(181 days)
5955648
No
The 510(k) summary describes a personal lubricant and does not mention any AI or ML technology.
No.
The product is intended to supplement natural lubrication and reduce friction during sexual intimacy, not to treat or prevent a disease or condition.
No
The device is a personal lubricant intended to reduce friction during sexual intimacy and supplement natural lubricating fluids, not to diagnose any condition or disease.
No
The device is a personal lubricant, which is a physical substance, not software. The description details its physical properties and packaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant to supplement natural lubrication and reduce friction during sexual intimacy. This is a physical function, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the gel (water-soluble, high viscosity, warming sensation) and its compatibility with condoms. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There are no mentions of analyzing biological fluids (like blood, urine, or tissue samples), detecting biomarkers, or providing any kind of diagnostic result or interpretation.
- Over-the-Counter Use: IVDs are typically used in clinical settings or require specific instructions for sample collection and analysis, which is not the case here.
- Predicate and Reference Devices: The predicate and reference devices are also personal lubricants, not IVDs.
In summary, the device's purpose is to facilitate sexual activity through lubrication, not to diagnose any medical condition.
N/A
Intended Use / Indications for Use
Sheffield's Warming LubriGel Personal Lubricant (formula number 3120) is a warming lubricant intended to be used with or without a condom. Sheffield's Warming LubriGel is specially formulated to help supplement the body's natural lubricating fluids and to reduce friction during sexual intimacy. This lubricant may be safely applied to vaginal, anal or penile tissues for the purpose of lubrication and provides a mild warming sensation when applied to the genital area. This product is compatible with latex condoms.
Product codes
NUC
Device Description
Warming LubriGel Personal Lubricant is a non-sterile, clear, colorless, odorless, non-greasy, non-staining, non-irritating personal lubricant. It is a water soluble, high viscosity gel-like liquid for use as a personal lubricant. This product provides a gentle warming sensation upon application, according to users' need for a lubricant that does not dry and is water-soluble and easily rinsed off with water. It is compatible with latex condoms as demonstrated in the Condom Compatibility Test conducted according to the standards as defined by ASTM D 3492-03.
The product is packaged in a convenient laminate tube with a flip top cap and peel seal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal, anal or penile tissues
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)
Shuster Laboratories performed a comparative evaluation between K-Y Warming Jelly and Sheffield's Warming LubriGel (formula NS# 3120). Sheffield's LubriGel received a overall rating of 10 in a point rating scale of 1-10 in which 10 is the highest comparative score. The sensory ratings were scored as identical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K-Y Brand Jelly Personal Lubricant 510 (K) No. 5955648
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
ffield Laboratories, Div. Faria Limited LLC
Manufacturer, Est. 1850
Date
2006 FEB 6
Image /page/0/Picture/3 description: The image contains the text "World's First Toothpaste" in a stylized font. To the right of the text is a circular emblem with a landscape scene inside. The word "SHEAF-FIELD" is written along the bottom of the emblem.
510(k) Summary
Sheffield Laboratories, Div. of Faria Ltd. Applicant: 170 Broad Street New London, Ct. 06320 USA
Signature of Applicant:
Thomas Faria - President
- (860) 442-4451 Phone: (860) 442-0356 Fax:
- Kathleen Hacku Contact: Quality Assurance Manager
- July 25, 2005 Date:
Manufacturing Site:
Sheffield Laboratories, Div. of Faria Ltd. 170 Broad Street New London, Ct. 06320 USA
Registration Number: 1210513
Device Class: Class I (reserved)
- Warming LubriGel Trade Name: .
- Common Name: Personal Lubricant .
- Classification Name: Patient Lubricant ◆
- 21 CFR section 880.6375 C.F.R. section: . Condom: 21 CFR section 884.5300
Obstetrical/Gynecological Classification Panel: Sheffield Laboratories Warming LubriGel Personal New Device's Name: Lubricant
- K-Y Brand Jelly Personal Lubricant Predicated Device(s) Ortho-McNeil Pharmaceuticals, Inc. 510 (K) No. 5955648
1
Current Marketed Device: K-Y Brand Warming Jelly R-1 Drand Warming one of McNeil PPC Inc 510 (K) No. K040164
Information supporting claims of substantial equivalence, as defined under the Federal Information supporting claims of successions offectiveness is summarized Food Drug and Cosmetic Act, with reviewer, this summary is formatted in accordance below. For the convenience of the reviewer, this sunding in a sunding to the ments" (21 CFR 807).
