(300 days)
Not Found
No
The device is a personal lubricant and the description focuses on its physical properties, ingredients, and compatibility with condoms. There is no mention of any computational or analytical functions that would utilize AI/ML.
No
This device is a personal lubricant intended to moisturize and lubricate for sexual activity, not to treat or cure a disease or condition.
No
The device is a personal lubricant intended to moisturize and lubricate for sexual activity, not to diagnose any condition.
No
The device is a personal lubricant, which is a physical substance (gel) and is described as being supplied in plastic pump canisters. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "vaginal and/or penile application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication." This describes a topical application for physical lubrication and comfort during sexual activity.
- Device Description: The device is a personal lubricant applied externally.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or treat any medical condition by examining samples taken from the body (like blood, urine, tissue, etc.). IVDs are specifically designed for these types of in vitro analyses.
The device is clearly described as a personal lubricant for physical application, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Pulse™ H2Oh! personal lubricant is intended for vaginal and/or penile application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.
This personal lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Product codes
NUC
Device Description
The Pulse H2Oh! is a personal lubricant intended for overthe-counter sale. It is sold, and used, not sterile. The lubricant is colorless to slightly yellow and unfragranced.
The product is used 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.
The Pulse H2Oh! lubricant is supplied in the form of individual plastic pump canisters, called pods. A pod is ~2.5 inches tall, has a diameter of ~1 inch and contains ~6.7 ml of lubricant. The pod pump allows the user to receive an aliquot of lubricant without touching the nozzle or inside of the container.
The Pulse H2Oh! lubricant is a gel with a pH of 4.8 - 5.2, and is comprised of the following ingredients:
- Purified water
- Propanediol / Zemea Propanediol ●
- Hydroxyethylcelluose / Natrosol 250H Pharm ●
- Potassium Sorbate ●
- Chia Seed Extract ●
- Citric Acid ●
Device specifications are: color, odor, appearance, weight gain/loss % (w/w), pH, specific gravity, viscosity, osmolality, total aerobic microbial count, total yeast and mold count, absence of specified microorganisms (P. aeruginosa, S. aureus and C. albicans) and antimicrobial effectiveness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal and/or penile
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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
Condom compatibility Testing - Test was performed in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The lubricant was found to be compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms.
Microbiological Testing Tested was performed in accordance with the following standards and passed.
- USP Microbiological Examination of -Nonsterile Products: Microbial Enumeration
- USP Microbiological Examination of Nonsterile -Products: Tests for Specified Microorganisms
- USP Antimicrobial Effectiveness Testing category 2 -
Biocompatibility Testing Biocompatibility was evaluated in accordance with ISO 10993 - Biological Evaluation of Medical Devices. Tests for cytotoxicity, vaginal irritation, sensitization, and acute systemic toxicity were completed and passed.
- Acute Systemic Toxicity: ISO 10993-11:2006 -
- Cytotoxicity: ISO 10993-5:2009 -
- Vaginal Irritation Testing: ISO 10993-10:2010 -
- Guinea Pig Maximization Test (GPMT): ISO 10993-10:2010 -
Shelf life - The shelf life of Pulse H2Oh! is 10 months. This is based on the results of real time aging studies that demonstrated that the device maintains its specifications over the duration of its shelf life.
Key Metrics
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
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2016
Toaster Labs, Inc Amy Buckalter CEO 2212 Queen Anne Avenue North, #269 Seattle, WA 98109
Re: K152628 Trade/Device Name: Pulse H20h! Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: May 27, 2016 Received: Mav 31, 2016
Dear Amy Buckalter,
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
2
Indications for Use
510(k) Number (if known) K152628
Device Name Pulse™ H2Oh!
Indications for Use (Describe)
The Pulse™ H2Oh! personal lubricant is intended for vaginal and/or penile application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.
