O Glide Personal Lubricant 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 not compatible with condoms.

Device Description

The O Glide Personal Lubricant is a non-sterile, oil-based personal lubricant designed to supplement the body's own natural lubrication fluids and to enhance the ease and comfort of intimate sexual activity.

The O Glide Personal Lubricant is specifically formulated with naturally occurring plant derived oils. The specifications for the subject lubricant include appearance, odor, viscosity, total microbial count (TAMC), total combined yeast and molds count, and absence of pathogenic organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Coliforms, and Clostridia). Osmolality, pH, and antimicrobial effectiveness are not applicable to the subject device because it is an oil-based lubricant.

The product is bottled in an LDPE white plastic tube with a white flip top cap. The tube is packaged in a carton for sale to consumers.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the "O Glide Personal Lubricant," which is a Class II medical device (condom product code NUC). It describes the technical characteristics and performance data to demonstrate substantial equivalence to a predicate device, Aloe Cadabra Personal Lubricant (K124044).

Here's an analysis of the provided information, focusing on the acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a typical quantitative format alongside performance. Instead, it describes performance across various tests, implying successful completion as the acceptance. Here's a table summarizing the tests and their reported outcomes:

Test Category	Specific Test	Purpose/Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Cytotoxicity (ISO Elution Method)	No cytotoxic effects	"The test article extract showed no evidence of causing cell lysis or toxicity."
	Acute Systemic Toxicity (Mice)	No mortality or evidence of systemic toxicity	"There was no mortality or evidence of systemic toxicity from the extracts injected into mice."
	Maximization Sensitization (Guinea Pig)	No dermal contact sensitization	"The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig."
	Vaginal Irritation (Rabbit with Histopathology)	Non-irritant to vaginal tissue	"The test article extracts were considered to be a non-irritant to vaginal tissue of the rabbit."
Shelf Life	Accelerated Aging Study	Maintain specifications over the proposed shelf life (1 year)	"The subject device met its specifications over the duration of the proposed shelf life."
Condom Compatibility	N/A	Not compatible with condoms (based on labeling and stated characteristic)	"The subject device is labeled not for use with condoms."

Beyond these specific tests, the "specifications for the subject lubricant" include appearance, odor, viscosity, total microbial count (TAMC), total combined yeast and molds count, and absence of pathogenic organisms. While no specific numerical criteria are given in this document, it's implied that the device met these specifications, as it passed the shelf-life testing. Osmolality, pH, and antimicrobial effectiveness were deemed "not applicable" due to the oil-based nature of the lubricant.

2. Sample sized used for the test set and the data provenance

Test Set Sample Sizes:
- Cytotoxicity: Not specified (in vitro cell culture).
- Acute Systemic Toxicity: "Mice" - specific number not provided.
- Maximization Sensitization: "Guinea pig" - specific number not provided.
- Vaginal Irritation: "Rabbits" - specific number not provided.
- Shelf Life: Not specified; likely involves multiple product samples tested over time intervals.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It implies prospective testing conducted for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to this document. The studies conducted are laboratory-based experimental tests on animals (mice, guinea pigs, rabbits) and in vitro cell cultures, as well as product stability testing. There is no "ground truth" derived from human experts in the context of diagnostic interpretation for this type of device (personal lubricant). The "ground truth" for these tests is the objective measurement of biological reactions or physical/chemical properties.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or expert review processes where there's a possibility of disagreement in interpretation (e.g., image reading). The tests performed for this lubricant are laboratory experiments with objective endpoints.

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 is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving image interpretation, and would assess the performance of human readers, potentially with or without AI assistance. This document pertains to a personal lubricant, not a diagnostic device involving human readers or AI.

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

This is not applicable. This document does not concern an AI algorithm or software. It is about a physical chemical product (personal lubricant).

