(90 days)
Not Found
No
The device is a personal lubricant with a simple chemical formulation and no mention of any computational or analytical capabilities.
No.
The intended use is to lubricate and moisturize to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication, which is not a therapeutic purpose.
No
The device is a personal lubricant intended to enhance comfort during sexual activity, not to diagnose any medical condition.
No
The device description clearly states it is a physical product (a lubricant) with a specific formulation and packaging, not a software application.
Based on the provided information, the Bloomi Smooth Water Based Personal Lubricant is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for penile and/or vaginal application to lubricate and moisturize, enhance sexual activity, and supplement natural lubrication. This is a topical application for physical comfort and function, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description details a personal lubricant with specific ingredients and packaging. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies focus on biocompatibility, shelf life, and condom compatibility. These are relevant to a personal lubricant's safety and effectiveness for its intended use, but not to diagnostic performance.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, the Bloomi Smooth Water Based Personal Lubricant is a medical device intended for topical application to facilitate sexual activity, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Bloomi Smooth Water Based Personal Lubricant is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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 polvurethane condoms.
Product codes
NUC
Device Description
The Bloomi Smooth Water Based Personal Lubricant is a non-sterile, water-based 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. Its formulation consists of Water, Hydroxyethylcellulose, Microcare SB (water, sodium benzoate, potassium sorbate), Activsoft S (Cyamopsis Tetragonoloba (Guar) Gum), Citric Acid, Sodium Hyaluronate, Organic Sunflower Extract, Organic Green Tea Extract (Organic Camellia Sinensis Leaf (Green Tea) Extract). The Bloomi Smooth Water Based Personal Lubricant is packaged in a MDPE (medium density polyethylene) 3 oz tube, packaged in an outer box for OTC use.
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
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" and ISO 10993-1:2009.
- Cytotoxicity (ISO 10993-5:2009/(R)2014): The results demonstrate that the subject lubricant is non-cytotoxic.
- Guinea Piq Maximization Sensitization (ISO 10993-10:2010/(R)2014): The results demonstrate that the subject lubricant is non-sensitizinq.
- Vaqinal Irritation (ISO 10993-10:2010/(R)2014): The results demonstrate that the subject lubricant is non-irritating.
- Acute Systemic Toxicity (ISO 10993-11:2017): The results demonstrate that the subject lubricant is not systemically toxic.
Shelf Life: An accelerated aging study was conducted for 3 months at 40°C per ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points, supporting a 8.5-month shelf-life.
Condom Compatibility: Bloomi Smooth Water Based Personal Lubricant was tested for compatibility with natural rubber latex, polyisoprene, and polyurethane condoms using ASTM D7661-18, Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results show that Bloomi Smooth Water Based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. Bloomi Smooth Water Based Personal Lubricant is not compatible with polyurethane condoms.
Key Metrics
- Absence of particulate matter: Clear viscous liquid
- Color: Off-white
- Odor: None
- Viscosity: 1,800 - 4,500 cps
- Osmolality: 110 - 140 mOsm/kg
- pH: 4.0 - 5.0
- Total yeast/mold count (TYMC): )
- Total aerobic microbial count (TAMC): )
- Presence of pathogenic organisms (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans): Absent (USP)
- Antimicrobial effectiveness: Meets USP acceptance criteria for Category 2 products.
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.
0
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.
August 4, 2022
The Bloomi, Inc. % Louie Goryoka Sr. QA/RA Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301
Re: K221328
Trade/Device Name: Bloomi Smooth Water Based Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 3, 2022 Received: May 6, 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.
