(107 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 for enhancing comfort during sexual activity, not for treating or diagnosing a disease or condition.
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 is a personal lubricant, which is a physical substance composed of chemical ingredients and packaged in a tube, not a software program.
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. This is a physical function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the composition and packaging of a lubricant. It does not describe a device designed to analyze biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition, monitor a disease, or screen for a health issue.
- Performance Studies: The performance studies focus on biocompatibility, shelf life, and condom compatibility, which are relevant to a personal lubricant, not a diagnostic device.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Astroglide Ultra Gentle Gel 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
NUC
Device Description
Astroglide Ultra Gentle Gel is a non-sterile, clear, odorless, and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. The device is composed of water, propylene glycol, hydroxyethylcellulose, polyquaternium 7, potassium sorbate, sodium benzoate and citric acid.
The product primary packaging is a white LDPE 3-ounce tube with a screw on cap. The tube and cap constitute the device 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
Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2009 as follows:
- 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)
The results of this testing demonstrate that the subject lubricant is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.
Shelf Life: The subject device is a non-sterile personal lubricant packaged in a 3 oz. bottle with a 24-month shelf-life in accordance with the results of an accelerated aging study, conducted for 8 months at 40 degrees 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: Astroglide Ultra Gentle Gel Personal Lubricant was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms using ASTM D7661-18, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results show that Astroglide Ultra Gentle Gel Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. Astroglide Ultra Gentle Gel Personal Lubricant is not compatible with polyurethane condoms.
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 26, 2022
BioFilm, Inc. Kevin Jamil Regulatory Affairs 3225 Executive Ridge Vista, CA 92081
Re: K220355 Trade/Device Name: Astroglide Ultra Gentle Gel Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 7, 2022 Received: April 27, 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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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) K220355
Device Name Astroglide Ultra Gentle Gel
Indications for Use (Describe)
Astroglide Ultra Gentle Gel 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary – K220355 Astroglide Ultra Gentle Gel
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 24, 2022 |
II. General Information on Device
| Proprietary Name: | Astroglide Ultra Gentle Gel |
|---|---|
| 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 |
|---|---|
| Glycerin & Paraben Free Astroglide | K072647 |
This predicate device has not been subject to a design-related recall.
IV. Description of Device
Astroglide Ultra Gentle Gel is a non-sterile, clear, odorless, and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. The device is composed of water, propylene glycol, hydroxyethylcellulose, polyquaternium 7, potassium sorbate, sodium benzoate and citric acid.
The product primary packaging is a white LDPE 3-ounce tube with a screw on cap. The tube and cap constitute the device final packaging.
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The specifications for Astroglide Ultra Gentle Gel Personal Lubricant are described in Table 1.
| Parameter | Specification (Test Method) |
|---|---|
| Color | Clear to golden |
| Clarity | Clear |
| Odor | Odorless |
| Absence of particulate matter | No particles |
| Viscosity | 10,000-25,000 cP |
| pH | 3.5-5.5 |
| Osmolality | 200-300 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 Ultra Gentle Gel 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 Ultra Gentle
Gel Personal Lubricant
(subject device) | Glycerin & Paraben Free
Astroglide (predicate
device) - K072647 | Comparison | |
|-----------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indication for use | Astroglide Ultra Gentle Gel 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 |
| Not a
contraceptive or
Spermicide | | Yes | Yes | Same |
| Non-sterile | | Yes | Yes | Same |
| Primary
Ingredients | | Water, Propylene glycol,
Hydroxyethylcellulose,
Polyquaternium 7, 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