The Bloomi Delight Oil-Based Personal Lubricant is a personal lubricant for penile and/or vaginal application, intended to lubricate, moisturize, and enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Device Description

The Bloomi Delight Oil-Based Personal Lubricant is a non-sterile, oil-based, overthe-counter use personal lubricant that is intended for penile and vaginal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is not compatible with natural rubber latex, polyurethane and polyisoprene condoms. Its formulation consists of Extra Virgin Coconut Oil, Organic Sunflower Seed Oil, Organic Cocoa Butter, Shea Butter (low melt), Sunflower Wax and Sea Buckthorn Fruit Oil. The Bloomi Delight Oil-Based Personal Lubricant is packaged in a 3 oz tube and is secondarily packaged in an outer box.

AI/ML Overview

This document is a 510(k) premarket notification for a personal lubricant, not an AI/ML medical device. Therefore, the questions related to AI/ML device acceptance criteria, study design, ground truth, and human reader performance are not applicable to the provided text.

The document discusses the substantial equivalence of “Bloomi Delight Oil-Based Personal Lubricant” to a predicate device, Astroglide O Oil Personal Lubricant & Massage Oil (K171985).

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Device Performance (Non-AI/ML)

The acceptance criteria are specifications based on the physical, chemical, and microbiological properties of the lubricant. The document states that the device met these specifications, implying performance acceptance.

Parameter	Specification (Test Method)	Reported Device Performance
Appearance	Semi-fluid	Semi-fluid
Color	Yellow	Yellow
Odor	Odorless	Odorless
Viscosity (USP<971>)	2,300-20,000 cps	Met specification
Total yeast/mold count (TYMC, USP<61>)	<10 cfu/g	<10 cfu/g
Total aerobic microbial count (TAMC, USP<61>)	<100 cfu/g	<100 cfu/g
Presence of pathogenic organisms (USP<62>, including Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans)	Absent	Absent

2. Sample Size and Data Provenance (Non-AI/ML)

The document does not specify sample sizes for the performance tests (e.g., number of batches tested for viscosity, microbial counts). The studies conducted for biocompatibility and shelf-life are typically performed in a laboratory setting. No information on country of origin or retrospective/prospective data collection is provided as this is not a clinical study in the traditional sense for an AI/ML device.

3. Number of Experts and Qualifications (Not Applicable for this Device)

These questions are not relevant as the performance evaluation for a personal lubricant involves lab-based testing against defined specifications, not expert interpretation of outputs.

4. Adjudication Method (Not Applicable for this Device)

Adjudication methods like 2+1 or 3+1 are used for consensus in reader studies, which are not applicable here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Not Applicable for this Device)

This is an AI/ML specific question and is not relevant to a personal lubricant.

6. Standalone (Algorithm Only) Performance (Not Applicable for this Device)

This is an AI/ML specific question and is not relevant to a personal lubricant.

7. Type of Ground Truth (Non-AI/ML)

The "ground truth" for this device's performance is established by objective laboratory testing against predefined chemical, physical, and microbiological specifications derived from relevant standards (e.g., USP monographs). For biocompatibility, it's based on the results of specific ISO 10993 tests.

8. Sample Size for Training Set (Not Applicable for this Device)

This is an AI/ML specific question and is not relevant to a personal lubricant.

9. How Ground Truth for Training Set was Established (Not Applicable for this Device)

This is an AI/ML specific question and is not relevant to a personal lubricant.

Summary of Non-Clinical Performance Testing (as described in the document):

Biocompatibility: Tests were performed in accordance with ISO 10993-1, including Cytotoxicity (ISO 10993-5), Guinea Pig Maximization Sensitization (ISO 10993-10), Vaginal Irritation (ISO 10993-10), and Acute Systemic Toxicity (ISO 10993-11). The results concluded the lubricant is non-cytotoxic, non-irritating, non-sensitizing, and not systemically toxic.
Shelf Life: A six-month shelf-life was established based on real-time aging testing. The device met all listed specifications (Table 1) across all time points.
Condom Compatibility: No testing was conducted, leading to the statement that the product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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.

November 15, 2022

The Bloomi, Inc. % Louie Goryoka Sr. QA/RA Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301

Re: K222175

Trade/Device Name: Bloomi Delight Oil-Based Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 28, 2022 Received: October 14, 2022

Dear Louie Goryoka:

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.

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.

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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 (QS) 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 mediation-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,

Michael T. Bailey -S

For 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222175

Device Name Bloomi Delight Oil-Based Personal Lubricant

Indications for Use (Describe)

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

Research Use (Part 21 CFR 301.Subpart D)	☑ Some Other Use (21 CFR 301.Subpart C)
------------------------------------------	-----------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary — K222175 Bloomi Delight Oil-Based Personal Lubricant

l. Submitter

Applicant:	The Bloomi, Inc.
Address:	3987 First StreetUnit KLivermore, CA 94551
Telephone:	(510)-410-5570
Contact Person:	Rebecca Story
Date Prepared:	November 10, 2022

II. Correspondent Information

Contact Person:	Louie Goryoka
Contact Title:	Sr. Regulatory/Quality Consultant
	Med-Device Consulting, Inc
Phone:	(818) 585-7488
Email:	mdci@m-dci.us

