(14 days)
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).
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.
This product is designed to fully conform to ISO 10993 and ISO 4074. It also conforms to ASTM D3492.
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 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.
Here’s an analysis of the provided text regarding the acceptance criteria and study for the Naked™ condom, structured as requested.
The provided text is a 510(k) summary and FDA clearance letter for a medical device (condom). It describes the device's characteristics and its substantial equivalence to predicate devices. However, it does not contain information about a study proving the device meets acceptance criteria in the manner typically understood for an AI or diagnostic imaging device. The "acceptance criteria" here refer to regulatory standards for condoms, and the "study" is more accurately a conformance to these standards, primarily through design and material properties.
It's important to note that the request's framework (e.g., test set, ground truth, MRMC study, human-in-the-loop) is primarily applicable to AI/diagnostic imaging devices, not typically for devices like condoms. The information below is extracted and adapted to the extent possible, but many sections will be marked as "Not Applicable" or "Not Provided" due to the nature of the device and the document.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Regulatory Standards) | Reported Device Performance (Conformance) |
|---|---|
| ISO 10993 (Biological evaluation of medical devices) | Product designed to fully conform to ISO 10993. |
| ISO 4074 (Natural latex rubber condoms - Requirements and test methods) | Product designed to fully conform to ISO 4074. |
| ASTM D3492 (Standard Specification for Rubber Contraceptives (Male Condoms)) | Product conforms to ASTM D3492. |
| Intended Use: Contraceptive purposes | Designed for contraceptive use. |
| Intended Use: Prophylactic purposes (preventing STDs) | Designed for prophylactic use. |
| Safety and Effectiveness: Creation of a safe, secure seal and barrier. | Design aims to ensure a safe, secure seal and barrier through a reservoir tip, integral ring, and snug fit at the base, while providing a relaxed fit along the main body. |
| Substantial Equivalence: To legally marketed predicate devices | Determined by FDA to be substantially equivalent to Oceans Seven, Intn'l The Official Condom of the 21st Century (They-Fit™) and Church & Dwight, Trojan® Magnum XL condoms. |
| Over-The-Counter Use | Indicated for Over-The-Counter Use (21 CFR 801 Subpart C). |
Study Details (Adapted for this Device Type)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a separate "test set" in the context of an AI device. Conformance to standards (ISO 10993, ISO 4074, ASTM D3492) would imply testing of product samples for various physical and biological properties. The exact number of condoms tested for these physical/material properties is not provided in this document.
- Data Provenance: Not stated. Testing to ISO and ASTM standards would typically be conducted by accredited laboratories.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. For a condom, "ground truth" relates to adherence to specified material properties and performance characteristics defined by international and national standards. This is typically assessed through laboratory tests, not expert consensus on interpretations of data.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / None. Adjudication methods like 2+1 are used in medical imaging interpretation when there's subjective assessment. For a condom, conformance to physical and biological standards is typically determined by objective measurements and passing predefined thresholds in laboratory tests.
-
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. An MRMC study is relevant for AI-assisted diagnostic or interpretive devices. This is a physical barrier contraceptive device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device does not have an "algorithm" in the context of AI or data processing. Its performance is inherent in its physical design and material properties.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" is defined by the specifications and required performance characteristics outlined in international and national standards such as ISO 10993, ISO 4074, and ASTM D3492. These standards specify physical properties (e.g., dimensions, burst pressure, freedom from holes) and biological compatibility. Conformance is determined by objective measurements against these predefined standards.
-
The sample size for the training set:
- Not Applicable. There is no "training set" in the context of AI model development for this device. The design and manufacturing process would be based on engineering principles and knowledge of material science to meet the performance standards.
-
How the ground truth for the training set was established:
- Not Applicable. As there's no training set, this question is not relevant. The "ground truth" for the device's performance is established by the engineering and regulatory standards it aims to meet.
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7 2006 APR
3. 510(k) Summary (21 CFR §807.92)
| Sponsor: | Veraxis Int'l Inc. (or "Veraxis")9663 Santa Monica Blvd., Suite 2500Beverly Hills, CA 90210(646) 285-7714 |
|---|---|
| Contact: | Jules T. Mitchel, PresidentTarget Health Inc.261 Madison Avenue, 24th FloorNew York, NY 10016Tel: (212) 681-2100Fax: (212) 682-2105JulesMitchel@TargetHealth.com |
| Date: | February 23, 2006 |
| Name of theDevice: | Trade Name: Naked™ |
| Common Name: Condom | |
| Classification Name: Condom 884.5300 Class II (Product CodeHIS). | |
| SubstantialEquivalence: | The Veraxis Naked™ condom is equivalent in intended use andtechnological characteristics to Oceans Seven, Intn'l The OfficialCondom of the 21st Century (They-Fit™) condoms and Church &Dwight, Trojan® Magnum XL condoms. |
| DeviceDescription: | By creating an actual physical barrier between partners engaged insexual activity, the condom represents the best available solutionto two of the world's major health challenges: sexually transmitteddiseases/AIDS and unwanted pregnancy. |
| The design of the condom is essential to its effectiveness. Theclosed end has a reservoir tip to contain semen. The condomdescribed herein has an integral ring at its base and a snug fitalong its lower portion in order to ensure a safe, secure seal andbarrier. | |
| Although standard condoms are one of the few over-the-counter,non-prescription contraceptives, condoms have many deficienciesthat limit their usage among sexually active populations: (i) they areuncomfortable, (ii) they do not transmit sensation well, and (iii) theyAIDS epidemic, and the high risk involved in unprotected sex, asignificant portion of sexually active populations decline to usecondoms or use them only occasionally. |
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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.
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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.
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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
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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
Page 1 of
007
§ 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.