(381 days)
Not Found
No
The device description and intended use clearly define a personal lubricant with no mention of AI or ML capabilities. The performance studies focus on physical and chemical properties, not algorithmic performance.
No
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity and ease insertion of other products. While it alters the body's function (lubrication), its primary purpose isn't to treat or prevent a disease or to restore an impaired function. It's more of an aid or cosmetic enhancement.
No
The device is a personal lubricant intended to moisturize and lubricate for sexual activity and to ease insertion of other medical devices. It is not designed to diagnose any condition.
No
The device description clearly indicates it is a physical product (lubricating jelly) packaged in a tube, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Walgreen's Personal Lubricating Jelly's Intended Use: The intended use of this product is for topical application to the body (penile, vaginal, rectal) to provide lubrication and moisture for comfort during intimate activity and for ease of insertion of certain items. It does not involve testing samples taken from the body.
- Device Description: The description details the composition and physical form of the lubricant, not a diagnostic test or assay.
- Lack of Diagnostic Information: The product does not provide any information about a person's health status, disease, or condition.
Therefore, based on the provided information, Walgreen's Personal Lubricating Jelly is a medical device (specifically, a personal lubricant) but not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NUC and HIS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal application, rectal
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)
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.
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.
KY Jelly Personal Lubricant- K810310
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.
0
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 Chavez |
| Regulatory Affairs | |
| Telephone: 818.332.4600 | |
| Common Name: | Personal Lubricant |
| Classification Name: | The General Hospital and Personal Use Device section of the |
| General Medical Devices Panel within the FDA's Center for Medical | |
| Device & Radiological Health considers patient lubricants be Class II | |
| devices when promoted as being compatible for use with condoms (21 | |
| CFR §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
1
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 Personal
Lubricating Jelly-
K080978 | KY Jelly Personal
Lubricant-
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
2
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.
3
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
4
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)
Arza Mr Vr
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n of Reproductive, Abdominal, and Radiological Devices
510(k) Number