TACTYLON CONDOM by SENSICON CORP.

For Latex Sensitive Condom Users: This is a TACTYLON® condom. This is not a latex condom. You may use this TACTYLON ® condom if you or your partner are allergic to latex. You should know: - . The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS (HIV infection), are not known for this condom. A study is being done. - . There are laboratory tests on this TACTYLON® material. These tests show that organisms even as small as sperm and viruses like HIV cannot pass through it. Latex condoms for men, if used correctly with every act of vaginal intercourse are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection).

Device Description

The synthetic TACTYLON® condom contains neither NRL protein allergens nor sensitizing chemicals. The TACTYLON® condom is made from styrene-ethylene-butylene-styrene thermoplastic elastomer block copolymer but has physical properties (e.g., strength, elasticity, and tactility) and dimensions that are substantially equivalent to a NRL condom.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the LUBRICATED HIGH ELONGATION CONDOM, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are based on demonstrating substantial equivalence to Natural Rubber Latex (NRL) condoms, particularly concerning barrier properties, clinical breakage/slippage rates, and safety (non-allergenicity, non-toxicity, non-irritating).

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Material Safety (Non-Toxicity)	Meets FDA Class VI requirements for materials.	TACTYLON® block copolymer meets FDA Class VI requirements. Plastisizer is USP recognized as safe for human consumption. No primary skin irritation or vaginal mucosal irritation in rabbits. No irritation or toxicity in 3-day, 7-day, or 90-day surgical mucosal implantation in rabbits. No delayed dermal sensitization in guinea pigs. No mutagenic changes in Salmonella typhimurium. No positive indicators in cytotoxicity tests (USP elution method, real-time aged 14 months, oven-aged at 70°C for 7 days). Lubricated condom tested for systemic toxicity (Saline & Cottonseed Oil) and vaginal irritation (saline extract) in rabbits, meeting USP requirements.	Extensively tested for various aspects of toxicity and irritation using animal models and in vitro methods.
Material Safety (Non-Allergenicity/Non-Sensitization)	No adverse reactions in latex-sensitive individuals or general population.	In a modified Draize test (200 human subjects), TACTYLON® was non-irritating and non-sensitizing in all subjects. In 20 latex-sensitive individuals (use tests and skin prick tests), TACTYLON® caused no adverse reactions.	Directly addresses concerns for latex-sensitive individuals.
Barrier Efficacy	Substantially equivalent to NRL condoms in preventing passage of viral surrogates.	In vitro challenge with viral surrogate (φ X174) to simulate HIV (AIDS) showed barrier properties substantially equivalent to NRL.	Tested against a viral surrogate, the primary concern for barrier efficacy.
Clinical Performance (Breakage & Slippage Rates)	Clinical breakage and slippage rates similar to predicate NRL condoms.	Clinical breakage rates of High Elongation TACTYLON® condoms were similar to the Standard TACTYLON® condom (which was previously cleared and presumed to be equivalent to NRL).	Clinical trial directly addresses real-world performance for breakage and slippage.
Chemical Stability/Aging	Resistance to conditions that accelerate aging (UV, ozone, oxygen, heat, humidity).	Copolymer has no unsaturated bond, providing resistance to UV radiation, ozone, oxygen, heat, and humidity, which can accelerate aging and adversely affect barrier properties.	An advantage over NRL in terms of potential shelf-life.

