JoyDrops® Natural Personal Lubricant Gel is a personal lubricant, for penile 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, polyisoprene, and polyurethane condoms.

Device Description

JoyDrops® Natural Personal Lubricant Gel is a water-based personal lubricant gel that is contained in a 3.38 fluid ounces (100 mL) polymer container with a pump dispenser.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: Joy Drops™ Natural Personal Lubricant Gel. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets acceptance criteria through clinical studies involving human readers or AI.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic device utilizing AI is not applicable to this document.

The document primarily focuses on:

Biocompatibility testing: To ensure the product is safe for contact with human tissue.
Condom compatibility testing: To ensure it doesn't degrade various types of condoms.
Comparison to a predicate device: To demonstrate substantial equivalence based on intended use, technological characteristics, and safety/performance data.

Here's an attempt to answer the questions based only on the information available for this specific product, acknowledging that many questions are not directly relevant to a lubricant's 510(k) submission:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (from text)	Reported Device Performance (from text)
Condom Compatibility:
Compatible with latex condoms (per ASTM D7 6661-10 and ARDL method)	Found to be compatible with latex condoms.
Compatible with polyisoprene condoms (per ASTM D7 6661-10 and ARDL method)	Found to be compatible with polyisoprene condoms.
Compatible with polyurethane condoms (per ASTM D7 6661-10 and ARDL method)	Found to be compatible with polyurethane condoms.
Biocompatibility (Safety):
No cellular toxicity (per ISO 10993 methodology)	No cellular toxicity was found.
No systemic toxicity (per NAMSA protocol, FDA approved)	No systemic toxicity was found. (Table: No Mortality or Evidence of Systemic Toxicity)
Non-irritant to vaginal tissue (per ISO 10993-10)	The test article was considered a non-irritant to vaginal tissue. (Table: No Irritation Observed)
No skin sensitization (per ISO 10993-10/AI standard practices)	No skin sensitization was reported. (Table: No Skin Sensitization was Observed for both animal and human patch tests)
No skin irritation (Human Patch Test, 30 min and 24 hours)	No Skin Irritation was Observed (for both 30 minutes and 24 hours).
Stability:
Shelf-life of three years	A shelf-life of three years was established based on data from temperature control cabinets (22°C and 60°C).
Microbiological specifications <10 cfu/mL-g	Microbiological specifications were set at <10 cfu/mL-g based on stability data.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the condom compatibility or biocompatibility tests (e.g., number of condoms tested, number of animals, or human subjects for patch tests). It refers to "standard practices" and ISO methodologies.

Data Provenance: The document does not specify the country of origin of the data for the tests. It refers to "an independent laboratory" for stability testing. The submitter is from Turkey (Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasal Urünler San. ve Tic. LTD ŞTI). The studies appear to be prospective, laboratory-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The device is a personal lubricant, not a diagnostic device requiring expert interpretation of results to establish ground truth for a test set. The tests performed (biocompatibility, condom compatibility) are objective laboratory measurements, not subjective expert evaluations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 are used for diagnostic interpretations by experts, which is not relevant for this product's testing. Laboratory tests have defined protocols and result interpretations.

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

This question is not applicable, as the device is a personal lubricant and does not involve AI, human readers, or diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable, as the device is a personal lubricant and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This question is not applicable in the context of diagnostic "ground truth." The "ground truth" for this product's performance refers to the objective results of standardized laboratory tests for:

Condom integrity: Measured by established ASTM and ARDL methods.
Biocompatibility: Measured by ISO 10993 standards for cytotoxicity, irritation, sensitization, and systemic toxicity.
Shelf-life: Measured by stability studies under controlled temperature conditions.

8. The sample size for the training set

This question is not applicable, as the device does not employ machine learning or AI, and therefore does not have a "training set."

9. How the ground truth for the training set was established

This question is not applicable, as the device does not employ machine learning or AI, and therefore does not have a "training set" or "ground truth for a training set."

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized design of three human profiles facing right, arranged in a cascading manner. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2015

Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa % Michael Scott President ST&T Research 2237 Chestnut Street San Francisco, CA 94123

Re: K140506

Trade/Device Name: Joy Drops™ Natural Personal Lubricant Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 13. 2015 Received: March 17, 2015

Dear Michael Scott,

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. 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. 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 (reporting of medical device

{1}------------------------------------------------

related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number: K140506

Device Name: JoyDrops® Natural Personal Lubricant Gel

Indications For Use:

______________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use __X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

{3}------------------------------------------------

ST&T Research Departments:

PRODUCT DEVELOPMENT & CLINICAL RESEARCH DRUG-DEVICES-COSMETICS-SUPPLEMENTS-FOOD/BEVERAGE US AGENT FDA-FTC-EPA-CUSTOMS - & GRAS REGISTRATION LABELING & INTERNATIONAL REGULATORY CONSULTATION

