(267 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a condom, with no mention of AI or ML technologies.
No.
The device is used for contraception and prophylaxis against STIs, which are preventative measures rather than therapeutic treatments for existing conditions.
No
Explanation: The device is a condom, which is described as a contraceptive and prophylactic device for preventing pregnancy and STIs. Its purpose is not to diagnose any condition.
No
The device description clearly states it is a physical condom made of polyisoprene rubber, not software. The performance studies also focus on physical properties and biological interactions.
No, 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 pregnancy and STIs. This is a physical barrier method used in vivo (on the body), not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The description details a physical device (a condom) made of polyisoprene, designed for physical use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting specific analytes, or providing diagnostic information. The performance studies focus on the physical properties of the condom (tensile strength, air burst, seal integrity, viral penetration as a barrier) and biocompatibility, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Polyisoprene Extra Large Condoms are used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).
Product codes
MOL
Device Description
The Polyisoprene Extra Large Condom is a male contraceptive prophylactic device made from synthetic polyisoprene rubber latex with a lubricant coating containing silicone gel with fragrance oil. The fragrance oil acts as a masking agent to minimize odor originated from the condom substrate. 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 200 ± 10mm, width 60 ± 2mm, and thickness 0.070 ± 0.01mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 5-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)
Biocompatibility:
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing were leveraged from the predicate device submission, which has an identical formulation, and were performed in accordance with the 2020 FDA guidance document, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009. The results of testing demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Performance Testing:
The subject condom was tested for compliance to all requisite parameters within ISO 23409:2011, "Male Condoms – Requirements and test methods for condoms made from synthetic materials" and meets requirements of ISO 4074:2015, "Natural rubber latex male condoms – Requirements and test methods" for dimensional, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume and air burst pressure requirements. In addition, a mechanical assessment of tensile and airburst properties, friction/tack, and swell testing were conducted on the subject condom and compared to natural rubber latex condoms with the same width. The subject condom met the predefined acceptance criteria, and the mechanical performance, friction/tack, and swell testing results were demonstrated to be non-inferior to a natural rubber latex condoms.
Package Integrity:
An evaluation of seal integrity was performed on three lots (3) of the subject device according to ISO 23409: 2011 with satisfactory results.
Barrier Properties/Permeability:
A viral penetration study was leveraged from the predicate device which was conducted on three (3) test lots of the subject polyisoprene condom, one lot of the commercially available predicate device, and a natural rubber latex condom comparator per ISO 23409: 2011. The cumulative results of the studies demonstrate the barrier effectiveness of the subject device as compared to the predicate device and natural rubber latex control condom for viral penetration under conditions of the in vitro study.
Shelf Life:
The Polyisoprene Extra Large Condom has a 5-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435 and ISO 23409:2011. All samples met predefined acceptance criteria.
Clinical Performance Testing:
Clinical testing was leveraged from the predicate device which was demonstrated to be non-inferior to the natural rubber latex condom comparator. The slippage and breakage study, which conforms to ISO 23409: 2011 and follows a protocol prepared to meet the FDA guidance "Testing Guidance for Male Condoms Made From New Material (Non-Latex)", was conducted using a polyurethane condom and a standard natural rubber latex condom as comparators. The predicate device was non-inferior to the control latex condom in both clinical breakage and slippage rate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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May 9, 2024
Suretex Limited % Donna Digangi Principal DiGangi Consulting, LLC 708 Firethorn Lane Round Rock, Texas 78664
Re: K232470
Trade/Device Name: Polyisoprene Extra Large Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: August 14, 2023 Received: August 16, 2023
Dear Donna Digangi:
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 (the 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 aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
K232470 - Donna Digangi
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232470
Device Name Polyisoprene Extra Large Condom
Indications for Use (Describe)
Polyisoprene Extra Large Condoms are used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).
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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4
510(k) Summary K232470 Polyisoprene Extra Large Condom
1. Submitter Information
| Applicant: | Suretex Limited |
|---|---|
| Address: | 31/1 Moo 4, Suratthani-Thakuapha Road |
| Tambon Khao Hua Kwai, Amphur Phunphin | |
| Suratthani, 84130, THAILAND | |
| Phone: | +66 77 277 400 |
2. Correspondent Information
| Company: | Suretex Limited |
|---|---|
| Contact: | Nicolas Coltel, Director QA and RA |
| Email: | nicolas.coltel@lifestyles.com |
May 9, 2024 3. Date prepared:
4. Device Information
| Device Name: | Polyisoprene Extra Large Condom |
|---|---|
| Common Name: | Synthetic Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | MOL (Condom, Synthetic) |
| Regulatory Class: | Class II |
5. Predicate Device Information
| Device Name: | SKYN Original Polyisoprene Lubricated Male Condom |
|---|---|
| 510(k) Number: | K160399 |
| Sponsor: | Ansell Healthcare Products, LLC |
The predicate device has not been subject to a design-related recall.