III. Device Information

Proprietary Name:	Bloomi Delight Oil-Based Personal Lubricant
Common Name:	Personal Lubricant
Regulation Name:	Condom
Regulation Number	21 CFR 884.5300
Regulatory Class:	II
Product Code:	NUC (Lubricant, Personal)

IV. Predicate Device

Predicate Device	510(k) Number
Astroglide O Oil Personal Lubricant & Massage Oil	K171985

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

V. Description of Device

The Bloomi Delight Oil-Based Personal Lubricant is a non-sterile, oil-based, overthe-counter use personal lubricant that is intended for penile and vaginal application

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to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is not compatible with natural rubber latex, polyurethane and polyisoprene condoms.

Its formulation consists of Extra Virqin Coconut Oil, Organic Sunflower Seed Oil, Organic Cocoa Butter, Shea Butter (low melt), Sunflower Wax and Sea Buckthorn Fruit Oil. The Bloomi Delight Oil-Based Personal Lubricant is packaged in a 3 oz tube and is secondarily packaged in an outer box.

Specifications for the Bloomi Delight Oil-Based Personal Lubricant are shown in Table 1.

Parameter	Specification (Test Method)
Appearance	Semi-fluid
Color	Yellow
Odor	Odorless
Viscosity (USP<971>)	2,300-20,000 cps
Total yeast/mold count (TYMC, USP<61>)	<10 cfu/g
Total aerobic microbial count(TAMC, USP <61>)	<100 cfu/g
Presence of pathogenic organisms(USP<62>, includingStaphylococcus aureus,Pseudomonas aeruginosa, andCandida albicans)	Absent

Table 1. Device Specifications

VI. Indications for Use

VII. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The following table compares the intended use and key technological characteristics of the subject and predicate device:

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Characteristic /Feature	Bloomi Delight Oil-BasedPersonal Lubricant(subject device) –K222175	Astroglide O OilPersonal Lubricant &Massage Oil (predicatedevice) – K171985	Comparison
Indication for use	The Bloomi Delight Oil-BasedPersonal Lubricant is apersonal lubricant for penileand/or vaginal application,intended to lubricate,moisturize, and enhance theease and comfort of intimatesexual activity andsupplement the body's naturallubrication. This product is notcompatible with naturalrubber latex, polyurethane,and polyisoprene condoms.	Astroglide O Oil PersonalLubricant & Massage Oil is apersonal lubricant for penileand/or vaginal application,intended to moisturize andlubricate, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is not compatible withcondoms.	Same intended use.
Oil-BasedLubricant	Yes	Yes	Same
Contains water	No	No	Same
Over the Counter	Yes	Yes	Same
Not acontraceptive orSpermicide	Yes	Yes	Same
Non-sterile	Yes	Yes	Same
PrimaryIngredients	Extra Virgin Coconut Oil,Organic Sunflower SeedOil, Organic CocoaButter, Shea Butter (lowmelt), Sunflower Wax,Sea Buckthorn Fruit Oil	Helianthus Annuus(Sunflower) Seed Oil,Ricinus Communis(Castor) Seed Oil, CocosNucifera (Coconut) Oil,Prunus AmygdalusDulcis (Sweet Almond)Oil, SimmondsiaChinesis (Jojoba) SeedOil, Argania SpinosaKernel (Argan Tree Nut)Oil, Tocopherol,Cananga Odorata (YlangYlang) Flower Oil	Different
Appearance/Color	Semi-fluid, yellow	Clear, light yellow	Different
Odor	Odorless	Coconut and ylang-ylang	Different
Microbial Limits	Total mold/yeast count <10 cfu/g	Total mold/yeast count <10 cfu/mL	Different
	Total aerobic microbial count <100 cfu/g	Total aerobic microbial count <10 cfu/mL
	Absence of pathogens (including Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus)	Absence of pathogens (including Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus)
Viscosity	2,300-20,000 cps	60-120 cps	Different
CondomCompatibility	Not compatible with condoms	Not compatible with condoms	Same

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The subject and predicate devices have similar indications for use and have the same intended use – to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations, device specifications, odor, viscosity, etc. The different technological characteristics do not raise different questions of safety and effectiveness.

VIII.Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 FDA quidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process." The following testing was conducted:

Cytotoxicity (ISO 10993-5:2009/(R)2014) ●
Guinea Piq Maximization Sensitization (ISO 10993-10:2010/(R)2014) ●
Vaginal Irritation (ISO 10993-10:2010/(R)2014) ●
Acute Systemic Toxicity (ISO 10993-11:2017) ●

The results of this testing demonstrate that the subject lubricant is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic.

Shelf Life

The subject device has a shelf-life of six months based on the results of real-time aging testing. The device specifications listed in Table 1 were tested across the device shelflife and the subject device met the specifications at all time points.

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Condom Compatibility

Condom compatibility testing was not conducted for the subject device. Therefore, Bloomi Delight Oil-Based Personal Lubricant is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

IX. Conclusion

The results of the testing described above demonstrate that Bloomi Delight Oil-Based Personal Lubricant is as 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.