(148 days)
Not Found
No
The device is a personal lubricant and the description focuses on its physical properties, biocompatibility, and compatibility with condoms. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The 'Intended Use / Indications for Use' states the device is for moisturizing and lubricating to enhance sexual activity and supplement natural lubrication, not to treat or prevent a disease or condition.
No
The device is described as a personal lubricant intended to moisturize and lubricate for intimate sexual activity, relieve vaginal dryness, and enhance pleasure. Its intended use does not include diagnosing any medical condition or physiological state.
No
The device is a personal lubricant, which is a physical substance applied to the body, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product 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 describes a product for physical application and lubrication, not for diagnosing a condition or testing a sample from the body.
- Device Description: The device description reinforces this by describing the product as a "non-sterile silicone based personal lubricant" or "non-sterile water-based personal lubricant" for facilitating condom use, relieving vaginal dryness, and enhancing pleasure.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a biological sample (like blood, urine, tissue, etc.) or to provide information about a person's health status or condition.
- Over-The-Counter Use: The product is available over-the-counter, which is typical for personal lubricants and not for IVD devices which often require professional use or specific instructions for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic, monitoring, or screening purposes. This product does not fit that description.
N/A
Intended Use / Indications for Use
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.
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® 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.
SASMAR® WARMING 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® CHERRY 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® MELON 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, polylsoprene, and polyurethane condoms.
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.
SASMAR® STRAWBERRY 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.
Product codes (comma separated list FDA assigned to the subject device)
NUC
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-the-counter.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Traditional 510(k) SASMAR, Inc.
P 1 3 2013
510(K) SUMMARY
ADMINISTRATIVE 510(k)
SASMAR, INC. 155 North Wacker Drive Suite 4250 Chicago, IL 60606 USA
SASMAR SPRL
Contact
Submitter
John-Michael Mancini Chief Executive Officer Tel: (773) 942 0030 Fax: (773) 337 9148
40-42 rue de l'Association 1000 Brussels Belgium Tel +32 2 880 8220 Fax +32 2 880 8221
Manufacturer
Date Prepared
September 9, 2013
DEVICE NAMES AND CLASSIFICATIONS
| Trade / Proprietary Names | SASMAR® ORIGINAL
SASMAR® CLASSIC |
|---------------------------|---------------------------------------------|
| Common Name | Personal Lubricant |
| Classification | Condom
Class II (21 CFR 884.5300)
NUC |
SUBSTANTIAL EQUIVALENCE
- For SASMAR® CLASSIC: . Lifestyles® Natural Personal Lubricant (K122054) For SASMAR® ORIGINAL:
- . K-Y® Brand Intrigue (K062796)
1
Traditional 510(k) SASMAR, Inc.
Image /page/1/Picture/2 description: The image shows the word "sasmar" in a stylized font. The word is enclosed in an oval shape. There is a small dot above the letter "a" in "sasmar."
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.
2
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three flowing lines representing support and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.
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.
4
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 (800) 638-2041 or (301) 796-7100 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
5
Image /page/5/Picture/0 description: The image shows the word "sasmar" in a stylized, oval-shaped logo. The text is in a bold, sans-serif font and appears to be white against a dark background. The oval shape surrounding the text has a thick border, giving the logo a distinct and recognizable appearance.
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)
6
Image /page/6/Picture/0 description: The image shows the word "sasmar" in a stylized font. The word is white and is surrounded by a black oval. The oval is thick and has a slightly irregular shape.
INDICATIONS FOR USE
| 510(k) Number: | K131084 |
|---|---|
| Device Name: | SASMAR® ORIGINAL |
| Indications for 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. |
| Prescription Use
| (Part 21 CFR 801 Subpart D) | _____________________________________________________________________________________________________________________________________________________________ |
|---|---|
| AND/OR Over-The-Counter Use | |
| (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)
7
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
8
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
×
9
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)
10
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
×
11
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)
12
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
×