(77 days)
The Lifestyles Zero Lubricated Latex Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
This condom is a single use and non-sterile device intended for in home use by a consumer. The condom is made of a natural rubber latex sheath, which completely covers the penis with closely fitted membrane. The condom provides a physical barrier to fluids which helps reduce the risk of pregnancy and the transmission of sexually-transmitted infections. The device is a straight walled, cylindrical, lubricated condom with a reservoir tip. Condom dimensions are length 180+/- 10 mm, width 52±2mm, and thickness 0.045+/-0.005 mm. The condom is designed to conform to the requirements of ASTM D3492:2015 - Standard Specification for Rubber Contraceptives (Male Condoms).
Here's a breakdown of the acceptance criteria and the study information for the Lifestyles Zero Lubricated Latex Male Condom, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Technological Characteristic | Standard/Test/FDA Guidance | Acceptance Criteria (Specification) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|---|
| Dimensions | ASTM D3492-15 | |||
| - Length | 170mm to 210 mm | 180 +/- 10 mm | Yes | |
| - Width | Maximum 57 mm | 52 +/- 2 mm | Yes | |
| - Thickness | Minimum 0.03 mm | 0.045 +/- 0.005 mm | Yes | |
| Burst Properties | ASTM D3492-15 | |||
| - Air Burst Test Pressure | Minimum 18L | Meets ASTM D3492-15 for Air Burst test pressure | Yes | |
| - Air Burst Test Volume | Minimum 1 kPa | Meets ASTM D3492-15 for Air Burst test volume | Yes | |
| Leakage AQL | ASTM D3492-15 | 0.25 (as per ASTM D3492-15) | Meets ASTM D3492-15 for Leakage AQL of 0.25 | Yes |
| Package Integrity AQL | ASTM D3492-15 | 2.5 (as per ASTM D3492-15) | Meets ASTM D3492-15 for Package Integrity AQL of 2.5 | Yes |
| Lubricant Quantity | Not defined | 400 – 600 mg | 400 – 600 mg | Yes |
| Biocompatibility | ISO 10993-5, 10993-10, 10993-11, FDA Guidance (June 16, 2016) | Not toxic (local or systemic), sensitizing, or locally irritating | Not toxic, sensitizer, or irritant (except for some cytotoxicity in vitro, explained and mitigated) | Yes |
| Shelf Life | 21 CFR 801.435 | 5 years (based on accelerated stability) | 5 years (based on accelerated stability) | Yes |
Regarding the Study Information:
The document describes several performance tests and validations performed to demonstrate the safety and effectiveness of the device, particularly in relation to the slightly thinner design compared to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test mentioned (e.g., the number of condoms tested for air burst, leakage, or dimensions). It refers to conformance with standards like ASTM D3492-15 and ISO 10993 series, which typically define appropriate sample sizes for such testing.
The data provenance is not explicitly stated as "country of origin" for the specific test data. However, the submitter is Ansell Healthcare Products LLC, located in Iselin, NJ, USA. The testing was conducted for regulatory submission in the USA. All studies appear to be prospective, laboratory-based, and animal-based (for some biocompatibility tests), rather than retrospective human studies with specific patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This type of information is generally not applicable to the tests described in this 510(k) summary. The "ground truth" for these tests (e.g., dimensions, burst properties, leakage, lubricant quantity) is established by the specified standards (ASTM D3492-15) and internal quality control specifications, measured by calibrated equipment and trained technicians, not by expert consensus in a clinical evaluation sense.
For the biocompatibility studies, the "ground truth" is based on established biological evaluation standards (ISO 10993 series) and the scientific interpretation of the test results by trained toxicologists and histopathologists. The document does not specify the number or qualifications of these expert interpreters, but it would be implied that they are qualified professionals in a laboratory setting.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for clinical trials or studies where human readers interpret data (e.g., medical images) and their assessments are compared to reach a consensus for ground truth. This is not applicable to the physical and biological performance tests described here. The results of the mechanical tests are quantitative measurements against defined specifications. The biocompatibility tests involve laboratory observations and interpretations, which are then reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices evaluating human performance, which is not the nature of this condom submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical product (a condom), not a software algorithm or AI-driven diagnostic tool.
7. The Type of Ground Truth Used
- For Physical Testing (Dimensions, Burst Properties, Leakage, Package Integrity, Lubricant Quantity): The "ground truth" is defined by the quantitative specifications and methodology within ASTM D3492-15 Standard Specification for Rubber Contraceptives (Male Condoms). These are objective, measurable parameters.
- For Biocompatibility (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity): The "ground truth" is established through adherence to and interpretation of results from ISO 10993-5, ISO 10993-10, and ISO 10993-11 standards, which include biological assays and animal studies. The "ground truth" here is the biological response (or lack thereof) observed in the standard test systems, interpreted by qualified personnel.
