(271 days)
The SancDam™ Latex Oral Dam is used as a barrier when engaging in oral/vaginal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.
The SancDam™ Latex Oral Dam are rectangular shaped, non-porous, intact polymer films made of natural rubber latex that are placed over the vagina or anus during oral sexual contact. The dam is used as a physical barrier to cover the external female genitalia or the anal area. The SancDam™ has a smooth surface on both sides. The size of the SancDam™ is 155 mm (± 5 mm) by 254 mm (± 5 mm) by 0.07 mm (± 0.02 mm). The SancDam™ available in 4 different flavors and colors versions as listed below: Pink Strawberry, Green Mint, Yellow Vanilla, Purple Grape.
This document is a 510(k) Premarket Notification for the SancDam™ Latex Oral Dam. It outlines the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence.
Based on the provided text, the device in question is a Latex Oral Dam, which is a physical barrier used during oral/vaginal and oral/anal sex to reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.
The document does not describe an AI/ML-driven device or study parameters that align with the request for information on acceptance criteria and study proving device meets acceptance criteria for such a device. The tests performed are standard non-clinical bench tests for a latex barrier device.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device from this document. The document describes a physical medical device, not a software or AI-based one.
No information provided in the document covers the following requested points:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes, data provenance, number of experts, adjudication methods, or ground truth types related to an AI performance study.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Training set details for an AI model.
The document focuses on non-clinical testing for a physical latex product and comparison to a predicate device for substantial equivalence, not on the performance of an AI/ML algorithm.
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March 28, 2022
Sanctuary Health Sdn. Bhd. Sumethi Selavaraju QAQC cum RA Deputy Manager No. 16, Persiaran Perindustrian Kanthan 1, Kawasan Perindustrian Kanthan Chemor, Perak 31200 Malaysia
Re: K212037
Trade/Device Name: SancDam™ Latex Oral Dam Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MSC Dated: February 18, 2022 Received: February 24, 2022
Dear Sumethi Selavaraju:
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212037
Device Name SancDam™ Latex Oral Dam
Indications for Use (Describe)
The SancDam™ Latex Oral Dam is used as a barrier when engaging in oral/vaginal 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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Image /page/3/Picture/0 description: The image shows the logo for Sanctuary Health. The word "Sanctuary" is written in red, and the word "HEALTH" is written in blue below it. To the right of the word "HEALTH" are two Chinese characters, also written in blue.
510(k) Summary
a. Submitter and Device Information
| Category | Comments |
|---|---|
| Submitter | Sanctuary Health Sdn. Bhd.No. 16, Persiaran Perindustrian Kanthan 1,Kawasan Perindustrian Kanthan,31200 Chemor, Perak Darul Ridzuan,Malaysia.Tel No: +605 - 201 2800Fax No: +605 - 201 7800 |
| Correspondent ContactInformation | Sumethi Selvaraju, QAQC cum RA Deputy ManagerTel: +605-201 2800 ext. 204E-mail: regulatory@sanctuaryhealth.com.myAdd: No. 16, Persiaran Perindustrian Kanthan 1,Kawasan Perindustrian Kanthan,31200 Chemor, Perak Darul Ridzuan,Malaysia. |
| Device Proprietary Name | SancDam™ Latex Oral Dam |
| Device Common Name | Latex Dam |
| Device Classification Number | 21 CFR 884.5300 |
| Device Classification Name | Condom |
| Device Class | II |
| Product Code | MSC (Barrier, Std, Oral Sex) |
| Predicate Device | |
|---|---|
| Predicate Device Manufacturer | Line One Laboratories, Inc. |
| Predicate Device CommonName | Latex Dam |
| Predicate Device ProprietaryName | Line One Trust Dam |
| Predicate Device PremarketNotification # | K091769 |
| Predicate Device Classification | 21 CFR 884.5300 - Condom |
| Predicate Device Class | II |
| Predicate Device Product Code | MSC (Barrier, Std, Oral Sex) |
| Design-related recall | The predicate device has not been subject to a design-related recall. |
b. Date Summary Prepared
March 24, 2022
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SancDam™ Oral Latex Dam - Traditional 510(k)
c. Description of Device
The SancDam™ Latex Oral Dam are rectangular shaped, non-porous, intact polymer films made of natural rubber latex that are placed over the vagina or anus during oral sexual contact. The dam is used as a physical barrier to cover the external female genitalia or the anal area.
