(237 days)
Not Found
No
The summary describes a personal lubricant and does not mention any AI or ML components or functionalities.
No.
The intended use of the device is for moisturizing and lubricating to enhance comfort during sexual activity, which is not considered a therapeutic function.
No
The device is a personal lubricant intended to moisturize and lubricate; it is not designed to diagnose any condition.
No
The device description clearly states it is a "personal lubricant" which is a physical substance, not software. The performance studies also focus on biocompatibility and shelf life, which are relevant to a physical product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This is a physical function applied to the body, not a test performed in vitro (outside the body) on a sample to diagnose a condition.
- Device Description: The description details the physical properties and ingredients of a lubricant, not components of a diagnostic test kit or instrument.
- Performance Studies: The performance studies focus on biocompatibility (how the product interacts with the body), shelf life, and condom compatibility. These are relevant to a topical medical device, not an IVD.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This product does not fit that description.
N/A
Intended Use / Indications for Use
Astroglide Sensual Strawberry is a personal lubricant, for penile and/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 natural rubber latex, polyisoprene, and polyurethane condoms.
Product codes
NUC
Device Description
Astroglide Sensual Strawberry personal lubricant is non-sterile, clear, colorless, and water based. It has a subtle flavor and fragrance of strawberry. Astroglide Sensual Strawberry is a proprietary blend consisting mainly of water soluble ingredients similar to the predicate device and other personal lubricant devices currently on the market. This product is not a spermicide or contraceptive. The product is provided in a clear bottle or a tube with flip top cap and it is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing was performed in accordance with ISO 10993, Biological Evaluation of Medical Devices.
- Cytotoxicity, ISO 10993-5: Results show the product is non-cytotoxic.
- Guinea Pig Maximization, ISO 10993-10: The product did not elicit any irritation or sensitization reactions.
- Vaginal Irritation, ISO 10993-10: The product was considered non-irritating to the vaginal mucosa in New Zealand White Rabbits as compared to the control article.
- Acute Systemic Toxicity, ISO 10993-11: The product met the requirements of ISO 10993-11. No test animals exhibited any biological reactivity.
Shelf Life: Astroglide Sensual Strawberry shows a shelf-life of 2 years based on an 8 month accelerated stability study and an ongoing real-time stability study. Preservative effectiveness was demonstrated at critical time-points throughout the stability testing. These studies demonstrated that the product specifications were maintained throughout the shelf-life period.
Condom Compatibility: Astroglide Sensual Strawberry was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane 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 is compatible with latex, polyisoprene, and polyurethane condoms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2014
BioFilm, Inc. Sherry Castello Regulatory Affairs Associate 3225 Executive Ridge Vista, CA 92081
Re: K140590 Trade/Device Name: Astroglide Sensual Strawberry Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 26, 2014 Received: October 1, 2014
Dear Sherry Castello,
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. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K140590
Device Name Astroglide Sensual Strawberry
Indications for Use (Describe)
Astroglide Sensual Strawberry is a personal lubricant, for penile and/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 natural rubber latex, 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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
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BIOFILM. INC.
510(k) Summary Astroglide Sensual Strawberry
General Information on Applicant:
Applicant: BioFilm, Inc. 3225 Executive Ridge Vista CA 92081 Phone: (760) 727-9030 Fax: (760) 727-8080
Contact Person: Sherry Castello, Regulatory Affairs Associate Email: sherry@biofilm.com Date Prepared: October 30, 2014 510(k) Number: K140590 Establishment Registration: 2025771
General Information on Device:
| Proprietary Name: | Astroglide Sensual Strawberry |
|---|---|
| Common Name: | Personal Lubricant |
| Classification Name: | Condom (21 CFR 884.5300, Product code: NUC, Class II) |
Predicate Device: 510(k) Number K122476, Lifestyles® Smooth™ 2-in-1 Massage and Lubricant, Ansell Healthcare Products, LLC; Class II, Product Code: NUC
Description of Device: Astroglide Sensual Strawberry personal lubricant is non-sterile, clear. colorless, and water based. It has a subtle flavor and fragrance of strawberry. Astroglide Sensual Strawberry is a proprietary blend consisting mainly of water soluble ingredients similar to the predicate device and other personal lubricant devices currently on the market. This product is not a spermicide or contraceptive. The product is provided in a clear bottle or a tube with flip top cap and it is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Indications for Use: Astroglide Sensual Strawberry is a personal lubricant for penile and/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 natural rubber latex, polyisoprene, and polyurethane condoms.
Technological Characteristics: There are no fundamental technological differences in Astroglide Sensual Strawberry as compared to the predicate device Lifestyles® Smooth™ 2-in-1 Massage and Lubricant. Both lubricants are non-sterile, water based lubricants with Strawberry flavor and scent. The indications for use are identical and the ingredients are very similar.
3225 Executive Ridge Vista, CA 92081 Page 5-1 800.848.5900 760.727.9030 FAX: 760.727.8080
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BIOFILM. INC.
Biocompatibility: Biocompatibility testing was performed in accordance with ISO 10993, Biological Evaluation of Medical Devices.
- Cytotoxicity, ISO 10993-5: Results show the product is non-cytotoxic .
- Guinea Pig Maximization, ISO 10993-10: The product did not elicit any irritation or . sensitization reactions.
- Vaginal Irritation, ISO 10993-10: The product was considered non-irritating to the . vaginal mucosa in New Zealand White Rabbits as compared to the control article.
- Acute Systemic Toxicity, ISO 10993-11: The product met the requirements of ISO . 10993-11. No test animals exhibited any biological reactivity.
Specifications: Astroglide Sensual Strawberry has the following lot release specifications: color, clarity, odor, absence of particulate matter, pH, viscosity, total yeast/mold count, total aerobic microbial count, and absence of pathogens including Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans.
Other: This product has been tested for osmolality.
Shelf Life: Astroglide Sensual Strawberry shows a shelf-life of 2 years based on an 8 month accelerated stability study and an ongoing real-time stability study. Preservative effectiveness was demonstrated at critical time-points throughout the stability testing. These studies demonstrated that the product specifications were maintained throughout the shelf-life period.
Condom Compatibility: Astroglide Sensual Strawberry was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane 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 is compatible with latex, polyisoprene, and polyurethane condoms.
Substantial Equivalence: Astroglide Sensual Strawberry personal lubricant has the same indications for use, similar ingredients, and basic technological characteristics as the predicate device. Astroglide Sensual Strawberry performed well in biocompatibility and stability testing showing it is as safe and effective as the predicate device.