SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT

K052162 · Sheffield Laboratories, Div. of Faria Limited, LLC · NUC · Feb 6, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K052162
• Device Name: SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT
• Applicant: Sheffield Laboratories, Div. of Faria Limited, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Feb 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Sheffield's Warming LubriGel Personal Lubricant (formula number 3120) is Sheffield's warming lubricant intended to be used with or without a condom. Sheffield's Warming LubriGel is specially formulated to help supplement the body's own 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.

Device Story

Warming LubriGel is a non-sterile, water-soluble, high-viscosity personal lubricant gel. Applied topically to vaginal, anal, or penile tissues by the user to reduce friction and supplement natural lubrication; provides a mild warming sensation upon application. Packaged in a laminate tube with a flip-top cap. Compatible with latex condoms. Used in home settings by consumers. Output is the physical lubrication and warming effect, aiding comfort during sexual activity.

Clinical Evidence

Bench testing only. Comparative evaluation performed between subject device and predicate K-Y Warming Jelly. Subject device received a 10/10 rating in a comparative sensory study; sensory ratings were identical to the predicate. Compatibility with latex condoms verified per ASTM D 3492-03.

Technological Characteristics

Water-soluble gel containing Propylene Glycol, Polyethylene Glycol, Hydroxypropylcellulose, and Lactic Acid. Non-sterile. Packaged in laminate tubes. Compatible with latex condoms per ASTM D 3492-03. No electronic or mechanical components.

Indications for Use

Indicated for individuals requiring supplemental lubrication during sexual intimacy. May be applied to vaginal, anal, or penile tissues. Compatible with latex condoms. Not a contraceptive or spermicide.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• K-Y Brand Jelly Personal Lubricant (K5955648)
• K-Y Brand Warming Jelly (K040164)

Reference Devices

• K-Y Liquid Personal Lubricant Jelly

Submission Summary (Full Text)

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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.

K052162

### 510(k) Summary

Sheffield Laboratories, Div. of Faria Ltd. Applicant: 170 Broad Street New London, Ct. 06320 USA

Signature of Applicant:

Thomas Faria - President

- [phone] Phone: [phone] 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

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### 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.

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# 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<br>LubriGel | K-Y Warming<br>Jelly | K-Y Liquid Jelly |
|--------------------------------------------|-----------------------------------------------|-----------------------------------------------------------|--------------------------------------|
| Manufacturer | Sheffield<br>Laboratories, Div.<br>Faria Ltd. | Personal Products<br>Company, Div. of<br>McNeil PPC, Inc. | Ortho-McNeil<br>Pharmaceutical, Inc. |
| Contains<br>Propylene Glycol | yes | yes | no |
| Contains<br>Polyethylene Glycol | yes | yes | no |
| Contains Cellulose<br>base jell thickeners | yes | yes | yes |
| Contains Lactic<br>Acid | yes | yes | no |
| Contains pH<br>adjuster | yes | yes | yes |
| Provides<br>Lubrication | yes | yes | yes |
| Compatible with<br>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.

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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.

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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 [phone] or [phone] 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

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### 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