(257 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a personal lubricant, with no mention of AI or ML.
No
A therapeutic device is used to treat or prevent a disease or condition. This device is a personal lubricant for enhancing comfort during sexual activity, which is not a therapeutic purpose.
No
The device is a personal lubricant used to moisturize and lubricate for sexual activity, not to diagnose a medical condition.
No
The device description clearly indicates it is a physical product (a water-based lubricant) and the performance studies are related to the physical and chemical properties of the lubricant, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal lubrication during sexual activity, applied to the body (penile, vaginal, and/or rectal).
- Device Description: It's a water-based personal lubricant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on or in the body) for lubrication.
N/A
Intended Use / Indications for Use
FLIP Lube is personal lubricant for penile, vaginal, and/or rectal 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 synthetic polyisoprene condoms. Not compatible with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
FLIP Lube is a water-based, personal lubricant used to provide lubrication during sexual intercourse. It is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
The specifications include appearance, color, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, vaginal, and/or rectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OTC – home 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance tests were conducted:
- Shelf Life (accelerated aging equivalent to 12 months per ASTM F1980-16)
- Condom Compatibility per ASTM D7661-10
- Biocompatibility
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation with Histopathology (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006)
The results of performance testing demonstrate that the proposed lubricant maintains all of its specifications over the duration of its proposed shelf life, is compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms, and biocompatible.
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/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 5, 2018
ImQuest BioSciences, Inc. % Paul Dryden Consultant ProMedic, LLC 131 Bay Point Dr. NE Saint Petersburg, FL 33704
Re: K171516 Trade/Device Name: FLIP Lube Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: January 3. 2018 Received: January 4, 2018
Dear Paul Dryden:
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
1
801); medical device reporting of medical device-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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
for 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)
K171516
Device Name
FLIP Lube
Indications for Use (Describe)
FLIP Lube is personal lubricant for penile, vaginal, and/or rectal 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 synthetic polyisoprene condoms. Not compatible with polyurethane condoms.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
XX 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 respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
EF PSC Publishing Services (301) 443-6740
3
| Submitter: | ImQuest BioSciences Inc.
7340 Executive Way, Suite R
Frederick, MD 21704
Tel - 301-696-0274 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Karen W. Buckheit - Director, Prevention Sciences, ImQuest
BioSciences Inc. |
| Proprietary or Trade Name: | FLIP Lube |
| Common/Usual Name: | Personal Lubricant |
| Classification Name | 21 CFR 884.5300 (Condom)
NUC (lubricant, personal)
Class II |
| Predicate Device: | K141913 - PJUR GROUP LUXEMBOURG SA -
Backdoor Anal Glide /Analyse Me!
The predicate device has not been subject to a design related
recall. |
Device Description:
FLIP Lube is a water-based, personal lubricant used to provide lubrication during sexual intercourse. It is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.
The specifications include appearance, color, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.
Indications for Use:
Flip Lube is personal lubricant for penile, vaginal, and/or rectal 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 synthetic polyisoprene condoms. Not compatible with polyurethane condoms.
Substantial Equivalence Discussion:
| Feature | Predicate
K141913
PJUR GROUP LUXEMBOURG SA -
Backdoor Anal Glide /Analyse Me! | Proposed
K171516
ImQuest BioSciences
FLIP Lube |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | 21CFR 884.5300 - NUC - Personal Lubricant | |
| Class | II / OTC | |
| Indications for Use | Personal lubricants for penile, vaginal, and/or anal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication | FLIP Lube is personal lubricant for penile, vaginal, and/or rectal 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 |
4
| | | natural rubber latex and synthetic
polyisoprene condoms. Not compatible with
polyurethane condoms. |
|----------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Environment of Use | OTC – home use | OTC – home use |
| Condom Compatibility | Natural rubber latex | Natural rubber latex
Polyisoprene
Not compatible with polyurethane condoms. |
| Type of lubricant | Water-based
Silicone-based | Water-based |
| Materials | Dimethicone
Dimethiconol
Simmondsia Chinensis (Jojoba) Seed Oil
Amyris Balsamifera Bark Oil | Water
Glycerol
Hydroxyethyl Cellulose
Methylparaben
Propylparaben
Sodium Phosphate |
Both lubricants have the same intended use, but different technological characteristics (e.g., base type). The different technological characteristics do not raise different questions of safety and effectiveness.
Summary of Performance Testing
The following performance tests were conducted:
- Shelf Life (accelerated aging equivalent to 12 months per ASTM F1980-16) ●
- Condom Compatibility per ASTM D7661-10
- Biocompatibility
- Cytotoxicity (ISO 10993-5:2009) O
- Sensitization (ISO 10993-10:2010) о
- Vaginal Irritation with Histopathology (ISO 10993-10:2010) O
- Acute Systemic Toxicity (ISO 10993-11:2006) o
The results of performance testing demonstrate that the proposed lubricant maintains all of its specifications over the duration of its proposed shelf life, is compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms, and biocompatible.
Conclusion
Based upon performance testing provided, the proposed device and predicate device are substantially equivalent.