(265 days)
Not Found
No
The device description and performance studies focus on the chemical composition, biocompatibility, and condom compatibility of a personal lubricant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to treat or cure a disease or medical condition.
No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to diagnose any medical conditions.
No
The device description clearly states it is a water-based personal lubricant, which is a physical substance, not software.
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, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Smile Makers Lubricants' Intended Use: The intended use of Smile Makers Personal Lubricants is for vaginal application to lubricate and moisturize for the purpose of enhancing sexual activity. This is a direct application to the body for a physical effect, not for analyzing a specimen outside the body.
- Device Description: The description details the ingredients and physical form of the lubricant, not components for analyzing biological samples.
- Performance Studies: The performance studies focus on biocompatibility (how the product interacts with the body) and condom compatibility, not on the accuracy or reliability of diagnostic measurements.
Therefore, based on the provided information, Smile Makers Personal Lubricants are classified as a medical device, but not an In Vitro Diagnostic device. They fall under the category of personal lubricants, which are typically regulated as Class II medical devices.
N/A
Intended Use / Indications for Use
Smile Makers Personal Lubricants are water-based personal lubricants for vaginal application, intended to lubricate and moisturize, 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
NUC
Device Description
Smile Makers personal lubricants are water-based personal lubricants. There are three formulations, Generous Gel, Stay Silky Serum, and Little Light Liquid, that contain the same ingredients, and only differ in amounts of specific ingredients. Ingredients of the lubricants include the following: water (aqua), glycerin, propylene glycol, methyl propanediol, carbomer, sodium benzoate, sodium hydroxide, and dipotassium glycyprizate. They are compatible with natural rubber latex and polyisoprene condoms, but are not compatible with polyurethane condoms. They are provided non-sterile.
The product is packaged in 30 ml transparent plastic bottles made of acrylonitrile styrene and polyethylene terephthalate. The bottle contains a pump dispenser made of polypropylene and the cap is made of an aluminum coated low density polyethylene. It is for over-the-counter use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal / penile
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter 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 Testing:
Studies were performed in accordance with the 2016 FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1: 2009.
- Cytotoxicity (ISO 10993-5: 2009)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010)
- Vaginal Irritation (ISO10993-10: 2010)
- Acute Systemic Toxicity (ISO 10993-11: 2017)
Results: The subject lubricants are non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic.
Condom Compatibility:
Evaluation was in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms".
Results: The subject device was determined to be compatible with natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms.
Shelf-life:
A one-year shelf-life based on the results of a real-time aging study.
Results: Testing demonstrated that the device met specifications for parameters shown in Table 1 (Appearance & Color, Odor, Osmolality, pH, Viscosity, Total Aerobic Microbial Count, Total Yeast & Mold Count, Antimicrobial Effectiveness, Absence of Pathogenic Organisms).
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 25, 2019
LFBeauty (Thailand) Limited % Shelley Shen, Ph.D. Consultant PharmEng Technology 23 Lesmill Road North York, M3B 3P6 Ontario CANADA
Re: K182100
Trade/Device Name: Smile Makers Personal Lubricants (Smile Makers Little Light Liquid, Smile Makers Stay Silky Serum, and Smile Makers Generous Gel) Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 19, 2019 Received: March 21, 2019
Dear Shelley Shen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. Iisting 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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,
Michael T. Bailey -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) K182100
Device Name
Smile Makers Personal Lubricants (Smile Light Liquid, Smile Makers Stay Silky Serum, and Smile Makers Generous Gel)
Indications for Use (Describe)
Smile Makers Personal Lubricants are water-based personal lubricants for vaginal application, intended to lubricate and moisturize, 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K182100 Smile Makers Personal Lubricants
I. Submitter
LFBeauty (Thailand) Limited 21/7 Moo 6 Kookot Lamlukka Pathum Thani, Thailand 12130
Applicant
Apasara Kaewlor Senior Manager - QA & QMS LFBeauty (Thailand) Limited (662) 987 6500 Ext.315 (Phone) (662) 987 6500 Ext.185 (Fax) Apasarakaewlor@LFBeauty.com
Contact Person
Shelley Shen Consultant, PharmEng Technology 23 Lesmill Road North York, CA M3B 3P6 Ontario 14 (163) 853-922 Ext.118 (Phone) 14 (163) 853-912 (Fax) shelley.s@pharmeng.com
Date Prepared
April 24, 2019
II. Subject Device
Trade Names
Smile Makers Personal Lubricants:
- Smile Makers Little Light Liquid 트
- 트 Smile Makers Stay Silky Serum
- I Smile Makers Generous Gel
Common Name
Personal Lubricant
Classification
Regulation Name: Condom Regulation Number: 21 CFR 884.5300
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Regulatory Class: II Product Code: NUC (lubricant, personal)
III. Predicate Device
BioFilm, Inc. - Astroglide Sensual Strawberry (K140590)
The predicate device has not been subject to a design-related recall.
