(228 days)
The Kwikeze Male Condom Applicator facilitates correct positioning (donning) of a male latex condom prior to sexual intercourse. The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
The Kwikeze™ Male Condom Applicator is an elliptical ring made of polyethylene plastic. When packaged, the applicator is collapsed on self-scored lines in a manner that allows the condom to be loosely positioned within the inner-folds of the ring. The collapsed applicator is held in position with a polyurethane band. The condom is stretched slightly to position it on top of the applicator. This configuration allows the condom to rest un-stretched until time of use. After opening the sealed foil package, and prior to use, the band is removed allowing the ring and condom to expand to its original oval shape. The device when pulled opened expands the attached condom enough to allow for easy insertion and correct positioning of the condom on the erect penis.
This document is a 510(k) summary for the Kwikeze™ Male Condom Applicator. It's a pre-market notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The document does not contain specific acceptance criteria or an explicit study proving the device meets those criteria, as such detailed performance data is typically not required for a 510(k) submission unless an entirely new technological principle is involved.
For devices like a condom applicator, the substantial equivalence relies more on demonstrating that the new device does not raise new questions of safety or effectiveness compared to the predicate, and that it performs as intended without compromising the function of the condom itself. The key elements presented are:
- Intended Use: The Kwikeze™ applicator facilitates correct orientation and donning of a male condom for contraception and prophylactic purposes, similar to the predicate device.
- Technological Characteristics: It's a single-use polyethylene plastic ring. Condoms used with it must have 510(k) clearance and conform to ASTM Latex Condom Standard D3492. This emphasizes that the primary safety and effectiveness of the condom itself is established separately, and the applicator's role is ergonomic.
Given the nature of the device and the 510(k) summary, the document does not include detailed clinical study data with acceptance criteria for performance metrics like sensitivity, specificity, or reader agreement, which are typically found in submissions for diagnostic or more complex therapeutic devices.
Therefore, many of the requested fields cannot be directly answered from the provided text.
Here's an attempt to fill in the table and information based on the provided text, noting where information is not available due to the nature of a 510(k) for this type of device:
1. Table of acceptance criteria and the reported device performance
| Criteria Category | Acceptance Criteria (Not Explicitly Stated in 510(k) Summary) | Reported Device Performance (Implied from 510(k) Summary) |
|---|---|---|
| Intended Use | Facilitates correct condom positioning for contraception and disease prevention (must be substantially equivalent to predicate). | "Has the same intended use as the predicate device." "Facilitate correct orientation of the condom... contribute to more effective and correct donning." |
| Material Safety | Device materials are safe for intended use (e.g., non-irritating, non-toxic). | Made of polyethylene plastic, which is generally inert and used in medical devices. |
| Functionality | Successfully expands and positions a condom for easy donning. | "The device when pulled opened expands the attached condom enough to allow for easy insertion and correct positioning of the condom on the erect penis." |
| Compatibility | Compatible with 510(k) cleared condoms meeting ASTM D3492. | "Condom(s) used with the device shall have 510(k) clearance and shall conform to ASTM Latex Condom Standard D3492." |
| Single Use | Clearly indicates single-use and disposability. | "Designed as a SINGLE USE ONLY device." "That precaution is included in the Instructions for Use." |
| No New Safety Concerns | Does not introduce new safety or effectiveness concerns compared to the predicate device. | Implied by the FDA's "substantially equivalent" determination. |
"The study that proves the device meets the acceptance criteria"
The provided document does not describe a specific study with quantitative data to demonstrate meeting acceptance criteria in the typical sense of a clinical trial for a diagnostic or therapeutic device. Instead, the 510(k) process for a device like this relies on demonstrating "substantial equivalence" to a predicate device based on:
- Similar intended use.
- Similar technological characteristics impacting safety and effectiveness.
- Meeting recognized standards (e.g., ASTM for condoms used with the applicator).
- Not raising new questions of safety or effectiveness.
The FDA's letter of "substantial equivalence" (K031007) is the primary "proof" that the device is deemed safe and effective for its intended use, based on the information provided in the 510(k) submission, which would include descriptions of the device, its function, materials, and comparison to the predicate. The 510(k) summary provided here is a high-level overview.
