(45 days)
SKORE Vanilla, SKORE Strawberry, SKORE Banana, SKORE Tangerine 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 Smooth Condoms - SKORE Colors & Flavors and SKORE Smooth Condoms -SKORE Vanilla 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 device is an update to the SKORE (Colors & Flavors) condoms cleared under K202403 to modify the texture (dotted to smooth), use a different yellow pigment, and introduce a new flavor (vanilla). The subject devices in this submission consists of
- SKORE Colors & Flavors SKORE Strawberry; SKORE Banana; SKORE . Chocolate; SKORE Tangerine; These condoms are parallel straight walled, teat ended, with SMOOTH surface Natural Rubber Latex having a Length of 190 ±10 mm, Width of 53 ± 2 mm and a Thickness of 0.06 ± 0.01 mm meeting the requirements as specified in ASTM D 3492 and ISO 4074. The subject devices include the colors, Red; Yellow; Brown; Orange; and flavors Strawberry, Banana, Chocolate and Tangerine.
- SKORE Flavors SKORE Vanilla; This condom is parallel straight walled, teat ● ended, with SMOOTH surface Natural Rubber Latex having a Length of 190 ±10 mm, Width of 53 ± 2 mm and a Thickness of 0.06 ± 0.01 mm meeting the requirements as specified in ASTM D 3492 and ISO 4074. The subject device include the flavor Vanilla and has a natural (no pigment) color.
This report refers to a 510(k) premarket notification for TTK Healthcare Limited's SKORE Smooth Condoms (SKORE Colors & Flavors, and SKORE Vanilla). The document indicates that the device has been found substantially equivalent to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to a predicate device by meeting established international and national standards for condom quality.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993) | Acute Systemic Toxicity (ISO 10993-11:2006/(R)2010): Device found non-systemically toxic. |
| Cytotoxicity (ISO 10993-5:2009): Device found non-cytotoxic. | |
| Vaginal Irritation (ISO 10993-10:2010): Device found non-irritating. | |
| Skin Sensitization (ISO 10993-10:2010): Device found non-sensitizing. | |
| Mechanical Performance (ISO 4074:2015 & ASTM D3492:2016) | Baseline testing: Three lots of the subject devices (SKORE Smooth Condoms - SKORE Colors & Flavors, and SKORE Vanilla) met the specified requirements of ISO 4074:2015 and ASTM D3492:2016. |
| Shelf Life (21 CFR 801.435) | Established a shelf-life of five years based on testing data. |
| Nominal Width (as compared to predicate) | 53 ± 2 mm (Matches predicate) |
| Nominal Length (as compared to predicate) | 190 ± 10 mm (Matches predicate) |
| Nominal Thickness (as compared to predicate) | 0.06 ± 0.01 mm (Slightly different from predicate's 0.065 ± 0.010 mm, but implied to be within acceptable range based on overall equivalence conclusion) |
| Air Burst Test Pressure (as compared to predicate) | > 1.0 kPa (Matches predicate) |
| Air Burst Test Volume (as compared to predicate) | 18 L (Matches predicate) |
2. Sample Size Used for the Test Set and Data Provenance:
- Mechanical Performance Testing: "Three lots of the subject devices" were tested. The exact number of individual condoms tested within these lots is not specified.
- Shelf Life Testing: The sample size is not explicitly stated, but it's based on "testing data" to support a 5-year shelf life.
- Biocompatibility Testing: The specific sample sizes for each biocompatibility test are not provided in this document.
- Data Provenance: The manufacturer is TTK Healthcare Ltd. located in Puducherry, India. The studies were likely conducted internally or by contracted labs, but the specific country of origin for the data generation beyond the manufacturer's location is not further detailed. The testing appears to be prospective as it was conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This document describes performance testing against established standards (ISO, ASTM, CFR). It does not involve establishing ground truth through expert consensus in the way a clinical study for an AI algorithm would. The "ground truth" for these tests is defined by the objective metrics and thresholds within the cited standards.
4. Adjudication Method:
Not applicable. This is not a study requiring adjudication of expert opinions or classifications. The performance is measured against objective standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is not a medical imaging device or an AI algorithm where human reader performance is a factor. This document concerns the physical and biological properties of a condom.
6. Standalone Performance Study (Algorithm Only):
No. This is not an AI algorithm. The performance studies evaluate the physical product itself.
7. Type of Ground Truth Used:
The ground truth used is based on established international and national standards and specifications for condoms, such as:
- ISO 10993 (Biological Evaluation of Medical Devices) for biocompatibility.
- ISO 4074:2015 (Natural rubber latex male condoms - Requirements and test methods) for mechanical performance.
- ASTM D3492:2016 (Standard Specification for Rubber Contraceptives (Male Condoms)) for mechanical performance.
- 21 CFR 801.435 for shelf life.
8. Sample Size for the Training Set:
Not applicable. This is not an AI product that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this 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.