The Harmony® Latex & the Harmony® Polyisoprene Dams are used as a barrier when engaging in oral/vaginal and oral/ anal sex to help reduce the transmission of bodily fluids, harmful pathogens and sexually transmitted infections.

Device Description

The Harmony® Latex and Harmony® Polyisoprene Dams are rectangular shaped non-porous, intact polymer film that are placed over the vagina or anus during oral sexual contact. The dam provides coverage to the external female genitalia or to the anal acts as a physical barrier to infectious agents responsible for the transmission of sexually transmitted infections (STIs). Both Harmony® Latex and Harmony® Polyisoprene Dams are 152.4 mm (6") x 254 mm (10") and 0.12 mm thick. The Harmony® Latex Dam contains natural polyisoprene rubber and the Harmon® Polyisoprene Dam contains synthetic polyisoprene rubber. The dams are slightly scented with vanilla fragrance and are provided in natural color.

AI/ML Overview

This document is a 510(k) summary for the Harmony® Latex Dams and Harmony® Polyisoprene Dams. It outlines the acceptance criteria and supporting studies for these devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the international standard ISO 29942:2011 Prophylactic dams -- Requirements and test methods and the 2020 FDA guidance Use of International Standard ISO 10993-1. The specific ranges or thresholds for these criteria are not provided in the document, but it states that "All test results were acceptable."

Acceptance Criteria Category	Specific Tests / Properties	Reported Device Performance
Physical Performance (ISO 29942:2011)	Dimensional Testing	Acceptable (Implies meeting specified dimensions: 152.4 mm x 254 mm, Thickness- 0.12 mm)
	Tensile Testing and Elongation at Break	Acceptable
	Tear Resistance and Tearing Force	Acceptable
	Freedom from Holes and Visual Defects	Acceptable
Barrier Integrity	Viral Barrier Properties	Acceptable
Packaging Robustness	Packaging Integrity Testing	Acceptable
Biocompatibility (ISO 10993-1, -5, -10, -11)	Cytotoxicity (ISO 10993-5:2009)	Acceptable
	Irritation Testing (ISO 10993-10:2010)	Acceptable
	Sensitization (ISO 10993-10:2010)	Acceptable
	Acute Systemic Toxicity (ISO 10993-11:2017)	Acceptable

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for each test in the acceptance criteria section. The data provenance is also not specified in terms of country of origin or whether it was retrospective/prospective. The testing appears to be prospective bench testing performed on manufactured Harmony® Latex and Harmony® Polyisoprene Dams.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable as the device is a physical barrier (dam) and the testing involves non-clinical bench tests (mechanical, barrier, biocompatibility), not interpretation of medical images or patient data that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as #3. Bench testing results are typically objectively measured against specified standards, not adjudicated by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This section is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation of results, especially in the context of AI assistance. The Harmony® Dams are physical barrier devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This section is not applicable. There is no algorithm or AI component in the Harmony® Dams. The performance evaluated is the physical and biological properties of the device itself.

7. Type of Ground Truth Used

The ground truth used for the non-clinical tests is established by international standards and FDA guidance. For example:

ISO 29942:2011 specifies requirements and test methods for prophylactic dams.
ISO 10993 series outlines biological evaluation of medical devices.
The ground truth is therefore defined by the specifications and thresholds outlined in these recognized standards.

8. Sample Size for the Training Set

This section is not applicable. There is no "training set" as this device is not an AI/ML algorithm or a diagnostic tool that learns from data.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reason as #8.

Summary

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August 5, 2021

Pamco Distributing, Inc. % Catriona Boyd Senior Medical Device Consultant Ironstone Product Development 250 Carlaw Avenue, Suite 108 Toronto. Ontario M4M 3L1 Canada

Re: K203727

Trade/Device Name: Harmony® Latex Dams, Harmony® Polyisoprene Dams Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MSC Dated: July 2, 2021 Received: July 6, 2021

Dear Catriona Boyd:

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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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/training-and-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-regulatoryassistance/contact-us-division-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,

for Jason R. Roberts, Ph.D. 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203727

Device Name Harmony® Latex Dams Harmony® Polyisoprene Dams

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

Harmony® Latex and Harmony® Polyisoprene Dams

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Pamco Distributing Inc. 231 Arnold Street Kitchener, ON, Canada N2H 6E8 Phone: +1-519-648-2200 Contact Person: Annette Maclean

Date Prepared: August 3, 2021

Name of Device

Harmonv® Latex Dams Harmony® Polyisoprene Dams

Device Classification and Product Code

Regulation Number: 21 CFR 884.5300 Requlation Name: Condom Requlatory Class: Class II Product Code: MSC (Barrier, Std, Oral Sex)

Predicate Device

Trust Dam (K091769)

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

Indications for Use

The Harmony® Latex & the Harmony® Polyisoprene Dams are used as a barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens and sexually transmitted infections.