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

The "ground truth" for the performance data presented is based on objective laboratory measurements and accepted biological responses in standardized animal models and cell cultures. For example:

Cytotoxicity: Observed cell lysis/toxicity.
Acute Systemic Toxicity: Mortality or observable systemic effects in mice.
Sensitization: Observable dermal contact sensitization in guinea pigs.
Vaginal Irritation: Histopathological findings in rabbit vaginal tissue.
Shelf Life: Adherence to defined physical, chemical, and microbiological specifications of the product.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a personal lubricant device. Training sets are used for machine learning algorithms.

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

This is not applicable as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is a stylized representation of a human figure, with three profiles facing right, stacked on top of each other.

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

July 24, 2015

Grafenberg Labs % Bosmat Friedman Regulatory Consultant MJRAC 1208-12 Rockford Road Toronto, Ontario M2R 3A2 Canada

Re: K142726 Trade/Device Name: O Glide Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 23, 2015 Received: June 25, 2015

Dear Bosmat Friedman,

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

for

Sincerely yours.

Herbert P. Lerner -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

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Indications for Use

510(k) Number (if known) K142726

Device Name O Glide Personal Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 [as required by section 807.92(c)] O Glide Personal Lubricant 510(k) Number K142726

1. SUBMITTER

Applicant's Name and Contact Information:

Grafenberg Labs 755 Second Avenue New York NY 10017 Tel: 212-599-5555 Ext. 143 212-599-5554 Fax:

Contact Person:

Bosmat Friedman Regulatory Affairs Consultant; MJ RAC 1208-12 Rockford Rd. Toronto, ON, M2R 3A2, Canada Phone: 647-975-3974; Fax: 647-427-1946; bosmat@pushmed.com

Date Prepared:

September 15, 2014 (Revised July 23, 2015)

DEVICE NAME AND CLASSIFICATION 2.

Trade Name:

O Glide Personal Lubricant

Common or Usual Name: Personal Lubricant

Classification Name: Condom Product Code: NUC Regulation No: 21 CFR 884.5300 Class: II Classification Panel: Obstetrics/Gynecology

3. PREDICATE DEVICES

Primary Predicate Device:

Aloe Cadabra Personal Lubricant - K124044

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4. DEVICE DESCRIPTION

The product is bottled in an LDPE white plastic tube with a white flip top cap. The tube is packaged in a carton for sale to consumers.

ട. INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6. PREDICATE DEVICE

The subject and predicate device have the same intended use. The subject and predicate devices do not have the same technological characteristics because the subject device is oil-based and the predicate is aloe-based. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions, as formulation differences are commonly addressed in personal lubricant 510(k) submissions. Accepted scientific methods exist to assess the effects of the different technological characteristics, including biocompatibility, condom compatibility, and stability testing.

7. PERFORMANCE DATA

Below is a list of the tests that have been performed and successfully completed for the O Glide Personal Lubricant.

Biocompatibility:

Cytotoxicity Study Using the ISO Elution Method

The test article was evaluated for potential cytotoxic effects using an in vitro mammalian cell culture test. The test article extract showed no evidence of causing cell lysis or toxicity.

O Glide Personal Lubricant

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ISO Acute Systemic Toxicity Study in Mice

The test article was evaluated for acute systemic toxicity in mice. There was no mortality or evidence of systemic toxicity from the extracts injected into mice.

ISO Maximization Sensitization Study

The test article was evaluated for the potential to cause sensitization in a guinea pig maximization test. The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig.

ISO Vaginal Irritation Study with Histopathology

The test article was evaluated for the potential to cause irritation to vaginal tissue in rabbits. The test article extracts were considered to be a non-irritant to vaginal tissue of the rabbit.

Shelf Life:

The subject device has one-year shelf life based on the results of an accelerated aging study conducted in the proposed packaging. The subject device met its specifications over the duration of the proposed shelf life.

Condom Compatibility:

The subject device is labeled not for use with condoms.

CONCLUSION 8.

The O Glide Personal Lubricant is substantially equivalent to the predicate device.

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.