8. The Sample Size for the Training Set
This product is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data an algorithm learns from. The device itself is manufactured, and its performance is tested against established standards.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an algorithm, this question is not applicable to this device submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The profiles are rendered in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2017
Ansell Healthcare Products, LLC Robert Mahler Director, Regulatory Affairs 111 Wood Avenue South, Suite 210 Iselin. NJ 08830
Re: K163107 Trade/Device Name: Lifestyles Zero Lubricated Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: HIS Dated: November 4, 2016 Received: November 7, 2016
Dear Robert Mahler,
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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) K163107
Device Name
Lifestyles Zero Lubricated Latex Male Condom
Indications for Use (Describe)
The Lifestyles Zero Lubricated Latex Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
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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510k Summary - K163107
Submitter:
Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830, USA
Contact Person:
Robert S. Mahler Director Regulatory Affairs for the Americas Phone: 732-345-2174 Rob.mahler@ansell.com
Date Prepared
January 23, 2017
Device Name:
| Proprietary Name: | Lifestyles Zero Lubricated Latex Male Condom |
|---|---|
| Common Name: | Condom, Natural Rubber Latex |
| Classification Regulation: | 21 CFR 884.5300 |
| Device Class: | Class II |
| Product Code: | HIS; condom |
| Classification Panel: | Obstetrics/Gynecology |
| Classification Name: | Condom |
Reason for 510(k) Submission:
New product.
Predicate Device:
K941258 – Latex Condom with Silicone Oil Lubricant. The predicate device has not been subject to a design related recall.
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Device Description:
This condom is a single use and non-sterile device intended for in home use by a consumer. The condom is made of a natural rubber latex sheath, which completely covers the penis with closely fitted membrane. The condom provides a physical barrier to fluids which helps reduce the risk of pregnancy and the transmission of sexually-transmitted infections. The device is a straight walled, cylindrical, lubricated condom with a reservoir tip. Condom dimensions are length 180+/- 10 mm, width 52±2mm, and thickness 0.045+/-0.005 mm. The condom is designed to conform to the requirements of ASTM D3492:2015 - Standard Specification for Rubber Contraceptives (Male Condoms).
Indications for Use:
The Lifestyles Zero Lubricated Latex Male Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).
Technological Characteristics:
The Lifestyles Zero Lubricated Latex Male Condom has the following technological characteristics as compared to ASTM or equivalent standards
| TechnologicalCharacteristic | Standard/Test/FDAGuidance | Specification |
|---|---|---|
| Dimensions | ASTM D3492-15 | |
| ■ Length | 170mm to 210 mm | $180 +/- 10$ mm |
| ■ Width | Maximum 57 mm | $52\pm2$ mm |
| ■ Thickness | Minimum 0.03 mm | $0.045+/-0.005$ mm |
| Burst Properties | ASTM D3492-15 | |
| ■ Air Burst TestPressure | Minimum 18L | Meets ASTM D3492-15 forAir Burst test pressure |
| ■ Air Burst TestVolume | Minimum 1 kPa | Meets ASTM D3492-15 forAir Burst test volume |
| Leakage AQL | ASTM D3492-15 | Meets ASTM D3492-15 forLeakage AQL of 0.25 |
| Package integrity AQL | ASTM D3492-15 | Meets ASTM D3492-15 forPackage Integrity AQL of 2.5 |
| Lubricant Quantity | Not defined | 400 – 600 mg |
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Substantial Equivalence:
| Predicate Device | Subject Device | SubstantialEquivalence | |
|---|---|---|---|
| Trade Name | Latex Condom with silicone oil lubricant | Lifestyles ZERO | Not applicable |
| 510(k) Number | K941258 | K163107 | Not applicable |
| Submitter | Suretex Ltd. | Ansell Healthcare Products LLC | Yes |
| Product Code | HIS | HIS | Yes |
| RegulationNumber | 21 CFR 884.5300 | 21 CFR 884.5300 | Yes |
| RegulationName | Condom | Condom | Yes |
| Indications forUse | This device is a latex condom indicated for contraception and as an aid to prevention of sexually-transmitted diseases (STDs) | The Lifestyles Zero Lubricated Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs) | Yes; minor difference in language of indications statements does not alter intended use |
| Prescriptionor Over-TheCounter-Use | Over-The-Counter-Use | Over-The-Counter-Use | Yes |
| Materials | Natural rubber latex | Natural rubber latex | Yes |
| Form | Straight wall, nipple end | Straight wall, nipple end | Yes |
| LubricantCoating | Silicone gel | Silicone gel | Yes |
| Design | Single use | Single use | Yes |
| Dimensions | ASTM D3492-15 | ASTM D3492-15 | Yes |
| Length | $180 +/- 10 mm$ | $180 +/- 10 mm$ | Yes |
| Width | $52\pm2 mm$ | $52\pm2 mm$ | Yes |
| Thickness | $0.060-080$ | $0.045+/-0.005 mm$ | Different |
| Burst Properties | ASTM D3492-15 | ASTM D3492-15 | Yes |
| Predicate Device | Subject Device | SubstantialEquivalence | |
| Air Burst TestPressure | Minimum 18L | Minimum 18L | Yes |
| Air Burst TestVolume | Minimum 1 kPa | Minimum 1 kPa | Yes |
| Leakage AQL | ASTM D3492-15 | ASTM D3492-15 | Yes |
| Packageintegrity AQL | ASTM D3492-15 | ASTM D3492-15 | Yes |
