(313 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a silicone-based lubricant, with no mention of AI or ML technology.
No.
The "Intended Use / Indications for Use" states that the device is intended to "moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication," which describes a personal lubricant and not a therapeutic device for treating a condition or disease.
No
The device is a personal lubricant, intended to moisturize and lubricate to enhance sexual activity, not to diagnose any condition.
No
The device description clearly states it is a "silicone-based personal lubricant" and is provided in "LDPE bottles," indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of Playboy Premium Silicone Lubricant clearly state that it is a personal lubricant applied to the body (penile, vaginal, and/or anal) to enhance sexual activity. It does not involve testing samples taken from the body for diagnostic purposes.
The information provided focuses on the physical properties, biocompatibility, shelf-life, and condom compatibility of the lubricant, which are relevant for a topically applied medical device, not an IVD.
N/A
Intended Use / Indications for Use
Playboy Premium Silicone Lubricant is indicated 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
Playboy Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for penile, anal, 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of dimethicone. Playboy Premium Silicone Lubricant is sold as an over-the-counter (OTC) product and is provided in 88.7 mL LDPE bottles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, vaginal and/or anal
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 studies were performed in accordance with the 2020 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. " The following testing was conducted: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Vaginal Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017). The results of testing support the biocompatibility of the device materials.
Shelf-Life: The subject device has a shelf-life of 36 months. Results from real-time testing demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life.
Condom Compatibility: The compatibility of Playboy Premium Silicone Lubricant with condoms was evaluated in accordance with ASTM D7661-10(R) 2017 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results of this test showed Playboy Premium Silicone Lubricant to be compatible with natural rubber latex and polyisoprene condoms. Results showed Playboy Premium Silicone Lubricant not to be compatible with polyurethane condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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November 23, 2021
Thai Nippon Rubber Industry Public Company Limited % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127
Re: K210095
Trade/Device Name: Playboy Premium Silicone Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 23, 2021 Received: October 26, 2021
Dear Kevin Walls:
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, 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.
1
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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210095
Device Name Playboy Premium Silicone Lubricant
Indications for Use (Describe)
Playboy Premium Silicone Lubricant is indicated 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. 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)
| Residential Use (Part 1 of SEE 301) | Crop Tier Certification (Part 1 of SEE 301) |
|---|---|
| ------------------------------------- | --------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K210095 Playboy Premium Silicone Lubricant
1. Submitter Information
| Applicant: | Thai Nippon Rubber Industry Public Company
Limited |
|------------|------------------------------------------------------------------------------------------|
| Contact: | Tossaporn Nilkhamhang, |
| Address: | 789/139 Moo 1 Pinthong Industrial Estate
Nongkham Sriracha Chonburi 20110
Thailand |
| Phone: | (+66-38-317999) |
2. Correspondent Information
| Company: | Regulatory Insight |
|---|---|
| Contact: | Kevin Walls |
| Phone: | (720) 962-5412 |
| Email: | kevin@reginsight.com |
3. Date prepared: November 22, 2021
4. Device Information
| Device Name: | Playboy Premium Silicone Lubricant |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (lubricant, personal) |
| Regulatory Class: | Class II |
5. Predicate Device Information
| Device Name: | K-Y Silicone |
|---|---|
| 510(k) Number: | K173504 |
| Manufacturer: | Reckitt Benckiser LLC |
The predicate device has not been subject to a design-related recall.
6. Device Description
Playboy Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for penile, anal, 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of dimethicone. Playboy Premium Silicone Lubricant is sold as an over-the-counter (OTC) product and is provided in 88.7 mL LDPE bottles.
Device specifications are listed in Table 1 below.
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| Property | Specification |
|---|---|
| Appearance | Clear, free from suspended matter and |
| sediment | |
| Color | Clear |
| Odor | Odorless |
| Viscosity | 315 – 385 cps |
| Total Aerobic Microbial Count (TAMC, per | |
| USP ) | ) |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |
| Escherichia coli | Absent |
| Salmonella | Absent |
Table 1: Device Specifications for Playboy Premium Silicone Lubricant
7. Indications for Use
Playboy Premium Silicone Lubricant is indicated 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
8. Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
Table 2: Comparator Table for Subject and Predicate Device
| | Playboy Premium Silicone
Lubricant
K210095
Subject Device | K-Y Silicone
K173504
Predicate Device |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Indications for Use | Playboy Premium Silicone Lubricant is
indicated 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. This product is compatible
with natural rubber latex and
polyisoprene condoms. This product is
not compatible with polyurethane
condoms. | K-Y® Silicone is indicated 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. This product is compatible
with natural rubber latex,
polyisoprene, and polyurethane
condoms. |
| Base type | Silicone | Silicone |
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| Primary ingredients | Dimethicone | Dimethicone |
|---|---|---|
| Rx/OTC | OTC | OTC |
| Sterile | No | No |
| Appearance/color | Clear, free from suspended matter and | |
| sediment | Colorless | |
| Odor | Odorless | Odorless |
| Viscosity | 315-385 cps | 80-110 cps |
| Total Aerobic Microbial | ||
| count (TAMC) |