(243 days)
Not Found
No
The device description and intended use are for a personal lubricant, and there is no mention of AI or ML in the provided text.
No
Explanation: The device is described as a personal lubricant intended to moisturize and lubricate for enhancing ease and comfort during intimate sexual activity, which classifies it as a general wellness or lifestyle product, not a therapeutic device.
No
The device is described as a personal lubricant intended to moisturize and lubricate for enhancing comfort during intimate sexual activity, not for diagnosing any medical condition.
No
The device description clearly indicates it is a liquid personal lubricant, a physical substance, not software.
Based on the provided information, the Medline Natural Lubricating Liquid is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "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 describes a product used on or in the body for physical comfort and function, not for testing samples taken from the body to diagnose or monitor a medical condition.
- Device Description: The description focuses on the physical properties and packaging of a lubricant. There is no mention of reagents, test strips, analyzers, or any components typically associated with IVD devices.
- Lack of IVD Characteristics: The document does not mention any of the hallmarks of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information
- Use in a laboratory or clinical setting for testing purposes
The device is clearly described as a personal lubricant for sexual activity, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Medline Natural Lubricating Liquid 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 (comma separated list FDA assigned to the subject device)
NUC
Device Description
The Medline Natural Lubricating Liquid is a non-sterile aqueous personal lubricant. Medline Natural Liquid is clear, odorless and colorless. The ingredients are similar to other personal lubricants currently on the market.
The Medline Natural Lubricating Liquid is compatible with natural rubber latex, polyisoprene and polyurethane condoms. The product will be offered in two sizes, a 2.5 fluid ounce and a 5 fluid ounce. The primary packaging consists of a polyethylene terephthalate (PETG) bottle with a screw down, flip top polypropylene closure. Each bottle of product will be packaged into a cardboard carton, which constitutes the product's outer packaging.
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
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)
A ten day in use clinical study was performed on the subject device. The study was conducted over a 10 day period with 27 subjects applying the Natural Lubricating Liquid once per day. The results of the study demonstrated that the Natural Lubricating Liquid is safe when used as intended.
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.
Astroglide Natural, K141581
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2015
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060
Re: K143322
Trade/Device Name: Medline Natural Lubricating Liquid Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 22, 2015 Received: May 26, 2015
Dear Jennifer Mason:
This letter corrects our substantially equivalent letter of July 2, 2015.
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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" (21CFR 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 vours.
Herbert P. Lerner -S
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)
Device Name
Medline Natural Lubricating Liquid
Indications for Use (Describe)
Medline Natural Lubricating Liquid is a personal lubricant, for penile 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)
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Image /page/3/Picture/0 description: The image shows the Medline logo. The word "MEDLINE" is written in blue, with a stylized blue starburst symbol behind it. The starburst has four points and a curved base, giving it a distinctive appearance.
510(k) Summary (as required per 21 CFR 807.92)
Summary Preparation Date
July 1, 2015
Submitter / 510(k) Sponsor
Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060
Contact Person
Jennifer Mason Sr. Regulatory Affairs Specialist Phone: 847-643-3652 Fax: 847-643-4482
Device Name / Classification
Device Name: Medline Natural Lubricating Liquid Proprietary Name: Medline Natural Lubricating Liquid Common Name: Personal Lubricants Classification Name: Condom (21 CRF 884.5300, product code - NUC)
Predicate Device
Astroglide Natural, K141581
Device Description
The Medline Natural Lubricating Liquid is a non-sterile aqueous personal lubricant. Medline Natural Liquid is clear, odorless and colorless. The ingredients are similar to other personal lubricants currently on the market.
The Medline Natural Lubricating Liquid is compatible with natural rubber latex, polyisoprene and polyurethane condoms. The product will be offered in two sizes, a 2.5 fluid ounce and a 5 fluid ounce. The primary packaging consists of a polyethylene terephthalate (PETG) bottle with a screw down, flip top polypropylene closure. Each bottle of product will be packaged into a cardboard carton, which constitutes the product's outer packaging.
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Image /page/4/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in blue, with a stylized blue starburst shape below it. The starburst has four points and a curved line connecting the bottom two points.
