(254 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of a personal lubricant, with no mention of AI or ML technology.
No.
The document states its intended use is to moisturize and lubricate to enhance the ease and comfort of intimate sexual activity, which is a lifestyle/comfort purpose, not a therapeutic treatment for a medical condition.
No
This device is a personal lubricant intended to enhance the comfort of sexual activity by moisturizing and lubricating; it does not diagnose any condition.
No
The device description clearly states it is a "non-sterile, plant-oil based personal lubricant" and is packaged in a "polyethylene single use applicator." This indicates a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states that AH! YES® OB COCO is a personal lubricant for vaginal and penile application, intended to moisturize and lubricate for intimate sexual activity. This is a topical application directly to the body, not a test performed on a sample taken from the body.
- Lack of Diagnostic Function: The device does not perform any diagnostic test or provide information about a patient's health status based on analyzing a sample.
Therefore, based on the provided information, AH! YES® OB COCO is a personal lubricant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal and penile
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:
- Study Type: Testing 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. Specific tests included:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006)
- Key Results: The AH!YES OB COCO personal lubricant is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic.
Shelf-Life:
- Study Type: Accelerated aging studies per ASTM F1980-16 and real time storage.
- Key Results: Demonstrated a 24-month shelf-life. All device specifications listed in Table 1 were evaluated for shelf-life and met at all time points.
Condom Compatibility:
- Study Type: Evaluation in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.
- Key Results: The device is not compatible with condoms.
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.
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
§ 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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510 (k) Summary – K191411
1. Submitter Information
| Applicant: | Bio-Tech Lubricants Limited |
|---|---|
| Address: | Epsilon House, Enterprise Road |
| Southampton Science Park, | |
| Southampton, SO6 7NS | |
| United Kingdom | |
| Phone: | +44 (0) 3450 94 11 41 |
| Email: | sarah@ahyes.org |
2. Correspondent Information
| Contact: | Karen Cornelius
Bio-Tech Lubricants Limited |
|----------|----------------------------------------------------------------------------------------------|
| Address: | C/O The Timber Barn,
Selborne Road, Greatham,
Hampshire.
GU33 6HG
United 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
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.
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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 | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) per USP | Less than 10 cfu/g |
| Presence of Pathogens per USP | 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 COCO
Personal Lubricant
(K191411) | YES Oil-based Personal
Lubricant (K162569) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification
Name | Lubricant, Personal | Lubricant, Personal |
| Product Code | NUC | NUC |
| 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 | YES OB personal lubricant is 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. This product is not
compatible with natural rubber
latex, polyurethane or
polyisoprene condoms. |
5
| Water soluble | No | No |
|---|---|---|
| Contains water | No | No |
| Oil based lubricant | Yes | Yes |
| Primary ingredients | Sunflower seed oil, Coconut oil, | |
| Jojoba seed oil, Dermofeel | ||
| Viscolid, 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 polyurethane | ||
| condoms | Not compatible with NRL, | |
| polyisoprene or polyurethane | ||
| condoms | ||
| Biocompatibility Tested | Yes | Yes |
| Total Microbial Count | Less than 100 cfu/g | Less than 10 cfu/g |
| Fungal/Yeast/Mold | ||
| Limits | Less than 10 cfu/g | Less than 10 cfu/g |
| Absence of Pathogenic | ||
| Organisms | 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
6
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.