KWIKEZE MALE CONDOM APPLICATOR

K031007 · Condax, LLC · HIS · Nov 14, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K031007
• Device Name: KWIKEZE MALE CONDOM APPLICATOR
• Applicant: Condax, LLC
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Nov 14, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

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)

Device Story

Kwikeze Male Condom Applicator is an elliptical polyethylene plastic ring; packaged in a collapsed state held by a polyurethane band with a condom positioned within inner folds. Upon removal of the band, the applicator expands to its original oval shape, stretching the attached condom to facilitate insertion and correct positioning on an erect penis. Used by consumers in a home setting. After the condom is donned, the applicator is discarded. The device ensures correct orientation of the condom, contributing to more effective and correct usage.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Single-use elliptical ring; material: polyethylene plastic; held in collapsed configuration by a polyurethane band. Designed for use with condoms conforming to ASTM Latex Condom Standard D3492. Non-electronic, mechanical device.

Indications for Use

Indicated for individuals using male latex condoms for contraception and prevention of pregnancy and sexually transmitted diseases. Facilitates correct donning of the condom on the erect penis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Mentor Plus Condom (K874383)

Submission Summary (Full Text)

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K031007

## Abbreviated 510 (k) Notification for a Male Condom Applicator

## 11. 510(k) SUMMARY

| Submitted By: | CONDAX, LLC<br>245 24th Street<br>New York, NY 10010 | Telephone: [phone]<br>Fax: [phone] |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Contact Person(s): | Leon B. Kassman<br>President, CONDAX, LLC | |
| | Eli J. Carter, Consultant<br>1219 Little Creek Road<br>Durham, North Carolina 27713<br>Telephone: [phone]<br>Fax: [phone] | |

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 [phone]. 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 [phone] or [phone], 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<br>(donning) of a male latex condom prior to sexual intercourse. The<br>condom is used for contraceptive and for prophylactic purposes (to help<br>prevent pregnancy and the transmission of sexually transmitted<br>diseases) |

## (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 | <img alt="" src="image_0.png"/> |
|----------------------|---------------------------------|
|----------------------|---------------------------------|

Nancy C. Broadon
(Division Sign-Off)

Division of Reproductive, Abdomi nal. and Radiological Device 510(k) Number.