(89 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 enhance comfort during sexual activity, not to treat a disease or condition.
No
The device is a personal lubricant intended to moisturize and lubricate for sexual activity, not to diagnose a condition.
No
The device described is a physical personal lubricant, not a software application. The summary details its physical properties, packaging, and performance studies related to biocompatibility and condom compatibility, with no mention of software components or 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 personal lubrication during sexual activity, applied directly to the body (penile, vaginal, and/or anal).
- Device Description: It's a personal lubricant.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for health issues.
- Performance Studies: The performance studies focus on biocompatibility, condom compatibility, and shelf life, which are relevant for a personal lubricant, not an IVD.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. This device is applied in vivo (on the body).
N/A
Intended Use / Indications for Use
Astroglide® X Silicone Personal Lubricant is a personal lubricant 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. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Astroglide® X Silicone Personal Lubricant is non-sterile, clear, odorless, and siliconebased lubricant. This product is not a spermicide or contraceptive. Astroglide® X Silicone Personal Lubricant is compatible with natural rubber latex condoms. Astroglide® X Silicone Personal Lubricant is not compatible with polyurethane, or polyisoprene condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is 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, vaginal, and/or anal
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 testing on the subject lubricant 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. The results of the testing demonstrate that the subject device is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.
Astroglide® X Silicone Personal Lubricant was tested for compatibility with natural rubber latex condoms using ASTM D7661-10. Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Results show that Astroglide® X Silicone Personal Lubricant is compatible with natural rubber latex condoms only.
Astroglide® X Silicone Personal Lubricant has a shelf-life of 3 years based on 12 months of accelerated aging testing results per ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. All specifications for the subject lubricant listed in Table 1 were met throughout the shelf-life study.
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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 28, 2021
BioFilm, Inc. Kevin Jamil Regulatory Affairs 3225 Executive Ridge Vista, CA 92081
Re: K210242
Trade/Device Name: Astroglide® X Silicone Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 27, 2021 Received: January 29, 2021
Dear Kevin Jamil:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210242
Device Name Astroglide® X Silicone Personal Lubricant
Indications for Use (Describe)
Astroglide® X Silicone Personal Lubricant is a personal lubricant 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. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane 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 - K210242 Astroglide® X Silicone 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: | Kevin Jamil |
| Contact Title: | Regulatory Affairs |
| Email: | kevin@biofilm.com |
| Date Prepared: | 4/27/2021 |
| Establishment Registration: | 2025771 |
ii. General Information on Device
| Proprietary Name: | Astroglide® X Silicone Personal Lubricant |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulatory Class: | II |
| Product Code: | NUC (Lubricant, Personal) |
iii. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| pjur® Backdoor Anal Glide and pjur® | |
| Analyse Me! | K141913 |
This predicate device has not been subject to a device-related recall.
iv. Description of Device
Astroglide® X Silicone Personal Lubricant is non-sterile, clear, odorless, and siliconebased lubricant. This product is not a spermicide or contraceptive. Astroglide® X Silicone Personal Lubricant is compatible with natural rubber latex condoms. Astroglide® X Silicone Personal Lubricant is not compatible with polyurethane, or polyisoprene condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is packaged in a cardboard carton which constitutes the final packaging.
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The specifications for Astroglide® X Silicone Personal Lubricant are described in the following table.
| Parameter | Specification (Test Method) |
|---|---|
| Appearance | Clear |
| Odor | Characteristic |
| Viscosity | 225 to 350 centipoise |
| Total yeast/mold count (USP ) | ) |
| Water activity (USP) | 0.3 Aw |
Table 1. Physical Specifications of Astroglide® X Silicone Personal Lubricant
V. Indications for Use
Astroglide® X Silicone Personal Lubricant is a personal lubricant 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. This product is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.
vi. Substantial Equivalence Discussion
The following table compares the intended use and key technological characteristics of the subject and predicate device:
5
| Characteristic /
Feature | Astroglide® X Silicone
Personal Lubricant
(Subject Device) | pjur® Backdoor Anal
Glide and pjur® Analyse
Me! (Predicate device) | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Astroglide® X Silicone
Personal Lubricant is a
personal lubricant 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.
This product is compatible
with natural rubber latex
condoms. This product is not
compatible with polyisoprene
and polyurethane condoms. | pjur® Backdoor Anal Glide
is a personal lubricant 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. This product is
compatible with natural
rubber latex, synthetic
polyisoprene, and
polyurethane condoms. | The subject and predicate
devices have the same
indications for use except
for a difference in condom
compatibilities. |
| Condom
Compatibility | This product is compatible
with natural rubber latex
condoms. This product is not
compatible with polyisoprene
and polyurethane condoms. | This product is
compatible with natural
rubber latex, synthetic
polyurethane, and
polyisoprene condoms. | The condom compatibility
of the predicate device is
different, but it does not
raise different questions
of safety and
effectiveness. |
| Silicone-Based
Lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Appearance | Clear | Clear | Same |
| Not a
contraceptive or
Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary
Ingredients | Cyclopentasiloxane
Dimethicone
Cyclohexasiloxane | cyclopentasiloxane,
dimethicone,
dimethiconol,
Simmondsia Chinensis
(Jojoba) Seed Oil | The ingredients of the
predicate device are
different; however,
differences in device
ingredients do not raise
different questions of
safety & effectiveness |
| Characteristic /
Feature | Astroglide® X Silicone
Personal Lubricant
(Subject Device) | pjur® Backdoor Anal
Glide and pjur® Analyse
Me! (Predicate device) | Comparison |
| Microbial Limits | - Total mold/yeast count