| LubricantQuantity | 400-600 mg | 400-600 mg | Yes |
| Sterilization | Non-Sterile | Non-Sterile | Yes |
| Shelf Life | 5 years | 5 years | Yes |
| Biocompatibility | "Under the conditions of thestudy, not an irritant" and"Under the conditions of thestudy, not a sensitizer" | "Under the conditions of thestudy, not an irritant" and"Under the conditions of thestudy, not a sensitizer" | Yes |
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The basic technological characteristics of the Lifestyles Zero Lubricated Latex Male Condom are similar to the predicate device. The Lifestyles Zero Lubricated Latex Male Condom and the predicate are made of natural rubber latex, both are straight walled, nipple ended, lubricated condom with an integral ring at the open end. The condom designs conform to the requirements of ASTM D3492:2015 - Standard Specification for Rubber Contraceptives (Male Condoms) and ISO 4074:2015 Natural rubber latex male condoms- Requirements and test methods. The only difference between the subject device and the predicate is the thickness of the condom: 0.040-0.050 mm for this device.
This difference in the technological characteristics does not raise different questions of safety or efficacy in the subject device.
Performance Data:
The subject condom has been tested in conformance with the 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" Guidance for Industry and Food and Drug Administration Staff," issued June 16, 2016. The subject device is indicated for contact with a skin and/or mucosal membrane surfaces for 24 hours or less. Therefore, the device was evaluated for cytotoxicity, irritation, sensitization and acute
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systemic toxicity as described below. The condom was demonstrated to be not toxic (local or systemic), sensitizing, or locally irritating.
Cytotoxicity
Lifestyles® Zero® Lubricated Latex Condom was tested per ISO 10993-5 Biological Evaluation of Medical Devices - Part 5. Tests for In Vitro Cytotoxicity
Cytotoxicity test were conducted using the elution method Utilizing serial dilutions of device extract ranged from undiluted to a ratio of 1:32. Severe cytotoxic reactivity was observed for extracts at undiluted and dilutions of 1:2, whereas no cytotoxic reactivity was found for any extracts at lower dilutions.
Such findings are not unexpected for synthetic and natural rubber latexes, and do not necessarily translate to local or systemic toxicity in clinical use. This was the case for the subject condom, where cytotoxic reactions were observed in cell culture assays but there was no evidence of systemic toxicity from the animal studies conducted (as described below).
Irritation and sensitization
Lifestyles® Zero® Lubricated Latex Condom was testing per ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10, Tests for Irritation and Sensitization
Based on the results obtained in the study, it is concluded that the Lifestyles® Zero® Lubricated Male Latex Condom is not considered an irritant or a sensitizer.
Vaginal irritation:
The test article was evaluated for vaginal irritation per ISO 10993-10:2010. The extracts of the test article did not show any signs of vaginal irritation and the average mucosal vaginal irritation scores were within acceptable limits. Test data demonstrates that the device is nonirritating.
Penile irritation:
The test article was evaluated for penile irritation test per ISO 10993-10:2010. No signs of penile irritation were evident macroscopically or microscopically. The penile irritation indices obtained were within the acceptable limit. Test data demonstrates that the device is non-irritating.
Sensitization:
The test article was assessed for sensitization using guinea pig maximization test per ISO 10993-10:2010. Under the conditions of the study, the device was demonstrated to not be a sensitizer.
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Acute systemic toxicity
Lifestyles® Zero® Lubricated Latex Condom conforms to the requirements of ISO 10993-11 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity.
The test article was evaluated for Acute Systemic Toxicity test. There was no mortality or evidence of systemic toxicity resulted from the test article extract. Test data showed that the test article extract did not show any systemic toxicity.
Physical Testing:
The Lifestyles® Zero® Lubricated Latex Condom was tested and met all the requirements of ASTM D3492-15 Standard Specification for Rubber Contraceptives (Male Condoms).
Shelf Life Testing:
The Lifestyles® Zero® Lubricated Latex Condom has a five-year shelf life based on the results of accelerated stability evaluations conducted as required in 21 CFR 801.435. Five-year expiration dating will be verified with ongoing real time stability evaluations as required in 21 CFR 801.435.
Conclusion:
The subject and predicate devices have the same intended use and similar technological characteristics. The subject device is different from the predicate device in that it is thinner. However, this difference does not raise different questions of safety or effectiveness. The difference was assessed through biocompatibility testing and mechanical performance testing. Performance data demonstrated that the subject device is as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate device.
§ 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.