(425 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a lubricating jelly, with no mention of AI or ML.
No
The sole purpose of the device is to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity, which is not a therapeutic function aimed at treating or preventing a disease or condition.
No
Explanation: The intended use of X-Y Lubricating Jelly is a personal lubricant for moisturizing and lubricating to enhance sexual activity, not for diagnosing conditions.
No
The device description clearly states it is a physical product (lubricating jelly) packaged in tubes, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for sexual activity, intended to moisturize and lubricate. This is a physical function, not a diagnostic one.
- Device Description: The description details a water-based lubricant with specific ingredients and packaging. There is no mention of components designed to analyze biological samples or provide diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, shelf-life, and condom compatibility. These are relevant to the safety and efficacy of a personal lubricant, not to diagnostic accuracy.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. X-Y Lubricating Jelly does not fit this description.
N/A
Intended Use / Indications for Use
X-Y Lubricating Jelly is a personal lubricant, for vaginal and/or penile 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
X-Y Lubricating Jelly is a non-sterile, water-based personal lubricant compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The lubricant formulation consists of water, glycerin, hydroxyethylcellulose, and methylparaben. X-Y Lubricating Jelly is packaged in 35 g and 100 g polyethylene tubes with a flip-top closure. The tube is then packaged in a carton. X-Y Lubricating Jelly is a personal lubricant for over-the-counter (OTC) use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal and/or 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
Biocompatibility studies, including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing 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 results of this testing demonstrated that the subject lubricant is biocompatible.
Shelf-Life: The subject device has a shelf-life of 3 years based on real-time testing. All specifications listed in Table 1 were met throughout the shelf-life duration.
Condom Compatibility: The compatibility of the subject device was evaluated in accordance with ASTM D7661-18 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." X-Y Lubricating Jelly was determined to be compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms.
Key Metrics
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.
0
Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 28, 2023
R&R Medical Corporation Ltd. % Kao Chih Hao Vice President Voler Biotech Consulting CO., Ltd. No. 3-1, Lane 58, Hejiang St., Zhongshan Disy. Taipei City Taiwan
Re: K220226 Trade/Device Name: X-Y Lubricating Jelly Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 17, 2023 Received: February 21, 2023
Dear Kao Chih Hao:
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,
Michael T. Bailey -S
For Monica 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) K220226
Device Name X-Y Lubricating Jelly
Indications for Use (Describe)
X-Y Lubricating Jelly is a personal lubricant, for vaginal and/or penile 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 31, SEPP 33) - Select One | Care-Taker Quarters (31, SEPP 33) - Select One |
|---|---|
| -------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K220226 Page 1 of 5
510(k) SUMMARY
K220226 X-Y Lubricating Jelly
| 510(k) Owner: | R&R Medical Corporation Ltd. |
|---|---|
| Street Address: | No. 4, Ln. 38, Zhongxing N. St., Sanchong Dist., New Taipei City 24158 |
| Taiwan (R.O.C.) | |
| Contact Person: | Wilson Chang |
| Contact Email: | wcchang@rr-medical.com |
| Contact Number: | Tel: +886-2-2697-6618 |
| Summary Preparation Date: | March 24, 2023 |
| Trade Name: | X-Y Lubricating Jelly |
| Common Name: | Personal Lubricant |
| Device Classification: | Regulation Name: Condom |
| Regulation Number: 21 CFR 884.5300 | |
| Product Code: NUC (lubricant, personal) | |
| Device Class: Class II | |
| Predicate Device: | OneTouch™ Lubricant Gel |
| 510(k) Number: K142790 | |
| Manufacturer: Thai Nippon Rubber Industry Co., Ltd. | |
| Product Code: NUC | |
| Device Class: Class II |
The predicate device has not been subject to a design-related recall.
Device Description:
X-Y Lubricating Jelly is a non-sterile, water-based personal lubricant compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The lubricant formulation consists of water, glycerin, hydroxyethylcellulose, and methylparaben. X-Y Lubricating Jelly is packaged in 35 g and 100 g polyethylene tubes with a flip-top closure. The tube is then packaged in a carton. X-Y Lubricating Jelly is a personal lubricant for over-the-counter (OTC) use.
4
The device specifications are listed in the tables below:
| Property | Specification |
|---|---|
| Appearance, color | Clear colorless |
| Odor | Odorless |
| pH per USP | 6.0-7.0 |
| Osmolality per USP | 200-900 mOsm/Kg |
| Viscosity per | 600-900 cPs |
| Antimicrobial effectiveness per | |
| USP | Bacteria: NLT 2.0 log reduction from the initial count at 14 |
| days, and no increase from 14 days 'count at 28 days; | |
| Yeasts/Molds: No increase from the initial calculated count at | |
| 14 and 28 days. | |
| Total aerobic microbial count | |
| (TAMC) per USP | |
| Bile-tolerant gram-negative | |
| bacteria | Absent/g |
| Pseudomonas aeruginosa | Absent/g |
| Staphylococcus aureus | Absent/g |
| Salmonella | Absent/g |
| Escherichia coli | Absent/g |
| Clostridia | Absent/g |
| Candida albicans | Absent/g |
Table 1: X-Y Lubricating Jelly Device Specifications
Indications for Use Statements:
X-Y Lubricating Jelly is a personal lubricant, for vaginal and/or penile 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.
