetic Polyisoprene Lubricated Male Condom – 5 Senses 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 comparison of technological characteristics between the Synthetic Polyisoprene Lubricated Male Condom - 5 Senses and the predicate device is shown in the table below:
| Device & Predicate Device(s): | K182438 (subject
device) | K171172 (predicate
device) | Comparison |
|-------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------|
| Condom Material | Polyisoprene | Polyisoprene | Same |
| Dimensions | Length 190±10 mm
Nominal width 53±2
mm
Thickness 0.065-0.075
mm | Length 190±10 mm
Nominal width 53±2
mm
Thickness 0.065-0.075
mm | Same |
| Shape | straight wall with a
reservoir tip | straight wall with a
reservoir tip | Same |
| Texture | Smooth | Smooth | Same |
| Lubricant | Silicone oil | Silicone oil | Same |
| Color Additives | None | None | Same |
| Fragrance Additives | None | Yes | Different |
| Sensate Additives | Yes | None | Different |
| Dusting Agent | Corn starch | Corn starch (different
amount per device) | Different |
The subject and predicate devices have similar technological characteristics. The primary difference is the use of fragrance and sensate additives in the subject device. These differences in technological characteristics do not raise different questions of safety or effectiveness as compared to the predicate device.
Performance Data:
Performance testing to assess the addition of new fragrant and sensate chemicals to the subject device was conducted in accordance with ISO 23409:2011, "Male Condoms -Requirements and test methods for condoms made from synthetic materials," and the 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.
Shelf-life testing was also conducted to demonstrate the subject device met its three-year shelf-life specification. The shelf life testing included an assessment of the mechanical burst properties of the subject device following aging.
5
In addition, biocompatibility testing was conducted in accordance with ISO 10993-1 to assess the addition of fragrant and sensate additives to the condom lubricant. The following biocompatibility testing was conducted:
- Cytotoxicity (Extraction Method, ISO 10993-5: 2009)
- Sensitization (Guinea Pig Maximization Sensitization, ISO 10993-10:2010)
- Irritation (Dermal, Vaginal, and Penile Irritation Studies in Rabbits, ISO 10993-10:2010) ●
- Acute Systemic Toxicity (Tests for Systemic Toxicity, ISO 10993-11: 2006) ●
The remainder of the performance testing outlined in the guidance document was deemed not needed to support the addition of fragrant and sensate chemicals to the condom lubricant.
Conclusion:
The subject and predicate devices have the same intended use and similar fundamental technological characteristics. The performance data demonstrate that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.