Sage 2-in-1 Personal Lubricant and Moisturizer is 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms

Device Description

Sage 2-in-1 Personal Lubricant and Moisturizer™ is a non-sterile, water-soluble personal lubricant for over-the-counter (OTC) use. The lubricant will be provided in a 1.6 oz tube and will also be supplied with a low-density polyethylene applicator.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a medical device called "Sage 2-in-1 Personal Lubricant and Moisturizer™". It asserts substantial equivalence to a predicate device, which inherently means it meets the same safety and effectiveness standards, rather than defining novel acceptance criteria or conducting a comparative effectiveness study.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sage 2-in-1 Personal Lubricant and Moisturizer™ are primarily based on established standards and physical/chemical properties, as well as biological safety. The "reported device performance" is essentially that the device met these specifications.

Parameter	Test Method	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Visual inspection	Opaque Gel	Met (Implied by FDA clearance)
Odor	Odor via smell of gel	Slight rose and sage odor	Met (Implied by FDA clearance)
pH	USP <791>	4.25-5.5	Met (Implied by FDA clearance)
Viscosity	USP <91>	3000-12000cps	Met (Implied by FDA clearance)
Osmolality	USP <785>	240-370 mOsmo/kg	Met (Implied by FDA clearance)
Antimicrobial Effectiveness	USP <51>	Bacteria: Not less than 2.0 log reduction from the initial count at 14 days, and no increase from the 14 days' count at 28 days Yeast and Molds: No increase at 14 and 28 relative to initial count.	Met (Implied by FDA clearance)
Total Aerobic Microbial Count (TAMC)	USP <61>	< 100 cfu/ml	Met (Implied by FDA clearance)
Total Fungal/Yeast/Mold Limits (TYMC)	USP <61>	< 10 cfu/ml	Met (Implied by FDA clearance)
Absence of Pathogenic Organisms (P.aeruginosa, S. aureys, E. Coli, Salmonella sp., C. albicans)	USP <62>	Absent	Met (Implied by FDA clearance)
Biocompatibility:
- Cytotoxicity	ISO 10993-5:2009	Compliant	Met (Implied by FDA clearance)
- Sensitization	ISO 10993-10:2010	Compliant	Met (Implied by FDA clearance)
- Vaginal Irritation	ISO 10993-10:2010	Compliant	Met (Implied by FDA clearance)
- Acute Systemic Toxicity (lubricant only)	ISO 10993-11:2006	Compliant	Met (Implied by FDA clearance)
Condom Compatibility	ASTM D7661-10	Compatible with natural rubber latex condoms. Not compatible with polyisoprene and polyurethane condoms.	Met (Confimed compatibility with natural rubber latex)
Shelf-Life	Accelerated aging study	All device specifications met at timepoints assessed (equivalent to 0-16 months of real-time aging).	16 months (accelerated aging study results met all specs)

2. Sample Size for the Test Set and Data Provenance

This document describes a 510(k) submission, which relies on non-clinical performance testing rather than a clinical "test set" in the sense of patient data for algorithm evaluation.

Sample Size: Not explicitly stated as a single "test set" in the context of device performance in humans.
- For biocompatibility tests (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity), these are typically performed on in vitro models or animal models. The exact number of samples or animals is not specified in this summary.
- For condom compatibility, the standard ASTM D7661-10 would specify the number of condoms and lubricant samples tested. This information is not provided in detail.
- For shelf-life, samples of the product would be subjected to accelerated aging conditions. The number of samples is not specified.
- For physical/chemical/microbiological tests, these are typically performed on batches of the manufactured product. The exact number of samples per test is not detailed.
Data Provenance: The tests are standard laboratory tests (e.g., USP, ISO, ASTM standards). The data would be generated in a laboratory setting, likely in the country where Fairhaven Health, LLC operates (USA), and would be considered prospective data for the purpose of validating the manufacturing and product characteristics. It is not patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable in the context of this 510(k) submission. "Ground truth" established by experts typically refers to clinical diagnosis or evaluation from medical images/records, which is not part of this device's validation. The "ground truth" here is adherence to scientific standards and specifications, which are validated by laboratory personnel qualified in their respective testing domains (e.g., microbiology, chemistry, toxicology).

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human readers or expert consensus on clinical findings. The "adjudication" (or rather, verification) is through the test methods themselves and their interpretation by trained laboratory personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not describe a MRMC comparative effectiveness study. It is a 510(k) for a personal lubricant, which does not involve human readers evaluating cases or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This device is a personal lubricant, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

Established scientific standards and specifications: (e.g., USP <791> for pH, ISO 10993 for biocompatibility, ASTM D7661-10 for condom compatibility).
Laboratory measurements and observations: Direct measurements of physical, chemical, and microbiological properties.
Safety assessment: Demonstrating non-toxicity, non-irritancy, and non-sensitization based on biocompatibility standards.
The overall "ground truth" for a 510(k) submission is that the device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model that requires a training set. The "training set" concept does not apply to the validation of a personal lubricant.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary

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July 16, 2019

Fairhaven Health, LLC Suzanne Munson VP of Product Development/Compliance 1410 11th St Bellingham, WA 98225

Re: K190150

Trade/Device Name: Sage 2-in-1 Personal Lubricant and Moisturizer™ Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 6, 2019 Received: June 17, 2019

Dear Suzanne Munson:

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. You must comply with all the Act's

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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 Andrews Assistant Division 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) K190150

Device Name

Sage 2-in-1 Personal Lubricant and Moisturizer™

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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| | 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 - K190150 Sage 2-in-1 Personal Lubricant and Moisturizer™

Submitter:

Applicant:	Fairhaven Health, LLC1410 11th StreetBellingham, WA 98225
Telephone:Email:Contact Person:	360-543-7888suzanne@fairhavenhealth.comSuzanne Munson
Date Prepared:	July 15, 2019

Device Information:

Device Name	Sage 2-in-1 Personal Lubricant and MoisturizerTM
Common Name:	Personal Lubricant
Regulation Number:	21 CFR 884.5300
Regulation Name:	Condom
Product Code:	NUC (Lubricant, Personal)
Regulatory Class:	II

Predicate Devices

Good Clean Love Bio-pHresh (K162207) manufactured by Good Clean Love, Inc Eugene, OR.