Indications for Use
Medline Natural Lubricating Liquid 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.
Summary of Technological Characteristics
Information within this Premarket Notification demonstrates that there are no significant differences in technological characteristics between Medline's Natural Lubricating Liquid and the cited predicate device.
| Feature | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Product Name | Medline Natural Lubricating Liquid | Astroglide Natural K141581 | N/A |
| Intended Use | 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 only compatible with natural rubber latex, polyisoprene and polyurethane condoms. | 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 only compatible with natural rubber latex and polyisoprene condoms. | Same |
| Aqueous Formulation | Yes | Yes | Same |
| Ingredients | Water Hydroxyethylcellulose Pectin Aloe Vera Gel Xylitol Chlorhexidine Gluconate Glucono Delta Lactone Tocopherol Acetate Chamomile Extract Sodium Benzoate | Water Hydroxyethylcellulose Pectin Aloe Barbadensis Leaf Juice Xylitol Potassium ascorbyl tocopheryl phosphate Chamomilla Recutita (Matricaria) Flower Extract Phenoxyethanol Lactic Acid | Similar |
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Image /page/5/Picture/0 description: The image shows the Medline logo in blue. The word "MEDLINE" is written in a bold, sans-serif font. Above and below the word is a stylized compass rose or star shape, also in blue. The logo is simple and clean, with a focus on the company name and a symbol that suggests direction or guidance.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486
| Non-sterile | Yes | Yes | Same |
|---|---|---|---|
| Packaging | Primary packaging - bottle | ||
| Secondary packaging - box | Primary packaging - bottle | ||
| Secondary packaging - box | Same | ||
| Over-the- | |||
| Counter Use | Yes | Yes | Same |
| Condom | |||
| Compatibility | Natural Rubber Latex, | ||
| Polyisoprene, Polyurethane | Natural Rubber Latex and | ||
| Polyisoprene | Similar |
The proposed Medline Natural Lubricating Liquid is identical in intended use and function to the Astroglide Natural cleared under K141581. Both lubricants are clear, water based lubricants. The ingredients in the Medline Natural Lubricating Liquid are very similar to the Astroglide Natural, with the primary difference being the preservative and pH adjuster used. The results of biocompatibility testing, condom compatibility testing and the in use clinical study support that these differences do not affect the safety and effectiveness of the device when used as labeled.
Summary of Non-Clinical Testing
The safety and effectiveness of Medline's Natural Lubricating Liquid is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
Biocompatibility testing of the Medline Natural Lubricating Liquid was conducted in accordance with ANSI/AAMI/ISO 10993:1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The following biocompatibility tests were performed:
Cytotoxicity according to ISO 10993-5:2009 Sensitization according to ISO 10993-10:2010 Vaginal Irritation according to ISO 10993-10:2010 Systemic Toxicity according to ISO 10993-11:2006 (2010)
The results of the biocompatibility tests demonstrated that the Medline Natural Lubricating Liquid is biocompatible.
Condom Compatibility
Condom compatibility testing was performed in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms". The testing evaluated the compatibility of the Medline Natural Lubricating Liquid with various types of condoms including natural rubber latex, polyisoprene and polyurethane. The results show the Medline Natural Lubricating Liquid met the acceptance criteria per ASTM D7661 and is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
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Image /page/6/Picture/0 description: The image shows the logo for Medline. The word "MEDLINE" is written in blue, block letters. Below the text is a blue, four-pointed star-like shape. The logo is simple and clean, with a focus on the company name and a recognizable symbol.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486
Shelf Life
Accelerated and real time shelf life studies were performed on the Medline Lubricating Liquid per ASTM F1980-07:2011. Preservative effectiveness was demonstrated at critical time-points throughout stability testing. These studies demonstrated that the product specifications were maintained throughout the shelf life period.
Summary of Clinical Testing
A ten day in use clinical study was performed on the subject device. The study was conducted over a 10 day period with 27 subjects applying the Natural Lubricating Liquid once per day. The results of the study demonstrated that the Natural Lubricating Liquid is safe when used as intended.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Natural Lubricating Liquid is safe, effective and substantially equivalent to the predicate device, Astroglide Natural K141581, as described herein.