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, 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.

AI/ML Overview

The provided text describes a 510(k) summary for a personal lubricant, not an AI-powered medical device that requires a study to prove acceptance criteria. Therefore, most of the requested information (such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this document.

However, I can extract the acceptance criteria and performance data related to the lubricant's safety and compatibility.

Acceptance Criteria and Reported Device Performance for Aloe Cadabra® Lubricants

The acceptance criteria for the Aloe Cadabra® Lubricants are established through various performance tests, primarily focusing on biocompatibility and condom compatibility, in comparison to the predicate device. The device aims to meet these criteria to demonstrate substantial equivalence to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance	Study Type/Standard Applied
Biocompatibility	Acute Systemic Toxicity	No systemic responses or biological reactivity in test animals.	All test group animals survived the test period and exhibited no biological reactivity at any tested time points.	ISO 10993-11: 2006
	Vaginal Irritation Testing	Non-irritating to vaginal mucosal tissue.	Considered non-irritating to the vaginal mucosa in female New Zealand White Rabbits.	ISO 10993-10: 2010
	Cytotoxicity	No cytotoxic effect.	Not considered to have a cytotoxic effect based on qualitative evaluation.	ANSI/AAMI/ISO 10993-5: 2009
	Skin Sensitization	No sensitization reactions.	Did not elicit sensitization reactions in the animals used.	ISO 10993-10: 2010
Product Stability	Shelf Life	Demonstrate a two-year shelf life.	Achieved a two-year shelf life based on real-time aging study results.	Real-time aging study
Condom Compatibility	Natural Rubber Latex Condoms	Compatible.	Compatible with natural rubber latex condoms.	ASTM D7661-10
	Polyisoprene Condoms	Compatible.	Compatible with polyisoprene condoms.	ASTM D7661-10
	Polyurethane Condoms	Compatible (or specified as incompatible).	Not compatible with polyurethane condoms.	ASTM D7661-10

2. Sample Size Used for the Test Set and Data Provenance

Acute Systemic Toxicity: Mice were used. Specific sample size not provided, but the standard implies a sufficient number for statistical relevance per ISO 10993-11.
Vaginal Irritation Testing: Female New Zealand White Rabbits were used. Specific sample size not provided, but the standard implies a sufficient number per ISO 10993-10.
Cytotoxicity: Not applicable to in vivo subjects; likely cell culture tests. Specific sample size (e.g., number of cell lines or replicates) not provided.
Skin Sensitization: Guinea pigs were used. Specific sample size not provided, but the standard implies a sufficient number per ISO 10993-10.
Shelf Life: Not applicable to biological samples; involves product samples over time. Specific number of product samples not provided.
Condom Compatibility: Involved all 5 versions of the lubricants. Specific number of condoms tested per type not provided.

Data Provenance: The studies are described as performance tests performed by the submitter (Seven Oaks Ranch, Inc.) or contracted labs according to international ISO standards. The country of origin for the studies is not explicitly stated, but the submission is to the US FDA. The studies are prospective in nature, actively testing the device to gather performance data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable. The "ground truth" for these tests refers to established biological responses (e.g., irritation, toxicity) as measured by standard laboratory methods outlined in the ISO documents. It does not involve expert consensus on image interpretation or similar qualitative assessments performed by medical professionals for diagnostic devices.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication typically refers to the process of resolving disagreements among experts when establishing ground truth. For these objective, standardized biological and physical tests, the results are determined by laboratory observations and measurements against defined criteria, not by human expert interpretation that requires adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. These studies are typically conducted for diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Aloe Cadabra® Lubricants are personal care products, not diagnostic devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this question is not applicable. Standalone performance refers to the performance of an algorithm without human intervention, usually in the context of an AI/ML-powered device. The Aloe Cadabra® Lubricants are physical products, not software algorithms.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests relies on objective, scientific measurements and observations performed according to established international standards (ISO, ASTM) for biological reactivity, irritation, toxicity, and material compatibility. For example:

Biocompatibility: Absence of adverse biological reactions in animal models or cell cultures, as defined by the specific ISO standards.
Shelf Life: The product maintaining its specifications (e.g., pH, viscosity, microbial count) over a defined period.
Condom Compatibility: The condoms maintaining their physical integrity and performance after exposure to the lubricant, as defined by ASTM D7661-10.

8. The Sample Size for the Training Set

This information is not applicable. A "training set" refers to data used to train an AI/ML algorithm. The Aloe Cadabra® Lubricants are physical products and do not involve AI/ML.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for an AI/ML algorithm.

Summary

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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 AloeAloe Cadabra® Personal Lubricant - Pina ColadaAloe Cadabra® Personal Lubricant - Tahitian VanillaAloe Cadabra® Personal Lubricant - French LavenderAloe Cadabra® Personal Lubricant - Peppermint
Submitter:	Seven Oaks Ranch, Inc.2658 Channel DriveVentura, CA 93003
Contact:	Calley Herzog, consultantBiologics Consulting Group, Inc.Phone: 720-883-3633Fax: 720-293-0014Email: cherzog@bcg-usa.comAUG 3 0 2013
Date Prepared:	July 12, 2013
ClassificationRegulation:	884.5300
Classification Name:	Condom
Panel:	Obstetrics/Gynecology
Product Code:	NUC
Predicate Device:	K061466 - INTIMOL™ Liquid Personal Lubricant (DLCLaboratories, Inc.)

Indication for Use:

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- Natural AloeAloe Cadabra Personal Lubricant- Pina ColadaAloe Cadabra Personal Lubricant- Tahitian VanillaAloe Cadabra Personal Lubricant- French LavenderAloe Cadabra Personal Lubricant- 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 andAloe Cadabra®Flavored/Scented Lubricantsare personal lubricants, forpenile and/or vaginalapplication, intended tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms.	INTIMOL™ Liquid Personal Lubricant isprincipally intended as personal lubricantto supplement the body's naturallubricating fluids, and to enhance the easeand comfort of intimate sexual activitywith 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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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Regulation Number and Section

§ 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.