1
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,
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
2
Indications for Use
510(k) Number (if known) K221328
Device Name Bloomi Smooth Water Based Personal Lubricant
Indications for Use (Describe)
The Bloomi Smooth Water Based Personal Lubricant is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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 polvurethane condoms.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K221328 Bloomi Smooth Water Based Personal Lubricant
l. General Information on Submitter
| Applicant: | The Bloomi, Inc. |
|---|---|
| Address: | 71 Royal ridge court, California, |
| 94507 USA | |
| Telephone: | (510) 410-5570 |
| Contact Person: | Louie Goryoka |
| Contact Title: | Sr. Regulatory/Quality Consultant |
| Med-Device Consulting, Inc. | |
| Email: | ndci@m-dci.us |
| Date Prepared: | July 27, 2022 |
II. General Information on Device
| Proprietary Name: | Bloomi Smooth Water Based Personal Lubricant |
|---|---|
| Common Name: | Personal Lubricant |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Regulatory Class: | II |
| Product Code: | NUC (Lubricant, Personal) |
lll. Predicate Device
| Predicate Device | 510(k) Number |
|---|---|
| The Sex Gel Personal Lubricant | K181078 |
This predicate device has never been the subject of a device recall.
IV. Description of Device
The Bloomi Smooth Water Based Personal Lubricant is a non-sterile, water-based 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. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
4
Its formulation consists of Water, Hydroxyethylcellulose, Microcare SB (water, sodium benzoate, potassium sorbate), Activsoft S (Cyamopsis Tetragonoloba (Guar) Gum), Citric Acid, Sodium Hyaluronate, Organic Sunflower Extract, Organic Green Tea Extract (Organic Camellia Sinensis Leaf (Green Tea) Extract).
The Bloomi Smooth Water Based Personal Lubricant is packaged in a MDPE (medium density polyethylene) 3 oz tube, packaged in an outer box for OTC use.
The specifications for Bloomi Smooth Water Based Personal Lubricant are described in Table 1.
| Parameter | Specification (Test Method) |
|---|---|
| Absence of particulate matter | Clear viscous liquid |
| Color | Off-white |
| Odor | None |
| Viscosity | 1,800 - 4,500 cps |
| Osmolality | 110 - 140 mOsm/kg |
| pH | 4.0 - 5.0 |
| Total yeast/mold count (TYMC) | ) |
| Total aerobic microbial count | |
| (TAMC) | ) |
| Presence of pathogenic organisms | |
| ( Staphylococcus aureus , | |
| Pseudomonas aeruginosa , and | |
| Candida albicans ) | Absent (USP) |
| Antimicrobial effectiveness | Meets USP acceptance criteria for |
| Category 2 products. |
Table 1. Device Specifications
V. Indications for Use
Bloomi Smooth Water Based Personal Lubricant is a water-based personal lubricant for penile and/or vaginal application, intended lubricate and moisturize, 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.
VI. Substantial Equivalence Discussion
The following table compares the intended use and kev technological characteristics of the subject and predicate device:
5
| Characteristic /
Feature | Bloomi Smooth Water
Based Personal
Lubricant (subject
device) | The Sex Gel Personal
Lubricant (predicate
device) - K181078 | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Bloomi Smooth Water Based
Personal Lubricant is a water-
based personal lubricant for
penile and/or vaginal
application, intended to
lubricate and moisturize,
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. | 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 compatible with
natural rubber latex and
polyisoprene and polyurethane
condoms. | Similar: The subject and
predicate devices have
similar indications for use,
with the exception of
condom compatibility
statement, and they have
the same intended use. |
| Water-Based
Lubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Not a
contraceptive or
Spermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| Primary
Ingredients | Water, Microcare SB,
Microcare SB,
Hydroxyethylcellulose,
Cyamopsis Tetragonoloba
(Guar) Gum, Citric Acid,
Sodium Hyaluronate, Organic
Helianthus (Sunflower) Seed
Extract, Organic Camellia
Sinensis Leaf (Green Tea)
Extract. | Water, aloe barbadensis
leaf juice, sorbitol,
hydroxyethylcellulose,
allantoin, lactic acid /
tocopherols
(vitamin E), sodium
hyaluronate,
sodium benzoate &
potassium sorbate | Different |
| Microbial Limits | Total mold/yeast count