(90 days)
Not Found
No
The device is a personal lubricant and the description focuses on its chemical composition and physical properties, with no mention of AI or ML.
No
The device is a personal lubricant intended to lubricate and moisturize to enhance sexual activity, which is not considered a therapeutic function.
No
The device is a personal lubricant intended to enhance comfort during intimate sexual activity, not to diagnose a condition or disease.
No
The device is a personal lubricant, which is a physical substance, not software. The description details its chemical composition and physical properties, not software functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This describes a topical product for physical lubrication, not a test performed on samples taken from the body to diagnose or monitor a medical condition.
- Device Description: The description lists ingredients of a personal lubricant. There is no mention of reagents, test strips, or any components typically associated with in vitro diagnostic tests.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The information provided clearly indicates this is a personal lubricant, which is a medical device but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Mano and Mano Personal Lubricant is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Product codes
NUC
Device Description
Mano and Mano Personal Lubricant (additionally branded as Nooky, Hello Sailor, or Lulu) is a clear, colorless, water-based personal lubricant composed of purified water, propylene glycol, hydroxethyl cellulose, sodium pyrrolidone carboxylic acid, potassium sorbate and citric acid.
This product has an initial shelf-life of 10 months. The shelf-life will be extended pending completion of further study.
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
Bench testing demonstrated that the subject device met the physical specifications (appearance, pH, viscosity and, osmolality) and the following microbiology specifications:
- Total Aerobic Microbial Count: ≤100 cfu/g (Methods: USP )
- Total Yeast and Mold Count: ≤10 cfu/g (Methods: USP )
- Absence of Pathogenic Organisms: Absence of pseudomonas aeruginosa, staphylococcus aureus, and candida albicans (Methods: USP )
- Antimicrobial Effectiveness: At least 2.0 log reduction from the initial count at 14 days; no increase from the 14 days count at 28 days; no increase from the initial calculated count at 14 and 28 days (Methods: USP)
Shelf-life (stability) testing conducted by a third-party laboratory demonstrated that the subject device maintained all physical and microbiology specifications at the end of shelf-life period.
The subject device has passed the following biocompatibility testing in accordance with relevant ISO standards:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006)
Key Metrics
Not Found
Predicate Device(s)
Poise Personal Lubricant (K120650)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2016
Mano and Mano Proprietary Limited % Gary Mocnik Regulatory Consultant ClinReg Consulting Services, Inc. 733 Bolsana Drive Laguna Beach, CA 92651
Re: K161585
Trade/Device Name: Mano and Mano Personal Lubricant (also branded as Nooky, Hello Sailor, or Lulu) Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: June 6, 2016 Received: June 8, 2016
Dear Gary Mocnik:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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/Resourcesfor You/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,
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) K161585
Device Name
Mano and Mano Personal Lubricant (additionally branded as Nooky, Hello Sailor, or Lulu)
Indications for Use (Describe)
Mano and Mano Personal Lubricant is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
| Type of Use (Select one or both, as applicable) |
|---|
| [Checkbox 1] [Checkbox 2] |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary (K161585)
| Applicant: | Mano and Mano Proprietary Limited
286 Chesterville Rd
Moorabbin, Victoria 3189
Australia |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Gary Mocnik
ClinReg Consulting Services, Inc.
733 Bolsana Drive
Laguna Beach, CA 92651
Phone: 949-433-0413
E-mail: gmocnik@cox.net) |
| Date Prepared: | August 16, 2016 |
| Proprietary Name: | Mano and Mano Personal Lubricant (also branded as Nooky, Hello Sailor, or
Lulu) |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulatory Class: | Class II |
| Product Code: | NUC |
| Predicate Device: | Poise Personal Lubricant (K120650) |
Device Description:
Mano and Mano Personal Lubricant (additionally branded as Nooky, Hello Sailor, or Lulu) is a clear, colorless, water-based personal lubricant composed of purified water, propylene glycol, hydroxethyl cellulose, sodium pyrrolidone carboxylic acid, potassium sorbate and citric acid.
This product has an initial shelf-life of 10 months. The shelf-life will be extended pending completion of further study.
Indications for Use:
Mano and Mano Personal Lubricant is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
4
Substantial Equivalence Discussion
The subject and predicate devices have the same indications. They both are clear, colorless, waterbased personal lubricants. Although there are differences in pH, osmolality, viscosity and formulation of these devices, the differences do not represent a new technology as they do not raise different questions of safety and effectiveness.
Performance Data
Bench testing demonstrated that the subject device met the physical specifications (appearance, pH, viscosity and, osmolality) and the following microbiology specifications:
| Criteria | Specifications | Methods |
|---|---|---|
| Total Aerobic Microbial Count | ≤100 cfu/g | USP |
| Total Yeast and Mold Count | ≤10 cfu/g | USP |
| Absence of Pathogenic | ||
| Organisms | Absence of pseudomonas aeruginosa, staphylococcus | |
| aureus, and candida albicans | USP | |
| Antimicrobial Effectiveness | At least 2.0 log reduction from the initial count at 14 | |
| days; no increase from the 14 days count at 28 days; no | ||
| increase from the initial calculated count at 14 and 28 | ||
| days | USP |
Shelf-life (stability) testing conducted by a third-party laboratory demonstrated that the subject device maintained all physical and microbiology specifications at the end of shelf-life period.
The subject device has passed the following biocompatibility testing in accordance with relevant ISO standards:
- Cytotoxicity (ISO 10993-5:2009) ●
- Sensitization (ISO 10993-10:2010) ●
- Irritation (ISO 10993-10:2010) ●
- Acute Systemic Toxicity (ISO 10993-11:2006) ●
Conclusion:
The subject and predicate devices have the same indications and fundamental technological characteristics. The differences in technological characteristics do not raise different types of questions and can be assessed by bench and biocompatibility testing. Performance data demonstrates that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness.