(135 days)
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.
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.
This document is a 510(k) premarket notification for a medical device (Water-soluble Personal Lubricant). It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through a traditional study with a test set, ground truth experts, and statistical evaluation as you would typically find for, say, an AI-powered diagnostic device.
Therefore, the requested information regarding acceptance criteria and a study proving device performance (especially for AI/ML aspects like accuracy, sensitivity, specificity, MRMC studies, etc.) is largely not applicable to this type of regulatory submission for a personal lubricant.
However, I can extract and present the performance specifications and the tests conducted to show that the device meets its own internal specifications and relevant industry standards, which serve a similar purpose to "acceptance criteria" in this context.
Here's how the provided information maps to your request, with an emphasis on what is and is not present:
Context: This document is a 510(k) submission for a Class II medical device: a Water-soluble Personal Lubricant. The primary goal is to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove clinical efficacy through comparative effectiveness studies on human subjects or complex AI algorithm performance.
1. A table of acceptance criteria and the reported device performance
For a personal lubricant, the "acceptance criteria" are primarily its physical, chemical, and microbiological specifications, along with compatibility and biocompatibility standards. The document presents these in Table 1, and the "reported device performance" implies that the device met these specifications.
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Implied) |
|---|---|---|
| Appearance | Semi-Viscous liquid | Met |
| Color | Clear | Met |
| Odor | Odorless | Met |
| Viscosity | 3,000 - 5,000 mPa.s | Met |
| pH | 5.0 - 6.0 | Met |
| Osmolality | 700 - 850 mOsm/kg | Met |
| Total Aerobic Microbial Count (TAMC, per USP <61>) | <100 cfu/g | Met (<100 cfu/g) |
| Total Yeast and Mold Count (TYMC, per USP <61>) | <10 cfu/g | Met (<10 cfu/g) |
| Presence of Pathogens (per USP <62>) | ||
| Pseudomonas aeruginosa | Absent | Met (Absent) |
| Staphylococcus aureus | Absent | Met (Absent) |
| Candida albicans | Absent | Met (Absent) |
| Escherichia coli | Absent | Met (Absent) |
| Clostridia | Absent | Met (Absent) |
| Salmonella | Absent | Met (Absent) |
| Bile tolerant Gram-negative bacteria | Absent | Met (Absent) |
| Antimicrobial Effectiveness Testing (per USP <51>) | ||
| Bacteria | Meets USP <51> 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 | Met |
| Yeast and Molds | No increase from the initial calculated count at 14 and 28 days | Met |
| Biocompatibility | Met ISO 10993-1, -5, -10, -11 | Met |
| Shelf-Life | 3 years (maintains specifications) | Met |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms | Met |
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of a "test set" for an algorithmic performance study. The tests performed are laboratory-based, chemical, physical, and microbiological analyses (e.g., measuring pH, viscosity, microbial counts) on samples of the product. The specific number of distinct product batches or individual units tested for each specification is not detailed in this summary.
- Data Provenance: The manufacturing entity is Foshan PingChuang Medical Technology Co., Ltd. in Foshan City, Guangdong, China. The testing would have been conducted by the manufacturer or a contracted lab. The document does not specify if the testing was prospective (e.g., part of a clinical trial) or retrospective (analysis of existing data), but for device specifications, it's typically part of the manufacturing quality control and development process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on interpretations (e.g., radiology images), is not relevant for this device. The "ground truth" for chemical and physical properties is defined by established laboratory standards and test methods (e.g., USP <61>, USP <62>, USP <51>, ISO 10993, ASTM D7661-10(R) 2017).
- Qualifications of Experts: Not applicable. The testing is performed by laboratory technicians following validated protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept is typically used in clinical studies where multiple human readers interpret data, and discrepancies need resolution. For laboratory testing of product specifications, results are definitive measurements against pre-defined criteria.
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
- MRMC Study: No. This is not an AI-powered device, nor is it a diagnostic device where comparative effectiveness with human readers would be relevant.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The ground truth for this device's performance is established by objective, standardized laboratory test methods and predefined physical, chemical, and microbiological specifications (e.g., pH meter readings, viscosity measurements, plate counts for microbiology, results from validated biocompatibility assays). There is no "expert consensus" or "pathology" involved in determining if the lubricant's pH is within specification.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As there is no training set for an algorithm, this question is not relevant.
In summary, this regulatory submission demonstrates the device's adherence to established safety and performance standards relevant to its classification as a personal lubricant, not the performance of an AI model or a complex diagnostic. The "acceptance criteria" are the physical, chemical, and biological specifications, and the "study" involves laboratory testing to confirm these specifications are met, along with biocompatibility and condom compatibility assessments.
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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.
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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
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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)
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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, LingangPioneer Park, Shunjiang NeighborhoodCommittee, 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, ZhongguanTimes 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.
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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, perUSP <61>) | <100 cfu/g |
| Total Yeast and Mold Count (TYMC, perUSP <61>) | <10 cfu/g |
| Presence of Pathogens (per USP <62>) | Specification |
| 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 (perUSP <51>) | Specification |
| Bacteria | Meets USP <51> criteria for category 2.No less than 2.0 log reduction from initialcount at 14 days and no increase from the 14-day count at 28 days |
| Yeast and Molds | No increase from the initial calculated count at14 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 PersonalLubricantK210104Subject Device | Agape Warming PersonalLubricantK200208Predicate Device | |
|---|---|---|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Indications for Use | Water-soluble Personal Lubricant is apersonal lubricant for penile, anal and/or vaginal application, intended tomoisturize and lubricate, to enhance theease and comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with natural rubber latex andpolyisoprene condoms. This product isnot compatible with polyurethanecondoms. | Agape Warming Personal Lubricant isa personal lubricant for penile, analand/or vaginal application, intended tolubricant and moisturize, to enhancethe ease and comfort of intimatesexual activity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms |
| Base type | Water | Water |
| Primary ingredients | Water, Propylene Glycol,Hydroxyethyl Cellulose, SodiumHyaluronate, Potassium Sorbate, CitricAcid, EDTA-2Na, Sodium Polyacrylate | Water, Propanediol,Gluconolactone,Hydroxyethylcellulose, SodiumBenzoate, Polysorbate 20, Citric Acidand 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 Microbialcount (TAMC) | <100 cfu/g | <100 cfu/g |
| Total Yeast and Mold Count(TYMC) | <10 CFU/g | <10 CFU/g |
| Absence of PathogenicOrganisms | Yes | Yes |
| Antimicrobial EffectivenessTested | Yes | Yes |
| Condom Compatibility | Compatible with natural rubber latex andpolyisoprene condoms | Compatible with natural rubber latexand polyisoprene condoms |
| Biocompatibility Tested | Yes | Yes |
| Shelf life | 3 years | 3 years |
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The subject and predicate device indications for use and intended use are the same. The subject and predicate device have different technological characteristics, including formulations, viscosity, pH, and osmolality specifications. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.
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9. Summary of Non-Clinical Performance Testing
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.
10. Conclusion
The results of the performance testing described above demonstrate that Water-soluble Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.