(220 days)
Not Found
No
The device description and performance studies focus on material properties and physical characteristics, with no mention of AI or ML.
No.
The device is described as a barrier to reduce the transmission of bodily fluids and infections during sexual contact, which positions it as a prophylactic device rather than one that treats or rehabilitates a disease or condition.
No
The device is described as a barrier to reduce the transmission of fluids and infections during sexual activity, not to diagnose any condition or disease.
No
The device description explicitly states that Lorals are "wearable, single-use, natural rubber latex oral dams" and describes their physical construction and materials. This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a physical barrier to reduce the transmission of bodily fluids and pathogens during sexual activity. This is a preventative measure, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device is a physical barrier made of natural rubber latex. It does not involve any reagents, instruments, or procedures for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely mechanical.
- Performance Studies: The performance studies focus on the physical properties of the material (tensile strength, tear resistance, freedom from holes) and biocompatibility, which are relevant for a barrier device, not a diagnostic test.
- Predicate Device: The predicate device is a "Prophylactic dam," which is also a barrier device, not an IVD.
In summary, the device's purpose and mechanism of action are entirely focused on providing a physical barrier during sexual activity, which is not the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lorals are used as a barrier when engaging in oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.
Product codes
MSC
Device Description
Lorals are wearable, single-use, natural rubber latex oral dams that are placed over the vagina and/or anus during oral sexual contact. Lorals are designed similar to underwear, with a region that covers the genital region and a waistband to keep the dam in place, all made from natural rubber latex. The dams are available in two designs, Shortie and Bikini, which provide the same coverage of the genital region, but have different waistband heights, based on user preference. Each design is available in 3 different gusset sizes. The dams are scented with vanilla fragrance and are provided in black only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anus, vagina, oral cavity (mouth)
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
Performance testing was performed on the subject device per the FDA recognized standard ISO 29942:2011 Prophylactic dams –Requirements and test methods. The following testing was performed:
- Dimensional Testing
- Tensile Testing and Elongation at Break
- Tear Resistance and Tearing Force
- Freedom from Holes and Visual Defects
- Packaging Integrity Testing
The bench testing was completed as outlined in the standard to support the 2-year shelf life.
Biocompatibility of the device was assessed per the recommendations outlined in the FDA guidance document Use of International Standard ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." The following testing was performed:
- 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.
April 22, 2022
Brazen Goods Inc. dba Lorals % Erin Gontang Regulatory Specialist AcKnowledge Regulatory Strategies LLC 2251 San Diego Avenue, B-257 San Diego, CA 92110
Re: K212928 Trade/Device Name: Lorals Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MSC, Dated: March 21, 2022 Received: March 22, 2022
Dear Erin Gontang:
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.
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.
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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 (QS) 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 mediation-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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212928
Device Name Lorals
Indications for Use (Describe)
Lorals are used as a barrier when engaging in 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
DATE PREPARED
April 21, 2022
MANUFACTURER AND 510(k) OWNER
Brazen Goods Inc. 106 1/2 Judge John Aiso St. #305, Los Angeles, CA 90012, USA Telephone: Official Contact: Melanie Cristol, Founder & CEO
REPRESENTATIVE/CONSULTANT
Erin A. Gontang, Ph.D. Allison C. Komiyama, Ph.D., RAC RQM+ Corp. Telephone: +1 (412) 816-8253 Email: egontang@rqmplus.com akomiyama@rqmplus.com Website: www.rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Lorals |
|---|---|
| Common Name: | Oral Dam |
| Regulation Number: | 21 CFR 884.5300 |
| Regulation Name: | Condom |
| Regulatory Class: | II |
| Product Code: | MSC (Barrier, Std, Oral Sex) |
PREDICATE DEVICE IDENTIFICATION
Lorals are substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K091769 | Trust Dam/Line One Laboratories, Inc. | ✓ |
The predicate device has not been subject to a design related recall.
