(77 days)
The Lifestyles Zero Lubricated Latex Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
This condom is a single use and non-sterile device intended for in home use by a consumer. The condom is made of a natural rubber latex sheath, which completely covers the penis with closely fitted membrane. The condom provides a physical barrier to fluids which helps reduce the risk of pregnancy and the transmission of sexually-transmitted infections. The device is a straight walled, cylindrical, lubricated condom with a reservoir tip. Condom dimensions are length 180+/- 10 mm, width 52±2mm, and thickness 0.045+/-0.005 mm. The condom is designed to conform to the requirements of ASTM D3492:2015 - Standard Specification for Rubber Contraceptives (Male Condoms).
Here's a breakdown of the acceptance criteria and the study information for the Lifestyles Zero Lubricated Latex Male Condom, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Technological Characteristic | Standard/Test/FDA Guidance | Acceptance Criteria (Specification) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|---|
| Dimensions | ASTM D3492-15 | |||
| - Length | 170mm to 210 mm | 180 +/- 10 mm | Yes | |
| - Width | Maximum 57 mm | 52 +/- 2 mm | Yes | |
| - Thickness | Minimum 0.03 mm | 0.045 +/- 0.005 mm | Yes | |
| Burst Properties | ASTM D3492-15 | |||
| - Air Burst Test Pressure | Minimum 18L | Meets ASTM D3492-15 for Air Burst test pressure | Yes | |
| - Air Burst Test Volume | Minimum 1 kPa | Meets ASTM D3492-15 for Air Burst test volume | Yes | |
| Leakage AQL | ASTM D3492-15 | 0.25 (as per ASTM D3492-15) | Meets ASTM D3492-15 for Leakage AQL of 0.25 | Yes |
| Package Integrity AQL | ASTM D3492-15 | 2.5 (as per ASTM D3492-15) | Meets ASTM D3492-15 for Package Integrity AQL of 2.5 | Yes |
| Lubricant Quantity | Not defined | 400 – 600 mg | 400 – 600 mg | Yes |
| Biocompatibility | ISO 10993-5, 10993-10, 10993-11, FDA Guidance (June 16, 2016) | Not toxic (local or systemic), sensitizing, or locally irritating | Not toxic, sensitizer, or irritant (except for some cytotoxicity in vitro, explained and mitigated) | Yes |
| Shelf Life | 21 CFR 801.435 | 5 years (based on accelerated stability) | 5 years (based on accelerated stability) | Yes |
Regarding the Study Information:
The document describes several performance tests and validations performed to demonstrate the safety and effectiveness of the device, particularly in relation to the slightly thinner design compared to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test mentioned (e.g., the number of condoms tested for air burst, leakage, or dimensions). It refers to conformance with standards like ASTM D3492-15 and ISO 10993 series, which typically define appropriate sample sizes for such testing.
The data provenance is not explicitly stated as "country of origin" for the specific test data. However, the submitter is Ansell Healthcare Products LLC, located in Iselin, NJ, USA. The testing was conducted for regulatory submission in the USA. All studies appear to be prospective, laboratory-based, and animal-based (for some biocompatibility tests), rather than retrospective human studies with specific patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of information is generally not applicable to the tests described in this 510(k) summary. The "ground truth" for these tests (e.g., dimensions, burst properties, leakage, lubricant quantity) is established by the specified standards (ASTM D3492-15) and internal quality control specifications, measured by calibrated equipment and trained technicians, not by expert consensus in a clinical evaluation sense.
For the biocompatibility studies, the "ground truth" is based on established biological evaluation standards (ISO 10993 series) and the scientific interpretation of the test results by trained toxicologists and histopathologists. The document does not specify the number or qualifications of these expert interpreters, but it would be implied that they are qualified professionals in a laboratory setting.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for clinical trials or studies where human readers interpret data (e.g., medical images) and their assessments are compared to reach a consensus for ground truth. This is not applicable to the physical and biological performance tests described here. The results of the mechanical tests are quantitative measurements against defined specifications. The biocompatibility tests involve laboratory observations and interpretations, which are then reported.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices evaluating human performance, which is not the nature of this condom submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical product (a condom), not a software algorithm or AI-driven diagnostic tool.
7. The Type of Ground Truth Used
- For Physical Testing (Dimensions, Burst Properties, Leakage, Package Integrity, Lubricant Quantity): The "ground truth" is defined by the quantitative specifications and methodology within ASTM D3492-15 Standard Specification for Rubber Contraceptives (Male Condoms). These are objective, measurable parameters.
- For Biocompatibility (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity): The "ground truth" is established through adherence to and interpretation of results from ISO 10993-5, ISO 10993-10, and ISO 10993-11 standards, which include biological assays and animal studies. The "ground truth" here is the biological response (or lack thereof) observed in the standard test systems, interpreted by qualified personnel.
8. The Sample Size for the Training Set
This product is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data an algorithm learns from. The device itself is manufactured, and its performance is tested against established standards.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an algorithm, this question is not applicable to this device submission.
§ 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.