FuckWater is a water-based personal lubricant for penile and/or rectal 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 polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

FuckWater is a non-sterile, home-use, water-based, personal lubricant. It is packaged in 20z, 40z, 8oz and 16oz bottles. The device is intended to be applied to the penis, vagina or rectum to reduce friction during sexual activity. The device is compatible with natural rubber latex and polyisoprene condoms. The device is not compatible with polyurethane condoms.

AI/ML Overview

This document is a 510(k) Premarket Notification for a personal lubricant called "FuckWater." It does not describe a study involving human readers or AI assistance, nor does it establish ground truth with experts in the context of medical image analysis or similar diagnostic tasks.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/human reader performance are not applicable to this document. This document details the non-clinical performance testing for a personal lubricant to demonstrate its substantial equivalence to a predicate device, as required for FDA clearance.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The document presents mechanical and chemical specifications for the personal lubricant, which serve as acceptance criteria for the product's quality and performance.

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter	Specification (Acceptance Criteria)	Reported Device Performance (Implied Met)
Appearance	Viscous, Semi-Opaque Fluid	(Implied met, as product was cleared)
Color	Off-White	(Implied met, as product was cleared)
Odor	Light Medicinal	(Implied met, as product was cleared)
pH	7.2 - 7.6	(Implied met, as product was cleared)
Osmolality	2,300-3,400 mOsm/kg	(Implied met, as product was cleared)
Viscosity	20,000 - 26,000 cP	(Implied met, as product was cleared)
Antimicrobial effectiveness (USP <51>) (Bacteria)	Not less than 2.0 log reduction from the initial count at 14 days, and no increase from the 14 days' count at 28 days	(Implied met, as product was cleared)
Antimicrobial effectiveness (USP <51>) (Yeast & Mold)	No increase from the initial calculated count at 14 and 28 days	(Implied met, as product was cleared)
Total Aerobic Microbial Count (USP <61>, <62>)	< 10 cfu/g	(Implied met, as product was cleared)
Total Yeast and Mold Count (USP <61>, <62>)	(Not specified, but implies meeting standard limits)	(Implied met, as product was cleared)
Absence of Pathogenic Organisms (USP <61>, <62>)	(Not specified, but implies complete absence)	(Implied met, as product was cleared)
Cytotoxicity	Non-cytotoxic (per ISO 10993-5:2009)	Was demonstrated to be noncytotoxic.
Hypersensitivity	Non-sensitizing (per ISO 10993-10:2010)	Results from treated animals support that the test article is non-sensitizing.
Vaginal Mucosal Irritation	Non-irritant (per ISO 10993-10:2010)	Was considered a non-irritant to the vaginal mucosa.
Rectal Irritation	Non-irritant (per ISO 10993-10:2010)	Was considered a non-irritant to the rectal mucosa.
Acute Systemic Toxicity	Not acutely toxic (per ISO 10993-11:2006)	Was demonstrated that the subject device is not acutely toxic.
Shelf Life	522 days (met accelerated aging ASTM F1980-16)	Demonstrated that the device met specifications for the proposed shelf-life.
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms; Incompatible with polyurethane condoms (per ASTM D7661-10)	Was found to be compatible with male natural rubber latex and polyisoprene condoms and incompatible with male polyurethane condoms.

Study Details (as applicable to a personal lubricant 510(k))

Since this document describes the clearance of a personal lubricant, the "study" refers to non-clinical performance testing rather than an AI or human reader study for diagnostic purposes.

2. Sample size used for the test set and the data provenance:

Biocompatibility Testing: The document mentions "New Zealand White rabbits" for irritation tests and "guinea pigs" for hypersensitivity, and "mice" for acute systemic toxicity. Specific numbers of animals (sample sizes) are not provided in this summary.
Bench Performance Testing: No specific sample sizes (e.g., number of lubricant batches or condom samples) are mentioned for physical property tests or condom compatibility.
Data Provenance: The tests are standard laboratory tests conducted according to ISO and ASTM standards. The document does not specify the country of origin for the underlying data generation. The submission itself is from a Canadian company with a US consultant. The studies are prospective insofar as they were explicitly performed to support this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This applies to diagnostic studies, not personal lubricant testing. The "ground truth" here is established by the results of standardized, objective laboratory tests against pre-defined scientific and regulatory criteria (e.g., pH values, microbial counts, irritation indices).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

N/A. This applies to studies involving subjective assessments, like medical image interpretation. Laboratory tests for a personal lubricant do not typically involve human adjudication in this manner.