PRE & POST- MARKET CONSUMER PRODUCT USE RESEARCH □INFORMATION& CONSULTING: 800-869-4636

Image /page/3/Picture/3 description: The image shows a logo for "S&T Research Intl." with the tagline "Science, Toxicology & Technology" underneath. The logo features a stylized "S" and "T" connected by a red bar at the top, with the "S" in black and the "T" partially in red. The words "RESEARCH INTL." are in a smaller font size and placed below the "S&T", followed by the tagline in an even smaller font.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [21 CFR 807.92(c)]

Date Revised: April 17, 2015

510(k) Number: K140506

Submitter:

Official Contact Person: Michael Scott, President. ST&T Research Intl. On Behalf of: Turkuaz Sağlik Hizmetleri Medikal Temizlik Kimyasal Urünler San. ve Tic. LTD ŞTI (Turkauz) Saadetdere Mah. 67 Sok No: 3 Esenyurt Istanbul TR-34513 Turkey Phone: 90-212-4286848 FAX: 90-212-4286853 Contacts: Nurhan Irmak

Device (807.92(a)(2): Trade or Proprietary Name: JoyDrops® Natural Personal

Lubricant Gel

Common or Usual Name: Personal Lubricant Classification Name: Condom Product Code: NUC Requlation Number: 21 CFR 884.5300 Device Class: Class II

Predicate Device [807.92(a)(3): Walgreens Personal Lubricating Jelly (K080978)

Indications for Use

SCIENCE · TOXICOLOGY & TECHNOLOGY RESEARCH

□ SAN FRANCISCO (mailing address) • C/O P.O. BOX 470116 • SAN FRANCISCO, CALIFORNIA 94147 • (415) 441-2163

{4}------------------------------------------------

K140506 Turkuaz Medical Page 2

Device Description

JoyDrops® Natural Personal Lubricant Gel is a water-based personal lubricant gel that is contained in a 3.38 fluid ounces (100 mL) polymer container with a pump dispenser.

Directions for Product Use

Remove the cap of the JoyDrops® Natural Personal Lubricant Gel, and then twist the pump to open. Gently squeeze the tube to obtain the desired amount of lubricant. A 1 to 2 inch strip should be sufficient. May be applied directly onto the condom or onto the penis or into the vagina.

Product Performance and Condom Compatibility

JoyDrops® Natural Personal Lubricant Gel has been tested for performance by subjecting it to Condom Compatibility testing. Condom Compatibility was tested using the procedure described in the ASTM D7 6661-10 method and the ARDL method. JoyDrops® Natural Personal Lubricant Gel was found to be compatible with latex condoms, and polyisoprene and polyurethane condoms. This is the same as the statement made by Walgeens Personal Lubricant Jelly, which is the "substantially equivalent" comparison product.

Summary of test data that confirm that JoyDrops® Natural Personal Lubricant Gel is safe for use. 807.92(b)(3)1

JoyDrops® Natural Personal Lubricant Gel has been tested for safety by subjecting it to cytotoxicity testing, systemic toxicity testing, vaginal irritation testing, and sensitization testing.

The cytotoxicity tests were conducted using the ISO 10993 methodology. No cellular toxicity was found.
The systemic toxicity testing was conducted using a standard protocol developed by NAMSA, and approved by FDA upon submission. No systemic toxicity was found.
Vaqinal irritation was studied using the International Organization for Standardization 10993-10, Biological Evaluation of Medical Devices. The test article was considered a nonirritant to vaginal tissue.
Skin sensitization patch tests in humans and skin sensitization tests in animals were conducted according to standard practices, including ISO 10993-10/AI. No skin sensitization was reported.

These tests are consistent with the expectations of this class of device, and are substantially equivalent to the predicate product.

Biocompatibility

Test	Result
In Vitro Cytotoxicity	No Cytotoxic Effects Seen
Skin Irritation (Human Patch Test)30 minutes	No Skin Irritation was Observed
Skin Irritation (Human Patch Test)24 hours	No Skin Irritation was Observed
Skin Sensitization - Animals(Guinea Pigs); 3 Weeks	No Skin Sensitization wasObserved
Vaginal Irritation(Rabbits)	No Irritation Observed
Systemic Toxicity	No Mortality or Evidence of

{5}------------------------------------------------

(Mice); 7 Days	Systemic Toxicity
----------------	-------------------

The test sample extract was prepared according to ISO 10993-12. Table 1 "Standard surface areas and extract liquid volumes". Since the test sample is irregularly shaped solid devices (powder, pellets, foam, non-absorbent molded items) 0.2 g/ml extraction ratio was used. In order to use diluted extract of sample, 0.1 g/ml extraction ratio was also used. According to ISO 10993-12; 10.3.5 Extraction using both polar and non-polar extraction vehicles were performed.