IV. Device Description
Smile Makers personal lubricants are water-based personal lubricants. There are three formulations, Generous Gel, Stay Silky Serum, and Little Light Liquid, that contain the same ingredients, and only differ in amounts of specific ingredients. Ingredients of the lubricants include the following: water (aqua), glycerin, propylene glycol, methyl propanediol, carbomer, sodium benzoate, sodium hydroxide, and dipotassium glycyprizate. They are compatible with natural rubber latex and polyisoprene condoms, but are not compatible with polyurethane condoms. They are provided non-sterile.
The product is packaged in 30 ml transparent plastic bottles made of acrylonitrile styrene and polyethylene terephthalate. The bottle contains a pump dispenser made of polypropylene and the cap is made of an aluminum coated low density polyethylene. It is for over-the-counter use.
The specifications for Smile Makers personal lubricants are listed in Table 1 below:
| Parameter | Specification (Test Method) |
|---|---|
| Appearance & Color | Clear gel, viscous, no visible foreign matter |
| Odor | Characteristic odor |
| Osmolality (10% (w/w) dilution with water) | 299 – 449 mOsm/kg |
| pH (at 25 °C) | 4.90 - 5.50 |
| Viscosity | 56,000 – 84,000 cps (Generous Gel) |
| 6,200 – 10,000 cps (Stay Silky Serum) | |
| 3,700 - 5,600 cps (Little Light Liquid) | |
| Total Aerobic Microbial Count | |
| (USP ) | ) |
| Escherichia coli, Pseudomonas | No less than a 2.0 log reduction from |
Table 1: Smile Makers Personal Lubricant Specifications
5
| aeruginosa, Staphylococcus
aureus | the initial count at 14 days, and no
increase from the 14 days' count at 28
days |
|-----------------------------------------------|----------------------------------------------------------------------------------------|
| Candida albicans, A. brasiliensis | No increase from the initial count at 14
and 28 days |
| Absence of Pathogenic
Organisms (USP ) | |
| Staphylococcus aureus | Absent |
| Pseudomonas aeruginosa | Absent |
| Candida albicans | Absent |
V. Indications for Use Statement
Smile Makers Personal Lubricants are water-based personal lubricants for penile and/or vaginal application, intended to lubricate and moisturize, 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.
VI. Comparison of Intended Use and Technological Characteristics
| Compared to Predicate | ||
|---|---|---|
| Smile Makers Personal | ||
| Lubricants | ||
| K182100 | ||
| Subject Device | Astroglide Sensual | |
| Strawberry | ||
| K140590 | ||
| Predicate Device | ||
| Sponsor | LFBeauty (Thailand) Ltd. | BioFilm, Inc. |
| Indication for Use | Smile Makers personal | |
| lubricants are water-based | ||
| personal lubricants for | ||
| penile and/or vaginal | ||
| application, intended to | ||
| lubricate and moisturize, 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. | Astroglide Sensual | |
| Strawberry is a personal | ||
| lubricant for penile and/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 natural rubber latex, | ||
| polyisoprene, and | ||
| polyurethane condoms. | ||
| Water-based | Yes | Yes |
Table 2: Technological Characteristics of Smile Makers Personal Lubricants Compared to Predicate
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| Appearance | Clear gel, viscous, no visible
foreign matter | Clear, colorless |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Primary Ingredients | Water, Glycerin, Propylene
Glycol, Methyl propanediol,
Carbomer, Sodium
Benzoate, Sodium
Hydroxide, Dipotassium
Glycyprizate | Not known |
| Provided Non-
Sterile | Yes | Yes |
| Condom
Compatibility | Natural rubber latex,
Polyisoprene | Natural rubber latex,
Polyisoprene, Polyurethane |
| Biocompatibility
Tested | Yes | Yes |
| Antimicrobial Tested | Yes | Yes |
The subject and predicate devices have the same indications for use statements with the exception of condom compatibility. The subject device is compatible with natural rubber latex and polyisoprene but not compatible with polyurethane condoms. The predicate device is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. These differences do not impact the intended uses of these devices, which are the same (i.e., lubrication during intimate sexual activity).
As noted in the table above, the subject and predicate device have different formulations and condom compatibilities. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.
VII. Performance Data
Biocompatibility Testing
Biocompatibility studies were performed in accordance with the 2016 FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1: 2009 as follows:
- Cytotoxicity (ISO 10993-5: 2009)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010)
- Vaginal Irritation (ISO10993-10: 2010)
- Acute Systemic Toxicity (ISO 10993-11: 2017)
The results demonstrate that the subject lubricants are non-cytotoxic, non-
7
sensitizing, non-irritating, and non-systemically toxic.
Condom Compatibility
The compatibility of the subject devices with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and was determined to be compatible with natural rubber latex and polyisoprene condoms. The subject device was determined not to be compatible with polyurethane condoms.
Shelf-life
The Smile Makers Personal Lubricant has a one-year shelf-life based on the results of a real-time aging study. Testing demonstrated that the device met specifications for parameters shown in Table 1.
VIII. Conclusion
The results of performance testing described above demonstrate that the Smile Makers Personal Lubricants are as safe and effective as the predicate device and support a determination of substantial equivalence.