Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical composition, biocompatibility, and physical properties of a personal lubricant, with no mention of AI or ML technology.

Therapeutic

No
The device is a personal lubricant intended to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity, which is not considered a therapeutic function.

Diagnostic

No.
The device is a personal lubricant intended to moisturize and lubricate for comfort during sexual activity, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states the product is a lubricant with a specific chemical formulation and is packaged in plastic tubes with a plastic applicator, indicating it is a physical product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as a personal lubricant for penile and/or vaginal application to moisturize and lubricate for intimate sexual activity. This is a topical application for physical lubrication, not for testing or diagnosing a condition in vitro (outside the body).
Device Description: The description details the physical properties and ingredients of a lubricant. There is no mention of components designed to interact with biological samples (like blood, urine, tissue) for diagnostic purposes.
Lack of Diagnostic Function: The document does not describe any function related to detecting, measuring, or analyzing substances in biological samples to provide diagnostic information.
Performance Studies: The performance studies focus on biocompatibility, condom compatibility, and shelf life, which are relevant for a personal lubricant, not an IVD.
Predicate Device: The predicate device is another personal lubricant (Hyalo Gyn Personal Lubricant), further indicating that this device falls under the category of personal lubricants, not IVDs.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

BioNourish Lubricant 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Product codes (comma separated list FDA assigned to the subject device)

NUC

Device Description

BioNourish Lubricant is a personal lubricant that is non-sterile, contains hyaluronic acid, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethylcellulose, hyaluronic acid, carrageenan, sodium chloride, xanthan gum, lactic acid, potassium sorbate, sodium benzoate, ceratonia siliqua (carob) gum, and calcium chloride. BioNourish is packaged in 2 fl. oz plastic tubes. The device is packaged with a low-density polyethylene (LDPE) applicator. BioNourish lubricant is a personal lubricant for over-the-counter (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

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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: BioNourish Lubricant has undergone biocompatibility testing in accordance with the 2016 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." Testing included:

Cytotoxicity per ISO 10993-5: 2009
Sensitization and Irritation testing using the human repeat insult patch testing, an alternative test method to ISO 10993-10:2010
Acute systemic toxicity testing per ISO 10993-11:2017.
The testing demonstrate that BioNourish Lubricant is non-cytotoxic, non-sensitizing, non-irritating, and not acutely-systemically toxic.

Condom Compatibility: The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and was determined to be compatible with natural rubber latex and polyisoprene condoms. The subject device was determined not to be compatible with polvurethane condoms.

Shelf Life: BioNourish Lubricant has a 1-year shelf life in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of its shelf life.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K094039

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

March 12, 2020

Good Clean Love, Inc. % Abhishek Gurnani Partner Amin Talati Wasserman, LLP 100 South Wacker Drive, Suite 2000 Chicago, IL 60606

Re: K193448 Trade/Device Name: BioNourish Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 11, 2019 Received: December 13, 2019

Dear Abhishek Gurnani:

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 control's 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. You must comply with all the Act's

1

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-regulatory-information/postmarketing-safety-reportingcombination-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,

For Sharon M. Andrews 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) K193448

Device Name BioNourish Lubricant

Indications for Use (Describe)

BioNourish Lubricant 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Type of Use (Select one or both, as applicable)
Production Use (21 CFR 201. Select Program)	On-The-Contract Use (21 CFR 201. Select Contract)

__ 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 - K193448

| Submitter/Owner: | Good Clean Love, Inc.
207 West 5th Avenue
Eugene, OR 97401
Contact: Wendy Strgar
Phone: 541-344-4483
Fax: 541-685-1335
Email: wendy@goodcleanlove.com |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparer/Contact: | Abhishek K. Gurnani
Amin Talati Wasserman, LLP
100 South Wacker Drive, Suite 2000
Chicago, IL 60606
Phone: 312-327-3325
Fax: 312-884-7352
Email: Abhishek@AminTalati.com |
| | |
| Summary Prepared: | March 10, 2020 |
| Trade Name: | BioNourish Lubricant |
| Common Name: | Personal Lubricant |
| Regulation Number: | 21 CFR 884.5300 |
| Regulatory Name: | Condom |
| Regulatory Class: | Class II |
| Product Code: | NUC (lubricant, personal) |

Identification of Predicate Device: Hyalo Gyn Personal Lubricant (K094039)

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

Device Description: BioNourish Lubricant is a personal lubricant that is non-sterile, contains hyaluronic acid, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethylcellulose, hyaluronic acid, carrageenan, sodium chloride, xanthan gum, lactic acid, potassium sorbate, sodium benzoate, ceratonia siliqua (carob) gum, and calcium

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chloride. BioNourish is packaged in 2 fl. oz plastic tubes. The device is packaged with a low-density polyethylene (LDPE) applicator. BioNourish lubricant is a personal lubricant for over-the-counter (OTC) use.

