(304 days)
Not Found
No
The 510(k) summary describes a personal lubricant and its physical and biological properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
A therapeutic device is generally defined as a device used to treat or cure a disease or condition. This device is a personal lubricant intended to enhance comfort during sexual activity, which is not a therapeutic use.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose a medical condition.
No
The device description clearly indicates it is a physical product (personal lubricant) bottled in a plastic tube, not software.
Based on the provided information, the O Glide Personal Lubricant is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for personal lubrication during sexual activity, applied to the body (penile and/or vaginal). This is a topical application for physical comfort and enhancement, not for diagnosing a condition or analyzing a sample taken from the body.
- Device Description: The description focuses on the physical properties and composition of the lubricant itself, not on any diagnostic function.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, shelf life, and condom compatibility, which are relevant to a personal lubricant, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The O Glide Personal Lubricant does not fit this definition.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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:
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.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/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
1
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
2
Indications for Use
510(k) Number (if known) K142726
Device Name O Glide Personal Lubricant
Indications for Use (Describe)
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.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
4
4. 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.
ട. INDICATIONS FOR USE
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.
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
5
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.