(136 days)
The Banana Gold condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Personal hygienic medical devices for contraception and preventing from sexually transmitted disease.
This document is a 510(k) premarket notification for the "Banana Gold" condom, asserting its substantial equivalence to a predicate device (K896987 / RUBBER CONDOM (NON-COLORED)).
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device, which implies that the new device meets established standards for condoms. The relevant performance criteria are drawn from the international standard ISO 4074:2014, specifically "airburst and dimensional specification testing," and ISO 10993 for biocompatibility.
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Banana Gold) |
|---|---|
| ISO 4074:2014 | Complies with "airburst and dimensional specification testing" |
| - Length | 180 min (mm) |
| - Thickness | 0.07 ± 0.02 mm |
| ISO 10993 | Meets the applicable requirements (biocompatibility was conducted on subject device which included color additive) |
Note: The predicate device for length has an acceptance criterion of "180 ± 10 mm", while the new device specifies "180 min". This suggests that the new device is at least 180mm, which would fall within the predicate's range. For thickness, both are "0.07 ± 0.02 mm".
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the "airburst and dimensional specification testing" or the biocompatibility studies.
- Data Provenance: The manufacturing company, Hankook Latex Gongup Co., Ltd., is located in the Republic of Korea. The testing would presumably be conducted by or for this manufacturer, likely in Korea or by a certified laboratory. The document does not specify if the testing was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is generally not applicable to the performance testing of physical devices like condoms. Ground truth in this context refers to the defined metrics and acceptable limits within the ISO standards themselves, not expert interpretation of results, as would be the case for image-based diagnostic AI. The standards are the "ground truth."
4. Adjudication Method for the Test Set:
Not applicable in the sense of expert adjudication as used for clinical trial data or AI performance. The results of the non-clinical tests (e.g., airburst volume, dimensions) are objectively measured against the specified limits of ISO 4074:2014.
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:
Not applicable. This is a physical medical device (condom), not an AI algorithm intended for human reader assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for evaluating the device's performance against the acceptance criteria is defined by international recognized standards:
- ISO 4074:2014 (for airburst and dimensional specifications)
- ISO 10993 (for biocompatibility)
These standards specify the methods of testing and the acceptable ranges for physical properties and biological safety.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the manufacturing and testing of a physical product like a condom.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for a physical device.
§ 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.