(117 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biocompatibility of a personal lubricant, with no mention of AI or ML technology.
No.
The device is a personal lubricant intended to enhance the ease and comfort of intimate sexual activity, not to treat or cure a medical condition.
No
The device is a personal lubricant intended to enhance comfort during intimate sexual activity, not to diagnose medical conditions.
No
The device is a physical product (oil-based lubricant) and the description focuses on its chemical composition, packaging, and biocompatibility testing, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal lubrication during sexual activity, applied directly to the body (penile and/or vaginal).
- Device Description: The description confirms it's a personal lubricant for topical application.
- Lack of In Vitro Testing: The description of performance studies focuses on biocompatibility and shelf life, not on testing biological samples in vitro (outside the body) to diagnose or monitor a condition.
- No Mention of Biological Samples: There is no indication that this device is used to analyze blood, urine, tissue, or any other biological sample.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This personal lubricant does not fit that definition.
N/A
Intended Use / Indications for Use
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.
Product codes
NUC
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Penile and/or vaginal application
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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)
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.
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 Street |
| Unit K | |
| Livermore, 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) | 2,300-20,000 cps |
| Total yeast/mold count (TYMC, USP) | ) |
| Staphylococcus aureus, | |
| Pseudomonas aeruginosa, and | |
| Candida albicans) | Absent |
Table 1. Device Specifications
VI. Indications for Use
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.
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-Based
Personal Lubricant
(subject device) –
K222175 | Astroglide O Oil
Personal Lubricant &
Massage Oil (predicate
device) – K171985 | Comparison |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Indication for use | 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. | Astroglide O Oil Personal
Lubricant & Massage Oil is a
personal lubricant 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 not compatible with
condoms. | Same intended use. |
| Oil-Based
Lubricant | Yes | Yes | Same |
| Contains water | No | No | Same |
| Over the Counter | Yes | Yes | Same |
| Not a
contraceptive or
Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary
Ingredients | Extra Virgin Coconut Oil,
Organic Sunflower Seed
Oil, Organic Cocoa
Butter, Shea Butter (low
melt), Sunflower Wax,
Sea Buckthorn Fruit Oil | Helianthus Annuus
(Sunflower) Seed Oil,
Ricinus Communis
(Castor) Seed Oil, Cocos
Nucifera (Coconut) Oil,
Prunus Amygdalus
Dulcis (Sweet Almond)
Oil, Simmondsia
Chinesis (Jojoba) Seed
Oil, Argania Spinosa
Kernel (Argan Tree Nut)
Oil, Tocopherol,
Cananga Odorata (Ylang
Ylang) 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