Detailed Information (as far as available from the text):
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document does not describe a test set or specific performance data from a study. As a condom applicator, its primary safety and effectiveness are tied to whether it aids in correct condom placement without damaging the condom or harming the user. Such assessment might involve usability testing or non-clinical verification, but details are not provided here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Available. There is no mention of a "test set" requiring ground truth established by experts in the context of this 510(k) summary.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. No test set or adjudication method is described.
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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 is not relevant to a condom applicator, which is a physical medical device, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithmic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available. No formal "ground truth" as typically defined for diagnostic performance is mentioned. The ground truth for this type of device would likely be its ability to correctly apply a condom without tearing or misplacement, and this would be assessed through usability and non-clinical testing rather than expert-adjudicated clinical cases.
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The sample size for the training set
- Not Applicable / Not Available. The document does not describe a training set for an algorithm.
-
How the ground truth for the training set was established
- Not Applicable / Not Available. The document does not describe a training set for an algorithm.
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Abbreviated 510 (k) Notification for a Male Condom Applicator
11. 510(k) SUMMARY
| Submitted By: | CONDAX, LLC245 24th StreetNew York, NY 10010 | Telephone: 212 779 3930Fax: 212 696 0330 |
|---|---|---|
| Contact Person(s): | Leon B. KassmanPresident, CONDAX, LLC | |
| Eli J. Carter, Consultant1219 Little Creek RoadDurham, North Carolina 27713Telephone: 919 544 4098Fax: 919 544 5849 |
Date Prepared: March 27, 2003
Kwikeze Male Condom Applicator Proprietary Name:
Common Name: Condom Applicator
Classification Name: Not Classified
Mentor Plus Condom; K874383 Predicate Device:
The Kwikeze™ Male Condom Applicator is an elliptical ring made of Description of Device: polyethylene plastic. When packaged, the applicator is collapsed on self-scored lines in a manner that allows the condom to be loosely positioned within the inner-folds of the ring. The collapsed applicator is held in position with a polyurethane band. The condom is stretched slightly to position it on top of the applicator. This configuration allows the condom to rest un-stretched until time of use. After opening the sealed foil package, and prior to use, the band is removed allowing the ring and condom to expand to its original oval shape. The device when pulled opened expands the attached condom enough to allow for easy insertion and correct positioning of the condom on the erect penis.
Intended Use of the Device:
The Kwikeze™ Male Condom Applicator has the same intended use as the predicate device. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). Both the applicator in the predicate device and the Kwikeze™ Applicator facilitate correct orientation of the condom with respect to the penis and therefore contribute to more effective and correct donning of the condom. Once the condom is positioned on the penis, the applicator is discarded.
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Technological Characteristics:
The Kwikeze™ applicator is designed as a SINGLE USE ONLY device. After donning of the condom, the applicator will be discarded; the condom will also be discarded after use. That precaution is included in the Instructions for Use.
Although different in design and appearance, this product has the same basic technological function as the predicate device identified above. Condom(s) used with the device shall have 510(k) clearance and shall conform to ASTM Latex Condom Standard D3492.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2003
Condax, LLC % Mr. Eli J. Carter Consultant 1219 Little Creek Rd. DURHAM NC 27713
Re: K031007
Trade Name/Device: Kwikeze™ Condom Applicator Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulation Number: 21 CFR 884.5310 Regulation Name: Condom with spermicidal lubricant Regulatory Class: Class II Product Code: 85 HIS and LTZ Dated: October 22, 2003 Received: October 28, 2003
Dear Mr. Carter:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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Page 2 - Mr. Carter
predicate device results in a classification for your device and thus, permits your device to proceed to the market.
Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR §884.5300 and 8884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in §801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, §801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 8801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in §801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR §807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html":
Sincerely yours.
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT VII.
| 510(k) Number | Not Known K031007 |
|---|---|
| Device Name | Male Natural Rubber Latex Condom |
| Indications for Use: | The Kwikeze Male Condom Applicator facilitates correct positioning(donning) of a male latex condom prior to sexual intercourse. Thecondom is used for contraceptive and for prophylactic purposes (to helpprevent pregnancy and the transmission of sexually transmitteddiseases) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEED Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | --------------------------------- |
Nancy C. Broadon
(Division Sign-Off)
Division of Reproductive, Abdomi nal. and Radiological Device 510(k) Number.
§ 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.