(396 days)
Not Found
No
The device description and performance studies focus on the mechanical function and material properties of a physical applicator, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a condom applicator, intended to facilitate correct positioning of a condom for contraceptive and prophylactic (STI prevention) purposes, not for treating a disease or medical condition.
No
Explanation: The device is a condom applicator, designed to facilitate the correct positioning of a male latex condom. Its intended use is for contraception and prophylaxis, not for diagnosing any medical condition or disease.
No
The device description clearly states it is a "bell shaped pouch that is open at one end and closed at the other" and "molded from polyethylene plastic," indicating it is a physical hardware device.
Based on the provided information, the Zeus™ Male Condom Applicator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This device is used externally on the penis.
- IVD devices are intended to provide information about a physiological state, health, or disease. This device is a mechanical aid for applying a condom for contraception and STI prevention.
- The intended use and device description clearly outline its function as a tool for condom application. There is no mention of analyzing biological samples or providing diagnostic information.
The device's function is purely mechanical and related to the physical application of a barrier device (the condom).
N/A
Intended Use / Indications for Use
The Zeus™ Male Condom Applicator facilitates the correct orientation of the condom with respect to the penis and therefore contributes to more effective and correct donning of the condom. Once the condom is positioned on the penis and prior to intercourse, the applicator is discarded.
The Zeus™ Male Condom Applicator facilitates correct positioning (donning) of a male latex condom prior to sexual intercoursc. The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Product codes
HIS
Device Description
The Zeus™ Male Condom Applicator is a bell shaped pouch that is open at one end and closed at the other. It is molded from polyethylene plastic. The applicator is designed to hold a latex condom in place for correct donning onto an erect penis. All surfaces and edges of the applicator are rounded to prevent damage to condom. Silicone or water-based lubricant is added to the condom prior to packaging.
Approximately 2.5 inches of the condom is unrolled and lies nestled, but not firmly held, within the walls of the applicator. The width of the applicator at the point where the condom is attached is 54mm thus enabling a 52mm (nominal width) condom to be held prior to use without imparting a permanent stretch to the condom. The applicator and condom are packaged and sealed in an aluminum foil wrapper.
The applicator and attached condom are removed together from the package prior to use. The user cups the device in either hand and then, during the application process, squeezes the edges of the applicator which forces the sides to bellow-out, and thus opens the attached condom The device is centered over the head of the penis and is lowered to a point that the penis makes contact with the interior condom wall. The user then uses his thumb to unroll the condom from the applicator and onto the penis. The user continues to unroll the bead as far down the penis as possible. The applicator is removed from the penis and discarded (prior to intercourse).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
user
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability: The applicator with attached condom was subjected to accelerated aging conditions to determine the potential shelf-life (expiration date) of the product. Tests were performed on three lots of condoms attached to the applicator after 7 days @70°C and 90 days @50℃. The applicator was also evaluated after conditioning. The results of this study show that both applicator and condoms remained compliant with ASTM D3492 airburst requirements after aging.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
| Abbreviated 510 (k) Notification for a Male Condom Applicator | Page 5 of 14 | |||
|---|---|---|---|---|
| K052206 | ||||
| II. | 510(k) SUMMARY | |||
| Submitted By: | CONDAX, LLC | |||
| 245 24th Street | ||||
| New York, NY 10010 | ||||
| Telephone: 212 779 3930 | ||||
| Fax: 212 696 0330 | ||||
| Email: condax@nyr.rr.com | SEP 1 2 2006 | |||
| Contact Person(s): | Leon B. Kassman | |||
| President, CONDAX, LLC | ||||
| Telephone: 212 779 3930 | ||||
| Eli J. Carter, Consultant | ||||
| Telephone: 919 544 4098 | ||||
| Email: carterej@aol.com | ||||
| Date Prepared: | August 5, 2005 | |||
| Proprietary Name: | Zeus™ Male Condom Applicator | |||
| Common Name: | Condom Applicator | |||
| Classification Name: | Not Classified | |||
| Predicate Device: | Kwikeze™ Male Condom Applicator (K031007) | |||
| Description of Device: | The Zeus™ Male Condom Applicator is a bell shaped pouch that is | |||
| open at one end and closed at the other. It is molded from polyethylene | ||||
| plastic. The applicator is designed to hold a latex condom in place for | ||||
