(311 days)
The Sustain Tailored Fit, Ultra Thin and Comfort Fit condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
The SUSTAIN Natural Rubber Latex Condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. These condoms conform to ISO 4074 Natural Rubber Latex Condoms - Requirements and Test Methods, ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condom), and ISO 10993 Biological Evaluation of Medical Devices.
This document is a 510(k) Summary for SUSTAIN Natural Rubber Latex Condoms. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to established standards and specifications as acceptance criteria. The device performance is deemed to meet these criteria by conforming to them.
| Acceptance Criteria / Standard | Reported Device Performance (Conforms to) |
|---|---|
| ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condom) | Yes |
| ISO 4074 Natural Rubber Latex Condoms - Requirements and Test Methods | Yes |
| ISO 10993 Biological Evaluation of Medical Devices | Yes |
| ISO 10993-5 [2009] Tests for In Vitro Cytotoxicity | Yes |
| ISO 10993-10 [2010] Tests for Irritation and Skin Sensitization (Penile Irritation) | Yes |
| ISO 10993-10 [2010] Tests for Irritation and Skin Sensitization (Primary Irritation) | Yes |
| ISO 10993-10 [2010] Tests for Irritation and Skin Sensitization (Vaginal Irritation) | Yes |
| ISO 10993-10 [2010] Skin Sensitization Study (GPMT) of Refined Cotton Seed Oil Extract in Guinea Pigs | Yes |
| ISO 10993-10 [2010] Skin Sensitization Study (GPMT) of Normal Saline Extract in Guinea Pigs | Yes |
| ISO 10993-11 [2009] Tests for Systemic Toxicity | Yes |
| Specific Product Specifications: | |
| Sustain Tailored Fit: | |
| Nominal Length | 186 ± 4 mm (meets ASTM D3492-08) |
| Nominal Width | 49 ± 2 mm (meets ASTM D3492-08) |
| Nominal Thickness | 0.065 ± 0.005 mm (meets ASTM D3492-08) |
| Sustain Ultra Thin: | |
| Nominal Length | 186 ± 4 mm (meets ASTM D3492-08) |
| Nominal Width | 52 ± 2 mm (meets ASTM D3492-08) |
| Nominal Thickness | 0.055 ± 0.005 mm (meets ASTM D3492-08) |
| Sustain Comfort Fit: | |
| Nominal Length | 186 ± 4 mm (meets ASTM D3492-08) |
| Nominal Width | 52 ± 2 mm (meets ASTM D3492-08) |
| Average Thickness | 0.065 ± 0.005 mm (meets ASTM D3492-08) |
Note: The document focuses on demonstrating substantial equivalence to predicate devices and conformance to recognized standards, rather than reporting specific numerical performance metrics from independent studies for each acceptance criterion with associated confidence intervals or statistical power. The "reported device performance" is essentially the statement that the devices "conform to" these standards.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test described under "Nonclinical Testing," nor does it mention the data provenance (e.g., country of origin, retrospective or prospective). It simply lists the standards and the types of tests performed. For biological evaluation, the ISO 10993 series refers to standardized testing protocols, which would inherently include specified sample sizes for in vitro and in vivo tests (like guinea pig sensitization). However, these specific sample sizes are not detailed in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device submission. The "ground truth" for male latex condoms is established by their adherence to international and national standards (ASTM, ISO), which define performance characteristics for efficacy (e.g., prevention of pregnancy, STI transmission) and safety (e.g., biocompatibility, physical properties). These standards are developed by expert committees, but the individual "experts" establishing ground truth for a specific test set are not described in this document in the context of human interpretation of data for diagnostic purposes.
4. Adjudication Method for the Test Set:
Not applicable. This device is a physical medical device (condom) and its performance is evaluated against engineering/material standards and biological safety tests, not through human interpretation of clinical data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic or imaging devices where human readers interpret medical images or data. The device in question is a physical barrier contraceptive.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is not an algorithm or AI system. Its performance is inherent in its physical properties and biocompatibility.
7. Type of Ground Truth Used:
The "ground truth" used for this device's evaluation is based on established international and national consensus standards and specifications (ASTM D3492-08, ISO 4074, ISO 10993 series). These standards define the acceptable physical properties (length, width, thickness), burst strength, leakage, and biocompatibility requirements for male latex condoms to be considered safe and effective for their intended use. This is a form of standards-based ground truth.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI or machine learning model, so there is no "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.