(327 days)
Not Found
No
The 510(k) summary describes a personal lubricant and its physical and biocompatibility properties. There is no mention of AI, ML, or any computational analysis of data.
No.
The product is intended to moisturize and lubricate for comfort during sexual activity, not to diagnose, cure, mitigate, treat, or prevent disease.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." This indicates a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly states it is a "non-sterile, aqueous-based personal lubricant," which is a physical substance, not software. The performance studies also focus on biocompatibility and compatibility with condoms, which are physical properties of the lubricant.
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 enhancing sexual activity and supplementing natural lubrication. This is a physical function, not a diagnostic one.
- Device Description: The description details a gel-like liquid for topical application, not a device designed to analyze biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility, irritation, and condom compatibility, which are relevant to a personal lubricant, not an IVD.
- Predicate Device: The predicate device is another personal lubricant, further confirming the device's classification.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
ONE® Personal Lubricant (water-based formulation) is an over-the-counter personal lubricant.
ONE® Oasis 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, polvisoprene, and polyurethane condoms.
Product codes
NUC
Device Description
ONE® Personal Lubricant (water-based formulation) is a non-sterile, aqueous-based personal lubricant for use with or without a condom. It is specifically formulated to be a clear, non-irritating, non-greasy, odorless, gel-like liquid. This device is not a contraceptive nor does it contain any spermicidal component. Two forms of packaging are intended. The first primary packaging (having direct contact with product) consists of a plastic packaging. The second primary packaging is foil wrappers.
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:
Testing Performed: Cytotoxicity, ISO Guinea Pig Maximization Sensitization Test, Vaginal Irritation with Histopathology, Penile Irritation with Histopathology, Acute Systemic Toxicity, Primary Skin Irritation.
Results: Product is Non-toxic, Product does not elicit a sensitization response, Product is non-irritating to vaginal tissue, Product does not cause penile mucosal irritation, There is no evidence of system toxicity, Dermal irritation response is negligible.
Biocompatibility testing was performed in accordance with ISO 10993-1.
Condom Compatibility:
Compatibility Testing was performed in accordance with Lubricant Compatibility DRAFT #2010-1 ASTM D11.40.01 04/30/2010 on three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polvurethane condoms.
The results demonstrated that the condom compatibility testing of the water-based lubricant is compatible with commercially available male condoms made from natural rubber latex, polyurethane, and polyisoprene materials.
Shelf-Life:
ONE® Oasis Personal Lubricant (water-based formulation) has a one-year shelf life based on the results of an accelerated aging study. The accelerated aging study evaluated both versions of packaging. The product met specifications.
A real-time aging study is being conducted to contirm results of the accelerated aging studv.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K11069 Page
II. 510(k) Summary
FEB - 1 2012
| 510(k) SUMMARY
Submitted by: | ONE®
12 Channel Street
Boston, MA 02210 | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Persons: | Sharon Pietila
Regulatory Affairs / Quality Assurance Manager
Tel.: 617-946-2800 ext. 15
Fax: 617-946-3246
Email: sharon@globalprotection.com | |
| | Davin Wedel
President
Tel.: 617-946-2800 ext. 14
Fax: 617-946-3246
Email: davin@globalprotection.com | |
| Date Prepared: | January 19, 2012 | |
| Propriety Name: | ONE® Personal Lubricant (Water-Based) | |
| Proposed Trade Name: | ONE® Oasis | |
| Common Name: | Personal Lubricant | |
| Classification Name: | Condom
Class II (21 CFR §884.5300)
NUC | |
| Predicate Device: | Wet Light Personal Moisturizer
Trigg Laboratories
510(k) No. K013086 | |
| Device Description: | ONE® Personal Lubricant (water-based formulation) is a non-
sterile, aqueous-based personal lubricant for use with or without a
condom. It is specifically formulated to be a clear, non-irritating,
non-greasy, odorless, gel-like liquid. This device is not a
contraceptive nor does it contain any spermicidal component. Two
forms of packaging are intended. The first primary packaging
(having direct contact with product) consists of a plastic
packaging. The second primary packaging is foil wrappers. | |
| Intended Use: | ONE® Personal Lubricant (water-based formulation) is an over-
the-counter personal lubricant. | |
1
ONE® Oasis is a personal lubricant, for penile and/or vaginal Indications For Use: 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, polvisoprene, and polyurethane condoms.
Technological Characteristics:
ONE® Personal Lubricant water-based formulation contains water and water-soluble ingredients similar to ingredients found in the predicate device.
Biocompatibility:
| Testing Performed | Results |
|---|---|
| Cytotoxicity | Product is Non-toxic |
| ISO Guinea Pig Maximization | |
| Sensitization Test | Product does not elicit a sensitization |
| response | |
| Vaginal Irritation with Histopathology | Product is non-irritating to vaginal tissue |
| Penile Irritation with Histopathology | Product does not cause penile mucosal |
| irritation | |
| Acute Systemic Toxicity | There is no evidence of system toxicity |
| Primary Skin Irritation | Dermal irritation response is negligible |
Biocompatibility testing was performed in accordance with ISO 10993-1.
Condom Compatibility:
Compatibility Testing was performed in accordance with Lubricant Compatibility DRAFT #2010-1 ASTM D11.40.01 04/30/2010 on three marketed brands of Natural Rubber Latex condoms, one brand of Polyisoprene condoms, and one brand of Polvurethane condoms.
The results demonstrated that the condom compatibility testing of the water-based lubricant is compatible with commercially available male condoms made from natural rubber latex, polyurethane, and polyisoprene materials.
Image /page/1/Picture/10 description: The image shows the word "ONE" in white letters against a black background. The letters are bold and sans-serif, and they are enclosed in a rounded rectangle. The letter "E" is stylized, with the middle stroke slightly shorter than the top and bottom strokes. There is a small star symbol in the bottom right corner of the rectangle.
2
Shelf-Life:
ONE® Oasis Personal Lubricant (water-based formulation) has a one-year shelf life based on the results of an accelerated aging study. The accelerated aging study evaluated both versions of packaging. The product met specifications.
A real-time aging study is being conducted to contirm results of the accelerated aging studv.
Image /page/2/Picture/5 description: The image shows the word "ONE" in white letters against a black background. The letters are bold and sans-serif, and they are contained within a rounded rectangle. The overall design is simple and eye-catching, with a clear contrast between the text and the background.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Ms. Sharon Pietila Regulatory Affairs/Ouality Assurance Manager ONE® 12 Channel Street BOSTON MA 02210
FEB - 1 2012
Re: K110691
Trade/Device Name: ONE® Oasis Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: January 19, 2012 Received: January 20, 2012
Dear Ms. Pietila:
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. The Act. 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 0011917 While and 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2 -
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin K. Evans
Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Abbreviated 510(k) Notification for ONE® Personal Lubricant (Water-Based)
Indications for Use Statement VII.
Indications for Use
510(k) Number:
Device Name:
5
ONE® Oasis Personal Lubricant
Indications For Use:
ONE® Oasis 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, polyisoprene, and polyurethane condoms.
| Prescription Use | AND/OR | Over-The-Counter Use | X |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (Part 21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Reproductive, Gastro-Renal, and Urological Devices |
| 510(k) Number | K110691 |
|---|---|
| --------------- | --------- |
| | 12 Channel Street
Boston, MA 02210 | | Page 20 of 234 |
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