O-RING Condom

K150828 · O-Ring Products, LLC · HIS · Dec 18, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K150828
• Device Name: O-RING Condom
• Applicant: O-Ring Products, LLC
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Dec 18, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.

Device Story

O-RING Condom is a natural rubber latex sheath designed to cover the erect penis; features a patented illuminated ring on the underside of the rolled condom; lubricated with silicone and dressed with cornstarch. Straight-walled design with reservoir tip; nominal length 180mm, flat width 52mm, thickness 0.07mm. Intended for over-the-counter use by individuals for contraception and prophylaxis against sexually transmitted diseases. Device functions as a physical barrier; illumination feature is integrated into the condom structure. No electronic processing or clinical decision-making output involved.

Clinical Evidence

Bench testing only. Device demonstrated compliance with ISO 4074 requirements for burst volume, burst pressure, water leakage, visual defects, and package integrity. Biocompatibility testing confirmed the device is non-cytotoxic (MEM Elution), non-sensitizing (Guinea Pig Maximization), non-irritant (Vaginal Irritation), and non-toxic (Acute Systemic Injection). Shelf life validated for 5 years per 21 CFR 801.435.

Technological Characteristics

Natural rubber latex sheath; straight-walled with reservoir tip; nominal length 180mm, flat width 52mm, thickness 0.07mm. Lubricated with silicone; cornstarch dressing. Features a patented illuminated ring. Conforms to ISO 4074 standards. Biocompatibility per ISO 10993 series.

Indications for Use

Indicated for use by individuals for contraception and the prevention of pregnancy and sexually transmitted diseases, including HIV.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• M.Dior Brand male latex (K083817)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2015

O-RING Products LLC William Mistler President 4012 Grand Manor Court, #208 Raleigh, NC 27612

Re K150828 Trade/Device Name: O-RING Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: HIS Dated: November 20, 2015 Received: November 25, 2015

Dear William Mistler,

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 [phone] or [phone] 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 [phone] or [phone] 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) K150828

Device Name O-RING Condom

#### Indications for Use (Describe)

The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: underline;">☐</span> Research Use Only (21 CFR 201.26) Select One | <span style="text-decoration: underline;">☒</span> Over-The-Counter Use Only (21 CFR 201.26) Select One |
|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|

__ 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

| Submitted by: | O-Ring Products, LLC<br>4012 Grand Manor<br>Court<br>Raleigh, NC 27612 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Persons: | William Mistler,<br>President<br>O-Ring Products, LLC<br>4012 Grand Manor Court<br>Raleigh, NC 27612<br>Tel: [phone]<br>Email:<br>[e-mail] |
| Date Prepared: | December 14, 2015 |
| Proprietary Name: | O-Ring Condom |
| Common Name: | Male Natural Rubber Latex Condom |
| Classification Name: | Condom |
| Regulation: | 21 CFR §884.5300 |
| Product Code: | HIS |
| Device Class: | Class II |
| Predicate Device: | M.Dior Brand male latex<br>K083817 |

#### Description of Device:

This condom is made of a natural rubber latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom design features a patented illuminated ring on the underneath side of the rolled condom. It is lubricated with silicone and cornstarch is used as a dressing material.

This condom is a straight walled with a reservoir tip; nominal length 180mm, nominal flat width 52mm, and nominal thickness 0.07 +/- 0.01 mm.

This condom is designed to conform to established national and international voluntary standards (ISO 4074).

#### Intended Use of the Device:

This natural rubber latex condom has the same intended use as the predicate condom.

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The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.

### Technological Characteristics:

The 510(k) subject condom, O-RING Condom, has the same technological characteristics as the predicate condom K083817.

## Performance Testing:

The following performance testing was completed on the subject condom.

# STRENGTH AND INTEGRITY TESTING RESULTS:

| Burst Volume | meets ISO 4074 requirements |
|-------------------|-----------------------------|
| Burst Pressure | meets ISO 4074 requirements |
| Water Leakage | meets ISO 4074 requirements |
| Visual Defects | meets ISO 4074 requirements |
| Package integrity | meets ISO 4074 requirements |

# BIOCOMPATABILITY TESTS

NLI #735574 MEM Elution GLP Report

non-cytotoxic

RESULTS

NLI #737876 ISO Guinea Pig Maximization Sensitization Test GLP

no elicit sensitization response

NLI #737877 ISO Mucosal (Vaginal) Irritation Test GLP

non-irritant

NLI #772222 ISO Acute Systemic Injection Test GLP

# no signs of toxicity

#### Shelf Life:

The O-RING Condom has a shelf life of 5 years based on studies conducted per 21 CFR 801.435 guidelines.

# Conclusion:

The O-RING Condom is substantially equivalent to the proposed predicate device.