DEVICE DESCRIPTION
Lorals are wearable, single-use, natural rubber latex oral dams that are placed over the vagina and/or anus during oral sexual contact. Lorals are designed similar to underwear, with a region that covers the genital region and a waistband to keep the dam in place, all made from natural rubber latex. The dams are available in two designs, Shortie and Bikini, which provide the same coverage of the genital region, but have different waistband heights, based on user preference.
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Each design is available in 3 different gusset sizes. The dams are scented with vanilla fragrance and are provided in black only.
INDICATIONS FOR USE
Lorals are used as a barrier when engaging in oral/vaginal sex and oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.
COMPARISON OF INDICATIONS FOR USE AND TECHNOLOGICAL CHARACTERISTICS
The intended use of the subject device, Lorals, and the predicate device, Trust Dams (K091769), are the same. Both the subject device and the predicate device are used as a barrier when engaging in oral/vaginal sex and oral/anal sex. Table 1 below compares the technological characteristics of the subject device and the predicate device.
| | Lorals
(Subject Device) | Trust Dam
(Predicate Device) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Lorals | Trust Dams |
| Manufacturer | Brazen Goods Inc. | Line One Laboratories Inc |
| 510(k) Number | K212928 | K091769 |
| Regulatory Class | II | II |
| Regulation Number | 21 CFR 884.5300 | 21 CFR 884.5300 |
| Product Code | MSC (Barrier, Std, Oral Sex) | MSC (Barrier, Std, Oral Sex) |
| Regulation Name | Condom | Condom |
| Indications for Use | Lorals are used as a barrier
when engaging in oral/vaginal
sex 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. |
| Material | Natural rubber latex | Natural rubber latex |
| Location of Use | Anus, vagina, oral cavity
(mouth) | Anus, vagina, oral cavity
(mouth) |
| Lubricated | No | No |
| Color | Black | Yellow, Red, Green |
| Fragrance/Flavor | Vanilla | Banana, Strawberry, Mint |
| Design & Dimensions | Rectangular sheet with
integrated waistband
Gusset width: 163 mm, | Rectangular sheet
Width: 154 mm |
Table 1 Comparison of Technological Characteristics of the Subject and Predicate Devices.
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| 188 mm, or 213 mm | Height: 250 mm | |
|---|---|---|
| Gusset Height: 228 mm | ||
| Thickness: 0.07 mm | Thickness: 0.07 mm | |
| Lorals Height: 264 mm | ||
| Waistband Width: 343 mm | ||
| Waistband Height: | ||
| Bikini: 61 mm | ||
| Shortie: 162 mm | ||
| Mechanical Properties | Tested in accordance with ISO | |
| 29942:2011, including the | ||
| following tests: | ||
| Tensile strength | ||
| Elongation at break | ||
| Tearing force | ||
| Tear resistance | ||
| Freedom from holes | Tested in accordance with | |
| ASTM D3492:2008 | ||
| Sterility | Non-Sterile | Non-Sterile |
| Shelf-life | 2 years | 5 years |
| Biocompatibility Tested? | Yes | Yes |
The intended use of Lorals is the same as the Trust Dam. Differences in technological characteristics include the dimensions, shape, packaging, color and flavor additives, and shelf life. However, these differences between the subject and predicate device, as described in Table 1, do not raise different questions of safety or effectiveness.
SUMMARY OF NON-CLINICAL TESTING
Performance testing was performed on the subject device per the FDA recognized standard ISO 29942:2011 Prophylactic dams –Requirements and test methods. The following testing was performed:
- Dimensional Testing
- Tensile Testing and Elongation at Break ●
- Tear Resistance and Tearing Force
- Freedom from Holes and Visual Defects ●
- Packaging Integrity Testing
The bench testing was completed as outlined in the standard to support the 2-year shelf life.
As required, biocompatibility of the device was assessed per the recommendations outlined in the FDA guidance document Use of International Standard ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." The following testing was performed:
6
- 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.
CONCLUSION
The results from the non-clinical bench testing above demonstrate that Lorals dams are as safe and effective as the predicate device and support a determination of substantial equivalence.