(120 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier effectiveness of a condom, with no mention of AI or ML.
No.
The device is indicated for contraception and prophylactic purposes (to reduce the risk of pregnancy and STIs), not for treating a disease or condition.
No
Explanation: The device is a contraceptive and prophylactic device used to prevent pregnancy and reduce STI transmission. It does not diagnose any condition or disease.
No
The device description clearly states it is a physical condom made of synthetic rubber, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a "male contraceptive prophylactic device" used for "contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections STIs)." It is a physical barrier device.
- Lack of Specimen Analysis: The device does not involve the analysis of any biological specimens from the body. Its function is purely mechanical (barrier).
Therefore, based on the provided information, the 45 Micron Polyisoprene Condom is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 45 Micron Polyisoprene Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections STIs).
Product codes (comma separated list FDA assigned to the subject device)
MOL
Device Description
The 45 Micron Polyisoprene Condom is a male contraceptive prophylactic device made from synthetic rubber (Polyisoprene latex) with a lubricant coating containing silicone gel with fragrance oil (Sensual Masking). 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 190 ± 10mm, width 53 ± 2mm, and thickness 0.045 ± 0.005mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life. Device specifications are listed in Table 1 below.
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
Over-The-Counter Use
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 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.
Results: The results of testing demonstrate that the subject device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Physical Performance Testing:
Type: Performance testing for compliance with ISO 23409:2011 and ISO 4074:2015.
Results: The subject condom met the predefined acceptance criteria for dimensional, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume and air burst pressure requirements. Tear resistance was also tested according to ASTM D624-00 (2020) and the 1995 FDA guidance document "Testing Guidance for Male Condoms Made From New Material (Non-Latex)" and met acceptance criteria.
Package Integrity:
Type: Seal integrity evaluation.
Sample Size: Three lots of the subject device.
Method: According to ASTM D6324-11.
Results: Satisfactory results.
Barrier Properties/Permeability:
Type: Viral penetration study.
Sample Size: Three test lots of the subject polyisoprene condom, one lot of the commercially available predicate device, and a natural rubber latex condom comparator.
Method: Per ISO 23409: 2011.
Results: 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:
Type: Accelerated stability evaluations.
Results: The 45 Micron Polyisoprene Condom has a five-year shelf life based on the results, and all samples met predefined acceptance criteria.
Clinical In-Use Slip/Break:
Type: Clinical testing.
Sample Size: Over 267 couples.
Comparators: Polyurethane condom and a standard natural rubber latex condom.
Key Results: The clinical breakage rate for the polyisoprene condom was 1.3% compared to 0.7% for the natural rubber latex control. The clinical slippage rate was 0.6% for the polyisoprene condom and 0.6% for the natural rubber latex control. The total clinical failure rate was 1.9% for the polyisoprene condom compared to 1.3% for the natural rubber latex control. The polyisoprene condom was statistically non-inferior from the natural rubber latex control in clinical breakage, slippage, and total clinical failure rate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical breakage rate for the polyisoprene condom: 1.3%
Clinical breakage rate for the natural rubber latex control: 0.7%
Clinical slippage rate for the polyisoprene condom: 0.6%
Clinical slippage rate for the natural rubber latex control: 0.6%
Total clinical failure rate for the polyisoprene condom: 1.9%
Total clinical failure rate for the natural rubber latex control: 1.3%
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
October 27, 2023
Suretex Limited % Carole C. Carey Senior Consultant C3-Carey Consultants, LLC 9451 Ellsworth Court Fulton, MD 20759
Re: K231908
Trade/Device Name: 45 Micron Polyisoprene Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: September 27, 2023 Received: September 27, 2023
Dear Carole C. Carey:
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" (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).
1
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 QS 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 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
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Indications for Use
510(k) Number (if known) K231908
Device Name 45 Micron Polyisoprene Condom
Indications for Use (Describe)
The 45 Micron Polyisoprene Condom is 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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3
510(k) Summarv K231908 45 Micron Polyisoprene 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: | +61 412 119 827 |
2. Correspondent Information
| Company: | Global QA RA |
|---|---|
| Contact: | Alison Arnot |
| Email: | Alison.Arnot@lifestyles.com |
October 25, 2023 3. Date prepared:
4. Device Information
| Device Name: | 45 Micron Polyisoprene Condom |
|---|---|
| Common Name: | Polyisoprene 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 45 Micron Polyisoprene Condom is a male contraceptive prophylactic device made from synthetic rubber (Polyisoprene latex) with a lubricant coating containing silicone gel with fragrance oil (Sensual Masking). 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 190 ± 10mm, width 53 ± 2mm, and thickness 0.045 ± 0.005mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life. Device specifications are listed in Table 1 below.
7. Indications for Use Statement
The 45 Micron Polyisoprene Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections STIs).
4
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
45 Micron Polyisoprene
Condom (K231908) | Predicate Device
SKYN Original
Polyisoprene Lubricated
Male Condom (K160399) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device & Predicate Device | 45 Micron Polyisoprene
Condom | SKYN Original Polyisoprene
Lubricated Male Condom |
| 510(K) Number | K231908 | K160399 |
| Product Code | MOL | MOL |
| Regulation Number | 21 CFR 884.5300 | 21 CFR 884.5300 |
| Regulation Name | Condom | Condom |
| Indications for Use | The 45 Micron Polyisoprene
Condom is 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 | $53 \pm 2$ mm | $53 \pm 2$ mm |
| Nominal Length | $190 \pm 10$ mm | $190 \pm 10$ mm |
| Nominal Thickness | $0.045 \pm 0.005$ mm | $0.070 \pm 0.005$ 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 and specifications; the subject device has reduced thickness compared to the predicate device. These differences do not raise different questions of safety and effectiveness.
5
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 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.
Physical Performance Testing:
The subject condom was tested for compliance with ISO 23409:2011, "Male Condoms - Requirements and test methods for condoms made from synthetic materials" and 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, condoms were tested for tear resistance according to ASTM D624-00 (2020) ("Standard Test Methods for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers'') and the 1995 FDA guidance document "Testing Guidance for Male Condoms Made From New Material (Non-Latex)." The subject condom met the predefined acceptance criteria.
Package Integrity:
An evaluation of seal integrity was performed on three lots (3) of the subject device according to ASTM D6324-11 with satisfactory results.
Barrier Properties/Permeability:
A viral penetration study was performed 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 45 Micron Polyisoprene Condom has a five-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435 and ASTM D6324-11. All samples met predefined acceptance criteria.
Clinical In-Use Slip/Break:
Clinical testing was performed to support clinical performance of the subject device. The physical performance testing described above demonstrated that the subject device had comparable physical
6
performance to the predicate device, regarding tensile strength, force at break, tensile elongation, airburst pressure, airburst volume, and tear resistance. The slippage and breakage study followed 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. Over 267 couples were included in the study, the clinical breakage rate for the polyisoprene condom was 1.3% compared to 0.7% for the natural rubber latex control. The clinical slippage rate was 0.6% for the polyisoprene condom and 0.6% for the natural rubber latex control. The total clinical failure rate was 1.9% for the polyisoprene condom compared to 1.3% for the natural rubber latex control. The polyisoprene condom was statistically non-inferior from the natural rubber latex control in clinical breakage, slippage, and total clinical failure rate. The 45 Micron Polyisoprene Condom was non-inferior to the control latex condom in clinical breakage, slippage, and total clinical failure rate.
10. Conclusion
The results of the performance testing described above demonstrate that the 45 Micro Polyisoprene Condom is as safe and effective as the predicate device and supports a determination of substantial equivalence.