(237 days)
SKORE Red, SKORE Yellow, SKORE Brown, SKORE Orange & SKORE Strawberry, SKORE Cherry, SKORE Banana, SKORE Pinacolada, SKORE Tangerine, SKORE Chocolate and SKORE Cool Mint, Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
SKORE Condoms (Colors & Flavors) and SKORE Condoms (Flavors) are made of a natural rubber latex sheath and are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. The subject devices in this submission consists of
- SKORE Colors SKORE Red; SKORE Yellow; SKORE Brown; SKORE Orange. . These condoms are parallel straight walled, teat ended, with a smooth surface Natural Rubber Latex Condoms in the colors Red. Yellow, Brown, and Orange; having a length of 190 ± 10 mm, width of 53±2mm and a thickness of 0.065 ±0.010 mm, per ASTM D3492:2016 and ISO 4074:2015.
- SKORE Colors & Flavors SKORE Strawberry; SKORE Cherry; SKORE . Banana; SKORE Pinacolada; SKORE Tangerine; SKORE Chocolate; SKORE Cool Mint. These condoms are parallel straight walled, teat ended, with a dotted surface having a length of 190 ± 10 mm, width of 53 ± 2 mm and a thickness of 0.065 ± 0.010 mm, per ASTM D3492:2016 and ISO 4074:2015.
The provided text describes a 510(k) summary for male natural rubber latex condoms (SKORE Colors & Flavors, SKORE Colors). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel efficacy or safety through clinical trials comparing a device to a human interpretation. Therefore, the information typically requested regarding acceptance criteria, study design for proving those criteria, human reader involvement, ground truth establishment, and training set details as they would apply to an AI/ML powered device, are not directly applicable in this context.
However, I can extract the relevant performance criteria and testing performed to demonstrate the device's conformance to established condom standards, which serve a similar function to "acceptance criteria" for a medical device of this type.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (Specifications) and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Nominal Width | 53 ± 2 mm | 53 ± 2 mm |
| Nominal Length | 190 ± 10 mm | 190 ± 10 mm |
| Nominal Thickness | 0.070 ± 0.010 mm | 0.065 ± 0.010 mm |
| Air Burst Test Pressure | > 1.0 kPa | > 1.0 kPa |
| Air Burst Test Volume | 18 dm³ | 18 L |
| Shelf Life | 5 Years | 5 Years |
| Biocompatibility (Acute Systemic Toxicity) | Non-toxic | Non-toxic |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (Vaginal Irritation) | Non-irritating | Non-irritating |
| Biocompatibility (Penile Irritation) | Non-irritating | Non-irritating |
| Biocompatibility (Skin Sensitization) | Non-sensitizing | Non-sensitizing |
| Material | Natural Rubber Latex | Natural Rubber Latex |
| Dusting Powder | Magnesium Carbonate & Calcium Carbonate | Magnesium Carbonate & Calcium Carbonate |
| Lubricant | Silicone Oil | Silicone Oil |
| Texture | Plain & Dotted | Plain & Dotted |
| Packaging Material | Laminate (Al foil + plastic) | Laminate (Al foil + plastic) |
Study to Prove Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as "Non-Clinical Performance Testing."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "Three lots of the subject devices" were tested for mechanical performance. The specific number of individual condoms tested within these three lots is not provided. For biocompatibility, the number of samples used for each test (e.g., for cytotoxicity, irritation, sensitization) is not specified.
- Data Provenance: Not explicitly stated regarding country of origin for the samples. The submission is from TTK Healthcare Ltd. in Puducherry, INDIA. The testing appears to have been conducted as part of the regulatory submission process. The testing would be considered prospective for the purpose of demonstrating compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- This question is not applicable as the device is a physical product (condom), not an AI/ML powered diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" is determined by established engineering standards and biological testing protocols.
4. Adjudication Method for the Test Set:
- This question is not applicable for the same reasons as #3.
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 the device is a physical product, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a physical product, not an algorithm.
7. The type of ground truth used:
- Mechanical Performance Ground Truth: Established by recognized international and national standards:
- ISO 4074:2015 - Natural rubber latex male condoms - Requirements and test methods
- ASTM D3492:2016 - Standard Specification for Rubber Contraceptives (Male Condoms)
- Biocompatibility Ground Truth: Established by recognized international standards:
- ISO 10993-1: Biological Evaluation of Medical Devices.
- ISO 10993-11:2006/(R)2010 (Acute Systemic Toxicity)
- ISO 10993-5:2009 (Cytotoxicity)
- ISO 10993-10:2010 (Vaginal Irritation, Penile Irritation, Skin Sensitization)
8. The sample size for the training set:
- This question is not applicable as there is no "training set" for physical product evaluation in this context.
9. How the ground truth for the training set was established:
- This question 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.