INSTEAD INTIMATE LUBRICANT

K033776 · Instead, Inc. · NUC · Jun 25, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K033776
• Device Name: INSTEAD INTIMATE LUBRICANT
• Applicant: Instead, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jun 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Instead Intimate Lubricant is intended to enhance the comfort and ease of intimate sexual activity and is compatible with latex and polyurethane condoms.

Device Story

Instead Intimate Lubricant is a water-glycerin based personal lubricant; formulated without fragrances or petroleum-based chemicals. Used by consumers to enhance comfort during sexual activity; compatible with latex and polyurethane condoms. Device provides lubrication; does not affect condom performance. Biocompatibility confirmed via penile, anal, and vaginal irritation studies. Product is non-sterile and packaged in plastic containers.

Clinical Evidence

No clinical trials performed. Evidence includes non-clinical bench testing (pH, viscosity, bioadhesive properties, and condom compatibility per ASTM D3492-02) and literature-based in-vivo biocompatibility data (penile, anal, and vaginal irritation studies).

Technological Characteristics

Water-glycerin based lubricant; contains thickening agents and preservatives. No fragrances or petroleum-based chemicals. Non-sterile. Packaged in plastic. Compatible with latex and polyurethane condoms per ASTM D3492-02.

Indications for Use

Indicated for individuals requiring a personal lubricant to enhance comfort and ease during sexual activity; compatible with latex and polyurethane condoms.

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

• The Just Between Us™ lubricant (K982673)
• CVS Personal Lubricant (K983216)

Submission Summary (Full Text)

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K033776
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JUN 2 5 2004

Corporate Headquarters: 4370 La Jolla Village Drive, Suite 960 San Diego, CA 92122 Tel. [phone] Fax [phone]

## 510K SUMMARY

This summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510K number is:_

- 1. Submitter's Identification:
- Instead Inc. 4370 La Jolla Village Drive, Suite 960 San Diego, California 92122 Telephone: [phone] Facsimile: 858-623-6991

Contact Person: Joe Pike, CEO/President

Date of Summary: 11-18-03

- 2. Device Name: Instead Intimate Lubricant
- 3. Classification Name: Lubricant (21 CFR 884.5300)
- 4. Predicate Device:
- a. K982673 The Just Between Us™ Iubricant by Key West Fragrance & Cosmetic Factor.
- b. K983216 CVS Personal Lubricant by San-Mar Laboratories.
- 5. Intended Use: Instead Intimate Lubricant is intended to enhance the confort and miended ose. "Instead maintate adomitible with latex and polyurethane condoms.

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- 6. Device Description/ Comparison:
Instead Intimate Lubricant is a water-glycerin based lubricant that uses mistead intimate Eubnount is a fragrances or petroleum-based chemicals are used in the formulation.

A comparison of the technological characteristics of the Instead Intimate A companson of the technological charactories (shown in the table below) substantiates the Eubricant with the prodicate don't (Intimate Lubricant to the predicate devices.

| Characteristic/<br>Feature | Instead<br>Intimate<br>Lubricant | The Just<br>Between<br>USTM<br>(K982673) | CVS<br>Personal<br>Lubricant<br>(K983216) |
|----------------------------|----------------------------------|------------------------------------------|-------------------------------------------|
| Contains purified water | Yes | Yes | Yes |
| Contains glycerin | Yes | Yes | Yes |
| Contains thickening agents | Yes | Yes | Yes |
| Contains preservatives | Yes | Yes | Yes |
| Container Material | Plastic | Plastic | Plastic |
| Label Condom Compatible | Yes | Yes | Yes |
| Sterile | No | No | No |

| | | Table 1. Comparison of Technological Characteristics |
|--|--|------------------------------------------------------|
| | | |

Non-clinical testing of the Instead Intimate Lubricant included measurement of Non-cillincal testing of the instead framato easen, viscosity and compatibility with bloadlesson, buttering copating of Instead Intimate Lubricant had better latex and polyulethane oonaoms: d its initial pH and viscosity better when mixed bioadnestve properties, maintained to ... The testing with semen suggested that with Sement than other labhounts weeks on the sperm motility (Carg, S. 2001). Latex the instead intimate Eubnount may rested in accordance with ASTM D3492-02 after exposure to Instead Intimate Lubricant for up to 24 hours. No effect on condom performance was found.

In-vivo testing (penile and anal irritation) confirmed the biocompatibility of the In-vivo lesting (penile and and and imaxill), a repeated dose vaginal irritation study instead Intimate Eubrisant. Addiscompatibility of the Instead Intimate Lubricant (Amaral et al. 2000).

Contraception, 64:67-75, 2001.

Amaral, E., et al. Study of the vaginal tolerance to acidform, an acid-buffering bioadhesive gel, Contraception, 60:361-366, 2000.

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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 or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

FEB 2 4 2014

Mr. Joe Pike CEO/President Instead, Inc. 4370 La Jolla Village Drive, Suite 960 SAN DIEGO, CA 92122

Re: K033776 Trade/Device Name: Instead Intimate Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): April 16, 2004 Received (Date on orig SE Itr): April 19, 2004

Dear Mr. Pike:

This letter corrects our substantially equivalent letter of June 25, 2004.

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. Iisting 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

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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); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Benjamin R. Fisher -S

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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510k Number (if Known): K033776

Device Name: Instead Intimate Lubricant

Indications for Use:

Instead Intimate Lubricant is intended to enhance the comfort and ease of intimate
the continues and the cities and selectronic condoms instead intimate Eubricant is interest and polyurethane condoms.

Prescription Use: (Per 21 CFR 801.109)

Over-the-Counter Use: OR

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- r

Concurrence of CFRH, Office of Device Evaluation (ODE)

David h. Sypman
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number