H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Device Description

H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are clear, semi-viscous personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.

H2O Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

H2O Anal Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz/60 mL and 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

JO 2 To Tango for Me is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

JO 2 To Tango Couples Pleasure Kit is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.

#LubeLife Sensations Cooling is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.

#LubeLife Sensations Pleasure Kit for Two is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.

These devices are composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Mentha Piperita (Peppermint) Leaf Extract and Sodium Hydroxide.

AI/ML Overview

The document describes the acceptance criteria and supporting studies for several H2O and JO brand cooling personal lubricants.

1. Table of Acceptance Criteria and Reported Device Performance:

Property	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Semi-viscous liquid	Met
Color	Colorless	Met
Odor	Peppermint	Met
Viscosity (cps) per USP <911>	2150 - 4000	Met
pH per USP <971>	3.50 - 4.50	Met
Specific Gravity per USP <841>	1.010 - 1.030	Met
Osmolality per USP <785>	1000 – 1100 (1:1 dilution with purified water)	Met
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products.	Met
Total aerobic microbial count (TAMC) per USP <61> and <1111>	Less than 100 cfu/g	Met
Total yeast and mold count (TYMC) per USP <61> and <1111>	Less than 10 cfu/g	Met
Presence of Pathogens per USP <62>: Pseudomonas aeruginosa	Absent	Met
Presence of Pathogens per USP <62>: Staphylococcus aureus	Absent	Met
Presence of Pathogens per USP <62>: Salmonella/Shigella	Absent	Met
Presence of Pathogens per USP <62>: Escherichia coli	Absent	Met
Presence of Pathogens per USP <62>: Candida albicans	Absent	Met
Biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity)	Demonstrates biocompatibility per ISO 10993 standards	Met
Shelf-Life	3 years (maintaining all device specifications)	Met
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms	Met

2. Sample size used for the test set and the data provenance:

Biocompatibility: The document states that "Biocompatibility studies... were performed," implying specific samples were used for testing. However, the exact sample sizes (e.g., number of animals or in-vitro replicates) are not specified. The provenance is not explicitly stated beyond being performed "in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1" and "ISO 10993-1:2019." These are international standards. The study is prospective in nature as it involves testing the device.
Shelf-Life: The document states "All the devices specifications listed in Table 1 were tested at 0, 1, 2 and 3 years." This indicates longitudinal testing of samples over time. The sample size at each time point is not specified. Data provenance is not detailed, but it's a real-time aging study, implying internal testing by the manufacturer. This is a prospective study.
Condom Compatibility: The document states "The compatibility... was evaluated in accordance with ASTM D7661-10 (Reapproved 2017)." The number of lubricant and condom samples tested is not specified. This is a prospective study following an ASTM standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the device is a personal lubricant, and the testing involves laboratory and in-vivo biocompatibility, shelf-life, and material compatibility tests, not clinical performance requiring expert interpretation of diagnostic images or patient data. The criteria are based on established scientific standards and physical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable for the type of testing performed (laboratory and material compatibility). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiology reads).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is a personal lubricant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is a personal lubricant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance criteria is established by:

Established physical and chemical specifications: For properties like appearance, color, odor, viscosity, pH, specific gravity, and osmolality.
Microbiological standards: For antimicrobial effectiveness (USP <51>) and microbial counts/absence of pathogens (USP <61>, <1111>, <62>).
International and national testing standards: Specifically ISO 10993 for biocompatibility and ASTM D7661-10 for condom compatibility. These standards define the methodologies and corresponding acceptance criteria.
Real-time aging study: For shelf-life, the ground truth is the documented stability of the product properties over the specified time period.

8. The sample size for the training set:

This information is not applicable. As a physical product, there is no "training set" in the context of machine learning or AI development.

9. How the ground truth for the training set was established:

This information is not applicable. There is no training set for this type of device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 10, 2021

CC Wellness LLC Marlent Perez Quality/Regulatory Affair Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355

Re: K210986

Trade/Device Name: H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 30, 2021 Received: April 1, 2021

Dear Marlent Perez:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210986

Device Name
H2O Cooling Personal Lubricant
H2O Anal Cooling Personal Lubricant
JO 2 To Tango for Me

JO 2 To Tango Couples Pleasure Kit #LubeLife Sensations Cooling #LubeLife Sensations Pleasure Kit for Two

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a logo for a wellness company. The logo features two stylized, cursive letters that appear to be "CC". To the right of the letters, the word "WELLNESS" is written in a simple, sans-serif font. The overall design is minimalist and elegant.