6. Device Description
The Polyisoprene Extra Large Condom is a male contraceptive prophylactic device made from synthetic polyisoprene rubber latex with a lubricant coating containing silicone gel with fragrance oil. The fragrance oil acts as a masking agent to minimize odor originated from the condom substrate. 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 200 ± 10mm, width 60 ± 2mm, and thickness 0.070 ± 0.01mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 5-year shelf-life. Device specifications are listed in Table 1 below.
7. Indications for Use Statement
Polyisoprene Extra Large Condoms are used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).
5
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below includes a comparison of the intended use and technological characteristics of the subject and predicate devices.
| | Subject Device
Polyisoprene Extra Large
Condom (K232470) | Predicate Device
SKYN Original
Polyisoprene Lubricated
Male Condom (K160399) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device & Predicate Device | Polyisoprene Extra Large
Condom | SKYN Original Polyisoprene
Lubricated Male Condom |
| 510(K) Number | K232470 | K160399 |
| Product Code | MOL | MOL |
| Regulation Number | 21 CFR 884.5300 | 21 CFR 884.5300 |
| Regulation Name | Condom | Condom |
| Indications for Use | Polyisoprene Extra Large
Condoms are used for
contraception and for
prophylactic purposes to help
reduce the risk of pregnancy
and the transmission of
sexually transmitted
infections (STIs). | The SKYN Original
Polyisoprene Lubricated
Male Condom is used for
contraception and for
prophylactic purposes (to
help reduce the risk of
pregnancy and the
transmission of sexually
transmitted infections STIs). |
| Prescription or Over-The-
Counter Use | Over-The-Counter | Over-The-Counter |
| Condom Material | Polyisoprene | Polyisoprene |
| Nominal Width | $60 \pm 2$ mm | $53 \pm 2$ mm |
| Nominal Length | $200 \pm 10$ mm | ≥180 mm |
| Nominal Thickness | 0.070 ± 0.01 mm | 0.065-0.075 mm |
| Lubricant | Silicone Oil | Silicone Oil |
| Sterilization | Non-Sterile | Non-sterile |
| Shape | Straight-walled & Reservoir-
ended | Straight-walled & Reservoir-
ended |
| Texture | Smooth Surface | Smooth Surface |
| Shelf Life | 5 Years | 5 Years |
| Color Additives | N/A | N/A |
| Flavor Additives | N/A | N/A |
The subject and predicate device have identical indications for use statements and the same intended use. The technological characteristics of the subject and predicate devices are similar in that they are polyisoprene-based and are lubricated with silicone oil. The subject and predicate condoms also have identical formulations. There are differences in dimensions specifications; the subject device has an increased width compared to the predicate device. These differences do not raise different questions of safety and effectiveness.
6
9. Summary of Non-Clinical Performance Testing
Biocompatibility:
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing were leveraged from the predicate device submission, which has an identical formulation, and were performed in accordance with the 2020 FDA guidance document, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- · Cytotoxicity (ISO 10993-5:2009/R 2014)
- · Sensitization (ISO 10993-10:2010/R 2014)
- · Vaginal Irritation (ISO 10993-10:2010/R 2014)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The results of testing demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Performance Testing:
The subject condom was tested for compliance to all requisite parameters within ISO 23409:2011, "Male Condoms – Requirements and test methods for condoms made from synthetic materials" and meets requirements of ISO 4074:2015, "Natural rubber latex male condoms – Requirements and test methods" for dimensional, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume and air burst pressure requirements. In addition, a mechanical assessment of tensile and airburst properties, friction/tack, and swell testing were conducted on the subject condom and compared to natural rubber latex condoms with the same width. The subject condom met the predefined acceptance criteria, and the mechanical performance, friction/tack, and swell testing results were demonstrated to be non-inferior to a natural rubber latex condoms.
Package Integrity:
An evaluation of seal integrity was performed on three lots (3) of the subject device according to ISO 23409: 2011 with satisfactory results.
Barrier Properties/Permeability:
A viral penetration study was leveraged from the predicate device which was conducted on three (3) test lots of the subject polyisoprene condom, one lot of the commercially available predicate device, and a natural rubber latex condom comparator per ISO 23409: 2011. The cumulative results of the studies demonstrate the barrier effectiveness of the subject device as compared to the predicate device and natural rubber latex control condom for viral penetration under conditions of the in vitro study.
Shelf Life:
The Polyisoprene Extra Large Condom has a 5-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435 and ISO 23409:2011. All samples met predefined acceptance criteria.
Clinical Performance Testing
Clinical testing was leveraged from the predicate device which was demonstrated to be non-inferior to the natural rubber latex condom comparator. The slippage and breakage study, which conforms to ISO
7
23409: 2011 and follows a protocol prepared to meet the FDA guidance "Testing Guidance for Male Condoms Made From New Material (Non-Latex)", was conducted using a polyurethane condom and a standard natural rubber latex condom as comparators. The predicate device was non-inferior to the control latex condom in both clinical breakage and slippage rate.
10. Conclusion
The results of the performance testing described above demonstrate that the Polyisoprene Extra Large Condom is as safe and effective as the predicate device and supports a determination of substantial equivalence.