SASMAR ORIGINAL, SASMAR CLASSIC

K131084 · Sasmar, Inc. · NUC · Sep 13, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K131084
• Device Name: SASMAR ORIGINAL, SASMAR CLASSIC
• Applicant: Sasmar, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Sep 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

SASMAR® ORIGINAL is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. SASMAR® CLASSIC is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Device Story

Personal lubricants (silicone-based Original; water-based Classic/flavored variants) designed for penile/vaginal application; intended to moisturize, lubricate, and enhance comfort during sexual intimacy. Compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Available over-the-counter in pump dispensers, tubes, or sachets. Used by consumers to supplement natural lubrication; facilitates condom use. No complex processing or clinical decision-making involved; device provides physical lubrication benefit.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, vaginal irritation, sensitization, systemic toxicity per ISO 10993), condom compatibility (ASTM D7661), and physical/microbial characterization (viscosity, pH, osmolarity, microbial counts, antimicrobial effectiveness). Shelf-life established via aging studies.

Technological Characteristics

Proprietary silicone-based (Original) and water-based (Classic/flavored) formulations. Physical properties: viscosity, pH, osmolarity, specific gravity. Compatibility: ASTM D7661 for condom interaction. Biocompatibility: ISO 10993. Microbial quality: USP testing for microbial counts and effectiveness. Shelf-life: 30 months.

Indications for Use

Indicated for individuals requiring personal lubrication for penile and/or vaginal application to moisturize, lubricate, and enhance comfort during sexual activity. Compatible with natural rubber latex, polyisoprene, and polyurethane condoms. No specific age or gender contraindications provided.

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

• Lifestyles® Natural Personal Lubricant (K122054)
• K-Y® Brand Intrigue (K062796)

Submission Summary (Full Text)

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Traditional 510(k) SASMAR, Inc.

P 1 3 2013

# 510(K) SUMMARY

ADMINISTRATIVE 510(k)

K131084

SASMAR, INC. 155 North Wacker Drive Suite 4250 Chicago, IL 60606 USA

SASMAR SPRL

Contact

Submitter

John-Michael Mancini Chief Executive Officer Tel: [phone] Fax: [phone]

40-42 rue de l'Association 1000 Brussels Belgium Tel [phone] Fax [phone]

Manufacturer

Date Prepared

September 9, 2013

#### DEVICE NAMES AND CLASSIFICATIONS

| Trade / Proprietary Names | SASMAR® ORIGINAL<br>SASMAR® CLASSIC |
|---------------------------|---------------------------------------------|
| Common Name | Personal Lubricant |
| Classification | Condom<br>Class II (21 CFR 884.5300)<br>NUC |

#### SUBSTANTIAL EQUIVALENCE

- For SASMAR® CLASSIC: . Lifestyles® Natural Personal Lubricant (K122054) For SASMAR® ORIGINAL:
- . K-Y® Brand Intrigue (K062796)

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Traditional 510(k) SASMAR, Inc.

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#### DEVICE DESCRIPTION

SASMAR® ORIGINAL is a non-sterile silicone based personal lubricant for penile and/or vaginal application intended to facilitate condom use, provide additional moisture to relieve vaginal dryness and enhance pleasure during sexual intimacy. The device may be used as a massage lotion and is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

This product is provided in a plastic pump dispenser or a foil laminate sachet and is available over-thecounter.

SASMAR® CLASSIC is a non-sterile water-based personal lubricant for penile and/or vaginal application intended to facilitate condom use, provide additional moisture to relieve vaginal dryness and enhance pleasure during sexual intimacy. The formula is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

The device is available in the following variant personal lubricant formulas: SASMAR® Warming, SASMAR® Vanilla, SASMAR® Melon, SASMAR® Cherry, SASMAR® Strawberry or SASMAR® Pina Colada.

This product is provided in a plastic pump dispenser, a plastic tube with flip-top closure or a foil laminate sachet and is available over-the-counter.

#### INTENDED USE

SASMAR® ORIGINAL is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms

SASMAR® CLASSIC is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

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Image /page/2/Picture/1 description: The image shows the word "sasmar" in white letters on a black oval background. The word is written in a sans-serif font, and the letters are slightly rounded. The oval is outlined in black, and there is a small amount of white space between the letters and the edge of the oval. The image is simple and clean, and the word is easy to read.

Traditional 510(k) SASMAR, Inc.

#### TECHNOLOGICAL CHARACTERISTICS

SASMAR® ORIGINAL and SASMAR® CLASSIC are proprietary formulations. The devices have similar ingredients, similar composition and intended use as other lubricants currently sold on the U.S market and are substantially equivalent to the predicate device. Any minor differences in technological characteristics between the predicate devices do not raise new issues of safety or efficacy. Testing per ASTM D7661 indicates that the lubricant formulations are compatible with condoms. As with the predicate, testing for cytotoxicity, vaginal irritation, sensitization and systemic toxicity in accordance with ISO 10993 indicated device biocompatibility. Bench testing indicated that the lubricant is has an appropriate viscosity, pH, osmolarity, specific gravity, appearance, color and odor for substantial equivalence to the predicates. USP testing for Total Aerobic Microbial Count, Total Yeast and Mold Count, absence of microbial pathogens and antimicrobial effectiveness indicated microbial quality. Long term, accelerated and real time aging tests for physical parameters and microbial characteristics indicate a 30 month shelf-life for the lubricants.

