(90 days)
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 polyurethane condoms.
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.
This document describes the acceptance criteria and the studies performed to demonstrate that the Bloomi Smooth Water Based Personal Lubricant meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance (Test Method) |
|---|---|---|
| Absence of particulate matter | Clear viscous liquid | Clear viscous liquid |
| Color | Off-white | Off-white |
| Odor | None | None |
| Viscosity | 1,800 - 4,500 cps | Within specification (1,800 - 4,500 cps) |
| Osmolality | 110 - 140 mOsm/kg | Within specification (110 - 140 mOsm/kg) |
| pH | 4.0 - 5.0 | Within specification (4.0 - 5.0) |
| Total yeast/mold count (TYMC) | <10 cfu/mL (USP <61>) | <10 cfu/mL |
| Total aerobic microbial count (TAMC) | <100 cfu/mL (USP <61>) | <100 cfu/mL |
| Presence of pathogenic organisms (Staphylococcus aureus,Pseudomonas aeruginosa, andCandida albicans) | Absent (USP<62>) | Absent |
| Antimicrobial effectiveness | Meets USP<51> acceptance criteria for Category 2 products. | Meets USP<51> acceptance criteria for Category 2 products. |
| Biocompatibility | ||
| Cytotoxicity | Non-cytotoxic (ISO 10993-5:2009/(R)2014) | Non-cytotoxic |
| Sensitization | Non-sensitizing (ISO 10993-10:2010/(R)2014) | Non-sensitizing |
| Vaginal Irritation | Non-irritating (ISO 10993-10:2010/(R)2014) | Non-irritating |
| Acute Systemic Toxicity | Not systemically toxic (ISO 10993-11:2017) | Not systemically toxic |
| Condom Compatibility | ||
| Natural rubber latex condoms | Compatible (ASTM D7661-18) | Compatible |
| Polyisoprene condoms | Compatible (ASTM D7661-18) | Compatible |
| Polyurethane condoms | Not compatible (ASTM D7661-18) | Not compatible |
| Shelf Life | ||
| Maintenance of device specifications | Meets specifications across shelf-life | Met specifications at all time points, supporting 8.5-month shelf-life |
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for each specific test within the non-clinical performance evaluations (Biocompatibility, Shelf Life, Condom Compatibility). The data provenance is derived from these non-clinical performance studies conducted on the device itself. The studies appear to be prospective, as they were carried out to demonstrate the device's characteristics for regulatory submission. There is no indication of country of origin of the data beyond the standards used (ISO, USP, ASTM).
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable. The device is a personal lubricant, and the evaluations performed are non-clinical (laboratory and in-vitro testing). Therefore, there is no "ground truth" established by human experts in the context of clinical interpretation, like radiologists or pathologists. The ground truth for these tests is based on established scientific and regulatory standards (e.g., ISO, USP, ASTM methods) and objective measurements.
4. Adjudication Method for Test Set
This information is not applicable. As explained above, the tests are non-clinical, objective measurements based on established protocols, not subjective human interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or other data, and the AI's assistance is evaluated. This is not relevant for a personal lubricant.
6. Standalone Performance (Algorithm Only)
This information is not applicable. The device is a physical product (personal lubricant), not an algorithm or AI system. Therefore, the concept of "standalone performance" without human-in-the-loop is not relevant.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance testing (biocompatibility, shelf life, condom compatibility) is based on:
- Established scientific and regulatory standards: ISO 10993 series for biocompatibility, USP <61>, <62>, <51> for microbial limits and antimicrobial effectiveness, and ASTM D7661-18 for condom compatibility.
- Objective laboratory measurements: Viscosity, Osmolality, pH, microbial counts, etc.
- Defined acceptance criteria: These criteria are based on scientific understanding and regulatory expectations for the safety and performance of personal lubricants.
8. Sample Size for the Training Set
This information is not applicable. As the device is a personal lubricant and not an AI/ML algorithm, there is no "training set." The product's formulation and manufacturing processes are developed and refined based on general scientific principles and quality control measures, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device.
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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.
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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,
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) 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 ConsultantMed-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.
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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) | <10 cfu/mL (USP <61>) |
| Total aerobic microbial count(TAMC) | <100 cfu/mL (USP <61>) |
| Presence of pathogenic organisms( Staphylococcus aureus ,Pseudomonas aeruginosa , andCandida albicans ) | Absent (USP<62>) |
| Antimicrobial effectiveness | Meets USP<51> acceptance criteria forCategory 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:
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| Characteristic /Feature | Bloomi Smooth WaterBased PersonalLubricant (subjectdevice) | The Sex Gel PersonalLubricant (predicatedevice) - K181078 | Comparison |
|---|---|---|---|
| Indication for use | Bloomi Smooth Water BasedPersonal Lubricant is a water-based personal lubricant forpenile and/or vaginalapplication, intended tolubricate and moisturize,enhance the ease and comfortof intimate sexual activity andsupplement the body's natural lubrication. This product iscompatible with natural rubberlatex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms. | Personal 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 compatible withnatural rubber latex andpolyisoprene and polyurethanecondoms. | Similar: The subject andpredicate devices havesimilar indications for use,with the exception ofcondom compatibilitystatement, and they havethe same intended use. |
| Water-BasedLubricant | Yes | Yes | Same |
| Over the Counter | Yes | Yes | Same |
| Not acontraceptive orSpermicide | Yes | Yes | Same |
| Non-sterile | Yes | Yes | Same |
| PrimaryIngredients | Water, Microcare SB,Microcare SB,Hydroxyethylcellulose,Cyamopsis Tetragonoloba(Guar) Gum, Citric Acid,Sodium Hyaluronate, OrganicHelianthus (Sunflower) SeedExtract, Organic CamelliaSinensis Leaf (Green Tea)Extract. | Water, aloe barbadensisleaf juice, sorbitol,hydroxyethylcellulose,allantoin, lactic acid /tocopherols(vitamin E), sodiumhyaluronate,sodium benzoate &potassium sorbate | Different |
| Microbial Limits | Total mold/yeast count <10cfu/mLTotal aerobic microbial count<100 cfu/mLAbsence of pathogens(Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus) | Total mold/yeast count <10cfu/mLTotal aerobic microbial count<100 cfu/mLAbsence of pathogens(Candida albicans,Pseudomonas aeruginosa,Staphylococcus aureus) | Different |
| Viscosity | 1,800-4,500 cps | 3,000-5,000 cps | Different |
| Osmolality | 110-140 mOsm/kg | 435-535 mOsm/kg | Different |
| pH | 4.0-5.0 | 4.0-5.0 | 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 and device specifications. The different technological characteristics do not raise different types of safety and effectiveness questions.
VII. 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" and ISO 10993-1:2009 as follows:
- . Cytotoxicity (ISO 10993-5:2009/(R)2014)
- Guinea Piq Maximization Sensitization (ISO 10993-10:2010/(R)2014) .
- Vaqinal 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-sensitizinq, and not systemically toxic.
Shelf Life
The subject device is a non-sterile personal lubricant packaged in a 3 oz. tube with a 8.5-month shelf-life in accordance with the results of an accelerated aging study. 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.
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.
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VIII. Conclusion
The results of the testing described above demonstrate that Bloomi Smooth Water Based Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.