(244 days)
SKORE Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The subject SKORE Male Natural Rubber Latex Condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane and used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted infections. The subject device in this submission consists of SKORE Smooth, Dotted &Thin Condoms, SKORE Bulbous Condoms, and SKORE Benzocaine Condoms.
The provided text describes the 510(k) summary for SKORE Male Natural Rubber Latex Condoms. It details the device, its intended use, comparison to a predicate device, and performance testing data.
Here's the requested information structured for acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility: | ISO 10993-1:2017 (Biological Evaluation of Medical Devices) | Demonstrates that the subject devices are biocompatible. |
| - Acute Systemic Toxicity | ISO 10993-11:2017 | Met specifications. |
| - In vitro Cytotoxicity | ISO 10993-5:2009 | Met specifications. |
| - Skin Sensitization | ISO 10993-10:2021 | Met specifications. |
| - Vaginal Irritation Test | ISO 10993-23:2021 | Met specifications. |
| Mechanical Performance Testing | ISO 4074:2015 (Natural rubber latex male condoms - Requirements and test methods) & ASTM D3492-16 (Standard Specification for Rubber Contraceptives) | The subject devices meet the standard specifications. |
| Air Burst Test Pressure | > 1.0 kPa (as per predicate device comparison) | > 1.0 kPa (as per predicate device comparison) |
| Air Burst Test Volume | 18 dm³ (as per predicate device comparison) | 18 dm³ (as per predicate device comparison) |
| Shelf Life | 5 Years (per ISO 4074:2015 & 21 CFR 801.435) | Supports a shelf-life of five years as per the requirements. |
2. Sample size used for the test set and the data provenance
- Sample Size:
- For Mechanical Performance Testing: "Three lots of subject devices, SKORE Male Natural Rubber Latex Condoms" were tested.
- For Biocompatibility and Shelf Life: The sample sizes are not explicitly stated, but the tests were performed on "SKORE Male Natural Rubber Latex Condoms."
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be conducted by the manufacturer, TTK Healthcare Ltd., which is based in India. The studies are prospective in nature, as they are conducted to demonstrate compliance of the device before market entry.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the evaluation of condoms. The ground truth for condom performance is established through adherence to recognized international and national standards (e.g., ISO 4074, ASTM D3492) and laboratory testing, rather than expert consensus on interpretive data.
4. Adjudication method for the test set
Not applicable. The tests are objective and quantitative, based on physical and chemical properties measured against established standards. There is no subjective interpretation requiring adjudication.
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 device is a medical product (condom), not an AI-based diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. Performance is determined through physical and biological testing.
7. The type of ground truth used
The ground truth used for this device is based on established international and national standards (ISO 4074:2015, ASTM D3492-16, ISO 10993 series, 21 CFR 801.435) for material properties (natural rubber latex), physical integrity (air burst pressure/volume), dimensions, biocompatibility, and shelf-life.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.