510(k) Summary – K210986

H2O Cooling Personal Lubricant/ H2O Anal Cooling Personal Lubricant/ JO 2 To Tango for Me/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Cooling/ #LubeLife Sensations Pleasure Kit for Two

K210986 Page 1 of 5

510(k) Owner:	CC Wellness LLC
Street Address:	29000 N. Hancock ParkwayValencia, CA 91355
Contact Person:	Marlent PerezQuality/Regulatory Affairs SpecialistBruce AlbertChief Scientific Officer
Contact Numbers:	Phone: (661) 295-1700, ext. 1007Phone: (661) 295-1700, ext. 231
Summary Preparation Date:	May 25, 2021
Trade Name:	H2O Cooling Personal LubricantH2O Anal Cooling Personal LubricantJO 2 To Tango for MeJO 2 To Tango Couples Pleasure Kit#LubeLife Sensations Cooling#LubeLife Sensations Pleasure Kit for Two
Common Name:	Personal Lubricant
Device Classification:	Regulation Name: CondomRegulation Number: 21 CFR § 884.5300Product Code: NUC (lubricant, personal)Device Class: Class II
Predicate Device:	Product Name: Agape Cooling Personal Lubricant510(k) Number: K200894Manufacturer: CC Wellness LLCProduct Code: NUC (lubricant, personal)Device Class: Class II

The predicate device has not been subject to a design-related recall.

{4}------------------------------------------------

510(k) Summary - K210986

Image /page/4/Picture/1 description: The image shows a logo with the letters "CC" in a stylized, cursive font. Below the letters, the word "WELLNESS" is written in smaller, sans-serif letters. The overall design is simple and elegant, suggesting a focus on health and well-being. The logo is in black and white.

K210986 Page 2 of 5

H2O Cooling Personal Lubricant/ H2O Anal Cooling Personal Lubricant/ JO 2 To Tango for Me/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Cooling/ #LubeLife Sensations Pleasure Kit for Two

Device Description:

{5}------------------------------------------------

510(k) Summary - K210986

Image /page/5/Picture/1 description: The image shows a logo for "CC Wellness". The logo features two stylized, cursive letters "C" connected by a flowing line. The word "WELLNESS" is written in small, sans-serif letters below the two "C"s.

K210986 Page 3 of 5

H2O Cooling Personal Lubricant/ H2O Anal Cooling Personal Lubricant/ JO 2 To Tango for Me/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Cooling/ #LubeLife Sensations Pleasure Kit for Two

The individual bottles are hermetically sealed during the production process.

These devices are composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Mentha Piperita (Peppermint) Leaf Extract and Sodium Hydroxide.

The devices specifications are listed in the table below:

Table 1: Device Specifications for H2O Cooling Personal Lubricant, H2O Anal Cooling
Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife
Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two

Property	Specification
Appearance	Semi-viscous liquid
Color	Colorless
Odor	Peppermint
Viscosity (cps) per USP <911>	2150 - 4000
pH per USP <971>	3.50 - 4.50
Specific Gravity per USP <841>	1.010 - 1.030
Osmolality per USP <785>	1000 – 1100 (1:1 dilution with purified water)
Antimicrobial effectiveness per USP <51>	Meets USP <51> acceptance criteria for Category 2 products.
Total aerobic microbial count (TAMC) per USP <61> and <1111>	Less than 100 cfu/g
Total yeast and mold count (TYMC) per USP <61> and <1111>	Less than 10 cfu/g
Presence of Pathogens per USP <62>	Specification
Pseudomonas aeruginosa	Absent
Staphylococcus aureus	Absent
Salmonella/Shigella	Absent
Escherichia coli	Absent
Candida albicans	Absent

Indications for Use:

H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are personal lubricants for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Comparison of Intended Use and Technological Characteristics to the Predicate Device:

The table below lists a comparison of the intended use and technological characteristics of the subject and predicate devices.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows a logo with the letters "CC" in a stylized, cursive font. To the right of the letters, the word "WELLNESS" is written in a smaller, sans-serif font. The overall design is simple and elegant, with a focus on the flowing lines of the cursive letters.