5. 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 document is for a medical device (personal lubricant), not an AI-powered diagnostic tool. The concept of human readers or AI assistance is irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A. Not an AI algorithm. The performance is the device's inherent physical and chemical properties and its biological interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device is based on objective, standardized laboratory measurements and assessments against established physical, chemical, and biological criteria, as defined by USP, ISO, and ASTM standards. For example:
- pH measurement provides a direct value.
- Microbial counts are quantifiable.
- Biocompatibility tests use histological analysis and scoring indices (like Irritation Index) often interpreted by trained toxicologists/pathologists who follow defined protocols.
- Condom compatibility is determined by physical integrity tests.

8. The sample size for the training set:

N/A. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

N/A. As above, no training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 7, 2017

Non-Friction Products Inc. % James W. Monroe CEO Monroe Medical Device Consulting, LLC 319 Shilling Drive Somerset, NJ 08873

Re: K171730 Trade/Device Name: FuckWater Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 9, 2017 Received: June 12, 2017

Dear James W. Monroe:

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.

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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); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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510k Summary: FuckWater Personal Lubricant

Submitter Information

Submitter:

Marc Barrette President, Non-Friction Products Inc. 551 Church Street Toronto, ON M4Y 2E2 Canada Phone: (416) 817-1745. Facsimile: (416) 967-0224 marc@nonfrictionproducts.com

Contact Person:

James W. Monroe CEO, Monroe Medical Device Consulting, LLC 319 Shilling Drive Somerset, NJ 08873 USA Phone: (908) 809-0081, Facsimile: (888) 834-1696 wmonroe@monroemdc.com

Date Prepared: August 23, 2017

Device Information

Device Name: FuckWater Common or Usual Name: Personal lubricant Classification: 21 CFR 884.5300; condom Product Code: NUC; lubricant, personal Device Class: II

Predicate: Glycerin and Paraben Free Astroglide, K072647

The predicate has not been the subject of a design-related recall.

Intended Use / Indications for Use

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Device Description

Parameter	Specification
Appearance	Viscous, Semi-Opaque Fluid
Color	Off-White
Odor	Light Medicinal
pH	7.2 - 7.6
Osmolality	2,300-3,400 mOsm/kg
Viscosity	20,000 - 26,000 cP
Antimicrobial effectiveness(USP <51>)	Bacteria: Not less than 2.0 log reduction from the initial countat 14 days, and no increase from the 14 days' count at 28 days
	Yeast and Mold: No increase from the initial calculated countat 14 and 28 days
Total Aerobic MicrobialCount (USP <61>, <62>)	< 10 cfu/g
	Total Yeast and Mold Count(USP <61>, <62>)
Absence of PathogenicOrganisms (USP <61>, <62>)

Comparison to Predicate Device

FuckWater is substantially equivalent to the predicate device listed below with respect to intended use/indications for use, principles of operation and technological characteristics.

Substantial Equivalence Table

Attribute	Fuck-Water(Subject Device)	Glycerin and ParabenFree Astroglide(Predicate)	Equivalence
510(k)	K171730	K072647	N/A
Product Code	NUC	NUC	Same
Indications for Use	FuckWater is a water-based personallubricant, for penile,vaginal and/or rectalapplication, intended tomoisturize andlubricate, enhance theease and comfort ofintimate sexual activityand supplement thebody's naturallubrication. Thisproduct is compatiblewith natural rubberlatex and polyisoprenecondoms. This productis not compatible withpolyurethane condoms.	Glycerin and ParabenFree Astroglide® is apersonal lubricant, forpenile, anal, or vaginalapplication, intended tomoisturize andlubricate, to enhancethe ease and comfort ofintimate sexual activityand supplement thebody's naturallubrication. Thisproduct is compatiblewith latex condoms.	Similar; minordifferences donot change theintended useand do notraise differentquestions ofsafety andeffectiveness.
CondomCompatibility	Natural Rubber LatexPolyisoprene	Natural Rubber Latex	Different;differences incondomcompatibilitydo not raisedifferentquestions ofsafety andeffectiveness.
Over-The-CounterUse	Yes	Yes	Same
Ingredients	Water, PropyleneGlycol, IsopropylPalmitate,Dimethicone,HydroxyethylCellulose, Polysorbate20, Sorbitan Stearate,Cetearyl Alcohol,Glyceryl Stearate,Sodium Benzoate,Gluconolactone	Water, ButyleneGlycol, Xylitol,Propylene Glycol,Polyquaternium 15	Different;differences informulation donot raisedifferentquestions ofsafety andeffectiveness.
BiocompatibilityTested	Yes	Yes	Same
Sterile	No	No	Same
Microbial Qualityand AntimicrobialEffectivenessTested	Yes	Yes	Same

