(67 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.
No.
The intended use of Astroglide® Diamond Silicone Gel Personal Lubricant is to moisturize and lubricate to enhance comfort during sexual activity, not to treat or prevent a disease or condition. It is a personal lubricant, which is not considered a therapeutic device.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity. Its stated "Intended Use / Indications for Use" and "Device Description" do not include any diagnostic purpose, such as detecting or identifying a medical condition.
No
The device is a physical product (a personal lubricant) and the description focuses on its chemical composition, packaging, and physical properties, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Astroglide's Intended Use: The intended use of Astroglide® Diamond Silicone Gel Personal Lubricant 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."
- No Specimen Testing: This product is applied directly to the body and does not involve the testing of any specimens taken from the body.
Therefore, based on its intended use and how it functions, Astroglide® Diamond Silicone Gel Personal Lubricant is a personal lubricant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Astroglide® Diamond Silicone Gel 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 compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Product codes
NUC
Device Description
Astroglide® Diamond Silicone Gel Personal Lubricant is non-sterile, clear, odorless, and silicone-based lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
This product primary packaging is a white LDPE 3 ounce tube with a screw on polypropylene flip-top cap. The tube and cap constitute the device final packaging.
The specifications for Astroglide® Diamond Silicone Gel Personal Lubricant are described in the following table.
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
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. Biocompatibility Testing included:
- Cytotoxicity, ISO 10993-5: 2009/(R)2014, Results: The test article was found to be non-cytotoxic.
- Guinea Pig Maximization, ISO 10993-10: 2010/(R)2014, Results: The test article was found to be non-sensitizing.
- Vaginal Irritation, ISO 10993-10: 2010/(R)2014, Results: The test article was found to be non-irritating.
- Systemic Toxicity, ISO 10993-11: 2006/(R)2010, Results: The test article was found to be non-systematically toxic.
Condom Compatibility: Astroglide® Diamond Silicone Gel Personal Lubricant 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® Diamond Silicone Gel Personal Lubricant is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Shelf life: Astroglide® Diamond Silicone Gel Personal Lubricant has a shelf-life of 2 years based on 8 months of accelerated aging testing results per ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Preservative effectiveness per USP was demonstrated at critical time-points throughout the stability testing including at the time zero (0) and eight-month (8) time points for the accelerated aging study. All specifications for the subject lubricant were met during the shelf-life study.
Key results: The results of the testing described above provide reasonable assurance that the Astroglide® Diamond Silicone Gel Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2017
BioFilm, Inc. Richard Hines Regulatory Affairs Manager 3225 Executive Ridge Vista, CA 92081
Re: K163395
Trade/Device Name: Astroglide® Diamond Silicone Gel Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 1, 2016 Received: December 5, 2016
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.
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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
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Indications for Use
510(k) Number (if known) K163395
Device Name
Astroglide® Diamond Silicone Gel Personal Lubricant
Indications for Use (Describe)
Astroglide® Diamond Silicone Gel 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 compatible with natural rubber latex, polyurethane, and polyisoprene 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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510(k) Summary – K163395 Astroglide® Diamond Silicone Gel Personal Lubricant
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: | February 9, 2017 |
| Establishment Registration: | 2025771 |
ii. General Information on Device
| Proprietary Name: | Astroglide® Diamond Silicone Gel Personal
Lubricant |
|----------------------|--------------------------------------------------------|
| 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 |
|---|---|
| ONE® SILICONE Personal Lubricant | |
| Original Applicant: ONE® | K110690 |
This predicate device has never been the subject of a device recall.
iv. Description of Device
Astroglide® Diamond Silicone Gel Personal Lubricant is non-sterile, clear, odorless, and silicone-based lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
This product primary packaging is a white LDPE 3 ounce tube with a screw on polypropylene flip-top cap. The tube and cap constitute the device final packaging.
The specifications for Astroglide® Diamond Silicone Gel Personal Lubricant are described in the following table.
4
| Parameter | Specification (Test Method) |
|---|---|
| Color | Colorless |
| Clarity | Clear |
| Odor | Odorless |
| Absence of particulate matter | Absent |
| Viscosity | 12,000-22,000 cP |
| Total yeast/mold count | ) |
| Total aerobic microbial count | ) |
| Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans | Absent (USP ) |
Predicate Device Comparison V.
The following table compares the Indications for Use and key technological characteristics of the subject and predicate device:
| Characteristic /
Feature | Astroglide® Diamond
Silicone Gel Personal
Lubricant (subject) | One Silicone Personal
Lubricant (predicate
device) - K110690 | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Astroglide® Diamond Silicone
Gel 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 compatible with
natural rubber latex,
polyurethane, and
polyisoprene condoms. | ONE® Silicone 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 compatible with
natural rubber latex,
polyisoprene, and
polyurethane condoms. | Same: The subject and
predicate devices have the
same indication for use, and
therefore have the same
intended use. |
| Silicone-based
lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Non-greasy &
odorless | Yes | Yes | Same |
| Not a
contraceptive or
Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
5
| Primary
Ingredients | Dimethicone, Cyclomethicone
Dimethicone / Vinyl
Dimethicone Crosspolymer,
Cocos Nucifera (Coconut) Oil | Information is unknown | Different: The ingredients
in the predicate device
are not known; however,
differences in device
ingredients do not raise
different questions of
Safety & Effectiveness (S
& E) (e.g.,
biocompatibility, condom
compatibility) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Microbial Limits | • Total mold/yeast count
was demonstrated at critical time-points throughout the stability testing including at the time zero (0) and eight-month (8) time points for the accelerated aging study. All specifications for the subject lubricant were met during the shelf-life study.
vii. Substantial Equivalence
The results of the testing described above provide reasonable assurance that the Astroglide® Diamond Silicone Gel Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.