(227 days)
The Harmony® Latex & the Harmony® Polyisoprene Dams are used as a barrier when engaging in oral/vaginal and oral/ anal sex to help reduce the transmission of bodily fluids, harmful pathogens and sexually transmitted infections.
The Harmony® Latex and Harmony® Polyisoprene Dams are rectangular shaped non-porous, intact polymer film that are placed over the vagina or anus during oral sexual contact. The dam provides coverage to the external female genitalia or to the anal acts as a physical barrier to infectious agents responsible for the transmission of sexually transmitted infections (STIs). Both Harmony® Latex and Harmony® Polyisoprene Dams are 152.4 mm (6") x 254 mm (10") and 0.12 mm thick. The Harmony® Latex Dam contains natural polyisoprene rubber and the Harmon® Polyisoprene Dam contains synthetic polyisoprene rubber. The dams are slightly scented with vanilla fragrance and are provided in natural color.
This document is a 510(k) summary for the Harmony® Latex Dams and Harmony® Polyisoprene Dams. It outlines the acceptance criteria and supporting studies for these devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the international standard ISO 29942:2011 Prophylactic dams -- Requirements and test methods and the 2020 FDA guidance Use of International Standard ISO 10993-1. The specific ranges or thresholds for these criteria are not provided in the document, but it states that "All test results were acceptable."
| Acceptance Criteria Category | Specific Tests / Properties | Reported Device Performance |
|---|---|---|
| Physical Performance (ISO 29942:2011) | Dimensional Testing | Acceptable (Implies meeting specified dimensions: 152.4 mm x 254 mm, Thickness- 0.12 mm) |
| Tensile Testing and Elongation at Break | Acceptable | |
| Tear Resistance and Tearing Force | Acceptable | |
| Freedom from Holes and Visual Defects | Acceptable | |
| Barrier Integrity | Viral Barrier Properties | Acceptable |
| Packaging Robustness | Packaging Integrity Testing | Acceptable |
| Biocompatibility (ISO 10993-1, -5, -10, -11) | Cytotoxicity (ISO 10993-5:2009) | Acceptable |
| Irritation Testing (ISO 10993-10:2010) | Acceptable | |
| Sensitization (ISO 10993-10:2010) | Acceptable | |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each test in the acceptance criteria section. The data provenance is also not specified in terms of country of origin or whether it was retrospective/prospective. The testing appears to be prospective bench testing performed on manufactured Harmony® Latex and Harmony® Polyisoprene Dams.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the device is a physical barrier (dam) and the testing involves non-clinical bench tests (mechanical, barrier, biocompatibility), not interpretation of medical images or patient data that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as #3. Bench testing results are typically objectively measured against specified standards, not adjudicated by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This section is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation of results, especially in the context of AI assistance. The Harmony® Dams are physical barrier devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This section is not applicable. There is no algorithm or AI component in the Harmony® Dams. The performance evaluated is the physical and biological properties of the device itself.
7. Type of Ground Truth Used
The ground truth used for the non-clinical tests is established by international standards and FDA guidance. For example:
- ISO 29942:2011 specifies requirements and test methods for prophylactic dams.
- ISO 10993 series outlines biological evaluation of medical devices.
The ground truth is therefore defined by the specifications and thresholds outlined in these recognized standards.
8. Sample Size for the Training Set
This section is not applicable. There is no "training set" as this device is not an AI/ML algorithm or a diagnostic tool that learns from data.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as #8.
§ 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.