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As noted in the table above, the differences between the subject and predicate devices include the indications for use, condom compatibility and ingredients. These differences do not alter the intended use or the fundamental technology of the subject device as compared to the predicate, and do not raise different questions of safety or effectiveness. The technological differences between the subject device and predicate were evaluated through performance testing as described in the section below.

Summary of Non-Clinical Performance Data

Biocompatibility

The subject device is intended to come into direct contact with the mucosa of patients for a limited (< 24hr) duration. Therefore, biocompatibility testing was conducted to evaluate vaginal and rectal irritation, systemic toxicity, hypersensitivity and cytotoxicity in accordance with ISO 10993 as described below.

Cytotoxicity

The purpose of this test was to examine the test article under evaluation for cytotoxic potential. This test was performed per ISO 10993-5:2009. Based on qualitative evaluation of the mouse fibroblast cells exposed to the test article, the test article was demonstrated to be noncytotoxic.

Hypersensitivity

The purpose of this test was to determine to what extent a test article has the potential to act as a contact sensitizer in guinea pigs. The assay was conducted according to the methods detailed in the ISO 10993-10:2010, Guinea Pig Maximization. Results from treated animals support that the test article is non-sensitizing. Under similar treatment conditions, all positive control animals used in the historical positive control study exhibited a strong sensitization response to the challenge dose compared to that of the control animals. The results from the historical positive control study demonstrate that the guinea pigs in the study reacted as expected when exposed to a known sensitizer (i.e., DNCB) and the results validate the sensitivity of this test.

Vaginal Mucosal Irritation

The purpose of this test was to assess the potential of the test material to produce irritation of the vaginal mucosal tissue in New Zealand White rabbits. This test was performed according to ISO 10993-10:2010. Vaginal Irritation Test. Based on the Irritation Index, the test article was considered a non-irritant to the vaginal mucosa.

Rectal Irritation

The purpose of this test was to assess the potential of the test material to produce irritation of the rectal mucosal tissue in New Zealand White rabbits. This test was performed according to ISO 10993-10:2010, Rectal Irritation Test. Based on the Irritation Index, the test article was considered a non-irritant to the rectal mucosa.

Acute Systemic Toxicity

The purpose of this test was to evaluate systemic responses to the test article following injection into mice. This test was conducted according to ISO 10993-11:2006, Acute Systemic Toxicity. Testing demonstrated that the subject device is not acutely toxic.

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Bench Performance Testing

The following non-clinical testing was conducted: Condom compatibility in accordance with ASTM D7661:10 and age testing (ASTM F1980-16) to justify claims of 522 days shelf-life.

Shelf Life

Shelf life for the subject device is claimed to be 522 days. Accelerated aging testing was conducted per ASTM F1980-16, which demonstrated that the device met specifications for the proposed shelf-life.

Condom Compatibility

Condom compatibility was conducted in accordance with ASTM D7661-10 - Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex. The subject device was found to be compatible with male natural rubber latex and polyisoprene condoms and incompatible with male polyurethane condoms.

Summary of Clinical Performance Data

No clinical data were submitted to support substantial equivalence.

Conclusion

The subject device has very similar indications for use to the predicate. Minor differences in the indications statements do not alter the intended use of the subject device. The subject device and the predicate have the same basic technological characteristics. Minor differences in technology do not alter the intended use or fundamental technology, and do not raise different questions of safety and effectiveness. The technological differences between the subject and predicate device were evaluated through performance testing, including biocompatibility, condom compatibility, and shelf-life. The results from performance testing support that the subject device is as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate device.

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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.