(287 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biocompatibility of a personal lubricant, with no mention of AI or ML technology.
No
The device is a personal lubricant for enhancing comfort during sexual activity, not for treating or curing a medical condition.
No
Explanation: The description states that the product is a personal lubricant intended to moisturize and lubricate to enhance comfort during intimate sexual activity. It does not mention any function for diagnosing conditions or diseases.
No
The device description clearly states it is a gel formulation with specific chemical components and packaging, 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. This is a physical function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a personal lubricant applied externally. It does not describe a device used to analyze biological samples (like blood, urine, tissue, etc.) to diagnose a condition or provide information about a person's health status.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility and condom compatibility, which are relevant to a personal lubricant, not a diagnostic device.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Astroglide® Organix® Gel 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 and polyisoprene condoms. The product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
Astroglide® Organix ® Gel is non-sterile, translucent, colorless to slight yellow, water-based personal lubricant intended for penile and vaginal application 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 and is not compatible with polyurethane condoms. This product is for over-the-counter (OTC) use.
Astroglide® Organix ® Gel's formulation consists of water, glycerine, xanthan gum, gellan gum, aloe barbabensis powder, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, vaccinium macrocarpon (cranberry) fruit extract, passiflora incarnata flower extract, sodium benzoate, potassium sorbate, and citric acid. It is packaged in white LDPE tube with a screw on flip top cap comprised of polypropylene. This product is also provided in 2.5 ml foil packs.
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
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
Biocompatibility: Astroglide® Organix® Gel has undergone biocompatibility testing 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." Testing included:
- Cytotoxicity per ISO 10993-5: 2009
- Sensitization and Irritation testing using the human repeat insult patch testing, an alternative test method to ISO 10993-10:2010
- Acute systemic toxicity testing per ISO 10993-11:2017.
The testing demonstrated that Astroglide® Organix® Gel is non-cytotoxic, non-sensitizing, non-irritating, and not acutely-systemically toxic.
Condom Compatibility: Astroglide® Organix® Gel was tested in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." Results showed that Astroglide® Organix® Liquid is compatible with natural rubber latex and polyisoprene condoms. Astroglide® Organix® Liquid is not compatible with polyurethane condoms.
Shelf life: Astroglide® Organix® Gel has a shelf-life of 6 months in 3 oz. LDPE tubes and 3 months in foils packs. Results from testing demonstrated that the device can maintain its specifications (as shown in Section IV) over the duration of its shelf-life in both packaging forms.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
November 13, 2020
BioFilm Inc. Richard Hines Regulatory Affairs Manager 3225 Executive Ridge Vista, CA 92081
Re: K200239 Trade/Device Name: Astroglide® Organix® Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 2, 2020 Received: October 14, 2020
Dear Richard Hines:
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.
1
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 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-regulatory-information/postmarketing-safety-reportingcombination-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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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
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Indications for Use
510(k) Number (if known) K200239
Device Name Astroglide® Organix® Gel
Indications for Use (Describe)
Astroglide® Organix® Gel 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 and polyisoprene condoms. The 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 - K200239 Astroglide® Organix ® Gel
i. Submitter Information
| Applicant: | BioFilm, Inc. |
|---|---|
| Address: | 3225 Executive Ridge |
| Vista, CA 92081 USA | |
| Telephone: | 760-727-9030 |
| Fax: | 760-727-8080 |
| Contact Person: | Richard Hines |
| Contact Title: | Regulatory Affairs Manager |
| Email: | richard@biofilm.com |
| Date Prepared: | November 12, 2020 |
Device Information ii.
| Trade Name: | Astroglide® Organix ® Gel | |
|---|---|---|
| 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 |
|---|---|
| Astroglide Natural | K141581 |
| Original Applicant: BioFilm Inc. |
The predicate device has not been subject to a device-related recall.
Description of Device iv.
Astroglide® Organix ® Gel is non-sterile, translucent, colorless to slight yellow, water-based personal lubricant intended for penile and vaginal application 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 and is not compatible with polyurethane condoms. This product is for over-the-counter (OTC) use.
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Astroglide® Organix ® Gel's formulation consists of water, glycerine, xanthan gum, gellan gum, aloe barbabensis powder, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, vaccinium macrocarpon (cranberry) fruit extract, passiflora incarnata flower extract, sodium benzoate, potassium sorbate, and citric acid. It is packaged in white LDPE tube with a screw on flip top cap comprised of polypropylene. This product is also provided in 2.5 ml foil packs.
Device specifications are listed in the table below.
| Parameter | Specification (Test Method) |
|---|---|
| Color | Colorless to slight yellow |
| Clarity | Hazy liquid |
| Odor | Odorless |
| Osmolality | 500-1000 mOsm/kg (1:5 dilution) |
| pH | 3.5-5.5 |
| Viscosity | 200,000-300,000 cP |
| Total yeast/mold count | ) |
| Total aerobic microbial count | ) |
| Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans | Absent (USP ) |
| 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 |
Indications for Use v.
Astroglide® Organix ® Gel 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Summary of Intended Use and Technological Characteristics of the Subject Device vi. in Comparison to the Predicate Device
The following table compares the Indications for Use and technological characteristics of the subject and predicate device:
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| Characteristic /
Feature | Astroglide® Organix ®
Gel (subject device) | Astroglide ® Natural
(predicate device) -
K141581 | Comparison |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
use | Astroglide® Organix Gel 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 and
polyisoprene condoms. This
product is not compatible
with polyurethane condoms. | Astroglide® Natural 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
and polyisoprene condoms.
This product is not
compatible with
polyurethane condoms. | Same: The subject and
predicate devices have the
same indication for use with
the exception that the it is not
compatible with polyurethane
condoms. Therefore, the
subject and predicate devices
have the same intended use
(provides lubrication during
intimate sexual activity). |
| Water-Based
Lubricant | Yes | Yes | Same |
| Over the | Yes | Yes | Same |
| Odorless | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary
Ingredients | Purified Water, Glycerin*,
Xanthan Gum, Gellan Gum,
Aloe Barbadensis Powder*,
Chamomilla Recutita
(Matricaria) Flower Extract*,
Calendula Officinalis Flower
Extract*, Vaccinium
Macrocarpon (Cranberry)
Fruit Extract*, Passiflora
Incarnata Flower Extract*,
Sodium Benzoate, Potassium
Sorbate, Citric Acid
*Indicates Organic | Water, Xylitol,
Hydroxyethylcellulose,
Phenoxyethanol, Aloe
Barbadensis Leaf Juice Extract,
Chamomilla Recutita
(Matricaria) Flower Extract,
Pectin, Potassium Ascorbyl
Tocopheryl Phosphate, Lactic
Acid | Different: The ingredients of the
predicate device are different;
however, differences in device
ingredients do not raise different
questions of Safety &
Effectiveness (S & E). |
| Microbial
Limits | • Total mold/yeast count