(87 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a personal lubricant, with no mention of AI or ML technologies.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to treat or prevent a disease or condition.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate during sexual activity, not to diagnose any condition.
No
The device is a physical product (personal lubricant) and the summary describes manufacturing, packaging, and biocompatibility testing, not software development or validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- FuckWater's Intended Use: The intended use of FuckWater is clearly stated as a personal lubricant for sexual activity, intended to moisturize and lubricate. It is applied externally to the body.
- No Specimen Analysis: The description and performance studies do not involve the analysis of any specimens taken from the body. The testing focuses on biocompatibility and compatibility with condoms.
Therefore, based on the provided information, FuckWater is a personal lubricant and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
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. The device has the following specifications:
| 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 ) | 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 |
| Yeast and Mold: No increase from the initial calculated count at 14 and 28 days | |
| Total Aerobic Microbial Count (USP , ) | , ) |
| Absence of Pathogenic Organisms (USP , ) |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, vaginal, rectal mucosa
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home-use
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)
Biocompatibility: Tested for cytotoxicity (ISO 10993-5:2009, mouse fibroblast cells, non-cytotoxic), hypersensitivity (ISO 10993-10:2010, Guinea Pig Maximization, non-sensitizing), vaginal mucosal irritation (ISO 10993-10:2010, New Zealand White rabbits, non-irritant), rectal irritation (ISO 10993-10:2010, New Zealand White rabbits, non-irritant), and acute systemic toxicity (ISO 10993-11:2006, mice, not acutely toxic).
Shelf Life: Accelerated aging testing conducted per ASTM F1980-16, demonstrated device met specifications for a proposed shelf-life of 522 days.
Condom Compatibility: Conducted in accordance with ASTM D7661-10 - Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex. Subject device found compatible with male natural rubber latex and polyisoprene condoms, and incompatible with male polyurethane condoms.
No clinical data were submitted.
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, with flowing lines above them.
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.
1
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
2
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
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.
3
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. The device has the following specifications:
| 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 ) | 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 | |
| Yeast and Mold: No increase from the initial calculated count | |
| at 14 and 28 days | |
| Total Aerobic Microbial | |
| Count (USP , ) | , ) |
| Absence of Pathogenic | |
| Organisms (USP , ) |
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 Paraben
Free Astroglide
(Predicate) | Equivalence |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K171730 | K072647 | N/A |
| Product Code | NUC | NUC | Same |
| Indications for Use | FuckWater is a water-
based personal
lubricant, for penile,
vaginal and/or rectal
application, intended to
moisturize and
lubricate, 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. | Glycerin and Paraben
Free Astroglide® is a
personal lubricant, for
penile, anal, or vaginal
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 latex condoms. | Similar; minor
differences do
not change the
intended use
and do not
raise different
questions of
safety and
effectiveness. |
| Condom
Compatibility | Natural Rubber Latex
Polyisoprene | Natural Rubber Latex | Different;
differences in
condom
compatibility
do not raise
different
questions of
safety and
effectiveness. |
| Over-The-Counter
Use | Yes | Yes | Same |
| Ingredients | Water, Propylene
Glycol, Isopropyl
Palmitate,
Dimethicone,
Hydroxyethyl
Cellulose, Polysorbate
20, Sorbitan Stearate,
Cetearyl Alcohol,
Glyceryl Stearate,
Sodium Benzoate,
Gluconolactone | Water, Butylene
Glycol, Xylitol,
Propylene Glycol,
Polyquaternium 15 | Different;
differences in
formulation do
not raise
different
questions of
safety and
effectiveness. |
| Biocompatibility
Tested | Yes | Yes | Same |
| Sterile | No | No | Same |
| Microbial Quality
and Antimicrobial
Effectiveness
Tested | Yes | Yes | Same |
4
5
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 (