(90 days)
No
The device description and performance studies focus on the physical properties and compatibility of a personal lubricant and condom, with no mention of AI or ML technology.
No.
The device's intended use is to enhance comfort and ease during intimate activity and to reduce the risk of transmission of HIV and other STDs through condom use, rather than to treat, cure, mitigate, or prevent disease directly by itself.
No
The device description and intended use clearly state that this product is a convenience kit containing a personal lubricant and a condom, intended to enhance comfort and ease intimate activity, and to reduce the risk of transmission of HIV and other STDs. There is no mention of diagnostic functionalities.
No
The device description clearly states it is a "convenience kit that provides a latex condom and a personal lubricant separately wrapped in the same outer package." This indicates the device is a physical product containing hardware (condom) and a substance (lubricant), not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enhance the comfort and ease of intimate activity" and the condom component is intended to "reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases". These are not diagnostic purposes.
- Device Description: The device is a personal lubricant and a condom. Neither of these components are designed to diagnose a condition or disease.
- Lack of Diagnostic Language: The text does not contain any language related to diagnosing, testing for, or identifying any medical condition or substance.
- Performance Studies: The performance studies described focus on the compatibility of the lubricant with condoms and biological evaluation for safety, not diagnostic accuracy.
IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The Key West Fragrance & Cosmetic Factory, Inc. Just Between Us™ Personal Lubricant & Condom convenience kit is intended to enhance the comfort and ease of intimate activity. The personal lubricant is compatible with latex condoms.
If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.
Product codes (comma separated list FDA assigned to the subject device)
85 HIS
Device Description
The Just Between Us™ Personal Lubricant and Condom kit is a non-sterile convenience kit that provides a latex condom and a personal lubricant separately wrapped in the same outer package. The condom is legally manufactured and marketed pursuant to 510(k) K910550 by the London International Corporation. Key West Fragrance & Cosmetic Factory, Inc. will manufacture the personal lubricant. The personal lubricant is non-staining, water-soluble, glycerine and water based lubricant containing Aloe Vera Gel.
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)
The Just Between Us™ Personal Lubricant was used to treat condoms that were subsequently tested in accordance with ASTM D 3492-97. The Just Between Us™ Personal Lubricant and Condom did not have a significant effect on the performance of the condom. The Just Between Us™ Personal Lubricant was tested and found to meet the in vivo test requirements of ISO 10993-1, Biological evaluation of medical devices-Part 1: Guidance on the selection of tests.
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.
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
Summary of Safety and Effectiveness
OCT 2 9 1998
Just Between Us™ Personal Lubricant & Condom submitted by Key West Fragrance & Cosmetic Factory, Inc. 524 Front Street Kev West. FL 33040 Phone: (305) 294-5592 Facsimile: (305) 294-0138
Identification of a Legally Marketed Predicate Devices
The Personal Lubricant used in this convenience kit is substantially equivalent to the following legally manufactured and marketed devices.
- K-Y® Brand Liquid™ Personal Lubricant manufactured by Ortho Phar-● maceutical Corporation pursuant to 510(k) K955648
- WonderGel® Personal Liquid Gel manufactured by Lake Consumer Prod-. ucts. Inc. pursuant to 510(k) K903910
Device Description
The Just Between Us™ Personal Lubricant and Condom kit is a non-sterile convenience kit that provides a latex condom and a personal lubricant separately wrapped in the same outer package. The condom is legally manufactured and marketed pursuant to 510(k) K910550 by the London International Corporation. Key West Fragrance & Cosmetic Factory, Inc. will manufacture the personal lubricant. The personal lubricant is nonstaining, water-soluble, glycerine and water based lubricant containing Aloe Vera Gel.
Intended Use
The Key West Fragrance & Cosmetic Factory, Inc. Just Between Us™ Personal Lubricant & Condom convenience kit is intended to enhance the comfort and ease of intimate activity. The personal lubricant is compatible with latex condoms.
1
Summary of Technological Characteristics
The table below compares the technological characteristics of the Just Between UsTM Personal Lubricant to the predicate devices.
| Feature | The Just Between
USTM | K-Y® Brand LiquidTM
Personal Lubricant | WonderGel® Per-
sonal Liquid Gel |
|------------------------------------|------------------------------------------------|-------------------------------------------|-------------------------------------|
| Manufacturer | Key West Fragrance &
Cosmetic Factory, Inc. | Ortho Pharmaceutical
Corporation | Lake Consumer Prod-
ucts, Inc. |
| Contains purified
water | Yes | Yes | Yes |
| Contains glycerine | Yes | Yes | Yes |
| Contains Aloe Vera
Gel | Yes | No | Yes |
| Contains Methyl-
paraben | Yes | Yes | Yes |
| Labeled Non-staining | Yes | Yes | Yes |
| Labeled odorless and
tasteless | Yes | No | Yes |
| Container Material | Plastic | Plastic | Plastic |
| Sterile | No | No | No |
| Labeled safe with
latex condoms | Yes | Yes | Yes |
Summary of Performance Data
The Just Between Us™ Personal Lubricant was used to treat condoms that were subsequently tested in accordance with ASTM D 3492-97.4 The Just Between Us™ Personal Lubricant and Condom did not have a significant effect on the performance of the condom. The Just Between Us™ Personal Lubricant was tested and found to meet the in vivo test requirements of ISO 10993-1, Biological evaluation of medical devices-Part 1: Guidance on the selection of tests.
The Just Between Us™ Personal Lubricant and Condom is substantially equivalent to K-Y Brand Liquid™ Personal Lubricant manufactured by Ortho Pharmaceutical Corporation pursuant to 510(k) K955648 and WonderGel® Personal Liquid Gel manufactured by Lake Consumer Products, Inc. pursuant to 510(k) K903910.
Since the HPBT meets the requirements of the stated standards and embodies technological characteristics essentially identical to the predicate device, we believe the device is
Key West Fragrance & Cosmetic Factory, Inc.
4 Standard Specification for Rubber Contraceptives (Male Condoms) American Society for Testing and Materials Designation D 3492-97 (1997)
2
safe and effective and performs as well as or better than the predicate devices. The Just Between UsTM Personal Lubricant and Condom convenience kit will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.
3
Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & H. MA." arranged around the top half of the circle. In the center of the logo is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1998
Mr. Joseph R. Liszka President Key West Fragrance & Cosmetic Factory, Inc. 524 Front Street Key West, FL 33040
Re: K982673
Just Between Us™, Personal Lubricant and Condom Dated: July 24, 1998 Received: July 31, 1998 Regulatory Class: II 21 CFR 884.5300/Procode: 85 HIS
Dear Mr. Liszka:
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 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. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmadsmam.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use . . .
Page 1 of 1
510(k) Number (if known):
Device Name Just Between Us™ Personal Lubricant & Condom
Indications for Use:
The Key West Fragrance & Cosmetic Factory, Inc. Just Between Us™ Personal Lubricant & Condom convenience kit is intended to enhance the comfort and ease of intimate activity. The personal lubricant is compatible with latex condoms.
If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases .
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
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