Device Description

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Comparison of Indications for Use and Technological Characteristics with the Predicate Device

The intended use of the subject devices, Harmony® Latex & the Harmony® Polyisoprene Dams, and the predicate device, Trust Dams (K091769), are the same. Both the subject devices and the predicate device are used as a barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens and sexually transmitted infections. Table 1 below compares the technological characteristics of the subject devices and the predicate device.

	Harmony® Dams(Subject Devices)	Trust Dam(Predicate Device)
Device Name	Harmony® Latex DamsHarmony® Polyisoprene Dams	Trust Dams
Manufacturer	Pamco Distributing Inc.	Line One Laboratories Inc
510(k) Number	K203727	K091769
Regulatory Class	II	II
Regulation Number	21 CFR 884.5300	21 CFR 884.5300
Product Code	MSC	MSC
Classification Name	Barrier, Std, Oral Sex	Barrier, Std, Oral Sex
Intended Use	The Harmony® Latex & theHarmony® Polyisoprene Dams areused as a barrier when engaging inoral/vaginal and oral/anal sex to helpreduce the transmission of bodilyfluids, harmful pathogens andsexually transmitted infections.	The Line One Trust Dam is used as abarrier when engaging in oral/vaginalsex and oral/anal sex to help reducethe transmission of bodily fluids,harmful germs, and sexuallytransmitted diseases.
Nominal Dimensions	152.4 mm X 254 mm, Thickness-0.12 mm	154 mm X 250 mm, Thickness- 0.07mm
Material	Harmony® Latex Dams:Natural rubber latexHarmony® Polyisoprene Dams:Synthetic polyisoprene	Natural rubber latex
Lubricated	No	No
Color	Natural Color / No Dye Added	Yellow, Red, Green
Fragrance/Flavour	Vanilla	Banana, strawberry, mint
MechanicalProperties	Tested in accordance with ISO29942:2011, including the followingtests:Tensile strengthElongation at breakTearing forceFreedom from holesTear resistance	Tested in accordance with ASTMD3492:2008
Sterility	Non-sterile	Non-sterile
Shelf-life	3 years	5 years
BiocompatibilityTested?	Yes	Yes

			Table 1 - Comparison of Technological Characteristics of the Subject and Predicate Devices
--	--	--	--------------------------------------------------------------------------------------------

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The intended use of the Harmony® Latex & the Harmony® Polyisoprene Dams is the same as the Trust Dam. The differences between the subject and predicate device include the materials (polyisoprene), colors, flavors, and shelf life. However, these differences in technological characteristics do not raise different questions of safety or effectiveness.

Summary Discussion of Non-Clinical Data

The following non-clinical testing was completed on the Harmony® Latex and Harmony® Polyisoprene Dams:

. Per ISO 29942:2011 Prophylactic dams -- Requirements and test methods
- o Dimensional Testing
- Tensile Testing and Elongation at Break O
- Tear Resistance and Tearing Force o
- o Freedom from Holes and Visual Defects
Viral Barrier Properties ●
. Packaging Integrity Testing
Per the 2020 FDA guidance Use of International Standard ISO 10993-1 "Biological evaluation of ● medical devices - Part 1: Evaluation and testing within a risk management process":
- Cytotoxicity (ISO 10993-5:2009) o
- Irritation Testing (ISO 10993-10:2010) o
- Sensitization (ISO 10993-10:2010) o
- Acute Systemic Toxicity (ISO 10993-11:2017) o

All test results were acceptable.

Conclusions

The results from the non-clinical bench testing above demonstrate that the Harmony® Latex Dams and Harmony® Polyisoprene Dams are as safe and effective as the predicate device and support 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.