(381 days)
Walgreen's Personal Lubricating Jelly 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. It can ease insertion of rectal thermometers, enemas and tampons. This product is compatible with latex condoms.
Walgreen's Personal Lubricating Jelly is a non-sterile, aqueous based personal lubricant designed to supplement the body's own natural lubrication fluids. It is specifically formulated to be a clear, nonirritating, non-greasy, gel-like liquid and is compatible for use with or without a condom during intimate sexual activity as evidenced by condom compatibility test results. Walgreen's Personal Lubricating Jelly is a water-based personal lubricant containing chlorhexidine digluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water. This product is designed in LDPE tube w/ plastic flip-top cap.
The Walgreen's Personal Lubricating Jelly is a personal lubricant. The provided information does not describe an AI/ML device, therefore, the requested information on studies, test sets, ground truth, and training sets is not applicable.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Condom Compatibility | Device meets established acceptance criteria |
| Biocompatibility | Device meets established acceptance criteria |
| Preservative Effectiveness | Device meets established acceptance criteria |
| Substantially Equivalent Ingredients to Predicate Device | Confirmed: Contains purified water, glycerin, gluconolactone, cellulose thickeners, chlorhexidine gluconate, methylparaben, sodium hydroxide. Does not contain alcohol and fragrance. Compatible with latex condoms. |
| Over-the-Counter Use | Yes |
| Labeled Water Soluble | Yes |
| Labeled Condom Compatible | Yes |
| Container Material | Plastic |
| Sterile | No |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The submission is for a medical device (personal lubricant) and not an AI/ML device that would typically involve test sets or data provenance in this context. The product was tested by independent laboratories, but specific sample sizes and data provenance for these tests are not provided in the summary.
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. The submission is for a medical device (personal lubricant) and not an AI/ML device. Ground truth as typically understood for AI/ML validation is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The assessment relied on laboratory testing for condom compatibility, biocompatibility, and preservative effectiveness, and comparison of chemical ingredients and intended use to a predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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APR 23 2009
510(k) Summary of Safety and Effectiveness (21 CFR 807.92) {21 CFR 807.87 (H)}
Walgreen's Personal Lubricating Jelly
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.87 (h), this information serves as a Summary of Safety and Effectiveness for the Walgreen's Personal Lubricating Jelly.
| Submitted by: | Vast Resources, 9401 De Soto Ave, Chatsworth, CA 91311 |
|---|---|
| Date: | September 23, 2008 |
| Contact Person: | Lorelei ChavezRegulatory AffairsTelephone: 818.332.4600 |
| Common Name: | Personal Lubricant |
| Classification Name: | The General Hospital and Personal Use Device section of theGeneral Medical Devices Panel within the FDA's Center for MedicalDevice & Radiological Health considers patient lubricants be Class IIdevices when promoted as being compatible for use with condoms (21CFR §884.5300). |
| Predicate Device: | KY Jelly, Personal Lubricant |
Intended Use:
Walgreen's Personal Lubricating Jelly 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. It can ease insertion of rectal thermometers, enemas and tampons. This product is compatible with latex condoms.
Device Description
Walgreen's Personal Lubricating Jelly is a non-sterile, aqueous based personal lubricant designed to supplement the body's own natural lubrication fluids. It is specifically formulated to be a clear, nonirritating, non-greasy, gel-like liquid and is compatible for use with or without a condom during intimate sexual activity as evidenced by condom compatibility test results. Walgreen's Personal Lubricating Jelly is a water-based personal lubricant containing chlorhexidine digluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water. This product is designed in LDPE tube w/ plastic flip-top cap.
Vast Resources 9401 De Soto Ave. Chatsworth, CA 91311
Confidential
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Summary of Technological Characteristics
Walgreen's Personal Lubricating Jelly contains ingredients that are substantially equivalent to those used in the manufacture of the predicate devices. The ingredients meet specifications defined in the United State Pharmacopoeia (USP) or National Formulary (NF), and are "generally recognized as safe for their intended use" (21 CFR 172.515).
Summary of Substantial Equivalence Information:
The intended use, ingredients, and application of the proposed device are substantially equivalent to those of the predicate devices. In determining substantial equivalence, the Walgreen's Personal Lubricating Jelly has been compared with the following legally marketed device to which the Sponsor claims substantial equivalence.
The table below compares the technological characteristics of Walgreen's Personal Lubricating Jelly to the predicate device, KY Jelly Personal Lubricant.
| Feature | Walgreen's PersonalLubricating Jelly-K080978 | KY Jelly PersonalLubricant-K810310 |
|---|---|---|
| Manufacturer | Vast Resources | McNeil-PPC Inc |
| Contains Purified Water | Yes | Yes |
| Contains Glycerin | Yes | Yes |
| Contains Gluconolactone | Yes | Yes |
| Contains Cellulose Thickeners | Yes | Yes |
| Contains Chlorhexidine Gluconate | Yes | Yes |
| Contains Methylparaben | Yes | Yes |
| Contains Sodium Hydroxide | Yes | Yes |
| Over the Counter Use | Yes | Yes |
| Labeled water soluble | Yes | Yes |
| Labeled condom compatible | Yes | Yes |
| Contains alcohol and fragrance | No | No |
| Container Material | Plastic | Plastic |
| Sterile | No | No |
The product was tested by independent laboratories for condom compatibility, biocompatibility and preservative effectiveness. Final results from these tests demonstrate that the device meets established acceptance criteria in accordance with the identified industry standards. In addition, this product is identical to the predicate device which has undergone all appropriate testing and has already been on the market for over 20 years.
Vast Resources 9401 De Soto Ave. Chatsworth, CA 91311
Confidential
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines extending from its head, all enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2009
Ms. Lorelei Chavez Regulatory Affairs Manager Topco Sales 9401 De Soto Avenue CHATSWORTH CA 91311
Re: K080978
Trade/Device Name: Walgreen's Personal Lubricating Jelly Regulation Number: 21 CFR §880.5300 Regulation Name: Personal lubricant Regulatory Class: II Product Codes: NUC and HIS Dated: April 2, 2009 Received: April 6, 2009
Dear Ms. Chavez:
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 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/..
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Indications for Use
510(k) Number (if known): K080978
Device Name: Walgreen's Personal Lubricating Jelly
Indications for Use: Walgreen's Personal Lubricating Jelly 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. It can ease insertion of rectal thermometers, enemas and tampons. This product is compatible with latex condoms.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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n of Reproductive, Abdominal, and Radiological Devices
510(k) Number
§ 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.