(101 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 technology.
No.
The product is explicitly stated as a personal lubricant for moisturizing and ease of intimate activity, and it is not described as treating or preventing any disease or condition.
No
The document describes a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity, not to diagnose any medical condition.
No
The device description clearly states it is a "water-based personal lubricant" and describes its physical form (liquid in a bottle) and packaging. It also details biocompatibility and condom compatibility testing, which are relevant to a physical substance, not software. There is no mention of software, algorithms, or digital processing.
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: The description confirms it's a personal lubricant for external application.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for health issues.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (on the body).
N/A
Intended Use / Indications for Use
Astroglide® Sensual Strawberry 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 or polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Astroglide® Sensual Strawberry Personal Lubricant is a non-sterile, clear, strawberry-scented and flavored, water-based personal lubricant intended for penile, anal, or vaginal application. This product is not a spermicide or contraceptive. Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms. It is not compatible with polyisoprene and polyurethane condoms. This product's primary packaging is a PETE clear bottle with a screw on polypropylene flip-top cap. The bottle is 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, vaginal, and/or anal 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing on Astroglide® Sensual Strawberry Personal Lubricant was conducted in accordance with the 2020 FDA quidance document "Use of International Standard ISO 10993-1.Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process." Testing included the following assessments:
- . Cytotoxicity per ISO 10993-5:2009
- Sensitization and irritation testing using the human repeat insult patch test, an ● alternative test method to ISO 10993-10:2010
- Acute systemic toxicity testing per ISO 10993-11:2017.
The testing demonstrated that Astroglide® Sensual Strawberry Personal Lubricant is non-cytotoxic, non-sensitizing, non-irritating, and not systemically toxic.
Astroglide® Sensual Strawberry Personal Lubricant was tested for compatibility with condoms using ASTM D7661-10, "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Results show that Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms and not compatible with polyisoprene or polyurethane condoms.
Astroglide® Sensual Strawberry Personal Lubricant has a shelf-life of 8.5 months based on 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, as stated in Section IV of the summary, 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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 3, 2022
BioFilm, Inc. Jennifer Keller R&D Formulation Chemist II 3225 Executive Ridge Vista, CA 92081
Re: K213671
Trade/Device Name: Astroglide® Sensual Strawberry Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 17, 2021 Received: November 22, 2021
Dear Jennifer Keller:
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); 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/cdrh-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,
For 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
2
Indications for Use
510(k) Number (if known) K213671
Device Name Astroglide® Sensual Strawberry Personal Lubricant
Indications for Use (Describe)
Astroglide® Sensual Strawberry 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 or 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
K213671 Page 1 of 5
510(k) Summary K213671 Astroglide® Sensual Strawberry Personal Lubricant
I. Submitter Information
| Applicant: | BioFilm, Inc. |
|---|---|
| Address: | 3225 Executive Ridge |
| Vista, CA 92081 USA | |
| Telephone: | 760-727-9030 |
| Fax: | 760-727-8080 |
| Contact Person: | Jennifer Keller |
| Contact Title: | Research & Development |
| Email: | Jennifer@biofilm.com |
| Date Prepared: | 2/25/2022 |
II. General Information on Device
| Proprietary Name: | Astroglide® Sensual Strawberry Personal |
|---|---|
| Lubricant | |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Product Code: | NUC (Lubricant, Personal) |
| Regulatory Class: | II |
III. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| Glycerin & Paraben Free Astroglide | |
| Applicant: BioFilm, Inc. | K072647 |
The predicate device has not been subject to a design-related recall.
IV. Description of Device
Astroglide® Sensual Strawberry Personal Lubricant is a non-sterile, clear, strawberry-scented and flavored, water-based personal lubricant intended for penile, anal, or vaginal application. This product is not a spermicide or contraceptive. Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms. It is not compatible with polyisoprene and polyurethane condoms. This product's primary packaging is a PETE clear bottle
4
with a screw on polypropylene flip-top cap. The bottle is then packaged in a cardboard carton which constitutes the final packaging.
The specifications for Astroglide® Sensual Strawberry Personal Lubricant are described in the following table.
| Physical Specification Tests | Ranges/Specifications |
|---|---|
| Particulate matter | No particles |
| Color | Clear to slight golden |
| Clarity | Clear |
| Odor | Strawberry sent |
| pH (per USP ) | 3.5-5.5 |
| Viscosity (per USP ) | 200 - 450 cps |
| Osmolality (per USP ) | 200 - 450 mOsm/kg, dilution factor of 5 |
| Antimicrobial effectiveness (per | |
| USP ) | Category 2, bacteria should show not less |
| than 2.0 log reduction at 14 days and no | |
| increase from 14-day count at the 28-day | |
| count. Yeast and molds should show no | |
| increase from the initial calculated count at 14 | |
| and 28 days | |
| Total yeast/mold count (per | |
| USP & USP ) | & USP ) |
| Pseudomonas aeruginosa , and | |
| Candida albicans - per USP & | |
| USP ) | Absent |
V. Indications for Use
Astroglide® Sensual Strawberry 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 or polyurethane condoms.
VI. Predicate Device Comparison
The following table compares the intended use and key technological characteristics of the subject and predicate device:
5
| Product Name | Astroglide® Sensual
Strawberry Personal
Lubricant
K213671
Subject Device | Glycerin & Paraben Free
Astroglide
K072647
Predicate Device | Comparison |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Astroglide® Sensual
Strawberry 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
or polyurethane condoms. | Glycerin & Paraben Free
Personal Lubricant
Astroglide® is a personal
lubricant, for penile, anal, 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 latex condoms. | Same: The
indications for use
for the subject and
predicate device are
the same.
Therefore, the
subject and
predicate device
have the same
intended use. |
| Over-the-
Counter Device | Yes | Yes | Same |
| Base Type | Water | Water | Same |
| Ingredients | Purified Water, Glycerin,
Propylene Glycol, Methyl
Gluceth-20, Natural & Artificial
Strawberry Flavor, Clear
Xanthan Gum,
Hydroxyethylcellulose, Sodium
Gluconate, Sodium Saccharin,
Sodium Benzoate, Potassium
Sorbate, Citric Acid | Purified Water, Butylene
Glycol, Propylene Glycol,
Xylitol, Polyquaternium-15 | Different: The
subject and predicate
device have
differences in
formulation. These
differences do not
raise different
questions of safety
and effectiveness
(S&E). |
| Condom
compatibility | Natural rubber latex
condoms. | Natural rubber latex
condoms. | Same |
| pH | 3.5-5.5 | 3.5-5.5 | Same |
| Osmolality | 200 - 450 mOsm/kg, 1:5
dilution factor | N/A | Different: The
subject and
predicate device
have different
osmolality
specifications.
Differences in
osmolality
specifications do not
raise different
questions of S&E. |
| Viscosity | 200 - 450 cps, | 1,100-1,500 cps | Different: The
subject and
predicate device
have different
viscosity
specifications. |
| Product Name | Astroglide® Sensual
Strawberry Personal
Lubricant
K213671
Subject Device | Glycerin & Paraben Free
Astroglide
K072647
Predicate Device | Comparison |
| | | | viscosity
specifications do not
raise different
questions of S&E. |
| Microbial Limits | • Total mold/yeast count
) | Category 2, bacteria should
show not less than 2.0 log
reduction at 14 days and no
increase from 14-day count
at the 28-day count. Yeast
and molds should show no
increase from the initial
calculated count at 14 and
28 days | Category 2, bacteria
should show not less than
2.0 log reduction at 14
days and no increase from
14-day count at the 28-
day count. Yeast and
molds should show no
increase from the initial
calculated count at 14 and
28 days | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Packaging | 2.5 oz PETE bottle
polypropylene cap | 2.5 oz PETE bottle with
HDPE cap | Different: The
subject and
predicate device
have different
packaging.
Differences in
packaging do not
raise different
questions of S&E. |
| Shelf-life | 8.5 months | 2 years | Different: The
subject and
predicate device
have different shelf-
life durations.
Differences in shelf-
life durations do not
raise different
questions of S&E. |
6
As noted in the table above, the subject and predicate device have the same indications for use and intended use (i.e., to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication). The subject and predicate device have differences in their technological characteristics.
7
However, as stated in the table, the differences in technological characteristics do not raise different questions of safety and effectiveness.
VII. Summary of Non-Clinical Performance Testing
Biocompatibility
Biocompatibility testing on Astroglide® Sensual Strawberry Personal Lubricant was conducted in accordance with the 2020 FDA quidance document "Use of International Standard ISO 10993-1.Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process." Testing included the following assessments:
- . Cytotoxicity per ISO 10993-5:2009
- Sensitization and irritation testing using the human repeat insult patch test, an ● alternative test method to ISO 10993-10:2010
- Acute systemic toxicity testing per ISO 10993-11:2017.
The testing demonstrated that Astroglide® Sensual Strawberry Personal Lubricant is non-cytotoxic, non-sensitizing, non-irritating, and not systemically toxic
Condom Compatibility
Astroglide® Sensual Strawberry Personal Lubricant was tested for compatibility with condoms using ASTM D7661-10, "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Results show that Astroglide® Sensual Strawberry Personal Lubricant is compatible with natural rubber latex condoms and not compatible with polyisoprene or polyurethane condoms.
Shelf-Life
Astroglide® Sensual Strawberry Personal Lubricant has a shelf-life of 8.5 months based on 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, as stated in Section IV of the summary, were met throughout the shelf-life study.
VIII. Conclusion
The results of the testing described above demonstrate that the Astroglide® Sensual Strawberry Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.