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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the Pulse™ H2Oh! personal lubricant, based on the provided FDA 510(k) summary:

This device is not an AI/ML medical device, therefore many of the requested categories are not applicable. The information below reflects the type of testing typically done for personal lubricants.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied by Standards)	Reported Device Performance
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms.	Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms.
Microbiological	Pass USP <61> (Microbial Enumeration), USP <62> (Specified Microorganisms), and USP <51> (Antimicrobial Effectiveness Category 2).	All microbiological tests passed.
Biocompatibility	Pass ISO 10993-11 (Acute Systemic Toxicity), ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Vaginal Irritation), and ISO 10993-10 (GPMT for Sensitization).	All biocompatibility tests passed.
Shelf Life	Maintain specifications over the stated shelf life.	Shelf life of 10 months demonstrated through real-time aging.
Device Specifications	Maintain specified color, odor, appearance, weight gain/loss %, pH (4.8 - 5.2), specific gravity, viscosity, osmolality, total aerobic microbial count, total yeast and mold count, absence of P. aeruginosa, S. aureus, C. albicans, and antimicrobial effectiveness.	All specifications found to be acceptable. (Specific values not reported in this summary, but the general acceptance is stated).

Study Information

As this is a traditional medical device (a personal lubricant) and not an AI/ML device, many of the requested categories regarding AI specific testing (like sample size for test set/training set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance) are not applicable.

Here's the relevant information based on the provided document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test type. For physical/chemical tests, this would typically involve a statistically relevant number of batches or samples. For biological tests (e.g., irritation, sensitization), in vitro tests use specified cell cultures, and in vivo tests use animal models (e.g., Guinea Pig Maximization Test). Condom compatibility testing would involve a specific number of condoms and lubricant applications as per ASTM D7661-10.
- Data Provenance: The document states that testing was "performed by independent laboratories/test centers." The country of origin of these labs is not specified. The studies are prospective in nature, as they are conducted specifically to demonstrate the product's compliance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable for this type of device. "Ground truth" in the context of AI/ML refers to human expert annotations. For a personal lubricant, compliance is determined by adherence to established, objective scientific standards and test methods recognized by regulatory bodies (e.g., USP, ISO, ASTM). The "experts" are the scientists and technicians performing and interpreting these standardized laboratory tests. Their qualifications would be in chemistry, microbiology, toxicology, and other relevant scientific disciplines.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve discrepancies in human expert annotations for ground truth. For this device, test results are typically objective (e.g., pass/fail for microbial growth, specific pH values, absence of adverse reactions in animal models).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. MRMC studies are for evaluating the performance of diagnostic devices often involving human interpretation (e.g., radiologists reading images). This is a physical/chemical/biological product.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical product, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device, in a general sense, is derived from established scientific standards and methodologies.
  - Condom Compatibility: Adherence to ASTM D7661-10 (a published standard for test methods).
  - Microbiological: Adherence to USP <61>, <62>, <51> (pharmacopeial standards for microbial limits and antimicrobial effectiveness).
  - Biocompatibility: Adherence to ISO 10993 series of standards (international standards for biological evaluation of medical devices), which involve specific in vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity in animal models) tests.
  - Shelf Life: Results of real-time aging studies, demonstrating the device maintains its pre-defined specifications over time.
The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established
- Not Applicable. There is no "training set" for this device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K152628

Device Name Pulse™ H2Oh!

Indications for Use (Describe)

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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510(k) Owner	Toaster Labs, Inc.
Address	2212 Queen Anne Avenue North, #269Seattle, WA 98109
Contact person	Amy C. Buckalter, CEO
Contact numbers	Phone: 206-910-8332 Fax: 206-331-4876
510(k) Summarypreparation 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

PredicateDevice	Name:	LifeStyles® Smooth™ 2-in-1Massage & 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.

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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 ●

Indications for Use:

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.

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Microbiological Testing Tested was performed in accordance ● with the following standards and passed.
- USP <61> Microbiological Examination of -Nonsterile Products: Microbial Enumeration
- USP <62> Microbiological Examination of Nonsterile -Products: Tests for Specified Microorganisms
- USP <51> 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.

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.