(58 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a personal lubricant, with no mention of AI or ML technology.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity, which is not a therapeutic purpose.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to diagnose any condition.
No
The device description clearly states that the device is a physical product consisting of a lubricant in a bottle with a cap, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Astroglide® O Oil Personal Lubricant & Massage Oil's Intended Use: The intended use clearly states it is 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 is a topical application for direct use on the body, not for testing samples taken from the body.
- Device Description: The description details a personal lubricant, not a testing kit, reagent, or instrument used for analyzing biological samples.
- Lack of IVD-Specific Information: The document does not mention any aspects related to sample collection, analysis, or diagnostic results, which are hallmarks of IVDs.
Therefore, based on the provided information, Astroglide® O Oil Personal Lubricant & Massage Oil is a personal lubricant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Astroglide® O Oil Personal Lubricant & Massage Oil 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
NUC
Device Description
Astroglide® O Oil Personal Lubricant & Massage Oil is non-sterile, light yellow, lightly coconut and ylang-ylang scented, and oil-based lubricant. All oils used in the subject formulation are certified organic, and the subject lubricant is a USDA certified organic final product. This product is not a spermicide or contraceptive. It is NOT compatible with natural rubber latex, polyurethane, or polyisoprene condoms.
This product primary packaging is a PETE amber bottle with a screw on polypropylene flip-top cap. The bottle and cap constitute the device are labeled front and back and then packaged in a cardboard carton which constitutes the final packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal application
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
Biocompatibility
Biocompatibility testing was performed in accordance with ISO 10993-1: 2009/(R)2013, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process.
- Cytotoxicity, ISO 10993-5: 2009/(R)2014: The test article was found to be non-cytotoxic.
- Guinea Pig Maximization, ISO 10993-10: 2010/(R)2014: The test article was found to be non-sensitizing.
- Vaginal Irritation, ISO 10993-10: 2010/(R)2014: The test article was found to be non-irritating.
- Systemic Toxicity, ISO 10993-11: 2006/(R)2010: The test article was found to be non-systematically toxic.
Condom Compatibility
Astroglide® O Oil Personal Lubricant & Massage Oil was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms using ASTM D7661-10, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Results show that Astroglide® O Oil Personal Lubricant & Massage Oil is NOT compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Shelf life
Astroglide® O Oil Personal Lubricant & Massage Oil has a shelf-life of 18 months based on 6 months of accelerated aging testing results per ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The accelerated aging study demonstrated that the subject device maintained its specifications over the duration of its shelf life.
Key Metrics
Not Found
Predicate Device(s)
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/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 30, 2017
BioFilm, Inc. Richard Hines Regulatory Affairs Manager 3225 Executive Ridge Vista, CA 92081
Re: K171985
Trade/Device Name: Astroglide® O Oil Personal Lubricant & Massage Oil Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 30, 2017 Received: July 3, 2017
Dear Richard Hines:
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.
1
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 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.
Charles Viviano -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)
Device Name
Astroglide® O Oil Personal Lubricant & Massage Oil
Indications for Use (Describe)
Astroglide® O Oil Personal Lubricant & Massage Oil 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)
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3
510(K) Summary - K171985 Astroglide® O Oil Personal Lubricant & Massage Oil
i. General Information on Submitter
| Applicant: | BioFilm, Inc. |
|---|---|
| Address: | 3225 Executive Ridge |
| Vista, CA 92081 USA | |
| Telephone: | 760-727-9030 |
| Fax: | 760-727-8080 |
| Contact Person: | Richard Hines |
| Contact Title: | Regulatory Affairs Manager |
| Email: | richard@biofilm.com |
| Date Prepared: | August 29, 2017 |
| Establishment Registration: | 2025771 |
ii. General Information on Device
| Proprietary Name: | Astroglide® O Oil Personal Lubricant & Massage Oil |
|---|---|
| Common Name: | Personal Lubricant |
| Classification Name: | Condom (21 CFR 884.5300) |
| Regulatory Class: | II |
| Product Code: | NUC (lubricant, personal) |
iii. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| O Glide Personal Lubricant | |
| Original Applicant: Grafenberg Labs | K142726 |
This predicate device has never been the subject of a device recall.
iv. Description of Device
Astroglide® O Oil Personal Lubricant & Massage Oil is non-sterile, light yellow, lightly coconut and ylang-ylang scented, and oil-based lubricant. All oils used in the subject formulation are certified organic, and the subject lubricant is a USDA certified organic final product. This product is not a spermicide or contraceptive. It is NOT compatible with natural rubber latex, polyurethane, or polyisoprene condoms.
This product primary packaging is a PETE amber bottle with a screw on polypropylene flip-top cap. The bottle and cap constitute the device are labeled front and back and then packaged in a cardboard carton which constitutes the final packaging.
4
The specifications for Astroglide® O Oil Personal Lubricant & Massage Oil are described in the following table.
| Parameter | Specification (Test Method) |
|---|---|
| Color | Light yellow |
| Clarity | Clear |
| Odor | Coconut and ylang-ylang |
| Absence of particulate matter | Absent |
| Viscosity | 60-120 cP |
| Total yeast/mold count | ) |
| Total aerobic microbial count | ) |
| Staphylococcus aureus, Pseudomonas | |
| aeruginosa, and Candida albicans | Absent (USP ) |
v. Indication for Use
Astroglide O Oil Personal Lubricant & Massage Oil 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.
Predicate Device Comparison vi.
The following table compares the Indications for Use and key technological characteristics of the subject and predicate device:
| Characteristic /
Feature | ®
Astroglide O Oil
Personal Lubricant &
Massage Oil (subject
device) | O Glide Personal
Lubricant (predicate
device) - K142726 | Comparison |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | ®
Astroglide O Oil Personal
Lubricant & Massage Oil 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. | 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. | Same: The subject and
predicate devices have the
same indication for use, and
therefore have the same
intended use. |
| Oil-Based
Lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Odorless | No | No | Same |
| Not a
contraceptive or
Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary
Ingredients | Helianthus Annuus
(Sunflower) Seed Oil*, Ricinus
Communis (Castor) Seed Oil*,
Cocos Nucifera (Coconut)
Oil*, Prunus Amygdalus Dulcis
(Sweet Almond) Oil*,
Simmondsia Chinesis (Jojoba)
Seed Oil , Argania Spinosa
Kernel (Argan Tree Nut) Oil,
Tocopherol, Cananga Odorata
(Ylang Ylang) Flower Oil*
*Indicates Organic | Olus (vegetable) oil,
Olea Europeaea (olive)
Fruit Oil, Argania
Spinosa Kernel Oil,
Pichia / Resveratrol
Ferment Extract | Different: The ingredients
of the predicate device
are different; however,
differences in device
ingredients do not raise
different questions of
Safety & Effectiveness (S
& E) (e.g.,
biocompatibility) |
| Microbial Limits | • Total mold/yeast count