(82 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and testing of a condom, with no mention of AI or ML technology.
No.
The document states that the device is "used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)", which aligns with preventing health issues rather than treating them.
No
Explanation: The device is a condom, used for contraception and preventing the transmission of sexually transmitted diseases. Its function is prophylactic, not diagnostic. It does not identify or analyze a disease or condition.
No
The device description clearly states it is a natural rubber latex sheath, which is a physical hardware component.
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. This is a physical barrier method used in vivo (on the body), not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The description clearly outlines a physical device (a condom) made of latex, not a reagent, instrument, or system used for testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information about a disease or condition
- Using reagents or laboratory equipment
This device falls under the category of a medical device, specifically a condom, used for physical barrier purposes.
N/A
Intended Use / Indications for Use
Kimono MicroThin with Aqua Lube / Reality Ultra Lubricated condoms are used for contraception 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
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is lubricated by a water based lubricant system.
Typical (Average) Product Characteristics are as follows:
• Straight walled, reservoir end
• Nominal length (mm): 190mm+/-10mm
• Nominal width (mm): 52 mm +/- 2mm
• Nominal thickness (mm) .04 -0.01
Kimono MicroThin with Aqua Lube: .049mm +/- 0.01
Reality Ultra Lubricated: .065mm +/- 0.01mm
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
Not Found
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)
All physical testing, air inflation testing, and other in-process and final release testing revealed results in conformance with required standards and Company specifications.
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.
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
MAR - 6 2012
Abbreviated 510(k) Notification-Rev.2
Kimono MicroThin with Aqua Lube Reality Ultra Lubricated
13686
II. 510(k) SUMMARY
| Submitted by: | Mayer Laboratories, Inc.
1950 Addison Street, Suite 101
Berkeley, CA 94704-1182 USA
Telephone:(510) 229-5300 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David P. Mayer, President
Email: davidm@mayerlabs.com |
| Date Prepared: | December 12, 2011 |
| Proprietary Name: | Kimono MicroThin with Aqua Lube
Reality Ultra Lubricated |
| Common Name: | Latex Condom |
| Classification Name: | Condom (21 CFR §884.5300) |
| Predicate Device: | Kimono MicroThin
510(k) number: K946374
Orion/XT-12
510(k) number: K872356/B
Original 510(k) submission clearance attached as
Attachment 5. |
| Description of Device: | This condom is made of a natural rubber latex
sheath, which completely covers the penis with a
closely fitted membrane. This condom is
lubricated by a water based lubricant system.
Typical (Average) Product Characteristics are as
follows:
• Straight walled, reservoir end
• Nominal length (mm): 190mm+/-10mm
• Nominal width (mm): 52 mm +/- 2mm
• Nominal thickness (mm) .04 -0.01
Kimono MicroThin with Aqua Lube:
.049mm +/- 0.01
Reality Ultra Lubricated: .065mm +/- 0.01mm |
1
Abbreviated 510(k) Notification-Rev. 2 Kimono MicroThin with Aqua Lube Reality Ultra Lubricated
510(k) SUMMARY (continued)
Intended Use: This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases.) Technological Characteristics: The basic design, composition (natural rubber latex) and manufacturer of these condoms are the same as the predicate male latex condoms, except that these condoms are lubricated with a water based lubricant system. The condom design conforms to the current edition of national and international standards: ASTM D3492 and ISO 4074. All physical testing, air inflation testing, and other in-process and final release testing revealed results in conformance with required standards and Company specifications. Accordingly, when compared to the predicate male latex condoms, the condoms intended to be introduced do not incorporate any significant changes in intended use, method of operations, materials, or design that could affect safety and effectiveness.
I:\QualityMgmlSystem\Device Master Records\Latex Condoms\Latex Condoms with Aqua Lube\510(k) submission Nov. 2011\Post Submission Communications\510(k) Abbreviated Notification-Rev.2.docx
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Mr. David P. Mayer President and CEO Mayer Laboratories, Inc. 1950 Addison Street, Suite 101 BERKELEY CA 94704
MAR - 6 2012
Re: K113686
Trade/Device Name: Kimono MicroThin with Aqua Lube / Reality Ultra Lubricated/Male Natural Rubber Latex Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: February 23, 2012 Received: February 28, 2012
Dear Mr. Mayer:
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 for abound in 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). and Oosmeter For (. 10.) has 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is elabellional 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 roublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso or ac nove a determination that your device complies with other requirements of the Act that I Dri has made a avon regulations administered by other Federal agencies. You must or any I vath all the Act's requirements, including, but not limited to: registration and listing Comply with an the Act 5 re (21 CFR Part 801); medical device reporting (reporting of medical
3
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerély vours,
Sincerely yours,
Benjamin K. Ticho
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT VII.
| 510(k) Number: | K113686 | |
|---|---|---|
| ---------------- | --------- | -- |
Kimono MicroThin with Aqua Lube / Reality Ultra Device Name: Lubricated/Male Natural Rubber Latex Condom
Indications For Use: Kimono MicroThin with Aqua Lube / Reality Ultra Lubricated condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR §801.109)
Over-The-Counter Use
Domiln Whay
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K113686
OR
A-26