AH! YES® OB COCO: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. AH! YES® OB COCO is not compatible with natural rubber latex, polyurethane or polyisoprene condoms.

Device Description

AH! YES OB COCO is a non-sterile, plant-oil based personal lubricant that consists primarily of sunflower oil and fractionated coconut oil and is not compatible with condoms. It is neither a contraceptive nor a spermicide. The formulation is an opaque paste that melts at body temperature. The product is packaged in a polyethylene single use applicator.

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) premarket notification for "AH! YES OB COCO Personal Lubricant" does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered medical device or diagnostic tool.

This document pertains to a medical device (a personal lubricant) that does not involve AI or algorithms requiring the types of studies you've requested (e.g., MRMC, standalone algorithm performance, expert consensus for ground truth on imagery).

Therefore, I cannot fulfill your request for the specific information regarding AI device acceptance criteria and study details. The document primarily focuses on:

Substantial equivalence to a predicate device based on similar indications for use and technological characteristics.
Non-clinical performance testing for biocompatibility, shelf-life, and condom compatibility for a physical product.

If you can provide a document that discusses an AI-powered medical device, I would be happy to analyze it for the information you've requested.

Summary

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February 6, 2020

Bio-Tech Lubricants Ltd Karen Cornelius Regulatory Affairs Manager C/O The Timber Barn, Selborne Road Greatham, Liss, Hampshire GU33 6HG UNITED KINGDOM

K191411 Re: Trade/Device Name: AH! YES OB COCO Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 23, 019 Received: December 23, 2019

Dear Karen Cornelius:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

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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 (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/trainingand-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-regulatory- assistance/contact-usdivision-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. Acting 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) K191411

Device Name AH!YES OB COCO Personal Lubricant

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 – K191411

1. Submitter Information

Applicant:	Bio-Tech Lubricants Limited
Address:	Epsilon House, Enterprise RoadSouthampton Science Park,Southampton, SO6 7NSUnited Kingdom
Phone:	+44 (0) 3450 94 11 41
Email:	sarah@ahyes.org

2. Correspondent Information

Contact:	Karen CorneliusBio-Tech Lubricants Limited
Address:	C/O The Timber Barn,Selborne Road, Greatham,Hampshire.GU33 6HGUnited Kingdom
Phone:	+44 (0) 3450 94 11 41
Email:	Karen@yesyesyes.org

3. Date prepared: February 04, 2020

4. Device Information

Device Name:	AH! YES OB COCO Personal Lubricant
Common Name:	Personal Lubricant
Regulation Number:	21 CFR 884.5300
Regulation Name:	Condom
Regulatory Class:	Class II
Product Code:	NUC (lubricant, personal)

5. Predicate Device Information

Device Name:	YES Oil-based Personal Lubricant
510(k) Number:	K162569
Manufacturer:	Bio-Tech Lubricants Limited
Regulatory Class:	Class II
Product Code:	NUC (lubricant, personal)

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

6. Device Description

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The device specifications for AH! YES OB COCO are listed in the table below:

Property	Specification
Appearance	Opaque paste below melt point, oily pale yellow liquid above melt point
Color	Pale yellow
Odor	Slight odor, strengthening with age
Specific Gravity	0.85 - 1.0
Total aerobic microbial count (TAMC) per USP <61>	Less than 100 cfu/g
Total yeast and mold count (TYMC) per USP <61>	Less than 10 cfu/g
Presence of Pathogens per USP <62>	Specification
Staphylococcus aureus	Absent
Candida albicans	Absent
Gram negative bacteria (e.g. Pseudomonas aeruginosa)	Absent

Table 1: Device Specifications for "AH! YES OB COCO personal lubricant"

7. Indications for Use

AH!YES® OB COCO: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. AH! YES® OB COCO is not compatible with natural rubber latex, polyurethane or polyisoprene condoms.

8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The table below lists the a comparison of the indications for use and technological characteristics of the subject and predicate device.

Table 2: Comparator Table for Subject Device – The AH!YES OB COCO Personal Lubricant and Predicate Device YES Oil-based Personal Lubricant

	AH!YES OB COCOPersonal Lubricant(K191411)	YES Oil-based PersonalLubricant (K162569)
Device ClassificationName	Lubricant, Personal	Lubricant, Personal
Product Code	NUC	NUC
Indications for Use	AH!YES® OB COCO: A personallubricant, for vaginal and penileapplication, intended to moisturizeand lubricate, to enhance the easeand comfort of intimate sexualactivity and supplement the body'snatural lubrication. AH! YES OBCOCO is not compatible withnatural rubber latex, polyurethaneor polyisoprene condoms	YES OB personal lubricant is apersonal lubricant, for vaginaland penile application, intendedto moisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product is notcompatible with natural rubberlatex, polyurethane orpolyisoprene condoms.

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Water soluble	No	No
Contains water	No	No
Oil based lubricant	Yes	Yes
Primary ingredients	Sunflower seed oil, Coconut oil,Jojoba seed oil, DermofeelViscolid, Grapeseed Oil, Vitamin E	Sunflower seed oil, Shea butter,Sweet almond oil, Bees wax,Cocoa seed butter, Vitamin E
Sterile	No	No
Condom Compatibility	Not compatible with NRL,polyisoprene or polyurethanecondoms	Not compatible with NRL,polyisoprene or polyurethanecondoms
Biocompatibility Tested	Yes	Yes
Total Microbial Count	Less than 100 cfu/g	Less than 10 cfu/g
Fungal/Yeast/MoldLimits	Less than 10 cfu/g	Less than 10 cfu/g
Absence of PathogenicOrganisms	Absent	Absent
Packaging materials	Plastic / Polyethylene	Plastic / Polyethylene

The subject and predicate device have similar indications for use and have the same intended use. The subject and predicate device have different technological characteristics, including different formulations and specifications. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing 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) ●
Sensitization (ISO 10993-10:2010) ●
Vaginal Irritation (ISO 10993-10:2010) ●
Acute Systemic Toxicity (ISO 10993-11:2006) .

The results of this testing demonstrated that the AH!YES OB COCO personal lubricant is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.

Shelf-Life

The subject devices are non-sterile personal lubricants with a 24-month shelf-life in accordance with the results of accelerated aging studies per ASTM F1980-16 and real time storage. All device specifications listed in Table 1 were evaluated for shelf-life. The subject device met the device specifications at all time points.

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

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Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test demonstrate that the device is not compatible with condoms.

10. Conclusion

The results of the performance testing described above demonstrate that the AH!YES OB COCO Personal Lubricant 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.