(14 days)
Not Found
Not Found
No
The device description focuses on the physical design and materials of a condom, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a contraceptive and prophylactic to prevent pregnancy and the transmission of sexually transmitted diseases. While it addresses health issues, it does not treat or cure a disease or condition, which is characteristic of a therapeutic device.
No
The device description clearly states its purpose as a physical barrier for contraception and prevention of sexually transmitted diseases, not for diagnosing conditions.
No
The device description clearly describes a physical barrier (condom) made of material, not software. It discusses physical characteristics like reservoir tips, rings, fit, and size, and references physical product standards (ISO and ASTM).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prevention of sexually transmitted diseases by creating a physical barrier. This is a mechanical function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description focuses on the physical properties and design of the condom as a barrier. It doesn't mention any components or processes for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition or disease.
- Regulatory Standards: The mentioned standards (ISO 10993, ISO 4074, ASTM D3492) are relevant to medical devices, particularly those involving materials and physical properties, but not specifically to IVDs.
- Predicate Devices: The predicate devices are other condoms, which are also not IVDs.
An In Vitro Diagnostic device is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This description clearly indicates a physical barrier device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Veraxis Int'l Inc. Naked™ condom is to be used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Product codes (comma separated list FDA assigned to the subject device)
HIS
Device Description
By creating an actual physical barrier between partners engaged in sexual activity, the condom represents the best available solution to two of the world's major health challenges: sexually transmitted diseases/AIDS and unwanted pregnancy.
The design of the condom is essential to its effectiveness. The closed end has a reservoir tip to contain semen. The condom described herein has an integral ring at its base and a snug fit along its lower portion in order to ensure a safe, secure seal and barrier.
The design of the Naked™ condom described herein addresses these deficiencies so that condom usage will significantly improve among sexually active populations. The condom described herein provides a slightly relaxed fit along the main body of the product between the snug base and reservoir tip. This relaxed fit provides a more natural feel during intercourse, an easier application process, and improved sensation, while maintaining a safe, secure seal and barrier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Oceans Seven, Intn'l The Official Condom of the 21st Century (They-Fit™) condoms, Church & Dwight, Trojan® Magnum XL condoms
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
7 2006 APR
3. 510(k) Summary (21 CFR §807.92)
| Sponsor: | Veraxis Int'l Inc. (or "Veraxis")
9663 Santa Monica Blvd., Suite 2500
Beverly Hills, CA 90210
(646) 285-7714 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jules T. Mitchel, President
Target Health Inc.
261 Madison Avenue, 24th Floor
New York, NY 10016
Tel: (212) 681-2100
Fax: (212) 682-2105
JulesMitchel@TargetHealth.com |
| Date: | February 23, 2006 |
| Name of the
Device: | Trade Name: Naked™ |
| | Common Name: Condom |
| | Classification Name: Condom 884.5300 Class II (Product Code
HIS). |
| Substantial
Equivalence: | The Veraxis Naked™ condom is equivalent in intended use and
technological characteristics to Oceans Seven, Intn'l The Official
Condom of the 21st Century (They-Fit™) condoms and Church &
Dwight, Trojan® Magnum XL condoms. |
| Device
Description: | By creating an actual physical barrier between partners engaged in
sexual activity, the condom represents the best available solution
to two of the world's major health challenges: sexually transmitted
diseases/AIDS and unwanted pregnancy. |
| | The design of the condom is essential to its effectiveness. The
closed end has a reservoir tip to contain semen. The condom
described herein has an integral ring at its base and a snug fit
along its lower portion in order to ensure a safe, secure seal and
barrier. |
| | Although standard condoms are one of the few over-the-counter,
non-prescription contraceptives, condoms have many deficiencies
that limit their usage among sexually active populations: (i) they are
uncomfortable, (ii) they do not transmit sensation well, and (iii) theyAIDS epidemic, and the high risk involved in unprotected sex, a
significant portion of sexually active populations decline to use
condoms or use them only occasionally. |
1
The design of the Naked™ condom described herein addresses these deficiencies so that condom usage will significantly improve among sexually active populations. The condom described herein provides a slightly relaxed fit along the main body of the product between the snug base and reservoir tip. This relaxed fit provides a more natural feel during intercourse, an easier application process, and improved sensation, while maintaining a safe, secure seal and barrier.
This product is designed to fully conform to ISO 10993 and ISO 4074. It also conforms to ASTM D3492.
The Veraxis Int'l Inc. Naked ™ condom is to be used for Intended Use: contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
The Veraxis Int'l Inc. Naked ™ condom is indicated for Over-The-Counter Use (21 CFR 801 Subpart C)
Technological Characteristics: This condom has the same technical characteristics as the predicate condoms identified above. The product described herein features a slightly relaxed fit along the main body of the product. The relaxed fit at the closed end of the condom provides a greater lay flat width than the width of the snug base and safety seal it creates at the open end of the condom. The nature and value of the relaxed fit is well expressed by Ansell Incorporated, the second largest manufacturer of condoms in the world, in an article in Mens Journal in April of 1998:
"For 20 years this industry has been telling people that thinner condoms are better, more sensitive, but really, you can't tell the difference between the standard thickness of .07 mm and the thin condom of .05 mm. The real difference is looseness (the relaxed fit), which allows for friction between the penis and the latex and the vaginal wall."
The Naked ™ condom comes in a range of sizes that provide increased customization for each individual which makes for a safer, more secure, and better fit. These two technical characteristics (relaxed fit and various sizes) maximize product effectiveness and sensation, and thereby increase product usage among the sexually active populations.
As stated in the product description, this product is designed to fully conform to ISO 10993 and ISO 4074. It also conforms to ASTM D3492.
2
Image /page/2/Picture/2 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the top half of the circle. In the center of the circle is a stylized image of an eagle with three lines representing its wings. The logo is black and white and appears to be a seal or emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 7 2006
Veraxis Int'l Inc. c/o Mr. Jeffrey D. Rongero Senior Project Engineer Conformity Assessment Services Underwriters Laboratories, Inc. Research Triangle Park Division 12 Laboratory Drive P.O. Box 13995 RESEARCH TRIANGLE PARK NC 27709-3995
Re: K060797
Trade/Device Name: Naked™ Condom Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: March 17, 2006 Received: March 24, 2006
Dear Mr. Rongero:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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 comply 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 forth in the quality systems (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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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/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
KO6797
2. Indication for Use
510(k) Number (if known): NHA KO60797
Device Name: Naked™ male natural rubber latex condom
Indications For Use: The Veraxis Int'l Inc. Naked™ condom is to be used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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