(91 days)
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.
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.
The provided document is a 510(k) premarket notification for a medical device (Personal Lubricating Jelly) and is generally not the type of document that would contain detailed information about acceptance criteria and comprehensive study designs as requested in your prompt regarding AI/algorithm performance.
However, I can extract what limited information is available related to performance testing to address some of your points.
Here's an analysis based only on the provided text:
This device is a personal lubricating jelly, not an AI or algorithm-based device, so most of your requested information (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) is not applicable or present in this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device, with one specific performance test conducted to support an added claim.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility with natural rubber latex condoms as per ASTM D7661-10. | The Personal Lubricating Jelly was tested in accordance with ASTM D7661-10, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The document states that the labeling will be modified to add a statement that the Personal Lubricating Jelly is compatible with natural rubber latex condoms, indicating that the device met the criteria of this standard for compatibility. (Specific numerical results are not provided in this regulatory summary). |
| Equivalence to predicate device for other aspects. | The subject device has the same formulation and specifications as the predicate device (K012203). Both have the same indications for use. This implies that for all other characteristics (e.g., pH, viscosity, osmolality, microbial limits, cytotoxicity, irritation, sensitization), the new device is expected to meet the same performance criteria as the predicate, which would have been established during the predicate's clearance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document for the condom compatibility testing. The ASTM D7661-10 standard would outline the required sample size, but the summary doesn't include it.
- Data Provenance: Not specified. The study was conducted to support a US FDA submission, but the location of the test facility is not mentioned. It was a prospective test as it was "collected in accordance with ASTM7661-10" to support a new claim.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not an AI/diagnostic device that requires expert ground truth. The condom compatibility test is a laboratory assay.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a laboratory test with objective measurements as defined by the ASTM standard, not a subjective assessment requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a personal lubricant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a personal lubricant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For condom compatibility: The "ground truth" is defined by the objective pass/fail criteria and measurements outlined in the ASTM D7661-10 standard, which evaluates the physical properties and integrity of the condom after lubricant exposure.
- For substantial equivalence (other aspects): The "ground truth" is established by the accepted safety and performance profiles of the legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This device did not involve machine learning or AI, and therefore no training set was used.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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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.
§ 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.