This personal lubricant 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)
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) Owner | Toaster Labs, Inc. |
|---|---|
| Address | 2212 Queen Anne Avenue North, #269 |
| Seattle, WA 98109 | |
| Contact person | Amy C. Buckalter, CEO |
| Contact numbers | Phone: 206-910-8332 Fax: 206-331-4876 |
| 510(k) Summary | |
| preparation date | May 26, 2016 |
| 510(k) | K152628 | |
|---|---|---|
| Trade Name | Pulse™ H2Oh! | |
| Common Name | Personal lubricant | |
| Device Classification | Regulation: | 21 CFR 884.5300 – |
| Lubricant, personal | ||
| Class: | Class II | |
| FDA product code: | NUC |
| Predicate
Device | Name: | LifeStyles® Smooth™ 2-in-1
Massage & Lubricant |
|---------------------|-------------------|---------------------------------------------------|
| | 510(k) number: | K122476 |
| | Manufacturer: | Ansell Healthcare Products, LLC |
| | Regulation: | 21 CFR 884.5300 – Lubricant,
personal |
| | Class: | Class II |
| | FDA product code: | NUC |
Device Description: The Pulse H2Oh! is a personal lubricant intended for overthe-counter sale. It is sold, and used, not sterile. The lubricant is colorless to slightly yellow and unfragranced.
The product is used 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.
4
The Pulse H2Oh! lubricant is supplied in the form of individual plastic pump canisters, called pods. A pod is ~2.5 inches tall, has a diameter of ~1 inch and contains ~6.7 ml of lubricant. The pod pump allows the user to receive an aliquot of lubricant without touching the nozzle or inside of the container.
The Pulse H2Oh! lubricant is a gel with a pH of 4.8 - 5.2, and is comprised of the following ingredients:
- Purified water
- Propanediol / Zemea Propanediol ●
- Hydroxyethylcelluose / Natrosol 250H Pharm ●
- Potassium Sorbate ●
- Chia Seed Extract ●
- Citric Acid ●
Device specifications are: color, odor, appearance, weight gain/loss % (w/w), pH, specific gravity, viscosity, osmolality, total aerobic microbial count, total yeast and mold count, absence of specified microorganisms (P. aeruginosa, S. aureus and C. albicans) and antimicrobial effectiveness.
Indications for Use:
The Pulse™ H2Oh! personal lubricant is intended for vaginal and/or penile application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.
This personal lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms
Summary of Technological Characteristics: The subject and predicate device have different technological characteristics, including their formulation, specifications, and condom compatibility. These differences do not raise different questions of safety and effectiveness because these differences are routinely encountered during 510(k) reviews of personal lubricants.
Summary of Testing: Testing of the Pulse H2Oh! lubricant was performed by independent laboratories/test centers and is summarized as follows. As noted below, all testing was found to be acceptable.
- . Condom compatibility Testing - Test was performed in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The lubricant was found to be compatible with natural rubber latex and polyisoprene condoms and not compatible with polyurethane condoms.
5
- Microbiological Testing Tested was performed in accordance ● with the following standards and passed.
- USP Microbiological Examination of -Nonsterile Products: Microbial Enumeration
- USP Microbiological Examination of Nonsterile -Products: Tests for Specified Microorganisms
- USP Antimicrobial Effectiveness Testing category 2 -
- Biocompatibility Testing Biocompatibility was evaluated in ● accordance with ISO 10993 - Biological Evaluation of Medical Devices. Tests for cytotoxicity, vaginal irritation, sensitization, and acute systemic toxicity were completed and passed.
- Acute Systemic Toxicity: ISO 10993-11:2006 -
- Cytotoxicity: ISO 10993-5:2009 -
- Vaginal Irritation Testing: ISO 10993-10:2010 -
- Guinea Pig Maximization Test (GPMT): ISO 10993-10:2010 -
- Shelf life - The shelf life of Pulse H2Oh! is 10 months. This is based on the results of real time aging studies that demonstrated that the device maintains its specifications over the duration of its shelf life.
Conclusion: The Pulse H2Oh! is substantially equivalent to the predicate device. Both the Pulse H2Oh! and the predicate have equivalent intended uses and the same basic technological characteristics. Differences in technological characteristics do not introduce different questions regarding safety or effectiveness.