FLIP Lube is personal lubricant for penile, vaginal, and/or rectal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and synthetic polyisoprene condoms. Not compatible with polyurethane condoms.

Device Description

FLIP Lube is a water-based, personal lubricant used to provide lubrication during sexual intercourse. It is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. The specifications include appearance, color, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.

AI/ML Overview

This document describes the premarket notification for FLIP Lube, a personal lubricant. It does not contain information about an AI/ML powered medical device. Therefore, it's not possible to describe acceptance criteria and associated studies in the context of AI/ML device performance or human reader improvement with AI assistance.

The provided text focuses on the substantial equivalence of FLIP Lube to a predicate device based on its intended use, classification, environment of use, and performance testing related to its physical and biological properties.

Here's a breakdown of the information that is present, in the closest possible interpretation of your request:

Acceptance Criteria and Device Performance (in the context of a personal lubricant)

While not "acceptance criteria" in the sense of an AI model's performance metrics (like sensitivity, specificity, AUC), the document outlines the tests conducted to demonstrate the lubricant's performance and safety.

Acceptance Criteria (Performance Test)	Reported Device Performance
Shelf Life (accelerated aging equivalent to 12 months per ASTM F1980-16)	"The results of performance testing demonstrate that the proposed lubricant maintains all of its specifications over the duration of its proposed shelf life..." (implies 12 months in this context)
Condom Compatibility per ASTM D7661-10	"...is compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms..."
Biocompatibility: Cytotoxicity (ISO 10993-5:2009)	"biocompatible." (This is a summary statement covering all biocompatibility tests; specific results for each criterion are not detailed in this public summary.)
Biocompatibility: Sensitization (ISO 10993-10:2010)	"biocompatible."
Biocompatibility: Vaginal Irritation with Histopathology (ISO 10993-10:2010)	"biocompatible."
Biocompatibility: Acute Systemic Toxicity (ISO 10993-11:2006)	"biocompatible."
Specifications (Appearance, Color, Odor, pH, Viscosity, Osmolality, Antimicrobial effectiveness, Total aerobic microbial count, Total yeast and mold count, Absence of pathogenic organisms)	"The results of performance testing demonstrate that the proposed lubricant maintains all of its specifications over the duration of its proposed shelf life..." (Specific values for each specification are not provided in this summary but are implied to have met internal acceptance criteria for substantial equivalence.)

Information NOT present in the document (due to the nature of the device: a personal lubricant, not an AI/ML medical device):

Sample size used for the test set and data provenance: Not applicable in the context of an AI/ML test set. The "test set" here refers to physical samples of the lubricant and materials for compatibility and biocompatibility.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a lubricant involves laboratory testing according to established standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by standardized laboratory testing methods (e.g., ASTM, ISO standards) for chemical, physical, and biological properties.
The sample size for the training set: Not applicable (no "training set" in the AI/ML sense).
How the ground truth for the training set was established: Not applicable.

This document is a 510(k) clearance for a Class II medical device (a lubricant) based on substantial equivalence. Such clearances typically rely on a comparison to legally marketed predicate devices and specific performance testing demonstrating safety and effectiveness for its intended use, rather than AI/ML model validation studies.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 5, 2018

ImQuest BioSciences, Inc. % Paul Dryden Consultant ProMedic, LLC 131 Bay Point Dr. NE Saint Petersburg, FL 33704

Re: K171516 Trade/Device Name: FLIP Lube Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: January 3. 2018 Received: January 4, 2018

Dear Paul Dryden:

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. 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 may be subject to 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

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801); medical device reporting of medical 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joyce M. Whang -S

for 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

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Indications for Use

510(k) Number (if known)

K171516

Device Name

FLIP Lube

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

XX Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (7/17)

Page 1 of 1

EF PSC Publishing Services (301) 443-6740

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Submitter:	ImQuest BioSciences Inc.7340 Executive Way, Suite RFrederick, MD 21704Tel - 301-696-0274
Official Contact:	Karen W. Buckheit - Director, Prevention Sciences, ImQuestBioSciences Inc.
Proprietary or Trade Name:	FLIP Lube
Common/Usual Name:	Personal Lubricant
Classification Name	21 CFR 884.5300 (Condom)NUC (lubricant, personal)Class II
Predicate Device:	K141913 - PJUR GROUP LUXEMBOURG SA -Backdoor Anal Glide /Analyse Me!The predicate device has not been subject to a design relatedrecall.

Device Description:

The specifications include appearance, color, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.

Indications for Use:

Flip Lube is personal lubricant for penile, vaginal, and/or rectal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and synthetic polyisoprene condoms. Not compatible with polyurethane condoms.

Substantial Equivalence Discussion:

Feature	PredicateK141913PJUR GROUP LUXEMBOURG SA -Backdoor Anal Glide /Analyse Me!	ProposedK171516ImQuest BioSciencesFLIP Lube
Product Classification	21CFR 884.5300 - NUC - Personal Lubricant
Class	II / OTC
Indications for Use	Personal lubricants for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication	FLIP Lube is personal lubricant for penile, vaginal, and/or rectal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with

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		natural rubber latex and syntheticpolyisoprene condoms. Not compatible withpolyurethane condoms.
Environment of Use	OTC – home use	OTC – home use
Condom Compatibility	Natural rubber latex	Natural rubber latexPolyisopreneNot compatible with polyurethane condoms.
Type of lubricant	Water-basedSilicone-based	Water-based
Materials	DimethiconeDimethiconolSimmondsia Chinensis (Jojoba) Seed OilAmyris Balsamifera Bark Oil	WaterGlycerolHydroxyethyl CelluloseMethylparabenPropylparabenSodium Phosphate

Both lubricants have the same intended use, but different technological characteristics (e.g., base type). The different technological characteristics do not raise different questions of safety and effectiveness.

Summary of Performance Testing

The following performance tests were conducted:

Shelf Life (accelerated aging equivalent to 12 months per ASTM F1980-16) ●
Condom Compatibility per ASTM D7661-10
Biocompatibility
- Cytotoxicity (ISO 10993-5:2009) O
- Sensitization (ISO 10993-10:2010) о
- Vaginal Irritation with Histopathology (ISO 10993-10:2010) O
- Acute Systemic Toxicity (ISO 10993-11:2006) o

The results of performance testing demonstrate that the proposed lubricant maintains all of its specifications over the duration of its proposed shelf life, is compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms, and biocompatible.

Conclusion

Based upon performance testing provided, the proposed device and predicate device are substantially equivalent.

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.