(135 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML technology.
Yes.
The device is clearly indicated as a "Personal Lubricant," which falls under the category of medical devices intended to aid in physical functions, making it a therapeutic device. The biocompatibility studies further support its classification as a medical device.
No
The device is a personal lubricant intended to moisturize and lubricate to enhance comfort during intimate sexual activity; it does not diagnose any condition.
No
The device description clearly states it is a "non-sterile, water-based personal lubricant" with a specific chemical formulation and is provided in "250 mL polyethylene terephthalate bottles," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is a personal lubricant for penile, anal, and/or vaginal application to enhance sexual activity and supplement natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description reinforces the intended use as a lubricant and moisturizer.
- Lack of Diagnostic Function: There is no mention of the device being used to test, examine, or diagnose any condition or sample taken from the human body. IVDs are used to perform tests on biological samples (like blood, urine, tissue) to provide information about a person's health.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility, which are relevant to a personal lubricant, not a diagnostic device.
Therefore, this device falls under the category of a medical device, but specifically a personal lubricant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Water-soluble Personal Lubricant is a personal lubricant for penile, anal 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 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
Water-soluble Personal Lubricant is a non-sterile, water-based personal lubricant 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, propylene glycol, hydroxyethyl cellulose, sodium hyaluronate, potassium sorbate, citric acid, EDTA-2Na, and sodium polyacrylate. Water-soluble Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 250 mL polyethylene terephthalate bottles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, anal and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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 3 years. 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 Water-soluble Personal 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 Water-soluble Personal Lubricant to be compatible with natural rubber latex and polyisoprene condoms. Results showed Water-soluble Personal Lubricant not to be compatible with polyurethane condoms.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 18, 2021
Foshan PingChuang Medical Technology Co., Ltd. % Joyce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518100 China
Re: K212104
Trade/Device Name: Water-soluble Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 8, 2021 Received: October 18, 2021
Dear Joyce Yang:
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.
1
Page 2
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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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) K212104
Device Name Water-soluble Personal Lubricant
Indications for Use (Describe)
Water-soluble Personal Lubricant is a personal lubricant for penile, anal 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 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K212104 Water-soluble Personal Lubricant
1. Submitter Information
| Applicant: | Foshan PingChuang Medical Technology Co., Ltd |
|---|---|
| Contact: | Huang Zhiyue, |
| Address: | Room 301, No. 3, Huaye Road, Lingang |
| Pioneer Park, Shunjiang Neighborhood | |
| Committee, Beijiao Town, Shunde District, | |
| Foshan City, Guangdong 528312, China | |
| Phone: | (+86-757-29269896) |
2. Correspondent Information
| Company: | Shenzhen Joyantech Consulting Co., Ltd. |
|---|---|
| Contact: | Joyce Yang |
| Address: | 1713A, 17th floor, Block A, Zhongguan |
| Times Square, Nanshan District, Shenzhen | |
| Phone: | (+86-755-86069197) |
| Email: | joyce@cefda.com |
3. Date prepared: November 18, 2021
4. Device Information
| Device Name: | Water-soluble Personal 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: | Agape Warming Personal Lubricant |
|---|---|
| 510(k) Number: | K200208 |
| Manufacturer: | CC Wellness LLC |
The predicate device has not been subject to a design-related recall.
6. Device Description
Water-soluble Personal Lubricant is a non-sterile, water-based personal lubricant 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, propylene glycol, hydroxyethyl cellulose, sodium hyaluronate, potassium sorbate, citric acid, EDTA-2Na, and sodium polyacrylate. Water-soluble Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 250 mL polyethylene terephthalate bottles.
4
K212104 Page 2 of 4
Device specifications are listed in Table 1 below.
| Table 1: Device Specifications for Water-Soluble Personal Lubricant | |
|---|---|
| Property | Specification |
| Appearance | Semi-Viscous liquid |
| Color | Clear |
| Odor | Odorless |
| Viscosity | 3,000 - 5,000 mPa.s |
| pH | 5.0 - 6.0 |
| Osmolality | 700 - 850 mOsm/kg |
| Total Aerobic Microbial Count (TAMC, per | |
| USP ) | ) |
| Pseudomonas aeruginosa | Absent |
| Staphylococcus aureus | Absent |
| Candida albicans | Absent |
| Escherichia coli | Absent |
| Clostridia | Absent |
| Salmonella | Absent |
| Bile tolerant Gram-negative bacteria) | Absent |
| Antimicrobial Effectiveness Testing (per | |
| USP ) | Specification |
| Bacteria | Meets USP criteria for category 2. |
| No less than 2.0 log reduction from initial | |
| count at 14 days and no increase from the 14- | |
| day count at 28 days | |
| Yeast and Molds | No increase from the initial calculated count at |
| 14 and 28 days |
7. Indications for Use
Water-soluble Personal Lubricant is a personal lubricant for penile, anal 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 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
| | Water soluble Personal
Lubricant
K210104
Subject Device | Agape Warming Personal
Lubricant
K200208
Predicate Device |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Indications for Use | Water-soluble Personal Lubricant is a
personal lubricant for penile, anal 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 and
polyisoprene condoms. This product is
not compatible with polyurethane
condoms. | Agape Warming Personal Lubricant is
a personal lubricant for penile, anal
and/or vaginal application, intended to
lubricant 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 |
| Base type | Water | Water |
| Primary ingredients | Water, Propylene Glycol,
Hydroxyethyl Cellulose, Sodium
Hyaluronate, Potassium Sorbate, Citric
Acid, EDTA-2Na, Sodium Polyacrylate | Water, Propanediol,
Gluconolactone,
Hydroxyethylcellulose, Sodium
Benzoate, Polysorbate 20, Citric Acid
and Capsicum Oleoresin |
| Rx/OTC | OTC | OTC |
| Sterile | No | No |
| Appearance | Semi-Viscous liquid | Semi-Viscous liquid |
| Color | Clear | Clear |
| Odor | Odorless | Odorless |
| Viscosity | 3,000-5,000 mPa.S | 2,150 - 4,000 mPa.S |
| pH | 5.0-6.0 | 3.4-4.5 |
| Osmolality | 700-850 mOsm/Kg | 575-750 mOsm/kg |
| Total Aerobic Microbial
count (TAMC) |