Study Information

Sample size used for the test set and the data provenance:
- Modified Draize Test: 200 human subjects.
- Latex-Sensitive Individuals Test: 20 latex-sensitive individuals.
- Clinical Trial for Breakage/Slippage: The document does not specify the exact number of subjects for the lubricated condom trial, but states it was a "large clinical trial" and references a previous study (Trussell J, Warner DL, Hatcher RA: Condom performance during vaginal intercourse: comparison of Trojan-enz and TACTYLON condoms. Contraception 1992;45:11-19) for the non-lubricated version.
- Data Provenance: Not explicitly stated, but clinical trials are typically prospective. References to published papers (e.g., in Contact Dermatitis and Contraception) suggest scientific rigor. Given the FDA submission context, it's implied these studies were conducted to support the device's market clearance. No specific country of origin is mentioned beyond the company's US address.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical studies. For the modified Draize test and latex-sensitive individual tests, the assessment of "non-irritating," "non-sensitizing," and "no adverse reactions" would have been performed by clinical professionals (e.g., dermatologists, allergists, nurses) following standardized protocols. For the clinical performance trial (breakage/slippage), data collection would likely involve patient self-reporting and/or clinical observation, potentially overseen by clinicians. The cited publications would have peer review by experts in the field.
Adjudication method for the test set:
- Not explicitly described. For the Draize and latex-sensitive tests, a single blinded assessment or consensus among clinical observers might have been used, but no specific method like "2+1" or "3+1" is mentioned. For the clinical performance, outcomes like breakage and slippage are generally observable events, and adjudication often involves clear definitions and reporting protocols.
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. This is a medical device (condom) and not an AI/imaging diagnostic tool. Therefore, a MRMC study for AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used:
- Material Safety (Toxicity/Irritation): In vitro assays, animal model histopathology and clinical observation (rabbit, guinea pig), and direct human clinical observation for skin reaction/sensitization.
- Material Safety (Allergenicity/Sensitization): Clinical observation and specific skin tests (e.g., skin prick tests, patch tests) on human subjects.
- Barrier Efficacy: In vitro viral surrogate challenge; this uses a controlled laboratory standard to simulate real-world conditions.
- Clinical Performance (Breakage/Slippage): Real-world clinical use data, likely involving user self-reporting and/or clinical observation during vaginal intercourse.
The sample size for the training set:
- This is not applicable as the device is a physical product, not a machine learning model requiring a "training set." The development process would involve iterative material science and engineering, with testing at various stages, but not in the sense of a machine learning training set.
How the ground truth for the training set was established:
- Not applicable for the same reason as point 7. The "ground truth" for the material's properties and performance would have been established through a combination of established engineering standards, material science testing (e.g., tensile strength, elasticity), chemical analysis, and preliminary biological/clinical tests to refine the formulation and design.

Summary

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LUBRICATED HIGH ELONGATION CONDOM 510(k) SUMMARY

OCT - 7 1997

17 /15 96

1102

This summary of safety and effectiveness is being submitted in accordance with the requirements of the SMDA of 1990.

Substantial Equivalence: (A)

1.	Submitted by:	Sensicon Corporation
	Address:	2595 Commerce WayVista, CA 92083
	Telephone:	(760) 734-6690
	Contact:	Jeff Grant

Natural Rubber Latex products present a risk of anaphylaxis for 2. individuals with Type I immediate hypersensitivity to Natural Rubber Latex (NRL) and can cause less dangerous, but uncomfortable, symptoms in individuals with Type IV delayed hypersensitivity. The synthetic TACTYLON® condom contains neither NRL protein allergens nor sensitizing chemicals. It therefore represents a suitable alternative for latex sensitive individuals. Furthermore, muscle exposure to NRL appears to be one of the primary routes of sensitization for Type I allergies.1
The TACTYLON® condom is made from styrene-ethylene-butylene-3. styrene thermoplastic elastomer block copolymer but has physical properties (e.g., strength, elasticity, and tactility) and dimensions that are substantially equivalent to a NRL condom.
The safety and efficacy of TACTYLON® involves two major issues: the potential (B) allergenicity and toxicity of the material and the efficacy of the material's barrier.
- The TACTYLON® block copolymer is a compound that meets the FDA 1. requirements for Class VI materials, the most stringent category for nontoxicity. The plastisizer used is a USP recognized by the FDA as safe for human consumption. Toxicity is therefore not a relevant safety issue as evidenced by the following studies of the non-lubricated Standard condom. Neither primary skin irritation nor vaginal mucosal irritation was found in a rabbit model. There was no evidence of irritation or toxicity in a 3-day, 7day, or 90-day surgical mucosal implantation study in a rabbit model. Furthermore, no delayed dermal sensitization occurred in a guinea pig model. No mutagenic changes were found in histidine dependent mutant strains of Salmonella typhimurium when exposed to either saline or DMSO

4 American Academy of Allergy & Immunology: Task force on allergic reactions to latex (committee report). J. Allergy Clin Immunol 1993; 92:16-18.