Intended Use:
e:
Sheffield's Warming LubriGel Personal Lubricant (formula number 3120) is Sheffield's warming Eubricant intended to be used with or without a all over-the-counter personaling LubriGel is specially formulated to help condom. Sherneld 3 warming 21st reveal lubricating fluids and to reduce friction supplement the body 5 0 williation nexual intimacy. This lubricant may be safely applied to vaginal, anal or penile tissues for the purpose of lubrication and provides a mild warming sensation when applied to the genital area. This product is compatible with latex condoms.
Device Description:
Warming LubriGel Personal Lubricant is a non-sterile, clear, colorless, Warming EdorFOr I elorio's reasy, non-staining, non-irritating personal odoricant. It is a water soluble, high viscosity gel-like liquid for use as a fubricant. It is a water soluct provides a gentle warming sensation upon personal lubricant. This produce province 's need for a lubricant that does not application, accingilou to micr-soluble and easily rinsed off with icer cold. "Warming Daorrolatex condoms as demonstrated in the Condom water. It is compatible waducted according to the standards as defined by ASTM D 3492-03.
The product is packaged in a convenient laminate tube with a flip top cap and peel seal.
and pour seat."
Regulatory Status:
As per 21CFR, 880.6375, Patient Lubricant is defined as a Class I medical As per 2101 te, 000.05 virposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. When used as an to faciliate entry of a clargestly bricant is reviewed by the FDA as a Class II Medical Device requiring 510(k) clearance.
Technological Characteristics:
Sheffield's Warming LubriGel has no exceptional technological Sherners b warming of safe water-soluble ingredients. Similar to K-Y Warming Jelly currently on the market, Sheffield's Warming LubriGel contains Propylene Glycol, Polyethylene Glycol, Hydroxypropylcellulose and Lactic Acid.
2
Summary of Technological Characteristics:
The table below compares the technological characteristics of Sheffield's The table below comparely marketed K-Y Brand Warming Jelly and Walling Lasted device KY Brand Liquid Personal Lubricant Jelly.
| Feature | Warming
LubriGel | K-Y Warming
Jelly | K-Y Liquid Jelly |
|--------------------------------------------|-----------------------------------------------|-----------------------------------------------------------|--------------------------------------|
| Manufacturer | Sheffield
Laboratories, Div.
Faria Ltd. | Personal Products
Company, Div. of
McNeil PPC, Inc. | Ortho-McNeil
Pharmaceutical, Inc. |
| Contains
Propylene Glycol | yes | yes | no |
| Contains
Polyethylene Glycol | yes | yes | no |
| Contains Cellulose
base jell thickeners | yes | yes | yes |
| Contains Lactic
Acid | yes | yes | no |
| Contains pH
adjuster | yes | yes | yes |
| Provides
Lubrication | yes | yes | yes |
| Compatible with
Latex condoms | yes | yes | yes |
| Non-sterile | yes | yes | yes |
| Fragrance Free | yes | yes | yes |
| Not a contraceptive | yes | yes | yes |
| Not a spermicide | yes | yes | yes |
| Container | laminate | laminate | laminate |
Substantial Equivalence:
Sheffield's Warming LubriGel has been shown in laboratory tests to be substantially equivalent the currently marketed K-Y Brand Warming Jelly and substantially equivalent to the predicated device K-Y Liquid Personal Lubricant Jelly. All are high viscous gel with the same intended use. Both warming lubricants have exactly the same ingredients, with the same variation in formula ingredients to K-Y Personal Lubricant Jelly. All of these products are sold over-the-counter and are indicated as personal lubricants.
Shuster Laboratories performed a comparative evaluation between K-Y Warming Jelly and Sheffield's Warming LubriGel (formula NS# 3120). Sheffield's LubriGel received a overall rating of 10 in a point rating scale of 1-10 in which 10 is the highest comparative score. The sensory ratings were scored as identical.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars representing the agency's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathleen Hacku QA Manager Sheffield Laboratories Div. Faria Limited LLC 170 Broad Street NEW LONDON CT 06320 Re: K052162 Trade/Device Name: Dr. Sheffield's Warming LubriGel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 11, 2006 Received: January 11, 2006
2006
FEB 6
Dear Ms. Hacku:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your he finding of substantial equivalence of your device to a legally prematively notification - results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please ir you dosite apour da nove of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Anot, prouse not regulation other general information on your responsibilities under the Act from the 001:57). " Carmay of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brigdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) INDICATIONS FOR USE FORM (Replica of FDA Form)
510 (k) Number (if known): #K052162
Device Name: Dr. Sheffield's Warming LubriGel
Indications for Use:
Indications for Cove
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON AN OTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
OR Over-the-Counter-Use ______________________________________________________________________________________________________________________________________________________
Nancy C. Brayton
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devi 510(k) Number