(66 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a natural rubber latex condom, with no mention of AI or ML.
No.
The device is used for contraception and prophylaxis, which are preventative measures, not therapeutic treatments for an existing condition.
No
The device is a condom used for contraception and reduction of STI transmission; its purpose is preventive, not diagnostic.
No
The device description clearly states it is a physical condom made of natural rubber latex, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for contraception and prophylactic purposes (preventing pregnancy and STIs). This is a direct physical barrier method, not a test performed on samples taken from the body.
- Device Description: The description details a physical device (a condom) that is applied externally.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The LifeStyles NRL Textured Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Product codes
HIS
Device Description
The LifeStyles® NRL Textured Condom is indicated for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections). The condom is a single use device made of a noncolored natural rubber latex sheath that covers the penis with a closely fitted membrane. The condom is textured with dots along its straight shaft, includes a reservoir tip at the closed end to contain semen, and is coated with a silicone lubricant. The LifeStyles® NRL Textured Condom has a nominal length of 190 mm, width of 53 mm, and thickness of 0.08 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Biocompatibility studies were performed in accordance with the 2020 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", as summarized below:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The results of testing demonstrate that the subject device is non-cytotoxic, nonirritating, non-sensitizing, and not acutely systemically toxic.
Physical Property Testing: The LifeStyles® NRL Textured Condom was tested and met the requirements of ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms) and ISO 4074:2015 Natural Rubber Latex Condoms - Requirements and test methods.
Shelf-Life: The LifeStyles® NRL Textured Condom has a five-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria.
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.
0
Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 5, 2023
Suretex Limited % Donna DiGangi Principal DiGangi Consulting, LLC 708 Firethorn Lane Round Rock, TX 78664
Re: K232279
Trade/Device Name: LifeStyles® NRL Textured Condom Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: July 27, 2023 Received: July 31, 2023
Dear Donna DiGangi:
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.
1
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.
Michael T. Bailey -S
For Monica D.Garcia, 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
2
Indications for Use
510(k) Number (if known) K232279
Device Name LifeStyles® NRL Textured Condom
Indications for Use (Describe)
The LifeStyles NRL Textured Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of 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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3
K232279 Page 1 of 4
510(k) Summary K232279
Submitter:
Suretex Limited 31/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai, Amphur Phunphin Suratthani 84130 THAILAND
Contact Person:
Alison Arnot Phone: +66 77 277 400 Fax: +66 77 277 428 Email: alison.arnot@lifestyles.com
Date Prepared:
September 28, 2023
Device Name:
| Trade Name: | LifeStyles® NRL Textured Condom |
|---|---|
| Common Name: | Male natural rubber latex condom |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Device Class: | Class II |
| Product Code: | HIS (Condom) |
Predicate Device Information:
| Trade Name: | FAMA Male Latex Condoms |
|---|---|
| 510K Number: | K220576 |
| Manufacturer: | Shanghai Personage Hygiene Products Co. Ltd |
| Common Name: | Male natural rubber latex condom |
| Regulation Name: | Condom |
| Regulation Number: | 21 CFR 884.5300 |
| Device Class: | Class II |
| Product Code: | HIS (Condom) |
4
The predicate device has not been subject to a design-related recall.
Device Description:
The LifeStyles® NRL Textured Condom is indicated for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections). The condom is a single use device made of a noncolored natural rubber latex sheath that covers the penis with a closely fitted membrane. The condom is textured with dots along its straight shaft, includes a reservoir tip at the closed end to contain semen, and is coated with a silicone lubricant. The LifeStyles® NRL Textured Condom has a nominal length of 190 mm, width of 53 mm, and thickness of 0.08 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.
The LifeStyles® NRL Textured Condom conforms with FDA-recognized consensus standards ASTM D3492-16 - Standard Specification for Rubber Contraceptives (male condoms) and ISO 4074:2015 - Natural Rubber Latex Condoms – Requirements and test methods.
| Parameter | Specification |
|---|---|
| Lubricant quantity (mg) | 400 – 600 |
| Length (mm) | 190±10 |
| Width (mm) | 53 ± 2 |
| Thickness (mm) | 0.080± 0.01 |
| Burst Volume, min (dm³) | 18 |
| Burst Pressure, min (kPa) | 1.0 |
Table 1. Condom Specifications
Indications for Use:
The LifeStyles NRL Textured Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
5
Comparison of Intended Use and Technological Characteristics with the Predicate Device
| Parameter | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Device Name | LifeStyles® NRL Textured | ||
| Condom | |||
| K232279 | FAMA Male Latex Condoms | ||
| K220576 | Same | ||
| Product Code | HIS | HIS | Same |
| Class | II | II | Same |
| Classification | 21 CFR 884.5300, Condom | 21 CFR 884.5300, Condom | Same |
| Indications for Use | The LifeStyles NRL Textured | ||
| Condom is used for | |||
| contraception and | |||
| prophylactic purposes (to | |||
| help prevent pregnancy and | |||
| the transmission of sexually | |||
| transmitted infections). | The FAMA Male Latex | ||
| Condoms are used for | |||
| contraception and | |||
| prophylactic purposes (to | |||
| help prevent pregnancy and | |||
| the transmission of sexually | |||
| transmitted infections). | Same | ||
| Prescription or Over | |||
| the Counter (OTC) | |||
| Use | OTC | OTC | Same |
| Style | Straight-walled, nipple ended | Straight-walled, nipple ended | Same |
| Texture | Dotted | Straight-walled, nipple ended | |
| Smooth, ribbed, or dotted | |||
| texture | Different | ||
| Color Additives | No | No | Same |
| Formulation | Natural Rubber Latex | Natural Rubber Latex | Same |
| Lubricant | Silicone oil | Silicone oil | Same |
| Dusting Agent | USP Grade Corn Starch | Silicon dioxide | Different |
| Length (mm) | $190\pm10$ | $180\pm10$ | Different |
| Width (mm) | $53 \pm 2$ | $53 \pm 2$ | Same |
| Thickness (mm) | $0.080mm \pm 0.01$ | 0.068 - 0.069 | Different |
| Burst Volume (dm³) | ≥18 | ≥18 | Same |
| Burst Pressure(kPa) | ≥1.0 | ≥1.0 | Same |
| Sterile | No | No | Same |
| Shelf Life | 5 years | 5 years | Same |
| Table 2. Technological Characteristics and Comparison to the Predicate Device | |||
|---|---|---|---|
The subject device has the same indications for use and intended use as the predicate device. The subject and predicate devices have differences in their technological characteristics (e.g., dusting agent, texture, length and thickness); however, these differences do not raise different questions of safety and effectiveness.
6
Summary of Non-Clinical Performance testing
Biocompatibility
Biocompatibility studies were performed in accordance with the 2020 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", as summarized below:
- Cytotoxicity (ISO 10993-5:2009) ●
- . Sensitization (ISO 10993-10:2010)
- Vaginal Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017)
The results of testing demonstrate that the subject device is non-cytotoxic, nonirritating, non-sensitizing, and not acutely systemically toxic.
Physical Property Testing
The LifeStyles® NRL Textured Condom was tested and met the requirements of ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms) and ISO 4074:2015 Natural Rubber Latex Condoms - Requirements and test methods.
Shelf-Life
The LifeStyles® NRL Textured Condom has a five-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435. All samples met predefined acceptance criteria.
Conclusion
The results of performance testing demonstrate that the LifeStyles® NRL Textured Condom is as safe and effective as the predicate device and supports a determination of substantial equivalence.