Device specifications are listed in Table 1 below.

			Table 1: Subject Device Specifications
--	--	--	----------------------------------------

Property	Specification
Appearance	Clear and transparent
Odor	Characteristic
Viscosity	5,000 – 28,000 cps
Osmolality	250 – 400 mOsm/kg
pH at 25 °C	3.8-4.2
Total Aerobic Microbial Count (USP
)	)
Absence of Pathogenic Organisms (USP
)
	Pseudomonas aeruginosa
Staphylococcus aureus	Absent
Candida albicans	Absent
Escherichia coli, Salmonella, Clostridium
Species	Absent
	Antimicrobial Effectiveness (USP)
initial count at 14 days and no increase
from the 14-day count at 28 days for
bacteria and no increase from the initial
calculated count at 14 and 28 days for
yeasts/molds.

Indications for Use Statement: BioNourish Lubricant 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

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	K193448	K094039	Comparison
	Subject Device	Predicate
Sponsor	BioNourish Lubricant	Hyalo Gyn Personal
Lubricant
Regulation
Number
Product Code
Device Class	844.5300
NUC
II	844.5300
NUC
II
Indications for
Use	BioNourish Lubricant
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
compatible with
natural rubber latex
and polyisoprene
condoms. This product
is not compatible with
polyurethane condoms.	Hyalo gyn is a personal
lubricant for penile and
/or vaginal application
intended to moisture and
lubricate, to enhance the
ease and comfort of
intimate sexual activity
and supplement the body's
natural lubricant. This
product is compatible
with condoms;
lubricated/nonlubricated
latex, lubricated
polyurethane, lubricated
natural skin.	Similar
Physical	Clear liquid	Clear liquid	Same
Water-based	Yes	Yes	Same
Primary
Ingredients	Water,
Hydroxyethylcellulose,
Hyaluronic Acid,
Carrageenan, Sodium
Chloride, Lactic Acid,
Potassium Sorbate,
Sodium Benzoate,
Ceratonia Siliqua
(Carob) Gum,
Xanthan Gum, and
Calcium Chloride	Water, Hydeal-D,
Propylene Glycol,
Carbomer, Methyl p-
hydroxybenzoate, Propyl
p-hydroxybenzoate,
Sodium Hydroxide	Different: The subject and
predicate devices have
differences in ingredients.
These differences do not
raise different questions of
safety and effectiveness
(S&E).
pH	3.8-4.2	5.5-6.5	Different: The subject
device has a lower pH than
the predicate. This
difference does not raise
different questions of S&E.
Osmolality	250-400 mOsm/kg	Not known	Different: The osmolality of
the predicate device is not
known. This difference does
not raise different questions
of S&E. Additionally, the
osmolality of the subject
device is comparable to other
cleared personal lubricant
products.
Viscosity	5,000-28,000 cps	Not known	Different: The viscosity of
the predicate device is not
known. This difference does
not raise different questions
of S&E.
Sterile	No	No	Same
Condom
Compatibility	Natural Rubber Latex
and Polyisoprene	Natural Rubber Latex,
Polyurethane, and Natural
Skin Condoms	Different: The subject and
predicate devices have
differences in condom
compatibility. This
difference does not raise
different questions of S&E.
Biocompatibility
Tested	Yes	Yes	Same
Antimicrobial
Tested	Yes	Yes	Same
Shelf-Life	One year	Three years	Different: This difference
does not raise different
questions of S&E.

Table 2. Technological Characteristics of BioNourish as Compared to the Predicate

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The subject and predicate devices have similar indications for use statements and the same intended use (i.e., lubrication during intimate sexual activity). As noted in the table above, the subject and predicate device have different technological characteristics, including differences in formulations, specifications, condom compatibility and shelf-life. The differences in technological characteristics between the subject and predicate device do not

7

raise different questions of safety and effectiveness.

Summary of Performance Data

Biocompatibility: BioNourish Lubricant has undergone biocompatibility testing in accordance with the 2016 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." Testing included:

Cytotoxicity per ISO 10993-5: 2009 ●
Sensitization and Irritation testing using the human repeat insult patch testing, an . alternative test method to ISO 10993-10:2010
Acute systemic toxicity testing per ISO 10993-11:2017. ●

The testing demonstrate that BioNourish Lubricant is non-cytotoxic, non-sensitizing, non-irritating, and not acutely-systemically toxic.

Condom Compatibility: The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and was determined to be compatible with natural rubber latex and polyisoprene condoms. The subject device was determined not to be compatible with polvurethane condoms.

Shelf Life: BioNourish Lubricant has a 1-year shelf life in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of its shelf life.

Conclusion: The results of the performance testing described above demonstrate that the BioNourish Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence