(60 days)
Not Found
No
The device description and performance studies focus on the chemical composition, biocompatibility, shelf life, and condom compatibility of a personal lubricant. There is no mention of AI or ML technology.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not to treat or cure a disease or condition.
No
Explanation: The provided text describes Astroglide® Glycerin & Paraben Free as a personal lubricant intended to moisturize and lubricate to enhance sexual activity. It does not mention any diagnostic capabilities, such as identifying, detecting, or monitoring a disease or condition. Its function is purely facilitative and comfort-enhancing for intimate acts.
No
The device description clearly states it is a "non-sterile, water-based liquid personal lubricant" and lists chemical components. This indicates a physical product, not software.
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 to the body (penile, vaginal, and/or anal). This is a topical application for physical comfort and enhancement, not for diagnosing a condition or examining specimens from the body.
- Device Description: The description details a personal lubricant with specific ingredients and packaging. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies focus on biocompatibility, shelf life, and condom compatibility. These are relevant to a personal lubricant's safety and effectiveness for its intended use, but not to diagnostic performance.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Astroglide® Glycerin & Paraben Free is a personal lubricant for penile, 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Astroglide® Glycerin & Paraben Free is a non-sterile, water-based liquid personal lubricant for penile, anal, and/or vaginal application. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The subject device is sold as an overthe-counter (OTC) product in a 2.5 oz. clear PETE bottle with a screw on polypropylene flip-top cap. The bottle is labeled front and back and then packaged in a cardboard carton which constitutes the final packaging.
This device is composed of water, butylene glycol, propylene glycol, xylitol, methyl gluceth-20, polyquarternium-7, hydroxyethyl cellulose, potassium sorbate, sodium benzoate, citric acid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile, and/or anal application
penile, anal, and/or vaginal application
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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:
- Cytotoxicity (per ISO 10993-5:2009/(R)2014)
- Human Repeat Insult Patch Testing (HRIPT) per ASTM D6355 to address ● sensitization and irritation
- . Systemic Toxicity (per ISO 10993-11:2017)
Results: the subject lubricant is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.
Shelf Life:
An accelerated aging study was conducted for 8 months at 40°C per ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points.
Condom Compatibility:
Tested using ASTM D7661-18, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
Results: Astroglide® Glycerin & Paraben Free is compatible with natural rubber latex and polyisoprene condoms. Astroglide® Glycerin & Paraben Free is not compatible with polvurethane condoms.
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.
May 6, 2022
BioFilm, Inc. Kevin Jamil Regulatory Affairs 3225 Executive Ridge Vista, CA 92081
Re: K220653
Trade/Device Name: Astroglide® Glycerin & Paraben Free Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 27, 2022 Received: March 7, 2022
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); 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,
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) K220653
Device Name Astroglide® Glycerin & Paraben Free
Indications for Use (Describe)
Astroglide® Glycerin & Paraben Free is a personal lubricant for penile, 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary - K220653 Astroglide® Glycerin & Paraben Free
l. 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: | May 6, 2022 |
II. General Information on Device
| Proprietary Name: | Astroglide® Glycerin & Paraben Free |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulatory Class: | II |
| Product Code: | NUC (Lubricant, Personal) |
lll. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| Astroglide® Glycerin & Paraben Free | K072647 |
This predicate device has not been subject to a design-related recall.
IV. Description of Device
Astroglide® Glycerin & Paraben Free is a non-sterile, water-based liquid personal lubricant for penile, anal, and/or vaginal application. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The subject device is sold as an overthe-counter (OTC) product in a 2.5 oz. clear PETE bottle with a screw on polypropylene flip-top cap. The bottle is labeled front and back and then packaged in a cardboard carton which constitutes the final packaging.
4
This device is composed of water, butylene glycol, propylene glycol, xylitol, methyl gluceth-20, polyquarternium-7, hydroxyethyl cellulose, potassium sorbate, sodium benzoate, citric acid.
The specifications for Astroglide® Glycerin & Paraben Free are described in Table 1.
| Parameter | Specification (Test Method) |
|---|---|
| Color | Clear to slight golden |
| Clarity | Clear |
| Odor | Slight sweet odor |
| Absence of particulate matter | Absent |
| Viscosity | 1000-2800 cP |
| pH | 3.5-5.5 |
| Osmolality | 230-300 mOsm/kg, 1:5 dilution factor |
| Total yeast/mold count (TYMC) | ) |
| Total aerobic microbial count (TAMC) | ) |
| Presence of Pathogenic Organisms | |
| (Staphylococcus aureus, Pseudomonas | |
| aeruginosa, and Candida albicans) | Absent (USP ) |
| Antimicrobial effectiveness | Meets USP acceptance criteria |
| for Category 2 products. |
Table 1. Device Specifications
V. Indications for Use
Astroglide® Glycerin & Paraben Free 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
VI. Substantial Equivalence Discussion
The following table compares the intended use and key technological characteristics of the subject and predicate device:
| Characteristic /
Feature | Astroglide® Glycerin &
Paraben Free (subject
device) | Astroglide® Glycerin &
Paraben Free Personal
Lubricant (predicate
device) — K072647 | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Astroglide® Glycerin & Paraben
Free 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 and polyisoprene
condoms. This product is not
compatible with polyurethane
condoms. | Glycerin & Paraben Free
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. | Similar: The subject and
predicate devices have similar
indications for use, with the
exception of the condom
compatibility statement, and
they have the same intended
use. |
| | | | |
| Water-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 | Purified Water, Xylitol, Butylene
Glycol, Methyl Gluceth-20,
Propylene Glycol,
Polyquaternium-7,
Hydroxyethylcellulose,
Potassium Sorbate, Sodium
Benzoate, Citric Acid | Not publicly available | Different: The ingredients of the
predicate device are different;
the ingredients do not raise
different questions of Safety &
Effectiveness (S & E) |
| Microbial Limits | Total mold/yeast count