(75 days)
Extra strength lubricated rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic.
Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested."
Additional Statement: This condom contains a latex condom and a spermicidal lubricant. The spermicide, Nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of preguancy if you lose your erection before withdrawal and some spill outside the condom. However the extent of the decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom
The device which is the subject of this application is a latex rubber condom (Class II medical device defined as "Condom (rubber) Contraceptive 85-LTZ") and is defined by ASTM 3492-93 as a Type I, Style 2, Class A rubber condom, and further defined by ISO 4074-6 (currently under revision). The device which is defined by these standards is also lubricated, contains a spermicide (Nonoxynol-9) and for the purposes of selection for labeling as "extra strength" is tested in the strength categories to a higher standard (See Exhibit A in K970791 as well as Exhibit 1) with added FDA certified color. The purpose of this medical device is for the prevention of pregnancy and the protection against sexually transmitted diseases, including HIV.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Custom Services International, Inc. condom device (K972430):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Minimum Requirements) | Reported Device Performance |
|---|---|
| Leakage: AQL 0.4 (no more than 4 devices per 1000) | "be free of holes and leaks at an AQL level of .4" "The applicant medical device meets the standards required" |
| Air Burst: 1 mPa to 20 liters of air at an AQL of 1.5 (per ISO 4074-6) | "air burst testing per ISO 4074-6 (under revision) of 1 mPa to 20 liters of air at an AQL of 1.5" "The applicant device has been tested and has met or exceeded all the voluntary standards concerning the applicant medical device" |
| Tensile Strength: Not less than 15 mPa | "tensile strength of not less than 15 mPa" "The strength standards (tensile, breaking force, thickness, and air burst) have been increased by the applicant to justify the addition of the term 'extra strength'... will meet all of the mechanical requirements outlined for the device covered by K970791" |
| Minimum Breaking Force: 18 N | "minimum breaking force of 18 N" "The strength standards (tensile, breaking force, thickness, and air burst) have been increased by the applicant to justify the addition of the term 'extra strength'... will meet all of the mechanical requirements outlined for the device covered by K970791" |
| Minimum Elongation: 625% | "minimum elongation of 625%" |
| Nonoxynol-9 Spermicide Content: Minimum 25 mg per device (SOP#2-021 specifies 30 mg ± 5 mg) | "each device contain a minimum amount of 25 mg. of Nonoxynol-9 spermicide." "SOP#2-021 which requires an independent insertion of the Nonoxynol-9 in the amount of 30 mg. ± 5 mg." "This testing includes Nonoxynol-9 content for shelf life data to prove and assure that the production process produced devices which were in compliance with the required standards" |
| Dimensions (ASTM 3492-93): 180 mm ± 20 mm length, 52 mm ± 2 mm width, .05 mm minimum thickness | "180 mm ± 20 mm in length, 52 mm ± 2 mm in width, .05 mm in thickness at a minimum, meeting all standards established by the predication K970791." |
| Colorfastness: AQL 0.50 (for colored devices) | "colorfastness verified. Colorfastness testing is designed to demonstrate that the color does not migrate from the device." "The applicant also verifies that the colorant is colorfast by testing to an AQL level of .50." |
| Shelf Life: 2 years (based on Nonoxynol-9, latex component meets 5-year standard) | "meet or exceed the voluntary standards at the end of the shelf life." "The applicant, however, intends to label its medical device for a two year shelf life based on the shelf testing of its supplier of Nonoxynol-9." "The latex component used in its medical devices comply with a five year standard." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Production samples were collected over "ten 8 hours shifts, spread over multiple days." These samples were divided in half to create "as manufactured" and "aged" samples.
- Specific numerical sample sizes (e.g., number of condoms per shift) are not provided in the text.
- Data Provenance: The manufacturing facility is located in the Peoples Republic of China. The testing involved "in process" samples and "aged" samples. The text does not explicitly state whether the data is prospective or retrospective, however, the description of collecting samples over production shifts and then subjecting them to aging tests suggests a prospective approach to gather data for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the use of human experts to establish "ground truth" for the device's physical and chemical properties. The ground truth for these properties is established by adherence to recognized industry standards (ASTM 3492-93, ISO 4074-6) and internal specifications.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to the device performance against objective, quantitative standards, not subjective assessments requiring expert 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 device (condom), not an imaging or diagnostic AI product, so MRMC studies are not relevant.
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 medical device and does not involve an AI algorithm. The performance evaluation is based on direct physical and chemical testing of the condom itself.
7. The Type of Ground Truth Used
The ground truth used for this device's acceptance is based on:
- Industry Standards: ASTM 3492-93 and ISO 4074-6 (currently under revision). These standards define the physical properties and leakage/air burst requirements.
- Regulatory Guidance: FDA guidance on spermicide content (minimum 25 mg Nonoxynol-9).
- Internal Specifications: The applicant's own "increased standards" for "extra strength" properties (e.g., tensile strength greater than 20% of the standard, other categories 10% greater).
- Laboratory Verification: Tested parameters were "independently verified by an FDA certified independent laboratory" (Nelson Laboratories, Inc.).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set." The manufacturing process data is used for process validation and quality assurance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 884.5310 Condom with spermicidal lubricant.
(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).