ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS

K124044 · Seven Oaks Ranch, Inc. · NUC · Aug 30, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K124044
• Device Name: ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS
• Applicant: Seven Oaks Ranch, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Aug 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

Aloe Cadabra® Lubricant and Aloe Cadabra® Flavored/Scented Lubricants are personal lubricants, 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Story

Aloe Cadabra is an aloe-based personal lubricant designed to supplement natural body fluids and enhance comfort during intimate sexual activity. The device is intended for over-the-counter use by consumers via penile and/or vaginal application. It is formulated with 95% organic aloe and food-grade ingredients. The product is supplied in HDPE bottles in five varieties: Natural Aloe, Pina Colada, Tahitian Vanilla, French Lavender, and Peppermint. It is not a contraceptive or spermicide. The lubricant is compatible with natural rubber latex and polyisoprene condoms, but incompatible with polyurethane condoms. Users apply the lubricant topically as needed to facilitate sexual activity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 standards: Acute Systemic Toxicity (ISO 10993-11), Vaginal Irritation (ISO 10993-10), Cytotoxicity (ISO 10993-5), and Skin Sensitization (ISO 10993-10). All tests showed no biological reactivity or irritation. Condom compatibility evaluated per ASTM D7661-10; confirmed compatible with natural rubber latex and polyisoprene, incompatible with polyurethane. Real-time aging study supports a two-year shelf life.

Technological Characteristics

Aloe-based personal lubricant; 95% organic aloe composition. Non-sterile. Packaged in HDPE opaque white bottles. Evaluated for pH, viscosity, osmolality, and microbial limits. Biocompatibility testing per ISO 10993; condom compatibility per ASTM D7661-10.

Indications for Use

Indicated for individuals requiring penile and/or vaginal lubrication to enhance comfort during sexual activity. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with 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

• INTIMOL™ Liquid Personal Lubricant (K061466)

Submission Summary (Full Text)

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# 510(k) Summary

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Aloe Cadabra Lubricant and Aloe Cadabra Flavored/Scented Lubricants is provided below.

| Device Common Name: | Personal Lubricant |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | Aloe Cadabra® Personal Lubricant - Natural Aloe<br>Aloe Cadabra® Personal Lubricant - Pina Colada<br>Aloe Cadabra® Personal Lubricant - Tahitian Vanilla<br>Aloe Cadabra® Personal Lubricant - French Lavender<br>Aloe Cadabra® Personal Lubricant - Peppermint |
| Submitter: | Seven Oaks Ranch, Inc.<br>2658 Channel Drive<br>Ventura, CA 93003 |
| Contact: | Calley Herzog, consultant<br>Biologics Consulting Group, Inc.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>AUG 3 0 2013 |
| Date Prepared: | July 12, 2013 |
| Classification<br>Regulation: | 884.5300 |
| Classification Name: | Condom |
| Panel: | Obstetrics/Gynecology |
| Product Code: | NUC |
| Predicate Device: | K061466 - INTIMOL™ Liquid Personal Lubricant (DLC<br>Laboratories, Inc.) |

## Indication for Use:

Aloe Cadabra® Lubricant and Aloe Cadabra® Flavored/Scented Lubricants are personal lubricants, 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

## Device Description:

Aloe Cadabra® Lubricant and Aloe Cadabra® Flavored/Scented Lubricants are non-sterile, aloe-based vaginal lubricants designed to supplement the body's own natural lubrication fluids,

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and to enhance the ease and comfort of intimate sexual activity. Aloe Cadabra® Lubricant and Aloe Cadabra® Flavored/Scented Lubricants are specifically formulated with 95% organic aloe. The remaining five percent of ingredients are in all cases food grade and in many cases certified organic. This device is not a contraceptive or spermicide, nor does it contain any such component. All ingredients in Aloe Cadabra Flavored/Scented Lubricants are GRAS (Generally Recognized as Safe by FDA). The specifications for the Aloe Cadabra Lubricants include appearance, odor, pH, viscosity, osmolality, total microbial count, fungal/yeast/mold limits, and absence of pathogenic organisms (straphylococcus aureus, pseudomonas aeruginosa, escheria coli, salmonella, bile tolerant gram negative bacteria, c. albicans and clostridia).

The product is bottled in an HDPE opaque white plastic bottle with a white flip top cap. The bottle is packaged into a carton for sale to consumers. The product comes in five varieties of scents and flavors including Natural Aloe, Pina Colada, Tahitian Vanilla, French Lavender, and Peppermint.

#### Performance Data:

Biocompatibility studies including Acute System Toxicity, Vaginal Irritation Testing, Cytotoxicity, and Skin Sensitization were performed according to ISO 10993 standards.

Acute Systemic Toxicity: This test evaluated systemic responses in mice after injection of Aloe Cadabra® Lubricant. The test was conducted according to ISO 10993-11: 2006 standards. All test group animals survived the test period and none of the test group animals exhibited any biological reactivity at any of the tested time points.