The SancDam™ has a smooth surface on both sides. The size of the SancDam™ is 155 mm (± 5 mm) by 254 mm (± 5 mm) by 0.07 mm (± 0.02 mm).
The SancDam™ available in 4 different flavors and colors versions as listed below:
| Color | Flavor |
|---|---|
| Pink | Strawberry |
| Green | Mint |
| Yellow | Vanilla |
| Purple | Grape |
d. Indications for Use
The SancDam™ Latex Oral Dam is 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.
e. Comparison of Indications for Use and Technological Characteristics with the Predicate Device
Table 1 below compares the technological characteristics of the subject device and the predicate device.
Table 1 - Comparison of Technological Characteristics of the Subject and Predicate Devices
| SancDam™ Latex OralDam(Subject Device) | Line One Trust Dam(Predicate Device) | |
|---|---|---|
| Device Name | SancDam Latex Oral Dam | Trust Dams |
| Manufacturer | Sanctuary Health Sdn. Bhd. | Line One Laboratories, Inc. |
| 510(k) | K212037 | 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 |
| Indications for Use | The SancDam™ Latex OralDam is used as a barrierwhen engaging inoral/vaginal and oral/anal sexto help reduce thetransmission of bodily fluids,harmful pathogens, andsexually transmittedinfections. | The Line One Trust Dam isused as a barrier whenengaging in oral/vaginal sexand oral/anal sex to helpreduce the transmission ofbodily fluids, harmful germs,and sexually transmitteddiseases. |
| Design & dimensionalaspects | Thin, rectangular sheet withsmooth surface both sides155 mm x 254 mm,Thickness 0.07 mm | Thin, rectangular sheet withsmooth surface both sides154 mm x 250 mm, Thickness0.07 mm |
| Material | Natural rubber latex | Natural rubber latex |
| Lubricated | No | No |
| Color | Yellow, Pink, Purple, Green | Yellow, Red, Green |
| Fragrance/Flavor | Vanilla, Strawberry, Grape,Mint | Banana, Strawberry, Mint |
| MechanicalProperties | Tested in accordance withISO 29942:2011, includingthe following tests:• Tensile strength• Elongation at break• Tearing force• Freedom from holes• Tear resistance | Tested in accordance withASTM D3492:2008 |
| Sterile | No | No |
| Body Location TargetArea | Anal, vaginal, oral cavity(mouth) | Anal, vaginal, oral cavity(mouth) |
| Single Use | Yes | Yes |
| Shelf-life | 2 years | 5 years |
| BiocompatibilityTested? | Yes | Yes |
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SancDam™ Oral Latex Dam – Traditional 510(k)
The intended use of the subject device, SancDam™ Latex Oral Dam, and the legally marketed predicate devices, Line One Trust Dam (K091769), are the same. Both the subject device 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. The differences between the subject and predicate device include the
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colors, flavors, and shelf life. However, these differences in technological characteristics do not raise different questions of safety or effectiveness.
f. Nonclinical Testing
The following non-clinical testing was completed on the SancDam™ Latex Oral Dam:
- . Per ISO 29942:2011 Prophylactic dams -- Requirements and test methods
- Dimensional Testing O
- Tensile Testing and Elongation at Break O
- Tear Resistance and Tearing Force O
- Freedom from Holes and Visual Defects o
- O Packaging Integrity Testing
The bench testing was completed on aged and unaged samples to support the 2-year shelf life.
- 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) о
All test results were acceptable.
g. Conclusion
The results from the non-clinical bench testing above demonstrate that the SancDam™ Latex Oral Dam are as safe and effective as the predicate device and support a determination of substantial equivalence.
§ 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.