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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the X-Y Lubricating Jelly, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (Specification)	Reported Device Performance (Throughout Shelf-Life)
Appearance, color	Clear colorless	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Odor	Odorless	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
pH per USP<791>	6.0-7.0	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Osmolality per USP<785>	200-900 mOsm/Kg	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Viscosity per USP<912>	600-900 cPs	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Antimicrobial effectiveness per USP<51>	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.	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Total aerobic microbial count (TAMC) per USP<61>	< 100 cfu/g	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Total yeast and mold count (TYMC) per method equivalent to USP<61>	< 10 cfu/g	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Presence of Pathogens per USP<62>
Bile-tolerant gram-negative bacteria	Absent/g	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Pseudomonas aeruginosa	Absent/g	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Staphylococcus aureus	Absent/g	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Salmonella	Absent/g	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Escherichia coli	Absent/g	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Clostridia	Absent/g	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Candida albicans	Absent/g	Met specification (implied, as "All specifications listed in Table 1 were met throughout the shelf-life duration.")
Biocompatibility	Demonstrated biocompatibility according to ISO 10993-1, 10993-5:2009, 10993-10:2010 (Sensitization & Vaginal Irritation), and 10993-11:2017.	The results of the testing demonstrated that the subject lubricant is biocompatible.
Shelf-Life	3 years (based on real-time testing with all specifications in Table 1 met)	The subject device has a shelf-life of 3 years. All specifications listed in Table 1 were met throughout the shelf-life duration.
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms (in accordance with ASTM D7661-18).	X-Y Lubricating Jelly was determined to be compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms.

2. Sample Size Used for the Test Set and Data Provenance

The document provides details of specific tests, but does not explicitly state the sample sizes for each test or the data provenance (e.g., country of origin, retrospective/prospective). The study refers to:

Real-time testing for shelf-life.
Biocompatibility studies following ISO standards (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity).
Condom compatibility testing following ASTM D7661-18.

Without further information, the exact sample sizes and provenance for these specific tests cannot be determined from this document. However, all these are typically prospective laboratory-based studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device and study. The "ground truth" for a medical lubricant is established through objective laboratory testing against material and biological specifications, not through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for studies involving human interpretation (e.g., radiologists reviewing medical images). The studies for this lubricant are laboratory-based, not interpretative.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This information is not applicable. MRMC studies are used for evaluating diagnostic imaging devices and the impact of AI on human readers. This document describes a lubricant, which is not a diagnostic device.

6. Standalone Performance Study (Algorithm Only)

This information is not applicable. This device is a physical product (lubricating jelly), not an algorithm or AI. The performance studies are for the physical properties and biological interactions of the lubricant.

7. Type of Ground Truth Used

The ground truth used for this device's performance studies is based on:

Established laboratory standards and specifications: From USP (United States Pharmacopeia) for pH, osmolality, viscosity, antimicrobial effectiveness, and microbial counts.
International standards: ISO 10993 series for biocompatibility.
Industry standards: ASTM D7661-18 for condom compatibility.
Real-time product testing: For assessing shelf-life performance against all established specifications.

8. Sample Size for the Training Set

This information is not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K220226

Device Name X-Y Lubricating Jelly

Indications for Use (Describe)

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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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 24158Taiwan (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: CondomRegulation Number: 21 CFR 884.5300Product Code: NUC (lubricant, personal)Device Class: Class II
Predicate Device:	OneTouch™ Lubricant Gel510(k) Number: K142790Manufacturer: Thai Nippon Rubber Industry Co., Ltd.Product Code: NUCDevice Class: Class II

The predicate device has not been subject to a design-related recall.

Device Description:

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The device specifications are listed in the tables below:

Property	Specification
Appearance, color	Clear colorless
Odor	Odorless
pH per USP<791>	6.0-7.0
Osmolality per USP<785>	200-900 mOsm/Kg
Viscosity per <USP 912>	600-900 cPs
Antimicrobial effectiveness perUSP <51>	Bacteria: NLT 2.0 log reduction from the initial count at 14days, and no increase from 14 days 'count at 28 days;Yeasts/Molds: No increase from the initial calculated count at14 and 28 days.
Total aerobic microbial count(TAMC) per USP<61>	< 100 cfu/g
Total yeast and mold count(TYMC) per method equivalentto USP<61>	< 10 cfu/g
Presence of Pathogens perUSP<62>	Specification
Bile-tolerant gram-negativebacteria	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:

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 JellyK220226	OneTouch Lubricant GelK142790	Comments
Indications for Use	X-Y Lubricating Jelly is a personallubricant, for vaginal and/orpenile application, intended tomoisturize and lubricant, toenhance ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product is	OneTouch Lubricant Gel is apersonal lubricant, for penileand/or vaginal application,intended to moisturize andlubricant, to enhance ease andcomfort of intimate sexual activityand supplement the body's naturallubrication. This product is	The indications for usestatements for thesubject and predicatedevices are nearlyidentical, with the sameintended use.

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	compatible with natural rubberlatex and polyisoprene condoms.This product is not compatiblewith polyurethane condoms.	compatible with natural rubberlatex and polyisoprene condoms.This product is not compatiblewith polyurethane condoms.
Base Type	Water	Water	Same: The subjectdevice and predicatedevice have the samebase type.
Shelf-life	3 years	3 years	Same: The subjectdevice and predicatedevice have the sameshelf-life.
Primary Ingredients	Water, Glycerin,Hydroxyethylcellulose,Methylparaben	Water, Hydroxyethylcellulose,Glycerin, Methylparaben,Propylparaben, Cremophor	Differences informulations do notraise differentquestions of safety andeffectiveness (S&E).
Over the counteruse	Yes	Yes	Same: The subjectdevice and predicatedevice are for OTC use.
Sterile	No	No	Same: The subjectdevice and predicatedevice are non-sterile.
Condomcompatibility	Compatible with natural rubberlatex and polyisoprene condoms.Not compatible withpolyurethane condoms.	Compatible with natural rubberlatex and polyisoprene condoms.Not compatible with polyurethanecondoms.	Same: The subjectdevice and predicatedevice have the samecondom compatibility.
BiocompatibilityTested	Yes	Yes	Same: The subjectdevice and predicatedevice were tested andshown to bebiocompatible.
AntimicrobialTested	Yes	Unknown	Unknown: Potentialdifferences in methodsdeterminingpreservativeeffectiveness do notraise differentquestions of S&E.
Microbial Tested(Total aerobicmicrobial count,total yeast and moldcount, absence ofpathogens)	Yes	Yes	Same: The subjectdevice and predicatedevice completed thistesting.
pH Tested	Yes	Unknown	Unknown: Potentialdifferences in pH donot raise differentquestions of S&E.
Osmolality Tested	Yes	Unknown	Unknown: Potentialdifferences inosmolality do not raisedifferent questions ofS&E.
Viscosity Tested	Shelf-life	Yes	3 years	Unknown	3 years	Unknown: Potentialdifferences in viscosity	differences in viscositydo not raise differentquestions of S&E.Same: The subject

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		device and predicatedevice have the sameshelf-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.

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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.

Regulation Number and Section

§ 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.