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extracts of TACTYLON®. In addition, there were no positive indicators resulting from a cytotoxicity test, by the USP elution method (MG 057), on samples which had been real-time aged for 14 months. Also, the lubricated condom was tested for cytotoxicity on unaged, as well as aged (oven conditioned), sample at 70°C for seven (7) days with no positive indicators. The lubricated condom was tested for systemic toxicity using Saline and Cottonseed Oil as well as for vaginal irritation in rabbits using saline extract. These tests both meet the USP requirements.

The barrier properties of TACTYLON® are substantially equivalent to NRL as demonstrated by an in vitro challenge with a viral surrogate (φ X174) to simulate the HIV (AIDS) measured by an extremely sensitive assay. As with NRL products, however, petroleum-based lubricants should be avoided. Because the chemical structure of the copolymer has no unsaturated bond, TACTYLON® is resistant to conditions such as ultraviolet radiation, ozone, oxygen, heat and humidity, that can accelerate aging and adversely affect barrier properties.

Clinical trials conducted on the non-lubricated TACTYLON® material 2. indicated it is nontoxic, nonirritating, and nonsensitizing. In the modified Draize test conducted in 200 human subjects, TACTYLON® was nonirritating and nonsensitizing in all 200 subjects. When a group of 20 latex-sensitive individuals was subjected to use tests and skin prick tests, TACTYLON® caused no adverse reactions.2
In a clinical trial of TACTYLON® lubricated condoms, the clinical 3. breakage and slippage rates as well as the subjective perceptions were studied. These trials showed that the clinical breakage of the High Elongation TACTYLON® condoms were similar to the Standard TACTYLON® condom cleared by 510(k) 953582.3
1. The results of both the nonclinical and the clinical studies suggest that TACTYLON® material is nonallergenic, nonirritating, and nontoxic when in contact with either the intact dermis or mucosal tissue for clinically relevant periods. Furthermore, the barrier was as impermeable to a viral surrogate as NRL in nonclinical studies and tolerated the stresses associated with use as well as NRL in a large clinical trial. The copolymer's chemistry confers a distinct advantage over NRL in terms of potential shelf-life.

2Lahti A, Camarasa JG, Ducombs G, et al: Patch tests with TACTYLON in patients with contact allergy to rubber. Contact Dermatitis 1992; 27:188.

3Trussell J, Warner DL, Hatcher RA: Condom performance during vaginal intercourse: comparison of Trojan-enz and TACTYLON condoms. Contraception 1992;45:11-19.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a stylized emblem. The emblem features a symbol that resembles a stylized caduceus or a representation of human figures, with flowing lines suggesting movement or interaction. The overall design is simple and recognizable, representing the department's role in health and human services.

OCT - 7 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jorge Haider Director Regulatory Affairs and Quality Assurance Sensicon Corporation 2595 Commerce Way · Vista, California 92083

Re: K971590

TACTYLON® Condom, Lubricated, High Elongation Dated: August 6, 1997 Received: August 8, 1997 Regulatory class: II 21 CFR §884.5300/Product code: 85 MOL

Dear Mr. Haider:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

W. Liao Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number: Company Name: Device Name:

K971590 Sensicon Corporation Male Condom

Page 1 of 1

Indications For Use:

For Latex Sensitive Condom Users:

This is a TACTYLON® condom. This is not a latex condom.

You may use this TACTYLON ® condom if you or your partner are allergic to latex.

You should know:

. The risks of pregnancy and sexually transmitted diseases (STDs), including AIDS (HIV infection), are not known for this condom. A study is being done.
. There are laboratory tests on this TACTYLON® material. These tests show that organisms even as small as sperm and viruses like HIV cannot pass through it.

Latex condoms for men, if used correctly with every act of vaginal intercourse are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Rathbun
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT,

and Radiological Devices

510(k) Number_K971190

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use $\checkmark$

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.