510(k) Summary – K210986

H2O Cooling Personal Lubricant/ H2O Anal Cooling Personal Lubricant/

JO 2 To Tango for Me/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Cooling/ #LubeLife Sensations Pleasure Kit for Two

Feature	H2O Cooling Personal LubricantH2O Anal Cooling Personal LubricantJO 2 To Tango for MeJO 2 To Tango Couples Pleasure Kit#LubeLife Sensations Cooling#LubeLife Sensations Pleasure Kit forTwo	Agape Cooling PersonalLubricant(K200894)
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Indications for Use	H2O Cooling Personal Lubricant, H2OAnal Cooling Personal Lubricant, JO 2 ToTango for Me, JO 2 To Tango CouplesPleasure Kit, #LubeLife SensationsCooling and #LubeLife SensationsPleasure Kit for Two are personallubricants for penile, anal and/or vaginalapplication, intended to lubricate andmoisturize, to enhance the ease andcomfort of intimate sexual activity andsupplement the body's naturallubrication. These products arecompatible with natural rubber latex andpolyisoprene condoms. These productsare not compatible with polyurethanecondoms.	Agape Cooling PersonalLubricant is a personallubricant for penile, analand/or vaginal application,intended to lubricate andmoisturize, to enhance theease and comfort ofintimate sexual activity andsupplement the body'snatural lubrication. Thisproduct is compatible withnatural rubber latex andpolyisoprene condoms. Thisproduct is not compatiblewith polyurethane condoms.
Water soluble	Yes	Yes
Contains water	Yes	Yes
Primary ingredients	Aqua, Glycerin, Polysorbate 20, PropyleneGlycol, Hydroxyethylcellulose,Chlorphenesin, Mentha Piperita(Peppermint) Leaf Extract and SodiumHydroxide	Aqua, Propanediol,Gluconolactone,Hydroxyethylcellulose,Sodium Benzoate,Polysorbate 20, CitricAcid and MenthaPiperita (Peppermint)Leaf Extract
Over the counter use	Yes	Yes
Sterile	No	No
Condom Compatibility	Latex and Polyisoprene	Latex and Polyisoprene
Biocompatibility Tested	Yes	Yes
Antimicrobial Tested	Yes	Yes
Shelf life	3 years	3 years

Table 2: Comparator Table for Subject and Predicate Device

The subject and predicate devices have similar indications for use statements and have the same intended use – to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics; for example, different formulations. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.

Summary of Performance Data:

Biocompatibility

{7}------------------------------------------------

510(k) Summary - K210986

Image /page/7/Picture/1 description: The image shows a logo for a wellness company. The logo features a stylized, cursive font. The word "WELLNESS" is written in smaller, block letters below the cursive letters.

K210986 Page 5 of 5

H2O Cooling Personal Lubricant/ H2O Anal Cooling Personal Lubricant/ JO 2 To Tango for Me/ JO 2 To Tango Couples Pleasure Kit/ #LubeLife Sensations Cooling/ #LubeLife Sensations Pleasure Kit for Two

Biocompatibility studies, including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity testing were performed in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2019 as follows:

Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO 10993-10:2010)
Vaginal Irritation (ISO 10993-10:2010)
Acute Systemic Toxicity (ISO 10993-11:2017)

The results of this testing demonstrated that the subject lubricants are biocompatible.

Shelf-Life:

The subject devices are non-sterile personal lubricants with a three-year shelf-life in accordance with the results of a real time aging study. All the devices specifications listed in Table 1 were tested at 0, 1, 2 and 3 years. The subject device met the device specifications at all time points.

Condom Compatibility:

The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated that H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Conclusion:

The results of the performance testing described above demonstrate that H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling and #LubeLife Sensations Pleasure Kit for Two are safe and effective as the predicate device and supports a determination of substantial equivalence.

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.