(448 days)
Not Found
No
The device is a personal lubricant and the description focuses on its chemical composition, physical properties, and biocompatibility testing. There is no mention of any computational or analytical functions that would involve AI/ML.
No
The device is described as a personal lubricant intended to enhance the ease and comfort of intimate sexual activity and supplement natural lubrication, not to treat or cure a disease or condition.
No
The intended use of the device is to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication, not to diagnose a condition.
No
The device is a physical product (lubricant) and the description details its chemical composition and packaging, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to lubricate and moisturize for intimate sexual activity. This is a physical function, not a diagnostic one.
- Device Description: The description details a personal lubricant applied to the body, not a device used to examine specimens from the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or treat a disease or condition based on in vitro examination of specimens.
- Performance Studies: The performance studies focus on biocompatibility, condom compatibility, and shelf-life, which are relevant to a personal lubricant, not an IVD.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device does not fit that description.
N/A
Intended Use / Indications for Use
Play and Joy Water-Based Lubricant is a 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 product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Play and Joy Water-Based Lubricant is a non-sterile, clear, semi-viscous water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Its formulation consists of water, xantham gum, glycerine, Chondrus crispus extract, sodium hyaluronate, saccharide isomerate, hydroxyethylcellulose, citric acid, sodium citrate, lactic acid, 1,2-pentanediol, phenoxyethanol, iodopropynyl butylcarbamate, hydroxyacetophenone, gluconolactone, and sodium benzoate. Play and Joy Water-Based Lubricant is for over-the-counter use and is provided in volumes of 50 mL and 100 mL in polyethylene tubes closed with polypropylene caps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Penile and/or vaginal application
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:
- Study type: Evaluation according to ISO 10993-1, ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization, Vaginal Irritation), ISO 10993-11:2017 (Acute Systemic Toxicity).
- Key results: The subject device is non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic.
Condom Compatibility:
- Study type: Evaluation according to ASTM D7661-10/(R)2017 -Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
- Key results: The Play and Joy Water-Based Lubricant is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Shelf Life:
- Study type: Accelerated aging study.
- Key results: The subject device has a shelf-life of 6 months and met all device specifications listed in Table 1, Device Specifications, over this duration.
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
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
July 11, 2023
InnoveMed Bio-tech Co., Ltd. % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, NJ 07436
Re: K221137
Trade/Device Name: Play and Joy Water-Based Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 8, 2023 Received: June 9, 2023
Dear Charles 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, 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,
Monica D. Garcia -S
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) K221137
Device Name Play and Joy Water-Based Lubricant
Indications for Use (Describe)
Play and Joy Water-Based Lubricant is a 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 product is compatible with natural rubber latex, polyurethane, and polyisoprene 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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3
510(k) Summary K221137 Play and Joy Water-Based Lubricant
1 Submitter Information:
InnoveMed Bio-tech Co., Ltd. 6F, No.184, Sec. 2, Chongqing N. Rd., Datang District., Taipei City 10357, Taiwan (R.O.C.) Contact person: Miss Linda Li TEL: +86-2-2552-9398-25 E-Mail: Linda(@innovemed.biz
2 Submission Correspondent:
Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, New Jersey 07436, USA Tel: 608-217-9358 Email: cyshen@aol.com
3 Date of Summary: July 6, 2023
4 Subject Device Information:
| Proprietary Name: | Play and Joy Water-Based Lubricant |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (lubricant, personal) |
| Device Class: | Class II |
5 Predicate Device Information:
K203654, Solvey Co. LLC Water-Based Lubricant
The predicate device has not been subject to a design-related recall.
Device Descriptions 6
Play and Joy Water-Based Lubricant is a non-sterile, clear, semi-viscous water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
4
Its formulation consists of water, xantham gum, glycerine, Chondrus crispus extract, sodium hyaluronate, saccharide isomerate, hydroxyethylcellulose, citric acid, sodium citrate, lactic acid, 1,2-pentanediol, phenoxyethanol, iodopropynyl butylcarbamate, hydroxyacetophenone, gluconolactone, and sodium benzoate.
Play and Joy Water-Based Lubricant is for over-the-counter use and is provided in volumes of 50 mL and 100 mL in polyethylene tubes closed with polypropylene caps.
Device specifications for the Play and Joy Water-Based Lubricant are listed in Table 1.
| Physical Specification | Specifications |
|---|---|
| Appearance | Clear, semi-viscous liquid |
| Color | Colorless |
| Odor | Odorless |
| PH@25° C (per USP ) | 4.92-5.38 |
| Viscosity (cps, per USP ) | 1727-3463 cps |
| Specific Gravity (per USP ) | 1.04-1.08 |
| Osmolality (mOsm/Kg, per USP ) | (944-984) mOsm/kg |
| Antimicrobial effectiveness (per USP ) | Category 2 product: bacteria should show not |
| less than 2.0 log reduction at 14 days and no | |
| increase from 14-day count at the 28-day | |
| count. Yeast and molds should show no | |
| increase from the initial calculated count at 14 | |
| and 28 days | |
| Total yeast and mold count (TYMC, per USP | |
| ) | ) |
| viscosity range for | |
| the subject device is | |
| wider than the | |
| predicate device. | |
| This difference | |
| does not raise | |
| different questions | |
| of S&E. | |
| Specific Gravity | 1.04-1.08 |
| Osmolality | 944-984 mOsm/kg |
| osmolality of the | |
| subject device is | |
| higher than the | |
| predicate device. | |
| This difference | |
| does not raise | |
| different questions | |
| of S&E. | |
| Antimicrobial | |
| Effectiveness Tested | |
| per USP | Yes |
| Total yeast and mold | |
| (TYMC) | |
| Condom | |
| Compatibility | Compatible with natural |
| rubber latex, | |
| polyurethane, and | |
| polyisoprene | |
| condoms | Compatible with natural |
| rubber latex, | |
| polyurethane, and | |
| polyisoprene | |
| condoms | Same |
| Biocompatibility | |
| Tested | Yes |
| Shelf life | 6 months |
| shelf-life for the | |
| subject device is | |
| less than the | |
| predicate device. | |
| This difference | |
| does not raise | |
| different questions | |
| of S&E. |
6
The subject device and predicate device have the same indications for use and intended use. As shown in the table, there are differences in the technological characteristics of the subject and
7
predicate devices, including formulation, specifications (pH, viscosity, and osmolality), and device shelf-life. These differences in technological characteristics do not raise different questions of safety and effectiveness.
9 Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility studies were performed in accordance with the 2020 FDA guidance 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) a.
- Sensitization (ISO 10993-10:2010) b.
- Vaginal Irritation (ISO 10993-10:2010) C.
- Acute Systemic Toxicity (ISO 10993-11:2017) d.
The results of testing demonstrated the subject device is non-cytotoxic, non-sensitizing, nonirritating, 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/(R)2017 -Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of testing demonstrated that the Play and Joy Water-Based Lubricant is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Shelf Life:
The subject device has a shelf-life of 6 months based on the results of an accelerated aging study. The shelf-life study evaluated all device specifications listed in Table 1, Device Specifications. The subject device met all device specifications over the stated shelf-life duration.
10 Conclusions
The results of performance testing described above demonstrate that the Play and Joy Water-Based Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence