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 .

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Just Between Us™ Personal Lubricant & Condom" device:

Important Note: The provided document is a 510(k) premarket notification for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full-scale clinical trial to prove de novo efficacy or safety against a specific set of acceptance criteria in the way a pharmaceutical might. Therefore, many of the typical questions for AI model validation or clinical studies won't have direct answers in this context. The "acceptance criteria" here are mainly about meeting specifications and showing similarity to already approved products.

Here's a breakdown based on your request, with N/A for information not present in the document.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission for a personal lubricant and condom kit, the "acceptance criteria" are predominantly about demonstrating that the new device's characteristics and performance are comparable to (substantially equivalent to) existing legally marketed predicate devices, and that it meets relevant industry standards.

Acceptance Criteria (Demonstrated Equivalence/Standard Compliance)	Reported Device Performance
Technological Characteristics:
Contains purified water	Yes (matches predicates)
Contains glycerine	Yes (matches predicates)
Contains Aloe Vera Gel	Yes (matches WonderGel, but not K-Y Brand Liquid) This difference was not deemed significant enough to prevent substantial equivalence.
Contains Methylparaben	Yes (matches predicates)
Labeled Non-staining	Yes (matches predicates)
Labeled odorless and tasteless	Yes (matches WonderGel, but not K-Y Brand Liquid, which is not stated as such) This difference was not deemed significant enough to prevent substantial equivalence.
Container Material: Plastic	Plastic (matches predicates)
Sterile: No	No (matches predicates)
Labeled safe with latex condoms	Yes (matches predicates)
Performance with Condoms:
Compatibility with condoms, tested in accordance with ASTM D 3492-97 (Standard Specification for Rubber Contraceptives (Male Condoms)).	The Just Between Us™ Personal Lubricant and Condom did not have a significant effect on the performance of the condom.
Biocompatibility:
Meet 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 was tested and found to meet the in vivo test requirements of ISO 10993-1.
Overall substantial equivalence to identified predicates	"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." and a finding by the FDA that 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..."

Detailed Study Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for either the ASTM D 3492-97 condom testing or the ISO 10993-1 biocompatibility testing. These standards prescribe sample sizes, but the specific number used in this particular study is not provided in the summary.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were performance/laboratory-based, not patient data studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. This kind of expert-driven ground truth is not applicable for the type of testing (material compatibility and biocompatibility) performed for this device. The "truth" is established by adherence to recognized international and national standards (ASTM and ISO).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. The testing involves objective measurements against established standard criteria, not subjective human assessment requiring adjudication.
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:
- N/A. This is a physical device (lubricant and condom kit), not an AI-assisted diagnostic or interpretation tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This concept is not applicable to this physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance testing is adherence to the specifications and methodologies outlined in recognized industry standards:
  - ASTM D 3492-97 (Standard Specification for Rubber Contraceptives (Male Condoms)) for condom compatibility.
  - ISO 10993-1 (Biological evaluation of medical devices-Part 1: Guidance on the selection of tests) for biocompatibility.
- The overall "ground truth" for marketing authorization is substantial equivalence to predicate devices already deemed safe and effective by the FDA.
The sample size for the training set:
- N/A. Not applicable, as this is not an AI/machine learning model but a physical medical device.
How the ground truth for the training set was established:
- N/A. Not applicable.

Summary

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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

Intended Use

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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 BetweenUSTM	K-Y® Brand LiquidTMPersonal Lubricant	WonderGel® Per-sonal Liquid Gel
Manufacturer	Key West Fragrance &Cosmetic Factory, Inc.	Ortho PharmaceuticalCorporation	Lake Consumer Prod-ucts, Inc.
Contains purifiedwater	Yes	Yes	Yes
Contains glycerine	Yes	Yes	Yes
Contains Aloe VeraGel	Yes	No	Yes
Contains Methyl-paraben	Yes	Yes	Yes
Labeled Non-staining	Yes	Yes	Yes
Labeled odorless andtasteless	Yes	No	Yes
Container Material	Plastic	Plastic	Plastic
Sterile	No	No	No
Labeled safe withlatex 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)

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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.

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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

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Indications for Use . . .

Page 1 of 1

510(k) Number (if known):

Device Name Just Between Us™ Personal Lubricant & Condom

Indications for Use:

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__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96) 2 1 - 1 -

Regulation Number and Section

§ 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.