(120 days)
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 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.
The provided document (K231908 510(k) Summary for 45 Micron Polyisoprene Condom) describes the acceptance criteria and the study that proves the device meets those criteria for a condom. This is not a medical imaging device or an AI/ML-enabled device, therefore, many of the requested elements of your prompt are not applicable (e.g., number of experts for ground truth, MRMC study, sample size for training set, etc.).
However, I can extract and present the available information most relevant to your request format, making it clear what information is and isn't provided in the context of this specific regulatory submission for a condom.
Acceptance Criteria and Device Performance for 45 Micron Polyisoprene Condom
1. Table of Acceptance Criteria and Reported Device Performance
For a condom, "performance" is primarily assessed through physical integrity, barrier properties, and clinical failure rates (breakage/slippage). The document refers to meeting various ISO standards and FDA guidance rather than listing specific numerical acceptance criteria (e.g., a "pass/fail" for an imaging diagnostic would have specific sensitivity/specificity targets).
| Test Category | Acceptance Criteria (Conceptual, based on standards adherence) | Reported Device Performance |
|---|---|---|
| Material/Biocompatibility | Non-irritating, non-sensitizing, not acutely/systemically toxic (per ISO 10993 series and FDA guidance) | The device demonstrated non-irritating, non-sensitizing, and non-acutely systemically toxic properties, leveraging data from the predicate device submission and performing specific tests (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity). |
| Physical Performance | Compliance with ISO 23409:2011, ISO 4074:2015, and ASTM D624-00 (2020) for dimensions, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume, and air burst pressure. Also, tear resistance. | The subject condom met the predefined acceptance criteria for all tested physical performance parameters (dimensions, tensile strength, force at break, lubricant quantity, visible defects, elongation, air burst volume, air burst pressure, and tear resistance). It demonstrated comparable physical performance to the predicate device regarding tensile strength, force at break, tensile elongation, airburst pressure, airburst volume, and tear resistance. |
| Package Integrity | Satisfactory seal integrity per ASTM D6324-11. | Seal integrity evaluation on three lots yielded satisfactory results. |
| Barrier Properties/Permeability | Effective barrier against viral penetration, comparable to predicate and natural rubber latex condoms (per ISO 23409:2011). | Viral penetration study on three test lots demonstrated the device's barrier effectiveness comparable to the predicate device and natural rubber latex control condom. |
| Shelf Life | Stability over time (e.g., 5 years) with all physical and biological properties maintained per 21 CFR 801.435 and ASTM D6324-11. | Accelerated stability evaluations supported a five-year shelf life, with all samples meeting predefined acceptance criteria. |
| Clinical In-Use Slip/Break | Non-inferiority to a control natural rubber latex condom for clinical breakage, slippage, and total clinical failure rates, following FDA guidance. | Clinical Breakage Rate: 1.3% (Polyisoprene) vs. 0.7% (Natural Rubber Latex Control) Clinical Slippage Rate: 0.6% (Polyisoprene) vs. 0.6% (Natural Rubber Latex Control) Total Clinical Failure Rate: 1.9% (Polyisoprene) vs. 1.3% (Natural Rubber Latex Control) Conclusion: The polyisoprene condom was statistically non-inferior to the natural rubber latex control for clinical breakage, slippage, and total clinical failure rate. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Biocompatibility: Leveraged from predicate device submission, with additional specific tests on the subject device. Sample sizes not explicitly stated for each test, but standard for biocompatibility studies.
- Physical Performance: Not explicitly stated for each test, but testing was "for compliance" with standards.
- Package Integrity: 3 lots of the subject device.
- Barrier Properties/Permeability: 3 test lots of the subject polyisoprene condom, one lot of the commercially available predicate device, and a natural rubber latex condom comparator.
- Shelf Life: "All samples" met criteria, specific number not stated.
- Clinical In-Use Slip/Break: Over 267 couples were included in the study.
- Data Provenance: The submission is from Suretex Limited, located in Thailand. The study details (where it was conducted, retrospective/prospective) are not explicitly stated, but clinical performance studies for regulatory submissions are typically prospective and conducted under Good Clinical Practice (GCP) guidelines. The document states it "followed a protocol prepared to meet the FDA guidance".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable as this is a physical medical device (condom) and not a medical imaging or AI diagnostic device. "Ground truth" for condom performance is established through objective physical and chemical testing, and clinical observation of real-world use rather than expert interpretation of images.
4. Adjudication Method for the Test Set
- This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in imaging studies where interpretations from multiple readers need to be reconciled. For a condom, performance is measured objectively (e.g., breakage, slippage, physical properties).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- This question is not applicable as this is not an AI/ML-enabled medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as this is not an AI/ML-enabled medical device.
7. The Type of Ground Truth Used
- For physical properties (tensile strength, air burst, etc.): Objective measurements against predefined ISO and ASTM standards.
- For biocompatibility: Laboratory testing results against established limits for toxicity, irritation, and sensitization.
- For barrier properties: Laboratory viral penetration testing.
- For clinical in-use performance (breakage/slippage): Direct observation of events (breakage or slippage) during actual use by participating couples. Non-inferiority was established by statistical comparison to a control latex condom.
8. The Sample Size for the Training Set
- This question is not applicable as this is a physical medical device and not an AI/ML-enabled device. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as this is a physical medical device and not an AI/ML-enabled device.
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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).
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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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510(k) Summarv K231908 45 Micron Polyisoprene Condom
1. Submitter Information
| Applicant: | Suretex Limited |
|---|---|
| Address: | 31/1 Moo 4, Suratthani-Thakuapha RoadTambon Khao Hua Kwai, Amphur PhunphinSuratthani, 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).
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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 Device45 Micron PolyisopreneCondom (K231908) | Predicate DeviceSKYN OriginalPolyisoprene LubricatedMale Condom (K160399) | |
|---|---|---|
| Device & Predicate Device | 45 Micron PolyisopreneCondom | SKYN Original PolyisopreneLubricated 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 PolyisopreneCondom is used forcontraception and forprophylactic purposes (tohelp reduce the risk ofpregnancy and thetransmission of sexuallytransmitted infections STIs). | The Skyn OriginalPolyisoprene LubricatedMale Condom is used forcontraception and forprophylactic purposes (tohelp reduce the risk ofpregnancy and thetransmission of sexuallytransmitted 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.
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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
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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.
§ 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.