(49 days)
The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 205mm, nominal flat width 57mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dression material. This condom is designed to conform to established. national and international voluntary standards including ASTM D3492 and ISO 4074.
This document is a 510(k) summary for a male latex condom, focusing on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the context of an AI/ML device.
Therefore, many of the requested elements (1-9) which are relevant to studies proving a device's performance against specific acceptance criteria (especially for AI/ML or diagnostic devices) are not directly applicable or available in this submission for a medical device like a condom.
However, I can extract the information that is present concerning the device's conformance to standards, which serves as its "acceptance criteria" and "proof of meeting these criteria" in this specific context.
Here's the breakdown based on the provided text, with explanations for why certain fields are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Conformance) | Reported Device Performance |
|---|---|
| Conformance to ASTM D3492 (Latex Condom Standard) | The condom is designed to conform to established national and international voluntary standards including ASTM D3492. |
| Conformance to ISO 4074 (Natural latex rubber condoms — Requirements and test methods) | The condom is designed to conform to established national and international voluntary standards including ISO 4074. |
| Same natural rubber latex compound as UNIDUS 510(k) K023059 | Uses the same natural rubber latex compound as listed in UNIDUS 510(k) number K023059. |
| Same production equipment as UNIDUS 510(k) K023059 | Uses the same production equipment as listed in UNIDUS 510(k) number K023059. |
| Comparable dimensions (longer length, wider flat width for "Magnum" size) | Nominal length 205mm, nominal flat width 57mm, nominal thickness 0.06mm (These are explicitly stated dimensions for the Magnum condom, differentiating it from "regular" sizes). |
| Lubricated with silicone | Lubricated with silicone (explicitly stated). |
| Cornstarch used as dressing material | Cornstarch is used as a dressing material (explicitly stated). |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission focuses on conformance to existing standards and demonstrating substantial equivalence to a predicate device based on material, design, and manufacturing process similarities, rather than a clinical trial or performance study with a "test set" in the sense of AI/ML or diagnostic device evaluation. Condom performance is typically evaluated through standardized physical tests (e.g., burst strength, leakage, dimensions) which are inherent to the ASTM and ISO standards it claims conformance with, but specific sample sizes for these tests are not provided in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See explanation for point 2. No "ground truth" in the clinical or diagnostic sense is established by experts here. Conformance to standards is the primary "verification."
4. Adjudication method for the test set
- Not Applicable. See explanation for point 2.
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 medical device (condom), not an AI/ML diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical device (condom), not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Conformance to established national and international voluntary standards (ASTM D3492 and ISO 4074). The "ground truth" here is adherence to engineering and material specifications defined by these standards, along with documented material and manufacturing similarities to a previously cleared device.
8. The sample size for the training set
- Not Applicable. See explanation for point 2. This device doesn't involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Not Applicable. See explanation for point 2.
§ 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.