Comparison of Intended Use and Technological Characteristics to the Predicate Device:
In the table below, the predicate for X-Y Lubricating Jelly is OneTouch Lubricant Gel.
| Feature | X-Y Lubricating Jelly
K220226 | OneTouch Lubricant Gel
K142790 | Comments |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | X-Y Lubricating Jelly is a personal
lubricant, for vaginal and/or
penile application, intended to
moisturize and lubricant, to
enhance ease and comfort of
intimate sexual activity and
supplement the body's natural
lubrication. This product is | OneTouch Lubricant Gel is a
personal lubricant, for penile
and/or vaginal application,
intended to moisturize and
lubricant, to enhance ease and
comfort of intimate sexual activity
and supplement the body's natural
lubrication. This product is | The indications for use
statements for the
subject and predicate
devices are nearly
identical, with the same
intended use. |
5
| | compatible with natural rubber
latex and polyisoprene condoms.
This product is not compatible
with polyurethane condoms. | compatible with natural rubber
latex and polyisoprene condoms.
This product is not compatible
with polyurethane condoms. | | | | | |
|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|------------------------------------------------|----------------------------------------------------------------------------------------------|
| Base Type | Water | Water | Same: The subject
device and predicate
device have the same
base type. | | | | |
| Shelf-life | 3 years | 3 years | Same: The subject
device and predicate
device have the same
shelf-life. | | | | |
| Primary Ingredients | Water, Glycerin,
Hydroxyethylcellulose,
Methylparaben | Water, Hydroxyethylcellulose,
Glycerin, Methylparaben,
Propylparaben, Cremophor | Differences in
formulations do not
raise different
questions of safety and
effectiveness (S&E). | | | | |
| Over the counter
use | Yes | Yes | Same: The subject
device and predicate
device are for OTC use. | | | | |
| Sterile | No | No | Same: The subject
device and predicate
device are non-sterile. | | | | |
| Condom
compatibility | Compatible with natural rubber
latex and polyisoprene condoms.
Not compatible with
polyurethane condoms. | Compatible with natural rubber
latex and polyisoprene condoms.
Not compatible with polyurethane
condoms. | Same: The subject
device and predicate
device have the same
condom compatibility. | | | | |
| Biocompatibility
Tested | Yes | Yes | Same: The subject
device and predicate
device were tested and
shown to be
biocompatible. | | | | |
| Antimicrobial
Tested | Yes | Unknown | Unknown: Potential
differences in methods
determining
preservative
effectiveness do not
raise different
questions of S&E. | | | | |
| Microbial Tested
(Total aerobic
microbial count,
total yeast and mold
count, absence of
pathogens) | Yes | Yes | Same: The subject
device and predicate
device completed this
testing. | | | | |
| pH Tested | Yes | Unknown | Unknown: Potential
differences in pH do
not raise different
questions of S&E. | | | | |
| Osmolality Tested | Yes | Unknown | Unknown: Potential
differences in
osmolality do not raise
different questions of
S&E. | | | | |
| Viscosity Tested | Shelf-life | Yes | 3 years | Unknown | 3 years | Unknown: Potential
differences in viscosity | differences in viscosity
do not raise different
questions of S&E.
Same: The subject |
6
| | | device and predicate
device have the same
shelf-life. |
|--|--|-------------------------------------------------------------|
| | | |
As stated in the table, the indications for use for the subject and predicate device are nearly identical. Therefore, the subject and predicate devices have the same intended use.
The subject and predicate devices have different technological characteristics. For example, different formulations. The different technological characteristics identified in the table do not raise different questions of safety and effectiveness.
Summary of Performance Data:
Biocompatibility
Biocompatibility studies, including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing 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", as follows:
- 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 this testing demonstrated that the subject lubricant is biocompatible.
Shelf-Life:
The subject device has a shelf-life of 3 years.
The shelf-life duration for the subject device is based on the results of real-time testing. All specifications listed in Table 1 were met throughout the shelf-life duration.
Condom Compatibility:
The compatibility of the subject device was evaluated in accordance with ASTM D7661-18 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." X-Y Lubricating Jelly was determined to be compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms.
7
Conclusion:
The results of the performance testing described above demonstrate that X-Y Lubricating Jelly is as safe and effective as the predicate device and support a determination of substantial equivalence.