| correct donning onto an erect penis. All surfaces and edges of the | ||||
| applicator are rounded to prevent damage to condom. Silicone or | ||||
| water-based lubricant is added to the condom prior to packaging. | ||||
| Approximately 2.5 inches of the condom is unrolled and lies nestled, | ||||
| but not firmly held, within the walls of the applicator. The width of | ||||
| the applicator at the point where the condom is attached is 54mm thus | ||||
| enabling a 52mm (nominal width) condom to be held prior to use | ||||
| without imparting a permanent stretch to the condom. The applicator | ||||
| and condom are packaged and sealed in an aluminum foil wrapper. | ||||
| The applicator and attached condom are removed together from the | ||||
| package prior to use. The user cups the device in either hand and then, | ||||
| during the application process, squeezes the edges of the applicator | ||||
| which forces the sides to bellow-out, and thus opens the attached | ||||
| condom The device is centered over the head of the penis and is | ||||
| lowered to a point that the penis makes contact with the interior | ||||
| condom wall. The user then uses his thumb to unroll the condom from | ||||
| the applicator and onto the penis. The user continues to unroll the bead | ||||
| as far down the penis as possible. The applicator is removed from the | ||||
| penis and discarded (prior to intercourse). |
. . . . . . .
1
Abbreviated 510(k) Notification for a Male Condom Applicator
p, zofz
Intended Use of the Device:
The Zeus™ Male Condom Applicator facilitates the correct orientation of the condom with respect to the penis and therefore contributes to more effective and correct donning of the condom. Once the condom is positioned on the penis and prior to intercourse, the applicator is discarded.
Technological Characteristics:
The Zeus™ 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 intercourse. 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 prodicate device identified above. Condom(s) used with the device shall have 510(k) clearance and shall conform to ASTM Latex Condom Standard D3492.
Stability: The applicator with attached condom was subjected to accelerated aging conditions to determine the potential shelf-life (expiration date) of the product. Tests were performed on three lots of condoms attached to the applicator after 7 days @70°C and 90 days @50℃. The applicator was also evaluated after conditioning. The results of this study show that both applicator and condoms remained compliant with ASTM D3492 airburst requirements after aging.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 1 2 2006
Condax LLC c/o Mr. Eli J. Carter Consultant 1219 Little Creck Road P.O. Box 12139 DURHAM NC 27709
Re: K052206
Trade/Devicc Name: Zeus™ Male Latex Condom Applicator Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: July 13, 2006 Received: July 17, 2006
Dear Mr. Carter:
We have reviewed your Section 510(k) premarket notification of intent to market the device WE nave reviewed your Bection 910(x) premailer is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commence use stated in the encrosury manelet planticity plant of the Medical Device Amendments, or to devices that prior to May 26, 1770, the chaolment and the no visions of the Federal Food, Drug, and Cosmetic have been reclassified in accordine infla premarket approval application (PMA). You may, Act (Act) that do not require approval othe general controls provisions of the Act. The general therefore, mations of the Act include requirements for annual registration, listing of devices, good controls provisions of the merade prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (Premarket IT your device is classifica (see above) mico and controls. Existing major regulations affecting your Apploval), it the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA device our be found mouncements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo includes the text "1906 - 2006" at the top and "Centennial" in the middle. Below the logo is the text "Protecting and Promoting Public Health".
3
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toals of a noved a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or cary I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF N Fart 60773 laceming (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) r ms lotet natification. The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-011 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-011 |
| 21 CFR 894.xxx | (Radiology) | 240-276-012 |
| Other | 240-276-010 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/edrlv/industry/support/index.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
Enclosure
4
INDICATIONS FOR USE STATEMENT
Male Condom Applicator Device Name The Zeus™ Male Condom Applicator facilitates correct positioning Indications for Use: (donning) of a male latex condom prior to sexual intercoursc. The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Prescription Use (Per 21 CFR 801, Subpart D) OR
مل Over-the-Counter Use __ (Per 21CFR 801, Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seyram
Division Sign Off
Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K052206