(85 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, ML, image processing, or any other technology that would suggest the use of AI/ML.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during intimate sexual activity, not to treat or cure a disease or condition.
No
Astroglide Warming is described as a personal lubricant intended to moisturize and lubricate to enhance comfort during sexual activity, not to diagnose any condition.
No
The device description clearly states the device is a "non-sterile, clear and water based personal lubricant" composed of various chemical ingredients, indicating it is 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 a sample taken from the body.
- Device Description: The device is a personal lubricant composed of various chemical ingredients. It does not involve any reagents, instruments, or procedures for testing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using techniques like immunoassays, molecular diagnostics, or clinical chemistry.
The performance studies listed (biocompatibility, shelf life, condom compatibility) are relevant to a personal lubricant, not an IVD.
Therefore, Astroglide Warming is classified as a personal lubricant, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Astroglide Warming 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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Astroglide Warming is non-sterile, clear and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms only. It is not compatible with polyurethane condoms. The device is composed of water, glycerin, propylene glycol, polyquaternium-7 and citric acid.
This product primary packaging is a PETE clear 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.
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
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 2.5 oz. bottle with a 8.5-month shelf-life in accordance with the results of an accelerated aging study, conducted for 3 months at 40°C per ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical 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
Astroqlide Warming 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 Warming is compatible with natural rubber latex and polyisoprene condoms. Astroglide Warming is not compatible with polyurethane 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.
July 1, 2022
BioFilm, Inc. Kevin Jamil Regulatory Affairs 3225 Executive Ridge Vista, CA 92081
Re: K221036 Trade/Device Name: Astroglide Warming Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 27, 2022 Received: April 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) K221036
Device Name Astroglide Warming
Indications for Use (Describe)
Astroglide Warming 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.
| 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
K221036 Page 1 of 4
510(k) Summary - K221036 Astroglide Warming
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: | June 27, 2022 |
II. General Information on Device Proprietary Name: Astroglide Warming Common Name: Personal Lubricant Regulation Name: Condom Regulation Number 21 CFR 884.5300 Regulatory Class: Product Code: NUC (Lubricant, Personal)
III. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| Astroglide Brand Warming Liquid Personal Lubricant | K041432 |
This predicate device has never been the subject of a device recall.
IV. Description of Device
Astroglide Warming is non-sterile, clear and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms only. It is not compatible with polyurethane condoms. The device is composed of water, glycerin, propylene glycol, polyquaternium-7 and citric acid.
4
This product primary packaging is a PETE clear 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.
The specifications for Astroglide Warming Personal Lubricant are described in the Table 1.
| Parameter | Specification (Test Method) |
|---|---|
| Absence of particulate matter | No particles |
| Color | Colorless |
| Clarity | Clear |
| Odor | Odorless |
| Viscosity | 175 - 330 cP |
| Osmolality | 2600 – 2800 mOsm/kg, dilution factor of 5 |
| pH | 3.5-5.5 |
| 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 Warming 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
Warming (subject
device) | Astroglide Brand
Warming Liquid
Personal Lubricant
(predicate device) –
K041432 | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Astroglide Warming 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. | Astroglide Brand Warming
Liquid is recommended as a
personal lubricant to enhance
intimate activities. It is
designed to help enhance the
sexual experience by providing
supplemental vaginal
lubrication during sexual
intercourse. Astroglide Brand
Warming Liquid may be used
with condoms. | Similar: The subject and
predicate devices have
similar indications for use,
with the exception of
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 | Purified Water, Glycerin,
Propylene Glycol,
Polyquaternium-7, Citric Acid | Not publicly available | N/A |
| Microbial Limits | Total mold/yeast count