(91 days)
Not Found
No
The 510(k) summary describes a personal lubricant with a standard formulation and intended use. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The performance studies are related to condom compatibility, not algorithmic performance.
No
The device is described as a personal lubricant intended to moisturize and lubricate to enhance comfort during sexual activity, which is not a therapeutic medical purpose.
No
This device is a personal lubricant intended to moisturize, lubricate, and enhance the ease and comfort of intimate sexual activity. It does not measure, analyze, or provide information about a medical condition or disease, which are characteristics of a diagnostic device.
No
The device description clearly states it is a "Personal Lubricating Jelly," which is a physical substance, 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 "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 device used on the body for physical comfort and function, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details a "water-based personal lubricant" with ingredients commonly found in such products. This aligns with a topical or applied device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays for testing
The information provided clearly indicates this is a personal lubricant intended for direct application to the body for comfort and lubrication during sexual activity. This falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is 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 device is compatible with natural rubber latex condoms and not compatible with polyurethane and polyisoprene condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
Personal Lubricating Jelly is a water-based personal lubricant containing ingredients that are commonly used in vaginal lubrication devices, including water, glycerin, hydroxyethylcellulose, chlorohexidine glucono delta lactone, methylparaben, and sodium hydroxide. It is provided non-sterile.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The only difference between the new Personal Lubricating Jelly and the already cleared Personal Lubricating Jelly is that device labeling will be modified to add a statement that the Personal Lubricating Jelly is compatible with natural rubber latex condoms. This statement is supported by performance data collected in accordance with ASTM7661-10, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms, an FDA-recognized Consensus Standard.
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.
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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 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 9, 2018
Perrigo New York, Inc. % Phil Triolo, Ph.D., RAC Principal Consultant Phil Triolo and Associates LC 86 Skycrest Lane Salt Lake City, UT 84108
Re: K180923 Trade/Device Name: Personal Lubricating Jelly Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 6, 2018 Received: April 10, 2018
Dear Phil Triolo:
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.
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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); 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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael T. Bailey -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) K180923
Device Name Personal Lubricating Jelly
Indications for Use (Describe)
This device is 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 device is compatible with natural rubber latex condoms and not compatible with polyurethane and polyisoprene 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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K180923 – 510(k) Summary
1. Submitter
Perrigo New York, Inc. 1700 Bathgate Ave. Bronx, NY 10457-7512
Submitted By
Karen Dombrowski, Sr. Regulatory Affairs Project Manager, Monograph Perrigo Company 515 Eastern Avenue, Allegan MI 49010 269-673-9149 (Phone) 269-673-1223 (Fax) karen.dombrowski@perrigo.com (email)
Contact Person / Prepared By
Phil Triolo, PhD, RAC President and Principal Consultant Phil Triolo and Associates LC 801 699 9846 (phone) / 801 328 2399 (fax) philt@philt.com (email)
Date Prepared
4 July 2018
2. Subiect Device
Trade Name Personal Lubricating Jelly
Common Name
Personal Lubricant
Classification
Regulation name: Condom Regulation number: 21 CFR 884.5300 Regulatory Class: II Product Code: NUC (lubricant, personal)
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3. Predicate Device
Personal Lubricating Jelly (K012203)
The predicate device has not been subject to a design-related recall.
4. Device Description
Personal Lubricating Jelly is a water-based personal lubricant containing ingredients that are commonly used in vaginal lubrication devices, including water, glycerin, hydroxyethylcellulose, chlorohexidine glucono delta lactone, methylparaben, and sodium hydroxide. It is provided non-sterile.
5. Indications for Use
This device is for penile and/or vaqinal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex condoms and not compatible with polvurethane and polyisoprene condoms.
Both the subject and predicate devices have the same intended use.
6. Technological Comparison with Predicate Device
The subject and predicate device have the same formulation and specifications. The only difference between the two devices is their condom compatibility statement. The predicate device made no claims related to condom compatibility, whereas the subject device claims to be compatible with natural rubber latex condoms (and not compatible with polyurethane and polyisoprene condoms). This difference in technological characteristics does not raise different questions of safety or effectiveness.
7. Performance Data
The only difference between the new Personal Lubricating Jelly and the already cleared Personal Lubricating Jelly is that device labeling will be modified to add a statement that the Personal Lubricating Jelly is compatible with natural rubber latex condoms. This statement is supported by performance data collected in accordance with ASTM7661-10, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms, an FDA-recognized Consensus Standard.
8. Conclusion / Summarv of Substantial Equivalence
Based on the information and data provided and analyzed in this 510(k) premarket notification, the Personal Lubricating Jelly is substantially equivalent to the predicate device.