(227 days)
No
The device description and performance studies focus on the physical properties and barrier function of a polymer film, with no mention of AI or ML technologies.
No.
The device is described as a barrier to reduce the transmission of bodily fluids and diseases, not to treat or cure a medical condition.
No
Explanation: The device is described as a physical barrier used to reduce the transmission of bodily fluids and sexually transmitted infections during sexual contact. Its purpose is preventative, not to diagnose any condition.
No
The device description clearly describes a physical barrier made of polymer film, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health. Examples include blood tests, urine tests, and tissue biopsies.
- This device is a physical barrier. Its function is to prevent the transmission of bodily fluids and pathogens during sexual activity. It does not analyze or test any biological samples.
The description clearly states its purpose is to act as a "physical barrier to infectious agents." This is a mechanical function, not an in vitro diagnostic one.
N/A
Intended Use / 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.
Product codes
MSC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, anus, external female genitalia
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
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
- Dimensional Testing
- Tensile Testing and Elongation at Break
- Tear Resistance and Tearing Force
- 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)
- Irritation Testing (ISO 10993-10:2010)
- Sensitization (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)
All test results were acceptable.
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/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.
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.
1
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
2
Indications for Use
510(k) Number (if known) K203727
Device Name Harmony® Latex Dams Harmony® Polyisoprene Dams
Indications for Use (Describe)
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.
| 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) 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
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.
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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 Dams
Harmony® 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 & 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. | The Line One Trust Dam is used as a
barrier when engaging in oral/vaginal
sex and oral/anal sex to help reduce
the transmission of bodily fluids,
harmful germs, and sexually
transmitted diseases. |
| Nominal Dimensions | 152.4 mm X 254 mm, Thickness-
0.12 mm | 154 mm X 250 mm, Thickness- 0.07
mm |
| Material | Harmony® Latex Dams:
Natural rubber latex
Harmony® 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 |
| Mechanical
Properties | Tested in accordance with ISO
29942:2011, including the following
tests:
Tensile strength
Elongation at break
Tearing force
Freedom from holes
Tear resistance | Tested in accordance with ASTM
D3492:2008 |
| Sterility | Non-sterile | Non-sterile |
| Shelf-life | 3 years | 5 years |
| Biocompatibility
Tested? | 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.