Vaginal Irritation Testing: The potential of Aloe Cadabra® Lubricant to produce irritation of the vaginal mucosal tissue was assessed according to ISO 10993-10: 2010 standards. Results of the testing show that Aloe Cadabra® Lubricant was considered non-irritating to the vaginal mucosa in female New Zealand White Rabbits.

Cyotoxicity: Aloe Cadabra® Lubricant was not considered to have a cytotoxic effect according to the qualitative evaluation of cells exposed to Aloe Cadabra® Lubricant based on grading criteria in ANSI/AAMI/ISO 10993-5: 2009.

Skin Sensitization: Maximization testing for delayed hypersensitivity was performed to determine to what extent Aloe Cadabrao Lubricant has the potential to act as a contact sensitizer in guinea pigs. This test was completed according to methods detailed in ISO 10-993-10: 2010. According to methods detailed in ISO 10-993-10: 2010, Aloe Cadabra® Lubricant did not elicit sensitization reactions in the animals used in the study.

Shelf Life: The Aloe Cadabra® Lubricants have a two-year shelf life based on the results of a real time aging study.

Condom Compatibility: The compatibility of the Aloe Cadabra® Lubricants was evaluated with natural rubber latex, polyisoprene, and polyurethane condoms per ASTM D7661-10. The condom compatibility testing was performed on all 5 versions of the lubricants. The testing showed that the lubricants are compatible with natural rubber latex and polyisoprene condoms and are not compatible with polyurethane condoms.

Conclusions drawn from Testing Performed: The non-clinical performance testing conducted demonstrates that the Aloe Cadabra Personal Lubricants are substantially equivalent to the proposed predicate device.

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## Substantial Equivalence:

Based on similar intended uses, similar technological characteristics and similar testing, the Aloe Cadabra® Lubricant and Aloe Cadabra® Flavored/Scented Lubricants can be found substantially equivalent to the INTIMOL™ Liquid Personal Lubricant (K061466).

| | K124044 | K061466 |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Aloe Cadabra Personal Lubricant<br>- Natural Aloe<br>Aloe Cadabra Personal Lubricant<br>- Pina Colada<br>Aloe Cadabra Personal Lubricant<br>- Tahitian Vanilla<br>Aloe Cadabra Personal Lubricant<br>- French Lavender<br>Aloe Cadabra Personal Lubricant<br>- Peppermint | INTIMOL Liquid Personal Lubricant |
| Manufacturer | Seven Oaks Ranch, Inc. | DLC Laboratories, Inc. |
| Classification | 884.5300 | 884.5300 |
| Product Code | NUC | NUC |
| Indication | Aloe Cadabra® Lubricant and<br>Aloe Cadabra®<br>Flavored/Scented Lubricants<br>are personal lubricants, for<br>penile and/or vaginal<br>application, intended to<br>moisturize and lubricate, to<br>enhance the ease and comfort of<br>intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is<br>compatible with natural rubber<br>latex and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms. | INTIMOL™ Liquid Personal Lubricant is<br>principally intended as personal lubricant<br>to supplement the body's natural<br>lubricating fluids, and to enhance the ease<br>and comfort of intimate sexual activity<br>with or without a latex condom. |
| Over-the-Counter | Yes | Yes |
| Contains Aloe | Yes | Yes |
| Provided Sterile | No | No |
| Biocompatible | Yes | Yes |

# Device Comparison Table

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

August 30, 2013

Seven Oaks Ranch, Inc. % Calley Herzog Consultant Biologics Consulting Group, Inc. 400 North Washington Street, Suite 100 Alexandria, VA 22314

- K124044 Re:
Trade/Device Name: Aloe Cadabra Personal Lubricant - Natural Aloe, Aloe Cadabra Personal Lubricant - Pina Colada, Aloe Cadabra Personal Lubricant - Tahitian Vanilla, Aloe Cadabra Personal Lubricant -French Lavender, Aloe Cadabra Personal Lubricant - Peppermint Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: July 17, 2013 Received: July 18, 2013

Dear Calley Herzog:

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 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 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.

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# Page 2 - Calley Herzog

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 tollfree 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Herbert P. Lerner -S

for

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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# Indications for Use Statement

510(k) Number (if known): K124044

Device Name:

Aloe Cadabra Personal Lubricant - Natural Aloe Aloe Cadabra Personal Lubricant - Pina Colada Aloe Cadabra Personal Lubricant - Tahitian Vanilla Aloe Cadabra Personal Lubricant - French Lavender Aloe Cadabra Personal Lubricant - Peppermint

#### Indications For Use:

Aloe Cadabra® Lubricant and Aloe Cadabra® Flavored/Scented Lubricants are personal lubricants, 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2013.08.30 10:56:3

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