#### CONCLUSION

SASMAR® ORIGINAL and SASMAR® CLASSIC have the same intended use and basic technological characteristics as the predicate devices and are as safe and effective as their predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

September 13, 2013

SASMAR, Inc. % John-Michael Mancini Chief Executive Officer 155 North Wacker Drive, Suite 4250 Chicago, IL 60606

Re: K131084

Trade/Device Name: SASMAR® CLASSIC, SASMAR® ORIGINAL, SASMAR® VANILI.A, SASMAR® WARMING, SASMAR® CHERRY, SASMAR™ MELON, SASMAR® PINA COLADA, SASMAR® STRAWBERRY Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC

Dear John-Michael Mancini,

Dated: July 29. 2013 Received: August 14, 2013

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 docs 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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Page 2 - John-Michael Mancini

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm | | 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicaiDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -S

for 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

K131084 510(k) Number:

SASMAR® CLASSIC Device Name:

SASMAR® CLASSIC is a personal lubricant, for penile and/or Indications for use: vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

_ AND/OR Over-The-Counter Use Prescription Use _ X ____________________________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# INDICATIONS FOR USE

| 510(k) Number: | K131084 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | SASMAR® ORIGINAL |
| Indications for use: | SASMAR® ORIGINAL is a personal lubricant, for penile and/or<br>vaginal application, intended to moisturize and lubricate, to<br>enhance the ease and comfort of intimate sexual activity and<br>supplement the body's natural lubrication. This product is<br>compatible with natural rubber latex, polyisoprene, and<br>polyurethane condoms. |

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | _____________________________________________________________________________________________________________________________________________________________ |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AND/OR Over-The-Counter Use<br>(21 CFR 801 Subpart C) | ________________________________________________________________________________________________________________________________________________ X ________ |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/7/Picture/0 description: The image shows the word "sasmar" in a stylized font. The word is enclosed in an oval shape. The text and the oval are both black, contrasting with the white background.

#### INDICATIONS FOR USE

K131084 510{k) Number:

SASMAR® VANILLA Device Name:

Indications for use: SASMAR® VANILLA is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

_ AND/OR Over-The-Counter Use Prescription Use _ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S

X

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Image /page/8/Picture/0 description: The image shows the word "sasmar" in a stylized font. The word is enclosed in an oval shape. The text and the oval are both in black, contrasting with the white background.

# INDICATIONS FOR USE

- K131084 510(k) Number:
SASMAR® WARMING Device Name:

SASMAR® WARMING is a personal lubricant, for penile Indications for use: and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

__ AND/OR Over-The-Counter Use Prescription Use _ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S

×

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Image /page/9/Picture/0 description: The image shows the word "sasmar" in white letters against a black oval background. The letters are in a simple, sans-serif font. The oval shape is slightly distorted, with some rough edges. The image has a simple and clean design.

## INDICATIONS FOR USE

- K131084 510(k) Number:
SASMAR® CHERRY Device Name:

SASMAR® CHERRY is a personal lubricant, for penile and/or Indications for use: vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

_ AND/OR Over-The-Counter Use × Prescription Use _ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/10/Picture/0 description: The image shows the word "sasmar" in white letters against a black oval background. The letters are in a simple, sans-serif font. The oval shape is slightly distorted, with a rough edge. The image appears to be a logo or brand mark.

# INDICATIONS FOR USE

- K131084 510(k) Number:
SASMAR® MELON Device Name:

SASMAR® MELON is a personal lubricant, for penile and/or Indications for use: vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polylsoprene, and polyurethane condoms.

_ AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S

×

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Image /page/11/Picture/0 description: The image shows the word "sasmar" in white letters against a black oval background. The letters are in a sans-serif font and appear to be slightly bolded. The oval shape is solid black, providing a stark contrast to the white text.

# INDICATIONS FOR USE

K131084 510(k) Number:

SASMAR® PINA COLADA Device Name:

Indications for use: SASMAR® PINA COLADA is a personal lubricant, for penile and/or vaginal application, Intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Prescription Use _ (Part 21 CFR 801 Subpart D)

_ AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

×

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/12/Picture/0 description: The image shows the word "sasmar" in a stylized font. The word is white and is set against a black oval background. The font appears to be sans-serif and slightly rounded.

### INDICATIONS FOR USE

K131084 510(k) Number:

SASMAR® STRAWBERRY Device Name:

SASMAR® STRAWBERRY is a personal lubricant, for penile Indications for use: and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

_ AND/OR Over-The-Counter Use _ Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S

×