The supplementation of basal culture media with animal serum of different origins is essential for cell growth, metabolism, and to stimulate proliferation ("mitogenic effect"). The major functions of serum in culture media are to provide (i) hormonal factors stimulating cell growth and proliferation and promoting differentiated functions, (ii) transport proteins carrying hormones (e.g. transcortin), minerals and trace elements (e.g. transferrin) and lipids (e.g. lipoproteins), (iii) attachment and spreading factors (Brunner et al., 2010, Altex 27; 1/10).

In order to support cell growth, 5% FBS was used until it was approximately 50% confluent. By adding extract of test materials the FBS concentration was decreased to 1% in order to continue cell growth and avoid cells to be overexposed to hormonal and growth factors according to the basic cell culture knowledge, since the percentage of the FBS has not been mentioned in the standard. According to our procedure, the extract condition includes 1% FBS.

The product is expected to be in contact with vaginal epithelial cells for less than 24 hours.

Packaging

JoyDrops® Natural Personal Lubricant Gel is packaged in 100 mL plastic polymer bottles. The bottle has a dispensing nozzle which in turn is covered by a plastic cap. The plastic cap has a tamper-resistant covering which must be removed in order to apply the gel. The bottle has a wrap-around label that meets the requirements of the FDA's labeling guidelines.

Technological Characteristics [807.92(a)(6)]:

Both the predicate device (Walgreens Personal Lubricating Jelly) and JoyDrops® Natural Personal Lubricant Gel have the same technological characteristics. They are both water-based gels that contain similar ingredients that allow vaginal lubrication and/or lubrication of condoms to ease the friction of sexual activity. Both lubricating gels are compatible with both latex-based condoms and common polymer-based condoms.

Substantial Equivalence [807.92(b)(1)]:

JoyDrops® Natural Personal Lubricant Gel is substantially equivalent to a marketed device: Walgreens Personal Lubricating Jelly. The intended use, active (lubricating) ingredients, presence of preservatives, and application of the proposed device are substantially equivalent to those of the predicative device. Both products are/will be sold over-the-counter and are indicated as personal lubricants.

{6}------------------------------------------------

	JoyDrops® NaturalPersonal Lubricant Gel	Walgreens PersonalLubricating Jelly
Manufacturer	Turkuaz	McNeil-PPC Inc
Intended use	Personal lubricant	Personal lubricant
Application	Topical	Topical
Over the counter use	Yes	Yes
Labeled water soluble	Yes	Yes
Labeled “condom compatible”	Yes	Yes
Contains Glycerin (Wetting Agent)	Yes	Yes
ContainsHydroxyethylcellulose (Gel	Yes	Yes
Contains Preservative andBuffering Ingredients	Yes	Yes
Contains alcohol	No	No
Contains fragrances	No	No
Container material	Plastic Polymer	N/A
Sterile	No	No

Product Characteristics

The primary characteristics of Joy Drops® Natural Personal Lubricant Gel include:

□Lubricating agent
□Adjusted to a pH of ≈ 7.0

■Water soluble

_Chemically preserved to insure freshness

□Non-sticky
□Gel consistency

_ Does not contain lipids

□Does not contain formaldehyde and salt

□Does not have fragrance or odor

Ingredients and Specifications

Ingredients	Quantity (W/V%)	CAS Number	Supplier
Hydroxy EthylCellulose	1.0-2.0	9004-62-0	Dow Chemical
Glycerin	12.0-17.0	9004-62-0	So Gis IndustriaChimica Spa Italy
Mono PropyleneGlycol	1.0-5.0	57-55-6	Sigma AldrichGermany
Citric Acid	0.01-0.1	77-92-9	Sigma AldrichGermany
Phenoxyethanol &Ethylhexylglycerin	0,05-0.2	122-99-6/70445-33-9	Sigma AldrichGermany/
Deionized water	q.s 100	7732-18-5

{7}------------------------------------------------

K140506 Turkuaz Medical Page 5

Packaqinq

JoyDrops® Natural Personal Lubricant Gel is packaged in 100 mL plastic bottles with a dispensing nozzle and plastic cap.

Stability 807.92(d)]:

JoyDrops® Natural Personal Lubricant Gel was placed in temperature control cabinets set at 22°C and 60°C. Based on the data obtained by an independent laboratory, a shelf-life of three years was established. Based on the data, microbiological specifications were set at <10 cfu/mL-g.

Software

There isn't any computer software that is required for the application of this product.

EMC and Electrical Safety

The device does not require EMC and Electrical safety evaluation.

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.