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

Indications for Use

Description of Device

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Parameter	Test Method	Specification
Appearance	Visualinspection	Opaque Gel
Odor	Odor viasmell of gel	Slight rose and sage odor
pH	USP <791>	4.25-5.5
Viscosity	USP <91>	3000-12000cps
Osmolality	USP <785>	240-370 mOsmo/kg
Antimicrobial Effectiveness	USP <51>	Bacteria: Not less than 2.0log reduction from theinitial count at 14 days,and no increasefrom the 14 days' count at28 daysYeast and Molds: Noincrease at 14 and 28relative to initial count.
Total Aerobic Microbial Count(TAMC)	USP <61>	< 100 cfu/ml
Total Fungal/Yeast/Mold Limits(TYMC)	USP <61>	< 10 cfu/ml
Absence of PathogenicOrganisms (P.aeruginosa, S.aureus, E. Coli,Salmonella sp., C. albicans)	USP <62>	Absent

Summary of technological characteristics compared to predicate device:

Subject &PredicateDevices:	K190150Subject Device	K162207Predicate Device
General DeviceCharacteristics
PersonalLubricant
Sponsor	Fairhaven Health LLC	Good Clean Love
Indication forUse Statement	Sage 2-in-1 Personal Lubricant andMoisturizer is for penile and/orvaginal application, intended tomoisturize and lubricate, to enhancethe ease and comfort of intimatesexual activity and supplement thebody's natural lubrication. Thisproduct is compatible with naturalrubber latex condoms. This productis not compatible with polyisoprene	Good Clean Love BIO-pHRESH is a personallubricant for penile and/orvaginal applicationintended to moisturize andlubricate, to enhance the easeand comfort of intimate sexualactivity and supplement thebody's natural lubrication. Thisproduct is compatible with
	or polyurethane condoms.	natural rubber latex andpolyisoprene condoms. It isnot compatible withpolyurethane condoms
RegulationNumberProduct CodeDevice Class	884.5300	884.5300
CondomCompatibility	Natural rubber latex	Natural rubber latex andpolyisoprene
Base Type	Water based	Aloe vera (water based)
Formulation	Purified WaterHypromellose (HPMC)Carbomerhomopolymer type bPhenethyl alcoholCaprylyl glycolSalvia SclareaSodium ChlorideL-Lactic Acidd-XyloseSodium HydroxideMonobasic Sodium PhosphateanhydrousPotassium Phosphate anhydrous	Aloe VeraXanthanPotassium SorbateSodium Benzonate
Characteristics
pH	4.25-5.5	-
Viscosity	3000-12000 Cps	-
Osmolality	240-370 mOsm/kg	-
AntimicrobialEffectiveness	Bacteria: Not less than 2.0 logreduction from the initial countat 14 days, and no increasefrom the 14 days' count at 28daysYeasts and Mold: No increase at 14and 28 relative to initial count.	Category 2 (Products formucosal application). Bacteria>=2.0 log reduction at day 14relative to initial count. Noincrease at day 28 relative today-14 count. Yeasts andMold: No increase at 14 and28 relative to initial count.
Total MicrobialCount	< 100 cfu/g	<10 cfu/g
Fungal/Yeast/Mold Limits	<10 cfu/g	< 10 cfu/g
Absence ofPathogenicOrganisms	Absent	Absent
Applicator	Yes	Yes

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The subject and predicate devices have same indications for use statements with the exception of the types of condoms they are compatible with. The difference in condom compatibility type do not impact the overall intended use of these devices, which is the same (i.e., lubrication during intimate sexual activity).

The subject and predicate devices have similar technological characteristics (e.g., base type, osmolality, packaging, etc.); however, differences in specifications and formulation exist.

The differences in technological characteristics described above between the subject and predicate devices do not raise different questions of safety and effectiveness. In addition, the specifications for the subject device are comparable to other devices of this type.

Summary of non-clinical performance testing:

Biocompatibility:

Biocompatibility studies of the lubricant and applicator were performed 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" and ISO 10993- 1:2009 as follows:

Cytotoxicity (ISO 10993-5:2009) O
Sensitization (ISO 10993-10:2010) O
Vaginal Irritation (ISO 10993-10:2010) O
Acute Systemic Toxicity (ISO 10993-11:2006) this test only conducted on о the personal lubricant component

Condom Compatibility:

Condom compatibility testing was performed in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results of testing demonstrated that the subject device is compatible with natural rubber latex condoms and is not compatible with polyisoprene and polyurethane condoms.

Shelf-Life:

The shelf-life of the device is 16 months in accordance with the results of an accelerated aging study. All device specifications (see table on page 2 of this summary) were met at all timepoints assessed (equivalent to 0-16 months of real-time aging).

Substantial Equivalence:

The results of the performance testing described above demonstrate that the Sage-2 in-1 Personal Lubricant and Moisturizer 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.